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Quality Assurance Project Plan for the Federal
PM2 5 Performance Evaluation Program
(PM25-PEP)
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[This page intentionally left blank.]
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EPA-454/B-22-004
May 2022
Quality Assurance Project Plan for the Federal PM2.5 Performance
Evaluation Program (PM2.5-PEP)
U.S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Air Quality Assessment Division
Research Triangle Park, NC
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PM2 5-PEP QAPP (EPA-454/B-22-004)
May 2022
Page 2 of 186
Foreword
U.S. Environmental Protection Agency (EPA) policy requires that all projects involving the
generation, acquisition, and use of environmental data be planned and documented and have an
Agency-approved Quality Assurance Project Plan (QAPP) in place prior to the start of data
collection. The primary purpose of the QAPP is to provide a project overview, describe the need
for the measurements, and define quality assurance/quality control (QA/QC) activities to be
applied to the project, all within a single document.
This document represents the QAPP for the environmental data operations involved in EPA's
PM2.5 Monitoring Network Performance Evaluation Program (PEP). This QAPP adheres to the
following EPA regulations and guidance on monitoring and QA:
¦ 40 Code of Federal Regulations (CFR) Part 50, Appendix L
¦ 40 CFR Part 58, Appendices A and C
¦ EPA QA/R-5, EPA Requirements for Quality Assurance Project Plans
¦ EPA QA/G-5, Guidance for Quality Assurance Project Plans.
This QAPP addresses the pertinent sections of the QAPP regulations and guidance.
EPA Regional PM2.5-PEP Leads responsible for implementing the PM2.5-PEP in their respective
EPA Regions have reviewed this QAPP and have found it acceptable (see the following approval
page).
Any mention in this document of corporation names, trade names, or commercial products does
not constitute EPA's endorsement or recommendation for use.
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PM2.5-PEP QAPP (EPA-454/B-22-004)
May 2022
Page 3 of 186
A. Project Management
AI QA Project Plan Approval
Title: Quality Assurance Project Plan for the Federal PM2.5 Performance Evaluation Program
The attached Quality Assurance Project Plan (QAPP) for the Federal PM2.5 Performance
Evaluation Program (PM2.5-PEP) is hereby recommended for approval and commits the
participants of the program to follow the Sections described within.
OAQPS
Region 2
Region 3
Region 4
Region 5
Region 6
Signature:
Name:
Region 1 Signature:
Dennis Grumpier, OAQPS PM2.5-PEP Lead
UADV I A ME ri 1771 IDC Digitally signed by MARY JANE CUZZUPE
'Vintl I JrtlNL LU££Uni Date: 2022.05.03 14:43:21 -04'Off
Printed Name: Mary Jane Cuzzupe, Region I PM2.5 PEP Lead
Signature: jq.
Printed Name: K30* SupriV8 [)
Digitally signed bv Rao. Supriva
ate: 2022.05.03 15:49:30
¦¥~wro
Signature:
Printed Name:
LQRETTA HYDEN
Digitally signed by LORETTA HYDEN
—Date 2022,05.0? 19:21 ;05 -0<1'00'
Signature: mm
Printed Name:
Signature:
Printed Name:
Digitally signed by SCOTT
Date: 2022.05.04 12:36:06 -05'00'
Signature: CLARENCE.
Printed Name:
Digitally signed by CLARENCE
JACKSON
Region 7 Signature:
Printed Name:
-THtexbRef
Digitally signed by THIEN BUI
Date: 2022.05.04 14:11:14 -05'00'
Date: 04/28/2022
Date: 05/03/2022
Date:
Date:
Digitally signed by KEITH HARRIS Date:
Date:
Date:
Date:
Region 8 Signature:
Digitally signed by JOSHUA
JOSHUA RICKARD TtCTKRD
Printed JName: Date:2022.05.0413:19:22-oew
Date:
Region 9 Signature:
Printed Name
; Bilaiid, Larry
DiqiUlly ti^iwd by BiUnd. l«iny
Date: 2022.05.26 12:28:41 -07'00!
Date:
Region 10 Signature:
Printed Name:
LJ H hi py \A/ A I I AfC Digitally signed by HENRY WALLACE
nCIMR I VVAALLAAV».C~ rwP. 14-4Q-S7 -oroo'
Date:
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PM2 5-PEP QAPP (EPA-454/B-22-004)
May 2022
Page 4 of 186
Acknowledgments
The original version of this QAPP was the product of the combined efforts of EPA's Office of
Air Quality Planning and Standards (OAQPS); the Office of Radiation and Indoor Air (ORIA)
support laboratories in Las Vegas, Nevada; EPA's ORIA National Exposure Research
Laboratory (NERL); EPA Regional offices; and state, local, and tribal (SLT) organizations.
This version of the QAPP is the product of the combined efforts of the EPA's OAQPS and EPA
Regional Offices. The following individuals are acknowledged for their contributions.
EPA Regions
Region:
1
Mary Jane Cuzzupe
2
Supriya Rao
3
Loretta Hyden
4
Keith Harris
5
Scott Hamilton
6
Clarence Jackson
7
Thien Bui
8
Joshua Rickard
9
Larry Biland
10
William Wallace
Battelle Memorial Institute
Brannon Seay, Shannon Hulbert, Robert Lordo, Mitchell Lawrence, Douglas Turner, Ian
MacGregor
Office of Air Quality Planning and Standards
Dennis Crumpler, Greg Noah
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PM2 5-PEP QAPP (EPA-454/B-22-004)
May 2022
Page 5 of 186
Acronyms and Abbreviations
°c
degrees Celsius
AAMG
Ambient Air Monitoring Group
AFC
Agency File Codes
AIRS
Air Innovation Research Site
AMTIC
Ambient Monitoring Technology Information Center
ANSI
American National Standards Institute
APTI
Air Pollution Training Institute
AQS
Air Quality System
ASTM
American Society for Testing and Materials
AWMA
Air and Waste Management Association
CAA
Clean Air Act
CBS A
core-based statistical area
CFR
Code of Federal Regulations
CMD
Contracts Management Division
CO
Contracting Officer
CO
carbon monoxide
COC
chain of custody
COR
Contracting Officer's Representative
CV
coefficient of variation
DC
direct current
DQA
data quality assessment
DQI
data quality indicator
DQO
data quality objective
EDO
environmental data operation
EMP
Enhanced Monitoring Plan
EPA
United States Environmental Protection Agency
ESAT
Environmental Services Assistance Team
FB
field blank
FCS
failed collocated sample
FDS
field data sheet
FEM
Federal Equivalent Method
FFB
failed field blank
FIPS
Federal Information Processing Standards
FIS
failed internal standard
FLB
failed laboratory blank
FOIA
Freedom of Information Act
FRM
Federal Reference Method
FS
field scientist
FTB
failed trip blank
g
grams
GSA
General Services Administration
HEPA
high-efficiency particulate air
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HVAC
heating, ventilation, and air conditioning
ID
identifier
IR
infrared
ISO
International Organization for Standardization
IUPAC
International Union of Pure and Applied Chemistry
LA
laboratory analyst
LIMS
laboratory information management system
LPM
liters per minute
LSASD
Laboratory Services and Applied Science Division (Region 4)
m3
cubic meter(s)
l^g
microgram(s)
[j,g/m3
microgram(s) per cubic meter
mg
milligram(s)
|im
micrometer(s)
MoPED
field data management system for the PM2.5-PEP
MQO
measurement quality objective
MSR
management system review
NAAQS
National Ambient Air Quality Standards
NADG
National Air Data Group
NCore
National Core multi-pollutant monitoring stations
NERL
National Environmental Research Laboratory
NIST
National Institute of Standards and Technology
no2
nitrogen dioxide
NPAP
National Performance Audit Program
NPD
normalized percent difference
NRMRL
National Risk Management Research Laboratory
03
ozone
OAQPS
Office of Air Quality Planning and Standards
OAR
Office of Air and Radiation
OEI
Office of Environmental Information
OMS
Office of Mission Support
ORD
Office of Research and Development
OSHA
Occupational Safety and Health Administration
PAMS
Photochemical Assessment Monitoring Station
Pb
lead
PC
personal computer
PD
percentage difference
PE
performance evaluation
PED
Performance Evaluation Database
PEP
Performance Evaluation Program
PM
particulate matter
PM2.5
particulate matter less than or equal to 2.5 micrometers in diameter
PM10
particulate matter less than or equal to 10 micrometers in diameter
POC
parameter occurrence code
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PM2 5-PEP QAPP (EPA-454/B-22-004)
May 2022
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PQAO
primary quality assurance organization
PTFE
polytetrafluoroethylene (Teflon™)
Qa
sampler flow rate at ambient (actual) conditions of temperature and pressure
QA
quality assurance
QAM
Quality Assurance Manager
QAPP
quality assurance project plan
QC
quality control
R&P
Rupprecht & Patashnick
RH
relative humidity
RPD
relative percent difference
RPO
Regional Project Officer
RTP
Research Triangle Park
SI
self instructional
SIP
State Implementation Plan
SLAMS
State and Local Ambient Monitoring Stations
SLT
state, local, and tribal
S02
sulfur dioxide
SOP
standard operating procedure
SPM
special purpose monitoring
SPMS
special purpose monitoring station
SRM
standard reference material
STAG
State and Tribal Assistance Grant
Ta
temperature, ambient or actual
TB
trip blank
TDF
Technical Direction Form
TOCOR
Task Order Contract Officer Representative
TSA
technical systems audit
UPS
United Parcel Service or uninterrupted power supply
USB
Universal Serial Bus
Va
air volume, at ambient or actual conditions
vscc
very sharp cut cyclone
WACOR
Work Assignment Contract Officer Representative
WINS
well impact or ninety-six
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PM2 5-PEP QAPP (EPA-454/B-22-004)
May 2022
Page 8 of 186
A2 Table of Contents
Page
A. Project Management 3
A1 QA Project Plan Approval 3
A2 Table of Contents 8
A3 Distribution and Document Control 15
A3.1 Standard Operating Procedures 16
A3.1.1 Field SOP Revisions 16
A3.1.2 Laboratory SOP Revisions 18
A4 Project/Task Organization 18
A4.1 PM2.5-PEP Roles and Responsibilities 19
A 4.1.1 OAQPS PM2.5-PEP Lead 19
A4.1.2 Regional PM2.5-PEP Leads 20
A4.1.3 Field Scientists 21
A4.1.4 PM2.5-PEP Weighing Laboratory Task Monitor 21
A4.1.5 PM2.5-PEP Weighing Laboratory Manager 22
A4.1.6 PM2.5-PEP Weighing Laboratory Analysts 22
A4.2 PM2.5-PEP Workgroups 23
A4.2.1 PM2.5-PEP QA Workgroup 23
A4.2.2 Interagency Air Monitoring QA Workgroup 24
A4.3 EPA's Office of Air Quality Planning and Standards (OAQPS) 24
A4.4 EPA Regional Offices 26
A4.4.1 Region 4 LSASD - PM2.5-PEP Gravimetric Weighing Laboratory 26
A4.5 EPA Contracts Supporting the PM2.5-PEP 27
A4.5.1 EPA Headquarters Contracting Officers 27
A4.5.2 EPA Headquarters (OAQPS) Project Officers 27
A4.5.3 EPA Regional Project Officers 28
A4.5.4 EPA Regional PM2.5-PEP Leads Contractor Oversight 28
A4.5.5 PM2.5-PEP Contractors 29
A4.6 State, Local, and Tribal Monitoring Organizations 29
A4.6.1 SLTPM2.5Monitoring Site Managers 30
A4.6.2 PM2.5-PEP Self-Implementing PQAOs 31
A4.6.3 PQAOs 34
A4.7 Other Participating Entities in the PM2.5-PEP 35
A4.7.1 EPA Office of Research and Development 35
A4.7.2 Acquisition Management in EPA's Office of Mission Support 35
A5 Problem Definition/Background 35
A5.1 B ackground 36
A5.2 PM2.5 Monitoring Networks 37
A5.3 Quality Considerations 38
A5.4 PM2.5-PEP Implementation 38
A6 Project/Task Description 40
A6.1 Description of Work to Be Performed 40
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A6.2 Field Activities 41
A6.2.1 PM2.s-PEP Field Equipment 41
A6.2.2 PM2.5-PEP Sampling Events 42
A6.2.3 Critical Field Measurements and Metadata 43
A6.3 Laboratory Activities 43
A6.3.1 Weighing Laboratory Activities 43
A6.4 Timing for PM2.5-PEP Activities 44
A6.4.1 PM2.5-PEP Annual Activities 44
A6.4.2 Ongoing PM2.5-PEP Activities 47
A7 Data Quality Objectives and Criteria for Measurement 48
A7.1 Data Quality Objectives for the PM2.5 Ambient Air Monitoring Program 48
A7.2 Data Quality Indicators and Associated Measurement Quality Objectives 49
A8 Training Requirements and Certifications 56
A8.1 Field Scientist Training 57
A8.1.1 Field Scientist Trainers 57
A8.1.2 Initial Training for New Field Scientists 57
A8.1.3 Annual PM2.5-PEP Field Operations Proficiency Re certification Training 59
A8.2 PM2.5-PEP Weighing Laboratory Analyst Training 60
A8.2.1 Initial Training for New PMzsP'EP Weighing Laboratory Analysts 60
A8.2.2 Laboratory Analyst Practical Training 60
A8.2.3 Laboratory Analyst Attendance at Annual PM2.5-PEP Field Scientist Training Session 61
A8.2.4 Laboratory Analyst Training Demonstration of Proficiency 61
A8.3 Certification of Regional PM2.5-PEP Leads and Field Scientist Trainers 62
A8.4 Additional Ambient Air Monitoring Training 62
A8.5 Training Requirements for Self-Implementing PQAO Staff 63
A9 Documentation and Records 64
A9.1 Information Included in the Reporting Package 64
A9.1.1 Data Reporting Package Format and Document Control 64
A9.1.2 Field and Laboratory Record Notebooks 68
A9.1.3 Electronic Data Collection and Archiving 68
A9.1.4 Hand-Recorded Data 69
A9.1.5 E-mail and Text Messages 70
A9.2 Laboratory Data Format for Uploading to AQS 70
A9.3 Data Archiving and Retrieval 71
B Data Generation and Acquisition 73
B1 Sampling Design 73
B1.1 Scheduled Proj ect Activities, Including Measurement Activities 73
Bl.1.1 Filter Holding Times 73
B1.2 Rationale for the Sampling Design 74
B1.3 Sampling Design Assumptions 74
B1.4 Validation of Non-Standard Measurements 75
B2 Sampling Methods and Requirements 75
B2.1 PM2.5-PEP Sampler 75
B2.2 Sample Event Preparation, Sample Collection, Sample Retrieval, and Sample
Shipment 76
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B2.2.1 Pre-Sampling Event Preparation 76
B2.2.2 Sampling Event Setup 78
B2.2.3 Sampling Event Filter Retrieval, Storage, and Shipping 79
B2.2.4 Return to the Field Office 79
B2.3 Sample Collection and Preservation 79
B2.3.1 Sample Contamination Prevention 80
B2.3.2 Sample Collection Volume and Duration 80
B2.3.3 Filter Temperature Preservation Requirements 80
B2.3.4 Permissible Time Schedule and Holding Times for Field-Related Activities 81
B2.4 Corrective Action for Field Activities 82
B3 Sample Handling and Custody 82
B4 Analytical Methods Requirements 84
B4.1 Analytical Facilities 84
B4.1.1 Laboratory Sample Contamination Prevention 85
B4.1.2 Laboratory Environment Requirements 85
B4.1.3 Filter Storage Environmental Requirements 85
B4.2 Analytical Equipment 86
B4.3 Analytical Process 86
B4.3.1 New Filter Receipt and Inventorying 87
B4.3.2 New Filter Inspection 88
B4.3.3 Filter Weighing Considerations 88
B4.3.4 Filter Lot Stability Testing 88
B4.3.5 Filter Conditioning and Measuring Pre-weights (Tare Weights) 89
B4.3.6 Filter Post-Sampling Conditioning and Weighing 90
B4.3.7 Filter Archiving 90
B4.4 Laboratory Corrective Actions 90
B5 Quality Control Requirements 91
B5.1 Laboratory QC Procedures 92
B5.1.1 Laboratory Instrument Calibrations 92
B5.1.2 Laboratory Quality Control Filter Samples 92
B5.2 Field QC Procedures 93
B5.2.1 Field QC Samples 94
B5.3 Evaluation of Blank Results 95
B5.3.1 Individual Blank Results Evaluation 95
B5.3.2 Aggregated Blank Results Evaluation 96
B5.4 PM2.5-PEP Precision 97
B5.4.1 PM2.5-PEP Regional Collocation Studies 97
B5.4.2 National Collocation Studies 102
B5.5 PM2.5-PEP Sampler Bias 102
B5.6 Control Charts 103
B5.6.1 Control Chart Use and Maintenance 103
B6 Instrument/Equipment Testing, Inspection, and Maintenance Requirements 104
B6.1 Instrument and Equipment Testing 104
B6.1.1 Field Instrumentation/Equipment Testing 104
B6.1.2 Laboratory Instrumentation/Equipment Testing 105
B6.2 Instrument and Equipment Inspection 105
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B6.2.1 Inspection of Field Items 105
B6.2.2 Inspection of Laboratory Items 106
B6.3 Equipment and Instrument Maintenance 107
B6.3.1 Field Equipment Maintenance 107
B6.3.2 Laboratory Equipment Maintenance 108
B7 Instrument Calibration and Frequency 109
B7.1 Laboratory Calibrations and Calibration Verifications 109
B7.1.1 Microbalance Calibration 109
B7.1.2 Environmental Monitoring Instrument Calibrations 113
B7.2 Field Sampler Calibration and Calibration Verification 115
B7.2.1 Field Instrument Calibration 115
B7.2.2 Field Instrument Calibration Verification 117
B8 Inspection/Acceptance for Supplies and Consumables 119
B8.1 Critical Supplies and Consumables 119
B8.1.1 Laboratory Supplies and Equipment 120
B8.1.2 Field Equipment and Supplies 121
B8.2 Acceptance Criteria on Equipment and Consumables 124
B8.3 Tracking and Quality Verification of Supplies and Consumables 125
B9 Acquisition of Non-Direct Measurement Data 129
B9.1 Chemical and Physical Properties Data 129
B9.1.1 Equipment Manufacturers' Literature 129
B9.1.2 Monitoring Site Information 130
B9.1.3 Monitoring Measurement Databases 130
B10 Data Management 131
B10.1 Background and Overview 131
B10.1.1 Information Management Security 134
B10.1.2 Field Data 134
B10.1.3 Laboratory Data 137
B10.2 Data Recording 137
B10.3 Data Validation 138
B10.4 Data Conversions 140
B10.5 Data Transmittal 140
B 10.6 Data Reduction and Data Integrity 141
B10.7 DataAnalysis 142
B10.8 Data Flagging—Sample Qualifiers 144
B10.9 Data Tracking 144
B10.10 Data Storage and Retrieval 146
C Assessment and Oversight 148
CI Assessments and Response Actions 148
Cl.l Assessment Activities and Project Planning 148
CI. 1.1 Management Systems Review 148
CI. 1.2 Data Quality Assessments 149
CI.1.3 Audits of Data Quality 149
CI.1.4 Technical Systems Audit 150
CI.1.5 Surveillance 155
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CI. 1.6 Laboratory Performance Evaluation Audit and Round Robin Study 156
CI. 1.7 Field Performance Audits 157
CI.2 Documentation of Assessments and Corrective Action 157
C2 Communication Framework and Reports to Management 158
C2.1 Communication 159
C2.1.1 Field Communication 161
C2.1.2 Laboratory Communications 163
C2.2 Reports 164
C2.2.1 Progress Reports 164
C2.2.2 QA Reports 165
C2.2.3 Response/Corrective Action Reports 167
C2.2.4 Assessment Reports 168
D Data Validation and Usability 169
D1 Data Review, Verification, and Validation Requirements 169
D1.1 Sample Data Collection Activities and Associated Controls 169
D1.2 Workflow of Data Verification and Validation Activities 170
D2 Verification and Validation Methods 174
D2.1 Process for Validating and Verifying Data 175
D2.2 Validation Considering Sample Filter Batching 183
D2.3 Validation Acceptance and Reporting 184
D3 Reconciliation with User Requirements 184
D3.1 Data Reporting 184
D3.2 Data Pairing 184
1)3.2.1 Routine PM2.5 Monitoring Network Data Verification and AQS Reporting 185
References 186
List of Appendices
Appendix A. Glossary
Appendix B. Data Qualifiers/Flags
Appendix C. Validation Template used by the PED in the first level Validation Algorithm
Appendix D. Revision History
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List of Tables
Page
Table A7-1. MQOs and Acceptance Criteria for PM2.5-PEP Field Activities 53
Table A7-2. MQOs and Acceptance Criteria for PM2.5-PEP Laboratory Activities 55
Table A8-1. Training Events for Maintaining Qualification as a PM2.5-PEP Lead and Trainer
62
Table A8-2. Supplemental Training Courses in Ambient Air Monitoring and QA 63
Table A9-1. Critical Documents and Records in the PM2.5-PEP 65
Table A9-2. PM2.5-PEP Reporting Package Information 66
Table A9-3. PM2.5-PEP Weighing Laboratory Data Description for AQS Upload via Browser-
based Tool 71
Table A9-4. Archive Policies for Filters, Data, and Records within the PM2.5-PEP 72
Table B1-1. Milestones from PM2.5-PEP Sample Retrieval to Availability in AQS 73
Table B2-1. PM2.5-PEP FRM Sampler Performance Specifications 76
Table B2-2. Permissible Field-Related Holding Times 81
Table B4-1. Performance Specifications for the PM2.5-PEP Weighing Laboratory 84
Table B4-2. PM2.5-PEP Filter Media Specifications 87
Table B5-1. Control Charts of QC Data for the PM2.5-PEP 103
Table B6-1. Routine QC Inspections of PM2.5-PEP Field Items 106
Table B6-2. Routine PM2.5-PEP Weighing Laboratory Equipment Inspections 107
Table B6-3. Field Maintenance for the PM2.5-PEP 107
Table B6-4. PM2.5-PEP Weighing Laboratory Maintenance Activities 108
Table B7-1. Microbalance Calibration Requirements for the PM2.5-PEP 110
Table B7-2. Environmental Temperature and Relative Humidity Probe Calibration
Requirements 114
Table B7-3. Sampler Temperature, Barometric Pressure, and Flow Rate Calibration
Evaluation Requirements 117
Table B7-4. Certification Requirements and Acceptance Criteria for Field Transfer Standards
117
Table B8-1. Weighing Laboratory Equipment and Supplies 120
Table B8-2. Field Equipment and Supplies 122
Table B10-1. PM2.5-PEP Data Collection Sources 131
Table B10-2. PM2.5-PEP Field Sampler Measurement Recording Requirements 135
Table B10-3. List of PM2.5-PEP data forms for critical data capture 138
Table B10-4. Validation check summaries used in the PM2.5-PEP 140
Table B10-5. Raw data calculations in the PM2.5-PEP 140
Table B10-6. Data Transfer Operations 141
Table B10-7. PM2.5-PEP Data Summary Equations 143
Table Cl-1. Field Sampler Performance Audits 157
Table Cl-2. Summary of Assessments 158
Table C2-1. Communication Pathways in the PM2.5-PEP 160
Table C2-2. Report Summary 164
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Table D2-1. Validation Template Indicating Critical Criteria 176
Table D2-2. Validation Template Indicating Operational Criteria 180
Table D2-3. Sample Batch Validation Template 183
Table D3-1. Due dates for PQAOs to Report Routine PM2.5 Data to AQS 185
List of Figures
Figure A3-1. Example PM2.5-PEP Quality Bulletin 17
Figure A4-1. Organizational Chart Indicating Technical and Contractual Relationships of the
PM2.5-PEP 19
Figure A4-2. Required Management Structure for Self-Implementing PQAOs 33
Figure Bl-1. Filter Holding Times 74
Figure B3-1. Example PM2.5-PEP Chain of Custody Form 83
Figure B5-1. PM2.5-PEP Noteworthy Quality Control Samples and Activities 91
Figure B8-1. Field/Laboratory Procurement Log Form (PRO-01) 126
Figure B8-2. Field/Laboratory Inventory Form (INV-01) 127
Figure B8-3. Field/Laboratory Equipment/Consumable Receiving Report Form (REC-01). 128
Figure B10-1. Overview of the PM2.5-PEP information management system under the PED
(left) and MoPED/LIMS paradigms (right; when available) 133
Figure B10-2. Information exchange routes between the PED and AQS (top) and the LIMS and
MoPED (bottom; when available) 147
Figure Cl-1. Overview of Technical Systems Audit Activities 151
Figure Cl-2. Example Assessment Finding Form 152
Figure CI-3. Assessment Finding Response Form 154
Figure Cl-4. Field or Lab Operations Surveillance Report Form 155
Figure C2-1. PM2.5-PEP Lines of Communication 159
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A3 Distribution and Document Control
The U.S. Environmental Protection Agency (EPA) is responsible for posting the current and
fully approved version of the PM2.5-Performance Evaluation Program (PEP) Quality Assurance
Project Plan (QAPP) on EPA's Ambient Monitoring Technology Information Center (AMTIC)
website1. This QAPP is accessible by the public via the AMTIC website. The QAPP posted on
AMTIC is under version control within its quality system for ambient air monitoring networks
and represents EPA's official QAPP document for the program. Downloaded or printed versions
of this document and circulated versions labeled DRAFT are considered working copies that
EPA does not control within its quality system.
The Office of Air Quality Planning and Standards (OAQPS) PM2.5-PEP Lead maintains a PM2.5-
PEP Contact List of Regional Leads and primary quality assurance organization (PQAO)
coordinators, consisting of Regional PM2.5-PEP Leads and points of contact for self-
implementing PQAOs of the PM2.5-PEP. The OAQPS PM2.5-PEP Lead (or designee) will notify
individuals on this list (via e-mail or through a Monitoring List Server Notice) when EPA
publishes this QAPP or any fully approved revision, attachment, or addendum to the AMTIC
website. As appropriate, this e-mail notification will also direct to destroy hardcopy or electronic
copies of prior versions of this QAPP which are superseded by the newly posted documents.
OAQPS will retain an archived electronic copy of the previously signed version for historical
reference.
As necessary, EPA will update the PM2.5-PEP Contact List when assigned personnel to the
specified PM2.5-PEP roles change. The OAQPS PM2.5-PEP Lead may also use the list of contacts
to circulate updated versions of this QAPP that are at some level of revision and thus considered
to be working drafts - such versions will clearly be labeled as working drafts. Changes other
than editorial or correction of typographical errors will require a consensus of all EPA Regional
PM2.5-PEP Leads and participating self-implementing PQAO PM2.5-PEP coordinators. Appendix
D (Revision History) includes a brief summary of the major changes made between approved
versions of this QAPP. The pages of the specific changes will be given a new date, on which the
change becomes effective. The OAQPS PM2.5-PEP Lead or any EPA Regional Lead can call for
a full, interim review and approval (signatures from each EPA Regional Lead) of the QAPP.
Otherwise, the QAPP will undergo full review beginning 4 years and 3 months after the date of
the official signed version, with the objective of publishing a newly signed QAPP at least every 5
years.
Regional PM2.5-PEP Leads and self-implementing PQAO PM2.5-PEP coordinators, their
Regional Quality Assurance Managers (QAMs), and the PQAOs within their respective EPA
Regions are responsible for ensuring that all staff and contractors participating in the PM2.5-
1 The AMTIC's main website is accessible at https://www.epa.gov/amtic. The PM2 5-PEP QAPP is accessible by
clicking on the following three links in this order: "Understand quality assurance procedures" (on the AMTIC's
main website), then "Pollutant/Network specific QA," then "PM2 5 Performance Evaluation Program" under the
National Performance Evaluation Program title.
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PEP's environmental data operations are aware of how to access this approved QAPP (and any
fully-approved revision, attachment, or addendum).
A3.1 Standard Operating Procedures
The Field and Laboratory SOPs for the PM2.5-PEP are maintained with the OAQPS PM2.5-PEP
Lead and distributed to the individuals responsible for overseeing and accomplishing the
described tasks. The SOPs are reviewed annually to ensure they are current and adequate and are
subject to revision 5 years from the approval date. Revisions to the SOPs can be requested by
individuals responsible for overseeing or accomplishing PM2.5-PEP activities according to
Sections A3.1.1 and A3.1.2.
A3.1.1 Field SOP Revisions
The field scientists (FSs) are responsible for reviewing and implementing the field activities
prescribed in this QAPP and the PM2.5-PEP field standard operating procedure (SOP) and are
therefore responsible for the quality of field data collected. If a FS recommends a change or
correction to this QAPP or field SOP, they will notify the Regional PM2.5-PEP Lead in writing.
The Regional PM2.5-PEP Lead will then convey the issue to the OAQPS PM2.5-PEP Lead and the
PM2.5-PEP Quality Assurance (QA) Workgroup, which will review the recommendation and
assign it to one of the following classes according to its impact on the data quality:
¦ Class 1 - The change would significantly improve data quality and would lead to a new
procedure that would replace the current procedure. If the PM2.5-PEP QA Workgroup
finds this change to be acceptable, the OAQPS PM2.5-PEP Lead would issue an SOP
revision. The document control information in the SOP heading would be revised to
contain a new revision number and date. A Quality Bulletin (Figure A3-1) would be
completed to describe the change, which OAQPS would distribute to all Regional PM2.5-
PEP Leads and FSs.
¦ Class 2 - The change would yield an alternate method that would not significantly
improve data quality but may provide for efficiencies in some circumstances or be more
cost effective. If the PM2.5-PEP QA Workgroup finds this change to be acceptable, the
original SOP would not be altered, but the OAQPS PM2.5-PEP Lead would initiate an
addendum to the procedure that describes the modification and provides an alternate
method. A Quality Bulletin (Figure A3-1) would be completed to describe the change,
which OAQPS would distribute to all Regional PM2.5-PEP Leads and FSs.
¦ Class 3 - The change would be purely grammatical or typographical (e.g., a clarification)
in nature and would not require any procedure change. The changes would be highlighted
and modified in a future Class 1 change (where appropriate) or would be corrected in a
future full SOP revision.
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Quality Bulletin
Subject:
Number
Date
Page of_
Supersedes No.
Dated
Replace and Discard Original
Add Material to Document
Notes:
PM2.5 QA Coordinator
Retain this bulletin until further notice ~
Discard this bulletin after noting contents ~
This bulletin will be invalid after (Date) ~
This bulletin will be incorporated into quality
Procedure No. by (Date) ~
Figure A3-1. Example PM2.5-PEP Quality Bulletin
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A3.1.2 Laboratory SOP Revisions
The laboratory analyst (LA) reviews and implements laboratory methods documented in this
QAPP and the laboratory SOP. If the LA recommends any change or correction to the methods
or QAPP, the LA notifies the PM2.5-PEP weighing laboratory manager in writing. The laboratory
manager will then convey the issue to the OAQPS PM2.5-PEP Lead and the PM2.5-PEP QA
Workgroup, which will review the recommendation and attempt to classify it into one of the
three class categories noted in Section B3.1.1.
A4 Project/Task Organization
This section prescribes the various roles of participants contributing to the PM2.5-PEP. It also
provides the lines of authority and reporting within the PM2.5-PEP.
The objectives of the PM2.5-PEP can only be achieved when all participating organizations
recognize that network deployment and operation are a shared responsibility. Thus, all must do
their part to ensure the program's success. The degree of complexity and the number of
contributing organizations associated with the EPA's particulate matter (PM) ambient air
monitoring network and the PM2.5-PEP require that the flow of information and associated
communications be structured to optimize the collective resources.
The role descriptions presented in this section aim to facilitate communications and to outline
basic responsibilities. This QAPP uses the generic term2 Field Scientist (FS) to represent an
individual conducting PM2.5-PEP sampling events and other field activities including:
¦ EPA contractor staff (reporting to Regional PM2.5-PEP Leads),
¦ EPA Regional staff, and
¦ Independent field staff reporting to PQAOs self-implementing the PM2.5-PEP.
Figure A4-1 provides the PM2.5-PEP's basic organization structure. The subsections that follow
summarize the roles and responsibilities of each component within the PM2.5-PEP.
2 Appendix B (Glossary) of this QAPP contains definitions of terms commonly used in the PM2 5-PEP.
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—~ Technical relationship
Contractual/funding relationship
Figure A4-1. Organizational Chart Indicating Technical and Contractual Relationships of
the PM2.5-PEP
A4.1 PM2.5-PEP Roles and Responsibilities
The following are critical roles in the planning and execution of the PM2.5-PEP. Note that the
responsibilities listed below relate to the basic functioning of the PM2.5-PEP and there may be
additional responsibilities required such as those listed in subsequent sections (A4.2 through
A4.7), such as for oversight or execution of contracts, data verification and validation, and
supporting PM2.5-PEP logistical aspects.
A4.1.1 OAQPS PM2s-PEP Lead
The OAQPS PM2.5-PEP Lead has the overall authority for planning and execution of the PM2.5-
PEP. In general, the OAQPS PM2.5-PEP Lead has the following responsibilities:
¦ Development and maintenance of the PM2.5-PEP quality system, comprising the
implementation plan, this QAPP, and the field and laboratory SOPs;
¦ Oversight of the PM2.5-PEP for coordinating and managing training events, corrective
actions, process improvements, and programmatic changes;
¦ Coordinating and training Regional PM2.5-PEP Leads;
¦ Approving with Regional PEP Leads any PQAOs that self-implement the PM2.5-PEP;
¦ In concert with the EPA Headquarters Project Officer and EPA Contracts Office,
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defining task order/work assignment/work order scope and details, and evaluating
contractor proposals, and providing direction to the National QA Contractor;
¦ Evaluating PM2.5-PEP performance annually against the data quality objectives (DQOs)
and measurement quality objectives (MQOs);
¦ Seeking and considering input and feedback in PM2.5-PEP performance, issues, and
improvements;
¦ Arranging funding for the PM2.5-PEP including allocations for the EPA Regions and self-
implementing PQAOs; and
¦ Scheduling and facilitating annual field scientist and laboratory analyst training events
and collocated sampler precision events.
A4.1.2 Regional PM2. s-PEP Leads
A Regional PM2.5-PEP Lead is assigned in each to oversee the PM2.5-PEP planning and
execution in each of the 10 EPA Regions. Section A4.4 lists additional responsibilities of the
Regional PM2.5-PEP Lead that pertain to management and oversight of PM2.5-PEP contractors.
The Regional PM2.5-PEP Lead has the following responsibilities:
¦ Overseeing self-implementing PQAOs in their Region;
¦ Serving as a technical resource and assisting in the PIVh.s-PEP's technical
implementation;
¦ Maintaining annual certification with OAQPS on the roles and responsibilities of an EPA
Regional PM2.5-PEP Lead;
¦ Staying up-to-date on current technical issues and changes in PM2.5-PEP sampling
equipment, procedures, and QA aspects;
¦ Attending conference calls and meetings on PM2.5-PEP sampling event activities;
¦ Assisting in the development, review, and revision of PM2.5-PEP quality system guidance
documents (e.g., this PM2.5 PEP QAPP and supporting SOPs);
¦ Participating in training activities, including national and regional conferences, web-
based seminars (webinars), conference calls, and other training events;
¦ Assisting in refresher training and certification of PM2.5-PEP field personnel (EPA
Regional staff, contractors, and/or staff of self-implementing PQAOs) after initial
training (in coordination with OAQPS);
¦ Providing technical oversight of the PM2.5-PEP field activities through conducting
technical systems audits (TSAs) of contractors and self-implementing PQAO partners;
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¦ Coordinating each year with state, local, and tribal (SLT) monitoring organizations to
develop the annual schedule of PM2.5-PEP sampling events and providing this schedule to
FSs;
¦ Annually confirming the upcoming PM2.5-PEP sampling event schedule with each PM2.5
monitoring organization in the Region;
¦ Reviewing validation data and determining whether PM2.5-PEP sampling events provided
valid data (accepting or rejecting the outcome);
¦ Co-approving and overseeing self-implementing PQAOs within their Region; and
¦ Evaluating PM2.5-PEP results and informing monitoring organizations of:
• Significant differences between individual PM2.5-PEP and SLT-measured routine
sample concentrations.
• Significant trends in bias that are beyond the target DQOs.
A4.1.3 Field Scientists
FSs are the individuals executing the field sampling component of the PM2.5-PEP and have the
following responsibilities:
¦ Training initially and periodically on field operations and pertinent aspects of laboratory
operations for the PM2.5-PEP;
¦ Calibrating, verifying calibration, and operating FRM PM2.5-PEP samplers within their
Region;
¦ Communicating their sampling schedule and changes to the schedule as well as issues or
problems with conducting PM2.5-PEP sampling events to their Regional PM2.5-PEP Lead
and self-implementing PQAO PM2.5-PEP Coordinator;
¦ Complying with the PM2.5-PEP requirements as detailed in the quality system documents;
¦ Documenting actions and measurements and maintaining records required to reconstruct
PM2.5-PEP activities;
¦ Maintaining equipment in appropriate operational and calibration condition to
successfully conduct PM2.5-PEP sampling events; and
¦ Communicating with the PM2.5-PEP gravimetric weighing laboratory when tared filters
are needed and when collected PM2.5-PEP sample deliveries are scheduled.
A4.1.4 PM2.5-PEP Weighing Laboratory Task Monitor
The EPA Region 4 Laboratory Services and Applied Science Division (LSASD) will assign a
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Task Monitor for the PM2.5-PEP Weighing Laboratory with the following responsibilities:
¦ Managing the PM2.5-PEP Weighing Laboratory Support Contractor;
¦ Reviewing and approving validated PM2.5-PEP data for submission to Regional PM2.5-
PEP Leads and self-implementing PQAO PM2.5-PEP Coordinators; and
¦ Seeking input from PM2.5-PEP Leads when reviewing and validating PM2.5-PEP data and
notifying PM2.5-PEP Leads when data are validated and suitable for reporting to AQS.
A4.1.5 PM2.5-PEP Weighing Laboratory Manager
The PM2.5-PEP Weighing Laboratory Manager has the following responsibilities:
¦ Oversight of the PM2.5-PEP weighing laboratory and weighing laboratory analysts;
¦ Assigning a primary and back-up weighing laboratory analyst;
¦ Communication of issues or problems with the PM2.5-PEP Weighing Laboratory Task
Monitor, EPA Region 4 PM2.5-PEP Regional Lead, and OAQPS PM2.5-PEP Lead; and
¦ Conducting first level review and validation of PM2.5-PEP data and contacting Regional
PM2.5-PEP Leads and FSs to clarify discrepancies and correct documentation errors to
troubleshoot data results that are subject to invalidation.
A4.1.6 PM2.5-PEP Weighing Laboratory Analysts
The weighing laboratory analyst plays a critical role in the PM2.5-PEP and has the following
responsibilities:
¦ Completing initial and ongoing laboratory analyst training;
¦ Compliance with the PM2.5-PEP requirements as detailed in the quality system
documents;
¦ Receiving, inventorying, and inspecting new filters;
¦ Conditioning new filters for measuring tare weights;
¦ Coordinating tare filter shipments to FSs;
¦ Receiving completed PM2.5-PEP sampling event shipments, storing sampled filters,
conditioning the sampled filters, and measuring post-sampling filter weights;
¦ Verifying calibration and proper operation of the laboratory analytical balance(s);
¦ Recording dispatched tared filter shipments and received sampled filter shipments;
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¦ Ensuring the environmental conditions of the weighing laboratory remain in the required
ranges and taking corrective actions when excursions occur; and
¦ Scheduling maintenance of the weighing laboratory heating, ventilation, and air
conditioning (HVAC) systems.
Note: PM2.5-PEP weighing activities occur at the EPA Region 4 LSASD weighing
laboratory. Self-implementing PQAOs have the option to utilize a third-party weighing
laboratory; however, such requires approval of the OAQPS PM2.5-PEP Lead. Should
third-party laboratories be approved, this QAPP will be amended to include the
responsibilities of the respective laboratory manager and laboratory analysts.
A4.2 PM2.5-PEP Workgroups
Staff in OAQPS' Ambient Air Monitoring Group (AAMG) chair and facilitate a series of
workgroups that provide technical advice to OAQPS and otherwise support the successful
implementation of QA monitoring and assessment procedures within the nation's ambient air
monitoring networks. The PM2.5-PEP QA Workgroup and Interagency Air Monitoring QA
Workgroup are specific to supporting implementation of the PM2.5-PEP.
A4.2.1 PM2.s-PEP QA Workgroup
The PM2.5-PEP QA Workgroup consists of the following members:
¦ OAQPS PM2.5-PEP Lead (Workgroup Chair);
¦ EPA Regional PM2.5-PEP Leads;
¦ Representatives of PQAOs which self-implement the PM2.5-PEP; and
¦ Other Federal or SLT staff who oversee and execute the field or laboratory operations of
the PM2.5-PEP either at the national level or within their respective jurisdictions.
The QA Workgroup aims to meet at least twice per year, or otherwise at the discretion of the
Workgroup Chair (typically via conference call). Participants serve as advisors to OAQPS and
the Regional Leads.
The QA Workgroup assists in the review and revision of PM2.5-PEP guidance and procedure
documents, including this PM2.5-PEP QAPP and the PM2.5-PEP field and laboratory SOPs.
OAQPS staff will arrange to make draft documents available to the QA Workgroup for peer
review and will announce each document's availability for review. The QA Workgroup focuses
reviews on issues that are national in scope or on PM2.5-PEP document revisions that may have
national implications.
The EPA PM2.5-PEP and self-implementing PQAO PM2.5-PEP field personnel are invited to
attend one or two meetings each year to provide operational feedback on the technical
implementation of field and laboratory procedures.
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As noted in Section B2, PM2.5-PEP FSs must comply with quality control (QC) and QA practices
and measurements prescribed in this QAPP as they prepare for and conduct PM2.5-PEP sampling
events. EPA Regional contractors are encouraged to notify OAQPS and Regional Leads of any
proposed changes or corrections that would benefit the program.
A4.2.2 Interagency Air Monitoring QA Workgroup
A broader workgroup convenes on occasion, as directed by the OAQPS AAMG QA Team, to
review and revise QA documents that are of national scope or importance. This QAPP will be
circulated to that group for comment; however, it will not affect the approval schedule of the
revision initiated by OAQPS. Subsequent QAPP reviews requested by any Region(s) may
involve a review by this workgroup if such participation is included in the initiating Region's
request. The list of individuals for this workgroup is maintained within EPA OAQPS.
A4.3 EPA's Office of Air Quality Planning and Standards (OAQPS)
Organized within the EPA's Office of Air and Radiation (OAR), OAQPS has the overall
responsibility for ensuring that data collected in the nation's ambient air monitoring networks
meet all established quality standards. EPA has documented specific regulations for the
development of a quality system for its ambient air monitoring networks within 40 Code of
Federal Regulations (CFR) Part 58, Appendix A.
While SLT monitoring agencies are responsible for implementing monitoring for the PM2.5
network, EPA has developed and implemented a federal PM2.5-PEP to conduct sampling events
independent from activities performed within the PM2.5 ambient air monitoring network. OAQPS
oversees activities of the Federal Independent PM2.5-PEP.
OAQPS is ultimately responsible for this QAPP, technical components (with support from the
EPA Regional Offices and monitoring organizations), and the resource estimates underlying
PM2.5-PEP implementation. OAQPS has the following responsibilities for PM2.5-PEP and staff
within OAQPS' AAMG are tasked with these responsibilities, unless directed otherwise.
¦ Developing the national level PM2.5-PEP budget for allocating the appropriate State and
Tribal Assistance Grant (STAG) funds to implement the federal PM2.5-PEP program in
each Region and self-implementing PQAO;
¦ Allocating the funding for the purchase and distribution of PM2.5-PEP portable Federal
Reference Method (FRM) samplers;
¦ Working with the Regions to determine which monitoring organizations will utilize the
federally implemented PM2.5-PEP and to determine how many PM2.5-PEP sampling
events are required per PQAO;
¦ Transferring the necessary funds to the EPA Regional Contracts Management Divisions
(CMDs) to support the PM2.5-PEP and to EPA Region 4 LSASD in Athens, Georgia for
gravimetric analyses, laboratory equipment, and consumables;
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¦ Providing filters to the PM2.5-PEP weighing laboratory to tare (pre-sample weighing) and
distribute to the Regional field offices;
¦ Preparing and updating documents such as the PM2.5-PEP Implementation Plan, the
PM2.5-PEP QAPP, scope statements for PM2.5-PEP contractors, and the PM2.5-PEP Field
SOP, and collaborating on the laboratory SOP;
¦ Developing or revising field and laboratory personnel requirements;
¦ Developing field training activities, participating in training, and providing technical
support and guidance to Regional PM2.5-PEP contacts;
¦ Maintaining a list of all PQAOs operating PM2.5 monitoring sites used for determining
National Ambient Air Quality Standards (NAAQS) attainment;
¦ Developing field information management systems;
¦ Maintaining the EPA's Air Quality System (AQS) data management system through the
OAQPS National Air Data Group (NADG);
¦ Assessing the PM2.5-PEP concentration information and completeness data in AQS and
taking action to address shortcomings or problems identified during the data review;
¦ Initiating and implementing a communications network (typically via the PM2.5-PEP QA
Workgroup) and acting as a liaison to EPA Regional Offices and PQAOs who implement
the PM2.5-PEP;
¦ Interacting with monitoring organizations concerning the implementation and data results
of PM2.5-PEP sampling events;
¦ Ensuring the success of the program by performing various oversight activities such as
management system reviews (MSRs) and/or TSAs of EPA Regional and participating
PQAO field operations and the supporting PM2.5-PEP gravimetric analysis (weighing)
laboratory;
¦ Arranging to document comments and responses pertaining to PM2.5-PEP reports,
scientific publications, and presentations as part of the peer review process of the Air
Monitoring QA Workgroup; and
¦ (Future responsibility) Maintaining the laboratory information management system
(LIMS), PM2.5-PEP field data storage application (jointly with the PM2.5-PEP weighing
laboratory), and the MoPED field data system software. [These capabilities were under
development at the time of this document's release.]
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A4.4 EPA Regional Offices
The EPA Regional Offices serve as the major communication link between the PM2.5 network
monitoring organizations and OAQPS within the PM2.5-PEP. This role is critical to the
implementation of the program. Each Regional office assigns a PM2.5-PEP Lead from its air
monitoring branch/division to oversee the technical aspects of its PM2.5-PEP field activities. The
responsibilities of the Regional PM2.5-PEP Lead are described in Sections A4.1.2 and A.4.5.4.
A4.4.1 Region 4 LSASD - PM2.5-PEP Gravimetric Weighing Laboratory
The Region 4 LSASD hosts and maintains the PM2.5-PEP weighing laboratory and has the
following responsibilities within the PM2.5-PEP:
¦ Assigning a task monitor to oversee the technical aspects of the laboratory and the
Federal contractor responsible for managing the PM2.5-PEP weighing laboratory;
¦ Assigning a Laboratory Manager to oversee the technical aspects of activities performed
by LAs;
¦ Developing and maintaining (with OAQPS) an approved laboratory SOP and periodically
reviewing and updating the SOP as needed;
¦ Selecting (with OAQPS) the parameters subject to QC check and internal audits;
establishing the procedures for assessing the parameters and establishing acceptance
limits of QA/QC checks and audit results;
¦ Serving as the primary analysis laboratory for the PM2.5-PEP with respect to logistical,
technical, and analytical support personnel, which includes the necessary facilities to
store, condition, weigh, distribute, and archive filters;
¦ Distributing tared filters, which are packaged in coolers with freezer bricks (ice
substitutes), and other supplies, to Regional field offices;
¦ Training and certifying LAs;
¦ Providing technical oversight of laboratory activities by performing ongoing assessment
of the laboratory's QA/QC data;
¦ Reviewing, correcting, and validating gravimetric laboratory data and field sampling data
prior to upload to AQS; and
Coordinating capital costs, labor, direct costs, and overhead with the National PM2.5-PEP
Lead to secure appropriate funding.
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A4.5 EPA Contracts Supporting the PM2.5-PEP
The contracts supporting the implementation and execution of the PM2.5-PEP are awarded at the
Regional level-'. Therefore, EPA Contracting Officers (COs), Regional PM2.5-PEP Leads, and
Regional Project Officers (RPOs) manage the contractors who support the PM2.5-PEP. The EPA
COs may be assigned to more than one Region. As the PM2.5-PEP continues to mature, EPA may
also utilize alternative contract vehicles such as General Services Administration (GSA)
contracts.
Some important aspects of EPA contracts used to support the PM2.5-PEP include the following:
¦ Only the Regional PM2.5-PEP Lead and the RPOs and COs of the contracts are authorized
to provide a PM2.5-PEP contractor with technical direction or clarification on work to be
performed. Direction or clarification must be provided in writing.
¦ The Regional PM2.5-PEP Leads and RPOs work together to prepare PM2.5-PEP work
assignments, task orders, and/or delivery orders to be placed on a contract. These
instruments are effective only upon CO approval.
The EPA document An Acquisition Guide for Executives4 describes the roles and responsibilities
of COs, RPOs, and other key individuals involved in Government acquisition of goods and
services; these need not be explained here. The important roles and responsibilities of individuals
involved in contracting to support the PM2.5-PEP are as follows:
A4.5.1 EPA Headquarters Contracting Officers
Responsibilities of COs supporting EPA Headquarters are as follows:
¦ Working with OAQPS staff to define, secure, obligate, commit, and approve application
of funds for work to be performed under contract;
¦ Ensuring that a contractor's work activities supporting the PM2.5-PEP fall within the
scope of the contract supporting OAQPS or a given EPA Regional program; and
¦ Approving work assignments, task orders, and delivery orders placed on contract for
which they are responsible.
A4.5.2 EPA Headquarters (OAQPS) Project Officers
Responsibilities of EPA Headquarters Project Officers are as follows:
3 Historically, EPA has used its Environmental Services Assistance Team (ESAT) contract vehicles to provide the
PM2.5-PEP with necessary services and resources. However, EPA no longer utilizes centralized ESAT contracts and
individual contracts are now fully administered within each Region.
4 Available at https://19ianuarv2017snapshot.epa.gov/contracts/acauisition-guide-executives .html. A PDF version
is on the AirQA website at https://ha.battelle.org/airqa/LinkClick.aspx?fileticket=zu 10ASG4adc%3d&portalid=0.
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¦ Serving as a liaison between the OAQPS QA Support Contractor, the OAQPS Program
Leads (who are qualified Work Assignment Contract Officer Representatives [WACOR]
or Task Order Contract Officer Representatives [TOCOR]), and the EPA CO;
¦ Serving as liaison between the contractor and CO;
¦ Providing contract-wide administration: Reviewing work assignments, task orders and
funding documents, and associated forms and forwarding them to the CO; and
¦ Working with the OAQPS Program Lead to submit specific forms and documentation for
unique tasks and activities under the contract, task order, or work assignment (e.g.,
paperwork for EPA-owned equipment transferred to the contractor-managed government
property list).
A4.5.3 EPA Regional Project Officers
Responsibilities for EPA Regional Project Officers are as follows:
¦ Preparing (with Regional PM2.5-PEP Leads) work assignments, task orders, and delivery
orders on the contract used for PM2.5-PEP support in their respective Region;
¦ Reviewing and approving work plans and/or proposals which PM2.5-PEP contractors
prepare and submit;
¦ Providing contract administration support to these contracts;
¦ Providing overall management and coordinating performance oversight of their PM2.5-
PEP contractors with the Regional PM2.5-PEP Leads;
¦ Reviewing the invoices of these contractors with input from Regional PM2.5-PEP Leads;
¦ Ensuring that their supporting contractors are qualified to perform their assigned duties
on the PM2.5-PEP; and
¦ Regularly communicating with program participants (OAQPS, other Regions, etc.).
A4.5.4 EPA Regional PM2.5-PEPLeads Contractor Oversight
The following are EPA Regional PM2.5-PEP Lead responsibilities related to oversight of
contractors (note these are in addition to technical responsibilities):
¦ Reviewing Regional PM2.5-PEP contractor proposals and/or work plans and preparing
findings on proposed tasks, labor hours, skill mix, and materials and quantities;
¦ Working with the RPO to prepare work assignments, task orders, and/or delivery orders
for their PM2.5-PEP contractors;
¦ Communicating with the OAQPS PM2.5-PEP Lead to determine PM2.5-PEP funding;
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¦ Monitoring contractor compliance with requirements stated in work assignments, task
orders, and/or delivery orders;
¦ Reviewing and verifying contractor deliverables received and accepted, and/or progress
made;
¦ Tracking costs and labor hours, providing technical direction (in accordance with the
terms of the contract), and reviewing and approving monthly technical and financial
reports/invoices;
¦ Communicating with the RPO and the OAQPS PM2.5-PEP Lead on contractor
performance, budgetary, and administrative/logistical issues (at least annually);
¦ Establishing a file system containing all relevant documentation, including notes of
conversations with contractors and other items that provide an audit trail of the
contractor's actions and PM2.5-PEP technical information; and
¦ Conducting performance assessments of (1) supporting contractors on PM2.5-PEP field
activities and (2) any self-implementing PQAOs within the Region's jurisdiction at least
annually and ensuring necessary corrective action is taken.
A4.5.5 PM2.5-PEP Contractors
¦ Understanding government regulations as they pertain to contracts and inherent
government functions;
¦ Developing a work plan and cost estimates for each work assignment, task order, or
delivery order;
¦ Providing qualified staff to meet all contract requirements;
¦ Implementing the activities described in the EPA-approved work assignment, task order,
or work plan;
¦ Receiving training and certification(s) necessary to perform field and laboratory PM2.5-
PEP activities; and
¦ Communicating with the WACOR, TOCOR, RPO, and/or Regional PM2.5-PEP Lead (as
applicable per the contract) on progress, problems, remedies, and plans, along with
spending reports, on PM2.5-PEP activities at a frequency and within a content format
dictated by the contract.
A4.6 State, Local, and Tribal Monitoring Organizations
The SLT organizations and their associated PQAO are responsible for entering the site locational
information, including the AQS site identifier (ID), into the AQS database. The AQS site ID
takes the form xx-yyy-zzzz, where xx is the state's two-digit Federal Information Processing
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Standards (FIPS) code, yyy is the three-digit FIPS county code, and zzzz is a four-digit site
identifier that uniquely identifies the site within the state and county. The AQS site ID has a two-
digit parameter occurrence code (POC) appended to it when denoting a specific sampler
(monitor) at the site. The SLT organization must confirm that the AQS site ID is entered into
AQS before it will be able to upload monitoring data from the site into the AQS database. For
the bias to be properly associated with the SLT's network, a PM2.5 sampler must be designated as
the primary monitor at each monitoring site. This assignment must be performed by designated
personnel in the SLT or cognizant PQAO.
Note that except for PQAOs that intend to self-implement the PM2.5-PEP, SLTs and PQAOs will
not receive nor be required to comply with this QAPP. Responsibilities listed below are those for
which the SLTs and PQAOs are expected under routine PM2.5 monitoring programs.
A4.6.1 SLTPM2.5 Monitoring Site Managers
EPA could not effectively plan and execute the PM2.5-PEP without the participation and
cooperation of SLT monitoring organizations around the country. The PM2.5-PEP provides an
invaluable QA/QC function on the overall performance of the national monitoring network and
often indicates potentially serious sampler performance, site, and/or laboratory issues. EPA
Regional offices rely on the SLT organizations to effectively operate their PM2.5-PEP networks,
and cooperation of SLT organizations is required to make each PM2.5-PEP sampling event
successful. SLT organizations may identify problems that will impede the PM2.5-PEP's mission
as early as possible and help find solutions.
Managers of SLT monitoring organizations responsible for operating and maintaining PM2.5
routine monitoring sites have the following responsibilities prior to and during PM2.5-PEP
sampling events:
¦ Maintaining an accurate list of all State and Local Ambient Monitoring Stations
(SLAMS), special purpose monitoring stations (SPMS), and/or tribal sites for the PQAO
in which the SLT participates. The list includes addresses, AQS site identifiers,
manufacturers and models of routine sampling equipment, and sampling schedules.
¦ Ensuring sufficient space for a PM2.5-PEP sampler to be collocated with the site's routine
PM2.5 sampler, while meeting siting requirements in 40 CFR Part 58, Appendix E and the
PM2.5-PEP Field SOP. The SLT site manager will contact the Regional PM2.5-PEP Lead
prior to the PM2.5-PEP sampling event if it is not possible for a site to meet the siting
requirements for a PM2.5-PEP sampler.
¦ Ensuring that adequate electrical power and connections are available to run PM2.5-PEP
samplers during a PM2.5-PEP sampling event.
¦ Ensuring that each site is safely accessible for a PM2.5-PEP sampling event.
¦ Ensuring that each site meets the applicable state Occupational Safety and Health
Administration (OSHA) safety requirements (e.g., providing secured ladders and
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appropriate safety rails and/or cages). While states generally have OSHA jurisdiction at
their facilities, EPA contractors must comply with Federal OSHA regulations. Therefore,
EPA may request compliance with Federal OSHA requirements if EPA's contractors or
FSs assert a violation renders a site unsafe to conduct a PM2.5-PEP sampling event.
¦ Ensuring that the PM2.5-PEP FS has necessary access to the site as many as two or more
days prior to and following the day of the PM2.5-PEP sampling event for setup and
equipment retrieval, as well as necessary information on site operation.
A4.6.2 PM2. s-PEP Self-Implementing PQA Os
PQAOs (consisting of one or more SLT monitoring organizations) have the option to self-
implement the PM2.5-PEP within their jurisdiction. Self-implementation requires the PQAO to
maintain a minimum level of independence and adequacy from the routine monitoring network
when fulfilling its PM2.5-PEP responsibilities. Information on adequacy and independence is
found in 40 CFR Part 58 Appendix A and the adequacy document, National Performance Audit
Program, PM2.5. PM10-2.5, and Lead Performance Evaluation Program Implementation Decision
Memorandum5. Because this information may change over time, OAQPS posts the adequacy
document on the AMTIC website and performs an annual review to make necessary updates.
For the purposes of self-implementation of the PM2.5-PEP, the PEP activities comprise an
independent assessment performed by an independent organization compliant with the following
definition:
Independent assessment: An assessment that is performed by a qualified individual, group,
or organization that is not part of the organization directly performing and accountable for
the work being assessed (i.e., must not be involved with conducting or overseeing generation
of routine ambient air monitoring data). An independent organization could be another unit
of the same agency sufficiently separated in terms of organizational reporting and able to
provide for independent sampling and filter weighing for PM2.5-PEP sampling events.
In practical terms, the self-implementing PQAO must have independent staff and equipment for
field and weighing laboratory activities from routine PM2.5 monitoring to ensure the PM2.5-PEP
activities comprise independent assessment.
When self-implementing the PM2.5-PEP, PQAOs have the following responsibilities:
¦ Adhering to the definition of independent assessment given above, which requires
assigning staff to the roles of PQAO PM2.5-PEP Coordinator (First Level Supervision in
Figure A4-2) and PQAO PM2.5-PEP FS (QA Field Sampling in Figure A4-2) who are
separated from routine field monitoring activities by minimally one additional level of
management (i.e., the PQAO PM2.5-PEP Coordinator must have one level of management
5 The memorandum for each calendar year is available at https://www.epa.gov/amtic/ambient-air-monitoring-
qualitv-assurance#npep. It is entitled National Performance Audit Program, PM2.5, PM10-2.5, and Lead
Performance Evaluation Program Implementation Decision Memorandum for Calendar Year XXXX, where
"XXXX" is the applicable year. A PDF of the 2021 version is available on the AirQA website at
https ://ha.battelle .org/airqa/LinkClick. aspx?fileticket=mG9dsYI VPU s%3 d&portalid=0.
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above them before management is common for the PM2.5-PEP and routine PM2.5 field
monitoring activities - as shown in Figure A4-2).
¦ Ensuring FSs attend and complete the required field training (Section A8).
¦ Implementing a comparable or equivalent PM2.5-PEP at the frequency prescribed by
Federal regulations specified in 40 CFR Part 58, Appendix A.
¦ Maintaining independent FRM PM2.5 samplers dedicated exclusively to PM2.5-PEP
sampling events. These samplers are subject to the verification procedures outlined in the
PM2.5-PEP field SOP and their calibration must be checked with transfer standards that
are independent of those used for routine PM2.5 sampling.
¦ Ensuring staff are properly trained and certified by participating in PM2.5-PEP training
and certification activities held by OAQPS or the self-implementing PQAO's respective
EPA Region.
¦ Procuring necessary equipment and consumables for the PM2.5-PEP.
¦ Developing required SOPs and QA procedures for administering the PM2.5-PEP and
incorporating them into their respective QAPPs.
¦ Including their PM2.5-PEP samplers in Regional collocation studies (i.e., parking lot
studies) for generating data to estimate precision in the measurement of PM2.5
concentrations using PM2.5-PEP samplers as described in Section B5.4.1.
¦ Coordinating with the Regional PM2.5-PEP Lead to identify PM2.5 monitoring sites within
their jurisdiction for conducting PM2.5-PEP sampling events and preparing the associated
sampling schedules.
¦ Cooperating in TSAs of its PM2.5-PEP activities as performed by the EPA Region.
¦ If the self-implementing PQAO employs a third-party laboratory for weighing their
PM2.5-PEP filters (note that utilizing a third-party weighing laboratory requires approval
of the OAQPS PM2.5-PEP Lead and is generally discouraged due to the additional
inherent variability this imparts to PEP measurements), ensuring the following:
Ensuring third-party weighing laboratories participate in an annual gravimetric round-
robin performance evaluation administered by OAQPS.
Ensuring third-party laboratories are subject to an annual TSA by EPA or an
independent assessor approved by the respective EPA Regional Lead.
Preparing and submitting to EPA a weighing laboratory annual report in an EPA-
specified format.
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Figure A4-2. Required Management Structure for Self-Implementing PQAOs
An organization can self-implement the PM2.5-PEP if their assessment is independent as defined
above and:
¦ Has a management structure that, at a minimum, will allow for the separation of its
routine sampling personnel from its auditing personnel by two levels of management, as
illustrated in Figure A4-2.
¦ Employs a separate laboratory facility and equipment for pre- and post-sample weighing
of PM2.5-PEP sample filters than the laboratory and equipment used to weigh sample
filters for routine monitoring (this is presumed to be the PM2.5-PEP weighing laboratory
unless the self-implementing PQAO employs a third-party weighing laboratory).
¦ The PM2.5-PEP laboratory personnel meet the PM2.5-PEP field and laboratory training
and certification requirements (Section A8).
¦ Participate in the PM2.5-PEP centralized field standards metrology certification process.
¦ Submit a plan for approval which demonstrates independence to the OAQPS PM2.5-PEP
Lead and to the EPA Regional office responsible for overseeing QA-related activities for
the ambient air monitoring network.
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A4.6.3 PQAOs
In the PM2.5-PEP, a PQAO is an SLT organization or a coordinated aggregation of SLT
organizations that is responsible for a set of routine PM2.5 monitoring sites from which data
quality assessments can logically be pooled. Each routine PM2.5 sampler within the national
monitoring network must be associated with one, and only one, PQAO. Within the PM2.5-PEP,
PQAOs have the following responsibilities:
¦ Operating within the PM2.5 national monitoring network according to the established
regulations and guidelines pertaining to proper siting, operations, and QA procedures; or
having a waiver for operating outside of requirements in 40 CFR Part 58 and its
appendices which has been approved by the respective EPA Regional Administrator.
¦ Participating in the Air Monitoring QA Workgroup chaired by OAQPS for development
and review of pertinent PM2.5-PEP guidance documents.
¦ Determining whether to continue using the federal PM2.5-PEP or to self-implement the
program on an annual basis.
¦ Ensuring that an SLT organization representative is aware of scheduling and is present (if
required by the EPA Region) when the PM2.5-PEP FS arrives and conducts the PM2.5-
PEP sampling event.
¦ Communicating with the SLT's site operator to ensure the routine sampler is in the
normal operating mode during PM2.5-PEP events.
¦ Notifying the EPA PM2.5-PEP FS if the monitoring site's routine primary sampler did not
perform adequately during a conducted PM2.5-PEP sampling event or performed in such a
way that would result in invalidation of the routine sampling. Such may allow the
possibility of substituting a result from a collocated sampler at the site.
¦ Ensuring that the monitoring site's routine sampling results are posted to the AQS and
notifying the EPA PM2.5-PEP FS if a substitute value from a collocated sampler was
submitted.
¦ Ensuring the program's success by coordinating and/or performing various internal
oversight activities of the PM2.5 monitoring network including performance checks,
audits of samplers, and internal TSAs of routine field and laboratory activities.
¦ Participating in training activities including multi-state conferences, EPA
teleconferences, and other training vehicles.
¦ Reviewing routine and PM2.5-PEP sample data and working with the Regions on
corrective actions.
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A4.7 Other Participating Entities in the PM2.5-PEP
A4.7.1 EPA Office of Research and Development
For the PM2.5-PEP, the EPA Office of Research and Development (ORD) has the following
responsibilities:
¦ Serving as a technical consultant, advisor, and arbiter of technical issues regarding the
sampling and analysis of PM2.5-PEP samples collected with the FRM BGIPQ200
sampler. This is primarily done through ORD's Center for Environmental Measurement
and Modeling (CEMM) which provides many of the applied research elements for the
PM2.5-PEP.
¦ Providing guidance to PM2.5-PEP for field and analytical activities.
¦ Designating ambient air samplers as a FRM or Federal equivalent method (FEM). ORD
designates the FRM/FEM portable sampler through the Federal Reference and
Equivalency Program (40 CFR Part 53).
¦ Providing access to its National Risk Management Research Laboratory (NRMRL)
Metrology Laboratory at Research Triangle Park (RTP), North Carolina, for annual
calibration/verification of the PM2.5-PEP's flow rate/pressure/temperature transfer
standards.
¦ Providing technical consultation support for the national monitoring procurement
contracts.
A4.7.2 Acquisition Management in EPA '.s Office of Mission Support
The Office of Mission Support (OMS) is responsible for issuing contracts and various national
procurements for EPA. These contracts are developed in concert with OAQPS Air Quality
Assessment Division technical staff. The OMS is responsible for communications with vendors
and extramural contract organizations.
For the PM2.5-PEP, the OMS's responsibilities include the following:
¦ Developing national contracts for the PM2.5-PEP sampler and filter purchases and
working with ORD and OAR contracts and technical staff to secure purchase and receipt
of these products.
¦ Providing support to COs and contract support staff for national procurements for federal
implementation of the PM2.5-PEP, major equipment repairs, and equipment upgrades.
A5 Problem Definition/Background
This section places the PM2.5-PEP in historical perspective, identifying the program's purpose
and position relative to the Ambient Air Quality Monitoring Program.
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A5.1 Background
In 1970, the Clean Air Act (CAA) was signed into law. The CAA regulates the ambient
concentrations of six criteria pollutants: particulate matter (PM), sulfur dioxide (SO2), carbon
monoxide (CO), nitrogen dioxide (NO2), ozone (O3), and lead (Pb). The CAA requires SLT
organizations to monitor these criteria pollutants through the Ambient Air Quality Surveillance
Program as defined in 40 CFR Part 58.
PM as a criteria pollutant is generally used to describe a broad class of substances that exist as
liquid or solid particles over a wide range of sizes. Two particle size fractions are measured in
the Ambient Air Monitoring Program: those less than or equal to 10 micrometers (PM10) and
those less than or equal to 2.5 micrometers (PM2.5). This QAPP focuses only on PM2.5.
The background and rationale for the implementation of the PM2.5 national monitoring network
can be found in EPA's 2004 Air Quality Criteria for Particulate Matter, which is available at
https://cfpub. epa.gov/ncea/risk/recordisplav. cfm?deid=87903. Some of the report's key findings
include:
¦ The characteristics, sources, and potential health effects of larger or "coarse" particles
(those between 2.5 to 10 micrometers [|im] in diameter) are very different from those
associated with smaller, or fine, particles (smaller than 2.5 |im in diameter).
¦ Coarse particles typically originate from sources such as windblown dust from the desert
or agricultural fields and dust that is circulated on unpaved roads from vehicle traffic.
¦ Fine particles are generally emitted from activities such as industrial and residential
combustion and from vehicle exhaust. Fine particles are also formed in the atmosphere
from gases, such as SO2, nitrogen oxides, and volatile organic compounds, which are
emitted from combustion activities and then become particles because of chemical
transformations or agglomeration in the air.
¦ Coarse particles can deposit in the respiratory system and contribute to adverse health
effects, such as aggravating asthma. Fine particles, which deposit deeply in the lungs and
can be transferred into the blood stream in some form, are more likely than coarse
particles to contribute to the adverse health effects (e.g., premature mortality and hospital
admissions) found in many published community epidemiological studies.
¦ Community studies found that adverse public health effects are associated with exposure
to particles at levels well below the current PM standards for both short-term (e.g., less
than 1 day to up to 5 days) and long-term (generally 1 year to several years) periods.
¦ Adverse health effects associated with fine PM included premature death and increased
hospital admissions and emergency room visits (primarily among the elderly and
individuals with cardiopulmonary disease); increased respiratory disease and disease
symptoms (among children and individuals with respiratory disease, such as asthma);
decreased lung function (particularly in children and individuals with asthma); and
alterations in lung tissue and structure and in respiratory tract defense mechanisms.
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A5.2 PM2.5 Monitoring Networks
Pursuant to 40 CFR Part 58, EPA has assigned the responsibility for measuring ambient PM2.5
concentrations using FRM or FEM and posting results in the AQS to SLT monitoring
organizations. Each of the individual SLT monitoring networks is designed to meet at least one
of the following six basic air quality monitoring objectives:
¦ Determining the highest concentrations to occur in the area covered by the network;
¦ Determining representative concentrations in areas of high population density;
¦ Determining the impact on ambient pollution levels of significant source or source
categories;
¦ Determining background (i.e., non-source impacted) concentration levels;
¦ Determining the extent of regional pollutant transport among populated areas and in
support of secondary pollutants; and
¦ Determining the welfare-related impacts in more rural and remote areas.
The EPA's Ambient Air Quality Monitoring Network consists of four component monitoring
networks that measure the criteria pollutants:
¦ SLAMS and Tribal Monitoring Network6 consists of approximately 4,000 monitoring
stations whose size and distribution are largely determined by the needs of SLT
organizations to meet their respective State Implementation Plan (SIP) and Tribal
Implementation Plan requirements. These monitoring stations are typically fixed and
operate for multiple years to measure pollutants for compliance with criteria pollutant
NAAQS.
¦ National Core (NCore) Network7 is a multi-pollutant network that integrates several
advanced measurement systems for PM, gaseous pollutants, and meteorology. The NCore
network contains approximately 80 sites, most of which have been operating since
January 2011.
¦ Photochemical Assessment Monitoring Station (PAMS) network8: Measures O3
precursors, meteorology, and O3 in each core-based statistical area (CBSA) with
population > 1 million. The current PAMS network has approximately 45 sites and will
be expanded to include Enhanced Monitoring Plan (EMP) sites for areas in non-
attainment.
¦ Special Purpose Monitoring (SPM): Program that provides for special studies that SLT
organizations perform to support their SIPs and other air program activities. SPM
sampling is not permanently established and, thus, can be easily adjusted to accommodate
6 https://www.epa.gov/amtic/amtic-pm25-monitoring-network
7 https://www.epa.gov/amtic/ncore-monitoring-network
8 https://www.epa.gov/amtic/photochemical-assessment-monitoring-stations-pams
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changing needs and priorities. SLT organizations use SPM to supplement their routine
monitoring as circumstances require and resources permit. If data from SPM are used for
SIP purposes, they must meet QA and methodology requirements for the SLAMS.
This QAPP prescribes the PM2.5-PEP, which is a QA program limited to the SLAMS and NCore
networks. The PM2.5-PEP supports network objectives and includes all PM2.5 FRM and FEM
samplers used to measure PM2.5 concentrations in ambient air for comparison to the PM2.5
NAAQS.
A5.3 Quality Considerations
PM2.5 measurements from PM2.5 FRM/FEM samplers within the SLAMS and NCore networks
are compared against the PM2.5 NAAQS. To draw conclusions from these comparisons with an
acceptable level of confidence, EPA has developed a quality system to optimize and quantify the
quality of data used to make PM2.5 NAAQS determinations. When developing the PM2.5
NAAQS, EPA used the DQO process to determine the allowable measurement system
imprecision and bias that would not significantly affect a decision maker's ability to compare
pollutant concentrations to the NAAQS. The precision (10% coefficient of variation [CV]) and
bias (±10%) requirements are based on total measurement uncertainty, which incorporates errors
from all phases of the measurement process (e.g., field sampling, sample handling, and
laboratory analysis). The SLT organizations operating monitoring sites within the PM2.5 national
monitoring network collect measurements from collocated samplers that can be used to generate
estimates of precision.
The PM2.5-PEP is a QA program that is used to independently evaluate the measurement system
bias of the national PM2.5 monitoring network and incorporates measurement uncertainties from
field and laboratory activities. The pertinent regulations for the PM2.5-PEP are outlined in 40
CFR Part 58, Appendix A, Section 3.2.4. The strategy is for the PM2.5-PEP to collocate a
portable PM2.5-PEP sampler within 1 to 4 meters of a statistically meaningful number of routine
PM2.5 samplers in each PQAO. During each sampling event, both the routine and PM2.5-PEP
samplers operate simultaneously. The SLT/PQAO's measurement is made routinely following
the normal procedure and the PM2.5-PEP measurement follows an independent collection and
analysis convention. The resulting routine PQAO measurement and PM2.5-PEP measurement are
then compared to calculate a percent difference of the PM2.5 concentrations which is used to
evaluate bias.
A5.4 PM2.5-PEP Implementation
In the originally proposed monitoring regulations for PM2.5, SLT organizations were responsible
for implementing the PM2.5-PEP. However, due to many comments received during the review
period for the December 13, 1996 PM2.5 NAAQS proposal, EPA made the following revisions:
¦ Made allowances to shift the implementation burden from the SLT organizations to the
federal government.
¦ Modified the system to include an independent PM2.5-PEP.
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¦ Reduced the burden of implementing the PM2.5-PEP by changing the frequency of the
PM2.5-PEP sampling events across all sites to 25% of the PM2.5 monitoring sites.
Between August and October 1997, EPA discussed the possibility of federal implementation
with EPA Regions and various SLT organizations. Most responses received from these
organizations favored federal implementation of the PM2.5-PEP.
EPA evaluated potential contracting mechanisms to assist in the implementation of this activity
and decided to use the ESAT contract within each EPA Region to provide the necessary field and
laboratory activities to the PM2.5-PEP. EPA no longer utilizes ESAT at the centralized contract,
therefore contracts supporting the implementation and execution of the PM2.5-PEP are awarded
at the Regional level and per the Regional office's preferred contract mechanism. Each Region is
responsible for implementing the field component of the PM2.5-PEP. The LSASD is responsible
for hosting and operating the PM2.5-PEP weighing laboratory.
Prior to 2007, only the State of Illinois chose to fully implement its own PM2.5-PEP, which
included field and gravimetric laboratory support. In response to the 2006 regulatory revisions, a
few more states and some Tribal organizations opted to partially self-implement the program in
2007. Those PQAOs that have chosen to partially self-implement the PM2.5-PEP are essentially
providing the same service that contractors provide at the Regional level, i.e., they conduct and
perform all of the necessary field activities. All SLT organizations that have chosen to partially
self-implement the PM2.5-PEP have agreed that a central service laboratory is the better
alternative to individual SLT organizations running their own independent service laboratory or
contracting with an independent laboratory. An important consideration is that the fully self-
implementing organization must ensure that its resulting PM2.5-PEP data are entered into the
AQS as prescribed in 40 CFR Part 58.16, which states, "The data and information reported for
each reporting period must contain all data and information gathered during the reporting period
and be received in the AQS within 90 days after the end of the quarterly reporting period."
Historically, the PM2.5-PEP has experienced delays in data availability for national assessments.
In March 2015, EPA conducted a Lean-based event to analyze and improve the business
processes associated with managing PM2.5-PEP data, as well as data from EPA's National
Performance Audit Program (NPAP). This Lean event resulted in the development of a new
business process for the PM2.5-PEP that is expected to reduce delays in submission of PM2.5-PEP
data to AQS by 68 percent and at a cost savings of $50,000 per year in contract costs. This
process will result in a new automated data collection and transfer software system called
MoPED. MoPED will replace the manual transfer of information on field data sheets (FDSs) that
FSs previously used to capture field data for eventual input to the PM2.5-PEP's Performance
Evaluation Database (PED) and into AQS. EPA is designing the MoPED to retrieve key
information that is stored in AQS and is necessary for performing the setup of each PM2.5-PEP
sampling event. MoPED also stores the pre-event performance checks and the sampler's logged
run data for the sampling event which are downloaded to a laptop or tablet personal computer
(PC). The MoPED will be used to upload sampling event data to AQS to combine with the filter
gravimetric result and calculate the 24-hour average ambient concentration for that sampling
period. As of the approval of this QAPP, the MoPED was not operational, therefore aspects of its
implementation are on hold. Aspects of the MoPED are described in sections as they are
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intended to be implemented when EPA is able to move forward with its implementation. Aspects
of the PM2.5-PEP that will be handled differently with the implementation of MoPED are
detailed in italics in subsequent sections of this QAPP. Concurrently with the development of the
MoPED, EPA is developing an updated sample handling database (new PED) or LIMS for the
PM2.5-PEP weighing laboratory to replace the existing PED, which is becoming obsolete.
A6 Project/Task Description
The purpose of this section is to provide an understanding of the various activities within the
PM2.5-PEP including types of measurements and their associated QA/QC goals, procedures, and
timetables.
A6.1 Description of Work to Be Performed
EPA designed the PM2.5-PEP to generate data to estimate total measurement system bias present
in the PM2.5 ambient air monitoring network. The PM2.5-PEP conducts a sampling event using
the EPA's FRM which employs a precise and consistently performing approved FRM air
sampler to collect 24-hour ambient air samples that are analyzed gravimetrically for calculating
the average concentration over the sampling period. These data are then compared with
coincident PM2.5 ambient concentration generated by the SLT routine sampler. SLT monitoring
agencies may use a variety of approved PM2.5 FRM samplers or FEM continuous or semi-
continuous monitors. Since the PM2.5-PEP serves as a monitoring network on its own merit, it
must collect and analyze ambient air PM2.5 samples using sampling and laboratory procedures
that adhere to the requirements of the PM2.5 FRMs in 40 CFR Part 50 Appendix L. In fact, the
PM2.5-PEP imposes the most stringent interpretation of the Appendix L FRM requirements to
optimize the consistency in the bias assessment of the SLT network across the US.
The PM2.5 FRM methodology involves collecting particulates less than or equal to 2.5 |im on
46.2-mm polytetrafluoroethylene (PTFE) Teflon™ filters independent from the national network
and gravimetrically determining the mass of PM2.5 collected on the filter. The mass collected on
the filter is then used to determine the 24-hour average concentration in |ig/m3 by dividing the
collected mass by the total volume of ambient air pulled through the sampler. Applicable
regulations for this activity can be found in 40 CFR Part 58, Appendix A, Section 3.2.3.
The following information briefly describes the PM2.5-PEP field and laboratory activities.
Detailed SOPs for field and laboratory activities are available to PM2.5-PEP participants (or
interested parties) via the AMTIC website and the AirQA website which supports the PM2.5-
PEP: http://www.airqa.org. The process is represented by the following steps:
¦ The OAQPS PM2.5-PEP Lead acquires and ships new PTFE filters to the PM2.5-PEP
weighing laboratory where they are inventoried, inspected, equilibrated, weighed, and
prepared for the field.
¦ The PM2.5-PEP weighing laboratory initiates a chain-of-custody (COC) form to
accompany each filter and ships or delivers to each Region specified numbers of filters in
protective sampling cassettes sealed in anti-static bags.
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¦ The FSs in each Region generate a FDS for each filter and transport the filter cassettes
and other necessary equipment with accompanying COC and FDS forms to the field and
conducts a PM2.5-PEP sampling event, sampling for 24 hours concurrent and collocated
with an SLT monitoring organization routine sampler.
¦ Upon conclusion of the PM2.5-PEP sampling event, the FS retrieves the collected PM2.5-
PEP filter(s), downloads the sampler logged data to a laptop or tablet PC, and sends the
filter cassettes, completed COC and FDS forms, and data (e.g., flash drive) to the PM2.5-
PEP weighing laboratory. Copies of COCs, FDSs, run data, and other pertinent records
including logbook entries are retained by the FSs' field office (which may or may not be
at an EPA facility). Hard copies of these records must be retained (refer to Section BIO).
¦ The PM2.5-PEP weighing laboratory receives, inspects, equilibrates, and weighs the
exposed sampling event filters in addition to designated field blanks (FBs) and trip blanks
(TBs). The difference between the post-collection weight and the tare weight is
calculated. The gained mass for exposed samples is normalized to the collected sample
volume to determine the concentration and the gained mass for FB and TB filters is
assessed to determine presence of incidental contamination. Sampling and weighing data
are validated within the PM PED, converted to 24-hour average concentrations, and
uploaded to the AQS database. (In the MoPED-servedprocess, the validation will be an
automated, logic-driven algorithm that is completed by AQS. The validation parameters
will not change.)
A6.2 Field Activities
In a PM2.5-PEP sampling event, a portable PM2.5-PEP sampler is collocated with a routine SLT-
operated PM2.5 sampler. The FS assembles the PEP sampler, performs calibration and operational
checks, installs the filter sample, and programs the sampler to collect over the 24-period assigned
for the monitoring site's routine sampler. Upon completion of the 24-hour sampling event, the
FS retrieves the collected filter(s), disassembles the portable PEP sampler, and ships the
collected filter(s) and associated sample collection and FDS/COC documentation to the PM2.5-
PEP weighing laboratory.
A 6.2.1 PM2.5-PEP Field Equipment
The PM2.5-PEP's FRM samplers are designed to be durable, rugged, and capable of frequent
transport. These samplers are constructed in groups of components for transport, with each group
weighing no more than 40 pounds and a total weight not exceeding 120 pounds.
To optimize consistency of nationwide PM2.5-PEP measurements, EPA has designated BGI
PQ200 portable samplers (Mesa Laboratories, Inc.; Lakewood, Colorado), with either controller
board Revision T or Revision U, as the preferred FRM sampler for conducting PM2.5-PEP
sampling events. The PM2.5-PEP Field SOP contains detailed sampler operating instructions,
based on the latest operating manual published by Mesa Laboratories. The SOP instructions must
be strictly followed to ensure data quality.
OAQPS purchases samplers for the PM2.5-PEP and distributes them among the Regional offices.
Self-implementing PM2.5-PEP PQAOs must acquire independent FRM samplers which are to be
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dedicated for PM2.5-PEP sampling events. If for any reason a self-implementing PQAO requests
use of a different FRM manufacturer and model they must conduct an extensive collocation
study with their EPA Region to demonstrate that the bias between the PQAO and EPA samplers
meets the Regional fleet collocation precision criteria (refer to Section B5.4.1).
A second practice critical to achieving nationally consistent results is the use of consistent
calibration and performance testing standards for flow rate, temperature, and barometric
pressure. For consistency, the PM2.5-PEP has evolved over time to using BGI (Mesa Labs)
standards as field (travel) transfer standards; however, other properly NIST-traceable transfer
standards are acceptable for use. The accuracy of the transfer standards is certified by comparing
their measurements to those of higher level standards certified by, or meeting tolerances
specified by, the National Institute of Standards and Testing (NIST). These certifications are
conducted within the EPA ORD metrology laboratory located in the RTP, North Carolina
campus.
A6.2.2 PM2.s-PEPSampling Events
The following are required for each PM2.5-PEP sampling to ensure acceptable data quality:
¦ The PM2.5-PEP sampler will be properly transported, assembled, calibrated, operated, and
maintained according to procedures and specifications given in the PM2.5-PEP field SOP
which are based on the guidance outlined in OA Guidance Document 2.12 Monitoring
PM2.5 in Ambient Air Using Designated Reference or Class I Equivalent Methods. 9
¦ FSs will verify the performance of the PM2.5-PEP sampler (as specified in 40 CFR Part
50, Appendix L) prior to conducting a sampling event.
¦ FSs will adhere to filter retrieval/recovery times and shipping schedule requirements (as
specified in Section A6.4).
¦ FSs will properly complete and submit the COC and FDS form for each sampling event
filter, field blank, and trip blank to the weighing laboratory.
o When EPA successfully launches MoPED, the FS performing a PM2.5-PEP sampling
event will utilize MoPED to collect and upload the sampling event's field data to
AQS. EPA is designing MoPED to streamline the verification and validation of
PM2.5-PEP field data to AQS. The PM2.5-PEP Field SOP will include instructions for
using MoPED during PM2.5-PEP sampling events.
In addition to adhering to the standards, principles, and practices outlined in this QAPP and the
supporting Field SOP, PM2.5-PEP activities and procedures may need to adjust to the relevant
site-specific conditions and operations. For example, the PM2.5-PEP sampler may not be able to
meet siting criteria specified in 40 CFR Part 58 Appendices C, D, and E if the PQAO has an
approved waiver from the EPA Regional Ambient Air Monitoring Program for varying from
siting requirements.
9 https://www.epa.gov/sites/default/files/2021-03/documents/pl00oi8x.pdf
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A6.2.3 Critical Field Measurements and Metadata
Field measurements used to calculate PM2.5 concentrations from PM2.5-PEP samples are a critical
component of the PM2.5-PEP. The sampler's average flow rate and the elapsed sampling time are
critical field measurements necessary to calculate total air volume sampled:
total air volume sampled = average flow rate x elapsed time
The mass of PM2.5 on the filter sample reported by the PM2.5-PEP weighing laboratory is divided
by the total air volume sampled to calculate the in-air PM2.5-PEP concentration.
The PM in separator inlet head and very sharp cut cyclone (VSCC) or well impactor ninety-six
(WINS) impactor PM2.5 separator are designed to operate at the design flow rate of 16.67 liters
per minute (LPM). Any deviation in flow rate from the design value will affect how precisely the
PM10 and PM2.5 separators eliminate particles larger than 10 |im and 2.5 |im, respectively, from
the ingested air. Recalibration action levels have been established (Section B7.2.2) to better
ensure the BGIPQ200 samplers perform within the flow rate range and with the flow rate
precision (CV) specified in the FRM.
The AQS Site ID code and the sampler start and end times and dates are critical metadata
necessary for AQS to pair PM2.5-PEP concentrations with their collocated routine PM2.5
monitoring network concentrations.
A6.3 Laboratory Activities
The PM2.5-PEP laboratory activities include filter handling, inspection, equilibration, weighing,
data entry/management, and archiving.
A 6.3.1 Weighing Laboratory A ctivities
The PM2.5-PEP weighing laboratory activities will comply with the standards, principles and
practices described in this QAPP and in the laboratory SOP. The SOP includes details to ensure
microbalance operation and calibration occurs in accordance with: the vendor's instruction
manual, the requirements for gravimetric analyses provided in 40 CFR 50, Appendix L, and the
OA Guidance Document 2.12 Monitoring PM2.5 in Ambient Air Using Designated Reference or
Class I Equivalent Methods. 10 The laboratory has defined filter shipping/receiving requirements
within the SOP which apply to shipping containers (i.e., insulated coolers), cold packs, and COC
requirements/documentation.
The following information summarizes the PM2.5-PEP weighing laboratory activities in a typical
chronological order.
A6.3.1.1 Filter Acquisition, Inspection, Conditioning, and Pre-sampling Weighing
The PM2.5-PEP weighing laboratory is responsible for the following filter activities:
10 https://www.epa.gov/sites/default/files/2021-03/documents/pl00oi8x.pdf
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¦ Receiving new PTFE filters from the OAQPS PM2.5-PEP Lead. Filters from the most
recent year's production run are utilized unless there is an insufficient quantity. In such
cases, the previous two years' excess filters are brought back into service.
¦ Performing integrity inspections (e.g., lack of pinholes, tears, discoloration, ring
separation) on the filters to be used.
¦ Inventorying each filter for subsequent data entry into the PED.
¦ Equilibrating the filters and measuring tare (pre-sampling) weights.
¦ Storing or preparing filters for field activities.
¦ Initiating a three-part carbonless COC form that accompanies each filter at each step of
its journey and life cycle until it returns to the laboratory
A 6.3.1.2 Post-Sampling Laboratory A ctivities
Once the FS completes filter sample retrieval and shipment, the PM2.5-PEP weighing LA is
responsible for the following activities:
¦ Receiving filters shipped from the field, measuring the shipment temperature upon
receipt, inspecting filters for integrity (e.g., damage), and logging them into the PED.
¦ Storing received sampled filters in cold storage (0-4 °C) until equilibrated for weighing.
¦ Removing filters from cold storage and equilibrating them in the climate controlled
weighing room.
¦ Weighing equilibrated filters and recording gravimetric data into the PED (a Microsoft®
Access database application).
¦ Archiving the weighed filters in cold storage
The laboratory SOP provides more details regarding these laboratory activities.
A6.4 Timing for PM2.5-PEP Activities
Laboratory and field activities in the PM2.5-PEP include those annual events that are completed
for preparing for approximately one year's worth of PM-PEP sampling events as well as
continual events that occur as PEP sampling events are conducted. These events are briefly
described below and additional detail on these activities is provided in the PM2.5-PEP field and
laboratory SOPs.
A6.4.1 PM2.5-PEP Annual Activities
The following PM2.5-PEP activities are conducted annually to prepare for approximately the next
year of PEP sampling events:
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1. Calibration verification/certification of the field transfer standard for temperature,
barometric pressure, and flow rate by the EPA RTP metrology laboratory or transfer
standard manufacturer metrology service.
2. Creating a list of network monitoring sites eligible for PM2.5-PEP sampling events.
3. Selecting sites from this list at which PM2.5-PEP sampling events will be performed in the
given calendar year.
4. Developing a schedule for PM2.5-PEP sampling events.
5. Calibration verification/certification and maintenance of the weighing laboratory
analytical balance(s) and environmental monitoring equipment.
6. Receiving and inspecting filter media and determining lot equilibration duration.
7. Annual maintenance of vehicles and trailers (as equipped), etc.
A6.4.1.1 Annual Selection of PM2.5-PEP Audits
Within 40 CFR Part 58, Appendix A, Section 3.2.4, the PM2.5-PEP sampling design was codified
and then amended in October 2006 to require the following:
¦ PQAOs with five or fewer monitoring sites within the network must conduct and report a
minimum of five (5) valid PM2.5-PEP sampling events per year.
¦ PQAOs with more than five monitoring sites within the network must conduct and report
a minimum of eight (8) valid PM2.5-PEP sampling events per year.
Additionally, among the primary routine samplers in the national monitoring network within a
PQAO:
¦ Each method designation represented among the primary monitors must be subjected to a
PM2.5-PEP sampling event each year.
¦ Each individual primary monitor must be subjected to a PM2.5-PEP sampling event at
least once every six (6) years.
Together, these two requirements result in conducting a PM2.5-PEP sampling event at
approximately 15% of all PM2.5 network monitoring sites each year.
A PM2.5-PEP sampling event is valid for completeness purposes (i.e., satisfies the CFR
requirement for the number of PM2.5-PEP events per PQAO) when the PM2.5-PEP sampler
collects a 24±1 hour filter sample concomitantly with the SLT monitoring site PM2.5 sampler and
both the PM2.5-PEP and routine SLT monitoring site sampler concentration data for the 24-hour
period are validated (i.e., not voided or invalidated) and are successfully reported to AQS.
Additionally, to be considered valid for the PM2.5-PEP bias assessment, both the PM2.5-PEP and
SLT monitoring site measured PM2.5 concentrations must be > 3 |ig/m3.
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EPA recognizes that ambient PM2.5 concentrations across the US have trended downward for the
last 15 years; consequently, the incidence of invalid data pairs for assessing bias due to one or
both SLT and the PM2.5-PEP concentrations being < 3 [j,g/m3 during a PM2.5-PEP sampling event
at a given site has increased significantly. At the same time EPA has firmly established that the
practical detection limit is substantially lower than the detection limit of 2 |ig/m3 stated in the
original promulgated FRM (40 CFR Part 50 Appendix L). Therefore, for purposes of
completeness in the PM2.5-PEP, sampling events are not invalidated when concentrations are < 3
|ig/m3, and therefore count toward the PQAO's completeness. However, data from these
sampling events are excluded from the bias assessment by AQS, and the affected PQAO will be
informed when the PM2.5-PEP concentration is confirmed to be < 3 |ig/m3. One extra PM2.5-PEP
sampling event should be scheduled and performed in each PQAO in those geographic areas
where historical data show PM2.5 concentrations (either as queried from AQS or from previous
PEP events) are < 3 [j,g/m3. Self-implementing PQAOs may conduct up to three extra PM2.5-PEP
events to increase the probability of achieving the prescribed number of data pairs of which both
concentrations exceed 3 [j,g/m3. PM2.5-PEP Regional Leads should designate additional PM2.5-
PEP sampling events to accommodate make-up sampling events when cancellations or invalid
sampling events occur.
A6.4.1.2 Scheduling PM2.5-PEPSampling Events
During the autumn of each calendar year, personnel from the SLT organizations work with the
Regional PM2.5-PEP Leads to prepare a list of PM2.5 network monitoring sites at which PM2.5-
PEP sampling events can be conducted and a schedule for conducting the PEP events in the next
calendar year. This list of monitoring sites and proposed schedule should be completed by
December 1 of the preceding year during which the PEP events are to occur. Self-implementing
PQAO PM2.5-PEP Coordinators should prepare their prospective PEP event lists and schedules
and seek Regional PM2.5-PEP Lead approval by January 1 of the year during which the PEP
events are to occur. The schedule of PEP events should be prepared to maximize efficiency in
consideration of the following:
¦ The required number of PM2.5-PEP sampling events noted in Section A6.4.1.1.
¦ Coordinating each PM2.5-PEP sampling event with the monitoring schedule of the
selected site's primary routine sampler.
¦ Inter-site proximity (PM2.5-PEP sampling events can be scheduled for the same day or
week among sites close in proximity to each other).
¦ Coordination with other QA programs (e.g., Pb-PEP and NPAP) if possible.
PM2.5-PEP sampling events at SLT monitoring sites conducting routine collocated sampling
should be scheduled preferentially to occur on dates for which the collocated monitor is also
sampling. This provides insurance that a valid result for the PM2.5-PEP event can be recorded in
the event the primary sampler fails to produce valid measurement data during the event.
A6.4.1.2.1 Make-Up PM2.5-PEP Events
In the event a PM2.5-PEP sample or associated SLT PM2.5 routine sample measurement is invalid
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for the PEP event, a make-up PEP event may be scheduled to ensure the required number of
valid annual audits is completed. PM2.5-PEP FSs are discouraged from scheduling make-up
events on days not on the national monitoring schedule unless there are special circumstances
(e.g., offshore travel or the event is near the end of the calendar year). When a sampling event is
known to be invalid at the time of sample retrieval and it is otherwise difficult to travel to the
location, the FS (with PM2.5-PEP Regional Lead approval) may schedule a make-up PEP
sampling event. If the SLT organization is amenable to hosting a PM2.5-PEP sampling event on a
day other than a routine sampling day and is willing to post the result of its collected sample to
AQS, then the sampling event can be scheduled for that day. Note that primary routine PM2.5
samplers operating continuously (e.g., FEMs) simplify the scheduling of make-up PM2.5
sampling events.
A6.4.2 Ongoing PM2. s-PEP A ctivities
Once the PM2.5-PEP sampling event schedule is completed and approved, numerous field and
laboratory activities occur periodically and on an ongoing event-by-event basis. The following is
a general timeline of events:
1. FSs notify (approximately one month in advance of the events) the PM2.5-PEP Weighing
Laboratory of the upcoming events and request the number of filters needed to
accomplish sampling and QC (i.e., FBs and TBs).
2. FSs verify field transfer standards are within certification dates and suitable for field
deployment.
3. FSs inspect transportation vehicles and equipment transport cases.
4. FSs inspect and replace shipping containers (i.e., insulated coolers), refrigeration bricks,
and other consumables.
5. LAs inspect and equilibrate new filters.
6. LAs measure and record tare weights on new filters, install filters in sampling cassettes,
generate COC forms, and package filters for shipment to FSs.
7. FSs set up the FRM PM2.5-PEP sampler at the SLT monitoring site, conduct pre-sampling
checks and calibration verifications, document activities on the FDS/COC form, and
program the sampler to sample during the SLT sampling event.
8. FSs retrieve the PM2.5-PEP filter sample, package it for shipping, and ship the filter and
accompanying FDS/COC form to the PM2.5-PEP weighing laboratory.
9. LAs receive filter shipments, measure shipment temperatures, log filter collection
information into the PED, and store filters refrigerated until conditioned for post-
sampling weight measurements.
10. LAs condition sampled filters, verify analytical balance calibration and operation,
measure post-sampling weights, and input measurement data into the PED.
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11. The PM2.5-PEP laboratory manager and EPA PM2.5-PEP Weighing Laboratory Task
Monitor review and verify the sample collection and mass measurement data in the PED.
Data that show as invalid or compromised are more closely reviewed and the PM2.5-PEP
laboratory manager and EPA PM2.5-PEP Weighing Laboratory Task Monitor
communicate with PM2.5-PEP Regional Leads and FSs to correct data as possible.
12. The PM2.5-PEP laboratory manager and EPA PM2.5-PEP Weighing Laboratory Task
Monitor approve data for upload to AQS.
A7 Data Quality Objectives and Criteria for Measurement
This section describes the DQOs established by EPA for the PM2.5 monitoring program and how
the PM2.5-PEP assesses conformance with the DQOs and the performance criteria for the
environmental data operation (EDO) used to generate PM2.5-PEP data.
A7.1 Data Quality Objectives for the PM2.5 Ambient Air Monitoring Program
DQOs are qualitative and quantitative statements derived from the DQO process that clarify the
objectives for capturing data, define the appropriate type of data to collect, and specify the
tolerable levels of decision errors or estimation uncertainty from the collected data. By applying
the DQO process to the development of a quality system for PM2.5 monitoring, EPA ensures that
committed resources are collecting data that can be used to meet their intended use (e.g.,
NAAQS comparison).
In 1997, EPA implemented the DQO process to the PM2.5 ambient air monitoring program. The
DQOs were based on the ability to measure ambient concentrations that can be compared to the
PM2.5 NAAQS, so that an attainment decision could be made for the given monitoring site to
within a given level of confidence (or equivalently, decision error percentage). EPA deemed
±5% to be an acceptable decision error limit. Practically, this means that 95% of the time a site's
designation as in attainment or non-attainment will be correct.
The DQO for acceptable precision (10% CV) and bias (± 10%) in the national PM2.5 monitoring
network are identified in 40 CFR Part 58 Appendix A Section 2.3.1.1. Bias is calculated
according to 40 CFR Part 58 Appendix A Section 4.2.5 (Section 4.2.5 references PEP audits as
conducted under Section 4.1.3; however, this is incorrect and should be a reference Section
3.2.4). EPA uses these precision and bias limits as goals against which to evaluate measurement
uncertainty. The PM2.5-PEP provides the measurements upon which the bias component of
the DQO for the PM2.5 ambient air monitoring program is evaluated.
Bias is conventionally measured and evaluated by introducing a standard reference material
(SRM) to the measurement process and evaluating the results. Because there is no convenient,
practical, or accurate way of introducing a known concentration of particles into a PM2.5
FRM/FEM sampler, EPA chose to standardize the PM2.5-PEP on the sampler that was deemed to
be the most precise of the FRM samplers under 40 CFR Part 50 Appendix L. Equally critically
important, the selected PM2.5-PEP's gravimetric laboratory is to comprise a climate control
system, gravimetric analysis equipment, and associated procedures that rigorously adhere to the
technical design, operational parameters, and QC requirements prescribed in the FRM. The
PM2.5-PEP serves, as closely as possible, as a reference standard by which a relative network
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bias and the relative accuracy of an SLT monitoring organization's PM2.5 measurement during a
given PM2.5-PEP sampling event can be determined.
The PM2.5-PEP bias assessment is national in scope and incorporates several QA concepts and
practices. It is important to ensure that the PM2.5-PEP collects a statistically sufficient number of
data points to assess bias. The more samples and data collected, the larger the confidence in the
bias assessment; however, the amount of data must be balanced against the finite and limited
annual PM2.5-PEP funding.
The minimum number of PM2.5-PEP samples needed to detect a bias of ±10% depends on the
precision (i.e., the CV) of PM2.5 measurements and the (unknown) amount of bias actually
present. Neither of these statistics were well characterized at the onset of the PM2.5-PEP. Initially
based on a statistical review, the frequency of PM2.5-PEP sampling events was set at 25% of the
PM2.5 national monitoring network each year (i.e., each primary routine sampler in the network
was audited once every four years). This frequency was shown to be adequate to evaluate bias
for a typical reporting organization assuming initial estimates of sampler CV of less than 10%
and allowing for a 10% decision error.
In 2005, the minimum sampling frequency required to detect a 10% bias over three (3) years was
re-evaluated using acquired network data to get an improved estimate of CV and bias. A
background paper from 2005 on this re-evaluation is available here:
https://www.epa.gov/sites/production/files/2020-09/documents/pepreduction.pdf.
Using the updated estimates, EPA determined that approximately 24 PM2.5-PEP sampling events
in large networks over a 3-year period and 15 sampling events in relatively smaller networks
(i.e., 8 per year and 5 per year, respectively) would be adequate to evaluate a ±10% bias for a
reporting organization. This resulted in the current regulations (40 CFR Part 58, Appendix A,
Section 3.2.4) on minimum numbers of PM2.5-PEP sampling events for a PQAO to conduct
annually (see Section A6.4.2). Per 40 CFR Part 58 Appendix A Section 4(b), EPA assesses bias
in concentrations generated by the PM2.5 ambient air monitoring network annually at the PQAO
level.
A7.2 Data Quality Indicators and Associated Measurement Quality Objectives
Once DQOs are established, the quality of the data must be controlled and evaluated to ensure
that it is properly maintained at the required level. EPA establishes MQOs to evaluate and
control various phases (e.g., sampling, preparation, analysis) of the measurement process to
ensure that total measurement uncertainty is within the range recommended by the DQOs.
Within the PM2.5 national monitoring program, EPA has defined MQOs in terms of the following
data quality indicators (DQIs):
¦ Precision. A measure of mutual agreement in PM2.5 measurements possessing identical
properties, usually under prescribed similar conditions. Precision is typically expressed as
a standard deviation.
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o For the PM2.5-PEP, the impact of field activities on precision is assessed by
collocating samplers from each Region's or self-implementing PQAO's PM2.5-PEP
sampler fleet and comparing filter samples collected from each for a given sampling
day (see Section B5.4.1). These are colloquially known as parking lot studies as they
are often conducted in a parking lot.
o The impact of laboratory handling and analysis on precision is estimated through
duplicate filter weighing (e.g., batch duplicates - Section B5.1.2.2).
¦ Bias. The systematic or persistent distortion of a measurement process which leads to
error in PM2.5 measurements in one direction. Bias is determined by comparing these
measurements against a true or reference value, expressed as a percentage difference
(PD) from the true or reference value, and noting whether the difference is consistently
positive or negative.
o For the PM2.5-PEP, the impact of field activities on bias is assessed based on sampler
flow rate. The impact of flow rate on the collected mass is complex due to
relationship between the particle size separator and flow rate. Independent of the
particle size separator, a flow rate that is biased low (i.e., the indicated flow rate is
higher than the actual flow rate) will result in overestimation of the collected volume
and will bias the in-air concentration low, and conversely will underestimate in-air
concentrations when the flow rate is biased high. The particle size cut point of the
PM2.5-PEP separators (i.e., the size of the PM collected or excluded) is dependent on
the flow rate. The separators (VSCC or WINS) are manufactured to operate at the
design flow rate of 16.67 LPM, in which any deviation from the design value will
affect how precisely the particulate separators eliminate particles larger or smaller
than PM2.5 from the filtrate. When a sampler's flow rate is biased low (less than 16.67
LPM), particulates larger than 2.5 |im are collected on the filter leading to an
overestimate of the PM2.5 concentration. Conversely, when the flow rate is biased
high (greater than 16.67 LPM), the largest particulate collected is smaller than 2.5
|im, excluding desired particulates and leading to an underestimate of the PM2.5
concentration. Therefore, EPA requires one-point sampler flow rate checks prior to
each PM2.5-PEP sampling event and quarterly flow rate audits on each PM2.5-PEP
sampler.
o Field activity bias for the PM2.5-PEP is also assessed by periodic collection of FB and
TB filter samples. Evidence of contamination on FB and TB filters indicates the
positive bias that may be due to filter handling, sampling, and/or transport). Note that
such field QC filter samples only indicate the potential for positive bias and do not
imply when negative bias may be present due to field activities.
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o The PM2.5-PEP weighing laboratory controls its filter conditioning environment to
minimize temperature and humidity variation and to eliminate airborne dust to keep
filters pristine, minimizing bias impacts. Temperature and relative humidity (RH)
must be maintained within specified ranges and within variability tolerances during
filter conditioning prior to filter weighing to eliminate the bias imparted by moisture
variation on the filter mass. The laboratory also incorporates laboratory filter blanks
into analytical batches to verify that contamination is not introduced to filters during
the conditioning, handling, and analysis processes. Acceptance criteria established for
laboratory blanks, FBs, and TBs evaluate the potential for negative and positive bias.
Routine periodic balance checks are employed to ensure the microbalance
measurements are not unacceptably biased.
¦ Accuracy - Represents closeness of a measurement to "truth" (typically represented by
an accepted reference value). Accuracy combines random error (precision) and
systematic error (bias) components that result from sampling and analytical operations.
This term is used throughout the CFR and in some of the sections of this document.
o Because it is extremely difficult to make accurate real-time measurements of airborne
PM2.5, the accuracy of filter-based PM2.5 measurements are apportioned into separate
assessments of precision and bias.
¦ Representativeness. A measure of the degree in which data accurately and precisely
represent a characteristic of a population, parameter variations at a sampling point, a
process condition, or an environmental condition.
o To adequately characterize bias within the PM2.5 national monitoring network, each
PQAO must perform a specified number of annual PM2.5-PEP sampling events (refer
to Section A6.4.1.1). The PM2.5-PEP sample duration must coincide with the same
24-hour duration (± 1 hour) of the routine SLT monitoring organization sampler and
must meet the PM2.5 sampler collocation siting and inlet height requirements
specified in 40 CFR Part 58 Appendices A, C, and E.
o The number of PM2.5-PEP sampling events required per PQAO described in Section
A6.4.1.1 was determined to be adequately representative of the routine PM2.5
monitoring network to properly characterize the network bias.
¦ Detectability. The determination of the low-range critical value of a characteristic that a
method-specific procedure can reliably discern.
o The laboratory analysis method is the primary driver of detectability for the FRM as it
requires a minimum PM2.5 mass collected on the filter to detect the PM2.5 mass
reproducibly. This minimum mass also impacts the volume of air flow during a field
sampling event, which is a function of sampling duration (24 ± 1 hour) and the
sampler flow rate (16.67 LPM). The laboratory method must be capable of detecting
a PM2.5 concentration of 2 |ig/m3 (equivalent to a deposited filter mass of -48 |ig) as
specified in 40 CFR Part 50 Appendix L Section 3.1. EPA OAQPS has determined
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that based on the laboratory method capability to detect, with certainty, a 20-|ig
difference between pre-sampling tare weight and post-sampling weight, a
concentration of 0.8 |ig/m3 can be detected on sampled filters.
¦ Sensitivity. The capability of a method/instrument to discriminate between small
differences in concentration. More generally, sensitivity measures a method's response to
a change in input.
Instrument specification requirements drive the level of sensitivity obtained in the
PM2.5-PEP. The ability to attain measurements resolved by 0.1 |ig/m3 requires
balance measurement differences of approximately 2.4 |ig.
¦ Resolution. The smallest unit of measurement indicated by an instrument.
CFR Part 50 Appendix L defines many of the PM2.5-PEP instrument resolution
requirements. For example, a PM2.5-PEP sampler's barometric pressure sensor must
have a resolution of at least 5 mmHg.
¦ Completeness. A measure of the amount of valid data obtained from a measurement
system compared to the amount that was expected to be obtained under correct, normal
conditions. Data completeness requirements for the PM2.5-PEP are included in 40 CFR
Part 58 Appendix A.
o The PM2.5-PEP requires completion of 100% of the required minimum number of
valid PM2.5-PEP sampling events each year for each PQAO. Note that there are two
metrics for completeness - that there are valid samples collected that meet all
technical acceptance criteria and are not invalidated and, samples considered valid for
the purposes of inclusion in the bias assessment. The PM2.5-PEP does not require
100% completeness for valid samples for bias assessment. While EPA attempts to
ensure that collected PEP samples are those with PM2.5 concentrations > 3 |ig/m3, this
is outside of the program's control.
¦ Comparability. A measure of confidence with which data in one dataset are comparable
to data in another.
o Because PM2.5-PEP samples are collected and analyzed using the same or equivalent
procedures and with equal or more stringent acceptance criteria as in the national
monitoring network, the routine and PEP data are suitably comparable.
EPA has defined an MQO and associated acceptance criteria for each DQI which is applicable
for specific phases of the EDO. Parts of Guidance Document 2.12 11 have identified some of
these acceptance criteria. In theory, if these acceptance criteria are met, then measurement
uncertainty should be controlled to the levels required by the DQOs.
11 https://www.epa.gov/sites/default/files/2021-03/documents/pl00oi8x.pdf
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The PM2.5-PEP is essentially an independent national monitoring program. However, because it
has the added importance of producing data that can be used to estimate bias at the PQAO level,
its data quality requirements are more stringent than those in the national PM2.5 monitoring
program. Table A7-1 and Table A7-2 list the QC activities related to the MQOs and acceptance
criteria for field and laboratory activities, respectively, in the PM2.5-PEP.
Table A7-1. MQOs and Acceptance Criteria for PM2.5-PEP Field Activities
l)QI (;iU-»iir\
l"lVt|lll-|llA
.W'lvpliiiii'i' C 'rili-riii
kilViviui-
Sampling
Representativeness -
Sampling Period (duration)
Each PM2.5-PEP filter
1,440 minutes ± 60 minutes (24 hours ± 1
hour)
Midnight to midnight local standard time
concurrently with the routine sampler
Part 50 App. L,
Sect. 3.3
Data Representativeness
(total sampling events
performed each year)
Annually within a
PQAO
Completion of
- 5 valid PM2.5-PEP sampling events for
PQAOs operating
< 5 sites or
- 8 valid PM2.5-PEP sampling events for
PQAOs operating
> 5 sites
Part 58 App. A,
Sect. 3.2.4
Data Representativeness
(sampling events
performed per method
designation, i.e., sampler
type)
Annually within a
PQAO
Completion of 1 valid PM2.5-PEP sampling
event per primary method designation
Part 58, App. A,
Sect. 3.2.4.1
Data Representativeness
(sampling events
performed per site)
At least once every 6
years within a PQAO
Completion of 1 valid PM2.5-PEP sampling
event of each primary monitor
Part 58, App. A,
Sect. 3.2.4.2
Data Completeness
(percentage of required
number of PM2.5-PEP
sampling events
performed)
Annually within a
PQAO
100% (concentrations < 3 (ig/m3 do not
invalidate a sampling event for purposes of
completeness)
Part 58 App. A,
Sect. 3.2.4
Sampling Instrument Spcci/iciilinns
Detectability - Lower
Detection Limit
All data
Approximately 2 (ig/m3
Part 50, App. L,
Sect. 3.1
Bias - Sampler Flow Rate
For the 24-hour
sampling period
±4% of 16.67 LPM
Part 50, App. L,
Sect. 7.4.3.1
Bias - External Leak Check
Each PM2.5-PEP audit
< 80 mL/minc
Part 50, App. L,
Sect. 7.4.6.1
Bias - Internal Leak Check
If external leak check
fails
< 80 mL/minc
Part 50, App. L,
Sect. 7.4.6.2
< ollocalcil Sampler Siting < riteria
Sampler
Representativeness - Inlet
spacing
Each PM2.5-PEP audit
Inlet to inlet must be within 4 meters of each
other and at least 1 meter apart
Part 58, App. A,
Sect. 3.2.3.4(b)
Sampler
Representativeness -
Horizontal distance from
supporting structures
Each PM2.5-PEP audit
> 2 meters
Part 58, App. E,
Sect. 11
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Table A7-1. MQOs and Acceptance Criteria for PM2.5-PEP Field Activities (continued)
I)QI (;iU-»iir\
l"lVt|lll-|llA
.W'lvpliiiii'i' C 'rili-riii
kilViviui-
Sampler
Representativeness -
Distance from trees to inlet
probe
Each PM2.5-PEP audit
>10 meters from dripline of nearest tree
Part 58, App. E,
Sect. 11
Sampler
Representativeness -
Distance from high volume
(> 200 L/minute) sampler
Each PM2.5-PEP audit
> 2 meters from inlet of high volume sampler
Part 58, App. E,
Sect. 11
/'!/_ /Vivi'wVi/i (I \ing ( ulliu aleil Samplers)-'
Precision - Regional PM2.5-
PEP Collocation Events
2/year (semi-annual)
individual samplers with CV >10% are ilagged
and filters are reweighed to confirm. If CV
>20%, all sampler data are flagged from the
last precision check, corrective action
initiated, and impact on data assessed.
PM2.5-PEP
Requirement
Precision - Regional PM2.5-
PEP Collocation Events
2/year (semi-annual)
Any sampler with at least 2 and more than
50% of all relative notable differences over
the collocation event (which may consist of
several days) is flagged and require further
evaluation.
PM2.5-PEP
Requirement
/M'Sampler Interna! imills''
Bias - Sampler Flow Rate
Audit
4/year (quarterly)
Percent difference within ± 4% of transfer
standard
Percent difference within ± 4% of design flow
(16.67 LPM)
Part 50, App. L,
Sect. 9.2.5;
PM2.5-PEP
Requirement
Bias - Barometric Pressure
Audit
4/year (quarterly)
Within ±10 mm Hg of transfer standard
Part 50, App. L,
Sect. 7.4.9 and 9.3
Bias - Temperature Audit
4/year (quarterly)
Within ± 2°C of transfer standard
Part 50, App. L,
Sect. 7.4.8 and 9.3
I'M:. Illanhs
Bias - Field Blank
1 per PM2.5-PEP
sampling event (PEPs
< 2 years old) or 1 per
trip (all other
programs)
± 30 \ig difference between pre-sampling &
post-sampling
Part 50, App. L,
Sect. 8.3.7
Bias - Trip Blank
1 per PM2.5-PEP
sampling trip
± 15 \ig difference between pre-sampling &
post-sampling
PM2.5-PEP
Requirement
a Twice per year, all PM2.5-PEP samplers used by the Region or self-implementing PQAO must be collocated
(parking lot study) and 24-hour concentrations analyzed as described in Section B5.4.1.
b Quarterly audits are performed similarly to the verification checks conducted prior to every PM2 5-PEP sampling
event. However, the audits should (preferably) be conducted by a certified and experienced technician other than
the PM2 5-PEP FS that typically uses the specific sampler. Also, the working standard used during the audit must
be a different standard than that used during verifications or calibrations.
c PQ200 sampler leak check criteria is to check for 5 cm H20 of vacuum pressure loss over 2 minutes. The listed
leak check criteria are stated per CFR requirements. The internal leak check procedure is not needed if the
external leak check passes criteria, as the external leak check incorporates the portion of the flow path assessed
with the internal leak check procedure.
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Table A7-2. MQOs and Acceptance Criteria for PM2.5-PEP Laboratory Activities
.Uli\ il\
I""|V(|IK'IK'\
.\i'i'i'|)l;iiHv ( rik-ri;i
Ki'li'iviuv
llltcr < oinlilioniiix I '.iivirouiiiciit
Bias - Pre-sampling filter
equilibration
All filters
24 hrs minimum3 in weighing room;
<5 jug change between sequential
weighing of each filter
Part 50, App. L, Sect. 8.2
Bias - Post-sampling
filter equilibration
All filters
24 hr minimumb with 7-day
maximum0 from start of
equilibration to post-weighing
PM2.5-PEP Requirement
Part 50, App. L, Sect. 8.2
Bias - Filter
Equilibration
Temperature Range
All filters
24-hr mean 20 to 23°C; individual 5-
min averages between 18 and 25°C;
no more than ten 5-min averages
missing from a 24-hour period
Part 50, App. L, Sect. 8.2.1
Bias - Filter
Equilibration
Temperature Control
All filters
Standard deviation of 5-minute
averages < 2°C over 24 hr
Part 50, App. L, Sect. 8.2.2
Bias - Relative Humidity
Range
All filters
24-hr mean 30 to 40%;
Individual 5-minute averages must
be between 25% and 45%
Part 50, App. L, Sect. 8.2.3
Bias - Relative Humidity
Control
All filters
Standard deviations of 5-minute
averages < 5% over 24 hr; and 24-
hour mean within ± 5% RH between
pre- & post-weighing
Part 50, App. L, Sect. 8.2.4
Laboratory Oiialily < onlrol < liixl,\
Bias - Laboratory Filler
Blank
1 per every 10 fillers in a
weighing session
± 1 5 ,ug/liller change between
weighings
Part 50, App. L, Sect. 8.3.7
Bias - Lot Stability Test
20 filters weighed
approximately every 24 hours
over successive days for each
new lot of filter media
Establishes conditioning period
required for each lot of filters for
filter tare weights: mass difference
of ±15 (ig/filter between successive
weighings following 24-hour
conditioning periods for 19 of 20
filters
PM2.5-PEP Requirement
Precision - Intra-batch
duplicates
One exposed filter weighed
earlier in the weighing
session, one required per post-
sampling weighing session
±15 (ig/filter change between
weighings
PM2.5-PEP Requirement
Precision - Inter-batch
duplicates
One exposed filter weighed in
a previous weighing session,
one per post-sampling
weighing session
±15 (ig/filter change between
weighings
PM2.5-PEP Requirement
Bias - Low mass (less
than expected weight of
an un-exposed filter)
standard microbalance
check
Beginning/end every weigh
session and after every 10
filter mass measurements
± 3 (j.g from certified assigned mass
PM2.5-PEP Requirement
Bias - High mass
(greater than expected
weight of an un-exposed
filter) standard
microbalance check
Beginning/end every weigh
session and one after every 10
filter mass measurements
± 3 (j.g from certified assigned mass
PM2.5-PEP Requirement
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Table A7-2. MQOs and Acceptance Criteria for PM2.5-PEP Laboratory Activities
(continued)
.Wli\ ii\
C'rili-riii
Ki'li'iviuv
Bias - Balance
performance evaluation
(PE) audit d
2/yr
All masses must be within ± 3 jug of
the assigned certified mass
PM2.5-PEP Requirement
Bias - Interlaboratory
comparison e
2/yr
Advisory limits set by OAQPS
PM2.5-PEP
Recommendation
a The minimum pre-sampling equilibration time is determined per filter lot and is either 24-hrs or the equilibration
time determined during the lot stability test, whichever is larger.
bThe minimum post-sampling equilibration time is minimally 96 hours except in extenuating circumstances in
which case the minimum equilibration time will be 24 hours.
c Review of inter-batch duplicate data suggests significant weight loss due to semi-volatile evaporation occurs
after 7 days of equilibration in the weigh lab.
d Standard weights for performing balance PE audits should be independent of standard weights used for other
verification activities performed by the PM2.5-PEP Laboratory. PE audit conducted at discretion of OAQPS
PM2.5-PEP Lead.
e Round-robin performance evaluation administered by OAQPS.
A8 Training Requirements and Certifications
This section prescribes the training required for implementing the PM2.5-PEP to ensure that
specific operational skills for staff performing activities can be verified, documented, and
updated, as necessary. Staff responsible for providing training will incorporate up-to-date
knowledge regarding field and laboratory operations in training exercises.
While there is some overlap in the field and laboratory activities, this section is organized such
that field activities and laboratory activities are discussed separately.
OAQPS has developed a training program to ensure PM2.5-PEP personnel have a baseline level
of knowledge about the PM2.5 national monitoring network, the principles and operation of the
PM2.5-PEP, and their QA procedures, which includes the following:
¦ National-level conferences and training workshops
¦ In-person training at EPA facilities for hands-on experience and operational reviews
¦ National- and Regional-level conference calls
¦ Individual training sessions upon request.
¦ Use of the AMTIC and AirQA websites to post documentation including this QAPP, field
and laboratory SOPs, and other current materials used in PM2.5-PEP training.
EPA, through its Regional offices and headquarters, has access to multiple training facilities,
which provide the capacity to:
¦ Develop internal expertise in fine PM monitoring and gravimetric analysis.
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¦ Have monitoring equipment readily accessible to EPA staff for questions and concerns.
¦ Perform field and laboratory training for personnel at EPA, Regional offices, monitoring
organizations, and contractors.
¦ Perform special studies (study sampler performance, evaluate measurement uncertainty).
¦ Perform research studies for future monitoring activities.
A8.1 Field Scientist Training
Focused training for the PM2.5-PEP includes is required initially and annually thereafter for FSs
who conduct PM2.5-PEP sampling events. This training and successful demonstration includes
the following:
¦ Specific, extensive hands-on field activity training sessions sponsored and developed by
OAQPS and which involve FSs and/or LAs (supporting EPA Regions and self-
implementing PQAOs), Regional PM2.5-PEP Leads, and Regional staff (if they perform
PM2.5-PEP sampling events).
¦ A program to certify the participants of the training sessions that involves satisfactory
performance on a written test and an operational proficiency test. Unsatisfactory
completion of either of these tests results in additional training until the individual
achieves successful certification.
Note that the training requirements as prescribed in this section are applicable to both the
Regional PM2.5-PEP Leads and FSs as well as the PM2.5-PEP coordinators and FSs at each self-
implementing PQAO.
A 8.1.1 Field Scientist Trainers
Trainers are certified by OAQPS as qualified field operations trainers and include OAQPS
personnel from the AAMG QA Team, Regional PM2.5-PEP QA staff, and EPA Regional
contractors who are certified FSs for the PM2.5-PEP. Trainers are required to complete the same
training as FS complete and therefore attend the initial, comprehensive field training course,
complete the exams, and attend ongoing training courses and demonstrate continued proficiency.
The PM2.5-PEP OAQPS Lead or Regional Lead approves and certifies trainers.
A8.1.2 Initial Training for New Field Scientists
Before performing a PM2.5-PEP sampling event unsupervised, a new FS trainee will complete
training coursework as well as shadow a certified PM2.5-PEP FS on two PM2.5-PEP sampling
events.
The FS trainee will attend the initial comprehensive PM2.5-PEP Field Operations training course.
Typically, the course is conducted annually at OAQPS headquarters; however, if there is a need
for a new trainee to perform PM2.5-PEP sampling events unsupervised before the next available
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national initial training course, at the discretion of the OAQPS PM2.5-PEP Lead, the training
course may be administered by an EPA Regional PM2.5-PEP Lead certified trainer (with
assistance from a Regional PM2.5-PEP contractor certified trainer, if available).
The FS will also attend two PM2.5-PEP sampling event trips with a certified FS and/or their
Regional PM2.5-PEP Lead as part of the initial training and certification. On the first sampling
event, the trainee observes the relevant field activities performed by the trainer: sampler
transport, sampler setup, verification of the sampler calibration and operation (temperature,
pressure, and flow rate, etc.). On the second sampling event, the trainee performs the relevant
field activities under the supervision of the trainer. Based on assessment by the trainer, the
trainee may need to attend additional sampling events to gain familiarity with the equipment and
procedures prior to successful training completion.
A8.1.2.1 Initial Comprehensive PM2.5-PEP Field Operations Proficiency Training Course
The Initial Comprehensive PM2.5-PEP Field Operations Proficiency Training Course typically
occurs over three full days where trainees attend lecture, observe trainers, and practice
conducting procedures to gain and strengthen familiarity with the equipment and procedures.
The training course covers the following topics:
¦ Introduction to PM2.5 monitoring for compliance with NAAQS
¦ QA requirements for monitoring PM2.5 for compliance with the NAAQS
¦ Introduction to the PM2.5-PEP
¦ Planning and preparation
¦ Filter receipt, storage, and handling
¦ Communications with the PM2.5-PEP weighing laboratory
¦ Sampler transport, placement, and assembly
¦ Equipment calibration verifications and checks
¦ Programming a sampling event
¦ Filter exposure and retrieval and concluding the sampling event
¦ Use of COC and FDS forms
¦ Use of the AirQA website to review the sampling event data for verification and
validation
¦ PM2.5-PEP QA/QC procedures and documentation retention
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¦ Troubleshooting in the field.
The training course consists of:
(a) classroom instruction,
(b) hands-on practice of field operational procedures,
(c) a proficiency exam to perform field procedures detailed in the Field Performance
Examination Checklist, and
(d) a written, open-book exam.
Trainees must score > 90% on both the field proficiency and written exams to achieve
certification. Trainees can revisit exam questions or repeat demonstration of procedures until
satisfactory performance is demonstrated to the examiner.
A8.1.3 Annual PM25-PEP Field Operations Proficiency Recertification Training
Each year the OAQPS PM2.5-PEP Lead, in consultation with the Regional PM2.5-PEP Leads,
determine the need, schedule, and agenda topics for a recertification training workshop. The
preferred format for the training is an in-person classroom instruction; however, a webinar
format may be necessary if travel ability is limited. The main objective of the training workshop
is to supplement and refresh FS skills and to verify FS recertification by proficiency testing.
Additional training objectives include: providing instruction on new operating procedures in the
laboratory and field, communicating developments in data management (such as the
implementation of MoPED), and communicating programmatic changes due to regulatory
changes or revisions in national QA policy and guidance. Attendance is mandatory for EPA
contractor FSs and it is encouraged for participating self-implementing PQAO agencies. In cases
where PQAO agencies cannot attend in person, they will be given an opportunity to participate
through web-based audio/video technology, as available. If there are individuals that cannot
attend, a separate follow-up session may be scheduled by the OAQPS PM2.5-PEP Lead and
respective Regional counterpart. Regional PM2.5-PEP Leads are encouraged to attend at least
every other year (refer to Section A8).
A8.1.3.1 Field Scientist Training Recertification
For the FS to successful demonstrate proficiency for recertification, the FS will score > 90% on
both the practical and written exams, which are typically conducted at the conclusion of the Field
Operations Proficiency Recertification Training workshop. Upon evaluating the exam scores, if
more than 5% of those tested (FS and Regional Leads) cannot achieve > 90% on the exams, then
the exam materials or training presentation materials and hands-on instruction activities may be
adjusted. The OAQPS PM2.5-PEP Lead and Regional Leads will confer and determine whether to
revise the exam questions and/or presented materials and instruction to improve communication
of concepts and requirements.
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If the certification activities identify individuals who appear to be incapable of properly
performing the field activities, the Regional PM2.5-PEP Lead and RPOs are notified so remedial
action can be taken.
A8.2 PM2.5-PEP Weighing Laboratory Analyst Training
PM2.5-PEP weighing LAs will undergo initial training before performing PM2.5-PEP filter
preparation activities unsupervised and, once certified, will undergo annual training to
demonstrate continued proficiency. Training consists of a practical demonstration of proficiency
and attendance at a training session workshop. The PM2.5-PEP Weighing Laboratory Manager or
properly trained designee will serve as the trainer.
A 8.2.1 Initial Training for New PM2. s-PEP Weighing Laboratory A nalysts
New PM2.5-PEP weighing LAs are required to undergo initial training before performing PM2.5-
PEP filter preparation activities unsupervised. Initial training consists of attending a practical
training session and two filter life cycle sessions with a certified trainer (e.g., another LA or the
PM2.5-PEP Weighing Laboratory Manager) where the trainee observes for the first filter life
cycle session and then performs the procedures for the second life cycle session under the
supervision of a trainer. Initial training is complete if the trainer determines the trainee
satisfactorily demonstrated proficiency of procedures on the second filter life cycle training
session. The Weighing Laboratory Performance Examination Checklist (maintained by the
OAPQS PM2.5-PEP Lead) provides guidance for the initial training.
The trainee is required to attend the next available Initial Comprehensive PM2.5-PEP Field
Operations Proficiency Training Course held at an EPA-operated facility (e.g., OAQPS
headquarters at RTP, North Carolina, or a Regional facility).
A8.2.2 Laboratory Analyst Practical Training
Laboratory analyst certification training for routine PM2.5-PEP filter preparation and weighing
activities consists of two full days of training at an OAQPS-designated PM2.5-PEP weighing
laboratory. Laboratory analyst training includes the life cycle training described above as well as
the following topics:
¦ General laboratory activities including facilities and filter handling
¦ Communications with FSs and laboratory management
¦ Filter conditioning, including overview of the weighing laboratory climate control system
and the requirements before performing a filter weighing session
¦ Filter weighing (static elimination, filter handling, balance operation)
¦ COC and FDS forms and their features
¦ PM2.5-PEP PED and data handling software (such may include LIMS or MoPED upon
release)
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¦ AirQA website
¦ QA/QC of filter weighing activities including parameters and action levels for the
balance as well as the standard masses and their treatment in the laboratory
¦ Equipment inventory and maintenance
¦ Equipment calibrations (balance, standard weights, environmental monitoring)
¦ Filter shipping
¦ Data entry into the PM2.5-PEP PED and other software systems (e.g., LIMS or MoPED
upon release) and data transfer
¦ Information retention schedules storage and archiving
¦ Filter archiving
¦ Troubleshooting of equipment and software.
A8.2.2.1 Laboratory Analyst Filter Life Cycle Training
Filter life cycles encompass the steps involved from inspection of new filters through final post-
sampling filter weight measurements and include the data entry and associated QA/QC practices.
Specifically, these include: filter inspection, filter equilibration, pre-sampling filter weighing,
loading the filter into a cassette, generating a COC form, filter packaging and shipping, post-
sampling filter weighing, and input of gravimetric measurements and associated QA/QC data
into the PED and other software (e.g., LIMS or MoPED once released).
Filter life cycle training involves demonstration of the procedures for the purposes of instruction
(i.e., to a new LA trainee) or evaluation of the individual performing the procedures (as
performed for certification of a certified LA).
A8.2.3 Laboratory Analyst Attendance at Annual PM25-PEP Field Scientist Training
Session
The LA is expected to provide a formal or informal report in each annual field operations
recertification workshop (this report may be made in person or via digital communications).
This report will include procedures that are operating satisfactorily and those that require
improvement (e.g., issues internal to the weighing laboratory, issues associated with the FS-lab
interface such as issues with filter ordering or shipping/receipt).
A8.2.4 Laboratory Analyst Training Demonstration of Proficiency
LAs will take a practical exam to demonstrate proficiency for certification and must achieve a
score of > 90%. If the certification activities identify individuals who appear to be incapable of
properly performing the laboratory activities, the Regional PM2.5-PEP Lead Laboratory Manager
are notified to initiate remedial action.
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A8.3 Certification of Regional PM2.5-PEP Leads and Field Scientist Trainers
Regional PM2.5-PEP Leads have critical responsibilities in the implementation of the PM2.5-PEP
among which is the potential need to train their contractors and participating PQAO field
personnel. They are required to concur on the certification of their Region's PM2.5-PEP FSs as
trainers for FS personnel such as new FS or FS that could not attend the annual certification
workshop (such as newly hired contractor FS or self-implementing PQAO PM2.5-PEP FSs). The
Regional Leads should also maintain their knowledge of current issues and changes in equipment
and/or PM2.5-PEP procedures, and changes in regulations or policies that affect the
implementation of the PM2.5-PEP or the validation and use of the resulting data for network bias
assessments. Table A8-1 presents the training events that Regional PM2.5-PEP Leads will attend
to obtain and maintain their status as qualified PM2.5-PEP Lead and PM2.5-PEP trainer. The
OAQPS PM2.5-PEP Lead or designee will approve the certification of each trainer.
Table A8-1. Training Events for Maintaining Qualification as a PM2.5-PEP Lead and
Trainer
Course and Level of Proficiency
Initial Comprehensive PM2.5-PEP Field Operations Proficiency Training Course
Score of > 90% on written and performance exams
Annual PM2.5-PEP and NPAP Regional Leads, co-leads, and self-implementing PQAO
PM2.5-PEP coordinators
Score of > 90% on written exam a
Annual PM2.5-PEP Field Operations Proficiency Recertification Training
Annual Regional PM2.5-PEP Lead and PQAO PM2.5-PEP Coordinators Recertification
Webinar b
a 1-day training course that pertains to the unique responsibilities of the Regional PM2.5-PEP Leads. This course can be held
annually based on installation of new PM2.5-PEP Leads or back-ups. It may be taught in advance of an annual training for FSs or
it may be held as a separate webinar.
b The annual EPA Regional PM2.5-PEP Lead and PQAO PM2.5-PEP Coordinator Recertification Webinar, hosted by OAQPS, is
generally an abbreviated version of the PM2.5-PEP FS recertification training, and topic updates generally specific to this group's
responsibilities.
A8.4 Additional Ambient Air Monitoring Training
Additional supplemental training for PM2.5 air monitoring and QA/QC training is offered through
the following organizations:
¦ OAQPS staff within AAMG
¦ Air and Waste Management Association (AWMA) (http ://www.awma.org)
¦ EPA Air Pollution Training Institute (APTI) (http://www.epa.gov/apti)
¦ EPA Office of Environmental Information (OEI)
(http://www.epa.gov/quality/trcourse.html)
¦ EPA Regional offices.
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Such training may consist of classroom lectures, workshops, teleconferences, and on-the-job
training. Table A8-2 presents a sequence of core ambient air monitoring and QA courses for FSs
and Regional QAMs (the latter marked with a single asterisk). The suggested course sequences
assume little or no experience in QA/QC or air monitoring.
Table A8-2. Supplemental Training Courses in Ambient Air Monitoring and QA
Sl'(|lll'IKY
C 011 r\i' Tilli- (Si-IT InsiriK'iiiiiiiil |SI|)
Cull I'M' II)
NiiihIkt
Si ill I'l l'
1*
Air Pollution Control Orientation Course, SI-422
422
APTI
2*
Principles and Practices of Air Pollution Control, 452
452
APTI
3*
Introduction to EPA Quality System Requirements
—
OEI
4*
Introduction to Ambient Air Monitoring, SI-434
434
APTI
5*
General Quality Assurance Considerations for Ambient Air Monitoring
(under revision), SI-471
471
APTI
6*
Quality Assurance for Air Pollution Measurement Systems, 470
470
APTI
7*
Introduction to Data Quality Objectives
—
OEI
8*
Introduction to Quality Assurance Project Plans
—
OEI
9
Atmospheric Sampling, 435
435
APTI
10
Analytical Methods for Air Quality Standards, 464
464
APTI
11
Chain-of-Custody Procedures for Samples and Data, SI-443
443
APTI
*
Introduction to Data Quality Assessment
—
OEI
*
Introduction to Data Quality Indicators
—
OEI
*
Assessing Quality Systems
—
OEI
*
Detecting Improper Laboratory Practices
—
OEI
*
Beginning Environmental Statistical Techniques, SI-473A
473
APTI
*
Introduction to Environmental Statistics, SI-473B
473B
APTI
*
Interpreting Monitoring Data
—
OEI
*
Interpreting Multivariate Analysis
—
OEI
*
Quality Audits for Improved Performance
QA6
AWMA
Air Quality System (AQS) Training
**
OAQPS
*
Federal Reference Method Performance Evaluation Program Training
(field/laboratory)
QA7
OAQPS
*
PM2 5 Monitoring Implementation (video)
PM1
OAQPS
* Courses recommended for Regional QAMs
** Information on AQS training is available at https://www.epa.gov/aas/aas-training
APTI courses are available at: https://www.apti-learn.net/LMS/EPAHomePage.aspx?m=l&n=Q
A8.5 Training Requirements for Self-Implementing PQAO Staff
PQAO staff performing PM2.5-PEP sampling events must undergo the training described for their
EPA counterparts in Sections A8.1 and A8.3. Completion of these training certifications is one
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of the program adequacy requirements for acquiring self-implementation status. The Regional
PM2.5-PEP Lead can work with the OAQPS PM2.5-PEP Lead to provide the Initial
Comprehensive PM2.5 Field Operations Proficiency Training Course for the PQAO personnel.
Self-implementing PQAO partners are encouraged to attend annual PM2.5-PEP recertification
workshops and webinars. In particular the PQAO PM2.5-PEP coordinators are expected to
provide briefings to their PQAO QA field personnel that are unable to attend. Similarly, contract
vendors that support self-implementing PQAO organizations are subject to the same training
requirements. Self-implementing PQAO staff and their support staff are encouraged to attend the
annual training sessions described in the sections above.
A9 Documentation and Records
The purpose of this section is to define the records that are critical to the PM2.5-PEP, the
information to be included in data reporting packages, data reporting formats, and document
control procedures to be used.
From a records management perspective, the following terms are defined:
¦ Document: A volume containing information that describes, defines, specifies, reports,
certifies, or provides data or results pertaining to environmental programs.
¦ Records: As defined in the Federal Records Act of 1950 and the Paperwork Reduction
Act of 1995 (now 44 U.S.C. 3101-3107), this term refers to "...books, papers, maps,
photographs, machine readable materials, or other documentary materials, regardless of
physical form or characteristics, made or received by an agency of the U.S. Government
under Federal Law or in connection with the transaction of public business and preserved
or appropriate for preservation by that agency or its legitimate successor as evidence of
the organization, functions, policies, decisions, procedures, operations, or other activities
of the Government or because of the informational value of data in them..."
¦ Reporting package: All information required to support the PM2.5-PEP concentration data
reported to EPA. This information includes all data required to be collected, as well as
other data which the PM2.5-PEP deems important.
EPA's Records Management Policy (https://www.epa.gov/sites/production/files/2015-
03/documents/cio-2155.3.pdf) clarifies requirements under the Federal Records Act. Regional
PM2.5-PEP Leads, FSs, and self-implementing PQAO staff are encouraged to refer to EPA's
Records Management Policy for any questions related to the creation, management, and
destruction of EPA records that are not addressed in this section. Table A9-1 lists the categories
and types of PM2.5-PEP records and documents that are applicable to document control within
EPA's quality system. They are filed according to the statute of limitations discussed in Section
A9.4 below.
A9.1 Information Included in the Reporting Package
A9.1.1 Data Reporting Package Format and Document Control
The PM2.5-PEP records management system is structured to satisfy requirements in EPA's
National Records Management Program (https://www.epa.gov/records). A file plan lists office
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records and describes how they are organized and maintained. A good file plan is a key
component of a recordkeeping system and leads to a successful records management program
through:
¦ Effective documentation of activities
¦ Consistent record identification
¦ Quick retrieval of records
¦ Ability to determine the disposition of records no longer needed
¦ Ability to meet statutory and regulatory requirements.
The PM2.5-PEP records management system uses Agency File Codes (AFCs) to facilitate easy
retrieval of information during TSAs and reviews. Individual EPA Regions and/or self-
implementing PQAOs may use a filing system other than AFC (e.g., Technical Direction Form
[TDF]) so long as it is equivalent in functionality and allows for appropriate responses to
interrogatories, TSAs, and/or other reviews. All filing system language and codes herein refer
specifically to the AFC system.
The PM2.5-PEP records management system follows official EPA records schedules, which
constitute EPA policy on how long to retain Agency records and appropriate disposition. For
more information on EPA records schedules, refer to https://www.epa.gov/records/epa-records-
schedules-detailed-information.
To archive the information as a cohesive unit, the PM2.5-PEP records management system files
each item from Table A9-1 under the major code "PM2.5-PEP," followed by the AFC function
code and the schedule numbers listed in Table A9-2.
Table A9-1. Critical Documents and Records in the PM2.5-PEP
CsiU'Sion
Kccorri/Dociimcnl T\pes
Management and organization
State Implementation Plan
Reporting agency information
Organizational structure
Personnel qualifications and training
Training certification
Quality Management Plan
Document Control Plan
EPA directives
Grant allocations
Support contract
Site information
Network description
Site characterization file
Site maps
Site pictures
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Table A9-1. Critical Documents and Records in the PM2.5-PEP (continued)
( alcgon
Kccurd/Duciimcnl T\ pes
Environmental data operations
Quality Assurance Project Plans
Standard operating procedures
Field and laboratory notebooks
Sample handling/custody records
Inspection/maintenance records
Raw data
Any original data (routine and QC data), including data entry forms
Data reporting
Air Quality Index Report
Annual state and local monitoring stations' air quality information
Data/summary reports
Journal articles/papers/presentations
Data management
Data algorithms
Data management plans/flowcharts
PM2.5 data
Data management systems
QA
Network reviews
Control charts
Data Quality Assessments
QA reports
System audits
Response/corrective action reports
Site audits
Table A9-2. PM2.5-PEP Reporting Package Information
Agcno l-'ile Code"
I'linclion
Cock'
Schedule #
Calcgon
Kccord/Documcnl T\pes
301-093
006
Program Management Files
006.1
Management
and organization
• Organizational structure for EPA and how the Regions and
contractors fit into running the PM2.5-PEP
• Organizational structure for the support contractors
• PEP project plans and subsequent revisions
• Quality Management Plan
006.2
Monitoring site
information
• Site characterization file (Site Data Sheets)
• Site maps and pictures
• SLT site contact information
006.3
Field operations and
data acquisition (by
EPA Regional staff or
contractors on behalf of
EPA)
• QAPPs and SOPs
• Field logbooks and communications
• Sample handling/COC forms
• Documentation of instrument inspection and maintenance
• Field testing of PM2.5-PEP equipment
006.4
Communications
(contractor technical
project activity)
• Telephone record and e-mail between contractors and SLT
organizations, and between contractors and the Contracting
Officer's Representative (COR)
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Table A9-2. PM2.5-PEP Reporting Package Information (continued)
Agencj File C(t(k';l
Function
Cock'
Schedule #
Calegon
Kccord/Dociimcnl T\pes
301-093
006.5
Communications (EPA
project activity)
• Telephone record and e-mail between EPA Regional or
Headquarters staff and SLT organizations, vice versa
• Telephone record and e-mail between EPA Regional and
other EPA personnel (Headquarters to Regions, vice versa)
006.6
Equipment/instruments
used by contractors in
the PM2.5-PEP (time
records would
reference AFC 405-
202)
• Procurement logs
• Inventories of capital equipment, supplies, consumables
• Repair and maintenance (e.g., vendor service records,
calibration records)
• Retirement or scrapping
Ageno File Code "
I'linclion
Code
Function
(ode
Ageno File Code"
Kccord/Dociinicnl Tjpes
405
202
Contract Management Records
202.1
Contract administration
• Work assignments, task orders, delivery orders, work plans
• Contractor monthly reports
• Technical directives from the COR to the contractor
• Invoices for consumables
• Requisite qualifications of FSs and LAs for PM2 5-PEP,
contractor-implemented activities
• Training records and certificates of contractors conducted
and issued by the EPA Regional COR
404-142-
179
Special Purpose Programs
01
179.1
Data administration
and integration
• Data management plans/flowcharts
• Raw data: any original data (routine and QC data), including
data entry forms
• Data algorithms
• Documentation of PM25-PEP database (PED)
(national/Regional level)
• PM2 5 PED data
• COC forms
404-142-
173
Data Files Consisting of Summarized Information
01
173.1
Data summaries,
special reports, and
progress reports
• Data/summary/monthly field activity reports
• Journal articles/papers/presentations
• Data validation summaries
108-025-
237
State and Local Agency Air Monitoring Files
01-01
237.1
QA/QC Reports
• Annual and 3-year PM25-PEP QA reports
• PEP Data Quality Assessments
• Other QA reports
• Response/corrective action reports
• Reports of site audits
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Table A9-2. PM2.5-PEP Reporting Package Information (continued)
Aiicno l-'ilc Code;|
l-'unclion
Code
l-'unclion
(ode
Ajicno l-'ilc ( ode;|
Kccord/Dociimcnl Tjpes
405
036
Routine Procurement
036.1
Acquisition of capital
equipment and supplies
by EPA (either
Headquarters or
Regional office)
• Needs assessments and reports
• Program copies of purchase requests
• Requests for bids or proposals
• Proposals, bids, or quotations
• Bills of lading
• Warranties and certificates of performance
• Evaluations of proposals, bids, quotations, or trial
installations
403-256
122
Supervisors' Personnel Files and Duplicate Official Personnel Folder Documentation
122.1
Personnel
qualifications, training,
and certifications
• Regional PM2.5-PEP Lead training certifications
• Certification as a PM2.5-PEP FS and/or LA
• Certification as a PM2.5-PEP FS trainer and/or LA trainer
a Regions and self-implementing PQAOs are not required to use the AFC system and may choose to use filing
system equivalent in functionality.
For example, according to Table A9-2,
¦ PM2.5-PEP project plans would be filed under the heading "PM2.5-PEP/301-093-006.1"
¦ COC forms would be filed under "PM2.5-PEP/301-093-006.3."
A9.1.2 Field and Laboratory Record Notebooks
The PM2.5-PEP requires each FS and LA to keep and maintain a record notebook (logbook) to
record field and laboratory activities. Each notebook will be uniquely numbered and associated
with the individual for the PM2.5-PEP. Although dedicated data entry forms are associated with
all routine environmental data operations, these record notebooks can be used to record
additional information about operations. In the laboratory, notebooks may also be associated
with the temperature and humidity recording instruments, cold storage (refrigerator) units,
calibration equipment and standards, and the analytical microbalances used for this program.
Notebooks should be used to record service dates and notes, records of certification, internal
audits, repairs or adjustments, replacements, cleaning, calibrations, etc.
A9.1.3 Electronic Data Collection and Archiving
Data collected electronically include data captured without the use of an individual employing
pen and paper, i.e., by an electronic system. Such electronically collected data include: data
logged by samplers during sample collection (recording flow rates, temperatures, etc.), balance
readings electronically recorded into the PED, measurements logged by environmental
temperature and relative humidity monitoring systems, and hand-entered data such as sample
observations entered into a computer into the PED or other electronic data software system (e.g.,
LIMS or MoPED).
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For the PM2.5-PEP weighing laboratory, these primary electronic data sources are required to
determine the PM2.5-PEP concentration, therefore must be acquired and maintained according to
the processes in Sections B9 and BIO. If electronic data need to be revised or edited based on
additional information, the PM2.5-PEP laboratory will follow Section B9 to determine whether
the captured field data are fit for use or should be invalidated.
The electronic data files captured from the PM2.5-PEP samplers during each PM2.5-PEP sampling
event (or other activities that characterize a sampler's reported data quality) serve as an official,
permanent record (e.g., data that lead to significant findings or conclusions). Therefore, they are
to be submitted to EPA and filed as a data reporting package within the PM2.5-PEP records
management system. This ensures that all PM2.5-PEP data are properly archived. They are also
archived at their respective Regional offices. Section A9.4, and Section BIO contain more
information on this process.
A9.1.3.1 Electronic Performance Data Tracking
Calibration verifications, performance audits, and calibrations of the PM2.5-PEP sampler (BGI
PQ200) are tracked on the AirQA website. AirQA also tracks the annual accuracy certification,
quarterly maintenance checks, and annual audits of the NIST traceable primary and transfer
standards used in PM2.5-PEP sampler verifications, audits, and calibrations. AOS andMoPED,
once implemented, will also maintain up-to-date information on samplers andfield calibration
standards. Each Region and self-implementing PQAO is expected to maintain a workbook of
calibration verification results of every PM2.5-PEP sampler as well as quarterly maintenance
checks and annual calibrations.
A9.1.4 Hand-Recorded Data
The PM2.5-PEP has implemented data processes that minimize the need for manual entry of data
as well as the chance of transcription and other clerical errors; however, FS are still required to
record some information by hand, such as to complete the sample COC/FDS. Information
recorded by hand must be legibly recorded using indelible ink. Necessary corrections are made
by inserting one line through the incorrect entry, placing the correct entry alongside the incorrect
entry by providing the information nearby or associated by annotation, and initialing and dating
the correction. If the rationale for the correction is not obvious, the individual making the
correction will notate the rationale to the correction.
PM2.5-PEP QA/QC data are generally stored in a digital format within the PED; however, paper
forms and logbooks are currently used for activities such as cleaning, quarterly performance
testing, calibration, and annual certification of samplers. Additionally, due to the design of the
PED user interface, the LA must select filter IDs by dropdown menu, which increases the
likelihood of incorrect filter ID selection. For this reason, the PM2.5-PEP LA hand records all
balance measurements on a dedicated form. These hand-recorded weight measurements are
maintained in the event there are data subject to invalidation, in such cases the Laboratory
Manager or Laboratory Task Monitor will consult the hand-recorded data to verify an electronic
record. The hand-recorded data are considered to be the primary data source and a representative
amount (approximately 10%) of the hand-recorded data are verified during data reviews.
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A9.1.5 E-mail and Text Messages
EPA's Records Management Policy (available at:
https://semspub.epa.gov/work/HQ/190129.pdf) provides the following guidance on the proper
use and management of e-mail and text messages:
"Official Agency business should first and foremost be done on official EPA
information systems. The FRA now prohibits the creation or sending of a federal record
using a non-EPA electronic messaging account unless the individual creating or sending
the record either: (1) copies their EPA email account at the time of initial creation or
transmission of the record, or (2) forwards a complete copy of the record to their EPA
email account within 20 days of the original creation or transmission of the record.
These FRA requirements are designed to ensure that any use of a non-EPA information
system does not affect the preservation of federal records for FRA purposes, or the
ability to identify and process those records if requested under the Freedom of
Information Act (FOIA), Privacy Act or for other official business (e.g., litigation,
congressional oversight requests, etc.). EPA strongly discourages the use of personal
email or other personal electronic messaging systems, including text messaging on a
personal mobile device, for sending or receiving Agency records, but to the extent such
use occurs, the individual creating or sending the record from a non-EPA electronic
messaging system must copy their EPA email account at the time of transmission or
forward that record to their EPA email account within 20 days of creation or sending.
Additionally, EPA discourages the use of text messaging on a mobile device for sending
or receiving substantive (or non-transitory) Agency records. However, EPA recognizes
that some Agency staff perform time-sensitive work that may, at times, require the
creation of substantive (or non-transitory) records in the form of text messages for
emergency or environmental notification purposes. In those limited instances, staff must
continue to save and manage any text message records related to their work.
A9.2 Laboratory Data Format for Uploading to AQS
Under the PED paradigm, the OAQPS QA Support Contractor extracts validated ambient
concentration results from the PED, converts the derived concentration data to a format accepted
by AQS, and uploads the data to AQS.
Once MoPED is in place, the PM2.5-PEP weighing laboratory LIMS software application
will extract and submit validated data to AQS via a browser-based upload tool found here:
httys://aqs.eya.sov/auditor upload. The analytical results must be a .csvfile type, and the
formatting must match that described in Table A 9-3.
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Table A9-3. PM2.5-PEP Weighing Laboratory Data Description for AQS Upload via
Browser-based Tool
Column 1 lender
l.\;unple En in
Description
Piv-Siimpliii" 1 'siiv \l;iss
Filter_ID
Tlllllll
Sample filter ID; an eight (8) character string starting with 'T'
and followed by 7 numerical digits
PreWeightDate
20191007 09:44
Date and time of pre-sampling weighing, formatted
YYYYMMDD HH:MM (in 24-hour clock time)
UnitsCode
131 a
AQS unit code For tare filter mass under the MoPED Regime
the unit code =131 (milligrams)
PreWeight
378.417
Mass (in milligrams) of tared filter
ExpirationDate
20191106 08:44
Filters must be exposed in a sampling event by this date/time
(formatted YYYYMMDD HH:MM [in 24-hour clock time])
or they must be reconditioned and pre-weighed again or
discarded
Posl-Sjiiiiplinii l-'illi'iilc Miiss
Filter_ID
Tlllllll
Sample filter ID; an eight (8) character string starting with 'T'
and followed by 7 numerical digits
AnalysisDate
20191017 00:04
Date and time of post-sampling weighing, formatted
YYYYMMDD HH:MM (in 24-hour clock time)
UnitsCode
131 a
AQS unit code. For exposed filter mass under the MoPED
Regime the unit code =131 (milligrams)
PostWeight
459.725
Mass (in milligrams) of the filter post-sampling
a Currently, the filter pre-sampling (tare) weight and post-sampling weight are not input to AQS. The data submitted
to AQS consists of the concentration value, for which the Units Code is 001, |ig/ml calculated from the mass
difference between the pre-sampling and post-sampling weights normalized to the collected sample volume during
the 24-hour PEP sample event.
A9.3 Data Archiving and Retrieval
FSs supporting PM2.5-PEP field activities retain the data reporting package according to the
archival policies for filters, data, and records listed in Table A9-4, for a four (4) year period
ending on the last day of the calendar year in which the fourth-year ends. For example, all data
collected in calendar year 2019 are archived until December 31, 2023. Upon reaching the end of
the four (4)-year data retention period, the FS (and/or supervisor if a contractor) informs the
OAQPS PM2.5-PEP Lead and the Regional PM2.5-PEP Lead that the material has met the archive
limit and asks for a decision on whether further archiving is necessary, or disposal should occur.
Some FS support contracts may require a retention time longer than four (4) years, in which case
the data/materials must be archived for this extended period before disposal.
The PED data will be archived indefinitely, and PED audit trail records will be maintained
minimally for 4 years.
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Table A9-4. Archive Policies for Filters, Data, and Records within the PM2.5-PEP
I);ilii T\|H'
Medium
l.ociilion
KiMcnlinn Time ¦'
l-'iiiiil Disposition h
Weighing records; COC
forms
Hard copy
Laboratory
> 2 full calendar years
(January through
December) in laboratory
facility, after which
archived in offsite archive
facility for 30 years
Discarded, with
permission from OAQPS
Laboratory notebooks
Hard copy
Laboratory
> 2 full calendar years
(January through
December) in laboratory
facility, after which
archived in offsite archive
facility for 30 years
Discarded, with
permission from OAQPS
Field notebooks
Hard copy
Air Quality
Division
> 4 years
Discarded
PED or LIMS Database
(excluding audit trail
records)0
Electronic
(network
drive)
Air Quality
Division
Indefinite
Back-up media retained
indefinitely
PED or LIMS audit trail
records0
Electronic
(back-up
tapes)
Air Quality
Division
> 4 years
Discarded
Weighing laboratory and
filter storage
environmental records
Electronic
and hard
copy
Air Quality
Division
Indefinite
Back-up media retained
indefinitely
Field transfer standard
calibration records
Electronic
and hard
copy
Air Quality
Division
Indefinite
Back-up media retained
indefinitely
Filters following post-
sampling weighing
Filters
Laboratory
> 4 years; 1 full calendar
year at 4°C, and then 3
additional calendar years
at ambient temperature
Discarded
" Some individual contracts may require a retention time longer than four (4) years, in which case the data/materials
must be archived for this extended period before disposition.
bOAQPS may request data retention times greater than four (4) years in unique situations, e.g., response to the New
Horizon oil spill during cleanups.
0 A commercial LIMS is not in place at the PM2.5-PEP weighing laboratory at the time this document was
distributed. The compiled Microsoft Access data base and reporting program called the PED has served the PM2.5
PEP as a LIMS for the life of the program beginning in 1999.
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B Data Generation and Acquisition
B1 Sampling Design
The section describes components of the PM2.5-PEP sampling design, the key parameters to be
evaluated, the number and types of samples to be expected, and how the samples are to be
collected.
Bl.l Scheduled Project Activities, Including Measurement Activities
If the PM2.5-PEP event adheres to the prescribed timeline with no interferences or internal
delays, the PM2.5-PEP sampling event data can be made available in AQS approximately 40 days
after a PM2.5-PEP sampling event. Historical timelines indicate PM2.5-PEP data are typically
available in AQS after approximately 60 days.
The successful implementation of the MoPED should enable more consistent achievement of
the 40-day objective.
Table B1-1 contains the general elapsed timeline from the end of the PM2.5-PEP sample
collection period to availability of the PM2.5-PEP data in AQS.
Table Bl-1. Milestones from PM2.5-PEP Sample Retrieval to Availability in AQS
Mik-slom-
1 illlclVilllH*
Retrieval of PM2.5-PEP filter sample
and sampler logged data
Within 24 hours of the end of sample collection is best practice. Make-
up events near year end or calamities may dictate up to 48 hours on
holidays or weekends, longer must be justified by Regional PEP Lead;
e.g., a medical emergency. Retrieval may never exceed 96 hours.
Shipment of filter samples to the PM2 5-
PEP weighing laboratory
On the same day as retrieval from the sampler (shipped by overnight
courier) and received the following day at the laboratory
Filter equilibration and final weighing
Within 30 days of the end of sample collection if the laboratory
receives the shipment at temperature < 4 °C or if received at
temperature > 4 °C and < 25 °C and the received temperature is < the
average 24-hr sampling period temperature.
Within 10 days of the end of sample collection if the laboratory
receives the shipment at temperature > 4 °C and < 25 °C.a
Approval of validated PM2.5-PEP filter
sample concentration and input to AQS
Goal is within 60 days of the conclusion of the sampling event
a Filters received > 25 °C are automatically invalidated but still are weighed within 10 days.
Bl. 1.1 Filter Holding Times
Filter holding times are critical aspects of the PM2.5-PEP. As illustrated in Figure Bl-1 and
stipulated in the CFR, filters must be used (exposed) within 30 days of their pre-sampling tare
weight measurement or they must be reconditioned and go through the pre-weighing process
(tare weighed) again. Therefore, the PM2.5-PEP weighing laboratory and FSs should stay in close
communication to ensure that sufficient filters are available for field deployment (conditioned
and tare-weighed) to ensure tare-weighed filters have sufficient time remaining of this 30-day
period for field sampling. The maximum duration from filter tare weight to post-sampling weight
measurements may not exceed 60 days as detailed in Figure Bl-1.
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Life Cycle of a PEP Filter
0 5 10 15 20 25 30 35 40 45 50 55 60
Days from Tare Weight
3 holding time is 10 days if receipt temperature is >4°C and ^ 25°C and receipt temperature is > average temperature during sampling
b holding time is 30 days if receipt temperature is ^ 4°C or if receipt temperature is both < average temperature during sampling and £ 25°C
Indicates filter sample invalidation
Figure Bl-1. Filter Holding Times
B1.2 Rationale for the Sampling Design
This QAPP documents the EDOs for a QA activity, not a routine monitoring activity. The PM2.5-
PEP sampling design has been codified in 40 CFR Part 58, Appendix A, Section 3.2.4. The
frequency of PM2.5-PEP sampling events is described in Section A7.
B1.3 Sampling Design Assumptions
The intent of the PM2.5-PEP sampling design is to collect data of sufficient quality and quantity
to characterize whether overall measurement bias achieves the DQOs described in Section A7.
To accomplish this, the DQO development process has been carefully followed to ensure that the
DQIs and associated MQOs are well-defined and bounded to optimize data collection. While the
initial DQO and related MQO process accomplished this, two recent developments in the routine
PM2.5 monitoring network have called into doubt that the defined MQOs can satisfy the initial
sampling design. Therefore, EPA is currently undertaking efforts to determine whether the
decision error of 5% holds with these new developments and whether MQO adjustments are
needed to the PM2.5-PEP. These two main developments are that the routine PM2.5 monitoring
network has increasingly adopted continuous FEM monitors and that the ambient concentrations
of PM2.5 are decreasing. Practically, these respectively have shown that bias, as determined by
the PM2.5-PEP has increased and that the PM2.5-PEP is increasingly likely to collect a sample
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with a concentration < 3 |ig/m3, which is not valid for bias assessment. The differences in
measurement principles and a decrease in data suitable for comparison combine to challenge the
ability of the PM2.5-PEP to adequately assess routine PM2.5 measurement bias at more typical
ambient concentrations at more locations across the US.
Two assumptions made for the PM2.5-PEP sampling design impact the representativeness:
¦ The PM2.5 FRM is the true PM2.5 measurement for the 24-hour period and that FEMs and
FRMs are suitably comparable for the measurement of PM2.5. EPA ORD has determined
the equivalency of FEMs to FRMs.
¦ Collocation of sampler inlets within 1 to 4 m results in the two samplers ingesting an
equivalent portion of the same air parcel. Historical information on PM10 collocation data
and preliminary PM2.5 data indicates that ambient air within 1 to 4 meters of the primary
routine sampler is homogenous. Therefore, EPA assumes that a PM2.5-PEP sampler
correctly positioned within this space will sample from the same PM2.5 air parcel as the
primary routine sampler.
B1.4 Validation of Non-Standard Measurements
The PM2.5-PEP collects no samples and analytical measurements considered to be non-standard;
therefore, this section is not relevant to the PM2.5-PEP.
B2 Sampling Methods and Requirements
The PM2.5-PEP has developed an SOP for the field operations {FieldStandard Operating
Procedures for the Federal PM2.5 Performance Evaluation Program) that describes in detail the
activities and procedures that are to be followed. The following sub-sections summarize these
activities.
B2.1 PM2.5-PEP Sampler
Limiting the PM2.5-PEP FRM sampler employed to a single make and model reduces bias and
precision differences inherent between different sampler models. The BGIPQ200 was the
portable sampler model of three designated as FRMs in 1999 and 2000 deemed the most
convenient, serviceable, and durable. The performance specifications for the FRM employed in
the PM2.5-PEP are detailed in Table B2-1. The older generation BGI PQ200s could not maintain
acceptable flow rates at elevations of 7000 feet and higher, therefore, EPA used the other
portable samplers (Andersen RAAS 200 or the Rupprecht & Patashnick 2000) at those sites.
Currently, the RAAS 200 and the R&P 2000 (later updated the Thermo-Fisher 2000 when
Thermo-Fisher purchased R&P) are no longer in production or supported. A new generation
direct current (DC) pump motor which overcomes problems derived from sampling at high
altitudes has been developed and approved for use in the BGI PQ200. The FS should confirm
that the newest generation Maxon DC motor is used to operate the sampler at elevations of 7,000
feet or higher.
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Table B2-1. PM2.5-PEP FRM Sampler Performance Specifications
IViioi inniKc PiiriinuMcr
Spociliciilion
RiToivikt
Sample flow rate
1.000 m3/hr
40 CFR Part 50, Appendix L, Section 7.4
Flow regulation
1.000 m3/hr ± 5%a
40 CFR Part 50, Appendix L, Section 7.4
Flow rate precision
2% CVb
40 CFR Part 50, Appendix L, Section 7.4
Flow rate accuracy
±2%
40 CFR Part 50, Appendix L, Section 7.4
External leakage
< 80 mL/min c
40 CFR Part 50, Appendix L, Section 7.4
Internal leakage
< 80 mL/min c
40 CFR Part 50, Appendix L, Section 7.4
Ambient temperature sensor
-30°C to 45°C
0.1 °C resolution; ± 2.0°C accuracy
Volume II-MS. 2.12
40 CFR Part 50, Appendix L, Section 7.4
Filter temperature sensor
-30°C to 45°C
0.1 °C resolution; ± 1.0°C accuracy
Volume II-MS. 2.12
40 CFR Part 50, Appendix L, Section 7.4
Barometric pressure
600 to 800 mm Hg
5 mm resolution; ± 10 mm accuracy
Volume II-MS. 2.12
40 CFR Part 50, Appendix L, Section 7.4
Clock/timer
Date/time
1 min resolution; ± 1 min/month
accuracy
Volume II-MS. 2.12
40 CFR Part 50, Appendix L, Section 7.4
a The PQ200 flowrate pre-event flowrate check acceptance level is ±4% to provide more assurance that the event
flow rate is within the FRM specifications.
b The 24-hour average CV achieved by the new Rev-U version of the BGIPQ200 controller board is routinely <
0.1%, therefore, troubleshooting should occur at an action level of 1% to maintain acceptable performance of the
PM2.5-PEP fleet.
0 PQ200 sampler leak check criteria is to check for 5 cm H20 of vacuum pressure loss over 2 minutes. This
criterion was shown to be equivalent to the listed leak check criteria stated in CFR requirements for the FRM.
As with all electronic components, the PQ200 electronic control boards have evolved over time.
The PQ200 used in the PM2.5-PEP must be updated to the Revision T (Rev-T) main controller
board or newer. Mesa Laboratories was given approval for a new generation Revision U (Rev-U)
control board in 2018. Rev-T boards went out of production in 2019 and are being replaced by
Rev-U as they reach the end of their lifecycle or require replacement due to failure. If it is ever
necessary to utilize other FRM sampler models in PM2.5-PEP sampling events, they must be
approved by OAQPS, confirmed to be serviceable, and participate in semi-annual collocation
events (Section B5.4.1) to demonstrate comparability.
B2.2 Sample Event Preparation, Sample Collection, Sample Retrieval, and Sample
Shipment
B2.2.1 Pre-Sampling Event Preparation
In planning a PM2.5-PEP sampling event for a given monitoring site, the FS records (or verifies)
the following information on a Site Data Sheet (Form SD-01; available in the PM2.5-PEP Field
SOP):
- AQS Site ID
¦ Method designation (e.g., EQPM-0308-170)
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¦ Sampler make and model (e.g., Met One BAM-1020)
¦ Site latitude and longitude coordinates
¦ PM2.5 network type (e.g., SLAMS)
¦ Reporting organization
¦ Reporting organization contact
¦ Street address
¦ Directions to and from a major thoroughfare
¦ Safety concerns (Report safety concerns to the EPA Regional PM2.5-PEP Lead
immediately)
¦ Location and directions to the nearest medical treatment facility
¦ Additional equipment needed (e.g., ropes, ladders)
¦ Closest EPA contracted courier package drop-off location for shipping PM2.5-PEP filter
samples (at the time of this document's release the United Parcel Service [UPS] is EPA's
contracted courier)
¦ Important free-form notes.
The FS may not have all this information when visiting a site for the first time (e.g., the site may
be newly established, the FS records may be out of date, or AQS may contain errant information)
and thus may need to complete parts of the Site Data Sheet during the visit. The information
within AQS must be verified during the site visit.
The FS will coordinate approximately one month in advance of the PEP event with the PM2.5-
PEP laboratory to ensure that the correct number of tared filters has been/will be supplied to
cover the needed samples and QC samples (e.g., FB and TB). The FS will verify the information
and use-by dates on the filter COC/FDS forms to ensure the information is correct and there is
sufficient time remaining for the filters to be used within their 30-day period. Filters will be
properly secured (refer to filter handling in Section B3) in the insulated cooler with frozen
freezer packs. The FS will also confirm that the filter COC forms, field notebook, Site Data
Sheets, and other required paperwork are present and secured for travel. Once MoPED is
implemented, a tablet or laptop PC with MoPED software will also be required.
Before embarking on a PM2.5-PEP sampling event trip, the FS will confirm that sampling
equipment (including a backup sampler and a backup set of calibration equipment) is operational
and securely stowed in the transport vehicle. The FS will also check that adequate supplies are
on hand to perform the scheduled sampling events and will contact the appropriate SLT site
operators to confirm sampling schedule and the monitoring site's accessibility on the proposed
setup and sampling dates.
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The FS will contact the SLT site operator (or designee) in advance of the sampling event as
described in Section C2.1.1.4.
B2.2.2 Sampling Event Setup
Upon arriving at the site, the FS meets the SLT site operator or other appropriate personnel who
will grant site access and the FS then performs an initial safety inspection prior to setting up
equipment. The FS is not obligated to visit a monitoring site or proceed with setting up
equipment for the PM2.5-PEP sampling event if it is determined that site conditions (e.g., weather
or dangerous monitoring platforms) may jeopardize personal safety. The FS will notify the
Regional PM2.5-PEP Lead immediately upon identifying unsafe conditions and will document
them on the Site Data Sheet. The Regional Lead will then take steps to communicate with the
SLT monitoring agency to ensure the site is safely accessible for a PM2.5-PEP sampling event.
If FS deems the site is safe, the PM2.5-PEP sampler is assembled and positioned such that the
inlet is within 1 to 4 meters horizontally of the site's routine primary PM2.5 sampler inlet (if a
collocated monitor is operating at the site and to be operating the date of the PEP event, the PEP
sampler inlet should optimally be positioned to within 1 to 4 meters of both the primary and
collocated routine sampler inlets), the PM2.5 separator inspected (e.g., VSCC grit pot emptied or
WINS impactor cleaned and oiled, as appropriate), the sampler checked for leaks, the sampler
clock time is verified per Section B2.2.2.1 below, and the sampler temperature (Section
B7.2.2.2), barometric pressure (Section B7.2.2.1), and flow rate (Section B7.2.2.3) calibration
verifications are performed per the PM2.5-PEP Field SOP.
If while on site the FS has no available PM2.5-PEP sampler that can pass calibration verification
checks, the FS contacts the Regional PM2.5-PEP Lead for instructions on how to proceed. The
Regional PM2.5-PEP Lead considers the specific failed verification checks when deciding. If no
recommendation to continue can be made, the FS should postpone and work with the SLT site
coordinator and the Regional PM2.5-PEP Lead to reschedule the PM2.5-PEP sampling event.
Once all pre-sampling operational and calibration verifications are completed, the filter cassette
is installed, and the sampler is programmed to run for 24 hours from midnight to midnight local
standard time. An exception to the midnight-to-midnight schedule should only be made when the
SLT primary routine sampler operates on a different schedule. If delays occur in the intended
PEP sampling schedule, the FS will notify the SLT site operator and the Regional PM2.5-PEP
Lead.
B2.2.2.1 Sampler Clock
Prior to each PM2.5-event at the monitoring site as described in the Field SOP. The FS checks the
sampler clock time and date by referring to the time linked to an atomic clock, such as that found
at http://www.time.gov, or to a known time standard (e.g., cellular/smart phone). If the FS uses a
personal device as a time standard, that device must be able to synchronize to local time, as the
FS can cross one or more time zones to travel to a PM2.5-PEP sampling event. Time
synchronization can occur prior to heading to the monitoring site, particularly if the site has no
reliable cellular/wi-fi service.
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B2.2.3 Sampling Event Filter Retrieval, Storage, and Shipping
Following completion of the PM2.5-PEP sampling event, the FS returns to the site(s) and follows
the procedures in the PM2.5-PEP Field SOP to retrieve (recover) the sampling filter cassette,
visually inspect the filter, appropriately store it (in a cooler with cold freezer packs) for transport
to the laboratory, and download the data from the sampler, typically to a removable storage
medium (e.g., USB flash drive) via the sampler's universal serial bus (USB) port.12 This flash
drive is to be included in the shipment to the PEP weighing laboratory. If there are safety
concerns or severe weather at the site during filter retrieval and sampler teardown, the sampler
data may be downloaded later when conditions are safe.
With the implementation of MoPED, the sampler's logged data will be directly uploaded to
the AQS database through the tablet or laptop PC which will eliminate the need to ship a
flash drive of the data to the weighing laboratory.
The FS completes the COC/FDS form(s) and the sampled PM2.5-PEP filters and their
corresponding COC/FDS forms are properly packaged and transported to the PM2.5-PEP
weighing laboratory as soon as possible following completion of the sampling event following
the procedures in the PM2.5-PEP Field SOP. Ideally, the filter is shipped the day of retrieval with
EPA's contracted courier for next-day delivery. The FS will retain a copy of the COC form and
file the form under PM2.5-PEP/301-093-006.3 (or other acceptable filing system), and will record
the number of containers shipped and the corresponding air bill number (tracking information) in
the field notebook. The FS then notifies (typically by email) the PM2.5-PEP weighing laboratory
(preferably at the time the shipment(s) is relinquished to the courier) of the anticipated delivery,
the quantity of containers included in the shipment, and the associated air bill number.
B2.2.4 Return to the Field Office
Upon completing a PM2.5-PEP sampling event trip, the FS returns to the Regional (field) office.
At the field office the FS ensures that necessary vehicle servicing is completed, and that
equipment and supplies are properly returned and stored. This is also an opportunity for the FS to
order needed supplies and perform necessary equipment maintenance, such as quarterly
inspection and cleaning. The FS will also prepare a backup, to be stored at the field office, of the
logged data from the sampler(s) for performed PM2.5-PEP events. The FS debriefs the Regional
PM2.5-PEP Lead on the trip and whether future PM2.5-PEP sampling events remain on schedule.
B2.3 Sample Collection and Preservation
This section details the requirements for maintaining sample integrity including sample
contamination prevention, sampling volume and duration requirements, temperature preservation
requirements, and permissible filter holding times. Information on sampler maintenance to
reduce contamination sources and ensure the collection of representative samples is discussed in
Section B6.
12 Data are typically transferred to a flash drive or to another external storage device through the USB connection. In
2006, BGI discontinued support for its DataTrans® data loggers. DataTrans® can still be used in the PM2.5-PEP
program (and recommended during inclement weather), but future support from MESA Labs will be unavailable
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B2.3.1 Sample Contamination Prevention
The PM2.5-PEP has established rigid protocols for preventing sample contamination. Once filters
have been pre-weighed, they are installed into cassettes, the metal cassette caps installed, and the
assembled filter cassette stored individually in static-resistant zipperlock plastic bags. Once a
filter cassette is shipped to the field, it must not be removed from the plastic bag and the cassette
caps must not be opened until installed in the sampler (or appropriately used for a blank) as the
filter could become exposed to dust, pollen, or other contaminants or could become damaged.
Filter cassettes must be stored in protective containers and in the transport container when not in
the sampler. Prior to handling a sample cassette, the FS must thoroughly clean their hands with
an alcohol wipe and allow them to air dry or (preferably) must wear clean powder-free
examination gloves (e.g., nitrile). The FS must reclean hands or replace gloves if they become
dirty or encounter any potentially contaminated surface.
B2.3.2 Sample Collection Volume and Duration
The total volume of sampled air to be collected, flow rate requirements, and sample duration are
specified in 40 CFR Part 50, Appendix L. The sampled air volume and the filtrate mass are the
two most critical measurements of the ambient monitoring FRM procedures. To determine the
sampled air volume the average flow rate and sampling duration must be known. The sampling
unit flow controller will control the flow to 16.67 LPM (1.00 m3/hour) and will log the flow rate
at least every 5 minutes over the 24-hour sampling duration for a total target sampling volume of
24 m3. A sampling period shorter or longer than 24 hours may be necessary in some cases, but
the sampling duration may not be less than 23 hours or greater than 25 hours or the sample is
invalidated (voided). In such cases, the FS must notify the Regional PM2.5-PEP Lead to schedule
a makeup PM2.5-PEP sampling event. Inaccurate measurement of flow rate and/or sampling
duration may introduce error or bias in the determination of the concentration through inaccurate
determination of the total sampling volume collected over the 24-hour sampling period.
B2.3.3 Filter Temperature Preservation Requirements
The filter temperature requirements for PM2.5 sample collection are specified in 40 CFR Part 50,
Appendix L. While no temperature requirements are specified for filters after completing tare
weights and during transport to the monitoring site, excessive heat is to be avoided (e.g., do not
leave in direct sunlight or in a closed vehicle during summer). During the 24-hour sampling
event, the filters are to be maintained near ambient temperature and shall not exceed the ambient
temperature by more than 5°C for more than 30 minutes.13 Upon retrieval of the sample, the
filter cassette is capped and placed in cold storage (e.g., a cooler with cold freezer packs) as soon
as possible to achieve < 4°C, which should be maintained through shipment to the weighing
laboratory. Upon receipt at the laboratory the filter is maintained at < 4°C until conditioning for
measuring post-collection weight.
13 In the event the filter temperature differential exceeds 5°C for a 30-minute interval, as indicated by the logged
sampler data, the FS will indicate this condition on the COC/FDS by the FS. The sampler places an "F" flag in the
data log.
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B2.3.4 Permissible Time Schedule and Holding Times for Field-Related Activities
Once the filter pre-weight is measured, the filter must be used for sampling (i.e., installed in a
sampler for a PEP event) or as a QC sample (e.g., FB or TB) within 30 days. If the 30-day period
is exceeded the filter tare weight must be re-established.
Following the 24-hour sampling duration, the collected sample holding time begins, which
permits not more than 30 days to weigh the sample filter(s) and may only permit 10 days if the
sample shipment temperature is not < 4°C or < the average temperature during the collection.
FSs should retrieve (recover) the filter and immediately place it in cold storage (< 4°C) within 24
hours of the end of collection (best practice) and this time period should not exceed 48 hours
such as may be required during holidays when the site may be inaccessible. Under no
circumstances may the retrieval exceed 96 hours from the end of collection (such samples are
invalidated), and this extended duration is only permissible during emergencies (such as if the FS
is ill or other extenuating circumstance). If the retrieval time exceeds 48 hours from the end of
collection, the FS must indicate on the FDS an explanation for the retrieval delay and the
maximum temperature during the post-sampling to retrieval period.
Once the filter(s) has been retrieved from the sampler(s) and is in cold storage awaiting transport,
the FS should ship the filter(s) to the weighing laboratory as soon as possible, preferably the
same day of retrieval (best practice) for arrival at the weighing laboratory the following day.
However, if the filter is retrieved from the sampler on a Friday, the FS should maintain the filter
in cold storage (< 4°C) until the next shipping day when overnight (next-day) shipping ensures
the filter arrives at the weighing laboratory on a weekday (e.g., a Sunday or Monday) and will
notify the laboratory of the delayed shipment and expected arrival date. Filter shipments received
at the laboratory should be < 4°C upon arrival to ensure the maximum holding time of 30 days
from the end of the 24-hour sample collection period (note that this is not the retrieval date) for
measuring post-collection weights. For filters arriving at the weighing laboratory > 25°C, the
sample(s) is invalidated. Table B2-2 lists permissible time intervals for field-related activities.
Table B2-2. Permissible Field-Related Holding Times
l-'icld Acli\ il\
Permissible Molding Time
Siart of 24-hr sample collection
< 30 days from date of filter pre-weighta
Retrieval of filter from sampler
and placement in storage < 4°C
Within 24 hours (best practice),
and may not exceed 96 hours
Shipment of retrieved filter to
PM2 s-PEP weighing laboratory at
< 4°C
Ship filter on day of retrieval via next-day delivery
(best practice) with frozen freezer bricks.
Filter must be shipped with sufficient time to be
received at weighing laboratory for conditioning and
weighing within 10 or 30 days of the end of sample
collection b
a Refer to the "use by" date on the PM2 s-PEP COC form.
b 30-day holding time applies for samples received < 4°C or < average ambient temperature during 24-hour sample
collection period, otherwise 10-day holding time applies.
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B2.4 Corrective Action for Field Activities
Corrective actions associated with field activities are imposed as necessary to ensure PM2.5-PEP
sampling events are acceptable. Common corrective actions for routine expected issues are listed
in the Field SOP. ThePQ200 Troubleshooting Guide, available on the AirQA website, provides
additional guidance on troubleshooting PM2.5-PEP sampler issues.
B3 Sample Handling and Custody
Because only a small amount of PM is typically collected on a sample filter, contamination and
improper handling are major sources of error in reportable PM2.5 concentration measurement.
Filter cassettes must be handled carefully to minimize contamination and to avoid dislodging
collected PM from exposed sample filters. Additionally, a portion of the deposited PM will
consist of semi-volatile material that evaporates and for which increased temperatures hastens
this evaporation. Additionally, the longer the duration after the completion of sampling until
performing the post-collection measurements, the greater extent of such material can evaporate.
To limit mass loss due to evaporation to the extent possible, sampled filters should be retrieved
as soon as possible and stored refrigerated until conditioned for post-collection weight
determination. For this reason, FS should avoid excessive delays between the end of sample
collection and sample retrieval. As much as possible, only the LA should handle bare filters and
FS should minimize any contact with the filter medium, only handling the cassette.
To maintain evidence of proper filter handling, the COC procedure must be properly followed
and documented. The COC procedures ensure that:
¦ Filters are processed, transferred, stored, and analyzed by authorized personnel.
¦ Sample integrity is maintained during all phases of sample handling and analysis.
¦ An accurate, written record is maintained for sample handling and treatment of filters
from the time filters are packaged for distribution to FSs through sampling, laboratory
analysis, and disposal.
Proper custody involves assigning responsibility for all stages of sample handling and ensuring
that any custody transfers are documented. An individual has custody of a sample filter if the
authorized individual is in physical possession of the filter, or the filter is stored in a secured area
that is restricted to authorized personnel. The COC form (an example is shown below in Figure
B3-1) originates at the PM2.5-PEP weighing laboratory, proceeds through field activities, and
then is returned to the laboratory. The PM2.5-PEP weighing laboratory transcribes the
information recorded on the COC form into its sample tracking system where the records are
available electronically.
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PEP Chain-of-Custody Form for BGI PQ200A
~ PM 2.5 event c PM 10 Event
PART I - ViTIGHING LABORATORY
Filter Weighing and Shipping Information from Weighing Lab or Shipping Log
Filter ID
Filter Cassette ID
~ TB - Trip Blank
Weighing Lab
Cassette Type
Analyst'Custodian
Tare Weight Date
Shipment Date
Tracking No.
Sen) to (PE Org)
Shipping Company
Date This Filter Must be Used bv
Return to:
Normally, the weighing laboratory completes Part I keeps J copy and sends 2 copies to thefteUf ojfice with the unexposed fiber cassette.
PART II - FIELD OFFICE
Date Received:
Received by:
Location:
Package Condition:
~ Good ~ Reject (Why?)
If rejected, the filter cassette should be returned to the weighing laboratory with the next outgoing shipment.
PART m-FIELD SITE
Sampling Event Information
Arrival Date at Site
PEP Field Scientist:
Site Name & Description
Primary SLT PM-2.5 Sampler
Make/Model:
Serial No.:
Primary SLT PM-10 Sampler
Make/Model
Serial No.:
AQS Site ID
POC:
Other Operators or Observers
Sampling Event Filter Data
Sampling Date:
Retrieval Date:
Time:
Event Filter integrity: C OK
C Reject (describe)
Sample Type
C RO - Routine PEP ~ FB - Field Blank fAssociated RO Cassette ID- ) O Other (describe)
~ CO - Collocated PEP ~ Expired Filter (not used)
~ TB - Trip Blank f Record last RO Cassette ID used in this audit trip:
1
~ Void (why?)
PEP Cut Point: ~ PM-2.5
~ PM-10
PEP PM-2.5 Separator Type: ~ WINS ~ VSCC
PART IV - HELD FILTER SHIPPING TO WEIGHING LAB
Shipment Date
Affiliation:
Shipped by
Shipping Destination:
Tracking No.
Shipping Company:
On completion of Part II-IV, the field scientist keeps one copy and sends the top (original) copy to the laboratory with the filter.
P.ART V - WEIGHING LABORATORY
Date Received
Received by:
Integrity Flag:
Shipment
Integrity OK?
C Yes O No
Max Temperature: X
Cold Pack Condition: ~ Frozen C Cold ~ Ambient
The weighing lab-oratory will DATE-STAMP and attach the COCform to the receiving log-book, in v.hich same irfo is recorded
Notes:
05-15-2017 vera tan
Figure B3-1. Example PM2.5-PEP Chain of Custody Form
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B4 Analytical Methods Requirements
This section describes how the PM2.5-PEP uses gravimetric analysis to determine the PM2.5 mass
collected on sample filters. The net mass increase on a sample filter is calculated by subtracting
the initial tare filter weight (pre-sampling) from the final filter weight (post-sampling). This
difference is assumed to be the PM2.5 mass deposited on the filter, given the filter handling
procedures noted in Section B3. This mass difference is divided by the total volume of sampled
air passed through the filter (as reported by the sampler logged data) to calculate the PM2.5
sample concentration in |ig/m3. This PM2.5-PEP-derived concentration is compared to the PM2.5
concentration measured by the SLT monitoring agency's primary monitor for the same 24-hour
period.
The PM2.5-PEP Laboratory SOP details the analytical methods used in the PM2.5-PEP. The
PM2.5-PEP weighing laboratory is responsible for implementing these analytical and associated
QA procedures and requirements.
The following sections prescribe the QA and QC requirements for the PM2.5-PEP laboratory
analytical procedures.
B4.1 Analytical Facilities
The PM2.5-PEP weighing laboratory has procedures in place to ensure that the MQOs described
in Table A7-2 are achieved. The laboratory's weighing room is used for filter conditioning,
weighing the filters, and staging the weighed filters before being moved to more permanent
storage facility. In case of emergency, EPA has arranged for laboratory facilities at EPA's
campus in RTP, North Carolina, to serve as a backup weighing laboratory for the PM2.5-PEP.
Table B4-1 lists performance specifications of the analytical laboratory environment and
equipment.
Table B4-1. Performance Specifications for the PM2.5-PEP Weighing Laboratory
i:iiH-ni
l\-iTorm;iiH'i- Spicillciilions
Microbalance
Readability < 1 (ig, repeatability of 1 |ig
Microbalance and Filter
Conditioning
Environment
Climate-controlled a draft-free room, chamber, or equivalent
Mean relative humidity between 30% and 40%, with a target of 35% and variability (1
standard deviation) not more than ±5% over 24 hours; no individual RH readings (5-minute
averages) falling below 25% or above 45%). The 24-hr average RH must be within ±5%o for
pre- and post-weighing. b
Mean temperature between 20°C and 23°C over 24 hours, with variability of the 5-minute
averages (1 standard deviation) not exceeding ±2°C over 24 hours; no individual 5-minute
average can be below 18°C or above 25°C. b No more than ten 5-minute average values are
permitted to be missing from a 24-hour period.
Mass Reference
Standards
Mass standards will bracket the expected nominal weight of filter plus typical loads by
approximately ± 200 mg
Individual (Class 1) standard weight tolerance within ± 10 (ig
a If mean temperature reading or relative humidity is outside of specified range, the laboratory manager should use discretion o
determine if the 24-hour conditioning period should be reset.
b 40 CFR Part 50, Appendix L, Section 8.3.3.
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B4.1.1 Laboratory Sample Contamination Prevention
The weighing room is equipped with a high-efficiency particulate air (HEPA) filtered air
handling system and adhesive sticky mats are installed on the floor to minimize contamination of
the filters from airborne dust and other contaminants. Weighing room access is restricted to
trained LAs and each must wear an anti-static (static dissipative) labcoat.
Filters are conditioned, equilibrated, and stored in protective petri dishes in the weighing room.
To reduce the risk of contamination, powder-free and antistatic gloves are worn while handling
filters, and filters are only contacted with smooth-tipped, non-serrated forceps.
B4.1.2 Laboratory Environment Requirements
The filter equilibration chamber (i.e., weighing room) is to be maintained within a tightly
controlled range of temperature and relative humidity to minimize filter weight mass fluctuation
contributed by filter humidity changes. The following weighing laboratory room temperature
requirements for the PM2.5-PEP are more stringent than those for the national PM2.5 monitoring
network (40 CFR Part 50, Appendix L, Section 8.2):
¦ Mean 24-hour temperature must be held to between 20°C and 23 °C, with a variability
(calculated as standard deviation from 5-minute averages) of not more than ± 2°C over 24
hours.
¦ Individual temperature readings (5-minute average readings) must remain within the
range of 18°C to 25°C.
The weighing laboratory room must meet the following RH requirements (40 CFR Part 50,
Appendix L, Section 8.2):
¦ Mean 24-hour RH must be controlled to between 30% and 40%, with a target of 35% and
with variability (calculated as standard deviation from 5-minute averages) of not more
than ± 5% over 24 hours.
¦ Individual RH readings (5-minute average readings) must remain within the range of
25% to 45%.
The temperature and RH of the weighing laboratory are to be continually measured and logged
(measurements recorded with a frequency of not less than every 5 minutes).
B4.1.3 Filter Storage Environmental Requirements
Filters are to be stored in protective packaging until inspected and equilibrated for measuring tare
weights. During equilibration (for tare weighing or post-sampling weighing), filters are stored in
the weighing room subject to the environmental conditions in Section B4.1.2. Following tare
weights, filters do not require specific environmental conditions (temperature extremes should be
avoided) and are packaged for use in sampling events or maintained in the laboratory for use as
laboratory QC samples. Once received from the field, filters are stored immediately in
refrigerated storage until equilibrated for post-sampling weights. This refrigerated storage is to
be maintained at 0 to 4°C and the temperature of the storage unit monitored continually (i.e.,
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temperature recorded by a logger every 5 minutes). Excursions from this temperature range are
not to exceed 30 minutes over a 24-hour period. The weighing laboratory manager and primary
analyst are notified when temperature excursions occur.
B4.2 Analytical Equipment
The PM2.5-PEP laboratory SOP contains a complete listing of analytical equipment used in the
PM2.5-PEP. Briefly, this includes an electronic microbalance with sufficient sensitivity and
stability, certified standard mass weights for verifying balance calibration, and static elimination
devices. Additional support equipment includes forceps for handling filters, racks and associated
trays for holding filters for conditioning, and a heavy vibration-free table (e.g., marble or similar)
on which the balance is installed.
The microbalance is the primary analytical instrument used for gravimetric analysis in the FRM
and must have a readability of < 1 ng and a readability of 1 ng. The PM2.5-PEP weighing
laboratory currently uses a Sartorius®MC-5 microbalance, which meets these specifications for
readability and repeatability. A technician services the microbalance twice annually, verifies the
balance calibration, and adjusts the calibration as necessary during these maintenance visits.
Within the weighing room, the microbalance is installed on a vibration-free table and is protected
from significant drafts (i.e., with baffles or located out of the path of significant drafts).
Static elimination devices consist of an anti-static brush and specially designed polonium-210
(210Po) strips that are replaced at the manufacturer recommended duration (i.e., every six
months).
B4.3 Analytical Process
The analytical determination of PM2.5 mass on filters requires two distinct weighing sessions: a
pre-sampling weighing session to determine the initial tared mass of the unexposed filter, and a
post-sampling weighing session to determine the final mass of the exposed filter. The difference
of these two mass measurements provides the mass of PM2.5 deposited on the filter during
sampling. Additional filter weighing sessions are also needed to determine the duration of
conditioning needed for new filter material and may be performed occasionally to confirm the
duration of conditioning needed for sampled filters. These additional weighing sessions involve
collection of successive filter weight measurements until a stable filter mass is achieved (i.e.,
mass difference <15 |ig) in consecutive sessions conducted approximately 24 hours apart.
The standard PM2.5-PEP weighing laboratory practice is to dedicate one entire week for pre-
sampling tare weighing sessions and the next entire week for post-sampling weighing sessions
and alternating these weeks. Sampled filters are maintained refrigerated at < 4°C until set out for
equilibration on the Friday of the week of the pre-sampling weighing session and then weighed
the following Tuesday during the post-sampling weighing session week. The only deviations to
this arrangement occur when sampled filters have a limited holding time until expiration, such as
occurs for filters received > 4°C, and require more immediate weighing to ensure the sample is
not invalidated (this situation is rare and occurs only every few months).
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B4.3.1 New Filter Receipt and Inventorying
Filter media are to meet the specifications listed below in Table B4-2. EPA purchases filters
from a reputable vendor for the PM2.5 monitoring program. A portion of the purchased filters are
earmarked for the PM2.5-PEP.
Table B4-2. PM2.5-PEP Filter Media Specifications
l-'.(|iii|)inonl
Spcciliciilions
KiTciviiit
i'illcr Design Spcci/ictilioii.s (( cilijlcd by 1 cntlor)
Size
46.2-mm diameter ± 0.25 mm
40 CFR Part 50, Appendix L, Section 6.1
Medium
Polytetrafluoroethylene
40 CFR Part 50, Appendix L, Section 6.2
Support ring
Polymethyl pentene or equivalent3
0.38 ± 0.04 mm thick
46.2 ± 0.25 mm outer diameter
3.68 (+ 0.00 mm, -0.51 mm) width
40 CFR Part 50, Appendix L, Section 6.3
Pore size
2 nm
40 CFR Part 50, Appendix L, Section 6.4
Filter thickness
30-50 |im
40 CFR Part 50, Appendix L, Section 6.5
Maximum pressure drop
30 cm H20 at 16.67 LPM
40 CFR Part 50, Appendix L, Section 6.6
Maximum moisture pickup
10-|ig increase in 24 hr
40 CFR Part 50, Appendix L, Section 6.7
Collection efficiency
99.7%
40 CFR Part 50, Appendix L, Section 6.8
Filter weight stability
<20 ng
40 CFR Part 50, Appendix L,
Sections 6.9.1 and 6.9.2
Alkalinity
< 25.0 micro-equivalents/g
40 CFR Part 50, Appendix L, Section 6.10
a The current suppler of PTFE filters uses a proprietary PTFE modified with a co-monomer for the support ring.
Upon receipt of new unexposed 46.2-mm PTFE filters at the PM2.5-PEP Laboratory, the
Laboratory Manager, primary LA will examine and inventory the filters. Filters are packaged by
the manufacturer in plastic clamshell boxes containing two stacks of 25 filters, with each stack
contained within a plastic holder and a thick paper sleeve, for a total of 50 filters per box. The
filters received in a shipment (which may consist of more than one individual shipment) for the
year are considered to be a lot of material, unless the manufacturer has otherwise defined the lot
by range of filter serial number. The examination and inventorying include the following
activities:
¦ Documenting (logging in) filter receipt in the laboratory's PED (or LIMS) by range of
filter ID. Filter IDs are the alphanumeric (e.g., T4664850) filter serial number assigned
by the manufacturer and are unique to each filter and are sequential in number.
¦ Labeling each box with the date of receipt and, if not already indicated by the
manufacturer, the filter ID range.
¦ Generally inspecting each box of filters and its contents to verify integrity, noting any
problems, and reserving filter boxes exhibiting obvious quality issues.
¦ Storing the filters securely until moved to the laboratory's conditioning and weighing
room.
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B4.3.2 New Filter Inspection
Once inventoried, new filters are to be inspected to ensure they are free from defects that would
compromise collection of field samples. Filters will be selected for inspection in a first-in first-
used convention such that older filters are inspected and placed into service first. Filters in lots
received more 2 years prior are discarded.
A laboratory analyst visually inspects filters according to the FRM criteria (with the aid of a
diffuse backlight) for defects such as pinholes, tears, ring separation, discoloration, and loose
material that would make them unsuitable for use. Defective filters may still be used for
laboratory QC procedures, such as for laboratory blanks.
B4.3.3 Filter Weighing Considerations
PTFE filters are especially susceptible to static electricity which both attracts dust and causes
interferences with the analytical balance stability of the filter weight measurement. To mitigate
the impact of static on the filter weighing, each filter is treated for static by exposing it to an
arrangement of anti-static polonium-210 strips that ionizes the atmosphere around the filter and
eliminates static on the filter.
QC activities associated with weighing sessions is described in Section B5.1.
B4.3.4 Filter Lot Stability Testing
With each new lot of filter material, the minimum equilibration period must be experimentally
determined by completing a lot stability test. The minimum equilibration time is 24 hours;
however, in practice this period is not sufficient to ensure mass stability of the filter media.
Filters are considered to be properly mass equilibrated when their mass change is < ± 15 |ig
between weights measured approximately 24 hours apart. Historical data show that this period is
between 48 and 72 hours. EPA Method 2.12 discusses performing this procedure on 9 total
filters where 3 filters each are selected from 3 different boxes (where each box contains 50
filters). The lot stability test for the PM2.5-PEP involves selecting 20 filters from minimally 5
different boxes (where not more than 4 filters are from the same box) and comprises the
following steps:
1. Select 20 inspected filters total from minimally five different boxes.
2. Equilibrate these 20 filters in petri dishes in the weighing laboratory/conditioning
environment for minimally and approximately 24 hours (i.e., not less than 24 hours but
not to exceed 2 days from equilibration start, -30 hours is acceptable). Filters are
conditioned within petri dishes with the lids attached loosely to allow air circulation.
3. Perform the typical balance calibration verifications and measure and record the mass of
each filter for the 24-hour equilibration weight.
4. Approximately 24 hours after the first weight, weigh each filter for a 48-hour
equilibration weight. If the masses of 19 of 20 of the filters at 48 hours of equilibration
are within ±15 |ig of the 24-hour equilibration mass, the equilibration period for the lot is
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determined to be minimally 24 hours. If fewer than 19 filters meet this criterion, continue
the equilibration and proceed to the next step.
5. Approximately 48 hours after the first weight, weigh each filter for a 72-hour
equilibration weight. If the masses of 19 of 20 of the filters at 72 hours of equilibration
are within ±15 |ig of the 48-hour equilibration mass, the equilibration period for the lot is
determined to be minimally 48 hours. If fewer than 19 filters meet this criterion, proceed
to the next step.
6. Approximately 72 hours after the first weight, weigh each filter for a 96-hour
equilibration weight. If the masses of 19 of 20 of the filters at 96 hours of equilibration
are within ±15 |ig of the 72-hour equilibration mass, the equilibration period for the lot is
determined to be minimally 72 hours. While significant mass changes exceeding 15
|ig/filter are not anticipated after 72 hours of equilibration, if fewer than 19 filters meet
the criterion, the minimum equilibration period is 96 hours for the lot and will require to
equilibration over weekends. In such cases, laboratory analysts should ensure that the
data indicating such a long equilibration time is warranted by closely examining the filter
weighing data to ensure that filters were not misidentified or subject to other weighing
error which would explain the extended equilibration period. Charting the weights over
time per filter will inform whether masses of the selected filters continue to change in the
same direction (e.g., gaining or losing mass together) during equilibration. If more than 3
filters are not stabilizing, recheck the static control devices (210Po) for malfunction or
exceedance of expiration period.
7. If an equilibration period of 96 hours or more is deemed necessary, continue to collect
weights approximately every 24 hours until the equilibration period is established (i.e., 19
of 20 filters show < 15 |ig of mass change between 24-hour weighings).
The tested filters may be cycled back into the general filter supply and used for field samples or
laboratory blanks.
B4.3.5 Filter Conditioning and Measuring Pre-weights (Tare Weights)
Inspected filters are individually placed into petri dishes to begin conditioning at the
environmental conditions in the weighing room. The petri dishes are kept unsealed (lids loosely
fitted) during conditioning/equilibration to allow air circulation. Filters are to be equilibrated
minimally for the equilibration period determined in the lot stability test conducted in Section
B4.3.4. Note that this equilibration period must be no less than 24 hours prior to collecting a pre-
sampling tare weight.
For measuring pre-sampling tare weights, each filter in the weighing session is weighed and then
reweighed for a replicate weight again later in the same weighing session. The difference
between these replicate weights must be < 5 |ig for each filter. For filters meeting this criterion,
the tare mass is considered stable and is assigned as the most recent (second) weighing, and the
filter is ready for field deployment. Filters with replicate weight differences that exceed 5 |ig will
need to be conditioned longer and weighed again in replicate until the criterion is met.
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Data generated by the weighing process (e.g., filter mass, filter ID, analysis date) are entered into
the laboratory's PED (or LIMS application when released) which notifies the LA when filter
masses do not meet prescribed acceptance criteria for equilibration time and replicate tare
weights. Following successful measurement of the tare weight, the LA installs filters for field
deployment into a cassette, installs the protective caps to the cassette, seals the assembled
cassette into a zipperlock anti-static bag, and generates a COC/FDS for each filter for field
deployment. Filters are then ready for field deployment based on need indicated by each Region
and self-implementing PQAO. Once the filter is installed in the cassette and leaves the weighing
room, it remains in the cassette until it returns to the weighing room for post-sampling
equilibration. The LA typically also assigns filters to be laboratory blanks at this time, which will
be weighed with the returned field collected filters. Filters which are not used for a field sample
or as a laboratory QC sample within 30 days will need to have tare weights re-established before
they can be returned to the pool of filters available for use.
Once MoPED is released, a file transfer application will upload the tare weight datafiles to
AQS.
B4.3.6 Filter Post-Sampling Conditioning and Weighing
Following return of the sampled filter shipments to the laboratory, the laboratory sample receipt
custodian (typically the LA) measures the sample shipment temperature, unpacks each shipment
to inspect the received filter(s), and logs them into the PED (or LIMS when/if applicable).
Received filters are stored in a refrigerator at < 4 °C until ready for conditioning/equilibration.
Filters are removed from cold storage and brought into the weighing laboratory where they are
equilibrated for a minimum of 24 hours; however, the PM2.5-PEP laboratory standard practice is
to equilibrate sampled filters for 96 hours. This is accomplished by beginning equilibration on
the Friday before the week dedicated to post-sampling filter weighing. Equilibrated filters are
then weighed on the following Tuesday, accomplishing equilibration of approximately 96 hours.
Concurrently, evidence has shown that extended equilibration periods encourage excessive
volatilization of collected PM on sampled filters, therefore equilibration should not exceed 7
days (168 hours) except in extenuating circumstances. Filter holding times are discussed in
Section B2.3.4.
B4.3.7 Filter Archiving
Once filters have finished with post-sampling weights and the data are validated/invalidated and
approved for reporting, the LA will archive the processed filters. Filters are archived through the
end of the next full calendar year, and then at room temperature for four additional years. For
example, a filter sample collected on March 1, 2021, will be archived in cold storage until
December 31, 2022, then at room temperature until December 31, 2026.
B4.4 Laboratory Corrective Actions
The PM2.5-PEP weighing laboratory will identify operational issues and take corrective action
when necessary to ensure the data meet quality criteria. The PM2.5-PEP Laboratory SOP provides
additional information on routine corrective actions.
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B5 Quality Control Requirements
The PM2.5-PEP prescribes QC procedures and associated acceptance criteria for the field and
laboratory activities to ensure that measurement systems are within appropriate control and
identifies when out of control conditions exist. These QC activities are routinely performed to
control bias and imprecision of measurements, and include: verifying calibrations (control bias),
demonstrating lack of positive bias from contamination (control bias), and conducting replicate
or duplicate measurements to evaluate precision (assess imprecision). These QC procedures
include: calibrations, calibration verifications, precision measurements (replicates), negative
control (blanks) measurements, and functional checks (leak checks). These practices generally
follow those in Method 2.12; however, some acceptance criteria are more stringent for the PM2.5-
PEP.
In the PM2.5-PEP, QC activities ensure that measurement uncertainty, as discussed in Section A7,
is maintained within acceptance criteria for DQO attainment. QC checks are performed on
sampling and measurement equipment prior to use and on an ongoing basis to ensure proper
performance. QC checks that do not meet acceptance criteria require corrective action to be
taken to correct out of tolerance conditions. Following correction of out of tolerance conditions,
the QC checks are to be repeated and meet criteria before data can be reported. Correction may
require sourcing a replacement instrument or adjusting procedures to address the root cause of
the out of tolerance condition.
Figure B5-1 illustrates some of the QC samples and activities that help evaluate and control data
quality within the PM2.5-PEP. They are aligned according to their purpose (as noted at the bottom
of the figure).
Figure B5-1. PM2.5-PEP Noteworthy Quality Control Samples and Activities
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B5.1 Laboratory QC Procedures
Laboratory QC procedures are designed to ensure that instruments and conditions critical to
ensuring that bias and precision for filter preparation and weighing are tightly controlled within
defined parameters. These QC procedures include calibrations and calibration verifications of the
microbalance, standard weights, and environmental monitoring instruments as well as analysis of
blank filter samples and replicate filter weights.
B5.1.1 Laboratory Instrument Calibrations
Refer to Section B7 for requirements for laboratory instrument and standards calibration and
calibration verifications.
B5.1.2 Laboratory Quality Control Filter Samples
Weighing sessions are dedicated for measuring pre-sampling tare weights or for measuring post-
sampling weight. Associated QC samples are tailored to the weighing session type.
Filter samples are assigned to a batch and all filters in the batch are weighed together in a
weighing session bracketed by working standard weights as described in Section B7.1. Filters to
be weighed for pre-sampling (tare) weights are typically assigned to batches that only contain
new filter samples and do not contain field-sampled filters. To determine post-sampling weights,
filter samples collected in the field are assigned to a batch with their associated field QC
samples. The filters and assigned batch QC samples are weighed together in each weighing
session for the batch. Note that due to the varying holding times and the impracticality of
tracking individual filters deployed to the field, filters exposed during PM2.5-PEP events are
assigned to a new batch after receipt and are not maintained within the same batch as assigned
during pre-sampling weights.
B 5.1.2.1 QC for Pre-Sampling Tare Filter Weights
For pre-sampling tare weight weighing sessions, the filters to be weighed will have been
inspected and conditioned/equilibrated in the weighing room and the environmental conditions
controlled to within the specified tolerances for the equilibration period determined in Section
B7.1. For the start of the weighing session, the LA calibrates the analytical balance by
performing the balance's internal calibration procedure. Once calibrated, the LA will verify the
calibration with standard weights bracketing the expected balance load (this is approximately
400 mg based on the current filter media). After calibrating and verifying calibration of the
balance, the LA will eliminate static on each filter to be weighed (with the 210Po anti-static strips)
and measure a tare weight of each filter, recording the mass in the PED. After every 10 filters,
the LA will weigh a standard weight as described in Section B7.1.1.1. Once a mass is measured
and recorded in the PED for each filter in the weighing session, the weighing session sequence is
repeated and each filter is weighed again (in replicate) with standard weight measurements
interspersed every 10 filters and concluding the weighing session. The replicate weights are to be
within ±5 jug of each other or further conditioning is required to ensure filter tare mass is stable.
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No dedicated filter QC samples are weighed during tare weight sessions; however, the LA will
select filters from those weighed to serve as laboratory filter blanks for the weighing session
associated with filters when returned from the field post-sampling. Laboratory blank filters are
negative controls intended to detect contamination or other mass changes in the filter
conditioning, filter handling, and filter weighing procedures. Laboratory blanks do not leave the
laboratory weighing room.
B 5.1.2.2 QC for Post-Sampling Filter Weights
Batch QC for post-sampling weighing sessions includes laboratory filter blanks, intra-batch
duplicates, and inter-batch duplicates.
Once post-sampled filters are properly equilibrated (e.g., for approximately 96 hours), the LA
conducts a weighing session dedicated to post-sampled filters. As with the pre-sampling tare
weight sessions, the LA calibrates the analytical balance and verifies the calibration with two
bracketing standard weights. After calibrating and verifying calibration of the balance, the LA
will eliminate static on each filter to be weighed (with the 210Po anti-static strips) and measure
the mass of each filter, recording the mass in the PED. After every 10 filters, the LA will weigh a
laboratory filter blank selected from those assigned in an associated pre-sampling tare weighing
session, which must show the mass is within ± 15 |ig of the mass from the initial tare weight. A
new filter is weighed for each of these laboratory filter blanks. Following the laboratory filter
blank, the LA will verify balance calibration with a standard mass weight as described in Section
B7.1.1.1. At the conclusion of the post-sampling weighing session, the LA will measure a
replicate weight of another filter (typically the first sampled filter) weighed in the session as an
intra-batch duplicate, as well as a field-collected filter sample from a previous post-sampling
weighing batch (this is typically from the most recent post-sampling weighing session from
approximately 11 days previous) as an inter-batch duplicate. Both the intra-batch duplicate and
inter-batch duplicate which must be within ±15 |ig of the initial weight.
If after taking corrective action for batch QC failure the QC sample results remain unacceptable,
the weighing session measurement data are not accepted and the weighing session is to be
repeated after remediating the out of tolerance condition. An exceedance of acceptance criteria
may be due to transcription error, microbalance malfunction, or insufficient conditioning of
filters such that they have not reached mass equilibrium before weighing. Corrective steps should
involve examining weighing session batch QC checks (e.g., working standard calibration
verifications and laboratory filter blanks) to eliminate microbalance malfunction.
B5.2 Field QC Procedures
Field QC procedures are designed to ensure the sampling unit is operating properly, the sampling
flow rate control is within the defined tolerance, and that the sampled air is representative of the
ambient air to be characterized. These activities include calibration verifications, operational
checks, and collection of field QC filter samples.
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Calibrations and calibration verifications of field equipment are covered in Section B7.2.2 and
are to precede the operational QC check, which is the sampler leak check. Field QC filter
samples consist of FBs and TBs.
Once the sampler is assembled and powered on, the FS will perform calibration checks on the
sampling flow rate, barometric pressure probe, and temperature probes (ambient and filter
probes), and will perform a leak check to ensure the sampler does not ingest air that was not
routed through the particle size separator.
B5.2.1 Field QC Samples
Field blanks are collected at about 55% of PM2.5-PEP events; trip blanks at about 10-15%.
These field QC blank filter samples are designed to demonstrate potential contamination that
may occur to sampled (exposed) field filter samples during field activities.
¦ Field blanks provide an estimate of total measurement system contamination
encompassing all procedures following the pre-sampling (tare) weight measurement
through the post-sampling weight measurement. To collect a field blank, the FS installs
the filter cassette in the sampling unit as is done for a typical sampling event; however,
does not activate the sampling flow, and retrieves the FB filter after a brief waiting period
of approximately 5 minutes. Apparent contamination on FBs prompts inspection of the
associated TB and laboratory filter blank samples to ascertain at which point(s) in the
process the contamination occurred. FBs are required to be collected at the following
frequency:
o For a self-implementing PQAO program that is less than 2 years old, a FB is required
to be collected with each PM2.5-PEP sampling event (i.e., at each site a PM2.5-PEP
sample is collected).
o For the federal PM2.5-PEP and self-implementing PQAO programs older than 2 years,
a FB is required to be collected with each PM2.5-PEP trip, where a trip may include
more than one PM2.5-PEP sampling event at more than one monitoring site. The FS
determines the site at which the FB will be collected, unless otherwise directed by the
Regional PM2.5-PEP Lead (such as when a problem is identified at a particular site).
¦ Trip blanks provide an estimate of measurement system contamination encompassing
filter handling, transport, and conditioning activities following the pre-sampling tare
weight measurement through the post-sampling weight measurement. To collect a TB,
the FS leaves the assembled TB filter cassette sealed in the plastic zipperlock anti-static
bag and the TB accompanies the associated exposed filter sample(s) and FB(s)
throughout the entire PM2.5-PEP trip. TBs provide a frame of reference when FB results
exhibit a mass gain that exceeds tolerance levels, indicative of potential contamination.
One trip blank is to be collected per PM2.5-PEP trip and each TB is to be associated with
at least one FB.
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B5.3 Evaluation of Blank Results
Results from blank samples, including laboratory blanks, TBs, and FBs, are evaluated for
contamination individually and then results can be aggregated to investigate contamination or
trends in mass changes for a given blank type.
B5.3.1 Individual Blank Results Evaluation
Results from a single individual filter blank that exceed the criteria prescribed in this section
initiate a review of the activities and environmental conditions associated with the event at which
the blank was generated. To evaluate the mass gain or loss of a filter blank, the absolute mass
difference is determined:
Absolute mass difference for a single filter (di). For a given blank filter, the absolute
difference in its mass measurements, di, is calculated as follows, where X, represents the mass
of the yet-unexposed filter (i.e., pre-sampling tare weight), and Yi represents the mass of the
filter in subsequent weighings, such as when returned to the laboratory following a sampling
event (i.e., post-sampling for TBs and FBs) or weighed with a post-sampling weighing batch
as a laboratory filter blank.
di = \Yi-Xi\
Note: Due to taking absolute value, the value of di is always non-negative and can be
convertedfrom a mass to an equivalent in-air concentration (ng/m3) by dividing by 24 m3.
Laboratory filter blanks do not leave the weighing laboratory and are expected to maintain a
stable mass within ± 15 |ig of the established tare weight for subsequent weighings. When this
criterion is exceeded, the LA should investigate the potential cause of the mass gain or loss of the
blank, which may include filter mix-up, balance calibration drift, incomplete static elimination,
omission of complete balance tare (re-zero) between filters, contamination, or damage to the
filter, for example. Other corrective actions may include verifying the correct data transcription,
cleaning the analytical balance weighing pan with the anti-static brush, extending the duration of
filter sample static elimination (210Po strip), examining environmental conditions for unstable
temperature and/or RH, cycling the balance draft shield door to ensure proper operation, and
reweighing the filter sample. If there is not an obvious error and the acceptance criterion remains
exceeded after these corrective steps (which has not occurred to the analyst's awareness), the
filter weighing session data are not accepted and the filter samples are equilibrated for minimally
an additional 12 hours and the weighing session repeated.
TBs and FBs experience increased handling during transport and field activities when compared
to laboratory blanks. TBs and FBs also require conditioning within the weighing laboratory to
achieve mass stability prior to measuring post-sampling weights. Generally, the level of
contamination (mass increase) on TBs is expected to be greater than that of associated laboratory
filter blanks, and FBs are generally expected to exhibit greater mass gain than both laboratory
filter blanks and TBs.
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¦ If the absolute mass difference (di) for an individual FB is > 30 |ig, then the associated
TB data should be examined for a mass gain indicating contamination, which could have
been introduced during procedures to load filters into cassettes, install metal cassette
caps, and seal the assembled cassettes into antistatic bags.
¦ If the absolute mass difference (d,) for an individual TB is > 15 |ig, then further
investigation is necessary to determine the source of the contamination. This would be
particularly true if an associated FB exhibits a normal value, e.g., within one (1) standard
deviation of the program mean for that year. For example, a problem may exist with
sample handling during loading or possibly ineffective cleaning of the cassette and
subsequent transfer of contamination from the cassette to the tared filter.
Depending on the outcome of the investigation of the mass difference exceedance, the TB and/or
FB may be flagged as failed trip blank (FTB) or failed field blank (FFB), respectively.
The mass measurement differences for laboratory filter blanks, TBs, and FBs are control charted
(see Section B5.6) and can be used to determine whether equilibrium status is less certain.
B5.3.2 Aggregated Blank Results Evaluation
Results from groups of blanks can illustrate norms and annual or seasonal trends at specified
levels of aggregation, e.g., by the National Program, Region, or individual FS. To evaluate the
blank data in aggregate, the mean of the individual absolute mass differences for a given blank
filter type is calculated:
Mean absolute difference (dz). For a group of n filters of a given blank type, the mean
absolute difference, d-_, is calculated as follows, where di through d„ represent the absolute
value of the mass difference for individual blanks within the group:
d^ "1" d.2 ^3 dyi
d7 =
n
Note: Blank filter types can be aggregated in numerous ways to investigate potential
contamination or bias, such as for an individual weighing batch, date range, Region(s),
FS(s), and/or Nationally.
Filter weighing will be suspended until the cause(s) of the laboratory blank mass instability is
identified and corrected when any individual laboratory filter blank exceeds ± 15 |ig from its tare
weight. Minimally, the LA will evaluate the mean difference for laboratory filter blanks within
the weighing batch for instability of the laboratory filter blank masses. Instability may be due to
fluctuating or drifting environmental conditions, microbalance operational or calibration
instability, or deteriorating static elimination.
When such instances occur, the filter sample weight data cannot be reported and the LA will
immediately notify the Laboratory Manager. If more than two (2) weeks are needed to resolve
the cause of the instability, then the PM2.5-PEP Laboratory Manager will notify the manager of
the backup weighing laboratory, and weighing operations will be temporarily shifted to the
backup laboratory until the issue is resolved. The problem and its eventual solution are to be
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reported and appropriately filed using the AFC system (or other acceptable filing system) under
response and corrective action reports (PEP/108-025-01-01-237.1, see Section A9).
Evaluation of mean differences may illustrate or suggest contamination or bias unique to that
level of aggregation (e.g., by Region, date range, etc.). The OAQPS PM2.5-PEP Lead (or
designee) will minimally evaluate the national aggregation of laboratory blanks, trip blanks, and
field blanks for each calendar year to investigate potential trends. The OAQPS PM2.5-PEP Lead
or designee will take corrective action when mean absolute differences aggregated nationally
exceed the following:
¦ Field blanks: dz > 20 |ig, or
¦ Trip blanks: dz > 10 |ig, or
¦ Laboratory blanks: d- > 10 |ig.
If further inspection of blank data indicates a potential issue at a smaller level of aggregation
(e.g., in a specific Region), the OAQPS PM2.5-PEP Lead (or designee) will initiate a review of
the activities and environmental conditions associated with the group of blank filters.
B5.4 PM2.5-PEP Precision
To satisfy the precision DQO for samples collected from PM2.5-PEP samplers, the PM2.5-PEP
must ensure the entire measurement process is within statistical control. The PM2.5-PEP
incorporates the following types of precision measurements:
¦ Measurements from filter samples collected from three or more collocated PM2.5-PEP
samplers during a Regional collocation event (Section B5.4.1), and
¦ Measurements from laboratory batch duplicates (Section B5.1.2.2).
B5.4.1 PM2.5-PEP Regional Collocation Studies
The precision (repeatability) of a single sampler cannot be characterized without the ability to
introduce an identical atmosphere for repeated sampling. Since this condition cannot be
practically accommodated, the PM2.5-PEP cannot practically evaluate the precision of a single
sampler. However, the ability to characterize the precision among discrete samplers (e.g., a fleet
of samplers) can be accomplished by collocating samplers and comparing the resulting measured
PM2.5 concentrations. To do this, PM2.5-PEP executes special collocation studies at the Regional
level to characterize total measurement precision associated with each Region's PM2.5-PEP
sampler fleet. These "parking lot" studies (because they are typically conducted in a parking lot)
also assess relative bias of a single PM2.5-PEP sampler compared to the other samplers involved
in the studies.
Twice per year (semi-annually), all of a Region's PM2.5-PEP samplers are to participate in a
collocation study. During a collocation study, the PM2.5-PEP samplers are collocated (and thus
are subject to the same atmospheric conditions) with all inlets within 1 to 4 meters of one another
and 24-hour PM2.5 samples are collected from each sampler over at least three days (not
necessarily consecutive). The concentration data obtained from a collocation study are used to
characterize precision in the samplers' PM2.5 measurements. These data also help identify
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individual PM2.5-PEP samplers that demonstrate a concentration bias trend when compared with
the remainder of the Regional sampler fleet.
Self-implementing PQAOs must participate in at least one semi-annual collocation study hosted
by their respective Region. If a self-implementing PQAO chooses to participate in only one
Regional collocation study in a year, then it must conduct one other collocation study on its own,
as long as the study involves at least three (3) PM2.5-PEP samplers and meets all other
collocation criteria such as the number of sampling days (3), sample duration (24 ± 1 hour),
sampler spacing, and general siting criteria. Regions and self-implementing PQAOs are each
responsible for the setup and operation of their own equipment in these studies.
The PM2.5-PEP weighing laboratory is responsible for shipping pre-weighed filters to the
Regions for use in collocation studies, performing the gravimetric analyses on the returned
exposed filters, and uploading the study results to the PED. The OAQPS QA Support Contractor
will analyze the acquired measurement data to evaluate the sampler precision and any
noteworthy findings such as identification of samplers demonstrating relative bias and/or poor
precision. Results of these evaluations are typically included in PM2.5-PEP QA reports.
B5.4.1.1 Single Sampler Precision Evaluation via CVAnalysis
EPA uses the Regional collocation study data to assess single sampler precision in the PM2.5-
PEP according to the following six-step decision framework:
1. Screen the PM2.5 concentration measurements. Exclude any individual daily
measurement from this assessment when < 3 [j,g/m3.
2. Create pairings of all PM2.5-PEP samples. Among all samplers in the collocation study
whose measurements are > 3 |ig/m3, pair them together so that a given sampler is paired
with every other sampler exactly once for each sampling date. If n such samplers
participate in a given study, there will be n x (n — 1)/2 total sampler pairs provided no
measurements are excluded. As the samplers are paired, so are their measured PM2.5
concentrations on a given sampling day within the collocation study.
3. Calculate the relative percent difference (RPDij,q) in PM2.5 concentration
measurements for each sampler pair (i,j) on each sampling day (q) within the study.
If Xij,q and Yij.q represent the PM2.5 concentrations for the two paired samplers i and j (i ^
j) on sampling day q, then RPl)Luq is calculated as follows (40 CFR Part 58 Appendix A,
Equation 6):
rpd^ - (£^5/2x 100
(Note that RPDij,q = RPDjxq.)
4.
Calculate the estimator of precision (CVj,q) for a single sampler (j) on a single
sampling day (q) within the study. A 90% upper confidence limit on the coefficient of
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variation (CVj,q) is used as the precision estimator for a single sampler (j) on a single
study day (q). Each sampler is represented within exactly k = n-1 distinct sampler pairs
(where n is defined in Step 2). If RPl)Luq is as defined in Step 3 and X2o.i,k-i is the 10th
percentile of a chi-squared distribution with k-1 degrees of freedom, then the precision
estimator (CVj,q) is calculated as follows (40 CFR Part 58 Appendix A, Equation 7):
The factor of two in the denominator adjusts for the fact that each value of RPDj,q is
calculated from two measurements containing error.
5. Calculate the precision of a single sampler (j) across the entire collocation study
(CVj). For a specific PM2.5-PEP sampler /, the day-specific values CVj,q from Step 4 are
aggregated over all days of the collocation study by calculating the square root of a
weighted sum of squares as follows, where m is the number of day-specific values CVj,q
for sampler j made during the collocation study. The value of m generally equals the
number of days in the collocation study for which the PM2.5 concentration measurements
from sampler j on each day was > 3 |ig/m3:
6. Apply corrective action on specific samplers when warranted. If the value of CVj
from Step 5 exceeds 10% for a specific PM2.5-PEP sampler (j), that sampler is flagged for
further evaluation and its filter samples from the collocation study may be reweighed to
confirm the finding.
a. If the value of CVj is between 10% and 20%, then the OAQPS QA Support
Contractor informs the OAQPS PM2.5-PEP Lead, who alerts the corresponding
Regional PM2.5-PEP Lead of the problem.
b. If the value of CVj exceeds 20%, then the OAQPS QA Support Contractor
provides a list of the PM2.5-PEP sampling events using that sampler since the
sampler's last precision check to the OAQPS PM2.5-PEP Lead. The OAQPS
PM2.5-PEP Lead alerts the corresponding Regional PM2.5-PEP Lead to initiate
corrective action. Control charts of CVs and relative percent differences (RPDs)
will be prepared to determine trends (Section B5.6).
c. Historical data have shown that if ambient concentrations are near or below 5
|ig/m3, every sampler pair (/, /) will have a very high probability of exceeding an
RPDij,q of 10%), even if the absolute difference between the two measurements is
< 1 |ig/m3. Several of the locations at which routine collocation studies were
previously performed have high probabilities of concentrations in this range and it
CV
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is probable in many sampling locations. Therefore, the ambient concentration on a
given day is considered when determining whether corrective actions are
warranted when CVj values exceed acceptance limits. EPA is currently developing
an updated decision framework for the evaluation of collocation data when
ambient concentrations are < 5 |ig/m3. In the interim, differences between sampler
measurements in this concentration range are considered acceptable if the
difference is < 1.7 |ig/m3.
B5.4.1.2 Single Sampler Precision-based Performance Test
EPA also uses the Regional collocation study data to assess PM2.5-PEP sampler performance and
to identify individual samplers that yield aberrant results14 according to the following seven-step
decision framework:
1. Screen the measured PM2.5 concentrations for reasonableness. Only concentrations
below 200 [j,g/m3 are considered "reasonable" under typical conditions (A wildfire or dust
storm might generate these levels of PM2.5) for a collocation study. PM2.5 measurements
obtained from the collocation study > 200 [j,g/m3 are removed from the dataset prior to
proceeding to the next step.
2. Create all pairs of PM2.5-PEP samplers (as described previously). Among all
samplers in the collocation study whose data are < 200 |ig/m3, pair them up so that each
sampler is paired with each other sampler exactly once. If n such samplers exist, there
will be n*(n-1)/2 total pairs provided no data are excluded. As the samplers are paired, so
are their PM2.5 concentrations measured in the study on a given sampling day.
3. Calculate the normalized percent difference (NPDi,j,q) in PM2.5 concentration
measurements for each sampler pair (i,j) on each sampling day (q). On a given study
day, NPDij,q is calculated as follows, where X,,q and Yj,q represents the PM2.5
concentrations for the paired samplers (i,j) on sampling day q, and mean equals the mean
PM2.5 concentration of all collocated samplers on the given study day:
I Yiq-Xjq\
Npo = Lid i£l x 100%
,J,H mean
4. Identify those sampler pairs with notable differences in PM2.5 concentration
measurements. On a given study day, those sampler pairs (i,j) with values of NPDij,q >
15% are flagged as "notable differences." Those pairs with values of NPDij,q < 15% are
accepted as being within the range of within-sampler precision historically observed
within the PM2.5-PEP.
5. Identify those sampler pairs with relevant notable differences in PM2.5
concentration measurements. EPA has determined that 3 [j,g/m3 is the lowest ambient
PM2.5 concentration that can be used to reliably characterize within-sampler precision.
14 Assessment results are reported on the AirQA website (http://www.airqa.org'). For more information on the
development of the decision framework, see Appendix C (Documents to Support Data Quality Objectives).
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Therefore, among sampler pairs having notable differences on a given study day, a pair is
flagged as having relevant notable differences if either PM2.5 concentration in the pair is
> 3 |ig/m3.
6. Flag those samplers requiring further evaluation. A PM2.5-PEP sampler is flagged for
further evaluation if both of the following hold:
o It is associated with more than one sample pair having a relevant notable difference on
a given study day, and
o It is associated with at least 50% of the sampler pairs having relevant notable
differences across the entire collocation study (i.e., across all study days).
While PM2.5 concentration measurements are expected to differ slightly among the
collocated PM2.5-PEP samplers on a given day due to various sources (e.g., sampler
variability, analytical variability), those samplers whose measurements are highly
inconsistent with the other collocated PM2.5-PEP samplers require further investigation.
For such samplers, the OAQPS PM2.5-PEP Lead alerts the corresponding Regional PM2.5-
PEP Lead of the problem. The respective Regional PM2.5-PEP Lead quarantines the
suspect sampler(s) from use in the PM2.5-PEP until corrective action can be taken and the
issue(s) resolved.
7. Further investigate collocation studies which produce a high number of relevant
notable differences. If the overall collocation study results show a high number of
notable differences, the OAQPS PM2.5-PEP Lead alerts the corresponding Regional
PM2.5-PEP Lead of the problem. The respective Regional PM2.5-PEP Lead will
investigate the samplers and the filter handling process for all personnel involved in the
collocation study.
B5.4.1.3 Review of Regional Collocation Study Results
Upon receiving data from the collocation studies for all Regions (and thus across the entire
national PM2.5-PEP sampler fleet) for a given calendar year, OAQPS, or a designee, performs a
review of the data to determine if repeatability of the samplers varies greatly among the Regions
(or weighing laboratories if filters in collocation studies are analyzed by laboratories other than
the PM2.5-PEP weighing laboratory). In this review, OAQPS (or its QA Support Contractor)
performs statistical tests for equal variances in PM2.5 concentration measurements among
Regions (or laboratories), using established tests such as Bartlett's test (an all-purpose statistical
test that can be used for equal and unequal numbers of samplers among the Regions), Hartley's
test (a statistical test that requires equal numbers of samplers per Region but is designed to find
differences between the largest and smallest variances), or Levene's test (an alternative to
Bartlett's test for testing for differences among the dispersions of several groups with greater
power than Bartlett's for non-normal distributions of data). OAQPS may apply additional
methods to evaluate data across collocation studies, as deemed appropriate. The PM2.5-PEP QA
Workgroup reviews new methods that may be proposed for these data analyses.
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Conclusions from these statistical tests for equal variance allow OAQPS to determine whether
corrective action must be taken to reduce the variability for any Region (or laboratory).
Corrective action may include a formal review of field and/or laboratory staff training and
operations to investigate the root cause. With these data, OAQPS is also able to evaluate the
certainty with which bias of the routine PM2.5 monitoring network can be estimated.
B5.4.2 National Collocation Studies
A national collocation event is the most comprehensive way to assess the precision of PM2.5-PEP
samplers for the nation. Such national collocation events can be scheduled to occur during PM2.5-
PEP annual refresher training as typically occurs at the Air Innovation Research Site (AIRS) at
the EPA's campus in RTP, North Carolina. Collected measurement data will be assessed as in
Section B5.4.1. EPA will make reasonable efforts to conduct a national collocation study every
two years; however, the national collocation study may not be conducted as intended, such as if
national training sessions are held virtually (and therefore field scientists do not travel), or other
scheduling conflicts exist.
B5.5 PM2.5-PEP Sampler Bias
Bias for the PM2.5-PEP samplers is determined for the entire PM2.5-PEP and for a single sampler
as follows:
National Review of Flow Rate Verifications—semi-annual and annual basis (|Bias|). Per 40
CFR Part 58, Appendix A, Section 4.2.2, absolute bias of the national PM2.5-PEP sampler fleet
over a specified time period is calculated as follows (40 CFR Part 58 Appendix A, Equation 3):
\Bias\ = AB + t0.95,n-i x -p
Vn
where AB and AS denote the mean and standard deviation, respectively, of the absolute values of
the percent differences (di) associated within a specified time period (refer to Section 7.2.2.3), n
is the number of measurement pairs within this period, and fo.95,n-i is the 95th percentile of the
two-sided Student-t distribution.
Per 40 CFR Part 58 Appendix A, Section 4.1.3.1 and 4.1.3.2, the 25th and 75th percentiles of the
percent differences (d\) are determined for the given time period. The absolute bias estimate
(\Bias\) is flagged as positive if both percentiles are positive and as negative if both percentiles
are negative.
The flow rate verification results should be aggregated at the Regional and national level on a
six-month and 12-month basis.
Bias of a single sampler—quarterly basis (Dj). For an individual PM2.5-PEP sampler j, the
average (/),) of the individual percent differences (di) from the past two and the past four quarters
for both flow rate verifications and flow rate audits is calculated as follows, where rij is the
number of individual percent differences produced for sampler j during the selected period (40
CFR Part 58, Appendix A, Equation 4):
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DJ = — XZKI
"./ i=i
The mean bias (/),) can also be used to identify a systematic drift in a sampler's performance. If a
systematic drift is noted, then the sampler may need to be recalibrated more frequently.
B5.6 Control Charts
The PM2.5-PEP employs control charts of QC data to visualize that the measurement processes
are within control limits and to observe trends in performance that may indicate an out of
tolerance condition is approaching. Control charts represent an early warning system to evaluate
trends in the collected QC data that may impact measurement precision and bias. Control charts
will include time (date and time, as appropriate) along the x-axis and the parameter value on the
y-axis and acceptance criteria will be shown on the chart. Table B5-1 indicates which QC data
are to be control charted.
Table B5-1. Control Charts of QC Data for the PM2.5-PEP
Mciisiironienl
I'lottcd I'simmclcr mill Associated Statistics
Laboratory conditioning environment
(temperature and relative humidity)
Daily mean and standard deviation
Lot stability test, laboratory blanks,
field blanks, and trip blanks
Difference of pre- and post-sampling weighed values
Intra-batch and inter-batch duplicate
filter weights
Mass difference for each filter replicate measurement pair
Microbalance standard weight checks
For each standard weight (e.g., 300-mg), plot the weighed mass and
the difference between the measurement and the certified mass
Sampler leak check
Difference between ending pressure and beginning pressure
Barometric pressure sampler check
Difference between transfer standard and sampler reading
Ambient temperature sampler check
Difference between transfer standard and sampler reading
Filter temperature sampler check
Difference between transfer standard and sampler reading
Flow rate sampler check
Percent difference between transfer standard and sampler reading
Collocation studies
Precision: Mass concentration CV of all samplers per semi-annual
basis (aggregated at the Regional and national levels). See CV
equation in step 4-5 of Section B5.4.1.1.
B5.6.1 Control Chart Use and Maintenance
With the implementation of MoPED and an updated PEP or LIMS at the weighing
laboratory, the PM2.5-PEP will be transitioning to near real-time tracking of verifications,
calibrations, and standardizations of samplers andfield and laboratory instruments with
these software systems and their capability for preparing control charts as listed in Section
B5.6. FSs andLAs will be responsible for reviewing control charts which apply to their
activities on a weekly basis when field and laboratory activities occur, respectively, andfor
taking corrective actions whenever conditions are trending toward an out-of-control
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condition. Control charts are to be reviewed at least quarterly by the PM2.5-PEP Laboratory
Manager and the Regional PM2.5-PEP Leads, for laboratory andfield data, respectively.
B6 Instrument/Equipment Testing, Inspection, and Maintenance
Requirements
This section describes the procedures for testing, inspecting, and maintaining instruments and
equipment to ensure they are in sound operating condition and performing acceptably.
Instrument inspection and maintenance activities are documented and filed using the AFC (under
PM2.5-PEP/301-093-006.3) or equivalent filing system. Individual Regions and/or self-
implementing PQAOs may use a filing system other than AFC (e.g., TDF) so long as it is
equivalent in functionality and allows for appropriate responses to interrogatories, TSAs, and/or
other reviews. Refer to Section A9 for details on document filing and records.
B6.1 Instrument and Equipment Testing
B6.1.1 Field Instrumentation/Equipment Testing
PM2.5-PEP samplers are FRM monitors (refer to Section B2.1) and EPA tests such equipment
using procedures described in 40 CFR Part 53 and summarized in Section B5.2.
New samplers acquired for use in the PM2.5-PEP are tested for proper operation as follows before
being deployed:
• A series of single-point calibration verifications (see Section B7.2.2), and recalibration if
verification results warrant such.
• A shakedown period in which the Regions perform a series of controlled tests and pilot
runs on new samplers to identify the presence of problems or specific sampler
components which attribute to deviations from normal operating ranges. Any problems
should be reported to the OAQPS PM2.5-PEP Lead, who will engage the manufacturer as
necessary to help resolve them.
• A collocation with at least two other samplers that are believed to be performing
satisfactorily. The collocation results will comply with acceptance criteria for a routine
collocation study (see Section B5.4.1).
This same inspection/testing is performed if new or upgraded FRM sampler hardware is
introduced for service (e.g., mass flow controller and/or control board).
Transfer standards for flow rate, temperature, and barometric pressure are calibrated as described
in Section B7.2.1 and will undergo a brief testing period prior to field deployment or
redeployment to ensure that readings and measurements are reasonable. No further scheduled
testing or inspections are needed for the transfer standards unless the FS suspects the transfer
standard is not performing properly.
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B6.1.2 Laboratory Instrumentation/Equipment Testing
The PM2.5-PEP weighing laboratory microbalance is verified with each weighing session for
proper operation by performing internal calibration routines and ongoing calibration verification
checks with standard mass weights as described in Section B7.1.1.1. Additional functional
checks are conducted as part of normal operation, and include proper taring between filters or
standard weights, proper draft door operation, and electronic transfer of measurement data to the
PED. Minimally annually, an accredited vendor will perform maintenance on the analytical
balance and test its performance. This testing will verify the proper balance operation at the
balance weighing pan edges by performing an eccentricity test which involves 4 replicate
weights of a mass minimally 30% of the balance capacity in each corner of the balance pan (or
an equivalent 90° apart on a circular balance pan). The replicate weights must be within ± 0.007
mg of the certified mass for each replicate weight, unless an alternative tolerance is specified by
the balance technician. The balance calibration is verified with no loading and at several masses
across the balance's measurement range (e.g., 50, 100, 500, and 1000 mg), which must be within
± 0.003 mg of the certified mass value at each tested mass. If the balance is new or repaired,
these functional tests will be completed prior to use of the balance for PM2.5-PEP measurements.
The balance technician should provide a certification report for the balance calibration and
functional tests (which includes indication of whether adjustment was required or performed)
and such reports are to be maintained in the laboratory records.
Certified weights employed for balance calibration checks and performing quarterly certified
weight verifications will be certified minimally annually by a metrology laboratory as described
in Section B7.1; however, will not undergo other testing.
Sensors for measuring and recording environmental conditions in the laboratory will be
calibrated and the calibration verified periodically as described in Section B7.1.2.1. The
weighing laboratory maintains a primary set of weighing laboratory/equilibration chamber
environmental sensors as well as a backup set in the event the primary set is malfunctioning (this
redundancy is to insure against data loss). The laboratory analyst will periodically compare the
measurements from the primary and backup sensors to verify proper operation; however, no
other formal functional checks or testing are performed.
LAs verify the operation of the HVAC system and the refrigeration storage units by examining
the recorded data in addition to employing alarms on the systems that notify the primary LA and
the laboratory manager when conditions fall outside of the required ranges.
B6.2 Instrument and Equipment Inspection
Routine inspection of equipment and components can be subdivided into laboratory and field
areas.
B6.2.1 Inspection of Field Items
Several PM2.5-PEP sampler components and filter cassette parts are subject to routine inspection,
both in the quarterly maintenance events and in the field before and after the PM2.5-PEP
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sampling event. These are covered in detail in Section 7.5 of the PM2.5-PEP Field SOP. Table
B6-1 lists these inspections and their required frequency.
Table B6-1. Routine QC Inspections of PM2.5-PEP Field Items
I'icld IU-111 Id
Inspect
Inspection
l'"iV(|iieno
Inspection l-'ocns
Inspcclion Action
Dociimcnliilion
Kc(|iiircmcnl
Sampler
downtube
Every sampling
event
Presence of visible
particulate on interior
Clean interior with a
clean dry cloth
Document in logbook
WINS
impactor well
Every sampling
event (for samplers
so equipped)
Presence of cone shape
of particulate on
impactor well
Replace impactor
well filter and
properly oil
Document in logbook
a
Very sharp-cut
cyclone
(VSCC)
Every 10 sampling
events or after a
dust storm or heavy
air pollution episode
(for samplers so
equipped)
Collection reservoir (grit
pot) laden with
particulate matter
Clean reservoir
Document in logbook
a
Sampler rain
collector
Every sampling
event
Sufficient volume of
condensation to pour
Empty rain collector
Document in logbook
Sampler flow
path O-rings
Every sampling
event
Damage or deformation
Replace o-rings
Document in logbook
Filter cassettes
After each sampling
event
Presence of visible
particulate matter
Check downtube and
WINS impactor/
VSCC
Document in logbook
Cassette seals
Each sample
Seals are clean and
smooth
Clean with a clean
dry cloth or replace
as needed
Document in logbook
when replaced
Sampler
backup battery
Every six months
Decrease in voltage
and/or battery life
Replace battery
Document in logbook
Transfer
standard
battery
Every sampling
event
Low battery condition
Replace battery as
needed
Document in logbook
a Performance also to be documented in MoPED once deployed.
B6.2.2 Inspection of Laboratory Items
Table B6-2 details the parameters requiring inspection in the laboratory weighing room.
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Table B6-2. Routine PM2.5-PEP Weighing Laboratory Equipment Inspections
Item
Inspection
l"rC(|IICIIC\
Inspection
l-ocns
Inspection Action
Dociimcnliilion
Kc(|iiimncnl
Weighing
room
temperature
Daily a
Temperature
within 20°C to
23°C
1. Check HVAC system
2. Call service provider that holds
maintenance agreement
3. Notify the PM2 5-PEP
Laboratory Manager
Document in logbook
Weighing
room relative
humidity
Daily a
Relative
humidity within
30% to 40%
1. Check HVAC system
2. Call service provider that holds
maintenance agreement
3. Notify the PM2 5-PEP
Laboratory Manager
Document in logbook
Dust in
weighing room
Monthly
Dust must not be
present (white
glove test)
Clean weigh room
Document in logbook
a The currently employed sensors report continuously to a cloud storage site provided by Dickson Instruments. This
cloud site user interface provides plots and tables of temperature and RH measurements and provides warnings
when measurements fall outside user-assigned action levels.
B6.3 Equipment and Instrument Maintenance
This section describes the required maintenance activities for field and laboratory equipment
including preventive maintenance.
B6.3.1 Field Equipment Maintenance
Table B6-3 details the appropriate maintenance checks of PM2.5 samplers and their frequency.
Section 7.5 of the PM2.5-PEP Field SOP provides procedures for cleaning the field equipment.
Table B6-3. Field Maintenance for the PM2.5-PEP
I'Vequencv
MiiinlciiiiiHT Item
Every 10 sampling
events or as needed
1. Clean VSCC (for samplers so equipped)
Quarterly (every 3
months)
1. Clean sampler inlet surfaces
2. Clean first stage size-selective inlet (PM10 head) and condensate line
3. Clean impactor housing (if applicable) and impactor jet surfaces
4. Clean VSCC (for samplers so equipped)
5. Clean interior of sampler unit
6. Check condition of sampler transport containers
7. Clean sampler downtube
8. Inspect cooling air intake fan(s) and filter; replace if necessary
9. Inspect all o-rings, visible and hidden, and reapply vacuum grease as
needed
10. Inspect vacuum tubing, tube fittings, and other connections to pump and
electrical components; service if necessary
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B6.3.2 Laboratory Equipment Maintenance
Maintenance of the environmental control system for the weighing room is handled through
service agreements with an external vendor for the weighing laboratory's HVAC system. The
HVAC service technician performs a functional check on the HVAC system quarterly, which
involves checking system component voltages as well as refrigerant and/or compressor
operational pressures. Note that the quarterly functional checks do not involve maintenance or
checking of the thermostat or humidistat measurements. The weighing laboratory relies on the
environmental monitoring probe measurements to signal out-of-tolerance conditions.
Additionally, the weighing laboratory manager or designee will inspect the humidity canister on
the HVAC system to ensure there is sufficient salt and water every six months and changes the
HVAC HEPA filter minimally annually.
Similarly, maintenance for the microbalances is performed by an accredited vendor and is
scheduled to occur at initial setup and minimally annually thereafter (this occurs currently every
six (6) months). The service vendor can be called for a service visit if there is a problem with the
microbalance that cannot be resolved within the laboratory. The laboratory maintains a spare
microbalance for use if the primary microbalance is not meeting operational specifications.
The PM2.5-PEP laboratory manager annually renews the service agreements for both the HVAC
system and the microbalance. In the event either company's service agreement is not renewed, a
new service provider is selected, and a contract put in place.
Table B6-4 details the weighing laboratory maintenance items and the required frequency.
EPA contractor(s) provide maintenance (e.g., backup) of network file shares used to store the
weighing laboratory's PED or LIMS database, according to policies established by EPA's Office
of Administration and Resource Management.
Table B6-4. PM2.5-PEP Weighing Laboratory Maintenance Activities
l.;il>or;iion MiiinlciiiiiKT Acti\ il>
Uc(|iiirod l-'ri'(|iK'iio
Perform functional check on HVAC system
Quarterly
Inspect HVAC system coolant levels and
water and salt levels in humidity canister
Every 6 months
Clean balance table
Each day of use
Clean overall laboratory (dusting and
organizing)
Monthly
Replace adhesive-coated floor mats
Weekly, or when soiled to a point of non-
performance
HEPA filter change
Annually
Polonium-210 strip change
Every 6 months
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Table B6-4. PM2.5-PEP Weighing Laboratory Maintenance Activities (continued)
l.;il>or;iion MiiinlciiiiiKT Acti\ il>
Uc(|iiirod l-'ri'(|iK'iio
Polonium-210 strip cleaning
Monthly, or more frequently if indicated by blank
data
Clean microbalance
Every 6 months, staggered from vendor and service
calibration
Service and calibrate microbalance
Annual (performed by vendor)
Backup PC connected to microbalance
Minimally weekly; automated daily backup
preferred
Computer virus check
Weekly, with automated on-access scans and on-
delivery e-mail scans
Filter weighing software database compaction
Checked monthly; compaction as needed to ensure
sufficient hard drive storage space
Computer system preventive maintenance
(e.g., archive files, compress hard drive, and
ensure sufficient storage space
Annually
B7 Instrument Calibration and Frequency
This section describes the calibration and calibration verification procedures used for instruments
generating field and laboratory measurements in the PM2.5-PEP and certification of standards
employed to calibrate and verify calibration of the instruments. Instruments that cannot be
successfully calibrated will be repaired or replaced as practical. Following calibration
(adjustment of instrument), calibration verifications are performed.
The PM2.5-PEP FSs or LAs are to document calibration events in field/laboratory records and/or
notebooks as indicated in the PM2.5-PEP Field and Laboratory SOPs. Calibration records are
appropriately filed using the AFC (under PM2.5-PEP/301-093-006.6) or equivalent filing system
(refer to Section A9).
B7.1 Laboratory Calibrations and Calibration Verifications
Standards for calibration and calibration verification of the laboratory balance, standard weights,
temperature, and RH are required to undergo aNIST-traceable calibration certification every
year.
B7.1.1 Microbalattce Calibration
The microbalance employed in the PM2.5-PEP weighing laboratory is calibrated minimally
annually by a contracted service technician accredited to perform balance maintenance,
adjustment, and calibration. The technician will verify the balance operation (as in Section B6.1)
and calibration using NIST-traceably certified weights and will service the balance and adjust the
calibration if function or calibration are shown to be out of tolerance. The microbalance is
calibrated each day of use prior to use employing the internal calibration function of the
microbalance (which employs weights installed internally to the balance by the manufacturer).
Following a successful internal microbalance calibration (as indicated by the balance), the LA
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verifies the balance calibration as described below in Section B7.1.1.1. Balance calibration and
calibration verification requirements are summarized in Table B7-1.
Table B7-1. Microbalance Calibration Requirements for the PM2.5-PEP
Acli\ il\
l"lV(|IK'IIO
( riU'i iii
Procedure Siimniiin
Calibration
and Servicing
At least
2/year
Calibration
check weights
from
approximately
0.050 to 1 g must
be within ±0.003
mg
The authorized service provider performs servicing and calibration
of the microbalance. The microbalance is tared and then a series of
NIST-traceable calibration masses from approximately 0.05 to 1.0 g
are weighed to verily calibration. If any weight is outside of ±0.003
mg, the technician adjusts the microbalance calibration.
Internal
Calibration
Prior to each
weighing
session
Successful
completion of
internal self-
calibration
LA activates the microbalance internal self-calibration procedure,
which employs a standard 5-g weight. If procedure cannot be
completed successfully, the LA will verily the microbalance is level
and that the balance is stable before repeating internal calibration.
If internal calibration cannot be successfully completed, perform an
external calibration (reference laboratory SOP and microbalance user
manual) and schedule servicing by a certified microbalance
technician.
Calibration
Verification
Following
internal
calibration at
the beginning
of each
weighing
session, after
every 10 filter
mass
measurement,
and
concluding
the weighing
session
Within ±3 |ig of
the certified
weight corrected
for the apparent
mass correction
(Cw)
1. Check that the microbalance grounding cable is properly and
securely connected.
2. Clean microbalance pan and draft shield with antistatic brush.
If the calibration verification continues to fail, halt the weighing
session, and perform maintenance/troubleshooting. Any filters
weighed during the weigh session since the last passing calibration
verification weight are to be re-weighed once the microbalance is
operating within specification.
B7.1.1.1 Microbalance Calibration Verification and Standard Weights
Following successful internal self-calibration of the microbalance and at the beginning of each
weighing session, the LA weighs two certified working standard weights to verify the balance
calibration at the balance load mass range of use. One of these weights is then weighed
periodically throughout the weighing session and concluding the weighing session.
The PM2.5-PEP uses American Society for Testing and Materials (ASTM) Class 1 or Class 0
NIST-traceable standard weight sets (standard weights must bracket the expected weight of an
un-exposed filter15) for its primary and secondary (working) standards. The weights weighed
include a low and high mass, typically 300 mg and 500 mg, respectively, which covers the
15 If the expected weight of an un-exposed filter is 375 mg, one standard weight must be less than 375 mg (e.g., 300
mg) and another greater than 375 mg (e.g., 500 mg).
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anticipated filter weight of approximately 375 to 425 mg (additional or alternative weights will
be weighed if filter masses are outside this typical range). The laboratory employs three weight
sets for calibration verifications and assessments of balance operation, a primary weight set, a
working weight set, and an independent assessment weight set.
Both working and primary standard weights are recertified annually against ASTM Level 00 or
Level 0 mass standards at an International Organization for Standardization (ISO)-17025
accredited laboratory. Standard mass weights must be within ±10 |ig of their certified value upon
recertification.
¦ Working standard weights - The working standard weights are to be used for
performing routine daily balance calibration verifications. On a quarterly basis, the
certified mass of the low and high mass working standard weights is to be assigned by
comparison with the primary standard weights following an apparent mass correction
process (Section B7.1.1.2). To check for mass changes in the working standard weights, a
double-substitution procedure is followed and an apparent mass correction of the working
standard weight (Section B7.1.1.2), Cw, is calculated. This procedure involves repeated
weighing of the working standard weight and corresponding primary standard weight.
¦ Primary standard weights - The primary weight set is the authoritative weight set
employed to verify the tolerance of the working standard weights. The primary weights
are reserved for this purpose and should only be used to verify the working standard
weights or to verify balance calibration if the working standard weights are unavailable
or suspected of being out of tolerance.
¦ Independent assessment weights - The independent assessment weights are reserved to
periodically independently verify balance calibration. This weight set is certified by a
metrology laboratory independent from that employed to certify the working and primary
standard weights. Their use for independent assessment is detailed in Section CI. 1.6.
As the weighing session progresses, the LA weighs one of the certified working standard weights
after each 10 filter weights and at the conclusion of the weighing session. Each measurement of a
working standard weight must show the balance reading is within ±3 |ig of the assigned Cw,
otherwise corrective action is necessary. Bracketing the beginning and end of the weighing
session as well as interspersing the calibration verification checks throughout the weighing
session demonstrates the balance was operating within tolerance throughout the weighing
session.
If the working standard weight check fails the acceptance criterion at the beginning of a
weighing session, corrective action may be as simple as allowing additional time for the
microbalance to sufficiently warm up followed by repeating the microbalance internal calibration
procedure. If the acceptance criterion is still not met when weighing the working standards, the
LA will verify the working standards against the primary standards as in Section B7.1.1.2. If it is
established that the microbalance does not meet acceptance criteria for both the working and
primary standards and other troubleshooting techniques fail, then the service technician should
be called to service the balance and the backup balance should be employed for weighing
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sessions.
Filter weight measurements for which the temporally bracketing (prior to and following)
working standard weight checks do not meet the acceptance criterion will not be accepted and
will need to be reweighed with passing bracketing balance calibration verifications. The affected
filters will remain in the conditioning environment to be reweighed once the microbalance meets
the acceptance criteria.
B 7.1.1.2 Apparent Mass Correction for Working Standard Weights
Prior to use and on a quarterly basis, the working standard weights will be compared to the
primary standard weights to determine the apparent mass correction. Calculate the apparent mass
correction, Cw, for each individual working standard weight by weighing both the working
standard weight and the corresponding primary standard weight (e.g., both are nominally 250-mg
weights). The procedure is described in detail in the Laboratory SOP and is summarized below
for calculation purposes. Subsequent determinations of Cw are compared to the initial Cw and
must be within ±2 |ig of the initially determined Cw.
Perform and record stable mass measurements for the working standard and primary standard
weight according to the following sequence:
1. working standard weight 1 (wi)
2. primary standard weight 1 (pi)
3. primary standard weight 2 (p2)
4. working standard weight 2 (W2)
Use the certified standard weight masses for the primary standard weight (Cp) and the nominal
mass of the working standard weight (Nw) and primary standard weight (Np) and determine Cw
per the following formula:
(wx - px + w2 - p2)
C = C + -—-—— ——¦ +N —N
2 p
For example:
The LA weighs a 250-mg nominal working standard weight and primary standard weight.
The primary standard weight certified mass is 250.0008 mg. The LA weighs records the
following measured masses for the working standard weight and primary standard weight:
wi = 249.9994 mg
pi = 250.0001 mg
P2= 250.0006 mg
wi = 249.9995 mg
Cw is calculated as (all values in mg):
r ocnnnno , (249.9994 -250.0001+249.9995-250.0003) - - ____
Cw = 250.0008 H 1- 250 — 250 = 249.9999 mg
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B7.1.2 Environmental Monitoring Instrument Calibrations
The PM2.5-PEP weighing laboratory utilizes temperature and RH probes connected to a data
logger to continuously monitor and record environmental conditions within the weighing lab.
The environmental monitoring probes are calibrated annually by an accredited metrology
laboratory. The metrology laboratory will verify that the temperature and RH probe responses
are within ±2°C and ±2% RH, respectively, at minimally two values bracketing the expected
measurement range in the weighing laboratory room, approximately 20 to 30°C and 20 to 60%
RH, respectively. If the tolerances are not met, the metrology laboratory will adjust the probe
response to within these specifications. The laboratory will provide a certificate of calibration to
the weighing laboratory for their records.
The weighing laboratory maintains five sets of environmental monitoring probes. Four of these
sets are the same make and model that serve as the working probes and one is a different make
and model and is maintained as the primary probe set to serve as a QC reference. The laboratory
ensures two of the working probe sets are installed and functioning properly at all times where
one of the two operating sets is assigned as the active working set and the other as the backup
set. This redundancy ensures constant environmental conditions data collection and permits
substitution from the backup in the event the active probe fails. The two sets of working probes
that are not installed are maintained within calibration so they can be rotated into service when
the active or backup probe sets are removed from service, typically toward the end of their valid
calibration period.
B7.1.2.1 Environmental Monitoring Instrument Calibration Verification
The active and backup temperature and RH probe calibrations are verified quarterly by
comparison to the primary probe set and must be within ± 2°C and ±2% RH, respectively, for the
temperature and RH probes. Corrective action must be taken if these criteria are not met, which
may include rotating in one of the reserved calibrated working probe sets. The LA and laboratory
manager will evaluate the impact of the out of tolerance condition on filter equilibration and
measured masses of filters since the most recent environmental probe acceptable calibration
verification. Such corrective actions and data impact will be discussed with the weighing
laboratory task monitor and may require elevation to the PM2.5-PEP OAQPS Lead depending on
the scope of the data impacted.
B 7.1.2.2 Refrigeration Unit Probe Monitor Calibration/Calibration Verification
The temperature probe employed for monitoring refrigerated storage units for sampled filters is
to be within calibration when initially placed into service and the calibration verified quarterly by
comparison to a temperature transfer standard at two temperatures bracketing 0 and 4°C (this
may be performed by an accredited metrology laboratory). The measured temperature must be
within ± 2°C at both of the tested temperatures. If this tolerance is exceeded, the temperature
probe response is adjusted such that the probe response is within the defined tolerance. For
tolerance exceedances, the LA and laboratory manager will assess the impact on the data for
sampled filters stored in the refrigerated storage units since the most recent acceptable
calibration verification. The data impact will be discussed with the weighing laboratory task
monitor and may require elevation to the PM2.5-PEP OAQPS Lead depending on the scope of the
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data impacted.
B7.1.2.3 Sample Shipment Thermometer Calibration/Calibration Verification
The infrared (IR) thermometer employed to measure temperatures of received sample shipments
is calibrated when new and is sent to an accredited metrology laboratory annually for
calibration/calibration verification. The thermometer must be within ±2°C of the temperature
standard and the metrology laboratory will provide a certificate of calibration for the IR
thermometer calibration for the laboratory records. Note that the calibration/calibration
verification must cover the range of temperature use, which is approximately -10 to 30°C.
Table B7-2. Environmental Temperature and Relative Humidity Probe Calibration
Requirements
Acli\ il\
I"iv(|iioiio
( rilcriii
Procedure Suiiiin;ir\
Working active and
backup
environmental
temperature probe
calibration
verification
Quarterly
± 2°C of NIST-
traceable standard
Comparison of the working standard probes to the
primary standard probes to verily calibration. If out of
tolerance, assess impact on collected measurement data
and on actively conditioning filters. Replace with
properly functioning probe.
Working active and
backup relative
humidity probe
calibration
verification
Quarterly
± 2% RH of
NIST-traceable
standard
Comparison of the working standard probes to the
primary standard probes to verily calibration. If out of
tolerance, assess impact on collected measurement data
and on actively conditioning filters. Replace with
properly functioning probe.
Primary temperature
probe
calibration/calibrati
on verification
Annually
± 2°C of NIST-
traceable standard
across
measurement
range
Calibration performed by metrology laboratory covering
range of use, which must cover 10 to 35°C
Primary relative
humidity probe
calibration/calibrati
on verification
Annually
± 2% RH of
NIST-traceable
standard across
measurement
range
Calibration performed by metrology laboratory covering
range of use, which must cover 15 to 80% RH
Infrared thermo-
meter
calibration/calibrati
on verification
Annually
± 2°C of NIST-
traceable standard
Calibration performed by metrology laboratory covering
range of use, which must cover -10 to 35°C
Refrigerated storage
unit temperature
probe
calibration/calibrati
on verification
Quarterly
± 2°C of NIST-
traceable standard
across
measurement
range
Calibration/calibration verification at minimally two
temperatures covering range of use, which must cover -5
to 10°C. Alternatively may be performed by an
accredited metrology laboratory.
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B7.2 Field Sampler Calibration and Calibration Verification
The PM2.5-PEP Field SOP provides details for corrective action for calibrations and calibration
verifications. Field equipment calibrations and calibration verifications use NIST-traceable
standards. In general, sampler calibration verifications must meet acceptance criteria before the
sampler can be used for PM2.5-PEP sampling events. Calibration verifications test the sampler in
the as-is condition before changes to the instrument calibrations are made. In the event of a failed
calibration verification, troubleshooting and corrective action occur, and the process is repeated
or adjustments to the calibration are made. If an instrument cannot be calibrated, a replacement
instrument is substituted, and the sampler is to be repaired.
The PM2.5-PEP sampler is calibrated initially, annually thereafter, and upon failure to pass
calibration verification checks listed in Section B7.2.2. The following sampler measurements are
subject to calibration:
¦ Ambient and filter temperature measurements against the temperature transfer standard
¦ Barometric pressure measurement against the barometric pressure transfer standard
¦ Flow rate measurement against the flow transfer standard (after a successful leak test)
¦ Sampler clock against a known time standard.
The FS records the calibration in the field log or other appropriate record, detailing the transfer
standards employed and their calibration dates.
When EPA successfully releases the MoPED system, all clock, pressure, temperature, leak
check, and flow verification information will be recorded in MoPED. Calibration will also be
documented in the MoPED system in the event of a failed verification check MoPED will
post an outcome record in AQS including the status of NIST-traceable calibration standards
for flow, temperature, barometric pressure, and calibration certification records of all
samplers. If a standardfails in the field or during its annual NIST certification test, it is
removedfrom the list of available and properly functioning instruments contained in AQS.
MoPED will not permit its use in the field, for quarterly audits, or for annual certification of
samplers until it is repaired and shown to be within proper calibration and operation by a
qualified metrology laboratory. Sampler performance and certification will be similarly
tracked. Samplers must be certified as having passed a NIST traceable certification annually
within 360 days of each event to which it is deployed.
B7.2.1 Field Instrument Calibration
The sampling unit comprises a flow controller, barometric pressure probe, ambient temperature
probe, and filter position temperature probe that must be calibrated and these calibrations
verified before each use (Section B7.2.2) by comparison to a certified transfer standard (typically
a MesaLabs DeltaCal). FSs are to maintain two separate, independent, transfer standards and
employ one for calibration establishment (the primary standard) and the other for calibration
verifications (the working standard).
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In general, sampler temperature, barometric pressure, and flow rate calibrations follow the
general outline steps below:
1. Calibration evaluation in as-is condition:
a. Verify using a primary or independent NIST-traceable standard reference
instrument and evaluate against the calibration acceptance criteria in Table B7-3
(note these are more stringent than the calibration verification criteria). If criteria
are exceeded recalibration per SOP is required.
b. If the sampler meets the calibration acceptance criteria without adjustment, repeat
the evaluation with the routine working transfer standard and evaluate against the
calibration acceptance criteria. If criteria are exceeded recalibration per SOP is
required.
c. If the sampler meets the calibration acceptance criteria with both the primary
transfer standard and working transfer standard, no adjustment is required. If the
calibration acceptance criteria are exceeded, the sampler calibration must be
adjusted (calibrated) with the primary calibration standard per the SOP.
2. Calibration adjustment
a. Following calibration adjustment per SOP, repeat the process above in Step la
through lc to evaluate the calibration.
b. If the instrument cannot be properly calibrated or evaluation acceptance criteria
are not met, troubleshoot the cause and provide remedial solution (corrective
actions are included in Table B7-3), which may involve consulting the
manufacturer for technical assistance or repair.
Certified transfer standards are evaluated annually by an accredited NIST-traceable metrology
laboratory to ensure the tolerances listed in Table B7-4 are met. The certifications are valid for
12 months from the date of certification. The metrology laboratory tests the transfer standard in
as-received condition and will make adjustments to the calibration if the evaluation shows the
standard to be out of tolerance.
The MoPED is designed to ensure that FSs do not use a transfer standard or sampler with an
expired calibration or verification. It will issue reminders to users when equipment is
nearing expiration of its calibration or verification. The MoPED system will not allow users
to complete sampler setup if the certification period for the flowrate, temperature, and
barometric pressure transfer standards has expired. The system will also not allow sampling
event entries using a PM2.5-PEP sampler that has not been calibrated within the previous 12
months with an independent transfer standard.
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Table B7-3. Sampler Temperature, Barometric Pressure, and Flow Rate Calibration
Evaluation Requirements
Ac(i\i(\ Piii'iimolcr
l"lV(|IIOIIO
ACCl'plillKT
(rik'rhi
( onvc(i\c Art inn I pun ( rik'rhi l;iilurc
Single-point
Temperature Probe
(ambient and filter)
Calibration
Evaluation
Annually and
after a failed
calibration
verification
+ 1°C of transfer
standard reading
Re-calibrate temperature probe per SOP. If re-
calibration fails, troubleshoot the probe and its
connection to the motherboard. Replace probe if
necessary. Do not use sampler for PM2 5-PEP
sampling events until probes are calibrated and pass
a single-point verification.
Single-point
Barometric Pressure
Calibration
Annually and
after a failed
single-point
verification
± 5 mm Hg of
transfer standard
Re-calibrate pressure sensor. If re-calibration fails,
troubleshoot the sensor. Replace sensor if necessary.
Do not use sampler for PM2 s-PEP sampling events
until the sensor is calibrated and passes a single-point
verification.
Single-point Flow
Rate Calibration
Annually and
after a failed
single-point
verification
± 2% from transfer
standard at the
design flow rate
(16.67 LPM)
Re-verify temperature and pressure calibration and
re-verify system is leak free. Re-calibrate sampler
flow rate. Do not use sampler for PM2 s-PEP
sampling events until the flow rate is calibrated and
passes a single-point verification.
Table B7-4. Certification Requirements and Acceptance Criteria for Field Transfer
Standards
Siiindiird Piiriinukr
l-'iV(|ik*no of Koccrti«ui
01' Yi'i'irii'iilinn
Accephince ( rik'rhi
Flow Rate
annually
± 2% of NIST-traceable standard
Thermometer
annually
± 1°C of NIST-traceable standard
Barometer
annually
± 5 mm Hg of NIST-traceable standard
Prior to calibration or calibration verification of the sampler temperature and/or barometric
pressure sensor, the sampler is powered on for 30 to 60 minutes to allow the electronics to
equilibrate to ambient conditions. The working standard is powered on for approximately one
hour to allow for equilibration to local temperature and barometric pressure. More or less time
may be required to reach this equilibrium and the FS should follow guidelines of the
manufacturer in deviating from 1 hour.
B7.2.2 Field Instrument Calibration Verification
Upon assembly of the PM2.5-PEP sampler, the FS powers on the sampler and allows it to warm
up and acclimate to the ambient conditions at the site. Once sufficiently equilibrated, the FS will
verify the calibration of the flow controller, barometric pressure probe, ambient temperature
probe, and filter position temperature probe by comparison to a certified transfer standard. To
ensure the flow controller references accurate temperature and barometric pressure readings, the
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temperature and barometric pressure calibration verifications must be performed before the flow
rate calibration verification.
Failure to meet the specified acceptance tolerances requires recalibration of the sampler slope
and intercept for the failing parameter to match the certified transfer standard reading(s). Once
the sampler calibration has been adjusted, the calibration verification checks must be repeated
and meet the criteria listed above. If any of the three calibration verification checks cannot meet
the specified criteria, the sampler may not be used for a PM2.5-PEP event.
B 7.2.2.1 Barometric Pressure Calibration Verification
Prior to each PM2.5-PEP sampling event, the FS will perform a routine one-point calibration
verification of the barometric pressure sensor by comparing the sampler's barometric pressure
reading of the ambient barometric pressure to that measured by the certified working transfer
standard. The sampler barometric pressure reading must be within ±10 mmHg of the certified
transfer standard or the sampler barometric pressure measurement system must be recalibrated.
If a re-calibration is necessary for a PQ200 sampler, a new one-point calibration curve is
generated at ambient barometric pressure per the Field SOP.
B7.2.2.2 Temperature Sensors Calibration Verification
Prior to each PM2.5-PEP sampling event, the FS will perform a routine one-point calibration
verification of the ambient temperature sensor and the filter temperature sensor by comparing the
sampler's temperature readings for these two probes to the certified working transfer standard.
The sampler temperature readings must be within ± 2°C of the certified transfer standard or the
sampler temperature sensor exceeding this criterion must be recalibrated.
If a re-calibration of either temperature probe is necessary for a PQ200 sampler, a new three-
point calibration curve is generated at the home facility per the instructions in the Field SOP.
B7.2.2.3 Flow Rate Calibration Verification
As part of each PM2.5-PEP sampling event, the FS implements a flow rate calibration verification
with each setup. The flow rate check measures a sampler's normal operating flow rate using a
certified flow rate transfer standard. The transfer standard flow rate and the corresponding flow
rate indicated by the sampler are reported.
Accuracy of a single sampler—single check basis (di). The percent difference, di, for a single
flow rate audit or verification, i, is calculated as follows (40 CFR Part 58, Appendix A, Equation
1):
Y- — X¦
di = x 100%
Xt
whereX represents the transfer standard's flow rate (known) and Y, represents the sampler's
indicated flow rate (measured).
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The single sampler flow rate verification is performed prior to each PM2.5-PEP sampling event to
ensure the sampler flow rate control is within calibration. The percent difference and the
measured flow rate must meet the following acceptance criteria before completing the PM2.5-PEP
sampling event:
¦ Percent difference from the transfer standard's flow rate (d,): < ± 4%
¦ Measured flow rate: < ± 4% from the design flow rate of 16.67 L/minute
The flow rate verification results are also used to calculate bias for the PM2.5-PEP (discussed in
Section B5.5), while the quarterly flow rate audits are used to evaluate sampler performance.
Table A7-1 provides the audit acceptance criteria for the PM2.5-PEP samplers.
During each PM2.5-PEP sampling event setup, and after the leak check, or temperature and
barometric pressure calibration verifications are performed on the PM2.5-PEP sampler, the FS
performs a one-point flow rate calibration verification using a NIST-traceable calibration
standard. A successful leak check must precede a flow rate calibration verification, as a leak in
the system will cause disagreement between the flow standard and the sampler-reported flow
rate. A limited two-point or three-point temperature calibration can be performed in the field per
the field SOP assuming the FS has a primary transfer standard.
B8 Inspection/Acceptance for Supplies and Consumables
The PM2.5-PEP relies on various supplies and consumables that are critical to its operation and
may directly or indirectly affect PM2.5-PEP data quality. This section presents the system for
inspecting, accepting, documenting, and tracking these supplies and consumables. By having
documented inspection and acceptance criteria, consistency of the supplies can be ensured.
Forms relevant to this section are found in the PM2.5-PEP Field and Laboratory SOPs, with
examples placed at the end of this section. They include:
¦ Field/Laboratory Inventory Form (INV-01; Figure B8-1)
¦ Field/Laboratory Procurement Log Form (PRO-01; Figure B8-2)
¦ Field/Laboratory Equipment/Consumable Receiving Report Form (REC-01; Figure B8-3).
EPA is moving most forms and periodic reports to electronic/digital formats for storage.
Electronic versions of the forms can be acquired from the National PM2.5-PEP Lead at OAQPS.
B8.1 Critical Supplies and Consumables
This section describes the needed supplies for the PM2.5-PEP and includes items for the weighing
laboratory and the field. Generally, critical field and laboratory equipment has been selected by
the PM2.5-PEP organizers based on the required performance specifications of resolution,
accuracy, and ease of use.
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B8.1.1 Laboratory Supplies and Equipment
Table B8-1 lists the critical laboratory equipment in the PM2.5-PEP. Equipment not deemed
critical (affecting data quality) can be selected at the discretion of the PM2.5-PEP Laboratory
Manager. To maintain consistency in the PM2.5-PEP, all consumables/equipment with a model
number in Table B8-1 are purchased using the same model number, if available, as supplies are
needed. The LA is required to keep an inventory of all equipment using the Field/Laboratory
Inventory Form (INV-01; Figure B8-1).
Table B8-1. Weighing Laboratory Equipment and Supplies
Qii;iiilil>
I nils
Ik-ill
I'ivI'itiviI Vi-mlm*:l
Morii-I #:l
2
Each
Microbalance
Sartorius
MC-5
2
Sets
ASTM Class 1 weights
Rice Lake Weighing Systems
11909
2
Each
Balance table
Thermo Fisher Scientific
HMO 19945
2
Each
Computer
Dell
2
Each
Barcode reader
1
Each
Relative humidity/temperature Weigh room
probe
Vaisala
E-37510-02
1
Each
Relative humidity/temperature Weigh room
probe
Dickson
15302225
2
Each
NIST-traceable thermometer sensor Primary
Dickson
15-041A
1
Each
Tacky mat plastic frame
Thermo Fisher Scientific
06-528A
1
Each
Uninterruptible power supply
Cole-Parmer
E-05158-60
1
Each
Refrigerator
1
Each
Freezer
1
Each
Sonicator bath
2
Each
Antifatigue floor mat
Richmond
19-61-763
2
Each
Equilibration rack
1
Each
Laser printer
1
Each
Dehumidifier
1
Each
Light table
1
Each
Microsoft Access 2000 or later
077-00370
2
Each
SartoWedge software for microbalances
Sartorius
YSW01
1
Each
Barcode-printing software
Cole-Parmer
E-21190-10
24
Each
HVAC filters
1
Case of
1,000
Powder-free antistatic gloves
Thermo Fisher Scientific
11-393-85A
12
Each
Polonium-210 strips
NRD
2U500
7
Pack of 100
Petri slides
Gelman
7231
1
Case of 12
bottles
Staticide
Cole-Parmer
E-33672-00
1
Case of 15
packs
Low-lint wipes (Kimwipes)
Kimberly-Clark
34155
1
Each
HVAC service contract
1
Each
Microbalance service contract (two scheduled
visits per year)
Sartorius
1
Cleaning supplies
2
Each
Worklon antistatic laboratory coats
Thermo Fisher Scientific
01-352-69B
2
Each
Forceps (stainless steel with plastic tips)
VWR
25672-100
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Table B8-1. Weighing Laboratory Equipment and Supplies (continued)
Qiiiinlih
I nils
Ik-ill
I'ivI'itiviI Vi-mlm*:l
Modi-I # '
1
Case
Antistatic 3" x 5" reclosable bags (for cassettes)
Consolidated Plastics
90202KH
1
Case of
1,000
Alcohol swipes
Thermo Fisher Scientific
14-819-2
20
Each
Coolers (6-pack size)
4
Case of 24
Reusable U-Tek refrigerant packs (~1°C)
Thermo Fisher Scientific
03-528B
1
Case
Antistatic 9" x 12" reclosable bags
Consolidated Plastics
90210KH
4
Each
Logbooks
3
120 sheets
Hard surface tacky mat (moderate tack)
Thermo Fisher Scientific
06-527-2
a When a preferred vendor or model number is not specified, the purchaser can determine an acceptable unit.
As consumables ran low or when new purchases are necessary, the LA is responsible for
assisting in the procurement of these items following the policy and requirements described in
the scope of work of the contract with the PM2.5-PEP weighing laboratory. The LA should
continue purchasing consumable equipment with the same model numbers as the equipment
initially procured unless the PM2.5-PEP Laboratory Manager suggests a different item due to
improved quality, reduction in contamination, improved ease of use, unavailability, or lower cost
(without sacrificing quality). Such changes should be approved by the PM2.5-PEP Laboratory
Task Monitor. Any unavoidable equipment changes that could affect the results of collected data
will be reported to the OAQPS National PM2.5-PEP Lead.
The LA performs the following procedures:
¦ Develop procurement requests as per EPA requirements.
¦ Upon order, add items to the Field/Laboratory Procurement Log Form (PRO-01).
¦ Once a month (or as needed), provide a copy of the PRO-01 to the PM2.5-PEP Laboratory
Manager and the Regional PM2.5-PEP Lead.
¦ File PRO-01 under AFC "PEP/301-093-006.6." or another acceptable/equivalent filing
system.
B8.1.2 Field Equipment and Supplies
To ensure consistency and to meet the DQOs, OAQPS either directly purchases or facilitates
purchases of all major capital equipment such as samplers and calibrator transfer standards.
OAQPS consults with Regions on consumables for PM2.5-PEP field activities. Table B8-2 lists
these items; quantities are not given as they vary with the size of the field operation (i.e., number
of PM2.5-PEP samplers and sites). Initial quantities to procure are arranged with each Regional
PM2.5-PEP Lead. The FS is required to keep and inventory all equipment, including any warranty
information.
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Table B8-2. Field Equipment and Supplies
<><>•
I>M:?-I>I'.I> I k-Id l;.<|iii|>iiK'iil ;iihI Supplies
Yiiiiliir/C ;il;il<><;
NiiihIkt"
Miiki'/Miuk'l
NiiihIkt"
Miiiiiiorin^ r.(|iii|)iiH-nl ;iihI Suppliis
Transport cases for loose equipment/consumables
Forestry Suppliers/31113
Collapsible crate
Backpack frame for carrying samplers
Forestry Suppliers/35913
Portable FRM PM2.5 sampler(s) with carrying case
Mesa Labs
BGI PQ200 (preferred)
Very sharp cut cyclone (VSCC)
Mesa Labs
VSCCB
WINS (if not using a VSCC)
Mesa Labs
Discontinued
Pre-weighed 46.2-mm diameter filters in the proper cassette
Supplied by weighing lab
COC form for each filter cassette
Anti-static ziplock bags for shipping COCs and data storage media
Impactor oil and dropper (NOTE: Dow 704 has been found to
solidify when sustained at 4°C for long periods.)
SPI Supplies
Octoil®-S
(SPI Number 00031)
Impactor filters (37-mm diameter glass fiber)
Mesa Labs (preferred)
Teflon-coated tweezers (for handling impactor filters)
Sample shipping containers (coolers)
Custody seals (tape or stickers)
Foam brick (ice substitutes), 36/box
Daigger
12-volt electric transport cooler with AC transformer (if used)
Globe Mart/5615-807
Coleman 16 quart
Filter transport coolers (6 quart)
Bubble wrap
PM2.5-PEP FRM Sampler Operations Manual
Field notebook(s)
Clipboard (8 inch' x 14 inch)
Grip binders
Data storage media (e.g., diskette, CD, or USB card)
Silicone grease for O-rings (e.g., vacuum grease)
Daigger/AX23061A
EF23061A
FRM PM2.5-PEP Field SOP (this document)
Laptop computer with PQ200 job-control software and MoPED
software
Datatrans™ to download data (ideal for use in inclement weather)
Discontinued
Discontinued
Cables for connecting the data-download device to the FRM
sampler
Magnetic compass or other means of determining site orientation
Tape measure (metric)
Smart/cell phone
Global positioning system (GPS) device
Mechanical pencils and markers (indelible)
Muuiiliii^ l'.(|iiipiiu'iil iiiul Tunis
Ladder and a rope for hoisting equipment
Hand truck/cart with wheels and straps for transporting equipment
Bubble level for checking the portable FRM sampler
Wooden shims or other means for leveling the FRM sampler
Toolbox with basic tools, including the following:
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Table B8-2. Field Equipment and Supplies (continued)
<¦?'>•
PM2 5-PI".I> I'ii'ld l'.(|iii|)iiH'in ;ind Supplies
NiiihIkt"
NiiihIkt"
Allen wrenches (metric and standard)
Micro screwdriver set
Pliers (multiple sizes and types)
Screwdrivers (standard straight and Philips head)
Wire cutters
Small cinch ties
Electrical tape
Soldering gun/solder
Hemostat (for flow rate troubleshooting)
Flashlight with spare batteries
Heavy-duty, grounded, weatherproof electrical extension cord with
multiple outlets (one 12 ft and one 25 ft length)
Tie-down cables, anchors, plywood sheet, and bungee cords to
anchor and stabilize the portable FRM sampler and to dampen
vibration (optional)
Masking tape
Packaging tape
Strapping tape
('.ilihr.ilion/YiTirk'.ilion Sl.imhirris mid Ri-hik-il I'cuiipiiunl
Downlube ilow rale adapter
Temperature, pressure, and flow verification device with external
temperature probe
BGI deltaCal
BGI Tri-Cal
Alicat
DC-1
TC-12
FP-25
Temperature verification/calibration standard (NIST-traceable) with
probe (optional)
VWR
61220-601
Styrofoam cup and deionized ice water for temperature calibrations
Flow-check filter in transport cassette
Impermeable "filter" disk for internal leak checks
Accurately set timepiece (cell phone)
S|);iiv I'll l is iilld ()|> 1 iiill;i 1 l'.(|lli|)llU'lll
Spare O-rings for the portable FRM sampler
Spare batteries (for all battery-powered equipment)
Fuses, as required by all equipment used
Spare in-line filters (if required by the portable FRM sampler)
Voltmeter/ammeter/ohmmeter for troubleshooting
Spare impactor(s)
Ground fault circuit interrupter (GFCI) tester
Portable GFCI device
Camera (digital) for site pictures
(,k';inin
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Table B8-2. Field Equipment and Supplies (continued)
<¦?'>•
PM2 5-PI".I> I'ii'ld l'.(|iii|)iiH'iil ;iml Supplies
Yi'iiilnr/Ciihilo^
Number-
M;iki-/M(i(k-I
Number1
Soft brush
Supply of deionized water for cleaning and rinsing equipment
Isopropyl alcohol to aid in removal of grease and dirt
Alcohol wipes for preloading hand wipe
Penetrating oil (silicone oil or 3-in-l™)
Lint-free pipe cleaners
Safety pin/dental pick
Lint-free cotton-tipped swabs
Wooden dowel and cloth wads to clean downtube
Spray bottle
Disposable powder-free examination gloves (e.g., nitrile)
* When no vendor/catalog number or make/model is specified in the above table, any vendor or make/model is
acceptable. Unless specifically stated, other equivalent equipment and supplies from different vendor makes/models
are acceptable
As consumables run low or when new equipment purchases are necessary, the FS is responsible
for assisting in the procurement of these items following the policy and requirements described
in the contractor scope of work. The FS should continue purchasing consumable equipment with
the same model numbers as the equipment that was initially procured unless the Regional PM2.5-
PEP Lead suggests a different item because of its improved quality, reduction in contamination,
increased ease of use, unavailability, or lower cost (without sacrificing quality). The Regional
PM2.5-PEP Lead will report any equipment changes that could affect the results of sampling
events to the OAQPS PM2.5-PEP Lead. The FS performs the following required procedures:
¦ Develop procurement requests as per EPA requirements.
¦ Upon order, add items to the Field/Laboratory Procurement Log Form (PRO-01).
¦ Once a month (or as needed), provide a copy of the PRO-01 to the Regional PM2.5-PEP
Lead.
¦ File PRO-01 under AFC "PEP/301-093-006.6" or other acceptable filing system.
B8.2 Acceptance Criteria on Equipment and Consumables
The PM2.5-PEP's major pieces of capital equipment include the following:
Laboratory Field
¦ Microbalances ¦ Portable samplers
¦ Calibration equipment ¦ Calibration equipment
¦ NIST-traceable mass standards
¦ Temperature recorder
¦ Relative humidity recorder
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EPA has selected equipment and consumables for the PM2.5-PEP based upon their advertised
specifications on accuracy and resolution, but the program has over 20 years of operating
experience, which also informs the selections. For example, the current fleet of PM2.5-PEP
portable samplers is built to FRM performance specifications and have a good track record of
dependability and serviceability.
Upon receipt, new PM2.5-PEP equipment is inspected and tested using calibration standards (see
Section B7) to ensure they operate within their required performance parameters. All samplers
undergo a break-in and shakedown (Section B6.1.1) to test major performance features,
expectations, and any new attributes introduced by the manufacturer in model updates. All
equipment is purchased under warranty and undergoes yearly calibration and certification as
described in Section B7.
PM2.5-PEP field and laboratory personnel use the Field/Laboratory Procurement Log Form
(PRO-01) (Figure B8-1) to record the purchase and receipt of new equipment and consumables
and to indicate whether these items were accepted or rejected upon receipt. In addition, the
laboratory and field personnel use the Field/Laboratory Inventory Form (INV-01) (Figure B8-2)
to list each equipment item and its warranty dates. These or equivalent forms can be produced
and stored electronically.
B8.3 Tracking and Quality Verification of Supplies and Consumables
Tracking and quality verification of supplies and consumables meet two needs:
1) the need of the end user of the supply or consumable to have an item of the required
quality, and
2) the need for the purchasing department to accurately track goods received so that
payment or credit of invoices can be approved.
Upon receiving packages containing new supplies and consumables, the receiving personnel
perform the following activities to address these needs:
¦ Perform a rudimentary inspection of the packages and note any obvious problems with a
shipment, such as crushed or open/damaged box or wet cardboard.
¦ Obtain the appropriate purchase order(s) for the incoming items from office files.
¦ Complete a Field/Laboratory Equipment/Consumable Receiving Report Form (REC-01)
(Figure B8-3), reconciling the received items and quantity against the purchase order and
inspecting the condition of each received item.
¦ If the received items match the purchase order and the condition of the equipment or
consumables is acceptable, record this finding on the form and file the form under AFC
"PEP/301-093-006.6" or other acceptable filing system.
¦ If the quantity of received items does not match the purchase order or if the condition of
the received items is not acceptable, complete REC-01 with remarks of these findings
added and send a copy of the form to the Regional and National PM2.5-PEP Leads. This
information will be vetted among all the PM2.5-PEP Leads and FSs. If the problem
presents an imminent risk to program-wide data quality, a conference call will be
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convened with the Regional PM2.5-PEP QA Workgroup to present the problem and arrive
at a program-wide solution.
1(0111
Model
N11111 her
PO#
Vendor
D.tle
Cosl
Iiiili;ils
Accept/
Reject
Ordered
Rccci\ ed
Figure B8-1. Field/Laboratory Procurement Log Form (PRO-01)
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1(0111
Vendor
Model Nilmher
(Ju;inlil>
Purchiiso l);ilc
\\ ;ut;iiiI\
Figure B8-2. Field/Laboratory Inventory Form (INV-01)
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¦ Contact the vendor to report any problem with the package and/or contents.
¦ Add receipt information to the Field/Laboratory Procurement Log Form (PRO-01) and to
the Field/Laboratory Inventory Form (INV-01).
In addition, any voice communication with vendors is transcribed onto a phone communication
form and this record maintained.
l-k'l(l/l.;il)(>r;ilor\ 1-'(|ii ipmoii l/C'oiisii Rccii\ inti Report In nil (KIK -01)
Dak-
Received From:
Shipped From:
Shipped Via:
Shipping Charge
Prepaid Collect
Freight Bill Number
Purchase Order Number
Quantity
Description of Item
Condition
Remarks:
A
xept Shipment
Problem
Notes:
Figure B8-3. Field/Laboratory Equipment/Consumable Receiving Report Form (REC-01)
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B9 Acquisition of Non-Direct Measurement Data
Most of the data used in the PM2.5-PEP are direct measurements acquired by the FSs and LAs
working for the PM2.5-PEP as described in Sections B1 through B8. However, some data are
obtained from sources outside the PM2.5-PEP or data acquired within the PEP are to be judged as
fit for use by the PM2.5-PEP laboratory. An example of chemical data might be the composition
of refrigerant foam in new generation cold temperature sealed refrigerant bricks. An example of
monitoring data might be field blank data from the SLTs that own and operate the samplers and
monitoring sites in the National PM2.5 network. This section addresses data that are not obtained
by direct measurement from PM2.5-PEP maintained equipment or analysis methods. It also
addresses quality issues related to the use of these non-direct data sources within the PM2.5-PEP.
B9.1 Chemical and Physical Properties Data
Physical and chemical property data and conversion constants are often required when
processing raw data into reporting units. This type of information, which was not specified in the
monitoring regulations, is obtained for the PM2.5-PEP from nationally and internationally
recognized sources. Other data sources may be used with approval from the OAQPS PM2.5-PEP
Lead. The following information sources may be used in the PM2.5-PEP without prior approval:
- NIST
¦ ASTM for certification of gravimetric balance verification and audit weights
¦ ISO, International Union of Pure and Applied Chemistry (IUPAC), American National
Standards Institute (ANSI), and other widely recognized national and international
standards organizations
¦ EPA published references, including:
o OA Handbook for Air Pollution Measurement Systems: "Volume II: Ambient Air
Quality Monitoring Program" EPA-454/B-13-003, May 2013 - Full Document and
subsequent revisions
¦ Standard handbooks including CRC Press' Handbook of Chemistry and Physics and
Lange 's Handbook of Chemistry.
B9.1.1 Equipment Manufacturers' Literature
Manufacturers' literature, which includes operations manuals and user manuals on specific
equipment, provides important numerical information and equations to the PM2.5-PEP. However,
these information sources should be used with caution as certain information may contain some
degree of error or may be of lower quality which could impact the quality of certain PM2.5-PEP
data. Examples include:
¦ Data containing insufficient precision
¦ Outdated values for physical constants
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¦ Typographical errors
¦ Incorrectly specified units
¦ Inconsistent values within a manual
¦ Use of different reference conditions than those specified in EPA regulations.
Thus, appropriate cross-checks are needed to verify the reasonableness of information in these
manuals. Whenever possible and during acceptance testing, the FSs compare physical and
chemical constants in the operator's manuals to those given in the above information sources. If
discrepancies are found, then the FS may raise these issues with the Regional PM2.5-PEP Lead
during PM2.5-PEP QA Workgroup conference calls and recertification training sessions.
B9.1.2 Monitoring Site Information
When preparing for a PM2.5-PEP sampling event at a monitoring site, the FS must rely on site-
specific information provided by the Regional PM2.5-PEP Lead or the SLT organization that
operates the site and its permanent PM2.5 samplers. This information includes the following:
¦ The name and AQS identifier of the PQAO responsible for the given site.
¦ The AQS site ID
¦ Type(s) of SLT-operated PM2.5 sampler(s) at the site, their status, and sampler method
designation(s)
¦ Information that distinguishes the primary monitor if multiple SLT site samplers exist
¦ Presence of any nearby contributors of airborne PM2.5 and the proximity of these sources
to the site
¦ General site information on PM2.5 levels and trends, and meteorological information.
This information should be included in the site file which is stored in the Regional field office.
Information on site location and presence of SLT-operated PM2.5 samplers should be available in
the AQS database for accuracy before proceeding to a site.
B9.1.3 Monitoring Measurement Databases
PM2.5-PEP policy dictates that no data obtained from outside organizations shall be used in
creating reportable data or published reports without prior approval from the OAQPS PM2.5-PEP
Lead. Requests to use such information may be made during the PM2.5-PEP QA Workgroup
conference calls or on an individual basis. This policy is intended to ensure the use of high-
quality data in PM2.5-PEP reporting.
Data from the EPA's AQS database may be included in published PM2.5-PEP reports but with
appropriate caution. Care must be taken in reviewing or using any data whose contents are
flagged or otherwise qualified due to questionable quality or validity. If data are flagged within
AQS, such data shall not be used unless it is clear that the data still meet critical QA/QC
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requirements. Because it is impossible to assure that a database such as AQS is completely free
from errors, including outliers and biases, caution and skepticism must be taken when comparing
routine data from other reporting agencies as reported in the AQS. Thus, PM2.5-PEP contributors
must review available QA/QC information to assure that the external data are comparable with
PM2.5-PEP measurements and that the original data generator had an acceptable QA program in
place. EPA presumes data reported by PQAOs to AQS are correct as the PQAO certifies that the
data are correct when reported to the database.
BIO Data Management
B10.1 Background and Overview
This section describes the data management operations, including data recording, transformation,
transmittal, reduction, validation, analysis, management, storage, and retrieval that pertain to
PM2.5 measurements for the PM2.5-PEP. This includes an overview of the mathematical
operations and analyses performed on raw ("as-collected") PM2.5 data.
Each PM2.5-PEP contributor (Section A4) is responsible for collecting quality compliant data
from his/her area of influence and distributing the data to the appropriate participants, including
OAQPS. Table B10-1 represents the data management structure for the PM2.5-PEP.
EPA is in the process of completing a major change to the PM2.5-PEP information
management system. This system, illustrated in Figure B10-1, features the total separation of
field and laboratory data until both are integrated (by PM2.5-PEP sampling event) upon their
independent upload to AQS (these data are stored within the QA module of AQS). FSs will
record and uploadfield data to AQS via MoPED software installed on a tablet PC in the
field while LAs in the PM2.5-PEP weighing laboratory utilize the PED (or other implemented
database) to upload laboratory gravimetric results to AQS.
Table B10-1. PM2.5-PEP Data Collection Sources
('onlrihulor
l >pc(s) ill' Diilii
Disli'ihulioii
Regional PM2.5-PEP Lead or PQAO
PM2 5-PEP coordinator
List of sites to participate
in the performance
evaluation for the target
year
AQS Site ID, POC (or
other unique identifier to
the primary sampler) and
method code of the
primary PM2 5 sampler
(Method code can be
determined once sampler
make and model are
known.)
-To SLT monitoring organizations
-To PM2 5-PEP Regional Office
Monitoring Program Contact(s)
-To AQS. AQS is set up to provide
each PQAO's PM2.5-PEP history and
target sites available each year
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Table B10-1. PM2.5-PEP Data Collection Sources (continued)
( onlrihiilor
l >|)ds) or l);il:i
Disli'ihulioii
PM2 5-PEP Field Scientist
Data from operation of the
PM2 5-PEP sampler,
including COC
The sampling event
download data
Data from quarterly
maintenance equipment
performance checks,
annual performance
calibrations and
certifications, and non-
routine maintenance
checks based on field
performance
-Sampling event data to AQS
-Sampling event download data
currently goes to the PM2.5-PEP
weighing laboratory for storage in
the PED. It will continue to be
transferred to the new LIMS system
when deployed and retrieved by a
utility in AirQA for rapid
identification and troubleshooting
potential sampler issues
-Historical data associated with
performance checks and annual
calibration/certifications has been
stored at the FS offices or EPA
Region; An AirQA utility will be
constructed to host this data for
identification and troubleshooting of
sampler and calibrator issues
PM2 5-PEP Laboratory
Mass concentrations for
PM2 5-PEP sampling
events
QA/AC data for laboratory
weighing sessions
-To OAQPS QA Support Contractor
PQAOs
Routine PM2.5 FRM and
FEM monitoring data
Monitoring site meta-data
including latitude,
longitude, and PM2.5
monitors operating at sites
-To AQS
OAQPS QA Support Contractor
Comprehensive
Performance Evaluation
Reports and PM2.5-PEP
QA/QC reports from data
extracted from Lab's
database and AQS
Pre- and post-sampling
filter mass, filter ID,
analysis date
-To OAQPS PM2.5-PEP Lead, EPA
Regional Leads, and partnering SLT
PM2.5-PEP coordinators
-Final Reports posted on AirQA and
AMTIC
-To AQS
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SLTPM„
Monitoring Site
Sample
Collection
Transport Sampler.
Unexposed Filter,
and COC
Transport Sampler,
and COC
Si;
Regional Offices
(Field Work)
COC Copy,
Sampler Data File
Ship Sample, COC. and FDS
(which includes sampler setup,
flow check measurements, and
sampler data file)
Ship Une;
Filter and COC
AQS
(Production)
Validated PM25-PEP
Results are Available
to AQS Data Users
and Decision Makers
SLT Measurement
Sample
^ Collection
Transport Samph
Unexposed Filter
and COC
Transport Sampler,
SLT PM„ ">«
Monitoring Site
AQS
(Production)
Validated PM25-PEP
Results are Available
to AQS Data Users
and Decision Makers
SLT Measurement
Figure B10-1. Overview of the PM2.5-PEP information management system under the PED (left) and MoPED/LIMS
paradigms (right; when available)
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Under the PM2.5-PEP 's new information management system, PM2.5-PEP sampling event
data will be available to AQS users only when PM2.5 concentrations for both samples in a
pair (PM2.5-PEP sampler and its collocated primary SLT routine sampler) are uploaded to
AQS and matched/linked by AQS.
The OAQPS PM2.5-PEP Lead, Regional PM2.5-PEP Leads, and FSs (if granted access16) are
encouraged to check the AirQA website (https://www.airqa.org) to track the status of PM2.5-PEP
sampling event completion, calibrator certification status, sampler verification status, and other
PM2.5-PEP metrics.
B10.1.1 Information Management Security
Access to data, applications, and reports on the AirQA website (https://www.airqa.org) is
restricted to pre-registered personnel supporting the PEPs and requires a unique username and
password for access. The PM2.5-PEP weighing laboratory maintains the PED (and its successor)
on an EPA file share, and access is restricted to authorized laboratory personnel. PM2.5-PEP data
can only be released from these two sources with written permission by the OAQPS PM2.5-PEP
Lead. Data available on AQS are publicly available through AQS data access applications (e.g.,
the AQS Datamart) and are not otherwise controlled from access.
PM2.5-PEP measurements that have not been loaded into AQS should not be released. Only
validated, approved data are loaded into AQS for public access. In addition, the PM2.5-PEP
weighing laboratory archives all hard copies of weighing logs and routine back-up copies of the
PED (or its LIMS successor) database. A comparison of the archived PED copies with the
current version of the PED allows unauthorized or altered entries to be detected in the current
PED/LIMS database.
BIO. 1.2 Field Data
At a given monitoring site, field data from a PM2.5-PEP sampling event originate from two
sources: data generated by the PM2.5-PEP sampler and recorded by the FS and the coincident
sampling event results from the SLT organization's primary PM2.5 sampler, which are only
available upon that organization loading the data into AQS.
BIO. 1.2.1 PXI2 s-PEPSampler Data
Before departing for a PM2.5-PEP sampling event, the FS updates the COC by completing the
appropriate filter information (routine PM2.5-PEP sample, field blank, or trip blank). The PM2.5-
PEP sampler, once appropriately programmed, and field transfer standard provide all other
required data. Data are downloaded to a portable PC upon recovery of the PM2.5-PEP sample
filter. Currently, these data are transmitted to the laboratory via a USB flash drive along with a
hard copy FDS.
16 Membership to the AirQA website is private. Once an account registration has been submitted, the website
administrator is notified, and the registration is subject to verification through the OAQPS PM2.5-PEP Lead and/or
the Regional PM2.5-PEP Lead.
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Before returning to the Regional field office (if possible), the FS updates the COC and FDS
forms and ships the original hardcopy COC form and sample(s) to the PM2.5-PEP weighing
laboratory. On a monthly basis, FSs receive (via email) copies of the FDS data as it has been
transferred into the PED for final verification. They are required to attest that the data correctly
matches the FS's copies of the COC and FDS. Disparities must be reconciled and proper
corrections to the FS's FDS or PED-generated FDS must be made.
When MoPED is activated the downloaded data files will be processed by the MoPED
software, which will automatically extract the necessary information neededfor upload to
AQS. Additional information will be documented in a FDS stored in MoPED to supplement
the information collected automatically. This electronic FDS will be also transmitted to the
lab for storage in the successor to the PED, or possibly to a different database such as one
maintained on the AIRQA website.
The PM2.5 FRM samplers employed in the PM2.5-PEP must comply with the data generation and
format requirements in 40 CFR Part 50 Appendix L as listed below in Table B10-2.
Table B10-2. PM2.5-PEP Field Sampler Measurement Recording Requirements
In In mi ill in 11 In he Prmidcd
Appendix 1.
Section
UiTcmuv
AinliiiH"'
A\;ii
l.iul nl°
Porind1'
\ isiiiil
Display
Diilii
Oiilpiil'1
1(1111
Digital
Residing'
lill
I nils
Flow rate polling, 30-second
maximum interval
7.4.5.1
—
*
xx.x
L/min
Flow rate, average for the
sample period
7.4.5.2
*
*
xx.x
L/min
Flow rate, coefficient of
variation (CV) for the sample
period
7.4.5.2
*
*
V •
xx.x
%
Flow rate, 5-minute average
out of specification
7.4.5.2
V •
On/off
-
Sample volume, total
7.4.5.2
*
V •
XX.X
m3
Temperature, ambient,
30-second interval
7.4.8
—
—
XX.X
°C
Temperature, ambient,
minimum, maximum, average
for the sample period
7.4.8
*
V •
XX.X
°C
Barometric pressure, ambient,
30-second interval
7.4.9
—
—
XXX
mmHg
Barometric pressure, ambient,
minimum, maximum, average
for the sample period
7.4.9
*
V •
XXX
mmHg
Filter temperature, 30-second
interval
7.4.11
—
—
xx.x
°C
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Table B10-2. PM2.5-PEP Field Sampler Measurement Recording Requirements (continued)
InToi'miilion In he Pnmdcd
Appendix 1.
Sod ion
UiTcmuv
AinliiiH"'
A\;ii
1.11(1 of
Period1'
Yisiiid
Display
Diilii
Output'1
lorn
Digital
Residing'
nil
I nils
Filter temperature,
differential, 30-minute
interval, out of specification
7.4.11
*
V •
On/off
Filter temperature, maximum
differential from ambient,
date, time of occurrence
7.4.11
*
*
*
*
X.X,
YY/MM/DD
HHmm
°C,
Yr/mo/day
hr min
Date and time
7.4.12
—
—
YY/MM/DD
HHmm
Yr/mo/day
hr min
Sample start and stop time
settings
7.4.12
YY/MM/DD
HHmm
Yr/mo/day
hr min
Sample period start time
7.4.12
—
V •
YYYY/MM/
DD HH mm
Yr/mo/day
hr min
Elapsed sample time
7.4.13
*
V •
HHmm
Hr min
Elapsed sample time out of
specification
7.4.13
—
V •
On/off
Power interruptions >1 min,
start time of first 10 power
interruptions
7.4.15.5
*
*
1HH:mm.
2HH:mm,
etc.
Hr min
User-entered information,
such as sampler and site
identification
7.4.16
V •
As entered
¦S Provision of this information is required.
— Not applicable.
* Provision of this information is optional. If information related to the entire sample period is optionally
provided before the end of the sample period, then the value provided should be the value calculated for the
portion of the sampler period completed up to the time the information is provided.
• Indicates that this information is also required to be provided to the AQS database.
a Information must be available at any time the sampler is operating, whether it is sampling or not.
b Information relates to the entire sample collection period and must be provided following the end of the sample
period until the operator manually resets the sampler or the sampler automatically resets itself upon the start of
a new sample period.
0 Information accessible from the instrument digital display.
d Information will be available as digital data at the sampler's data output port following the end of the sample
period until the operator manually resets the sampler or the sampler automatically resets itself upon the start of
a new sample period.
e Digital readings, both visual and data output, shall have no less than the number of significant digits and
resolution specified in this table.
f Flag warnings may be displayed to the operator by a single-flag indicator or each flag may be displayed
individually. Only a set (on) flag warning must be indicated; an unset (off) flag may be indicated by the
absence of a flag warning. Sampler users should refer to Section 10.12 of Appendix L about the validity of
samples for which the sampler provided an associated flag warning.
BIO. 1.2.2 SLT Organization's Primary PM2.5 Sampler Data
The SLT organization's primary PM2.5 sampler at the monitoring site, whose data are used for
determining PM2.5 NAAQS attainment, is operated in accordance with its normal operational
schedule. The organization's field operator acquires the data which are validated and reported to
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AQS as detailed in the organization's QAPP and SOPs and available for matching with the
PM2.5-PEP measurement.
B10.1.3 Laboratory Data
Laboratory data used by the PM2.5-PEP originate from the PM2.5-PEP weighing laboratory (for
PM2.5-PEP sample data).
BIO. 1.3.1 PM2.5-PEP Weighing Laboratory Data
The PM2.5-PEP weighing laboratory weighs filters pre- and post-sampling according to the
PM2.5-PEP Laboratory SOP. The data acquired by the weighing laboratory are collected and
validated as detailed in Section Dl. Currently the PM2.5-PEP event's validated ambient
concentration data are extracted from the PED and uploaded to AQS by the OAQPS QA Support
Contractor.
Upon activation of MoPED, the PED's successor will record the acquired sample mass data
and validate the result based on:
Critical lab climate data
Balance performance checks
Laboratory blank andfield blank data
Any notification from the field that the sample is invalid based on field observations
Data from the laboratory weighing sessions are extracted and electronically delivered to
AQS via a browser-based upload tool.
BIO. 1.3.2 SLT Organization Laboratory Data
The SLT support PM2.5 filter weighing laboratory operates in accordance with its own SOPs. The
data acquired by the laboratory follows the normal path as detailed in the SLT governing QAPP
and SOPs.
B10.2 Data Recording
Forms are available for those methods that generate information for use in the PM2.5-PEP in
which the data must be hand recorded. Table B10-3 lists these forms and their reference sources.
Other data forms could be used for taking interim notes or for backup purposes, but any critical
data must be captured through approved automated data capture processes.
Data are also captured electronically as recorded by the sampler while operating and within the
laboratory through the PED as samples are logged in, temperatures of shipments are recorded,
filter and standard weights are measured, and environmental conditions of the laboratory and
refrigerated storage units are logged. These electronic data sources are recorded into or by
computer and maintained electronically.
To minimize the chances of transcription and other clerical errors, OAQPS will be replacing
the PM2.5-PEP hard copy field data capture forms with the MoPED software. This software
also verifies the field data and transmits the field data to AQS.
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Table B10-3. List of PM2.5-PEP data forms for critical data capture
KiTciviiit
l onn l illc
Laboratory SOP, Section 8
BAT-01 - PM2 5-PEP Filter Weighing Data Entry Form
Laboratory SOP, Section 9
COC-01 - PM2 5-PEP Chain-of-Custody Form
¦f This COC form has undergone several formatting changes over the years. The current form is maintained by the OAQPS
National PM2.5-PEP Lead.
B10.3 Data Validation
Data validation represents a combination of confirming that data processing operations have
been correctly performed and of monitoring the quality of the field and laboratory operations.
Data validation can identify problems in either of these areas. Once problems are identified, the
data can be corrected or invalidated, and corrective actions can be taken for field or laboratory
operations. Numerical data stored in the PM2.5-PEP weighing laboratory's PED (and its
successor) are never internally overwritten by condition flags. Flags that denote error conditions
or QA status are saved as separate fields in the database, so that the original data can be
recovered. Appendix C (Validation Template used by the PED in the first level Validation
Algorithm) presents a data validation template from the PED, which is currently used by the
PM2.5-PEP Laboratory Manager and EPA Laboratory Task Monitor to assist in validating data.
The PED application (named "PEDuser") provides the EPA PM2.5-PEP Laboratory Lead with the
validation checks necessary to enable a first level review and approval of the data for upload to
AQS. The PM2.5-PEP will continue to utilize the PED for data validation until MoPED is
implemented.
The successful launch of the MoPED is dependent in part on the success of a new LIMS
database application which can host the necessary data and generate a delimited data file
with the necessary information that can be directly uploaded to AQS. Under the new
paradigm, the laboratory will transfer gravimetric data from a LIMS-generated .csv file to
AQS to be paired with the sampler run data (entered by the FS via MoPED) for calculating a
PM2.5 concentration within AQS. Regional PM2.5-PEP Leads will have an opportunity to
approve or invalidate results in AQS for 14 days. After 14 days, approval is assumed and
AQS will post the data in tables for the respective PQAO's QA data (e.g., available in report
AMP251).
The following validation functions are performed with the data in the PED to ensure the quality
of PM2.5-PEP data:
¦ 100% data review. Filter weight reports and COC forms are currently subjected to a
100% data review by the PM2.5-PEP Laboratory Manager and the EPA PM2.5-PEP
Laboratory Task Monitor or designee reviews a representative amount of the filter
concentration data each month. The EPA PM2.5-PEP Laboratory Task Monitor has final
approval authority on validated laboratory and FDS data.
¦ Range checks. The FS is responsible for identifying pre-event verification data and any
logged sampler run-time data outside of specified ranges. For example, valid sample start
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and stop times must be between 00:00 and 23:59. The FS also verifies the temperature
range for the sample collection, which are typically between 10°C and 50°C in the
summer.
¦ Comprehensive data checks. As data are processed, the data record must be
comprehensive and complete. For example, each PM2.5-PEP sampling event record must
indicate a start time, an end time, an average flow rate, filter weigh dates, and operator
and technician names.
¦ Internal consistency and other reasonableness checks. The data undergo internal
consistency checks. For example, the end collection time of a filter sample event must be
later than the collection start time. Computed filter volume (integrated flow) must be
approximately equal to the exposure time multiplied by the average flow rate.
¦ Data and sample filter retention. The PM2.5-PEP weighing laboratory will retain raw
data records for a minimum of four (4) calendar years. These records must be readily
available for audits and data verification activities. After four (4) years, the FS or LA
may request instructions from the OAQPS PM2.5-PEP Lead on the disposition of hard
copy records and computer back-up media. The laboratory archives sample filters in cold
storage through the end of the next full calendar year, and then at room temperature for
three additional years. For example, the laboratory archives a filter sample collected on
March 1, 2019, in cold storage until December 31, 2020, and then at room temperature
until December 31, 2023.
NOTE: The time frame for retention and disposition of Agency records is determined by
EPA records schedules (see Section A 9 Documentation and Records); however, records
may need to be retained for longer periods. For example, some individual contracts may
require a retention time longer than four (4) years, in which case the data/materials must
be archivedfor this extended period before disposal.
¦ Statistical data checks. Errors found during statistical screening are traced back to original
data entry files and to the raw data records, if necessary. These checks shall be conducted
on a monthly schedule and before any data are submitted to AQS. Data verification is the
process in which raw data are screened and assessed before acceptance by AQS.
¦ Sample batch data validation. Data collected in batches (e.g., a weighing session) are
reviewed together due to their common QC practices. As such, data may be compromised
within a batch and may therefore have flags applied to all samples in the batch.
¦ Comparison of field blank and associated event result. Historically, FB filter data
occasionally (but rarely) have been incidentally transposed with the associated 24-hour
PM2.5-PEP sampling event data. A test can be devised to determine if the concentration
results of two filters associated with the same sampling event fall into the historical
ranges of 24-hour ambient samples for that particular site or the historical norms for field
blanks. Such allows the laboratory manager to reasonably adjust the sample data in such
cases where an exposed collected filter sample shows little or no mass accumulation, but
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the associated FB shows mass accumulation commensurate with the typical ambient filter
collection.
Table B10-4 summarizes the validation checks applicable to the PM2.5-PEP data.
Table B10-4. Validation Check Summaries Used in the PM2.5-PEP
T\|>c or Diilii Check
l-'.lcclrnnic Tninsmissinn
«Si Sloniiie
Miiniiiil
Checks
Auloiiiiilcd
Checks
Data parity and transmission protocol checks
V
Data review
V
V
Date and time consistency
V
V
Completeness of required fields
V
V
Range checking
V
Statistical outlier checking
V
Manual inspection of charts and reports
V
Sample batch data validation
V
V
B10.4 Data Conversions
Calculations for transforming raw data from measured units to final concentrations are relatively
straightforward. Formulas given in Table B10-5 pertain to PM2.5 sampling and analysis.
Table B10-5. Raw Data Calculations in the PM2.5-PEP
Piii'iimclcr
I nils
T\ pc of Con\crsion
r.(|iiiilinn
Sampler volume (V)*
m3
Calculated from average flow rate (Ome) in
L/min and total elapsed time (1) in minutes
multiplied by the unit conversion (m3 to L)
v = Q^tx 10-3
Gravimetric PM2 5
mass on filter (M2.5)
lig
Calculated from filter post-weight (Mj) in
mg and filter pre-weight (M,) in mg
multiplied by the unit conversion (jug to
mg)
M25 = {mf -M.)xl03
PM2.5 concentration
(ig/m3
Calculated from gravimetric PM2 5 mass on
filter and sampler volume
M25
PMn , = —^
2.5 y
* PM2.5-PEP samplers compute this value from the integrated flow over the collection period.
B10.5 Data Transmittal
Data transmittal occurs when data are transferred from one person or location to another or when
data are copied from one form to another. Examples of data transmittal are
1) Submission of downloaded instrument data files saved on a portable storage device
(typically a USB-B flash drive) for subsequent upload into a data entry system, and
2) Transcription of raw data from a laptop or notebook into an electronic data entry
system.
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Table B10-6 summarizes data transfer operations.
Table B10-6. Data Transfer Operations
Description of l);il;i
11'iinslVr
Ori^iiiiilor
Recipient
(}.\ Measures Applied
C ap Lin o ofgra\ inieinc
data into the PED
LA
LA
lUU'.'u ic\ icw, ivpivs>oiiiali\ e anioiuiL
checks by the PM2 5-PEP Laboratory
Task Monitor or designee
Electronic data transfer
Between computers
or over network
-
Parity checking; transmission protocols
Unexposed filter
receiving and COC forms
LA
FS
Filter IDs are verified upon receipt; LA
checks data entry with 100% review
Exposed filter receiving
and COC forms
FS
LA
Filter numbers are verified upon receipt;
FS checks data entry with 100% review
Verification/calibration
data
FS
FS
FS checks sampler pre-event verification
entry and sampler event summary data
with 100% review
Sample Event Collection
Data
FS
Transcribed into
PED by LA
100% review; representative amount
checks by the PM2 5-PEP Laboratory
Task Monitor or designee
AQS data
FS and LA
AQS (EPA)
Data transfer is checked by the OAQPS
QA Support Contractor
The PM2.5-PEP reports all PM2.5 ambient air quality data and information specified by the AQS
Data Coding Manual in the required format for acceptance into AQS. These air quality data and
information are fully screened and validated prior to direct submission to AQS via electronic
(AQS formatted) transmission. These data are stored in a hidden QA data table of AQS until the
result acquired from the SLT site's measured (primary sampler) value is posted in AQS by the
SLT. Only then are the paired data posted to the production module within AQS and available
for download via the AMP256 report. SLAMS and NCore sites are required to post their site data
to AQS on the schedule shown in Table D3-1. This means that PM2.5-PEP data are often not
posted to the viewable production module of AQS until after the due dates in Table D3-1. In
cases where the site data have been uploaded to AQS and validated on or before the due date, the
PM2.5-PEP sampling event data are also posted and viewable.
The successful activation ofMoPED will replicate this process, but force compliance with
the conventions as the data are recorded in MoPED or in the Lab's LIMS (the PED
successor).
B10.6 Data Reduction and Data Integrity
Data-reduction processes involve aggregating and summarizing results so that they can be
understood and interpreted in different ways. The PM2.5 monitoring regulations require certain
summary data to be computed and reported regularly to EPA, such as:
¦ Average PM2.5 concentration
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¦ Accuracy, bias, and precision statistics based on accumulated FRM/FEM data
¦ Data completeness reports based on the numbers of valid samples collected during a
specified period.
Prior to deployment and following updates or changes, the electronic databases or systems
employed to capture, reduce, calculate, and report data are to be properly validated and records o
of this validation maintained. Such systems include databases or software systems (e.g., LIMS or
MoPED) that serve to streamline and simplify data processing and data flagging regimes.
Validation is performed by inputting data into the system and independently (either with a
separate validated system or by hand calculation) the expected result is returned.
The integrity of PM2.5-PEP data reduction can be verified by independent review of the data and
algorithms used. Verification of data integrity requires that PM2.5-PEP data be stored in a manner
that permits any data modification to be detected. Detection of data changes is facilitated by the
record-keeping requirements of the PM2.5-PEP Laboratory SOP, which requires archiving of
hard-copy records for important data (e.g., weighing session reports and sample COC forms).
These archived records enable EPA to trace raw data used in PM2.5-PEP sampling events to
original raw data records.
In addition, the PM2.5-PEP Laboratory SOP requires that the PM2.5-PEP weighing laboratory
archive regular copies of the PED (and database into read-only media and regularly stored at an
off-site location. These archival database copies may also be used to evaluate data integrity and
to verify that data from a specific PM2.5-PEP sampling event matches the data on hard-copy
records.
Data hand-transcribed (i.e., manually entered) into electronic systems are to be verified 100%
and this verification documented.
B10.7 Data Analysis
The PM2.5-PEP implements the data summary and analysis requirements contained in 40 CFR
Part 58 Appendix A. Additional data analysis procedures may continue to evolve to meet the
internal QA/QC needs of the PM2.5-PEP. The following specific summary statistics are tracked
and reported within the PM2.5-PEP (primarily in the annual and 3-year QA reports):
¦ Single sampler bias (based on flow rate performance audits)
¦ Single sampler precision (based on collocated data)
¦ Network-wide bias and precision (based on collocated data, internal flow rate
performance audits)
¦ Data completeness.
Table B10-7 lists the equations used in generating these summary statistics.
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Table B10-7. PM2.5-PEP Data Summary Equations
l);il;i Siimniiin
l-'.(|ii;ilinn
KcI'oivikt
Single sampler flow rate bias - single point
check calculating percent difference (<:/,).
where A, is the reference flow and ), is the
measured flow
di = ——— x 100
Xi
40 CFR 58,
Appendix A,
Section 4.1.1
Network-wide PM2.5-PEP flow rate bias -
bias estimate, where AB and. IS denote the
mean and standard deviation, respectively,
of the absolute value of the <1, (equation
above) over the time period, n is the number
of measurement pairs over the period, and
fo 95,11-1 is the 95th percentile of the Student-/
distribution
AS
\Bias\ = AB + t0.95,n-l x ~F
Vn
40 CFR 58,
Appendix A,
Section 4.1.3
Network-wide sampler flow rate bias
tendency - Assigning a sign
(positive/negative) to the bias estimate
Calculate the 25th and 75th percentiles of the
percent differences (ch) for a given time
period. Flag the bias estimate (\Bias\) as
positive if both percentiles are positive and
negative if both percentiles are negative
40 CFR 58,
Appendix A,
Section 4.1.3.1
and 4.1.3.2
Mean (AB) - the average bias
1 n
AB = - X V|d;|
n L—i
i=i
40 CFR Part 58,
Appendix A,
Section 4.1.3
Standard deviation (AS)—An estimate of
the variability of the average bias.
AS =
y
nxYi=1\di\2 - (Zi=1\di\)2
n(n — 1)
40 CFR Part 58,
Appendix A,
Section 4.1.3
Single sampler precision - Relative percent
difference (RPDij?q) of a single collocation,
where Xq and ), are concentrations from two
collocated PM2.5-PEP samplers
RPDi j Q = 7^—X 100
l']'q (Yi+Xj)/2
40 CFR 58,
Appendix A,
Section 4.2.1
Single sampler precision - Sampler (/')
precision on the q'1' day, where k is the
number of pairs of collocated measurements
from collocated samplers, and J^o.i,n-i is the
10th percentile of a chi-squared distribution
with k-\ degrees of freedom.
CVJ,
A
X
%
?
hxZi*JRPDfM-(Zi*jRPDijiqy
2k(k — 1)
k- 1
Y2
*0.1,k-1
40 CFR 58,
Appendix A,
Section 4.2.1
For PM2 5-PEP Collocation studies only:
Normalized percent differences (NPDij?q) in
concentration for each sampler pair (/,/) on
the f/lh sampling day - where A',,i; and Yj?q
represents the PM2 5 concentrations for the
paired samplers, and mean equals the mean
concentration of all collocated samplers on
the given study day
\Yja-Xiq\
Npo = Ud idl x 100%
,J,H mean
Section A5.4.1
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Table B10-7. PM2.5-PEP Data Summary Equations (continued)
Diilii Siimniiin
K(|iiiilion
RiToivikt
Completeness - PM2.5-PEP completeness is
assessed where:
1. Nmud only includes concentrations > 3
Hg/m3, or
2. NVaiid includes all concentrations for
not-invalidated sample data regardless
of concentration
Completeness = valld * 100
N scheduled
Section A7.2
B10.8 Data Flagging—Sample Qualifiers
When field and/or laboratory data do not meet an acceptance criterion, the data are flagged in the
PED. These PED flags consist of three alphanumeric characters that indicate the condition. For
overall sample concentrations results for a given filter sample for which the data are
compromised, one of the following three scenarios will apply:
¦ The sample did not produce a numeric result (a concentration cannot be calculated).
¦ The sample produced a valid numeric result, but the data are compromised in some
fashion.
¦ The sample produced a numeric result, but a critical criterion has not been met and the
result is not to be reported.
Qualifiers signify captured data that do not meet all acceptance criteria as may be due to
contamination, special events, or failure of associated QC limits. The sampling instrument
generates flags for operational deviations (refer to the instrument manual). Appendix F (Data
Qualifiers/Flags) of this QAPP contains a complete list of data qualifiers for PM2.5-PEP field and
laboratory activities. LAs and the laboratory manager should reference the quality criteria in
Tables D2-1, D2-2, and D2-3 when flagging laboratory data. The PED includes automatic
flagging of sample data in some instances when established criteria are not met. The data
validator considers these flags when determining data validity.
B10.9 Data Tracking
Table D3-1 listed the due dates for SLT organizations to post their routine PM2.5 sample data to
AQS. AQS pairs PM2.5-PEP measurements and SLT measurements (assuming the PM2.5-PEP
measurements were previously uploaded via MoPED software) and therefore allows for the
information to enter into bias calculations. If PM2.5-PEP sample measurements are not available
in AQS on the date given in Table D3-1, the data flow in Figure B10-1 can identify possible
impediments to the data reporting. The annual QA reports include analyses to determine why
PM2.5-PEP event results are not in AQS.
If a PM2.5-PEP measurement is posted to AQS, but its paired SLT sample measurement is not,
the SLT routine laboratory can check its LIMS on the status of the data record containing that
measurement. If the SLT routine laboratory has no record of the sample data, the SLT
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organization's data flow should be investigated, and the Regional PM2.5-PEP Lead and OAQPS
PM2.5-PEP Lead should be notified.
If the SLT sample measurement is posted to AQS, but the PM2.5-PEP sample measurement has
not, this could be due to one of the following reasons:
1. Validation of the PM2.5-PEP sample measurement may be pending by the Regional
PM2.5-PEP Lead (or the PQAO's PM2.5-PEP coordinator). The Regional PM2.5-PEP Lead
should be contacted within seven (7) days (when the validation time frame expires). If
this time frame does expire, the PM2.5-PEP Laboratory Manager and OAQPS PM2.5-PEP
Lead determine if the particular result is to be validated or invalidated. If validated, the
result is made available for pairing with the appropriate SLT routine PM2.5 measurement.
2. The PM2.5-PEP sample data may not have been uploaded to AQS. The PM2.5-PEP
database (the PED or its LIMS successor) can be checked to verify the status of the
sample data. Additionally, the QA contractor responsible for uploading data may have
experienced errors when uploading the data to AQS.
3. The PM2.5-PEP weighing laboratory data may have its validation step still pending or
may not have been approved. The PM2.5-PEP Laboratory Manager should be contacted to
verify status.
4. The PM2.5-PEP weighing laboratory may not have weighed the exposed filters. The
PM2.5-PEP Laboratory Task Monitor should be contacted whenever PM2.5-PEP data
appear to be missing. The Region 4 PM2.5-PEP Lead can consult the LA and Laboratory
Manager to resolve the status of the samples associated with the missing data. The PED,
or its LIMS successor, will have a record of all pre- and post-sampling weighed filters.
LAs also have access to the laboratory's archive, which contains original COCs, raw
data, and processed data.
5. The PM2.5-PEP filter sample may not have been shipped to the PM2.5-PEP weighing
laboratory, or the shipment could have been lost by the shipper. The FS routinely contacts
the LA via e-mail to alert them to sample shipments. The shipper can confirm the
delivery or actual misplacement of the filter samples. If confirmed to have been
delivered, the LA will access the received shipment log and the PED (or its LIMS
successor) to locate the records. LAs with access to the PED (or its LIMS successor) can
generate one of the following tracking reports:
¦ List of all filters that have been received but have not been analyzed
¦ List of all filters analyzed
¦ List of all filters in the filter archive
¦ Ad hoc reports
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The PM2.5-PEP Laboratory Manager or designee is responsible for tracking filter status at least
twice per week and for following up on anomalies such as excessive holding time in the
laboratory before reweighing.
Figure B10-2 illustrates the type of information exchange routes where data loss may occur.
BIO. 10Data Storage and Retrieval
The PM2.5 data reside on a Microsoft® Windows-compatible computer in the PM2.5-PEP
weighing laboratory that operates on the EPA's information system. The security of data in the
PED (and its LIMS successor database) is ensured by using the following controls:
¦ Network security passwords for access to the project and database files
¦ Regular password changes (as specified by EPA network security)
¦ Storage of media, including back-up tapes in locked, restricted access areas.
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Weigh Session and Field
Information:
Concentration
Analysis Date
AQS Unit Code
AQS Site ID
Etc.
PM„ Laboratory
PED
Field Audit Information
• Run Time
• Run Date
• FlowCV
• AQS Site ID
• Etc.
Site Metadata Available
Filter ID'S
Field Scientist
Individual Weigh Session Info
• Filter ID
• Mass
• Analysis Date
• AQS Unit Code
• AQS Data Flags
• Filter ID Destination
Site Metadata
Available Filter ID'S
PM? 5 Laboratory LIMS
Field Audit Information
Run Time
Run Date
Flow CV
AQS Site ID
Etc.
MoPED
Users
Figure B10-2. Information Exchange Routes between the PED and AQS (top) and the
LIMS and MoPED (bottom; when available)
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C Assessment and Oversight
CI Assessments and Response Actions
This section is relative to the quality system implemented exclusively for the PM2.5-PEP. For the
purposes of this QAPP, an assessment is defined as an evaluation process used to measure the
performance or effectiveness of the quality system and various measurement phases of the data
operation.
The results of assessments indicate whether the QC efforts are adequate or need to be improved.
Documentation of all QA and QC efforts implemented during the data collection, analysis, and
reporting phases are important to data users and decision makers, who can then consider the
impact of these control efforts on the data quality (see Section C2). Both qualitative and
quantitative assessments of the effectiveness of these control efforts will identify those areas
most likely to impact the data quality. Periodic assessments of PM2.5-PEP data quality are
required to be reported to OAQPS. However, the selection and extent of the QA and QC
activities used by the PM2.5-PEP depend on many local factors, such as the field and laboratory
conditions, the objectives for monitoring, the level of the data quality needed, the expertise of
assigned personnel, the cost of control procedures, and pollutant concentration levels.
To ensure the adequate performance of the quality system, OAQPS and the Regions implement
an assessment program that utilizes the following:
¦ Limited MSRs
¦ Data quality assessments (DQAs)
¦ Audits of data quality (ADQs)
- TSAs
¦ Incidental surveillance by the National and Regional PM2.5-PEP Leads
¦ Performance evaluations including laboratory round robin studies
Cl.l Assessment Activities and Project Planning
CI. 1.1 Management Systems Review
An MSR is a qualitative assessment of data collection operations and/or organization(s) to
establish whether the quality management structure, policies, practices, and procedures are
adequate to ensure that the desired quality of data needed are met. A complete MSR would
encompass more than just the implementation of the PM2.5-PEP; consequently, OAQPS and the
EPA Regional PM2.5-PEP Leads will limit the scope of the MSRs and combine the activity with
TSAs of the PM2.5-PEP.
The following MSR elements will be incorporated into TSAs conducted at EPA Regional
Offices and self-implementing SLT agencies:
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¦ Procedures and criteria for designing and conducting audits.
¦ Tracking systems for assuring that the QA program is operating and that corrective
actions disclosed by audits have been taken.
¦ The degree of management support.
¦ Responsibilities and roles of the QA Program Manager in the PM2.5-PEP and authorities
of the various line managers for carrying out the PM2.5-PEP.
CI. 1.2 Data Quality Assessments
The PM2.5-PEP complies with DQOs established for the national PM2.5 network run by SLT
agencies. A DQA is a statistical analysis of environmental data used to determine whether the
quality and quantity (i.e., completeness) of data is adequate to support a decision based on
conformance to or compliance with the DQOs. DQAs are performed by the OAQPS PM2.5-PEP
Lead or designee (e.g., the OAQPS QA Support Contractor). Data are appropriate if the level of
uncertainty is acceptable for the decision for which the data are collected. The DQA process is
described in detail in Guidance for the Data Quality Assessment Process (EPA QA/G-9) 17. A
DQA takes the form of data summaries which are included as part of each PM2.5-PEP Annual
QA Report, discussed in Section C2. These summaries are based on data collected at the
individual monitors/sites, but also aggregated at PQAO, Regional, laboratory, and national
levels. Formal corrective actions are not expected from the DQA; however, Regional PM2.5-PEP
Leads may act upon information in the report where improvements are indicated.
DQAs include estimating measurement uncertainty. Measurement uncertainty includes
completeness, accuracy, bias, and precision; these terms are found in 40 CFR Part 58, Appendix
A and are defined in Section A7.2 of this QAPP.
CI. 1.3 Audits of Data Quality
An ADQ examines not just the data used to determine monitor bias at the various levels of
aggregation, but also the types of data used to reflect the efficacy of the PM2.5-PEP's QC system.
It reveals how data were handled, what judgments were made, and data handling or calculation
problems or inconsistencies within examined data. ADQs can often identify the means to correct
systematic data reduction errors. OAQPS performs ADQs annually as part of each laboratory and
Regional TSA. Thus, sufficient time and effort is devoted to this activity so that the auditor or
TSA team has a clear understanding and complete documentation of data flow. Pertinent ADQ
questions appear on TSA checklists to ensure that the integrity of data collected at each stage are
maintained. The ADQ serves as an effective framework for organizing the extensive amount of
information gathered during the audit of laboratory, field monitoring, and support functions
within the agency. The ADQ has the same reporting/corrective action requirements as the TSA,
as described in the next subsection.
17 Document available at: https://www.epa.gov/sites/default/files/2015-06/documents/g9-final.pdf
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CI. 1.4 Technical Systems Audit
A TSA is an evaluation of a data collection operation or organization to establish whether the
policies, practices, and procedures are adequate for ensuring that the type and quality of data
needed are obtained. TSAs are conducted on field and laboratory activities within both EPA
Regions and PQAOs that self-implement PM2.5-PEP activities and allow OAQPS to assess
consistency of operation among the Regions and allow the Regions to understand the quality of
the data they are producing with an overall objective to improve the quality system.
Comprehensive TSAs are performed by an individual assessor or a team of assessors. Key
personnel interviewed in a TSA are those with responsibilities for planning, conducting field
and/or laboratory activities, QA/QC, data management, and reporting. A TSA considers one or
more of the following areas:
¦ Field activities - Filter receipt, instrument setup and calibration verifications, sampling,
QA/QC, shipping, and record keeping
¦ Laboratory activities - Pre-sampling weighing, shipping, receiving, post-sampling
weighing, archiving, and associated QA/QC
¦ Data management activities - Information collection, flagging, data review and
validation, data security, and data reporting.
The following TSAs are to be performed within the PM2.5-PEP:
¦ Weighing Laboratory TSA: OAQPS and/or a designee (e.g., national QA Support
Contractor) performs a TSA of the PM2.5-PEP weighing laboratory annually. Aspects of
this TSA are shown on the left side of Figure Cl-1.
¦ Comprehensive Field TSA: OAQPS and/or a designee (e.g., national QA Support
Contractor) perform comprehensive TSAs with limited MSR elements (see Section
CI.1.1) of Regional field operations on a "3-3-4" schedule (i.e., all Regional offices are
audited every three years, with either three or four Regional offices audited each year
such that all 10 Regions undergo audit every 3 years). This TSA supplants the need for a
Regional PM2.5-PEP Lead or designated auditor to perform a modified TSA (as described
in following bullet) on their contractor and/or any self-implementing PQAO in the same
year. Aspects of the field TSA are shown on the right side of Figure Cl-1.
¦ Modified Field TSAs: Each Regional PM2.5-PEP Lead performs a modified TSA in one
of the two years not targeted for a 3-year comprehensive TSA (as described in previous
bullet). The field operations for a self-implementing PQAO are also included in this
requirement. The Regional PM2.5-PEP Lead will focus their examination on QA
performance data generated by the field operations and a review of management systems
for both contractors and self-implementing PQAOs. These TSAs should include the
observation of a sampling event performed by the contractors and/or self-implementing
PQAO, which can be either a parking lot collocation event or a PM2.5-PEP sampling
event. Reviews of self-implementing PQAOs will include a check of their adequacy and
independence criteria, which are identified in the Adequacy and Independence Guidance
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for Agencies Who Self-implement the PM2.5-PEP. An example of achieving adequate
independence is the clear separation of the PM2.5-PEP field operations from the PQAO
monitoring network operations (as detailed in Figure A4-2).
Each of the above TSA types are guided by reports and checklists maintained by the OAQPS
PM2.5-PEP Lead. Additional resources include the oral and hands-on exam checklists used in
PM2.5-PEP training, as they provide a convenient guide for auditing field and laboratory
operations performed by the Regional contractors. The OAQPS PM2.5-PEP Lead maintain
comprehensive TSA forms used for conducting TSAs of the weighing laboratory. These forms
include evaluations of significant Regional EPA management/MSR elements and field
assessments of their PM2.5-PEP contractors. Modified TSAs must exclude the Regional PM2.5-
PEP management sections of the checklists since Regional PM2.5-PEP Leads should not self-
evaluate.
¥
Figure Cl-1. Overview of Technical Systems Audit Activities
The purpose in evaluating the FS(s) and self-implementing PQAO and management structure
will be to document significant findings. If performance issues are identified prior to one of the
mid-period assessments, the Regional PM2.5-PEP Leads are encouraged to conduct a more
thorough TSA.
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Following a TSA, the assessor(s) prepare a comprehensive written summary of findings
organized into the following areas: planning, field operations, laboratory operations, QA/QC,
data management, and reporting. Problems found in specific areas are discussed, and they are
ranked in order of their potential impact on data quality. Serious problems are summarized on an
Assessment Finding Form (example shown in Figure CI-2).
Audit Title:
Audit Number:
Finding Number:
Audited Agency:
Finding:
Discussion:
OA Lead Signature:
Date:
Auditor Signature:
Date:
Figure Cl-2. Example Assessment Finding Form
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The Assessment Finding Form is completed for each major deficiency that requires formal
corrective action and the assessor will include information such as the impact, estimated time
period of deficiency, site(s) affected, and reason for action. The Assessment Finding Form
notifies the laboratory or field office of serious problems that may compromise the quality of the
data and therefore require specific corrective actions. If the assessed organization agrees with the
finding, the form is signed by the PM2.5-PEP contract organization during the TSA debriefing. If
a disagreement occurs, the assessor(s) records the organization's opinions and sets a future time
to address the finding. Completed Assessment Finding Forms are filed under the AFC heading
"PM2.5-PEP/108-025-01-01-237.1" or other acceptable filing system (see Section A9
Documentation and Records).
CI. 1.4.1 Post-TSA Activities
Serving as the primary post-TSA activity, the TSA assessment report includes the following:
¦ Assessment title, number, and any other identifying information.
¦ Assessment team leaders, assessment team participants, and assessed participants.
¦ Background information, purpose and dates of the assessment, particular measurement
phase or parameters assessed, and a brief description of the assessment process.
¦ Summary and conclusions of the assessment and corrective action required.
¦ Attachments or appendices that include all assessment evaluations and assessment
finding forms.
To prepare the TSA assessment report, the TSA team meets and compares observations with
collected documents and with interviews and discussions with key personnel. Expected QAPP
implementation is compared with observed accomplishments and deficiencies, and the
assessment findings are reviewed in detail. Within 30 calendar days of the completion of the
assessment, the TSA team prepares a draft TSA assessment report and submits it to the
appropriate personnel and is appropriately filed under the AFC heading "PM2.5-PEP/108-025-01-
01-237.1" or other acceptable filing system.
If the PM2.5-PEP contract organization has written comments or questions pertaining to the TSA
report, the TSA team reviews and incorporates them as appropriate and prepares and resubmits
the report in final form within 30 days of receiving the written comments. The final TSA report
includes an agreed-upon schedule for corrective action implementation.
CI. 1.4.2 Follow-up and Corrective Action Requirements
The Regional office and FSs may work together to solve required corrective actions stated in the
TSA report. As part of corrective action and follow-up, the assessed organization completes an
Assessment Finding Response Form (Figure Cl-3) for each Assessment Finding Form submitted
by the TSA team. In addition, PM2.5-PEP Contractors include corrective action in its monthly
progress reports. The Assessment Finding Response Form is signed by the assessed organization
and is sent to the Regional PM2.5-PEP Lead, who reviews and accepts the corrective action. The
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assessed organization completes the Assessment Finding Response Form within 30 days of
acceptance of the TSA report. Assessment Finding Response Forms are filed under the AFC
heading "PM2.5-PEP/108-025-01-01-237.1" or other acceptable filing system.
Audit Title:
Audit Number:
Finding Number:
Finding:
Cause of the Problem:
Action Take of Planned for Correction:
Responsibilities and Timetable for the above actions:
Prepared by:
Date:
Signed by:
Date:
QA Division
Reviewed by:
Date:
Remarks:
Is this audit finding closed?
Date:
Figure Cl-3. Assessment Finding Response Form
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CI. 1.5 Surveillance
Surveillance is defined as continual or frequent monitoring and verification of the status of an
entity and the analysis of records to ensure that specified requirements are being fulfilled.
Surveillance is similar to a TSA except that it serves as a more frequent review of certain
important phases of the measurement system (i.e., calibrations and run setup) rather than a
review of the entire implementation process. Because the PM2.5-PEP has matured, surveillance is
limited to specific issues that might be identified by OAQPS, the Regional PM2.5-PEP Leads, or
the PM2.5-PEP Laboratory Manager. A Field or Lab Operations Surveillance Report Form
(Figure Cl-4) is used for documentation and filed under AFC heading "PM2.5-PEP/108-025-01-
01-237.1" or another acceptable filing system. PM2.5-PEP is in a continuous process of creating
host utilities on the AirQA website that record data sets that are determined to be useful in the
Surveillance effort. An example would be PM2.5-PEP annual completeness at the Regional and
PQAO levels of aggregation. The AirQA website is updated monthly.
Reviewer:
Date of Review:
Personnel Reviewed:
Activity Monitored
Acceptable Performance
YES
NO
Notes:
Signature: Date:
Figure Cl-4. Field or Lab Operations Surveillance Report Form
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CI. 1.5.1 Overall Program Review of PM2.5-PEP Data
The PM2.5-PEP Laboratory Manager, Regional PM2.5-PEP Leads, and the OAQPS PM2.5-PEP
Lead will review PM2.5-PEP data on a periodic basis, no less frequently than annually. Such
reviews will minimally involve review of routine laboratory QC data (e.g., balance calibration
checks, laboratory blank data, and environmental control data), FB and TB data, and sample data
that were invalidated. They will report significant issues related to PM2.5-PEP operations to the
PM2.5-PEP Workgroup. These reviews occur after data are submitted to AQS, therefore do not
impact the ongoing routine activities of the PM2.5-PEP field and laboratory.
Cl.l. 6 Laboratory Performance Evaluation Audit and Round Robin Study
Per the direction of the PM2.5-PEP OAQPS Lead, twice annually the weighing laboratory will
undergo a performance evaluation (PE) audit. The PE will involve the LA and back-up LA
weighing a modified standard weight(s) and/or a set of filters.
For the modified standard weights, the PM2.5-PEP OAQPS Lead (or designee) will prepare one
or more modified standard weights (i.e., remove a small portion of the standard weight) and
determine the mass by comparison to primary standard weight (similar to the calculation
performed for determining Cw in Section B7.1.1.2). The mass reported by the weighing
laboratory must be within ±15 |ig of the assigned mass.
For the set of filters, the PM2.5-PEP OAQPS Lead (or designee) will prepare a set of two to four
filters which are equilibrated in a suitable weighing laboratory and weighed for mass
determination. The mass difference between each individual filter pairing will be determined
(i.e., for two filters there will be one mass difference, for three filters there will be three mass
differences, and for four filters there will be six mass differences) and will be the values against
which the weighing laboratory is evaluated. While the overall absolute mass measurement of a
given filter is expected to be potentially quite different due to moisture equilibration conditions
and buoyancy effects, these effects are essentially equivalent for all filters, therefore the mass
differences between filters are assumed constant regardless of moisture equilibration or
buoyancy effects. The weighing laboratory reported mass differences must be within ±15 jug of
the assigned mass differences for each filter pair evaluated.
OAQPS is in the process of restarting a national interlaboratory comparison of several PM2.5
weighing laboratories, a round robin study in which a batch of filter samples and standard
weights are exchanged between the laboratories for weighing and comparison.18 The PM2.5-PEP
weighing laboratory is encouraged to participate in this study when made available on an
approximate semi-annual basis, as a check on the performance of its equipment and activities of
LAs. The laboratory measurements must meet the acceptance limit prescribed in the given study.
If the PM2.5-PEP filter weighing laboratory measurements display deviations in any of the
weighing comparisons, the LA must inform the PM2.5-PEP Laboratory Manager and the OAQPS
PM2.5-PEP Lead. The LA will immediately begin troubleshooting to investigate the discrepancy.
18 OAQPS suspended the gravimetric round robin in 2018 due to a loss of personnel and funds. OAQPS is planning
to restart the program in 2022. Until the round robin is reinstituted, OAQPS and its QA Support Contractor will
prepare blind filter samples for a mini-performance test during the annual TSA of the PM2 5-PEP gravimetric
laboratory.
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Cl.l. 7 Field Performance Audits
Field sampler calibrations and calibration verifications are to be assessed quarterly by
performance of an audit of the sampler's temperature, barometric pressure, and flow rate
readings against a transfer standard independent of those employed for calibration (the primary
standard) or calibration verifications (the working standard). These performance audits are to
meet the acceptance criteria for calibration verifications as described in Section B7.2.2 and
summarized below in Table Cl-1.
Table Cl-1. Field Sampler Performance Audits
Assi-ssim-iil
I""|V(|IK'IK'\
C'rili-riii
kilViviui-
Sampler Flow Rate Audit
4/year (quarterly)
Percent difference within ±4% of transfer
standard
Percent difference within ± 4% of design flow
(16.67 LPM)
Part 50, App. L,
Sect. 9.2.5;
PM2.5-PEP
Requirement
Barometric Pressure Audit
4/year (quarterly)
Within ±10 mm Hg of transfer standard
Part 50, App. L,
Sect. 7.4.9 and 9.3
Temperature Audit
4/year (quarterly)
Within ± 2°C of transfer standard
Part 50, App. L,
Sect. 7.4.8 and 9.3
C1.2 Documentation of Assessments and Corrective Action
Assessments demonstrating out of tolerance or problematic conditions require corrective action
and documentation of the assessment outcome and the corrective action. Corrective actions for
typical field and laboratory out of tolerance conditions (e.g., calibration verification failures) are
described in the respective SOPs. For systematic problems such as improper performance of an
activity or unrealized error, the entity undergoing assessment will need to take corrective actions
that are not readily prescribed.
The assessor will prepare a report on the outcome of the assessment and distribute the report to
the appropriate parties. The party under review is generally responsible for following up on
corrective actions stated in the report. The reports should clearly state the scope of the
assessment, state any finding, and provide recommendations for improvement. The assessments
to be conducted and the entity receiving the assessment report are summarized below in Table
CI-2.
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Table Cl-2. Summary of Assessments
Assossnu'iil
1 > \W
Psirlj I mk-r
liiM'sliiiiilion
l"lV(|IICIIO
Assessor
Report Due l);i(e
I'.irlj Responsible
lor Kosolnlion
Report Reeipienl;|
DQAs
Regional PM2 5-
PEP offices
Annually
OAQPS and
Regional PM2 5-
PEP Leads
120 days upon end
of calendar year
Regional PM2 5-PEP
Lead
Regional PM2 5-
PEP offices
ADQs
PM25-PEP
weighing
laboratory
Annually
OAQPS PM2 5-
PEP Lead or
designee
30 days after the
assessment
pm25-pep
Laboratory Manager
pm25-pep
weighing
laboratory
Regional PM2 5-
PEP offices
Annually
OAQPS PM2 5-
PEP Lead or
designee
120 days upon end
of calendar year
Regional PM2 5-PEP
Lead
Regional PM2 5-
PEP offices
Regional PM2 5-
PEP Lead and
PEP Contractor
Comprehensive
3-3-4 peryr
(all Regions every
3 yr)
OAQPS PM25-
PEP Lead or
designee
30 days after the
TSA completion
Regional PM2 5-PEP
Lead and/or PM2 5-
PEP Contractor
Regional PM2 5-
PEP Lead and
PEP Contractor
TSAs
pm25-pep
Contractor FS -
Modified
1 every 3 years; not
same year as
comprehensive
TSA
Regional PM2 5-
PEP Lead or
designee
30 days after the
TSA completion
pm25-pep
Contractor
pm25-pep
Contractor FS and
OAQPS PM2 s-PEP
Lead
pm25-pep
weighing
laboratory
Annually
OAQPS PM2 5-
PEP Lead or
designee
30 days after the
TSA completion
pm25-pep
Laboratory Manager
pm25-pep
weighing
laboratory
Self-
Implementing
PQAO FS -
Modified
1 every 3 years; not
same year as
comprehensive
TSA
Regional PM2 5-
PEP Lead or
designee
30 days after the
TSA completion
SLT PM2 s-PEP
coordinator
Self-Implementing
PQAO FS and
OAQPS PM2 s-PEP
Lead
PE or Round
Robin Study
pm25-pep
weighing
laboratory
Recommended
Semi-Annually
OAQPS
30 days after the
assessment
LA and Laboratory
Manager
PM2 s-PEP LA,
Laboratory
Manager, and
Laboratory Task
Monitor
Surveillance
Various
As needed
OAQPS and/or
Regional PM2 5-
PEP Lead
30 days after the
assessment
Party surveilled
Party surveilled and
party responsible
for
a OAQPS PM2 5-PEP Lead is to be included on all reporting unless they originated the report.
C2 Communication Framework and Reports to Management
This section describes the quality-related reports and communications to management necessary
to support the PM2.5-PEP.
Effective communication among all personnel is an integral part of a quality system. Regular,
planned quality reporting provides a means for tracking the following:
¦ Adherence to scheduled delivery of equipment, data, and reports
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¦ Documentation of deviations from approved QA and SOPs and the impact of these
deviations on data quality
¦ Analysis of the potential uncertainties in decisions based on the data.
C2.1 Communication
An organized communications framework facilitates the flow of information among the
participating organizations and other users of the information produced by the PM2.5-PEP.
Figure C2-1 represents the principal communication pathways.
M ~ Technical communication
>> Contractual communication
Figure C2-1. PM2.5-PEP Lines of Communication
In general, LAs and FSs are responsible for informing the PM2.5-PEP Laboratory Task Monitor
and the Regional PM2.5-PEP Lead, respectively, about technical progress, issues, and contractual
obligations. On the technical side, the Regional PM2.5-PEP Lead(s) are responsible for
communicating with SLT organizations and for informing the OAQPS PM2.5-PEP Lead and the
PM2.5-PEP Laboratory Manager about issues that require technical attention. Table C2-1 lists key
communication networks in the PM2.5-PEP.
The FSs communicate with the PM2.5-PEP weighing laboratory and the Regional PM2.5-PEP
Leads on the progress of their activities and any problems and issues associated with them.
Resolution of these issues should take place in the Regions unless the issue could affect the
implementation of the PM2.5-PEP at a national level. In those cases, it can be discussed and
resolved through the communications between the OAQPS PM2.5-PEP Lead, the Regional PM2.5-
PEP Leads, and, if needed, the affected contract officers.
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Clear and effective communication among PM2.5-PEP participants is critical to program success.
The PM2.5-PEP Field SOP and PM2.5-PEP Laboratory SOP contain additional information and
procedures for communication and documenting this information.
Table C2-1. Communication Pathways in the PM2.5-PEP
Person
('01111111111 ic:i(os In
Priniii('01111111111 ic;i 1 ion Topics
PM25-PEP
Laboratory Manager
Regional PM2 5-PEP Lead or Self-
Implementing PQAO Lead
Notification of availability of gravimetric
and FDS data for verification by FS.
Lab schedule changes or conditions in the
lab that affect availability of tared
filters
Alerts when there is an apparent departure
by the FS from the Field SOP that has
a negative impact on Laboratory
support
OAQPS PM2 s-PEP Lead
Request filter supply replenishments
Corrective actions
Technical Changes to equipment
Funding and resource needs
Problems and issues
Program improvements
Regional PM2 5-PEP
Lead or Self-
Implementing PQAO
Leada
PM2 5-PEP Laboratory Managera
Request tared filters a
OAQPS PM2 s-PEP Lead
Funding and resource needs
Problems and issues
Program improvements
FS
PM2 5-PEP sampling event site selection
and scheduling
Problems and issues
Audit scheduling and follow-up
Corrective action for field activities
LA b
PM2 5-PEP Laboratory Manager
and PM2 5-PEP Laboratory Task
Monitor
Laboratory progress
Problems and issues
Program improvements
Scheduling
FS
Out-going filter/equipment shipment
Filter shipment receipt from field
Field procedure issues
OAQPS PM2 s-PEP Lead or
OAQPS QA Support Contractor
Database management and AQS uploads
Problems and issues
FS
LA
Filter shipment from field
Significant recovery schedule changes
that could affect the weighing schedule
Field data verification
FS
SLT organization representative
(for sites hosting a PM2 5-PEP
sampling event)
Arrange scheduling, plan logistics, and
obtain access for sampling event.
Note any schedule delays or safety
concerns, plans for rescheduling
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Table C2-1. Communication Pathways in the PM2.5-PEP (continued)
Person
<'011111111 niciilcs In
Priniiin ('01111111111 ic;i 1 ion Topics
OAQPS PM2.5-PEP
Lead or designee
Regional PM2.5-PEP Leads
Requests reviews of PM2.5-PEP COC and
field data to verify accuracy or
troubleshoot failed uploads to AQS
Data quality and management issues
Audit assistance
Findings of concern in TSAs or Regional
Lead's reports of data reviews and
reviews of self-implementing PQAO
PM2.5-PEP
OAQPS PM2.5-PEP
Lead
Regional PM2.5-PEP Leads or Self-
Implementing PQAO Lead
Funding and resource needs
Contract performance issues
Program information dissemination
Training information
Note: Regional PM2.5-PEP Leads also include PM2.5-PEP coordinators from self-implementing PQAOs.
a This exchange generally occurs between the FS and LA.
b LA refers to the Lab Analyst, but this may include participation by the Region 4 Contract Team leader who
oversees the LA and PM2.5-PEP Field Activity.
C2.1.1 Field Communication
PM2.5-PEP-related communication is to be logged. Field communications can take place by
phone or e-mail. Important phone messages or conversations are recorded on either the Phone
Communication Form (COM-1; Appendix C of the PM2.5-PEP Field SOP) or e-mail, provided it
contains the same information, and stored in the field notebook. Notes include the following:
¦ Date
¦ Time
¦ Personnel involved
¦ Issue(s)
¦ Decision(s)
¦ Follow-up action(s)
¦ Follow-up action responsibility
¦ Follow-up action completed by (date).
If follow-up action is required by the FS, then these actions are included in the monthly progress
reports (see Section C2.2.1). At a minimum, the FS will keep the original hardcopy in the field
notebook or in electronic record maintained on a PC.
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Field communication between the FS and the Regional PM2.5-PEP Lead may be required. These
can occur via cellular phone. The Regional PM2.5-PEP Lead should also identify alternates to
receive field communications when they are not in the office
C2.1.1.1 Requesting and Receipt of Filter Shipments
Upon request from the FS, the LA ships filters to the field offices, provided that the request is
submitted a minimum of two weeks in advance of need by the FS (no later than Thursday).
Advance notice of requests is required to allow the LA to begin pre-sample equilibration on
Friday and pre-weighing can begin the following week.
On the day of receipt, the FS will contact the LA indicating the filters have been received. In the
event the order is incorrect, the following information is provided to the LA:
¦ Date of receipt
¦ Number of filter cassettes in shipment
¦ Number of filter cassettes requested
¦ Number of boxes in shipment
¦ Tracking number.
C2.1.1.2 Shipping Coolers and Freezer Bricks
On approximately a monthly basis, the PM2.5-PEP weighing laboratory ships coolers and freezer
bricks (ice substitutes) to the FSs' field offices. On the day of receipt, the FS will contact the LA
indicating the equipment has been received. In the event the order is incorrect, the following
information is provided to the LA:
¦ Date of shipment
¦ Tracking number
¦ Number of boxes with freezer bricks in shipment
¦ Number of additional shipping boxes requested
¦ Number of additional freezer bricks requested
C2.1.1.3 PM2.5-PEP Conference Calls
There may be occasions when the FS needs to communicate with the EPA Regional PM2.5-PEP
Lead due to a unique situation that exists or has developed in conjunction with a PM2.5-PEP
sampling event. During this call, the FS uses the Phone Communication Form (COM-1) to
record issues and action items that pertain to their activities. It is also permissible to take notes in
a field logbook and subsequently generate an email to confirm and document the conversation.
These items are included in the next monthly progress report.
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C2.1.1.4 Communicating with Reporting Organizations and Site Operators
Dates for a PM2.5-PEP sampling event should be coordinated with the site's normal operating
schedule. This coordination must be completed in advance so that the FS and the SLT
organization's site operator have ample advanced notice and time to prepare for the event's setup
and subsequent sample recovery. The procedure for such communications includes the
following:
¦ The Regional PM2.5-PEP Lead (or designee) will contact each SLT organization's
ambient air monitoring supervisor/manager/coordinator before the site visit. Contact must
be made by phone if it is within 30 days of the site visit, but e-mail is sufficient
otherwise. In preparation for initial contact with the site supervisor/manager/coordinator,
The PM2.5-PEP Lead and/or FS will confirm those SLT operated samplers that are
reporting data for NAAQS attainment purposes. During initial contact with the site
supervisor/manager/coordinator, the Regional PM2.5-PEP Lead will report any site
information that appears erroneous. The SLT organization may need to update site- or
sampler-specific data in AQS prior to the PM2.5-PEP sampling event.
¦ Approximately one (1) week before the PM2.5-PEP sampling event, the FS contacts the
SLT site operator to confirm that the sampling event remains on schedule and to confirm
meeting arrangements. A confirmation should be documented either as an e-mail from
the SLT operator or by the FS to the EPA Regional PM2.5-PEP Lead.
C2.1.2 Laboratory Communications
Laboratory personnel use the Phone Communications Form (COM-1) in the same manner as the
FS (Section C2.1.1). E-mail can similarly be used to create the needed documentation.
C2.1.2.1 Filter Shipment
On a biweekly schedule, the PM2.5-PEP weighing laboratory ships tared, unexposed filters to the
Regional field offices via EPA's contracted courier. On the day of shipment, the LA sends an e-
mail to Regional field office representatives with the following information:
¦ Date of shipment
¦ Number of filter cassettes in shipment
¦ Number of boxes in shipment
¦ Tracking number.
C2.1.2.2 Shipping Boxes and Freezer Bricks
Monthly, or as needed, the PM2.5-PEP weighing laboratory ships coolers and freezer bricks to the
Regional offices via EPA's contracted courier. On the day of shipment, the LA communicates
with the field contact and provides the following information by e-mail:
¦ Date of shipment
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¦ Number of boxes and freezer bricks in shipment
¦ Tracking number.
C2.2 Reports
This section discusses the various types of reports that are generated in the PM2.5-PEP. Table
C2-2 provides a summary of these reports.
Table C2-2. Report Summary
Report l\|R'
l-"iV(|iieno
Report I'lvpiiivr
Report Distribution
Field Progress
Monthly
FS
Regional PM2 5-PEP Lead
Laboratory Progress
Monthly
LA/Laboratory Manager
EPA PM2 5-PEP Laboratory Task
Monitor, Regional PM2 5-PEP
Leads
Data Quality Assessment
Report
1/5 yr
OAQPS PM2 s-PEP Lead and
Regional PM2 5-PEP Lead
Program distribution
Precision and Bias Report
1/yr
Regional PM2 5-PEP Lead
Program distribution
PM2 5-PEP QA Report
1/yr
OAQPS and Regions
FS, Regional PM2 5-PEP Leads
C2.2.1 Progress Reports
PM2.5-PEP field and laboratory activities will be reported to the appropriate Regional PM2.5-PEP
and PM2.5-PEP Laboratory Task Monitor, respectively, each month. The following subsections
detail the information to include in each such report.
C2.2.1.1 Laboratory Monthly Progress Report
As part of the monthly reporting as required by the PM2.5-PEP laboratory management and
operations contract, the primary LA and Laboratory Manager will compile a report to document
the activities, progress, and issues (new or ongoing) since the previous monthly report. This
monthly progress report will be due by the 15th of each month and will include the following
details:
¦ Reporting date - Report beginning and end dates
¦ Reporter - Report author
¦ Progress - laboratory activities conducted within the reporting period, including:
¦ Number of filter sample shipments received
¦ Number of outgoing tare-weighed filter shipments
¦ Number of filter weights including pre-sampling tare weights, post-sampling filter
weights, and QC samples including laboratory blanks, duplicate samples, and balance
calibration check weights
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¦ Issues or problems occurring in the weighing laboratory
¦ Number and type of equipment calibrations and calibration verifications
¦ Number of filters inspected
¦ Corrective actions taken during the month and progress on ongoing corrective actions
or issues
The PM2.5-PEP Laboratory Task Monitor may request more information be included in the
weekly reports if deemed necessary.
C2.2.1.2 Field Monthly Progress Report
The FS will provide the Regional PM2.5-PEP Lead with a written Field Monthly Progress Report
to document progress made in the preceding month. The deadline for delivering this report is the
15th calendar day of the following month unless otherwise specified by the Regional PM2.5-PEP
Lead. This Field Monthly Progress Report will contain the following information:
¦ Reporting date - Report beginning and end dates
¦ Reporter - Report author
¦ Progress - Progress on field activities from the preceding month, including PM2.5-PEP
sampling events scheduled and performed, required sampler maintenance, data
verification, and parking lot (fleet precision) study results.
¦ Issues - Issues reported in earlier reports that have not been fully resolved, and new
issues arising within the reporting period that might affect the validation of a sample
result or impact completion of anticipated activities.
¦ Actions - Action necessary to resolve issues, the person(s) responsible for resolving
them, and the anticipated dates when they will be resolved.
A Regional PM2.5-PEP Lead may request more information to be included in the Field Monthly
Report if deemed necessary. Also, a Regional PM2.5-PEP Lead may require a version of this
report be prepared and distributed more frequently than monthly, such as weekly or bimonthly.
C2.2.2 QA Reports
Various QA reports have been developed to document the quality of data for the PM2.5-PEP.
- DQA. This assessment is a scientific and statistical evaluation performed annually to
determine if data are of the right type, quality, and quantity to support their intended use.
The PM2.5-PEP QA/QC data can be statistically assessed at various levels of aggregation
to determine its quality. DQAs are primarily the responsibility of the Regions (Regional
assessments) and OAQPS (national assessments).
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¦ Precision and Bias reports. These reports include the actual network precision and bias
data produced by the PM2.5-PEP. Precision reports can be generated on-demand as data
are loaded in AQS by the PQAOs. The AQS uses the AMP256 and AMP504 reports to
retrieve these values but raw data reports can also be generated through the AMP251
report. Annually the PQAOs certify that these network data are accurate and suitable (or
not) for calculating attainment and non-attainment design values. The precision and bias
are calculated by AQS against the acceptance criteria using the statistics documented in
40 CFR Part 58 and presented in the AMP256 and AMP600. The Regions review these
certifications and concur or non-concur on the certifications and AQS tracks all results.
The Air Quality Analysis Group of the Air Quality Assessment Division of OAQPS
utilizes the certified data to calculate design values for all U.S. SLT air pollution
agencies. These results are published annually.
¦ QA summary reports. A QA report provides an evaluation of QA/QC data for a given
period to determine whether the DQOs were met. QA reports are more evaluative than
the precision and accuracy reports as they combine various assessments and the QA data
to report on the overall quality system. OAQPS generates QA Reports on the PM2.5-PEP
and its resultant data quality.
C2.2.2.1 Data Quality Assessment Reports
OAQPS and EPA Regions will develop a national DQA report and Regional DQA report,
respectively, periodically (e.g., every five years or sooner if annual QA reports indicate a need).
DQA reports evaluate and summarize the PM2.5-PEP QA/QC data to ensure collected date are
sufficient in quality and quantity and to examine whether revisions or improvements are
warranted to the program.
C2.2.2.2 Precision and Bias Reports
EPA Regions will annually generate precision and bias reports following PQAO annual
certification of their routine PM2.5 measurement data. The outcomes of these examinations will
inform whether improvements to the routine monitoring networks are required after evaluating
the PQAO precision and bias for routine monitoring activities.
C2.2.2.3 Annual and Multiple-Year QA Reports
OAQPS will prepare an annual QA summary report of the PM2.5-PEP to compile and summarize
data collected during the prior calendar year. Such annual reports may additionally include data
from prior years when their inclusion in the report is necessary to frame data outcomes or
observations. The annual report will present data on completeness aggregated at the PQAO, EPA
Region, and national levels for collocated site precision measurements and PM2.5-PEP bias.
Completeness is determined under the two sets of criteria previously described: (1) based solely
on valid completed measurements (not invalidated and with concentration values, regardless of
magnitude) and (2) based on valid measurements to be included in the bias assessment, i.e., those
that yield concentrations above the DQO calculation threshold given in 40 CFR Part 58
Appendix A (both PM2.5-PEP and routine SLT/PQAO concentration in compared data pairs must
be > 3 |ig/m3). Precision (percent CV) and PM2.5 -PEP bias (average RPD) are presented at the
same organizational levels of aggregation, but also as historical trends for the past 3 years and 6
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years. QA sample data for FBs and TBs as well as calculations of lower detection limits are also
reported at the national level for the year of interest and previous 3- and 6-year averages. In
addition to concentration bias calculations as detailed in the CFR, the reports will include
determination of flow rate bias of routine PM2.5 FRM and FEM monitors based on SLT
monitoring organization flow rate check and audit data reported to AQS (which began in 2017).
The annual QA reports will, at the direction of the PM2.5-PEP OAQPS Lead, incorporate
summaries of the following PM2.5-PEP QC measurement parameters:
1. PM2.5-PEP sampler fleet precision measurements (i.e., parking lot study data)
2. Metrological certifications of flow rate, ambient temperature, and barometric pressure
calibration and reference check standards
3. PM2.5-PEP laboratory sample shipment receipt temperatures
4. Weighing laboratory internal balance checks and audits using ASTM-certified check
weights and independent audit weights
5. Continuous monitoring of gravimetric weighing chamber climate controls as measured
with NIST-traceable temperature and RH sensors and data loggers.
6. Weighing session batch QA/QC data for filters weighed in replicate and laboratory blank
filters.
7. Measured mass data for field blank and trip blank filters.
8. Staff training completed
9. TSAs conducted and noteworthy findings
10. Recommendations for program improvement
A multi-year (e.g., 3-year or 5-year) QA Report is a composite of annual QA reports, but with a
more narrative interpretation and evaluation of longer-term trends with respect to PM2.5-PEP
sampler and operational performance. A multi-year report may be prepared at the direction of the
PM2.5-PEP OAQPS Lead.
C2.2.3 Response/Corrective Action Reports
During TSAs, the response/corrective action reporting procedure is followed whenever there is
an assessment finding. The reporting procedure is designed as a closed-loop system. The
Response/Corrective Action Report Form identifies the originator (who reported and identified
the problem), states the problem, and may suggest a solution. The form also indicates the name
of the person(s) assigned to correct the problem. The appropriate supervisor fills in details on the
assignment of personnel to address the problem and the schedule for completion.
The reporting procedure closes the loop by requiring that the recipient state on the form how the
problem was resolved and the effectiveness of the solution. Copies of the completed
Response/Corrective Action Report Form are distributed when the problem has been identified
and the action has been scheduled, and then again when the correction has been completed. The
originator, the Regional PM2.5-PEP Lead, and the OAQPS PM2.5-PEP Lead are included in both
distributions.
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C2.2.4 Assessment Reports
Reports for assessments are covered in Section Cl.l.
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D Data Validation and Usability
D1 Data Review, Verification, and Validation Requirements
This section describes how the PM2.5-PEP will verify and validate the data collection operations
associated with the program. Verification is defined for the PM2.5-PEP as confirmation by
examination and provision of objective evidence that specified MQO requirements have been
fulfilled (e.g., the pre-event sampler performance checks were conducted during set-up by the
FS; the number of laboratory weight checks occurred as prescribed). Validation is defined as
confirmation by examination and provision of objective evidence that the requirements for a
specific intended use are fulfilled (e.g., that the totality of the verified data meet the program
needs as indicated by examination of field QC sample data and laboratory QC data).
The majority of the data review, verification, and validation activities are performed by the
PM2.5-PEP laboratory staff, with support from the FSs. As many of the data verification and
validation activities share common procedures and aspects, they are listed together in Section
D 1.2 in the manner in which they occur and are not formally categorized specifically as a
verification or validation activity.
To verify and validate the phases of the data collection operation, the PM2.5-PEP uses various
qualitative assessments (e.g., TSAs, network reviews) to verify that the QAPP and supporting
SOPs are being followed. These assessments rely on the various QC measurements at various
phases of the data collection operation and are used to validate that the PM2.5-PEP's bias data
will meet the DQOs described in Section A7. While these assessments are important to the PEP
and the resulting data quality, they do not enter into the routine data verification and validation
activities the PM2.5-PEP weighing laboratory and FS staff conduct. If assessment findings result
in compromising data quality and resultingly call into question the validity of collected data,
these are aspects that occur after the data have been reported to AQS typically, unless
intervention is implemented in advance. The OAQPS PM2.5-PEP Lead maintains the authority to
review and alter the validation status of PM2.5-PEP data based on outcomes of assessments,
including findings from annual QA reports, TSAs, ADQs, and DQAs, and other data sources.
Dl.l Sample Data Collection Activities and Associated Controls
The PEP incorporates controls to ensure to the extent possible that data are collected that meet
the program requirements. Such controls include the conduct of calibration verifications prior to
each sampling event to ensure that the sampler operation was within tolerance during each
sampling event. The FSs employ certified transfer standards for this purpose and record
measurements and observations with each sampling event and follow established practices to
ensure successful sample and data collection. In the weighing laboratory, variables that impact
data quality are tightly controlled and continuously monitored to again ensure data collected
meet program requirements. Additionally, the PED has been developed and employed to capture
the data that support evidence the recorded data meet program requirements and are flagged
when data are compromised. These built-in features in the overall process maximize the
likelihood that data will be valid and meet program requirements. Additionally, they eliminate
and reduce the likelihood that compromised data will inadvertently slip through when they
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should be invalidated.
Periodic TSAs of field and laboratory staff provide additional confidence that procedures and
activities are performed according to those established and approved and that measurement data
are representative of the conditions under which they were collected.
Field controls include the provision of backup samplers and backup transfer standards to ensure
there is a calibrated and operable sample available in the event of malfunction. Data logged by
the sampler during the sampling event can be examined to ensure conditions were within control
during sampling.
Laboratory controls include the functions built into the PED and environmental conditions
monitoring that notify the LA when out of tolerance conditions exist. For example, the continual
environmental conditions data logger is programmed to alarm when conditions are out of
tolerance which allows correction before data are impacted. This functionality will permit the LA
to delay conducting filter weigh sessions if filters require further conditioning due to out of
tolerance environmental controls. The PED includes functions that notify the LA if a measured
mass for a standard weight is not within tolerance which prompts corrective action to prevent
measurements produced by a balance with calibration out of tolerance. Additional PED functions
notify the LA in real time when laboratory filter blanks or batch duplicate samples exceed
acceptance criteria, which again permits corrective action to be taken before measurements are
collected in out of tolerance conditions, risking invalidation.
The review of calibration verification data and QC data including FBs, TBs, laboratory filter
blanks can be used to validate data collection activities. Data that indicate unacceptable levels of
bias or precision or a tendency (e.g., trend on control charts) should be investigated and
reconciled in the event of a transcription or other typographic error. Investigation may uncover
related issues that call into question data validity or identify improper procedures.
D1.2 Workflow of Data Verification and Validation Activities
The controls in place described in Section Dl.l eliminate a significant amount of manual
inspection that would otherwise be required to verify data meet acceptance criteria. Even still,
there are opportunities for errors to occur that require manual inspection during the data review
and verification process. The general workflow of data verification and validation activities
follows. Specific details for decisions on data validation or invalidation are detailed in Section
D2.
1. The LA conditions and measures tare weights on filters and ships them to the FSs. The
dates and times of the filter equilibration and measurements are recorded in the PED for
reference of holding times and will produce flags for filters if holding times are exceeded.
After completing a weighing session (pre-sampling or post-sampling), the LA reviews the
recorded measured masses and the weighing batch QC results for the blank filters,
duplicate weights, and standard mass results to ensure they fall within the prescribed
acceptance criteria (refer to Section B7.1). Balance measurements are electronically
transferred from the balance to the PED, eliminating potential transcription errors. Filters
are assigned to virtual trays and batches which allows entry of equilibration dates and
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times to a number of filters simultaneously.
The updated PEP or the LIMS will allow the LA to weigh samples only if the previous
24-hour climatic conditions in the weighing chamber are acceptable and all balance
self-calibrations and check weight tests have been completed with satisfactory results.
2. The FS conducts the field sampling event and records all required data to document that
the sampling event followed the established procedure. Prior to packaging the completed
FDS/COC form and retrieved filter for shipment, FSs review the electronic logged
sampler data and completed FDS/COC form to ensure all required information is
recorded comprehensively, accurately, and legibly. Missing information may result in
sample invalidation and the need to schedule a make-up sample.
MoPED will incorporate features to eliminate or reduce the potential for inputting
erroneous data before users can continue the field sampling event. When MoPED is
in place, field data should be reported to AQS within 24 hours of sample retrieval (if
possible).
3. Upon receipt of samples by the PM2.5-PEP weighing laboratory, the LA reviews the
FDS/COC form for completeness and notates any missing or discrepant information. The
LA will contact the FS to resolve any incomplete or discrepant information and/or
illegible information. The LA may also consult the electronically logged data (provided
on the removeable data storage device shipped with the filter(s) samples) to correct
missing or discrepant data. The LA measures the shipment temperatures and stores filters
appropriately until beginning equilibration. The LA will document the receipt
temperature and the average sample collection temperature (if needed) in addition to the
date and time the filter was placed into storage (if not immediately placed into the
weighing lab for equilibration) and the start date and time of filter equilibration. When
inputting data into the PED, the LA inputs flags for aspects of the sample collection,
transport, or receipt that do not meet acceptance criteria. The PED stores these flags and
will reference the various entries in determining holding times based on the receipt
temperatures and sample collection average temperatures, dates, and times. If any critical
aspects do not meet the prescribed criteria, the sample is invalidated and marked as such
in the PED.
The LA files records of all invalid samples in the PED and includes a summary of why
the sample was invalidated, along with the associated flags.
Samples flagged as invalid in the field are returned to the weighing laboratory for
analysis unless they are physically damaged or have been subject to a unique
environmental condition (e.g., a wildfire that generates enough PM to overwhelm the
flow controller) that renders them invalid. All field-collected filters will be weighed for
post-sampling mass unless a filter is unweighable due to obvious physical damage or
contamination. The LA should not make judgement calls as to what should or should not
be weighed, if the filter integrity is intact.
4. The LA equilibrates the received filters and measures and records the equilibration start
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times in the PED. When subsequently weighing filters, the PED records the date and time
of mass measurement and will add flags if holding times are exceeded. The PED will also
notify the LA if weighing session QC are not met. The LA will notate in the PED for any
affected filters whether the environmental conditions were outside the acceptable
tolerance range, for which the PED will add flags appropriately. Balance measurements
are electronically transferred from the balance to the PED, eliminating potential
transcription errors. As for pre-sampling tare weights, filters are assigned to trays and
batches to assign QC samples and common equilibration times and dates to the filters in
the batch. Once the weighing session is complete, the LA can examine the QC data in
control charts to quickly ascertain that criteria were met.
The updated PED or the LIMS will allow the LA to weigh samples only if the previous
24-hour climatic conditions in the weighing chamber are acceptable and all balance
self-calibrations and check weight tests have been completed with satisfactory results.
Under the MoPED regime, the LA will upload the data directly to AQS via the
browser-based upload tool available at https://aqs. epa. sov/auditor upload. The LA
uploads pre- and post-sampling weigh session data immediately following the
completion of each weighing session. Since all relevant validation data have been
ostensibly loaded by the FS via MoPED, the validation logic algorithm of MoPED
has prequalified most of the data and AQS completes the validation process along
with the calculation of the resulting ambient concentration.
5. Upon completion of post-sampling weighing batch, the LA ensures batch QC criteria
were complete and met the acceptance criteria. At this stage, the PED contains all of the
information needed to calculate an in-air PM2.5 concentration for the filter sample or a
mass gained for FBs and TBs.
6. The LA will then prepare a filter report for each post-sampling weighed filter which
includes the sample collection data from the FDS/COC and the laboratory mass data.
7. Once post-sampling weighing activities have been completed at the weighing laboratory,
approximately every month, the LA and/or Laboratory Manager sends the concentration
results to the respective FS to complete verification of COC/FDS data and review of the
calculated PM2.5 filtrate mass and in-air concentration. Each FS will digitally sign an
accompanying form stating the data are consistent with their records; or data that appear
to be incorrect are identified and a resolution process is initiated to establish the correct
value or result. Once the FS verifies all data are correctly transcribed/entered, the FS
attests to the veracity of the data.
8. The LA marks the data as complete in the PED which adds the data to a list of filters to
be reviewed and validated by the laboratory manager.
9. Following the completion of FS review and concurrence of data veracity, the filter
sample data in the PED is ready for the Laboratory Manager to review and approve for
reporting. For this process, the Laboratory Manager employs the validation reports within
the PED. The PED incorporates numerous data verification and validation checks the are
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summarized in a data summary report for each field-collected (PM2.5-PEP filter sample,
FB, and TB) filter sample. The validation report contains the field collection data verified
by the FS, the laboratory weighing data, and comments or flags applied by the LA or
automatically by the PED. The report is arranged such that critical criteria and their
satisfaction are together where the laboratory manager can quickly ascertain if a sample
was invalidated. The Laboratory Manager generates these reports for all of the samples to
be completed in the monthly batch of samples and reviews the reports. The reports
reviewed include those for filter samples for which all weighing activities have been
completed since the previous monthly data review. An example report is shown in
Appendix C. As part of their validation activities, the Laboratory Manager will attempt to
correct data where possible. When data are revised, the Laboratory Manager documents
the change in form VALFORM-1 to log and trace the change. In instances where changes
are not obvious errors for which the Laboratory Manager can clearly justify a change,
they may contact the Regional PM2.5-PEP Lead, self-implementing PQAO PM2.5-PEP
partner, and/or FS for clarification or correction.
The PED's successor (i.e., the LIMS) will provide validation of the gravimetric
results. There will continue to be an assessment of blank results by the PM2.5-PEP
Laboratory Manager (or designee) since acceptance limits are operational criteria as
defined by the FRM, EPA 's QA handbook, or QA Guidance Document 2.12:
Monitoring PM2.5 in Ambient Air Using Designated Reference or Class I Equivalent
Methods. Upon successful launch ofMoPED, the final validation check based on field
criteria will be provided through AQS, however, EPA Regional PM2.5-PEP Leads will
be able to reverse any decisions within 14 days of the AQS posting in an interim
results table.
10. The laboratory manager reviews the validation report for each filter sample, paying
particular attention to filter samples that include flags - particularly numerous flags - and
flags indicating the sample is invalid. The laboratory manager also reviews closely the
validation reports for TBs and FBs to ensure they meet acceptance criteria, and if not,
assess the impact on associated field samples.
11. The laboratory manager may identify errors in data entry which result in incorrect
application of flags or the omission of flags when they are warranted. The scope of the
validation activities the laboratory manager performs may include reviewing weighing
batch QC data, environmental conditions data, calibration data, and original FDS/COC
forms to verify specific recorded data and context for inclusion or omission of flags. If
changes or corrections to data are required, the laboratory manager will document these
changes on VALFORM-1 and detail the rationale for the change. These completed forms
are maintained in the laboratory and available for TSAs and program reviews. The
laboratory manager will document the scope of the validation activities and include notes
and observations in a record.
12. Following review of the data validation reports and completion of needed changes to data
and flags, the data are marked as ready for approval.
13. At the time this QAPP was approved, the PM2.5-PEP Weighing Laboratory Task Monitor
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performs final review the filter sample data following completion of validation. The
Laboratory Task Monitor will review the validation data and laboratory manager
observations and notations, paying particular attention to field QC samples (FBs and
TBs) as well as filter samples for which additional changes were made (i.e., the
VALFORM-1 records), as well as to invalidated samples. The Laboratory Task Monitor
may ask for additional changes or clarifications to recorded and validated data prior to
approval.
14. Once the Laboratory Task Monitor approves the data, the Laboratory Manager then
notifies the OAQPS QA support contractor that the data are ready for coding and
submission to AQS and provides a copy of the PED with the approved data. Data are
provided to the QA Contractor approximately monthly and currently consist of
transmission of a complete copy of the PED updated with the current records.
EPA intends to institute a formal notification procedure following the Laboratory
Task Monitor approval which provides all valid and invalid results to the respective
EPA Regional PM2.5-PEP Lead and self-implementing PQAO PM2.5-PEP
coordinators. Once notified, the EPA Regional PM2.5-PEP Lead or self-implementing
PQAO PM2.5-PEP coordinator will be given 14 days to approve valid data,
otherwise, the data will automatically be posted to AQS. During this 14-day period,
the Regional PM2.5-PEP Leads and self-implementing PQAO PM2.5-PEP
coordinators will either affirm invalidations or work with the FS and the laboratory
to correct the source of the invalidation, if feasible.
When MoPED is implemented, MoPED will validate data which will eliminate the
need for an individual to do this. In this case, the Region 4 PM2.5-PEP Laboratory
Manager will review analytical results and associated QC data that suggest the
results should be invalidated (e.g., gravimetric laboratory temperature and/or
relative humidity data do not meet criteria, but the gravimetric measurements were
posted regardless).
Upon successful launch of MoPED, once the field collection and laboratory data
have been submitted to AQS for a given PM2.5-PEP sample, AQS pairs the sample's
field and laboratory data into a single record and this result is held in a pre-
production area within AQS. Once this pairing is completed in the pre-production
area within AQS, the Regional PM2.5-PEP Lead or self-implementing PQAO PM2.5-
PEP coordinator has fourteen (14) days to approve or invalidate the sample data
within the pre-production area within AQS. If no action is taken within the 14-day
period, the sample result will automatically move to the production area in AQS.
Once in the production area of AQS, the PEP data result will be available for pairing
with the coincident routine network concentration measurement.
D2 Verification and Validation Methods
If the processes prescribed in this QAPP and supporting SOPs are followed as written, then the
PM2.5-PEP should obtain the necessary data quality to evaluate the DQO. However, exceptional
field and laboratory events may occur, and field and laboratory activities may negatively affect
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the integrity of samples. In addition, it is expected that QC checks will occasionally fail to meet
acceptance criteria. Information about problems that affect the integrity of data is recorded in the
PED as flags associated with specific filter samples. It is important to determine how these
failures affect the collected data. The review of collected data and their associated QC data are
verified and validated on a sample basis, on groups of samples, and on a sample batch basis
based on the impact of the issue.
D2.1 Process for Validating and Verifying Data
Data are presumed to be valid unless a critical criterion has not been satisfied. In some cases, the
PED may mark a critical criterion as unsatisfied, and therefore invalidate a sample result; when
the critical criterion has been satisfied but there is a data transcription error. Therefore, it is
critical that an individual (i.e., the Laboratory Manager or designee) review invalidated data to
ensure the critical criterion is indeed unsatisfied.
A filter sample may be invalidated based on many criteria, such as known or suspected field or
laboratory contamination, field or laboratory accidents, or failure of critical acceptance criteria.
Table D2-1 lists the cases where single samples or groups of samples may be invalidated based
on failure of any one critical acceptance criterion.
Flags may be used in combination to invalidate samples. Table D2-2 identifies the operational
evaluation criteria that can be used in combination to invalidate single samples or groups of
samples. Because the possible flag combinations are overwhelming and cannot be anticipated,
the PM2.5-PEP Laboratory Manager reviews the flags associated with single values or groups of
samples and recommends acceptance or invalidation to the Laboratory Task Monitor.
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Table D2-1. Validation Template Indicating Critical Criteria
FAILURE OF ONE OF THESE CRITICAL CRITERIA WILL RESULT IN INVALIDATION OF THE AFFECTED SAMPLE OR
GROUP OF SAMPLES
Kc(|iiiivnH-nl
1 > \W
Scope
Am'plsiiK'c Crilcriii
i'illcr Holding limes
40 ( I K
UcIVivmcc
l lii» Yiilui-
Filter Retrieval from
Sampler After
Collection
s
All filters
< 96 hours from sample end date and time
Part 50, Appendix L,
Section 10.10
HTE
Post-sampling weighing
s
All filters
< 30 days if TreCeiveda < 4°C
< 30 days if 4°C < TreCeived < 25°C and
Tsampling ^ Treceived
< 10 days if 4°C < TreCeived < 25°C and
Tsampling < Treceived
Sample invalidated if TreCeived > 25°C
Part 50, Appendix L
refers to Quality
Assurance Guidance
Document 2.12
HTE
Sampling start date and
time
s
All filters
Sampling must be < 30 days from pre-
sampling tare weight measurement
Part 50, Appendix L,
Section 8.3
HTE
Sump/in^ Period
Samplnm period
s
\ll sampled fillers
1. 'So 1,5oo mini (2 '-25 Ikuiis)
S'tim/>/iiix Instrument
I'ail 5o. \ppcndi\ L
Seclion ' '
i:sr
Flow rate audit
s
Each sampling event
+ 4% of calibration standard at design
flow (16.67 LPM)
Part 50, App L, Sec. 7.4.3
FQC
External leak check6
s
Each sampling event
<80 mL/min
Part 50, Appendix L,
Section 7.4.6
FQC
Internal leak check6
s
Each sampling event
<80 mL/min
Part 50, Appendix L,
Section 7.4.6
FQC
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Table D2-1. Validation Template Indicating Critical Criteria (continued)
FAILURE OF ONE OF THESE CRITICAL CRITERIA WILL RESULT IN INVALIDATION OF THE AFFECTED SAMPLE OR
GROUP OF SAMPLES
Kc(|iiircmcnl
Tj |>C
Scope
Acccphincc ( rilcriii
40 ( I K
Reference
ILili Yiiluc
Filter temperature
sensor
S
All sampled filters -
average flow rate for
sampling period
No excursions of >5°C lasting longer than
30 min
Part 50, Appendix L,
Section 7.4
FLT
Flow rate (indicated by
sampler logged data)
S
All sampled filters -
average flow rate for
sampling period
within ± 4% of design flow (16.67 LPM)
Part 50, Appendix L,
Section 7.4
FLR
s
All sampled filters - for
sampling period
< 2% CV
Part 50, Appendix L,
Section 7.4.3.2
FLR
s
All sampled filters - for
sampling period
flow rate measured over time intervals of
5 minutes within + 5% of design flow
(16.67 LPM)
Part 50, Appendix L,
Section 7.4.3.1
FVL
i'illcr
Filler liilegrilN
s
All Illicit
No coiiianiiiialion, damage, pinholes,
particles, ring separation, or other
imperfections
Pail 50, Appendix L,
Section 6.0
CON.
DAM
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Table D2-1. Validation Template Indicating Critical Criteria (continued)
FAILURE OF ONE OF THESE CRITICAL CRITERIA WILL RESULT IN INVALIDATION OF THE AFFECTED SAMPLE OR
GROUP OF SAMPLES
Kc(|iiircmcnl
Tj |>C
Scope
Acccphincc ( rilcriii
40 ( I K
Reference
ILili Yiiluc
i'illcr ('oiirfilioiiinx linvironmcnl
Equilibration prior to
pre-sampling tare
weight or post-sampling
weight
G
All filters
> 24 hours of equilibration
Part 50, Appendix L,
Section 8.2
ISP
Weighing room
temperature range
G
All filters
24-hr mean 20 to 23 °C
Part 50, Appendix L,
Section 8.2
ISP
during equilibration
G
All filters
5-minute average values within
18 to 25°C
Part 50, Appendix L
refers to Quality
Assurance Guidance
Document 2.12
ISP
Weighing room
temperature control
during equilibration
G
All filters
standard deviation of 5-minute averages
< 2°C over 24 hr 0
Part 50, Appendix L,
Section 8.2; Quality
Assurance Guidance
Document 2.12 (Table 9-
1)
ISP
Weighing room
relative humidity range
G
All filters
24-hr mean 30 to 40% RH
Part 50, Appendix L,
Section 8.2
ISP
during equilibration
G
All filters
5-minute average values within
25 to 45% RH
Part 50, Appendix L
refers to Quality
Assurance Guidance
Document 2.12
ISP
Weighing room
relative humidity
control during
equilibration
G
All filters
standard deviation of 5-minute averages
< 5% RH over 24 hr 0
Part 50, Appendix L,
Section 8.2; Quality
Assurance Guidance
Document 2.12 (Table 9-
1)
ISP
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Table D2-1. Validation Template Indicating Critical Criteria (continued)
FAILURE OF ONE OF THESE CRITICAL CRITERIA WILL RESULT IN INVALIDATION OF THE AFFECTED SAMPLE OR
GROUP OF SAMPLES
Kc(|iiircmcnl
Tj |>C
Scope
Acccphincc ( rilcriii
40 ( I K
Reference
ILili Yiiluc
Weighing Room
Pre-/post-sampling
relative humidity
difference
S/G
All filters
24-hr means within + 5% RH
Part 50, Appendix L
refers to Quality
Assurance Guidance
Document 2.12
ISP
NOTE: S = single filter; G = group of filters (i.e., batch)
a Treceived = the maximum measured temperature of the filter immediately after unpacking the cooler after arrival at the laboratory.
b Tsampling = the 24-hour average ambient temperature during the sampling event.
c Variability estimate not defined in CFR.
e The PQ200 sampler leak check criterion is to check for 5 cm H2O of vacuum pressure loss over 2 minutes. The listed leak check criterion is equivalent to the CFR
requirements, as originally certified by Mesa Laboratories and approved by EPA .
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Table D2-2. Validation Template Indicating Operational Criteria
OPERATIONAL EVALUATIONS
Kc(|iiircmcnl
1 > |H>
Scope
Acceptance (rilcrhi
Ih'li'clioii l.intil
40 ( I K Ucl'civnco or Source
IliiU
Yiiluc
Lower detection limit
G/Gl
All field collected sample
filters
2 |ig/m3
1.0 |ig/m3
Part 50, Appendix L, Section 3.1
PM2 5-PEP established based on
historical field blank data
BDL
Upper concentration
limit
G/Gl
All field collected sample
filters
200 |ig/m3
Part 50, Appendix L, Section 3.2
NA
J 'iiitl +20 ng (3-month average of filters;
refer to Section B5.3)
Pail 50, Appendix L, Seelion 8.3
PM2 5-PEP Requirement
1TB
Trip Blank (TB)
G
1 per audit trip d
+ 15 |ig change between pre- and post-
weighings
PM2 5-PEP has set this as a
corrective action level
FTB
l.ubiirulory (J( ' ( hccks
Laboratory filter blank
G
After every 10 filter
weights in a post-sampling
weighing session
< ±15 ng change between weighings
Part 50, Appendix L, Section 8.3
FLB
Balance calibration
verification
G
Beginning/end of weighing
session and after every 10
filter weights
- 3 Hg
Part 50, Appendix L, Section 8.3
FQC
Duplicate filter
weighing
G
1/post-sampling weighing
session,
1 carried over to next
session
+ 15 |ig change between weighings
Part 50, Appendix L, Section 8.3
FLD
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Table D2-2. Validation Template Indicating Operational Criteria (continued)
OPERATIONAL EVALUATIONS
Kc(|iiircmcnl
1 > |>C
Scope
Acccphincc ( rilcriii
40 (T'U Reference or Source
lliiii
Yiiluc
.Accuracy performance checks and audits ''
Flow rate audit
G1
4/yr (manual)
+ 4% of calibration standard at design flow
(16.67 LPM)
PM2 5-PEP Requirement
FQC
Temperature calibration
verification
S
each sampling event
+ 2°C of calibration standard
Part 50, Appendix L, Section 9.3
FQC
Barometric pressure
calibration verification
S
each sampling event
+ 10 mm Hg of calibration standard
Part 50, Appendix L, Section 7.4
FQC
Balance audit (PE)
G
2/yr
+ 3^g of NIST-traceable (ASTM level 2)
standard
PM2 5-PEP Experience
FQC
Precision (using collocated samplers) 1
All samplers
(mandatory)
G
2/year (semi-annual)
CVq < 10% (see SectionB5.1.5.1)
Part 50, Appendix L, Section 5.0
FCS
( iilibralion 1 erificalion
Single-point flow rate
verification
G1
Every sampling event
+ 4% of working standard or 4% of design
flow (16.67 LPM)
Part 50, Appendix L, Section
9.2.5
FSC
Single-point
temperature verification
G1
Every sampling event
+ 2°C of working standard
Part 50, Appendix L, Section 9.3
FSC
Single-point barometric
pressure verification
G1
Every sampling event
+ 10 mmHg
Part 50, Appendix L, Section 7.4
FSC
Clock/timer verification
G1
Every sampling event
± 1 min from time standard
Not described
NA
Laboratory temperature
sensor verification
G
1/quarter
+ 2°C
Not described
FLT
Laboratory relative
humidity sensor
verification
G
1/quarter
+ 2% relative humidity
Not described
FLH
NOTE: S = single filter; G = group of filters (i.e., batch); G1 = group of filters from one instrument
a Treceived = the maximum measured temperature of the filter immediately after unpacking the cooler after arrival at the laboratory.
b Tsampling = the 24-hour average ambient temperature during the sampling event.
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Table D2-2. Validation Template Indicating Operational Criteria (continued)
c For a new self-implementing PQAO program (i.e., <2 years old), the frequency for FBs is one per FRM/FEM audit event. For all others, one FB will be performed per
FS per trip. A trip may include more than one audit event. It is up to the FS to determine which site to perform the FB, unless otherwise directed by their Regional
PM2.5-PEP Lead (such as when a problem is identified at a specific site).
d TBs are performed at a frequency of one per audit trip.
e These are independent of any sampling event and likely to occur during quarterly maintenance and the annual calibration/certification. Placing a sampler into service,
even though it has failed one or more of these operational criteria in a calibration or quarterly performance check is a violation of the Field SOP.
f Twice per year, all of the PM2.5-PEP samplers used by the Region (and any self-implementing PQAO) must be collocated in a "parking lot study" as described in
Section B5.4.1. If the measured concentration is below 5 (ig/m3,CVa> 10% may be accepted if the absolute differences are <,1.7 (ig/m3.
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D2.2 Validation Considering Sample Filter Batching
Filter samples are associated with QC samples by batching samples together and are considered
within these batches for validation. Invalidation is not warranted with a single exceedance of an
acceptance criterion for batch QC; however, depending on the magnitude of the exceedance and
whether more than one similar type of exceedance may be considered a minor or major deviation
from expected performance. In such instances, flags will be added to the filter data and may rise
to the level where filters assigned to the batch are invalidated. The PM2.5-PEP has developed a
validation template to consider sample validity in such instances and is shown in Table D2-3.
Table D2-3. Sample Batch Validation Template
Kc(|iiiiviiioiil
Number
Per
liiik-h
Aeeeplsinee
(rilerhi
Mii.jor l)e\ in 1 ion ¦'
HltlllliS
Minor l)e\ iiiiion h
lliili
Field blanks 0
1
<±30 ng
Blank > ± 40 ng
One blank > ± 30 ng
FFB
>1
Mean < ± 30 ng
Mean> ± 30 |ig
FFB
Laboratory blanks
1
<± 15 ng
Blank > ± 17 ng
Blank >± 15 ng
FLB
>1
Mean<± 15 |ig
Mean> ± 15 |ig
FLB
Trip blanks0
1
<± 15 ng
Blank > ± 40 ng
One blank > ± 30 ng
FTB
>1
Mean<± 15 |ig
Mean> ± 30 |ig
FTB
Precision ( hccks
1'illcr diiplicales
1
1 5 II U
Duplicalc 1" uu
Duplicalc 15 11 u
N.I)
Aeeur;ie\
Balance checks
4
-
l our checks 3 (ig
Tw 0 checks 3 (ig
11s
a If two major deviations occur, then the data in the batch are invalidated. See exception in footnote c. In general,
when exceedances occur that prompt invalidation, corrective action will be taken to address the exceedance and
the filters in the batch weighed in a successive weighing batch, the intent to successfully attain QC acceptance
criteria.
b If four minor deviations occur, then the data in the batch are invalidated. Two minor deviations equal one major
deviation. See exception in footnote c.
0 Sample weighing batches will not be wholly invalidated when FB and/or TB samples exceed these listed criteria.
Instead, these exceedances will be reviewed in context with the associated field samples to investigate potential
contamination and the impact to the associated filter samples.
As noted in the footnotes to Table D2-3, data for a given batch may be invalidated based on the
number of major and minor deviations assigned. The LAs evaluate the batch and generate a
report based on the results described in the validation template. If the report indicates
invalidating the batch of data, then the batch may be reweighed to confirm the aberrant results.
Prior to re-analysis, all efforts are made to take corrective actions and, depending on the type of
QC checks that were outside of acceptance criteria, to correct the problem. If the aberrant results
are confirmed, the associated filter data in the batch are invalidated.
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D2.3 Validation Acceptance and Reporting
To the extent possible, the PM2.5-PEP strives to minimize data invalidation. The weighing
laboratory will make reasonable efforts to salvage data that may be invalidated when
transcription or data recording errors are responsible for failure of a critical criterion. The
weighing laboratory may undertake additional periods of equilibration and repeat filter
weighings to confirm aberrant results or eliminate a nonconformance condition such as
equilibration environmental conditions excursions. Reversal of invalidation based on subjective
assessment of criteria may be possible, but must be clearly identified by the Region 4 PM2.5-PEP
Laboratory Manager and approved by the EPA PM2.5-PEP Laboratory Task Monitor.
D3 Reconciliation with User Requirements
The PM2.5-PEP data are ultimately employed to calculate bias in the PM2.5 routine monitoring
network. To do this, the PM2.5-PEP and routine PM2.5 measurement data must be reported to
AQS where they can be associated with coincident routine network sampling results for bias
determination.
D3.1 Data Reporting
Once post-sampling weighing and data validation activities are complete and the PM2.5-PEP
Weighing Laboratory Task Monitor has approved the sample data for reporting, the OAQPS QA
Support Contractor extracts the concentration data stored in the PED, performs coding regimens
to translate the data into an AQS-friendly format, and uploads them to AQS. Air quality data
submitted for each reporting period are edited, validated, and entered into the AQS using the
procedures described in the AQS User Guide and the AQS Data Coding Manual (available at
https://www.epa.gov/aqs/aqs-manuals-and-guides).
Invalidated PM2.5-PEP sampling events cannot be posted to AQS as there is currently no
provision in the AQS QA transaction data record format for adding NULL Qualifier codes.
Occasionally, validated PM2.5-PEP results may not upload to AQS. Reasons for this include
assignment of incorrect AQS site identifiers or issues with metadata associated with the site at
which the PM2.5-PEP event was conducted. These results and error reports are compiled by the
national QA support contractor and then distributed to the Laboratory Manager and the Regions
or self-implementing PQAOs believed to be the origin of the rejected PM2.5-PEP event result. If
the error cannot be resolved at this level, the results are submitted to the EPA National Air Data
Group for further investigation on the failed upload to AQS.
D3.2 Data Pairing
The AQS pairs PM2.5-PEP data with the coincident PQAO's routine measurement from their
primary (or routine collocated) sampler. Historically, the PM2.5-PEP sampling event results are
not available for posting and pairing until approximately 40 to 50 days after the conclusion of the
sampling event (to allow time for processing and data validation). This has typically preceded
the posting of validated routine PM2.5 data by at least a week or more when the routine sampler is
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an FRM. However, as more routine networks utilize FEM samplers, these data are generally
validated and posted to AQS sooner.
After the launch of MoPED, in cases where the PM2.5-PEP sampling event results are
available, but the coincident network routine measurements are not available, the PM2.5-PEP
sampling event results are not viewable in AQS. On a 24-hour cycle, AQS checks for
matching data from the PM2.5-PEP upload table and SLT/PQAO network
D3.2.1 Routine PM2.5 Monitoring Network Data Verification and AQS Reporting
To characterize PM2.5 routine measurement bias, data for each PM2.5-PEP sample is matched to
the data for its corresponding co-collected routine PM2.5 measurement. This QAPP does not
address verification, validation, and reporting of the SLT network's routine PM2.5 monitoring
sample data. Per 40 CFR Part §58.16, PQAOs are required to upload their routine PM2.5
monitoring data to AQS within 90 days of the end of the calendar quarter in which the
measurement was collected. The PM2.5-PEP sample data cannot be paired with their collocated
routine PM2.5 monitoring data until the latter are uploaded to AQS. Table D3-1 lists the due dates
for routine PM2.5 monitoring data submission to AQS based on when the sample was collected.
Table D3-1. Due dates for PQAOs to Report Routine PM2.5 Data to AQS
I'M:? Moiisiiivinoiil
( ulk'Cliun Period
l);ilc l);il;i Duo (0
AQS
January 1 to March 31
June 30
April 1 to June 30
September 30
July 1 to September 30
December 31
October 1 to December 31
March 31
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References
Neter, J., W. Wasserman, and M.H. Kutner. 1985. Applied Linear Statistical Models (2nd
edition). Homewood, IL: Richard D. Irwin, Inc.
Taylor, J.K. 1987. Quality Assurance of Chemical Measurements. Lewis Publishers: Chelsea,
MI. p. 328.
U.S. EPA (Environmental Protection Agency). 2015. Records Management Policy.
https://www.epa.gOv/sites/production/files/2015-03/documents/cio-2155.3.pdf
U.S. EPA (Environmental Protection Agency). 2013. QA Handbook for Air Pollution
Measurement Systems. Volume II: Ambient Air Quality Monitoring Program. EPA-454/B-
13-003, May 2013
U.S. EPA (Environmental Protection Agency). 2017. National Performance Audit Program,
PM2.5, PM10-2.5, and Lead Performance Evaluation Program Implementation Decision
Memorandum for Calendar Year 2017.
https://www3.epa.gov/ttn/amtic/files/ambient/pm25/qa/Final%202017 07-27-074109.pdf
U.S. EPA (Environmental Protection Agency). 2008. PM2.5-PEP Program Adequacy and
Independence Criteria: Monitoring Rule Requirements and Implementing Instructions.
Revised July 23, 2008.
U.S. EPA (Environmental Protection Agency). 2006a. Revisions to Ambient Air Monitoring
Regulations. 40 CFR Parts 53 and 58. Federal Register 71(200):61235-61328. October 17.
U.S. EPA (Environmental Protection Agency). 2006b. National Ambient Air Quality Standards
for Particulate Matter—Final Rule. 40 CFR Part 50. Federal Register 71(200):61144-61233.
October 17.
U.S. EPA (Environmental Protection Agency). 2004. Air Quality Criteria for Particulate Matter.
U.S. Environmental Protection Agency, Washington, DC, EPA 600/P-99/002aF-bF, October.
U.S. EPA (Environmental Protection Agency). 2000. Guidance for Data Quality Assessment:
Practical Methods for Data Analysis; EPA QA/G-9,QA00 UPDATE. United States
Environmental Protection Agency, Office of Environmental Information, Washington, DC,
EPA/600/R-96/084. July.
U.S. EPA (Environmental Protection Agency). 1998. EPA Guidance for Quality Assurance
Project Plans. EPA QA/G-5, EPA/600/R-98/018. February.
U.S. EPA (Environmental Protection Agency). 2016. Quality Assurance Guidance Document
2.12: Monitoring PM2.5 in Ambient Air Using Designated Reference or Class I Equivalent
Methods. January 2016. https://www3.epa.gov/ttnamtil/files/ambient/pm25/qa/m212.pdf
U.S. EPA (Environmental Protection Agency). 1997. National Ambient Air Quality Standards
for Particulate Matter—Final Rule. 40 CFR Part 53. Federal Register 62(138):38651-38760.
July 18.
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Appendix A
Glossary
The following glossary contains terms commonly used in the PM2 5-PEP. All terms listed may not
actually be used in this document.
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Glossary
Acceptance criteria—Specified limits that are placed on the characteristics of an item, process, or
service defined in requirements documents (American Society of Quality Control definition).
Accuracy—This term refers to a measure of the closeness of an individual measurement or the average of
a number of measurements to the true value. Accuracy includes a combination of random error (precision)
and systematic error (bias) components that are due to sampling and analytical operations; the EPA
recommends using the terms "precision" and "bias," rather than "accuracy," to convey the information
usually associated with accuracy.
Activity—This all-inclusive term describes a specific set of operations of related tasks to be performed,
either serially or in parallel (e.g., research and development, field sampling, analytical operations,
equipment fabrication) that, in total, result in a product or service.
Air Quality System (AQS)—The AQS, which is EPA's repository of ambient air quality data, stores
data from more than 10,000 monitors, 5,000 of which are currently active. SLT agencies collect
monitoring data and submit it to the AQS periodically.
American National Standards Institute (ANSI)—ANSI is the administrator and coordinator of the U.S.
private-sector voluntary standardization system.
American Society for Testing and Materials (ASTM)—The ASTM is a professional organization that
develops and distributes protocols for testing and provides reference standards.
ANSI/ASTM Class 1 and 2 standards—These are the standards for weighing operations with a
microbalance that is certified by their manufacturer as being in conformance with ASTM's standard
specification for laboratory weights and precision mass standards (E 617-9), particularly the Class 1 and 2
specifications. These standards are traceable to the National Institute of Standards and Technology
(NIST).
AQS Monitor ID—This is a 10-digit combination of the AQS Site ID and POC (see each in this
glossary) that together uniquely defines a specific air sampling monitor for a given pollutant.
AQS Site ID —This is a unique identifier for an AQS sampling site consisting of a 9-digit numeric code.
The AQS Site ID is frequently combined with the Parameter Occurrence Code (POC) (see POC in this
glossary) to provide a unique 10-digit monitor ID. The first nine digits uniquely identify each air
monitoring site (two-digit state code, three-digit county code, and four-digit site code). The tenth digit
(POC) identifies the monitor at that site. The state and county codes are Federal Information Processing
Standard (FIPS) codes. The four-digit site codes are assigned by the local agency, which may allocate
them in any way it chooses, as long as there is no duplication in the county. AQS Site IDs are associated
with a specific physical location and address. Any significant change in location will typically require a
new site ID.
Assessment—This term refers to the evaluation process that was used to measure the performance or
effectiveness of a quality system and various measurement phases of data operation. As used here,
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"assessment" is an all-inclusive term that is used to denote any of the following: an audit, a Performance
Evaluation (PE), a management systems review (MSR), peer review, inspection, or surveillance.
Audit (quality)—A systematic and independent examination to determine whether quality activities and
related results comply with planned arrangements and whether these arrangements are implemented
effectively and are suitable to achieve objectives.
Audit of Data Quality (ADQ)—A qualitative and quantitative evaluation of the documentation and
procedures associated with environmental measurements to verify that the resulting data are of acceptable
quality.
Authenticate—The act of establishing an item as genuine, valid, or authoritative.
Bias—The systematic or persistent distortion of a measurement process, which causes errors in one
direction (i.e., the expected sample measurement is different from the sample's true value).
Blank—A sample that is intended to contain none of the analytes of interest and is subjected to the usual
analytical or measurement process to establish a zero baseline or background value. A blank is sometimes
used to adjust or correct routine analytical results. A blank is used to detect contamination during sample
handling preparation and/or analysis.
Calibration drift—The deviation in instrument response from a reference value over a period of time
before recalibration.
Calibration—A comparison of a measurement standard, instrument, or item with a standard or
instrument of higher accuracy to detect and quantify inaccuracies and to report or eliminate those
inaccuracies by adjustments.
Cassette—A device that is supplied with PM2 5 samplers to allow a weighed Teflon® filter to be held in
place in the sampler and manipulated before and after sampling without touching the filter and to
minimize damage to the filter and/or sample during such activities.
Certification—The process of testing and evaluation against specifications designed to document, verify,
and recognize the competence of a person, organization, or other entity to perform a function or service,
usually for a specified time.
Chain of custody—An unbroken trail of accountability that ensures the physical security of samples,
data, and records.
Characteristic—Any property or attribute of a datum, item, process, or service that is distinct,
describable, and/or measurable.
Check standard—A standard that is prepared independently of the calibration standards and analyzed
exactly like the samples. Check standard results are used to estimate analytical precision and to indicate
the presence of bias due to the calibration of the analytical system.
Collocated samples—Two or more portions collected at the same point in time and space, so as to be
considered identical.
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Comparability—A measure of the confidence with which one data set or method can be compared to
another.
Completeness—A measure of the amount of valid data obtained from a measurement system compared
to the amount that was expected to be obtained under correct, normal conditions.
Conditioning environment—A specific range of temperature and relative humidity values in which
unexposed and exposed filters are to be conditioned for at least 24 hours immediately preceding their
gravimetric analysis.
Confidence interval—The numerical interval constructed around a point estimate of a population
parameter, combined with a probability statement (the confidence coefficient) linking it to the
population's true parameter value. If the same confidence interval construction technique and
assumptions are used to calculate future intervals, then they will include the unknown population
parameter with the same specified probability.
Confidentiality procedure—A procedure that is used to protect confidential business information
(including proprietary data and personnel records) from unauthorized access.
Configuration—The functional, physical, and procedural characteristics of an item, experiment, or
document.
Conformance—An affirmative indication or judgment that a product or service has met the requirements
of the relevant specification, contract, or regulation; also, the state of meeting the requirements.
Consensus standard—A standard established by a group representing a cross section of a specific
industry or trade, or a part thereof.
Contractor—Any organization or individual contracting to furnish services or items or to perform work.
Control chart—A graphical presentation of quality control (QC) information over a period of time. If a
procedure is "in control," the results usually fall within established control limits. The chart is useful in
detecting defective performance and abnormal trends or cycles, which can then be corrected promptly.
Corrective action—Any measures taken to rectify conditions adverse to quality and, where possible, to
preclude their recurrence.
Correlation coefficient—A number between -1 and 1 that indicates the degree of linearity between two
variables or sets of numbers. The closer to -1 or +1, the stronger the linear relationship between the two
(i.e., the better the correlation). Values close to zero suggest no correlation between the two variables.
The most common correlation coefficient is the product-moment, which is a measure of the degree of
linear relationship between two variables.
Data of known quality—Data that have the qualitative and quantitative components associated with their
derivation documented appropriately for their intended use; documentation is verifiable and defensible.
Data Quality Assessment (DQA)—The scientific and statistical evaluation of data to determine if data
obtained from environmental operations are of the right type, quality, and quantity to support their
intended use. The five steps of the DQA process include: 1) reviewing the Data Quality Objectives
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(DQOs) and sampling design, 2) conducting a preliminary data review, 3) selecting the statistical test, 4)
verifying the assumptions of the statistical test, and 5) drawing conclusions from the data.
Data Quality Indicators (DQIs)—The quantitative statistics and qualitative descriptors that are used to
interpret the degree of acceptability or utility of data to the user. The principal data quality indicators are
bias, precision, and accuracy (bias is preferred); comparability; completeness; and representativeness.
Data Quality Objectives (DQO) Process—A systematic planning tool to facilitate the planning of
environmental data collection activities. DQOs are the qualitative and quantitative outputs from the DQO
process.
Data Quality Objectives (DQOs)—The qualitative and quantitative statements derived from the DQO
process that clarify a study's technical and quality objectives, define the appropriate type of data, and
specify tolerable levels of potential decision errors that will be used as the basis for establishing the
quality and quantity of data needed to support decisions.
Data reduction—The process of transforming the number of data items by arithmetic or statistical
calculations, standard curves, and concentration factors and collating them into a more useful form. Data
reduction is irreversible and generally results in a reduced data set and an associated loss of detail.
Data usability—The process of ensuring or determining whether the quality of the data produced meets
the intended use of the data.
Deficiency—An unauthorized deviation from acceptable procedures or practices or a defect in an item.
Demonstrated capability—The capability to meet a procurement's technical and quality specifications
through evidence presented by the supplier to substantiate its claims and in a manner defined by the
customer.
Design change—Any revision or alteration of the technical requirements defined by approved and issued
design output documents and by approved and issued changes thereto.
Design review—A documented evaluation by a team, including personnel such as the responsible
designers, the client for whom the work or product is being designed, and a quality assurance (QA)
representative, but excluding the original designers, to determine if a proposed design will meet the
established design criteria and perform as expected when implemented.
Design—The design refers to specifications, drawings, design criteria, and performance requirements, as
well as the result of deliberate planning, analysis, mathematical manipulations, and design processes.
Detection limit (DL)—A measure of the capability of an analytical method to distinguish samples that do
not contain a specific analyte from samples that contain low concentrations of the analyte; the lowest
concentration or amount of the target analyte that can be determined to be different from zero by a single
measurement at a stated level of probability. DLs are analyte and matrix specific and may be laboratory
dependent.
Distribution—This term refers to 1) the appointment of an environmental contaminant at a point over
time, over an area, or within a volume; and 2) a probability function (density function, mass function, or
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distribution function) used to describe a set of observations (statistical sample) or a population from
which the observations are generated.
Document control—The policies and procedures used by an organization to ensure that its documents
and their revisions are proposed, reviewed, approved for release, inventoried, distributed, archived,
stored, and retrieved in accordance with the organization's requirements.
Document—Any written or pictorial information describing, defining, specifying, reporting, or certifying
activities, requirements, procedures, or results.
Dry-bulb temperature—The actual temperature of the air, which is used for comparison with the wet-
bulb temperature.
Duplicate samples—Two samples taken from and representative of the same population and carried
through all steps of the sampling and analytical procedures in an identical manner. Duplicate samples are
used to assess variance of the total method, including sampling and analysis (see also collocated
samples).
Electrostatic charge buildup—A buildup of static electrical charge on an item, such as the PM2 5 filter,
which makes it difficult to handle, attracts or repels particles, and can influence its proper weighing.
Environmental conditions—The description of a physical medium (e.g., air, water, soil, sediment) or a
biological system expressed in terms of its physical, chemical, radiological, or biological characteristics.
Environmental data operations—Any work performed to obtain, use, or report information pertaining
to environmental processes and conditions.
Environmental data—Any parameters or pieces of information collected or produced from
measurements, analyses, or models of environmental processes, conditions, and effects of pollutants on
human health and the environment, including results from laboratory analyses or from experimental
systems representing such processes and conditions.
Environmental monitoring—The process of measuring or collecting environmental data.
Environmental processes—Any manufactured or natural processes that produce discharges to, or that
impact, the ambient environment.
Environmental programs—An all-inclusive term that pertains to any work or activities involving the
environment, including but not limited to, the characterization of environmental processes and conditions;
environmental monitoring; environmental research and development; the design, construction, and
operation of environmental technologies; and laboratory operations on environmental samples.
Environmental technology—An all-inclusive term used to describe pollution control devices and
systems, waste treatment processes and storage facilities, and site remediation technologies and their
components that may be used to remove pollutants or contaminants from, or to prevent them from
entering, the environment. Examples include wet scrubbers (air), soil washing (soil), granulated activated
carbon unit (water), and filtration (air, water). Usually, this term applies to hardware-based systems;
however, it can also apply to methods or techniques used for pollution prevention, pollutant reduction, or
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containment of contamination to prevent further movement of the contaminants, such as capping,
solidification or vitrification, and biological treatment.
Equilibration chamber—A clean chamber that is usually constructed of plastic or glass, held at near
constant temperature and relative humidity, and is used to store and condition PM2 5 filters until they and
their collected particulate sample (if the filters have been exposed) have reached a steady state of moisture
equilibration.
Estimate—A characteristic from the sample from which inferences on parameters can be made.
Evidentiary records—Any records identified as part of litigation and subject to restricted access,
custody, use, and disposal.
Expedited change—An abbreviated method of revising a document at the work location where the
document is used when the normal change process would cause unnecessary or intolerable delay in the
work.
Field (matrix) spike—A sample prepared at the sampling point (i.e., in the field) by adding a known
mass of the target analyte to a specified amount of the sample. Field matrix spikes are used, for example,
to determine the effect of the sample preservation, shipment, storage, and preparation on analyte recovery
efficiency (the analytical bias).
Field blank filter—New, randomly selected filters that are weighed at the same time that pre-sampling
weights are determined for a set of PM2 5 filters and used for QA purposes. These field blank filters are
transported to the sampling site in the same manner as the filter(s) intended for sampling, installed in the
sampler, removed from the sampler without sampling, stored in their protective containers inside the
sampler's case at the sampling site until the corresponding exposed filter(s) is (are) retrieved, and returned
for post-sampling weighing in the laboratory, where they are handled in the same way as an actual sample
filter and reweighed as a QC check to detect weight changes due to filter handling.
Field blank—A blank that provides information about contaminants that may be introduced during
sample collection, storage, and transport. A clean sample is carried to the sampling site, exposed to
sampling conditions, returned to the laboratory, and treated as an environmental sample.
Field Scientist—An individual that conducts PM2 5-PEP sampling events and other field activities. This
individual could be an EPA contractor staff, EPA Regional staff, or and independent field staff reporting
to SLT agencies self-implementing the PM2 5-PEP.
Field split samples—Two or more representative portions taken from the same sample and submitted for
analysis to different laboratories to estimate inter-laboratory precision.
Filter chamber assembly—As shown in Figures 5.6 and 5.7 in the PM2 5-PEP Field SOP, this is
referencing the mechanism in the interior of the BGI main unit. This assembly contains the WINS
impactor assembly in the upper half and the filter cassette or holder assembly in the lower half.
Financial assistance—The process by which funds are provided by one organization (usually
governmental) to another organization for the purpose of performing work or furnishing services or items.
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Financial assistance mechanisms include grants, cooperative agreements, and governmental interagency
agreements.
Finding—An assessment conclusion that identifies a condition having a significant effect on an item or
activity. An assessment finding may be positive or negative, and is normally accompanied by specific
examples of the observed condition.
Goodness-of-fit test—The application of the chi square distribution in comparing the frequency
distribution of a statistic observed in a sample with the expected frequency distribution based on some
theoretical model.
Graded approach—The process of basing the level of application of managerial controls applied to an
item or work according to the intended use of the results and the degree of confidence needed in the
quality of the results (see also Data Quality Objectives (DQO) Process).
Grade—The category or rank given to entities having the same functional use but different requirements
for quality.
Guidance—A suggested practice that is not mandatory; it is intended to be an aid or example in
complying with a standard or requirement.
Guideline—A suggested practice that is not mandatory in programs intended to comply with a standard.
Hazardous waste—Any waste material that satisfies the definition of hazardous waste given in 40 CFR
261, Identification and Listing of Hazardous Waste.
High-efficiency particulate air (HEPA) filter—A HEPA filter is an extended-media, dry-type filter
with a minimum collection efficiency of 99.97% when tested with an aerosol of essentially monodisperse
0.3-^m particles.
Holding time—The period of time a sample may be stored prior to its required analysis. Although
exceeding the holding time does not necessarily negate the veracity of analytical results, it causes the
qualifying or "flagging" of any data not meeting all of the specified acceptance criteria.
Identification error—The misidentification of an analyte. In this error type, the contaminant of concern
is unidentified and the measured concentration is incorrectly assigned to another contaminant.
Independent assessment—An assessment that is performed by a qualified individual, group, or
organization that is not a part of the organization directly performing and accountable for the work being
assessed.
Inspection—The examination or measurement of an item or activity to verify conformance to specific
requirements.
Internal standard—A standard added to a test portion of a sample in a known amount and carried
through the entire determination procedure as a reference for calibrating and controlling the precision and
bias of the applied analytical method.
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Item—An all-inclusive term that is used in place of the following: appurtenance, facility, sample,
assembly, component, equipment, material, module, part, product, structure, subassembly, subsystem,
system, unit, documented concepts, or data.
Laboratory Analyst—A staff member who weighs the new and used filters and computes the
concentration of PM2 5 in «g/m3.
Laboratory blank filters—New filters that are weighed at the time of determination of the presampling
(tare) weight of each set of PM2 5 filters intended for field use. These laboratory blank filters remain in the
laboratory in protective containers during the field sampling and are reweighed in each weighing session
as a QC check.
Laboratory split samples—Two or more representative portions taken from the same sample and
analyzed by different laboratories to estimate the inter-laboratory precision or variability and the data
comparability.
Limit of quantitation—The minimum concentration of an analyte or category of analytes in a specific
matrix that can be identified and quantified above the method detection limit and within specified limits
of precision and bias during routine analytical operating conditions.
Local Standard Time—The time used in the geographic location of the sample site that is set to standard
time. Standard time is used in the Federal Reference Method (FRM) program to match continuous
instruments to filter-based instruments. During the winter months, all areas of the country use standard
time; however, in the summer months, some areas may go to Daylight Saving Time (1 hour ahead of
standard time).
Management system—A structured, nontechnical system describing the policies, objectives, principles,
organizational authority, responsibilities, accountability, and implementation plan of an organization for
conducting work and producing items and services.
Management Systems Review (MSR)—The qualitative assessment of a data collection operation and/or
organization(s) to establish whether the prevailing quality management structure, policies, practices, and
procedures are adequate for ensuring that the type and quality of data needed are obtained.
Management—Those individuals who are directly responsible and accountable for planning,
implementing, and assessing work.
Mass reference standard—The NIST-traceable weighing standards, generally in the range of weights
expected for the filters.
Matrix spike—A sample that is prepared by adding a known mass of a target analyte to a specified
amount of matrix sample for which an independent estimate of the target analyte concentration is
available. Spiked samples are used, for example, to determine the effect of the matrix on a method's
recovery efficiency.
May—When used in a sentence, this term denotes permission but not a necessity.
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Mean (arithmetic)—The sum of all the values of a set of measurements divided by the number of values
in the set; a measure of central tendency.
Mean squared error—A statistical term for variance added to the square of the bias.
Measurement and Testing Equipment (M&TE)—Tools, gauges, instruments, sampling devices, or
systems used to calibrate, measure, test, or inspect to control or acquire data to verify conformance to
specified requirements.
Memory effects error—The effect that a relatively high concentration sample has on the measurement of
a lower concentration sample of the same analyte when the higher concentration sample precedes the
lower concentration sample in the same analytical instrument.
Method blank—A blank that is prepared to represent the sample matrix as closely as possible and
analyzed exactly like the calibration standards, samples, and QC samples. Results of method blanks
provide an estimate of the within-batch variability of the blank response and an indication of bias
introduced by the analytical procedure.
Method—A body of procedures and techniques for performing an activity (e.g., sampling, chemical
analysis, quantification), systematically presented in the order in which they are to be executed.
Microbalance—A type of analytical balance that can weigh to the nearest 0.001 ug (i.e., one microgram,
or one-millionth of a gram).
Mid-range check—A standard used to establish whether the middle of a measurement method's
calibrated range is still within specifications.
Mixed waste—A hazardous waste material as defined by 40 CFR 261 and the Resource Conservation
and Recovery Act (RCRA) and mixed with radioactive waste subject to the requirements of the Atomic
Energy Act.
Must—When used in a sentence, this term denotes a requirement that has to be met.
Nonconformance—A deficiency in a characteristic, documentation, or procedure that renders the quality
of an item or activity unacceptable or indeterminate; nonfulfillment of a specified requirement.
Objective evidence—Any documented statement of fact, other information, or record, either quantitative
or qualitative, pertaining to the quality of an item or activity, based on observations, measurements, or
tests that can be verified.
Observation—An assessment conclusion that identifies a condition (either positive or negative) that does
not represent a significant impact on an item or activity. An observation may identify a condition that has
not yet caused a degradation of quality.
Organization structure—The responsibilities, authorities, and relationships, arranged in a pattern,
through which an organization performs its functions.
Organization—A company, corporation, firm, enterprise, or institution, or part thereof, whether
incorporated or not, public or private, that has its own functions and administration.
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Outlier—An extreme observation that is shown to have a low probability of belonging to a specified data
population.
Parameter—A quantity, usually unknown, such as a mean or a standard deviation characterizing a
population. Commonly misused for "variable," "characteristic," or "property."
Peer review—A documented, critical review of work generally beyond the state of the art or
characterized by the existence of potential uncertainty. Conducted by qualified individuals (or an
organization) who are independent of those who performed the work but collectively equivalent in
technical expertise (i.e., peers) to those who performed the original work. Peer reviews are conducted to
ensure that activities are technically adequate, competently performed, properly documented, and satisfy
established technical and quality requirements. An in-depth assessment of the assumptions, calculations,
extrapolations, alternate interpretations, methodology, acceptance criteria, and conclusions pertaining to
specific work and of the documentation that supports them. Peer reviews provide an evaluation of a
subject where quantitative methods of analysis or measures of success are unavailable or undefined, such
as in research and development.
Performance Evaluation (PE)—A type of audit in which the quantitative data generated in a
measurement system are obtained independently and compared with routinely obtained data to evaluate
the proficiency of an analyst or laboratory.
PM2.5 —Particulate matter (suspended in the atmosphere) having an aerodynamic diameter less than or
equal to a nominal 2.5 um. as measured by a reference method based on 40 CFR Part 50, Appendix L,
and designated in accordance with 40 CFR Part 53.
PM2.5 sampler—A sampler that is used for monitoring PM2 5 in the atmosphere that collects a sample of
particulate matter from the air based on principles of inertial separation and filtration. The sampler also
maintains a constant sample flow rate and may record the actual flow rate and the total volume sampled.
PM25 mass concentration is calculated as the weight of the filter catch divided by the sampled volume. A
sampler cannot calculate PM2 5 concentration directly.
POC (Parameter Occurrence Code)—A one-digit identifier used in AQS (see both defined in this
glossary) to distinguish between multiple monitors at the same site that are measuring the same parameter
(e.g., pollutant). For example, if two different samplers both measure PM2 5, then one may be assigned a
POC of 1 and the other a POC of 2. Note that replacement samplers are typically given the POC of the
sampler that they replaced, even if the replacement is of a different model or type.
Pollution prevention—An organized, comprehensive effort to systematically reduce or eliminate
pollutants or contaminants prior to their generation or their release or discharge into the environment.
Polonium-210 (210Po) antistatic strip—A device that contains a small amount of 210Po that emits a
particles (He2+) that neutralize the static charge on filters, making them easier to handle and their weights
more accurate.
Polytetrafluoroethylene (PTFE)—Also known as Teflon, this is a polymer that is used to manufacture
the 46.2-mm diameter filters for PM2 5 FRM and Federal Equivalent Method (FEM) samplers.
Population—The totality of items or units of material under consideration or study.
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Precision—A measure of mutual agreement among individual measurements of the same property,
usually under prescribed similar conditions expressed generally in terms of the standard deviation.
Procedure—A specified way to perform an activity.
Process—A set of interrelated resources and activities that transforms inputs into outputs. Examples of
processes include analysis, design, data collection, operation, fabrication, and calculation.
Project—An organized set of activities within a program.
Qualified data—Any data that have been modified or adjusted as part of statistical or mathematical
evaluation, data validation, or data verification operations.
Qualified services—An indication that suppliers providing services have been evaluated and determined
to meet the technical and quality requirements of the client as provided by approved procurement
documents and demonstrated by the supplier to the client's satisfaction.
Quality Assurance (QA) Supervisor or Coordinator—A staff member who assists in preparation of the
reporting organization's quality plan, makes recommendations to management on quality issues
(including training), oversees the quality system's control and audit components, and reports the results.
Quality assurance (QA)—An integrated system of management activities involving planning,
implementation, assessment, reporting, and quality improvement to ensure that a process, item, or service
is of the type and quality needed and expected by the client.
Quality Assurance Program Description/Plan—See Quality Management Plan.
Quality Assurance Project Plan (QAPP)—A formal document that describes in comprehensive detail
the necessary QA, QC, and other technical activities that must be implemented to ensure that the results
of the work performed will satisfy the stated performance criteria. The QAPP components are divided
into the following four classes: 1) Project Management, 2) Measurement/Data Acquisition, 3)
Assessment/Oversight, and 4) Data Validation and Usability. Guidance and requirements on preparation
of QAPPs can be found in EPA, Requirements for Quality Assurance Project Plans, EPA QA/R-5 and
Guidance for Quality Assurance Project Plans, EPA QA/G-5.
Quality control (QC) sample—An uncontaminated sample matrix that is spiked with known amounts of
analytes from a source independent of the calibration standards. This type of sample is generally used to
establish intra-laboratory or analyst-specific precision and bias or to assess the performance of all or a
portion of the measurement system.
Quality control (QC)—The overall system of technical activities that measures the attributes and
performance of a process, item, or service against defined standards to verify that they meet the stated
requirements established by the customer; operational techniques and activities that are used to fulfill
requirements for quality. The system of activities and checks used to ensure that measurement systems are
maintained within prescribed limits, providing protection against "out of control" conditions and ensuring
the results are of acceptable quality.
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Quality improvement—A management program for improving the quality of operations. Such
management programs generally entail a formal mechanism for encouraging worker recommendations
with timely management evaluation and feedback or implementation.
Quality management—That aspect of the overall management system of the organization that
determines and implements the quality policy. Quality management includes strategic planning, allocation
of resources, and other systematic activities (e.g., planning, implementation, and assessment) pertaining to
the quality system.
Quality system—A structured and documented management system that describes the policies,
objectives, principles, organizational authority, responsibilities, accountability, and implementation plan
of an organization for ensuring quality in its work processes, products (items), and services. The quality
system provides the framework for planning, implementing, and assessing work performed by the
organization and for carrying out required QA and QC.
Quality—The totality of features and characteristics of a product or service that bears on its ability to
meet the stated or implied needs and expectations of the user.
Radioactive waste—This refers to waste material that contains or is contaminated by radionuclides and is
subject to the requirements of the Atomic Energy Act.
Readability—The smallest difference between two measured values that can be read on the microbalance
display. The term "resolution" is a commonly used synonym.
Readiness review—A systematic, documented review of the readiness for the startup or continued use of
a facility, process, or activity. Readiness reviews are typically conducted before proceeding beyond
program milestones and prior to initiation of a major phase of work.
Record (quality)—A document that furnishes objective evidence of the quality of items or activities and
that has been verified and authenticated as technically complete and correct. Records may include
photographs, drawings, magnetic tape, and other data recording media.
Records schedule—This schedule constitutes EPA's official policy on how long to keep Agency records
(retention) and what to do with them afterwards (disposition). For more information, refer to
http://www.epa.gov/records/policy/schedule on EPA's Web site or see file plan.
Recovery—The act of determining whether the methodology measures all of the analyte contained in a
sample.
Remediation—The process of reducing the concentration of a contaminant (or contaminants) in air,
water, or soil media to a level that poses an acceptable risk to human health.
Repeatability—This refers to a measure of the ability of a microbalance to display the same result in
repetitive weighings of the same mass under the same measurement conditions. The term "precision" is
sometimes used as a synonym. Repeatability also refers to the degree of agreement between independent
test results produced by the same analyst, using the same test method and equipment on random aliquots
of the same sample within a short time period.
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Reporting limit—The lowest concentration or amount of the target analyte required to be reported from a
data collection project. Reporting limits are generally greater than detection limits and are usually not
associated with a probability level.
Representativeness—A measure of the degree to which data accurately and precisely represent a
characteristic of a population, a parameter variation at a sampling point, a process condition, or an
environmental condition.
Reproducibility—The precision, usually expressed as variance, that measures the variability among the
results of measurements of the same sample at different laboratories.
Requirement—A formal statement of a need and the expected manner in which it is to be met.
Research (applied)—A process, the objective of which is to gain the knowledge or understanding
necessary for determining the means by which a recognized and specific need may be met.
Research (basic)—A process, the objective of which is to gain fuller knowledge or understanding of the
fundamental aspects of phenomena and of observable facts without specific applications toward processes
or products in mind.
Research development/demonstration—The systematic use of the knowledge and understanding gained
from research and directed toward the production of useful materials, devices, systems, or methods,
including prototypes and processes.
Round-robin study—A method validation study involving a predetermined number of laboratories or
analysts, all analyzing the same sample(s) by the same method. In a round-robin study, all results are
compared and used to develop summary statistics such as inter-laboratory precision and method bias or
recovery efficiency.
Ruggedness study—The carefully ordered testing of an analytical method while making slight variations
in test conditions (as might be expected in routine use) to determine how such variations affect test
results. If a variation affects the results significantly, the method restrictions are tightened to minimize
this variability.
Scientific method—The principles and processes regarded as necessary for scientific investigation,
including rules for concept or hypothesis formulation, conduct of experiments, and validation of
hypotheses by analysis of observations.
Self-assessment—The assessments of work conducted by individuals, groups, or organizations directly
responsible for overseeing and/or performing the work.
Sensitivity—The capability of a method or instrument to discriminate between measurement responses
representing different levels of a variable of interest.
Service—The result generated by activities at the interface between the supplier and the customer, and
the supplier internal activities to meet customer needs. Such activities in environmental programs include
design, inspection, laboratory and/or field analysis, repair, and installation.
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Shall—A term that denotes a requirement is mandatory whenever the criterion for conformance with the
specification permits no deviation. This term does not prohibit the use of alternative approaches or
methods for implementing the specification so long as the requirement is fulfilled.
Should—A term that denotes a guideline or recommendation whenever noncompliance with the
specification is permissible.
Significant condition—Any state, status, incident, or situation of an environmental process or condition,
or environmental technology in which the work being performed will be adversely affected sufficiently to
require corrective action to satisfy quality objectives or specifications and safety requirements.
Software life cycle—The period of time that starts when a software product is conceived and ends when
the software product is no longer available for routine use. The software life cycle typically includes a
requirement phase, a design phase, an implementation phase, a test phase, an installation and check-out
phase, an operation and maintenance phase, and sometimes a retirement phase.
Source reduction—Any practice that reduces the quantity of hazardous substances, contaminants, or
pollutants.
Span check—A standard used to establish that a measurement method is not deviating from its calibrated
range.
Specification—A document that states requirements and refers to or includes drawings or other relevant
documents. Specifications should indicate the means and criteria for determining conformance.
Spike—A substance that is added to an environmental sample to increase the concentration of target
analytes by known amounts. Spikes are used to assess measurement accuracy (spike recovery), whereas
spike duplicates are used to assess measurement precision.
Split samples—Two or more representative portions taken from one sample in the field or in the
laboratory and analyzed by different analysts or laboratories. Split samples are QC samples that are used
to assess analytical variability and comparability.
Standard deviation—A measure of the dispersion or imprecision of a sample or population distribution
expressed as the positive square root of the variance and having the same unit of measurement as the
mean.
Standard Operating Procedure (SOP)—A written document that details the method for an operation,
analysis, or action with thoroughly prescribed techniques and steps and that is officially approved as the
method for performing certain routine or repetitive tasks.
Supplier—Any individual or organization furnishing items or services or performing work according to a
procurement document or a financial assistance agreement. An all-inclusive term used in place of any of
the following: vendor, seller, contractor, subcontractor, fabricator, or consultant.
Surrogate spike or analyte—A pure substance with properties that mimic the analyte of interest. It is
unlikely to be found in environmental samples and is added to them to establish that the analytical method
has been performed properly.
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Surveillance (quality)—Continual or frequent monitoring and verification of the status of an entity and
the analysis of records to ensure that specified requirements are being fulfilled.
Technical review—A documented critical review of work that has been performed within the state of the
art. The review is accomplished by one or more qualified reviewers who are independent of those who
performed the work, but are collectively equivalent in technical expertise to those who performed the
original work. The review is an in-depth analysis and evaluation of documents, activities, material, data,
or items that require technical verification or validation for applicability, correctness, adequacy,
completeness, and assurance that established requirements have been satisfied.
Technical Systems Audit (TSA)—A thorough, systematic, on-site qualitative audit of facilities,
equipment, personnel, training, procedures, recordkeeping, data validation, data management, and
reporting aspects of a system.
Traceability—This term refers to the ability to trace the history, application, or location of an entity by
means of recorded identifications. In a calibration sense, traceability relates measuring equipment to
national or international standards, primary standards, basic physical constants or properties, or reference
materials. In a data collection sense, it relates calculations and data generated throughout the program
back to the requirements for the quality of the program. This term also refers to the property of the result
of a measurement or the value of a standard whereby it can be related to stated references, usually
national or international standards, through an unbroken chain of comparisons, all having stated
uncertainties. Many QA programs demand traceability of standards to a national standard. In most cases
this can be achieved through a standard traceable to NIST.
Trip blank—A clean sample of a matrix that is taken to the sampling site and transported to the
laboratory for analysis without having been exposed to sampling procedures.
Validation—Confirmation by examination and provision of objective evidence that the specific
requirements for a specific intended use have been fulfilled. In design and development, validation refers
to the process of examining a product or result to determine conformance to user needs.
Variance (statistical)—A measure or dispersion of a sample or population distribution. Population
variance is the sum of squares of deviation from the mean divided by the population size (number of
Sections). Sample variance is the sum of squares of deviations from the mean divided by the degrees of
freedom (number of observations minus one).
Verification—Confirmation by examination and provision of objective evidence that specified
requirements have been fulfilled. In design and development, verification refers to the process of
examining a result of a given activity to determine conformance to the stated requirements for that
activity.
Wet-bulb temperature—The temperature of the wet-bulb thermometer at equilibrium with a constant
flow of ambient air at a rate of from 2.5 meters to 10.0 meters per second.
Wet-bulb thermometer—A thermometer with a muslin-covered bulb, which is moistened and used to
measure the wet-bulb temperature.
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Will—A term that denotes a requirement is mandatory whenever the criterion for conformance with the
specification permits no deviation. This term does not prohibit the use of alternative approaches or
methods for implementing the specification so long as the requirement is fulfilled.
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Appendix B
Data Qualifiers/Flags
A sample qualifier or a result qualifier consists of three alphanumeric characters which act as an indicator
of the fact and the reason that the subject analysis (1) did not produce a numeric result; (2) produced a
numeric result, but it is qualified in some respect relating to the type or validity of the result; or (3)
produced a numeric result, but for administrative reasons, it is not to be reported outside the laboratory.
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Field Qualifiers
Code
Definition
Description
CON
Contamination
Contamination, including observations of insects or other
debris
DAM
Filter damage
Filter appeared damaged
EST -
Elapsed sample
time
Elapsed sample time out of specification
EVT
Event
Exceptional event expected to have effected sample (e.g.,
dust, fire, spraying)
FAC
Field accident
An accident in the field occurred that either destroyed the
sample or rendered it not suitable for analysis
FLR a
Flow rate
Flow rate, 5-minute average out of specification
FLT a
Filter temperature
Filter temperature differential, 30-minute interval out of
specification
FMC
Failed multipoint
calibration
verification
Failed the initial multipoint calibration verification
FPC
Failed pressure
check
Barometric pressure check out of specification
FSC
Failed single-point
calibration
verification
Failed the initial single-point calibration verification
FVL
Flow volume
Flow volume suspect
GFI
Good filter integrity
Filter integrity, upon post-sampling field inspection looks
good
LEK
Leak suspected
Internal/external leak suspected
SDM
Sampler damaged
Sampler appears to be damaged which may have affected
filter
a Flag generated by sampling equipment
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Laboratory Qualifiers
Code
Definition
Description
ALT
Alternate
measurement
Subject parameter determined by using an alternate
measurement method; value believed to be accurate but
could be suspect
AVG
Average value
Average value (used to report a range of values)
BDL
Below detectable
limits
There was not a sufficient concentration of the parameter
in the sample to exceed the lower detection limit in force
at the time the analysis was performed. Numeric results
field, if present is at best, an approximate value.
BLQ
Below limit of
quantitation
The sample was considered above the detection limit but
there was not a sufficient concentration of the parameter
in the sample to exceed the lower quantitation limit in
force at the time the analysis was performed
CAN
Canceled
Analysis of this parameter was canceled and not
performed
CBC
Cannot be calculated
Calculated analysis result cannot be calculated because an
operand value is qualified
EER
Entry error
The recorded value is known to be incorrect but the
correct value cannot be determined to enter a correction.
FBK
Found in blank
The subject parameter had a measurable value above the
established QC limit when a blank was analyzed using the
same equipment and analytical method. Therefore, the
reported value may be erroneous.
FCS
Failed collocated
sample
Collocated sample exceeded acceptance criteria limits
FFB
Failed field blank
Field blank samples exceeded acceptance criteria limits
FIS
Failed internal
standard
Internal standards exceeded acceptance criteria limits
FLB
Failed laboratory
blank
Laboratory blank samples exceeded acceptance criteria
limits
FLD
Failed laboratory
duplicate
Laboratory duplicate samples exceeded acceptance criteria
limits
FLH
Failed laboratory
humidity
Laboratory humidity exceeded acceptance criteria limits
FLT
Failed laboratory
temperature
Laboratory temperature exceeded acceptance criteria
limits
FQC
Failed quality control
The analysis result is not reliable because quality control
criteria were exceeded when the analysis was conducted;
numeric field, if present, is estimated value.
FTB
Failed trip blank
Trip blank sample exceeded acceptance criteria limits
GSI
Good shipping
integrity
Integrity of filter upon receipt by shipping/receiving
looked good
HTE
Holding time exceeded
Filter holding time exceeded acceptance criteria limits
ISP
Improper sample
preservation
Due to improper preservation of the sample, it was
rendered not suitable for analysis
INV
Invalid sample
Due to single or a number or flags or events, the sample
was determined to be invalid.
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Code
Definition
Description
LAC
Laboratory accident
There was an accident in the laboratory that either
destroyed the sample or rendered it not suitable for
analysis.
LLS
Less than lower
standard
The analysis value is less than the lower quality control
standard.
LTC
Less than criteria of
detection
Value reported is less than the criteria of detection
NAR
No analysis result
There is no analysis result required for this subject
parameter
REJ
Rejected
The analysis results have been rejected for an unspecified
reason by the laboratory. For any results where a mean is
being determined, these data were not used to calculate
the mean.
REQ
Re-que for re-analysis
The analysis is not approved and must be re-analyzed
using a different method.
RET
Return(ed) for re-
analysis
The analysis result is not approved by laboratory
management and re-analysis is required by the bench
analyst with no change in the method.
RIN
Re-analyzed
The indicated analysis results were generated from a re-
analysis
STD
Internal standard
The subject parameter is being used as an internal
standard for other subject parameters in the sample. There
is no analysis result report, although the theoretical and/or
limit value(s) may be present
UND
Analyzed but
undetected
Indicates material was analyzed for but not detect
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Appendix C
Validation Template used by the PED in the first level Validation Algorithm
Figure C-l below is a two-page validation template from in the PED application that is filled
with critical and non-critical criteria that are compiled through the collection of field and
laboratory data. The PM2.5-PEP Laboratory Manager and EPA Laboratory Task Monitor use this
form to assist in validating data.
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PM2.5 Performance Evaluations
Record Last Changed:
PE Filter ID:
Distance from AQS Lat/long (m):
AIRS Site Code:
Sampler ID:
POC:
Site Name
AQS Site Addr:
AQS Site Name:
Fitter Lot:
Sampler Serial No.:
Audited By:
PE Cassette ID:
Companion Filter
Sampler Model:
Companion Cassette:
Secondary Separator Type:
PE Run Time
PE Start Date
Elapsed Time (days)
PE Stop Date
Filter Removed Date
Sample Flow/Volume
Flow Avg (Umin)
Flow CV
Sample Vol. (ms)
Concentration
Measured by PE Sampler (|jg/m3):
Measured by Site (pg/m3):
Percent Difference:
Field Hag:
Comment:
Ambient Sample Temperature (°C) Barometric Pressure (mm Hg)
Average:
Minimum:
Maximum:
Average:
Minimum:
Maximum:
Out of Spec.
Time
Temperature
Flow
~
~
~
Field Verifications
BP:
~
Temperature:
n
Row:
~
Field Blank
Cassette ID
Filter ID
Pre- Wt. (mg)
Post- Wt. (mg)
Wt. Change (mg)
Trip Blank
Cassette ID
Filter ID
Pre- Wt. (mg)
Post- Wt. (mg)
Wt. Change (mg)
Lab Blank
Cassette ID
Filter ID
Pre- Wt. (mg)
Post- Wt. (mg)
Wt. Change (mg)
Collocated Samplers
Col located
~
Count
Std. Dev.
Mean
Max CV (%)
Pre-sample (Unexposed)
Post-sample (Exposed)
Pre/Post
Weigh Sessions
Equilibration Tray:
Equilibration Time (hours):
Weigh Session ID:
(Sample
Mass)
Holding Time (days):
Filter Weight (mg):
Weighing Room Conditions
Avg. Temperature (°C):
Temp. Std. Dev. (°C):
(RH Diff.)
Avg. Relative Humidity (%):
RH Std. Dev. (%):
Batch Duplicates
Filter ID:
Primary Weight (mg):
Duplicate Weight (mg):
Weight Change (mg):
Low Mass Balance Checks
Verified Weight (mg):
(Max.
Overall
Minimum Weight (mg):
Maximum Weight (mg)
Wt. Diff.)
Maximum Wt. Diff. (mg)
High Mass Balance Checks
Verified Weight (mg):
(Max.
Overall
Minimum Weight (mg):
Maximum Weight (mg):
Wt. Diff.)
Maximum Wt. Diff. (mg):
Lab Approval
Valid Data: ~
PE Rejected: Q
Complete: P
Page 1 of 2
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PM2.5 Performance Evaluations Record Last Changed:
PE Filter ID: AIRS Site Code: P°<=: Site Name
Distance from AQS Lat/long (m): Sampler ID: AQS Site Addr:
AQS Site Name:
Quality Control Checks
Check Date:
Check
Auto QC
Override
ID Code
Description
Check Value Pass
Fail
Pass Fail Comment
Critical criteria
3 points per failure, if not overridden
1 DAM
no filter damage (visual defect)
~
~
~
~
2 EST
sample period 1380-1500 min
min
~
~
~
~
3 FLR1
flow rate <= ± 5% of 16.67 Limin
L/min
~
~
~
~
4 FLR_2
flow rate <= 2% CV
~
~
~
~
5 FVL
no flow rate excursions > ± 5% for >5 min
~
~
~
~
6 HTE_1
sample recovery <= 96 hours from sample end date
hours
~
~
~
~
7 HTE_2
post-sample weighing <=10 days at 25 deg C or <= 30 days
at 4 deg C
days, deg C
(cold pack: )
~
~
~
~
8 ISP_1
pre-sample minimum 24 hour equilibration
hours
~
~
~
~
9 1SP_2
pre-sample mean temperature 20-23 degrees C
degrees C
~
~
~
~
10 !SP_3
pre-sample temperature control ± 2 degrees C over 24 hours
degrees C
~
~
~
~
11 ISP_4
pre-sample mean RH 30-40%
percent
~
~
~
~
12 ISP5
pre-sample RH SD control ± 5%
percent
~
~
~
~
13 fSP_6
post-sample minimum 24 hour equilibration
hours
~
~
~
~
14 ISP7
post-sample mean temperature 20-23 degrees C
degrees C
~
~
~
~
15 ISP_8
post-sample temperature control ± 2 degrees C over 24 hours
degrees C
~
~
~
n
16 1SP_9
post-sample mean RH 30-40%
percent
~
~
~
~
17 ISPJO
post-sample RH SD control ± 5%
percent
~
~
~
~
18 ISP_11
pre/post sample RH ± 5%
percent
~
~
~
~
Sample batch validation with major and minor flags
3 points per failure, if not overridden
19 FIS 1
pre-sample 100 mg balance check (max diff from verified wt)
<= ± 3 ug
pre-sample 200 mg balance check (max diff from verified wt)
<= ± 3 ug
pre-sample duplicate filter'weight ± 15 ug
ug
~
~
~
~
20 FIS_2
ug
~
~
~
~
21 FLD1
ug
~
~
~
~
22 FIS_3
post-sample 100 mg balance check (max diff from verified wt)
<= ± 3 ug
post-sample 200 mg balance check (max diff from verified wt)
<= ± 3 ug
post-sample duplicate filter weight ± 15 ug
ug
~
~
~
~
23 FIS_4
ug
~
~
~
~
24 FLD_2
ug
~
~
~
~
25 Fl_B
lab blanks ± 15 ug
ug
~
~
~
~
26 FFB
field blanks ± 30 ug
~
~
~
~
Operational evaluation criteria
1 point per failure, if not overridden
27 FLT
filter temperature, no excursions of > 5 degrees C lasting
longer than 30 min
~
~
~
~
28 FAT
temperature verification ± 2 degrees C
~
~
~
~
29 FPC
barometric pressure verification ± 10 mm Hg
~
~
~
~
30 FSC
flow rate verification ± 4%
~
~
~
~
31 HTE_3
(pre-sample) filter holding <= 30 days from pre-weigh
days
~
~
~
~
32 BDL
lower detection limit (PM2.5 conc. >= 2 ug/m3)
ugton3
~
~
~
~
33
upper concentration limit (PM2.5 conc. <= 200 ug/m3)
ug/m3
~
~
~
n
34 FCS
collocated CV <= 10%
%
~
~
~
~
39 FRW_5
pre-sample filter replicates <= 5 ug between weighings
(single filter)
ug (diff.)
~
~
~
~
40 FRW_6
post-sample batch stability test < 15 ug between weighings
(consecutive weights for 2 of 3 filters)
of filters < 15 uc
~
~
~
~
Total Score: (Events with total score < 3 meet scoring criteria.)
Page 2 of 2
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PM2 5-PEP QAPP (EPA-454/B-22-004)
May 2022
Page D-l of D-2
Appendix D
Revision History
Kc\ ision
Number
Dale
Responsible P;irl\
Description of C"h;iniic
1
March, 2009
OAQPS
2
May 2022
OAQPS
Changes made throughout the entire document based on
the evolution of the program over time as well as
anticipated software updates (i.e., MoPED and LIMS).
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PM2 5-PEP QAPP (EPA-454/B-22-004)
May 2022
Page D-2 of D-2
[This page intentionally left blank.]
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United States Office of Air Quality Planning and Standards Publication No. EPA-454/B-22-004
Environmental Protection Air Quality Assessment Division May 2022
Agency Research Triangle Park, NC
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