EPA
Implementation Plan
Pb Performance
Evaluation Program
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Pb-PEP
July, 2009
DRAFT
Implementation Plan for the
Pb Performance Evaluation Program
Ambient Air Monitoring Group
Office of Air Quality Planning and Standards
U.S. Environmental Protection Agency
RTP,NC 27711
in
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Foreword
This document is available as a PDF file on the Internet under the Ambient Monitoring Technical
Information Center (AMTIC) Homepage (http://www.epa.gov/ttn/amtic/npepqa.html). The document can
be read and printed using Adobe Acrobat Reader software, which is freeware that is available from many
Internet sites (including the EPA web site).
IV
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Pb-PEP
July, 2009
DRAFT
Abstract
The purpose of this Pb-PEP Implementation Plan is to provide the necessary technical, logistical,
and administrative information to successfully implement the federally implemented program.
It is intended to establish a framework for communication among the organizations participating
in this program, as well as allowing interested parties to understand the implementation aspects
of the PEP. The specific purposes include identifying:
provide background on the Pb-PEP
each important phase of the program and explaining how it will be implemented.
the roles and responsibilities of all affected agencies and organizations
the specific lines of communication between the EPA organizations, the monitoring
organizations, and the ESAT contractors
the pertinent milestones involved with this program
the resources required for successful implementation
the logistical elements, field and laboratory, required for this program
the data management activities to ensure the resultant data is properly recorded, transferred,
and archived
the necessary quality assurance and quality control procedures required to ensure the quality
of the data meets the objectives of the program
the assessment and reporting components
the training and certifications that are required to fulfill the technical aspects of the program
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Pb-PEP
July, 2009
DRAFT
Contents
Section Page
Foreword iv
Abstract v
Figures viii
Tables viii
List of Abbreviations ix
1. Introduction
1.1 Monitoring Program 1
1.2 Pb Performance Evaluation Program 2
1.3 Purpose of this Document 5
2. Roles and Responsibilities
2.1 Monitoring Organizations 1
2.2 EPA Office of Air Quality Planning and Standards 2
2.3 ESAT Organizations 3
2.4 EPA Regional Office 5
2.5 ESAT Contractors 6
2.6 Other Affected Entities 6
Accuracy - Flow Rate Audits 11
Bias-Performance Evaluation Program and Routine Data 12
3. Communications
3.1 Planning (6/09 through 12/09) 1
3.2 Implementation (1/2010 and on) 2
3.3 Assessment Communication 4
3.4 Reporting Communication 4
3.5 AMTIC 5
3.6 Summary 5
4 Timelines/Milestones
4.1 Planning Timelines 1
4.2 Implementation Timelines 2
4.3 Assessment Timelines 4
4.4 Reporting Timelines 4
5 Resources
5.1 Source of Funds 1
5.2 Resource Estimates 1
5.3 Personnel 4
5.4 Equipment 6
5.5 SOPs, QAPPs and Other Documentation 7
5.6 Training 7
6 Logistics
6.1 Pro gram Initialization 2
6.2 Field Logistics 4
6.3 Laboratory Logistics 7
7 Data Management
7.1 Performance Evaluation Data Collection 2
7.2 Performance Evaluation Data Transfer and Archive 4
8 Quality Assurance Quality Control
8.1 Overview 1
vi
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Pb-PEP
July, 2009
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Section Page
8.2 QA Roles and Responsibilities 2
8.3 Planning 3
8.4 QA/QC Implementation 5
8.5 Assessments 7
8.6 Reporting 8
Field Training/Certification of Personnel
9.1 Certification 2
9.2 Additional Out Year Training 2
Appendices
A: Adequacy and Independence Criteria: Monitoring Rule Requirements and Supplemental
Guidance July 2009
B: Field Data Sheet and Chain of Custody Form
Vll
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Tables
Pb-PEP
July, 2009
DRAFT
Figures
Figure Title
2 i Organizational Lines of Communication
31 Communication Pathways
4 i Planning Timeline
7 i Information Management System Flow
81 QC Sample Flow
Section Page
Table Title
3-1 Overview of Principle Communication Lines
5-1 Pb-PEP Cost Estimate for FY2009 and FY2010
5-2 Field Equipment List
5-3 Laboratory Equipment List
6-1 Logistical Support
6-2 Filter Tracking Form
7-1 PEP Data Management Structure
7-2 Data Transfer and Archiving
8-1 QA Roles and Responsibilities
8-2 Laboratory QC Checks
8-3 Field QC Checks
Section Page
3
5
5
5
6
6
7
7
8
8
8
6
2
6
7
1
8
2
4
3
6
7
Vlll
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List of Abbreviations
AAMG Ambient Air Monitoring Group
AQAD Air Quality Assessment Division
AQS Air Quality System
CFR Code of Federal Regulations
CV coefficient of variation
DOPO delivery office project officer
DQA data quality assessment
DQOs data quality objectives
EPA Environmental Protection Agency
ESAT Environmental Services Assistance Team
FEM Federal Equivalent Method
FRM Federal Reference Method
FS field scientist
MQOs measurement quality objectives
NAAQS National Ambient Air Quality Standards
NERL National Exposure Research Laboratory
NIST National Institute of Standards and Technology
NRMRL National Risk Management Research Laboratory
OAQPS Office of Air Quality Planning and Standards
ORD Office of Research and Development
PE performance evaluation
PEP Performance Evaluation Program
PM2.5 particulate matter < 2.5 microns
PQAO primary quality assurance organization
QA quality assurance
QAPP quality assurance project plan
QA/QC quality assurance/quality control
QMP quality management plan
RPO Regional Project Officer
SLAMS state and local monitoring stations
SOP standard operating procedure
SPM special purpose monitor
STAG State and Tribal Assistance Grants
TOPO task order project officer
TSA technical systems audit
IX
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Pb-PEP Implementation Plan
Section 1
Date:7/25/09
Page: 1 of 5
DRAFT
1.0 INTRODUCTION
1.1 Pb Monitoring Program
On November 12, 2008 EPA substantially strengthened the national ambient air quality
standards (NAAQS) for lead (see 73 FR 66934). EPA revised the level of the primary (health-
based) standard from 1.5 micrograms per cubic meter (|ig/m3) to 0.15 |ig/m3, measured as total
suspended particles (TSP) and revised the secondary (welfare-based) standard to be identical in
all respects to the primary standard. In conjunction with strengthening the lead (Pb) NAAQS,
EPA identified the need for states to improve existing lead monitoring networks by requiring
monitors to be placed in areas with sources that emit one ton per year (tpy) or more of lead and
in urban areas with more than 500,000 people. Depending on specific circumstances, States may
have the option of using monitoring for either lead in TSP (Pb-TSP) or lead in PMio (Pb-PMio)
using approved Federal Reference Methods (FRM's) or Federal Equivalent Methods (FEM's) to
demonstrate compliance.
Due to the promulgation of the lower Pb NAAQS, EPA made some changes in the QA
requirements in 40 CFR Part 58 Appendix A. The following are the highlights of the changes
that occurred in Appendix A:
• DQO Goals -EPA utilized the DQO process to determine appropriate precision and bias
measurement quality objectives. Measurement quality objectives for precision will be
20% for a 90% confidence limit coefficient of variation and an overall absolute bias
upper bound goal of 15%. Goals will be assessed on 3 years of data at the PQAO level of
aggregation.
• Flow Rates-No changes occurred to flow rate. Flow rate verification will be
implemented monthly (PMio Lo-Vol) or quarterly (TSP Hi-Vol) and flow rate
performance evaluations will be implemented every six months.
• Collocated Monitoring-No changes occurred to the collocation requirements.
Collocation will continue to be required at 15% of each method designation within a
primary quality assurance organization at a l-in-12 day sampling frequency. EPA added
language encouraging monitoring organizations to site the first collocated sampler in
each network at the highest concentration site. This will allow the site to operate over the
longest time period and since it may be the site that affects the NAAQS and it is
allowable to substitute collocated data for missing data from the primary monitor, this
siting would be advantageous for improving data completeness at a very important site.
Routine/collocated data pairs will be used when Pb concentrations of both samples are
greater than or equal to 0.02 |J,g/m3. Prior to 2008, this cutoff value was 0.15 |J,g/m3.
• Pb Strip Audits-The requirement for the analysis of 6 Pb audit strips per quarter (3 strips
at 2 concentration ranges) has not changed. However, the audit concentrations ranges
have changed. The lower concentration range is 30-100% of the NAAQS and the higher
concentration range is 200-300% of the NAAQS.
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• Pb-Performance Evaluation Program (Pb-PEP)-The implementation of an audit
similar to the PM2 5 Performance Evaluation program (PEP) is a new requirement and it
provides some assessment of overall bias but will be a mix of one or two Pb-PEP audits
with additional collocated sampling. The number of audits required is based on the
number of routine sites within a primary quality assurance organization PQAO. The
program will require the same number of audit samples as required for PM2 5 meaning:
o PQAOs with < 5 sites require 5 audits (1 Pb-PEP, 4 collocated)
o PQAOs with > 5 sites require 8 audits (2 Pb-PEP, 6 collocated)
Implementation of the Pb-PEP for Pb monitoring is new and is the focus of this Implementation
Plan.
1.2 The Pb Performance Evaluation Program (PEP)
Since the data for the SLAMS network is used for NAAQS comparisons, the quality of this data
is very important. Therefore, a quality system has been developed to control and evaluate the
quality of data in order to make NAAQS determinations within an acceptable level of
confidence. During the development of the Pb NAAQS, the EPA used the data quality objective
process to determine the allowable measurement system imprecision and bias that would not
significantly effect a decision makers ability to compare pollutant concentrations to the NAAQS.
The precision requirement (20% CV) and bias requirement ( +15%) are based on total
measurement uncertainty, which incorporates errors coming from all phases (field sampling
handling, analysis etc.) of the measurement process. The collocated samples provide adequate
estimates of precision. The Pb-PEP, if properly implemented, can provide the bias estimate.
The Pb-PEP is a quality assurance activity which will be used to evaluate measurement system
bias of the Pb monitoring network. A performance evaluation is defined as 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 the an analyst or laboratory.
In the case of the Pb-PEP, the goal is to evaluate total measurement system bias, which includes
measurement uncertainties from the field and the laboratory activities. The pertinent regulations
for this performance evaluation are found in 40 CFR Part 58, Appendix A, section 3.3.4.4. The
strategy is to collocate a portable Pb TSP air sampling instrument within 2 to 4 meters of a
routine SLAMS air monitoring instrument, operate both monitors in exactly the same manner,
and then compare the results. In addition to collocation with a portable audit sampler, 4 or 6
(depending on number of sites within a PQAO) collocated samples as described in 40 CFR Part
58, Appendix A, section 3.3.4.3 will be sent to the audit laboratory. EPA expects that these
collocated samples would be submitted on a monthly basis to the audit laboratory.
The implementation of the Pb-PEP is a monitoring organization responsibility. However, similar
to the PM2.5 PEP program, EPA has included a federally implemented Pb-PEP and provides
monitoring organizations the option to self implement or utilize the federally implemented
program. Self implementation will require monitoring organizations to meet a level of
independence and adequacy. Appendix A provides the information on adequacy and
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Section 1
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DRAFT
independence. Since this information may change over the years, the Appendix will also be
posted on AMTIC and will be reviewed annually and updated as necessary.
EPA will use the Environmental Services Assistance Team (ESAT) Contract that is currently in
place in each Region to provide the necessary field and laboratory activities. Each EPA Region
will implement the field component of this activity while Region 9 will operate the laboratory
component. In addition, the EPA NHERL Metrology Laboratory will function as a field
standards verification facility.
The Pb-PEP can be segregated into a field and a laboratory component. The following
information provides a brief description of these activities. Detailed standard operating
procedures (SOPs) will be developed for all field and laboratory activities.
Field Activities:
TSP portable audit samplers will be used in a collocated manner to perform the evaluations.
These samplers have been approved by EPA as a Federal Reference Method and are designed to
be durable, rugged, and capable of frequent transport. These samplers are constructed in
modules with each module weighing no more than 40 pounds each. Specific detailed operating
instructions will be found in the Pb-PEP Quality Assurance Project Plan (Pb-PEP QAPP) and the
Standard Operating Procedures (SOPs) which are under development and being designed
specifically for this program.
The following steps must be observed to ensure the quality of the data:
• adherence to the vendor's operations manual for the proper operation of the sampler; this
includes the proper assembly, transport, calibration, and operation
• adherence to the Pb-PEP Field SOPs
• adherence to the standards, principles, and practices outlined in the Pb-PEP QAPP
• completion of the required certification training program
• special attention must also be given to any activity involving filter handling (loading,
transport, removal, etc.); this area contains the greatest potential for measurement
uncertainty and care must be given to the proper handling of the TSP glass fiber filters
and 47 mm Teflon filters (both may be used in this program)
Field Activity 1, Pb-PEP audit
1. One fully trained field scientist will transport a portable Pb-PEP sampling device to an
established Pb site which shall be located at any of the SLAMS/SPM sites within each
PQAO.
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2. The field scientist will assemble the instrument, collocate the sampler, perform a
calibration following the SOPs, install a filter and operate the instrument to the same 24-
hour sampling mode as the routine instrument (midnight to midnight).
3. If scheduling allows, the field scientist will leave this location to set up an additional 24-
hour performance evaluation at another routine sampling location. If the schedule does
not allow for another set up, the field scientist may perform additional activities at the
site.
4. The field scientist shall return to each site after 24-hour sampling time, download the
stored electronic monitoring data, remove and properly store the filter for transport, and
disassemble the instrument.
5. The field scientist shall properly package the filter following the QA guidelines for
transport to the pre-determined audit laboratory.
Field activities 2, Collocated Audit Sample
Monitoring organizations are required to implement collocated monitoring at 15% of the Pb sites
within their network as described in 40 CFR Part 58 Appendix A Section 3.3.4.3. In addition to
this requirement, the monitoring organization will sample an additional 4-6 collocated samples
and send these samples to either their own independent Pb-PEP laboratory or to the national Pb-
PEP laboratory (Region 9) for analysis. Monitoring organization will follow their own SOPs and
QAPP to perform this additional collocation. If utilizing federal implementation, the monitoring
organization will be required to fill out a field chain of custody form that will be included with
each filter.
Laboratory Activities:
The Pb-PEP FRM performance evaluation also requires extensive laboratory activities, including
filter handling, sample extraction, analysis, data entry/management and archival. Region 9 will
develop the Pb-PEP laboratory. Specific detailed instructions will be found in the Pb-PEP QAPP
and the SOPs which are under development and being designed specifically for this program.
In addition to the Good Laboratory Practices (GLP) which must be followed, the following
activity must also be observed concerning the laboratory activity
• adherence to the vendor's operations manual for the proper operation of the extraction
and analytical equipment.
• adherence to the SOPs for the program.
• adherence to the standards, principles, and practices outlined Pb-PEP QAPP
• special attention must also be given to any activity involving filter handling. This area
contains the greatest potential for measurement uncertainty and care must be given to the
proper handling of both TSP and 47 mm Teflon filters.
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NOTE: Monitoring organizations deciding to self-implement Pb-PEP may choose to
use the Region 9 National Pb-PEP for analysis with the appropriate allocation of
STAG funds.
1.3 Purpose of this document
The purpose of this Pb-PEP Implementation Plan is to provide the necessary technical, logistical,
and administrative information to successfully implement the federally implemented program.
The specific purposes include identifying:
provide background on the Pb-PEP
each important phase of the program and explaining how it will be implemented.
the roles and responsibilities of all affected agencies and organizations
the specific lines of communication between the EPA organizations, the monitoring
organizations, and the ESAT contractors
the pertinent milestones involved with this program
the resources required for successful implementation
the logistical elements, field and laboratory, required for this program
the data management activities to ensure the resultant data is properly recorded,
transferred, and archived
• the necessary quality assurance and quality control procedures required to ensure the
quality of the data meets the objectives of the program
• the training and certifications that are required to fulfill the technical aspects of the
program
• the assessment and reporting components
As stated earlier, monitoring organizations can choose to self-implement the Pb-PEP or allow
for federal implementation. Self implementation will require the development of an adequate
program and an established level of independence. Both adequate and independence are be
described in this document (see Appendix A). However the detail in this document should not
be construed as the necessary requirements for a self-implemented program. This document's
intent is to focus on the federal program and can be used by monitoring organizations in their
implementation decisions.
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Pb-PEP Implementation Plan
Section 2
Date:7/25/09
Page: 1 of 6
DRAFT
2.0 ROLES AND RESPONSIBILITIES
The degree of complexity and the number of agencies involved with the Pb monitoring program
and the subsequent Pb-PEP requires that the flow of information and associated communications
be structured to optimize the collective resources. The only realistic perspective on
implementing this program is one that recognizes that deployment and operation of this network
is a shared responsibility among all the involved organizations. The purpose of the following
descriptions of roles across programs is to facilitate communications, and to outline very basic
responsibilities. Figure 2.1 provides a basic diagram of the organization and lines of
communication.
Monitoring Organizations
Implementation Decisions
ESAT PO
DC- Overall SOW
Region 1-10
TOPO/DOPOs &
RPOs
Technical Aspects
Contractual
Funding aspects
Figure 2.1 Organizational lines of communication
2.1 Monitoring Organizations
EPA could not effectively plan and execute this program without monitoring organization
participation. State and local agencies bear a tremendous level of responsibility for developing,
implementing, and tracking the entire national Pb monitoring program. It is imperative that the
monitoring organizations work with the EPA Regional Offices throughout this process to
identify problems as early as possible, and to help find solutions to many of these issues. The
monitoring organizations have the following specific responsibilities:
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Section 2
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If self-implementing the Pb-PEP:
• implementing the Pb-PEP at the same frequency and at comparable adequacy to the
federal program and adhering to the definition of independent assessment (see Appendix
A)
• undergoing training and certification activities
• procuring necessary equipment and consumables
• developing the necessary SOPs and QA procedures into their respective QAPPs
• transmitting data to AQS
• selecting the sites for evaluation
If utilizing the Federal Pb-PEP:
• operating their Pb monitoring network according to the established regulations and
guidelines; this includes proper siting, operations, and quality assurance procedures
• assisting, through review activities, in the development and revisions of pertinent Pb-PEP
guidance documents
• on a yearly basis, determining whether to continue utilizing the federal implementation
of the Pb-PEP
• identifying the sites within their monitoring network where Pb-PEP evaluations will be
performed each year
• ensuring a site operator is on-site when the Pb-PEP field scientist arrives and performs
the evaluation; this includes communicating with the field scientist, operating the routine
monitor in the normal operating mode, and generally supporting the Pb-PEP
• ensuring the success of the program by performing various oversight activities such as
technical systems audits of field and laboratory activities
• reviewing routine and performance evaluation data and working with the EPA Region on
corrective actions
2.2 EPA Office of Air Quality Planning and Standards (OAQPS)
OAQPS has the overall responsibility for ensuring the quality of the nation's ambient air data.
OAQPS has developed specific regulations for the development of a quality system as found in
40 CFR Part 58, Appendix A. OAQPS has the following responsibilities to ensure the
development of this Pb-PEP Program:
• providing a contractual vehicle for the manufacturing and distribution of the Pb-PEP
portable evaluation sampler
• developing and or continuing the Memorandum of Understanding with the ESAT Office
• working with the EPA Regions to determine which monitoring organizations will utilize
the federally implemented Pb-PEP
• acquiring the appropriate STAG funds to implement the federally implemented Pb-PEP
program.
• transferring the necessary funds to the EPA Regional ESAT contracts management
division to support the Pb-PEP and to the Region 9 office for laboratory equipment and
consumables
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Section 2
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• developing the Pb-PEP Implementation Plan, the ES AT Scope of Work (SOW), field
standard operating procedures (SOPs), Pb-PEP.
• developing the field and laboratory personnel requirements
• developing the field and laboratory training activities, participating in training, and
supplying national experts to answer specific technical questions
• developing a list of primary quality assurance organizations (PQAOs) who are
monitoring Pb and SLAMS and SPM sites.
• developing field and laboratory information management systems
• assessing the Pb-PEP concentration information entered into the AQS data base
• initiating and instituting a communications network and acting as a liaison to groups
working on the Pb-PEP
• interacting with the monitoring organizations concerning the set-up, operation, and data
results of the performance evaluations
• ensuring the success of the program by performing various oversight activities such as
management systems reviews
Most budgetary and technical planning activities are coordinated through OAQPS. The Ambient
Air Monitoring Group (AAMG) within the Air Quality Assessment Division (AQAD) is
ultimately responsible for this Implementation Plan, most technical components (with support
from the EPA Regional Offices and monitoring organizations), and the resource estimates
underlying program implementation. Various forms of resource guidance necessary for the
State and Tribal Assistance Grants (STAG) distribution is coordinated through OAQPS. In
addition, the OAQPS National Air Data Group is responsible for the AQS data management
system.
2.3 ESAT Organization
The ESAT contract is administered by the Office of Superfund Remediation and Technology
Innovation (OSRTI) Technology Innovation and Field Services Division (TIFSD) Analytical
Services Branch (ASB). OAQPS has entered into a memorandum of understanding with this
office in order for the ESAT contract to provide the services necessary for Pb-PEP. The ESAT is
organized of contracting officers (COs) at the Headquarters office in DC and with Task Order
Project Officers (TOPOs), Delivery Order Project Managers (DOPOs) and Regional Project
Officers (RPOs) within each Region. The AMTIC website1 provides the current ESAT contacts
list.
Some important aspects of the ESAT contract include:
• only the TOPO/DOPO, RPO and COs are authorized to give instructions or clarification
http://www.epa.gov/ttn/amtic/npepqa.html
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Section 2
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DRAFT
(technical direction) to the ESAT contractor on the work to be performed. This technical
direction is provided in writing
• the work assignments will be prepared by the TOPO/DOPO and are effective only upon
approval by the Contracting Officer
The EPA Contracts Manual describes the roles and responsibilities of contracting officers,
specialists and project officers which need not be explained here. The important roles and
responsibilities for the PEP are described below
Head Quarters Contracting Officers
• working with OAQPS on the securing, obligating, committing and distributing funds for
work performed under the ESAT Contract.
• developing a Memorandum of Understanding with OAQPS
• ensuring work assignment activities fall within the ESAT Scope of Work
• approving work assignments
Regional PO
• providing overall management and overseeing performance of respective regional ESAT
personnel
• reviewing region specific invoices with input from TOPO/DOPO
• assisting in the preparation Pb-PEP work assignments
• assisting in the development of the FRM Performance Evaluation Program
Implementation Plan and the ESAT Scope of Work as it relates to the Pb-PEP
• ensuring there is qualified contractual personnel available to implement, facilitate, and
perform the Pb-PEP evaluations
• providing administrative and logistical support for the ESAT contract
• communicating on a regular basis with program participants (OAQPS, Region, etc.)
TOPO/DOPO
The TOPO/DOPO will, in most cases, be a technical person from the Regional air monitoring
branch/division who will be responsible for assisting in the technical aspects of the program.
Some of the TOPO/DOPO activities may also include the activities listed in Section 2.4, but the
responsibilities, as they relate to the ESAT contract, include the following:
• preparing (with RPO) Pb-PEP work assignments
• setting up a file system containing all relevant documentation including notes of
conversations with the contractor and other items that will provide an audit trail of their
actions under the work assignment as well as all technical information related to the Pb-
PEP
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Section 2
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DRAFT
reviewing the contractors workplan and preparing findings on proposed tasks, labor hours
skill mix, and materials and quantities
monitoring compliance with the work assignments
tracking dollars and hours, providing technical direction (in accordance with the terms of
the contract) and reviewing monthly technical and financial reports
verifying contractor representations of deliverables received and accepted, and/or
progress made
communicating contractor performance and administrative/logistical issues to RPO
2.4 EPA Regional Office
The EPA Regional Offices are the major communication link with monitoring organizations and
OAQPS. This role is absolutely necessary for the development of effective policies and
programs. For the Pb-PEP, the Regional offices have the following specific responsibilities:
All Regions—
• assisting in the development of all pertinent Pb-PEP evaluation guidance documents
• reviewing and approving the workplans submitted by the ESAT contractors
• identifying TOPO/DOPOs to oversee the technical aspects of field activities that are
performed by the ESAT contractors
• training and certifying ESAT field personnel after initial training
• providing technical oversight of the field activities by performing technical systems
audits of these activities
• providing a yearly schedule of site evaluations for the ESAT contractors
• working with monitoring organizations in developing a yearly schedule of site
evaluations
• informing monitoring organizations of an upcoming performance evaluation
• evaluating the performance evaluation data and informing monitoring organizations of
significant differences
• participating in training activities, including multi-State conferences, EPA satellite
broadcasts, and other training vehicles
• Attending conference calls and meetings on performance evaluation activities
Region 9 (including items listed above)—
• identifying work assignment managers to oversee the technical aspects of laboratory
activities that are performed by the ESAT contractors
• developing the primary laboratory for this program with respect to logistical, technical,
and analytical support, including necessary facilities to store, and archive filters and
extracts.
• training and certifying ESAT laboratory personnel after initial training
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• providing technical oversight of the laboratory activities by performing technical systems
audits of these activities
2.5 ESAT Contractors
The ESAT contractors will perform the specific tasks associated with the Pb-PEP. The ESAT
contractors responsibilities include:
• developing a work plan and cost estimates for each work assignment
• staffing appropriately to meet the requirements of the work assignment
• successfully implementing the activities described in the work plan and work assignment
• learning and implementing SOPs
• understanding government regulations as they relate to contracts and inherent
government function
2.6 Other Affected Entities
EPA Office of Research and Development (ORD)
The ORD's primary role in the implementation of the Pb-PEP will be as a technical consultant
and advisor. This action will be primarily through the National Environmental Research
Laboratory (NERL) which provides many of the technical infrastructure elements for the
program. ORD also has the overall responsibility for designating all air monitors as Federal
Reference or Federal Equivalent Method. The portable TSP audit sampler must be designated by
ORD through their Federal Reference and Equivalency program. This overall responsibility
includes:
• designating Pb samplers as FRM/FEM and providing technical support
• providing technical support for the national procurement contracts
• providing guidance for field and analytical activities
In addition, the ORD National Risk Management Research Laboratory (NRMRL) Metrology
Laboratory will provide annual verification of the flow/pressure/temperature standards used for
the Pb-PEP.
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Pb-PEP Implementation Plan
Section 3
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DRAFT
3.0 COMMUNICATIONS
Monitoring
Orgs
Technica
Contractua
1
— 1
OAQPS
ESAT
Contracts Office
Region
ESAT
TOPO/DOPO
^>
»•
* ^
Region
ESAT RPO
^\ "
ESAT
Contractors
Figure 3.1 Communication pathways
An organized communications framework is needed
to facilitate the flow of information among the
parties discussed in Section 2.0 as well as other users
of the information produced by the Pb network.
Figure 3.1 represents the principal communications
pathways. In general, ESAT contractors will be
responsible for keeping the Regional TOPO/DOPOs
and RPOs fully informed about technical progress,
issues and contractual obligations. On the technical
side, the EPA Regional TOPO/DOPOs will be
responsible for communicating with monitoring
organizations and informing OAQPS on issues that
require technical attention. Contractual issues will be
conveyed from the ESAT contractor through RPO's to the ESAT Contracts Office and if
necessary, to OAQPS. The communication network will be described as it relates to planning,
implementation assessment and reporting stages.
3.1 Planning (6/09 through 12/09)
During the planning stages, technical discussions on the implementation aspects will take place
in order to review and concur on the products developed by OAQPS and the EPA Regions.
OAQPS will take the lead in the development of drafts of the Implementation Plan, the field
SOPs and the Pb-PEP QAPP. OAQPS will also draft a memo each July that will be used by
monitoring organizations to decide whether to self-implement the Pb-PEP or allow for federal
implementation. The Region 9 laboratory will take the lead on the development of the laboratory
methods and will address the laboratory sections of the Pb-PEP QAPP. OAQPS will distribute
this information to the ESAT contacts. Pb-PEP personnel will have an opportunity to comment
on the drafts until there is general agreement on the various aspects of the program. The
documents will then be distributed on AMTIC for wider review and comment by monitoring
organizations. In order to facilitate this process OAQPS will organize two workgroups
Laboratory Workgroup - This Workgroup is made up of personnel from OAQPS, Region 9
and Region 7. It was established in 3/09 to develop the laboratory capabilities of Region 9 and
Region 7. Although there is a need for one National Pb-PEP laboratory, Region 7 also supports
OAQPS in providing check analysis of laboratory audit strips. Both Region 9 and 7 will use a
consistent extraction and analysis method are working together to develop one method (ICP-
MS).
ESAT Workgroup - This workgroup was established in 7/09 to discuss the technical,
contractual and implementation activities of the ESAT contract, and will include OAQPS, the
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EPA Regional DOPO/TOPOs and RPO's, and the ESAT Contracts Office (as needed). At the
planning stages, it will not include ESAT contractor personnel. The frequency of the call will be
determined by the Workgroup and will include topics such as:
• • personnel requirements
• • funding and equipment acquisition
• • work assignment development
• • implementation schedules
•• logistics
Monitoring organizations deciding to self-implement the Pb-PEP will be invited to attend the
Workgroup meetings to ensure they develop an adequate program.
Notes from each Workgroup call will be taken and distributed electronically within five working
days of the call. Workgroup participants will have an opportunity to comment on the notes
which will be revised as appropriate.
3.1.1 Regional Communication with Monitoring Organizations
Prior to implementation, the EPA Regions and monitoring organizations will select the sites that
will be visited in the calendar year. The site selection will be based on the regulations in 40
CFR Part 58 Appendix A and on discussions with the primary quality assurance organization
(PQAOs). A tentative evaluation schedule for the year will then be developed that will take into
account the logistics, and monitoring frequencies of each monitor. This information will then be
distributed to each affected PQAO for review and comment. Communication at this level will be
the responsibility of the EPA Regional DOPO/TOPOs
3.2 Implementation (1/2010 - •)
3.2.1 National Communication
During implementation, the ESAT Workgroup will remain the primary mode of communication
for the participants in the program. ESAT contractors may be involved in the call in order to
supply technical information and progress reports. Since most of the planning aspects should be
completed, these calls will be scheduled at frequencies of once a month, for the first year, and
will be used primarily for updates, progress reports and issue resolution. Any issues discussed
that result in a change in how the Pb-PEP will be implemented will also be communicated
through the ESAT Workgroup and on AMTIC. Once implementation is found to be fairly
routine and most issues resolved, conference calls will be reduced to a quarterly frequency.
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3.2.2 Regional Communication
The following types of communication will take place at the Regional level
ESAT Contractors
The ESAT contractors will have frequent communication with Regional DOPO/TOPOs on the
progress of their activities and any problems/issues associated with them. Resolution of these
issues should take place in the Regions unless it is something that could affect the
implementation of the program at a national level, where it can be discussed and resolved
through the ESAT Workgroup conference call.
ESAT Lab/ Field Communication
Since the Region 9 laboratory will support the field activities for the 10 Regional ESAT
contracts, frequent communication will be required in the following areas:
Field communication to lab:
• upon shipment of filters to the laboratory, including date of shipment, number of boxes,
a listing of each filter and the shipping tracking number
• electronic and flash drive mailing of field data from data loggers for each sample
Lab communication to field:
• upon receiving filters and data from the field
• issues related to field information
Each Region will designate a field and laboratory communications coordinator from the ESAT
contract staff to ensure adequate communications.
Monitoring Organizations
Prior to implementation of the Pb-PEP, the EPA Regions will have worked with the monitoring
organizations to develop an implementation schedule for their respective Region. One week
prior to an actual visit, the Regional TOPO/DOPO and/or the ESAT field scientist will call the
monitoring organization to inform them of the upcoming evaluation and to coordinate any
necessary field activities.
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3.3 Assessment Communication
During the assessment of the evaluation results, the following communication avenues will be
developed.
3.3.1 National
Data from the Pb-PEP, once validated, will uploaded to AQS. If possible, the data will be placed
in the AQS system and will remain inaccessible until the value from the routine sampler is rerted
to AQS. At that point a comparison of the two values through AQS software will occur. Further
discussion on this will take place in Section 7. OAQPS, the EPA Regional TOPO/DOPO and
monitoring organizations will assess this information. During ESAT Workgroup conference
calls, the data will be discussed as it relates to any observed trends (i.e., overall bias, bias of
particular instruments), corrective action needed or additional assessments.
There is also a need to assess the implementation of the Pb-PEP. This will take place during
management systems reviews of EPA Regions (see section 8). It is anticipated that OAQPS will
be instituting a QA meeting once a year. During this meeting, time will be devoted to assessing
the implementation of the Pb-PEP. By 4/2011, an assessment report will be written by OAQPS
discussing the positive/negative aspects of the first year of the program including any
information coming from the meeting or any Regional, or monitoring organization assessments
of the Program.
3.3.2 Regional and Monitoring Organization Assessments
Detailed reviews and discussion of the Pb-PEP data will occur at the EPA Regional/monitoring
organization level. If data is outside acceptance criteria, the Regions and monitoring
organizations may decide to perform additional PEs at the site(s) where the out-of-criteria values
were generated. Information on these corrective actions will be forwarded back to OAQPS in
order to track the number of corrective actions and there outcome for future improvements to the
Pb-PEP.
Regions will forward technical systems audits (TSAs) performed on the ESAT contractors to
OAQPS for review and use during program assessments. Monitoring organizations will also be
asked to provide any assessments they have performed on the Pb-PEP to the Regions and
OAQPS.
3.4 Reporting Communication
It is critical to the success of the program that any pertinent information that is collected is
reported in a timely fashion in order to implement improvements in the quality of routine Pb data
as well as to improve the implementation of the Pb-PEP.
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3.4.1 National Reporting
Every year OAQPS will develop a QA summary report that will provide a data summary of the
QA activities performed during the calendar year and will include information that can be
retrieved and assessed through AQS. The PE data will be included in this report. The ESAT
Workgroup will have input to the content and structure of the report and will have the
opportunity for internal peer review prior to distribution on AMTIC.
Every three years OAQPS will develop a QA report assessing three years worth of data. This
report differs in the yearly report in that it will be more interpretive and will integrate all facets
of the QA program. The ESAT Workgroup will have input to the content and structure of the
report and will have the opportunity for internal peer review prior to distribution on AMTIC.
3.5 AMTIC
Another important avenue of communication on QA activities is AMTIC. AMTIC presently has
an area devoted to Pb monitoring1 and an area devoted to the Pb-PEP2. Important information
and guidance documents will posted in these areaa. EPA will utilize AMTIC extensively
throughout the planning, implementation, assessment, and reporting processes.
3.6 Summary
A good line of communication is important to establish early and it must be followed to ensure
that all parties receive the appropriate information in a timely manner. Figure 3.1 presented the
general lines of communication. By following this figure and using the Workgroups currently
established, it is anticipated that the Pb-PEP should be implemented in an efficient manner.
Table 3-1 provides a summary of the technical aspects that each organization will be responsible
for communicating
1 http://www.epa.gov/ttn/amtic/pb-monitoring.html
2 http://www.epa.gov/ttn/amtic/npepqa.html
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Table 3.1 Overview of Principal Communication Lines.
OAQPS
ORD
EPA Regions
ESAT
Contractors
ESAT RPOs
Monitoring
Organizations
Program requirements, training procedures, guidance documentation, contractual information,
program funding, data analysis, coordination, QA reporting.
Federal Reference and Equivalency information, technical advice. Logistics on field standards
verification
Field and laboratory support, monitoring organization implementation schedules, data
assessments, corrective action , TSAs, information on the project officers and task managers,
work plan review information, ESAT progress reports.
Information concerning the specific tasks of the performance evaluation, any feedback to the
operation and training procedures, information concerning the annual work plans,
implementation progress, information on the operation of the FRM portable audit sampler
itself.
Any information concerning the training, personnel and specific tasks of the performance
evaluations, information concerning the financial, administration or logistical support of the
program
Information concerning the network, the specific sites to be evaluated, any required training,
guidance needed, information on the operation of the routine monitor itself, any feedback on
the entire program, TSAs
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4.0 TIME LINES/MILESTONES
In order to ensure that the PEP is implemented in calendar year 2010, many aspects of the
program must be completed in a timely and efficient fashion.
4.1 Planning Time Lines
Figure 4.1 provides the key planning aspects of the program that must be completed within the
specified time frames in order to meet a 1/1/2010 implementation date.
ID
1
2
3
4
S
6
7
e
9
10
11
12
13
14
15
16
17
13
19
20
21
Task Name
Samplers
Request for Price
Sampler Delivery
Field Equipment
Equipment List
Field Equipment Ordering
Equipment in Regions
Filters in Regions
Documents
Implementation Plan
Draft Lab SOPs
Final Lab SOPs
Draft Field SOPs
Final Field SOPs
Draft QAPP
Final QAPP
Implementation Memo
Audit Site Selection
Audit Schedule
Field Training/Certification
Field Implementation
2009 201 0
Oct Nov I Dec Jan Feb Mar Apr May Jun Jul Auq Sep Oct Nov I Dec Jan Feb Mar Apr May Jun Jul
BiBSHh
:
P "W
iimi^
'^•-n
> 9/18
4 10/30
iiiil
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+ 1116
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Figure 4.1 Planning Timeline
A brief explanation of the timeline is provided below
Samplers
Request for Price - OAQPS is purchasing two portable TSP samplers per Region.
Modifications are being made to be able to transport the instruments safely. We expect to
award a vendor by August, 2009
Sampler Delivery- OAQPS expect delivery of all samplers to the EPA Regions by
November, 2009
Field Equipment
Equipment List- A complete list of equipment will be completed by July, 2009
Equipment Ordering- All equipment for the Regions will be ordered by August, 2009
Equipment in Regions- by September, 2009
Filters in Regions- TSP Filters will be purchased through a National Filter Contract in
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OAQPS and distributed to the Regions by October, 2009
Documents
Implementation Plan-OAQPS is expected to complete a draft of this document by July,
2009 and finalize it by August, 2009
Lab SOPs- Region 9 and 7 will complete draft laboratory SOPs by July, 2009 and finalize
these by November 2009
Field SOPs- OAQPS is expected to complete a draft of this document by August, 2009 and
finalize these by November 2009
Pb-QAPP- OAQPS is expected to complete a draft of this document by the beginning of
October, 2009 and finalize it by November, 2009
Implementation Memo- Is the memo to the monitoring organization asking for decisions to
self-implement or utilize federal implementation. OAQPS will develop the memo in July, 2009
and will provide monitoring organization until Aug 31, 2009 to make decisions. A memo similar
to this will be sent out each year.
Audit Site Selection- Monitoring organization will provide the Regions information on which
sites to audit in 2010. Sites will be selected by mid-December, 2009
Audit Schedule- ESAT field scientists working with EPA Regional TOPO/DOPOs will submit a
tentative audit schedule to the monitoring organization in December for approval.
Field Training /Certification- for ESAT and monitoring organizations self implementing will
be held in early December, 2009
4.2 Implementation Time Lines
There are some other important dates that must be met during implementation activities. They
involve both laboratory and field activities.
4.2.1 Laboratory Time Lines
Unlike PM2.5 PEP, the Region 9 laboratory does not need to prepare the TSP filter media prior to
sampling so TSP filter media will be sent directly to each EPA Regional Office. Based on some
initial estimates of proposed Pb sites in each state, the total number of samples (PEP and
collocated) arriving at the Region 9 lab is estimated at around 300 per year. This equates to
approximately 25 samples a month. This number of samples is conducive to batching all
samples arriving in one month together for one analysis run. Therefore, the laboratory will
schedule analysis for the last week each month (if there are more than 2 working days in that
week). A tentative schedule for 2010 would be the following:
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Jan 25 Feb 22 Mar 29 April 26 May 24 June 28
July 26 Aug23 Sept 27 Oct 25 Nov 22 Dec 27
A new schedule will be posted on AMTIC each year. The Region 9 laboratory will alert the
Regions and any monitoring organizations using the laboratory at least two weeks in advance if
there is a change in the batch analysis schedule.
Data Input/Assessment/Upload
It is anticipated that an automated data entry system will be in place so that minimum data entry
will be required. Once a batch of samples has completed analysis, the data will be reviewed,
verified, and validated. This process will be completed in 10 working days. Upon data
validation and acceptance by the EPA TOPO/DOPO, the data will be uploaded to AQS. This
should be completed within 5 working days from data validation. The data will only be available
to monitoring organizations once they upload the routine data results.
4.2.2 Field Time Lines
Pb-PEP filters will be collected within 48 hours of the sample end date. In most instances the
field scientist will collect the filters within 8 hours of the sample end date unless the scientist is
visiting multiple sites in the sampling week. The collocated filters can be collected by the
monitoring organization during the next scheduled sampling day. PEP samples will be sent the
day of removal by next day delivery to the Region 9 laboratory. Data will be immediately
downloaded from the portable sampler and stored in two mediums (laptop hard drive and flash
drive). One flash drive of the data will be shipped with the sample(s). Within 8 hours of sample
removal the sampler data will also be transmitted, via modem, to the appropriate laboratory.
4.2.3 Implementation Summary
Table 4-1 provides a summary of the key activities discussed on the implementation sections
above.
Table 4-1 Implementation Summary
Implementation Phase
Laboratory
Field
Activity
Sample Analysis
Data Input/review/validation
AQS Upload
Filter Collection
PEP
Collocated Sample
Sample Shipping
PEP
Collocated sample
Acceptable Timeframe
30 days
10 working days
5 working days of data validation
8-48 hours from sample end date/time
Next normal sample collection period
Day of sample collection (unless Friday)
Within 3 days of sample collection
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4.3 Assessment Timeliness
In order to assess the PE data, the data from the routine sampler must also be available in AQS.
Monitoring organization requirements for data upload to AQS is 90 days after the quarter in
which the data is collected. If possible, submittal of routine sampler data as soon as possible is
encouraged if data assessment is to occur in a timely manner.
4.3.1 OAQPS Assessments
Once both routine data and PE data for a site are in AQS, OAQPS, Regions and monitoring
organizations can use the AQS data evaluation programs to assess this information. The
statistics for these assessments can be found in 40 CFR Part 58 Appendix A. In addition, the
AMP255 report in AQS provides the appropriate statistical assessment and the Data Assessment
Statistical Calculator (DASC) tool will be revised to provide the Pb-PEP statistics. The DASC
tool can be found on AMTIC1. Initially OAQPS will review this information quarterly and will
summarize their comments on ESAT Workgroup conference calls. Every year, after the July
certification date EPA will post a version of the AMP255 report on AMTIC as an annual
summary.
4.4 Reporting Time Lines
4.4.1 OAQPS Reporting
QA Reports
As mentioned in Section 3, OAQPS plans on the development of a yearly QA Summary Report
and the interpretive QA Report every three years. The yearly report will be based on a calendar
year and will be completed around August, when data from the previous calendar year should be
reported to AQS. The three year QA Report will be generated 9 months after the last valid entry
of routine data by the monitoring organizations for the final year.
1 http://www.epa.gov/ttn/amtic/parslist.html
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5.0 RESOURCES
This section will explain the source of funding, the development of resource estimates, and the
schedule for resource allocations for the Pb-PEP.
5.1 Source of Funds
Since the Pb-PEP is a monitoring organization responsibility, the source of funds for the Pb-PEP
are 105 State and Tribal Assistance Grants (STAG). Every year funds will be allocated to the
monitoring organizations to operate the Pb Ambient Air Quality Monitoring Program. A portion
of these funds are allocated for performing the Pb-PEP. Each year the primary quality assurance
organization (PQAO) will decide to either self-implement or utilize the federal Pb-PEP.
Decisions on whether a PQAO will choose to continue federal implementation must take place
by August of the previous calendar year to allow the ESAT contract enough time to
appropriately staff for following calendar year. Funds will be appropriately reallocated from the
STAG funds to EPA in order to implement the audit for that PQAO.
5.2 Resource Estimates
Table 5-1 provides estimates for the FY09 (planning), FY10 (year 1) activities respectively. The
FY10 estimate will reflect out year costs unless there is an increase in the number of sites
requiring Pb monitoring.
5.2.1 FY 09-Year 0, Planning (blue font)
Since the first year of implementation of the Pb-PEP starts 1/1/2010, FY09 and the months of
October through December of FY10 will be used to plan the Pb-PEP, acquire the necessary
personnel, capital equipment/consumables, and develop and implement training activities.
Figure 4.1 provides a schedule for these activities. Table 5-1 was developed in order to estimate
the resources required for FY09, but was based on the personnel and the sites that will be
running in the full Pb air monitoring network. Important points about the FY09/10 estimates
follow:
Samples -Based on initial estimates of the size of the Pb monitoring network and the
distribution of Pb-monitoring sites within PQAOs, it is estimated that about 300 samples (-70
Pb-PEP and -230 collocated) will be collected each year if all PQAOs utilized the federal Pb-
PEP.
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Table 5-1 Pb-PEP Cost Estimate for FY2009 and FY2010
Field Capital Consiimmahle Costs Needed
Samplers (2/Region + 2 RTF) 22
Calibration Kit (1/Region
Shipping Containers
Filters
Standard Recert
Misc/Maintenance
Field Implementation
Training
Implementation
Prep/Reporting/Eval
Travel
Sample Shipping
Gas
Lab Costs
Analysis
Equipment
Miles/audit
300
Samples
300
SOP/QAPP
Data Base Management
+• 1 RTP)
Number
12
70
70
70
Number of
audits
70
Cost*
/Sample
110
11
50
120
11
10
Hours
20
13
4
Cost /unit
5000
2000
10
S.5
165
1000
S/hour
60
60
60
Flight
375
Samples I/shipment
70
Total
Miles
21000
Hours
160
e
Miles per
Gal
15
$/hour
120
Number of
Gal
Sub Tot
Hotel/Per
390
240
$/gal
1400 2.5
Sul) Tot.
Sub Tot
FY09
Cost
$110,000
$22,000
FY10
Cost
$500
$1 ,020 $1 ,020
$10,000
$143,520
$10,000
$30,000
$19,200
$59,200
PI) Pep Total $202,720
$1,815
$20,000
$22,835
$23,5BO
$75,600
$16,800
$16,800
$560
$2,625
$135,%5
$33,000
$5,000
$5,000
$43,000
$201.300
Field capital equipment - Capital equipment costs for the field include portable audit sampling
devices, verification standards, miscellaneous equipment (travel boxes etc.), consumables
(filters, gloves), information management devices, and transportation. Two portable samplers
will be purchased for each Region since it is possible that a field scientist may utilize two
portable samplers in one day (sites in close proximity) and it is important for each EPA Region
to have minimally one spare sampler.
Field Implementation - Field personnel used for the PM2.5 PEP will be trained and certified for
the Pb-PEP. The sample collection activities between the two programs will be very similar.
EPA made the assumption that about 50% of the trips scheduled for Pb-PEP will include a PM2.5
PEP and therefore travel costs can be shared between to two programs. Therefore, training and
implementation costs are reduced by 25% for the Pb-PEP.
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Lab Costs - Region 9 ESAT personnel provide routine analytical services for the Region which
includes metals analysis for soils and water. Costs for Pb analysis by ICP-MS are estimated at
$110.00/sample. The cost includes sample preparation through data reporting and is comparable
to other analytical laboratories. Since the Region was not doing air sample analysis,
approximately $20,000 was provided to develop standard operating procedures, to undergo
federal equivalent method acceptance testing and application procedures and to assist OAQPS in
the development of the laboratory portion of the QAPP.
Laboratory capital equipment - Since the laboratory already conducts this type of analysis, a
limited amount of extraction/analytical equipment and consumables are needed. Start-up costs
for equipment/consumables have been estimated at $10,000 and $5,000 in the out years.
5.2.2 FY2101- Year 1, Implementation (red font)
Table 5-1 also represents the resource estimate for the first year of implementation. FY2010 will
represent implementation of the PEP starting 1/1/2010 for the active sites within the fiscal year.
Important points about the FY2010 estimate follow.
Field and laboratory capital costs- The majority of the capital costs have been have been
allocated in FY09. Therefore the costs in FY2010 reflect field and laboratory consumable costs,
and the cost of having the flow rate standards verified at the EPA National Risk Management
Research Laboratory (NRMRL) Metrology Laboratory.
Field and laboratory FTE Costs - These cost make up the majority of costs and should be
constant from year to year as long as the program is implemented at the federal level. It should
be noticed that for field implementation a number of 70 Pb-PEP samples is used since this
represents the 1 or 2 PEP audits that are implemented by the ESAT field scientists. However the
analysis costs use both these -70 PEP samples and the -230 collocated samples that are sent to
the national Pb-PEP laboratory from the monitoring organizations for a total of 300 samples.
Shipping - Next day shipping to the laboratories and ground shipping from the laboratories will
be an expense incurred in FY2010. Since shipping will not require cold transportation, it will be
a nominal expense.
Total Costs per PQAO - Base on the data in Table 5-1, a preliminary estimate of the costs for
the Pb-PEP program for PQAOs with ^5 sites would be $3,300 (1 PEP 4 collocations) and
PQAOs with > 5 sites would cost $5,250 (2 PEP 6 collocations)
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5.3 Personnel
Personnel will be required for three types of activities: field implementation, filter analysis, and
standards certification.
In general, the PEP requires personnel with a degree in the environmental sciences, preferably in
atmospheric science. Due to the nature of the PEP and the care in which the sample filters must
be prepared and handled, personnel must be able to understand and follow standard operating
procedures (SOPs), document and communicate important information, and be able to make
decisions in situations that are not covered in SOPs. Clear verbal and written communication
skills are required. The following are brief descriptions of the duties for the three activities
mentioned above.
Field Scientist - are responsible for transporting a portable TSP federal reference method (FRM)
audit sampling device to an established Pb site which shall be located at any of the SLAMS/SPM
sites within each EPA Region. The field scientist shall be prepared for transport of the sampling
device in various environmental situations (e.g., various weather conditions, the tops of
buildings, distant rural settings). For ease of operations and the safety of the operators, the
portable audit sampler was designed in sections with each individual section not weighing more
than 40 Ibs. Field personnel must be able to lift/carry these sections up stairs and/or ladders.
Due to the nature of the sampler, ground transportation of the sampler is encouraged. Extensive
travel will be required of field personnel and flexible hours (10 hour days etc) may be necessary.
The field scientist will perform the following activities.
1. A yearly allotment of filters will be received from EPA. Receipt of the shipment should
be checked for gross damage, logged in, and stored in an appropriate manner.
2. The field scientist will contact the monitoring organization to ensure that they are aware
of a scheduled visit.
3. The field scientist will prepare filters and equipment for travel to the field site.
4. The field scientist will assemble the instrument, collocate the sampler, perform a
verification following SOPs, install a filter and operate the instrument to the same 24 hr.
sampling mode as the routine instrument (midnight to midnight).
5. If scheduling allows, the field scientist may leave this location to set up an additional 24-
hour performance evaluation at another routine sampling location or perform additional
activities at the site if so tasked.
6. The operator shall return to each site after 24-hour sampling period, download the stored
electronic monitoring data, and enter additional information as required, remove and
properly store the filter for transport, and disassemble the instrument.
7. The operator shall properly package the filter following the chain-of-custody procedures
for transport to the Region 9 laboratory.
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Filter Analysis Personnel - The personnel at the filter preparation laboratory have the following
duties:
1. Laboratory supplies and consumables- The laboratory will maintain supplies and
consumables necessary for preparation and analysis of TSP and PM10 filters (47 mm
Teflon).
2. Filter receipt -Laboratories will receive filters either by mail or carried in by the field
scientist. The filters will be logged in following chain of custody procedures,
checked for integrity, initially entered into the laboratory information management
system (LIMS) and appropriately stored until ready for analysis. Field data for each
sample will also be checked to ensure completeness and this information will either
be entered or downloaded into the LIMS.
3. Filter extraction and analysis- Each month, filters not yet analyzed will be batched
as appropriate, extracted and analyzed according to SOPs.
4. Filter data entry and preparation for field activities or storage -Filter post-field
information and necessary data from extraction and analysis will be entered on data
entry sheets or in the LEVIS along with appropriate QA/QC. Checks of QA/QC
information will determine corrective action.
5. Concentration calculation-The LEVIS will be used to calculate final concentrations
in • g/m3.
6. Quality Assurance -Quality assurance and quality control samples will be included
in each run of routine samples. This information will be reviewed to verify and
validate routine data.
7. Data transfer to AQS-Once data validity is assured, the data will be uploaded to the
AQS system via AQS data upload protocols.
Standards Certification Personnel- A laboratory will be dedicated to certifying flow rate,
temperature and barometric pressure transfer standards. Standards certification personnel
will have the following duties:
1. Primary standard certification - will ensure that the primary standards used in the
certification laboratory will be compared to a NIST primary standard once a year.
2. Instrument receipt - transfer standards will be received by each EPA Region.
Certification lab personnel will log in the instruments and inspect them for damage.
3. Standards verification - will compare the transfer standards against the primary
standards per SOPs.
4. Documentation/communication- will document all verifications via hardcopy or
electronic records and appropriately file this information.
5. Instrument distribution- will distribute transfer standards and verification
information back to appropriate Regional offices.
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5.4 Equipment
5.4.1 Field Equipment
Table 5-2 represents the equipment required for the field. Most of the equipment needed for
the Pb-PEP is already available in the Region since the equipment needs are very similar to
the PM2 5 PEP. OAQPS will purchase the TSP filters (through the national filter procurement
contract), the portable audit samplers and transport containers, and the flow/temperature
pressure verification devices and will develop the field data sheets and the chain of custody
sheets. The remaining equipment will be purchased at the regional level. The use of trade
names or vendors does not constitute an endorsement by the Agency.
Table 5-2 Field Equipment List
Activity
Initial Set-up
Checks
Maintenance
Operation
Data Transfer
Required Equipment
Knife
Tool kit (screw driver, pliers, etc.)
Transfer standards (1 per region)
Watch/clock check device
Cleaning solution
Soft bristle brush
Cotton swabs
Cleaning cloth
Distilled water
Isopropyl Rubbing Alcohol
Clipboard/log book
pencils
permanent marker
FRM portable audit sampler (1)
Backup FRM portable audit samplers (1)
Sampler transport carrying cases (1 set)
Ropes
Folding ladder
Gloves (powder free)
Forceps
Data down loader device
Laptop computer
Field data sheets
Chain of custody sheet (COC)
TSP filters
Field blank filters
Packing envelope for filters
Anti Static ziplock bags (13"x9") for samples
Plastic ziplock bags for field and COC sheet
Pre-labeled Federal Express Packages
Modem
Data Logger
SD Memory Cards
SD Memory Card Reader
Identified Source
Available through PM 25 PEP
BGi Hi-Vol calibrator Performs
flow/temp/pressure
Available
Available through PM 25 PEP
Available through PM 2.5 PEP
Available through PM 25 PEP
Available through PM 25 PEP
Available through PM 25 PEP
Available through PM 2.5 PEP
Available through PM 2.5 PEP
Available through PM 25 PEP
Available through PM 2 5 PEP
Available through PM 25 PEP
Available through PM 25 PEP
Available through PM 25 PEP
Available through PM 25 PEP
Available through PM 25 PEP
Sandisk (1 GB)
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DRAFT
5.4.2 Lab Equipment
Table 5-3 represents a listing of the equipment and consumable required by the Region 9
laboratory. Costs associated with some of the equipment are estimates. The use of trade
names or vendors does not constitute an endorsement by the Agency.
Table 5-3 Laboratory Equipment List
Activity
Preparation
Analysis
Description
Hot Block Digestion System
Pipettors
Pipettes
Nitric Acid (HNO3), concentrated
Gloves
Tweezers
Polypropylene Digestion Vessels
Ribbed Watch Glass,
Polycarbonate Transfer Racks
Paper cutter or scissors
Plastic or Teflon wash bottles
Glass Fiber Filter
Teflon Filters
ICP-MS
Autosampler
Autodilutor
Peristaltic Pump
Refrigerated Circulator
Argon gas supply
Auto-sampler tubes
volumetric flasks,
volumetric pipettes
storage bottles
Automatic pipettes
disposable pipette tips
Details
variable volume for dispensing reagents and acids
calibrated fixed volume and digital variable volume with appropriate plastic
ACS Reagent Grade or better, suitable for trace metals analysis.
Environmental Express P/N SC505 or equivalent
Environmental Express P/N SC505 or equivalent
Environmental Express P/N SC200 or equivalent
EPA National Filter Procurement
EPA National Filter Procurement
Perkin Elmer Elan DRC Plus
Cetac Autosampler, or equivalent
Cetac Autodilutor, or equivalent
Gilson MinipuIsS Peristaltic Pump, or equivalent
Polyscience 6105 - Refrigerated Circulator, or equivalent
high-purity grade, 99.99%
Class A graduated cylinders, and funnels (glass and/or metal-free plastic)
Class A
Narrow-mouth with screw closure, 125-mL to 1-L capacities
capable of delivering volumes of 10 to 1 ,000 [iL
Metal-free
5.5 SOPs, QAPPs and Other Documentation
OAQPS is utilizing internal funds to develop the Pb-PEP Implementation Plan, the field
SOPs and the majority of the QAPP. It will utilize STAG funds and contractor support for
the development of the laboratory SOPs and the laboratory portion of the QAPP.
5.6 Training
One annual training/certification session is anticipated for field activities. Since Region 9
already has developed the capability to perform Pb analysis, a training session for analysis is
not needed. STAG funds will be allocated for each field scientist to attend the field training
session. Training is discussed in more detail in Section 9.
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6.0 LOGISTICS
Logistics is defined as the science dealing with procurement, maintenance and transport of
materials, facilities and personnel or the handling of the details of an operation. This section will
focus on these activities to ensure proper implementation of the Pb-PEP. The logistics of the Pb-
PEP will be an integrated effort by all affected participants. Table 6-1 suggests how the logistics
will be outlined.
Table 6-1 Logistical Support
STAKEHOLDER
OAQPS
Regions
ESAT Contractors
ESAT Division
Monitoring Organizations
LOGISTICAL SUPPORT
Provide STAG funding, regulations, guidance, SOPs, training,
contractual vehicle support, support for the development of the
calibration laboratory data analysis.
Provide support for the development of the Regional laboratory,
provide project officers and task monitors, provide oversight, ensure
communications with monitoring organizations and OAQPS
Provide trained personnel with administrative support
Provide liaison support between OAQPS and the ESAT contractors
Provide operational support of the monitoring network, develop site
criteria, ensure operator is present during performance evaluation
The logistical support issues will be detailed in the Quality Assurance Project Plan, standard
operating procedures, and other guidance documentation which is under development and
designed specifically for the Pb-PEP. The logistical issues in general terms will address the
following concerns:
1 Program Initialization:
2 Field activity:
3 Laboratory activity:
One-time set-up activity such as equipment purchasing and
distribution, development of guidance documentation, and
training.
Pre-trip planning including site selection, visit scheduling,
monitoring organization notification, travel arrangements,
and implementation.
Regional support for the laboratory including
communications, preparation and implementation activities
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6.1 Program Initialization
The following logistics issues will be covered during the planning stages of the Pb-PEP.
6.1.1 Contract/task negotiation and funding
OAQPS will work with the Superfund ESAT Contracts Management Office to negotiate the
appropriate scope of work. Time lines for these activities are found in Figure 4.1. OAQPS will
be responsible for providing a description of the personnel requirements, and developing a draft
and final scope of work that will be reviewed and approved by the ESAT TOPO/DOPOS/RPOs.
6.1.2 Equipment
Equipment Selection, Purchase and Inventory
Lab equipment- The Region 9 laboratory has the appropriate laboratory equipment (see Table
5.5). The Regional DOPO will develop an initial inventory of the equipment, spare parts, and
consumables purchased. During implementation, the ESAT lab contractors will keep a running
inventory of spare parts, consumables and any additional capital equipment purchases which will
be available for TOPO/DOPO review. Inventories of consumable equipment should not get
below a 2 months supply.
Field equipment- OAQPS, with review from the Pb-PEP ESAT Workgroup, will select the
appropriate field capital equipment and consumables (see Table 5-4) within the timelines
provided in Figure 4.1. This equipment will be distributed to the Regions by November, 2009.
During implementation, the ESAT field contractors will keep a running inventory of
consumables and any additional capital equipment purchases which will be available for
TOPO/DOPO review. Inventories of consumable equipment should not get below a 2 months
supply.
Field transportation- Ground transportation for field personnel have been funded with STAG
resources that will transferred to ESAT Office for acquisition. Vehicles used in the PM2.5-PEP
will be shared for the Pb-PEP activity. Once vehicles are selected the ESAT contractors will be
responsible for maintenance.
Sample filters- OAQPS has a national contract for filters. Filters will be purchased by OAQPS
and sent to the 10 EPA Regions.
6.1.3 Operating Procedures
Standard operating procedures for both the field and laboratory activities will be developed by
OAQPS and the Region 9 laboratory and reviewed and approved by the ESAT Workgroup.
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DRAFT
Drafts that will be adequate to initiate the ESAT work assignment will be completed in July with
final SOPs completed as indicated in Section 4.
Field SOPs- The field SOPs would include procedures on:
• Equipment inventory/maintenance
• Preparation
• Communications (Regions/ State and locals)
• Equipment set-up/take-down
• Calibrations
• Sample handling, chain-of-custody
• Sampling
• Data entry/transfer
• Sample shipping
• Documentation/filing
• QA/QC activities
Lab SOPs- The field SOPs would include procedures on:
• Equipment inventory/maintenance
• Preparation
• Communications (Regions/ State and locals)
• Calibrations
• Filter conditioning
• Filter shipping (to field)
• Filter handling, chain-of-custody, archiving
• Pre-sampling and post-sampling weighing
• Data entry/transfer
• Documentation/filing
• QA/QC activities
6.1.4 Training
Field Training - The field training session will be combined with the annual PM2 5 PEP
training/certification session. A formal training schedule/agenda will be developed by the end
of October, 2009. The ESAT field contractors will be trained on the SOPs in the areas
mentioned in the previous section above. Trainers will include OAQPS personnel and
contractors who have developed the SOPs. It is anticipated that field training will be a 2-day
event devoted to hands on training and testing/certification. TOPO/DOPOs will also participate
in the training activity as well as any monitoring organizations that may be self-implementing the
program.
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6.2Field Logistics
6.2.1 Site Selection-
The SLAMs/SPM sites that are scheduled to be up and running by 1/1/2010 will be the pool of
sites from which the initial audit sites will be selected. Although an evaluation will eventually be
performed on all sites, the performance evaluations should be initially implemented at sites that
have or are expected to have concentrations around the NAAQS. Also, since it is cost effective
to perform Pb-PEP and PM2 5-PEP audits in the same week (to allow cost sharing between the
programs), thought should be given to selecting PM2.5 and Pb sites in close proximity to one
another.
Monitoring organizations will be asked to select the sites they feel meet the criteria above and
provide a list of sites for the evaluations conducted in each calendar year on or before October 1,
of the previous year. The Regional WAMS, with the assistance of the ESAT contractors, will
attempt to determine the most efficient site visit schedule. This schedule should be based upon:
1. the criteria in CFR
2. meeting the schedule set up for the routine sampler being evaluated.
3. the sites that are closest in proximity to each other (can be visited within the same day or
week)
For each site, a Site Data Sheet will be developed that contains information such as:
AQS Monitor Site ID Monitor ID
Method Designation Monitor Make and Model
Site Coordinates Site Type
Reporting Organization Reporting Organization Contact
Street address Directions to the site (from Regional Office)
Directions to the site from major thoroughfare Safety concerns
Additional equipment needed (ropes, ladders etc.) Closest Hospital (address)
Closest Express Mail Facility Closest Hardware Store
Recommended Hotel (address) Important free form notes
Closest site 2nd closest site
This information listed above can be placed on one sheet and included in a site file (filed by AQS
Site ID) and in a site notebook for each field scientist. Software such as MapQuest® (Internet
accessible) can help provide information on directions to sites. In addition, maps for each state
and city where a monitor is located will be acquired. Sites can be placed on these maps along
with the site IDs,
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6.2.2 Field Visit Scheduling
Based upon the site selection criteria, an implementation schedule will be developed for each
calendar year by mid-December of the previous year that will be disseminated to each
monitoring organization. The schedule will be based upon the number of evaluations that can be
practicably completed in a week. For example there may be areas where a number of sites can be
evaluated on the same day whereas other areas that are so remote that only one site will be
visited. Since there may be more than one task that can be implemented at a site, during the
development of the site visit schedule, the tasks that will be implemented at each site during that
visit will be identified by the TOPO/DOPO and identified on the schedule.
During Pb-PEP implementation, the ESAT personnel and TOPO/DOPO will meet regularly to
discuss progress as it relates to the site schedule. The schedule will be updated as required and
monitoring organizations will be contacted as the schedule changes.
One week prior to an evaluation visit, the field scientist and/or TOPO/DOPO will contact the
monitoring organization to make them aware of the visit and ensure the routine monitor is
operating on schedule and to find out if there are any particular site access problems where
special equipment will be needed (ropes, ladders etc.). Details, such as where and when to meet
the routine operator, will be discussed.
6.2.3 Field Sampling
Filter Receipt -
The EPA Regions will receive a years supply of TSP filters from OAQPS. The field scientist
will inspect the filters thoroughly for defects. If a large percentage of filters are failing the
inspection, OAQPS should be immediately notified and the defective filters shipped back.
Field Preparation -
Prior to a evaluation excursion for the week, and based upon the number of sites to be visited, the
sampling equipment and consumables will be inspected to ensure proper operation and adequate
supplies. At least one spare portable monitor should be on hand. Filters will be selected and
stored appropriately (per SOPs) for transport to the sites. Filter chain-of custody forms should be
started and the filters should be checked to ensure integrity. Site data sheets should be available
for each site. For initial visits, some of the information on the site data sheets may be blank and
must be completed during the first visit. The field scientists will review the site schedule to be
sure that they understand which tasks will be implemented at the sites they are visiting that week.
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Field Implementation--
Field scientists will travel to the sites and contact the person (typically the site operator) that will
allow them access to the monitoring site. The portable FRM monitors will be transported to
within 2-4 meters of the routine monitor, set-up and calibrated per the SOPs. Filters will be
installed and the monitor set to run on the required midnight-to-midnight schedule. The field
scientist will then either perform additional tasks as required at this site or proceed to another site
for sampling. If there are any delays in the sampling schedule, the ESAT field scientist will
contact the affected monitoring organization(s) and also contact the Regional TOPO/DOPO.
Upon completion of sampling, the field scientist will return to the site(s), download the data per
SOPs, remove the sampling filter, visually inspect the filter and store it appropriately for
transport to the laboratory. During data download it is suggested that the field scientist and the
routine operator exchange or compare monitor download information. This would help
determine that the monitors were operating properly and were indicating the same sampling
conditions. Each field scientist will have a portable laptop and/or data logger. Either hardware
device may be used to download monitor information but it will eventually need to be stored on
the laptop. A flash drive of this information is required to be sent to the national laboratory
along with the filters, field data sheets and chain of custody. The field data sheet and chain of
custody form can be found in Appendix B.
Safety- Safety in the field is of primary importance. Sites should not be visited or set-up in
conditions that are deemed unsafe. Unsafe conditions include weather as well as monitoring
platforms where the field scientist feels that he/she cannot transport or set up the monitor without
jeopardizing their personnel safety. If these situations arise, the field scientist should document
this so mechanisms can be instituted to make the platform safely accessible for a performance
evaluation. The field scientist should also know where the closest emergency facilities are
located. This information should be included on the site data sheet.
Filter Transportation--
It is important that the filters be properly stored and transported to the national laboratory as soon
as possible. It is suggested that filters be shipped via next day express mail the same day that
they are removed from the monitors. Copies of the field data sheet, chain-of-custody form and a
diskette of the monitor information will be included in the shipment.
OAQPS will utilize a blanket contract with a next day delivery vendor. The locations of the
closest shipping centers will be identified for each site. Preprinted shipping labels will be
developed for the field scientist. The field scientist will keep a copy of the chain of custody form
which would include the number of containers shipped and the air bill number. The day of
shipping, the field scientist will inform the national laboratory of the shipment and provide the
laboratory with the number of containers shipped and the air bill number.
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Return to Station—
Upon completion of a sampling excursion the field scientist will return to the Regional Office.
The field scientist will ensure all equipment and consumables are properly stored and determine
if resupply or equipment maintenance is required. An electronic copy of the weeks' field
information will be transferred to the TOPO/DOPO. Vehicles will be serviced as required. The
field scientist will debrief the TOPO/DOPO on the field excursion including whether the site
visits remain on schedule.
6.3 Laboratory Logistics
6.3.1 Preparation
From the months of June through December 2009, the Region 9 national laboratory will be
preparing for routine implementation of the Pb-PEP. OAQPS will coordinate a conference call
with Region 9 laboratory to ensure activities are on track for implementation in 2010.
All equipment and consumables for laboratory implementation will be at the laboratory by
November 2009. The laboratory personnel will be responsible for developing and maintaining
an equipment, spare parts, and consumable supply lists. During implementation, inventories of
consumables should not go below a 2 months supply.
6.3.2 Laboratory Implementation
Laboratory logistics activities during implementation include
• Communications
• filter receipt
• sample tracking
The laboratory implementation activities as they relate to filter extraction and analysis will be
covered in the Pb-PEP laboratory SOPs.
Communications—
During Pb-PEP implementation, the TOPO/DOPOs will be in communication with the
laboratory personnel as deemed necessary. OAQPS will continue the monthly ESAT Workgroup
conference call which will include the appropriate laboratory personnel. In addition to these
regular communications, laboratory personnel will inform TOPO/DOPOs if problems arise in
the laboratory aspects of the program.
The laboratory personnel will also have communications with the Regions they are supporting.
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DRAFT
Filter Receipt -
The laboratory will not only receive Pb-PEP filters from the ESAT Field scientists but will
receive 4 to 6 collocated filters directly from the monitoring organizations. Each year OAQPS
will develop a listing of PQAOs that have SLAMS/SPM Pb monitoring sites that will require the
implementation of Pb-PEP and be shipping the laboratory collocated sample filters. The
laboratory will use this list to ensure they are receiving filters within the appropriate timeframe.
If not, the laboratory will contact the EPA Region TOPO/DOPO who will follow up with the
PQAO.
Sample Tracking-
The laboratory shall track filters from sample receipt to AQS upload using Table 6-2. All filters
that are received will be placed on this tracking form. If filters are voided for some reason along
the process, a flag should be included on the form. The Tracking Form should help inform field
scientists, EPA Regions and monitoring organizations at what stage of implementation a filter is
undergoing. Based upon the concepts for the LIMS (see Section 7) the information on this form
will be included on other data entry screens and therefore the Filter Tracking Form will simply
be a reporting feature. This form may be posted to AMTIC on a monthly or quarterly basis.
Table 6-2 Filter Tracking Form
Filter Tracking Form
Filter
ID
Region
PQAO
PEP Filter (P)
Collocated
Filter (C)
Sample Date
Laboratory
Receipt Date
Sample
Analyzed
AQS
Upload Date
Flag
Laboratory Maintenance-
A maintenance list will be developed for all sensitive capital equipment. The list will contain the
item, its maintenance schedule and date columns that will be filled in when scheduled or
unscheduled maintenance is performed. This list will be included in the laboratory SOPs and Pb-
PEP QAPP.
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DRAFT
7.0 DATA MANAGEMENT
Success of the Pb-PEP rely on data and their interpretation. It is critical that data be available to
users and that these data are:
• Reliable
• Of known quality
• Easily accessible to a variety of users
• Aggregated in a manner consistent with it prime use.
In order to accomplish this activity, information must be collected and managed in a manner that
protects and ensures its integrity. This encompasses multiple activities including: where data is
produced, how it is transferred and archived, the various levels of validation, and ultimately, how
decision makers will evaluate the data. In order to perform these multiple activities a laboratory
information management system (LIMS) will developed. The Region 9 Pb-PEP LEVIS will be
run on local area networks with appropriate security and back-up safeguards.
Most of the data collected from the Pb-PEP will be collected through automated systems at
laboratory. These systems must be effectively managed by using a set of guidelines and
principles by which adherence will ensure data integrity. The EPA has a document entitled
Good Automated Laboratory Practices (GALP). The GALP defines six data management
principles:
1. DATA: The system must provide a method of assuring the integrity of all entered data.
Communication, transfer, manipulation, and the storage/recall process all offer potential for
data corruption. The demonstration of control necessitates the collection of evidence to prove
that the system provides reasonable protection against data corruption.
2. FORMULAE: The formulas and decision algorithms employed by the system must be
accurate and appropriate. Users cannot assume that the test or decision criteria are correct;
those formulas must be inspected and verified.
3. A UDIT: An audit trail that tracks data entry and modification to the responsible individual is
a critical element in the control process. The trail generally utilizes a password system or
equivalent to identify the person or persons entering a data point, and generates a protected file
logging all unusual events.
4. CHANGE: A consistent and appropriate change control procedure capable of tracking the
system operation and application software is a critical element in the control process. All
software changes should follow carefully planned procedures, including a pre-install test
protocol and appropriate documentation update.
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DRAFT
5. STANDARD OPERATING PROCEDURES (SOPS): Control of even the most carefully
designed and implemented systems will be thwarted if appropriate procedures are not followed.
The principles implies the development of clear directions and Standard Operating Procedures
(SOPs); the training of all users; and the availability of appropriate user support documentation.
6. DISASTER: Consistent control of a system requires the development of alternative plans for
system failure, disaster recovery, and unauthorized access. The control principle must extend to
planning for reasonable unusual events and system stresses.
The principles listed above apply to both the Region 9 LIMS and the central information
management systems (AQS).
7.1 Performance Evaluation Data Collection
The Pb-PEP is dependent upon the collection of quality data which will come from several
different sources, such as the Pb-PEP field and laboratory activities as well as the field and
laboratory data collection activities for the routine sampling activities where a PE was
performed.
Each of the individual stakeholders are responsible for collecting quality data from their area of
influence and distributing the data to the appropriate participant. Table 7-1 represents the data
management structure for the Pb-PEP.
Table 7-1 PEP Data Management Structure
STAKEHOLDER
Regions
Monitoring organization field
monitoring staff
Field Performance Evaluation
Operator
State/local agency laboratory
staff
TYPE OF DATA
Sites to participate in the
performance evaluation for the
year
Filter ID from the operation of
their Primary Pb monitor, AQS
site ID, POC, and Method Code.
Note: Method Code can be
determined if sampler make and
model are known.
Chain of custody information for
collocated sample.
Data from the operation of the
FRM portable audit sampler
Routine sample data
DISTRIBUTION
-To monitoring organizations
-To ESAT contractor
-To the ESAT field scientist during Pb-PEP
-To Region 9 laboratory
-To Region 9 laboratory
-To Regional TOPO/DOPO
-To monitoring organization staff.
Use same distribution and validation procedures
as all other Pb data produced by the monitoring
organization, then uploaded to AQS.
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DRAFT
STAKEHOLDER
Performance Evaluation
Laboratory Analyst
Performance Evaluation
Laboratory Manager
TYPE OF DATA
Pb Laboratory Data
Comprehensive Performance
Evaluation Reports
DISTRIBUTION
-To LIMS
-To AQS
-To EPA Regions
-To monitoring or£
-To OAQPS
'anization QA Manager
7.1.1 Pb Performance Evaluation Portable Sampler Data
The Pb portable sampler, once appropriately programmed, provides all the required data that
needs to be collected by the field scientist with the exception of the filter ID. Data download
will be accomplished by utilizing either a lap top computer or data download link just after
recovery of the performance evaluation sample. Additional information may be documented
to supplement the information collected automatically. Once the standard fields that will be
automatically generated by the Pb portable sampler are downloaded to the field laptop, the
filter ID, and AQS site ID and any freeform notes about the sampling activity will be input.
7.1.2 Pb Primary Sampler Data
The primary sampler will be operated in accordance with its normal operational schedule.
The data acquired by the routine field operator will follow its normal path as detailed in the
monitoring organizations QAPP and SOPs.
7.1.3 Performance Evaluation Laboratory Data
The performance evaluation laboratory will be operated by ESAT personnel according to the
appropriate laboratory SOPs. The data acquired by the laboratory will be collected and
validated as detailed in the Pb-PEP SOPs and QAPP. The data will be handled by a
management information system that acquires data both manually and automatically.
7.1.4 Routine Laboratory Data
The routine laboratory will be operated in accordance with its normal operational procedures.
The data acquired by the laboratory should follow its normal path as detailed in the
monitoring organizations QAPP and SOPs.
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DRAFT
7.2 Performance Evaluation Data Transfer and Archiving
Data transfer and archiving in the Pb-PEP will take place at multiple levels. Table 7-2 presents
information such as where various data are produced, and how/when it will be
archived/transferred.
Table 7-2 Data Transfer and Archiving
Data Produced
Performance Evaluation Field Sampler Data
Performance Evaluation Laboratory
How to Archive
Download each field data set to lap-top
computer or data link.
Archive data to second computer at
main field office
Back-up of database occurs each night
as per laboratory computer network
storage procedures
When to Transfer
Transfer data via flash drive with
each sample to Region 9
Laboratory. Data will also be
transferred via modem.
Validated data to AQS once a
month
Concentration data will be uploaded to the AQS database in a Precision & Accuracy Transaction.
This transaction will be one that will allow for reporting of P&A data without having both
concentration values available at the same time.
7.3 Information Management Flow
Figure 7.1 provides a flow of the information management system for the PEP. In general,
hardcopy/electronic information will be collected at various stages of the field and laboratory
procedures. The field information will be stored at both the Regional field office and in Region
9. The required AQS fields, once verified and validated will be uploaded to AQS where it will
be compared with the routine data that has been uploaded from the State and local agencies. The
Pb-PEP QAPP will provide the details of this procedure.
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DRAFT
Sample collection
and
data download
Region 9
Lab LIMS
Data Transfer
'
AQS
n n a a
n a a a
Field data: Sample,
Flash drive,
COC, field data sheet
Sample Receipt
Sample Login
Data transfer
Sample Analysis
Yes
Data Validation
Entry
Field
Office
1
Sample Storage
(pre-analysis)
Sample Storage
(post-analysis)
* 3
Legend
Sample
Paper
Electronic-
Data
Figure 7.1 Pb-PEP Information/Sample Flow
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DRAFT
8.0 QUALITY ASSURANCE/QUALITY CONTROL (QA/QC)
8.1 Overview
An important concern in any organization that is collecting and evaluating environmental data
must be the quality of the results. A quality system must be developed and documented to ensure
that the Pb monitoring, in general, and specifically the Pb-PEP evaluation results:
• meet OAR's regulatory and scientific data needs;
• satisfy customers expectations;
• comply with applicable standards and specifications;
• comply with statutory (and other) requirements, and
• reflect consideration of cost and economics.
A quality system is a structured management system describing the policies, objectives,
principles, organizational authority, responsibility, accountability, and implementation plan of an
organization for ensuring quality in its work processes, products, and services. The Pb-PEP is a
QA/QC procedure that is part of the quality system of the Ambient Air Quality Monitoring
Program. However, the Pb-PEP must be able to evaluate and control the data quality within its
own environmental data operations. Therefore, QA/QC procedures must be developed for the
PEP. The following are key assumptions or ideas that should be kept in mind:
• The DQO Process drives the quality system- The DQO Process for the Pb program
established the acceptable risk (decision error) for total bias at + 15%. The Pb-PEP data
will be used to assess total bias. Therefore, EPA must control the quality of the Pb-PEP
data so that this bias estimate can be made within a specified level of confidence.
• QA/QC activities are required to evaluate and control Pb-PEP measurement
system bias and precision- The measurement system represents all data collection
activities, from the field through data reduction and reporting to AQS. At each phase of
this process, errors can occur. Development of QA/QC activities are necessary in order
to understand where these errors are occurring, determine their magnitude, and to
improve data quality.
• Independent assessments and internal quality control are important- Development
of QA/QC activities requires both components. An independent assessment provides an
objective review of the Pb-PEP measurement system. Technical system audits would be
considered independent assessments. Internal quality control includes types of samples
that allow personnel implementing the measurement system real-time information to
evaluate and control measurement error in order to meet the DQOs. Collocated PE
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samples and the use of various blanks and duplicates will be used to control various
phases of the measurement system.
• QA data represents routine data precision and bias- The intent of a good quality
system is to collect enough precision and bias information to adequately represent the
measurement uncertainty of the routine Pb-PEP data with a specified degree of
confidence.
To assure the quality of data from air monitoring measurements, two distinct and important
interrelated functions must be performed. One function is the control of the measurement
process through broad quality assurance activities, such as establishing policies and
procedures, developing data quality objectives, assigning roles and responsibilities,
conducting oversight and reviews, and implementing corrective actions. The other function is
the control of the measurement process through the implementation of specific quality
control procedures, such as audits, calibrations, checks, replicates, routine self-assessments,
etc. In general, the greater the control of a given monitoring system, the better will be the
resulting quality of the monitoring data.
The development of the QA/QC activities for the Pb-PEP requires a coordinated effort
between EPA Headquarters and Regions, and the monitoring organization community.
Elements of the QA/QC activities include planning, implementation, assessment, and
reporting. The topics within each element will be discussed in their perspective sections
This intent of this Section is to describe how the major phases of the Pb-PEP quality system
will be implemented, not to describe the detailed technical aspects or rationale for the quality
system. The quality system will be thoroughly described in the Pb-PEP QAPP. The
implementation strategy will discuss the following sections:
• QA Roles and Responsibilities
• Implementation
• Assessments
• Reporting
8.2 QA Roles and Responsibilities
The three major entities involved in the Pb implementation include the Federal organizations
(OAQPS and EPA Regions), monitoring organizations and ESAT Contractors. Following the
theme of planning, implementation, assessment and reporting, Table 8-1 provides a list of the
QA roles and responsibilities of these organizations. Table 8-1 illustrates that a number of
activities (e.g., DQOs, field/laboratory training) are shared responsibilities that will be discussed
and coordinated through the ESAT Workgroup.
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Table 8-1 QA Roles and Responsibilities
Pb QA Activities
Activity/Organiz ation
Responsibilities ( * indicates a contributing role of review/comment/or assistance)
Planning
OAQPS
EPA Regions
Monitoring Orgs
ESAT Contractors
QA Regs, DQOs, Implementation Plan, PEP QAPP, acceptance criteria, guidance
documentation, training program, field SOPs, lab SOPs*, management system reviews,
AMTIC
DQOs*, Implementation Plan*, PEP QAPP*, guidance documentation*, training*, field
SOPs*, lab SOPs, technical systems audit
PEP QAPP development*, program planning review*
Review of Work Plan, SOPs, PEP QAPP, QA related guidance
Implementation
OAQPS
EPA Regions
Monitoring Orgs
ESAT Contractors
field/laboratory training, ESAT Workgroup, AMTIC
ESAT WAM, QAPP approval, data reviews, quality control, corrective action , local
training
Routine monitoring including data verification/validation
Training certification, internal QC implementation, data verification/validation
Assessments
OAQPS
EPA Regions
Monitoring Orgs
EPA Metrology Lab
ESAT Contractors
Management systems reviews, technical systems audits, data quality assessments, critical
review reports
technical systems audits, data quality assessments
technical systems audits, data quality assessments
field standards verification
Performance audits, data quality assessments
Reporting
OAQPS
EPA Regions
Monitoring Orgs
ESAT Contractors
P&A reports, QA reports, Data quality assessments, MSR reports
Technical system audit reports,
Technical system audit reports, data reports
QA reports,
8.3 Planning
The majority of the QA planning efforts will initially occur with the OAQPS QA Team and the
ESAT Workgroup. These groups have contributed to the development of this Implementation
Plan.
8.3.1 Pb Data Quality Objectives
In FY2008, OAQPS implemented the DQO process in order to identify the bias and precision
required to make attainment/nonattainment decisions within a known level of confidence. The
goal for acceptable measurement uncertainty is defined for precision as an upper 90 percent
confidence limit for the coefficient of variation (CV) of 20% and bias as an upper 95%
confidence limit for the absolute bias of 15 % . The DQO process will be used by the OAQPS
QA team to develop the implementation requirements for Pb-PEP and the acceptance criteria for
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various quality control samples implemented at the various measurement phases of the PEP data
collection effort (Tables 8-2 and 8-3)
8.3.2 Methods
In order to ensure consistent implementation of Pb-PEP environmental data operations, EPA will
develop draft field and laboratory SOPs by the end of July 2009 that will be available for review
and comment. Final versions will be completed by November 2009 before training activities.
8.3.3 PEP QA Project Plan
Planning for the development of the quality system will be implemented through the ESAT
Workgroup. The major planning document for this activity is the Pb-PEP QAPP. 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 or QAPP
prior to the start of data collection. The primary purpose of the QAPP is to provide an overview
of the project, describe the need for the measurements, and define QA/QC activities to be applied
to the project, all within a single document. Effective implementation of the QAPP assists
project managers in keeping projects on schedule and within the resource budget. Agency QA
policy is described in the Quality Manual and EPA QA/R-1, EPA Quality System Requirements
for Environmental Programs. In addition the EPA QA Management Staff has developed
guidance for the development of QAPPs. These documents can be found on the Quality Staff
Website1.
8.3.4 QA Training
Training will be discussed in Section 9.0. The field and laboratory training will include:
• Calibrations
• Quality control activities
• Corrective actions requirements
• Data verification/validation
• QA reporting
OAQPS will be responsible for implementing the QA training activities.
http://www.epa.gov/qualitv I/
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8.4 QA/QC Implementation
Table 8-1 presents a listing of the implementation responsibilities of the organizations
participating in the Pb-PEP. Implementation in the Pb-PEP quality system is defined as those
quality assurance activities that attempt to control and/or evaluate either the entire measurement
system or a phase of the system.
8.4.1 Verifications/Calibrations of Field Standards
Field standards (flow/pressure/temperature) will need to be verified and or calibrated once a
year. Verification is defined as confirmation by examination and provision of objective evidence
that specified requirements have been fulfilled. Verification of the accuracy of a standard is
established by (1) relating the output to a standard of higher authority and (2) demonstrating that
the repeatability of the transfer standard is within the limits. Calibration refers to the comparison
of a measurement standard, instrument, or items with a standard or instrument of higher accuracy
to detect and quantify inaccuracies and to report or eliminate those inaccuracies by adjustments.
The Pb-PEP QAPP will identify any equipment or instrumentation that requires
verification/calibration to maintain acceptable performance and will indicate the acceptance
criteria and the frequency of these calibrations along with corrective actions.
Verification/calibration activities follow a three step process:
1. Certifying the calibration standard and/or transfer standard against an authoritative
standard. This activity will be accomplished once a year by the EPA RTF Metrology
Laboratory. This laboratory currently verifies the PM2 5 PEP standards.
2. Comparing the standard against an OAQPS traveling standard that will be used to
verify the samplers one a year. The flow rate percent differences between the
verification standards and the traveling standard must be <4%
3. Comparing the standard against the routine sampling/analytical instruments. This
check will occur each day of sampling. Although this check is primarily used to
ensure the sampling instrument is operating properly, it can also be used as a check
against the standard since the standard can be also checked against the second
sampling instrument in the Region if the first is out of the acceptable range. If both
sampling instruments are out of acceptable range, one might suspect the standard.
As mentioned in bullet 1, EPA will utilize the EPA Metrology laboratory or standards
verifications. This lab will house a set of primary standards that will also be certified once a year
against NIST standards. The primary standards will then be used to verify the transfer standards
that are used in the field. The transfer standard laboratory will set up a schedule to receive all the
field transfer standards in the November/December time frame for verification
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8.4.2 Quality Control
Quality Control (QC) is the overall system of technical activities that measures performance
against defined standards to verify that they meet the stated requirements established by the
customer that are used to fulfill requirements for quality. Figure 8.1 represents the flow of some
of the more important QC samples that will be used to evaluate and control data quality at
various phases of the Pb-PEP. Field and laboratory personnel will implement these checks.
Field
Sampling
Field
Blank
Field QC
Checks
Routine |
Sample 1
| Collocated
• PEP Sample
PEP
Sample
Laboratory
Analysis
Field
Blank
Routine
Sample
I Collocated
| PEP Sample
Meas. System Instrument
Contamination precision/bias
Meas. System
Bias
Lab
Contamination
Lab
Precision/Bias
Figure 8.1 QC Sample Flow
Tables 8-2 and 8-3 summarize the criteria and frequency of the QC checks that will be used in
the laboratory and the field respectively. The PEP QAPP will describe the procedures for each
check, corrective actions and the statistical formulas for assessing the data.
Table 8-2 Laboratory QC Checks
Parameter
Correlation Coefficient
Instrument Calibration Verification
Continuing Calibration Verification
Calibration Blank
Second Source Calibration Blank
Quantitation Limit Standard
Method Blank
Lab Control Sample (LCS)
LCS Duplicate, Precision
Matrix Duplicate, Precision
Matrix Spike, Accuracy
Internal Standard
Audit Strips
(details in R9 Laboratory SOP)
Frequency
Each ICAL
After ICAL
Every 10 Samples
After each ICV/CCV
After ICAL
After ICAL & after every 40 analytical samples
Each Batch
Each Batch
Each Batch
(ForPM 10 Filter Only)
Every 20 samples
(For TSP Filter Strip Only)
Every 20 samples
(For TSP Filter Strip Only)
Every analysis
1/quarter
Criteria
> 0.995
90 - 110%
90 - 110%
< '/2 QL
90- 110%
60 - 140%
< '/2 QL
85- 115%
< 20 RPD
<20RPD
70 - 130%
60- 125% of initial CB
+ 10%
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Table 8-3 Pb-PEP Field QC
Requirement
Calibration Standards
Flow Rate Transfer Std.
Field Thermometer
Field Barometer
Sampling Instrument
Calibration/Verification
Flow Rate (FR) Calibration
FR multi-point verification
One point FR verification
External Leak Check
Temperature Calibration
Temp multi-point verification
One- point temp Verification
Pressure Calibration
Pressure Verification
Clock/timer Verification
Audits (Traveling Standard)
Flow rate audit
Temperature Audit
Pressure Audit
Blanks
Field Blanks
Precision Check
Collocated samples
Check Standards Verification
(Traveling Standard)
FR multi-point verification
Temp multi-point verification
Pressure Verification
Frequency
1/yr
1/yr
1/yr
If multi-point failure
1/yr
every set-up
every 5 sampling events
If multi-point failure
1/yr
Every set-up
If multi-point failure
Every set-up
Every set-up
1/yr
1/yr
1/yr
1 every 4 audits
2/year
1/yr
1/yr
1/yr
Acceptance Criteria
+2% of NIST -traceable
Std.
+ 0.1°C resolution
+ 0. 5° C accuracy
+ 1 mm Hg resolution
+ 5 mm Hg accuracy
+ 2% of transfer standard
+ 2% of transfer standard
+ 4% of transfer standard
80 mL/min
+ 2% of standard
+ 2'Cof standard
+ 4° C of standard
+10 mm Hg
+10 mm Hg
+ 5 min
+ 4% of audit standard
+ 2°C
+10 mm Hg
CV<20%
+ 4% of transfer standard
+ 2'Cof standard
+10 mm Hg
+ 5 min
8.5 Assessments
An assessment is an evaluation process used to measure the performance or effectiveness of the
system and its elements. For the Pb-PEP, assessments will include: technical systems audits and
management systems reviews. Table 8-1 indicates the organizations responsible for the various
assessments.
The quality system for Pb has been developed at three levels of oversight. Since EPA policy
states that data collected using the public resources must have a quality system in place and it
also states that quality assurance is an inherently governmental function, OAQPS and the EPA
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Regions have developed a quality system that will allow for independent assessments of the
quality assurance program at each level to ensure that the DQOs are met.
Technical Systems Audit (TSA) - A systems audit is an on-site review and inspection of a
monitoring organizations ambient air monitoring program to assess its compliance with
established regulations governing the collection, analysis, validation, and reporting of ambient
air quality data. The EPA Regions will perform technical systems audits of the field and
laboratory activities once a year. Key personnel to be interviewed during the audit are those
individuals with responsibilities for: planning, field operations, laboratory operations, QA/QC,
data management, and reporting.
To increase uniformity of the TSA, an audit checklist will be developed and included in the Pb-
PEP QAPP. It will review activities similar to the training certification forms but be more
detailed.
The auditor will prepare a brief written summary of findings, organized into the following areas:
planning, field operations, laboratory operations, quality assurance/quality control, data
management, and reporting. Problems with specific areas should be discussed and an attempt
made to rank them in order of their potential impact on data quality. For the more serious of
these problems, audit findings will be drafted from which corrective actions will be
implemented.
Management Systems Reviews (MSR) - This is a qualitative assessment of a data collection
operation or organization 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. This would allow OAQPS to assess consistency of operation among the
Regions and improve the quality system. The AAMG QA Team proposes implementing 2-3
management systems reviews each year of the EPA Regions on their implementation of the
Ambient Air Monitoring Program and will include a review of Pb-PEP activities.
8.6 Reporting
Many of the QC checks discussed above result in measurement data that can be used to compute
statistical indicators of data quality. The following types of reports are anticipated
Data quality assessment (DQA) -is the scientific and statistical evaluation to determine if data
are of the right type, quality, and quantity to support their intended use. The Pb-PEP QA/QC
data can be statistically assessed at various levels of aggregation to determine its quality. The
statistics to be used to evaluate bias are included in 40 CFR Part 58 Appendix A. A formal DQA
will be performed by OAQPS every three years.
P & A Reports - This reports will be generated annually and evaluate the precision and bias data
against the acceptance criteria using the statistics documented in 40 CFR Part 58. These reports
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will be generated through the AMP255 reports on AQS system and will be responsibility of
OAQPS. However, any person with AQS access can generate these reports at any time.
Assessment Reports - Technical systems audits and network reviews will be on file at the EPA
Regional office and OAQPS. The audit check sheets will be sent to OAQPS for central filing.
AQS will include an audit tracking area that will allow the placement of dates when an audit was
implemented. Management systems reviews will be on file in AAMG with tracking information
on AQS.
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9.0 FIELD TRAINING/CERTIFICATION OF PERSONNEL
Prior to implementation on 1/1/2010, all personnel involved in the field aspects of the Pb-PEP
will be trained. Personnel include EPA Regional TOPO/DOPOs, ESAT contractors and any
monitoring organization that are self-implementing the program. Field training for the Pb-PEP
will involve four phases:
1. Classroom lecture- will include an overall review of the Pb program and it's relation to
the Pb-PEP. Classroom lectures will also be implemented for each training module (see
below) but may be accomplished through remote training prior to hands-on activities.
2. Hands-on activities- After a class room lecture, personnel will be taken to the training
area where the field/lab activities will be demonstrated and then the trainees will perform
under instruction.
3. Certification-Written exam- a written test to cover the activities of importance in each
of the training modules.
4. Certification-Performance evaluation- this is a review of the actual field
implementation activities under evaluation by the trainer/evaluator.
In FY09, training is scheduled for the December time frame. In subsequent years, annual
training will be sometime between October and mid-December.
Field training is expected to last two full days; one day of lecture and hands-on, and one day
of training/certification. Trainers and trainees may be required to be available a third day for
any individuals requiring additional training.
Field Training Modules
Field training will be segregated into the following discreet modules:
• • Site visit scheduling
• • Communication
• • Equipment inventory and maintenance
• • Filter receipt/ storage/tracking
• • Calibration/verification
• • Monitor set-up/filter installation
• • Filter removal/storage/shipping
• • Data download/storage/transfer
•• QA/QC
• • Monitor diassembly/packing
• • Documentation /filing/records
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9.1 Certification
Certification will help to ensure that field personnel are sufficiently trained to perform the
necessary Pb-PEP activities at a level that does not compromise data quality and also inspires
confidence in the Pb-PEP by the monitoring organizations.
Both the written exam and the performance review are considered part of the certification
requirements. The written exam is gauged to a review of the more critical aspects of the Pb-
PEP and to identify where the individual requires additional training. The performance
review is focused on ensuring that the individual understands and follows the SOPs. The
trainer(s) will evaluate the trainees implementation of the field modules mentioned above.
The intent of the certification activities is not to fail individuals but to determine where
additional training is required in order to ensure that the Pb-PEP is implemented comparably
across the Nation. If there are enough individuals failing a particular module, it may also
indicate that the classroom or hands-on training were not appropriate. In any case, failure by
individuals of parts of either written or performance evaluation will indicate that additional
training in these areas are required. Trainees will be required to attend additional training on
these modules. Trainers will be available for an additional day of field/lab training and will
ensure personnel are certified by the end of the training session.
If the certification/retraining activities identify individuals that appear to be incapable of
performing the field/lab activities, the ESAT Regional Project Officers will be notified and
appropriate action will be taken.
9.2 Additional/Out Year Training
Each year a training/certification/recertification session will be scheduled which will cover
the majority of the field scientists needing certification/recertification. However, it is
expected that there will be contractor personnel turnover and therefore the need for additional
training beyond the annual training course. Since Regional ESAT TOPO/DOPOs will be
trained and certified along with ESAT contractors. These certified TOPO/DOPOs will be
given all training course material and will be certified to train additional ESAT personnel. In
addition, OAQPS will make available to the Regions an opportunity for training additional
personnel in RTF as long as schedules can be negotiated.
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Appendix A
Pb-PEP Adequacy and Independence Criteria:
Monitoring Rule Requirements and Supplemental Guidance
July 2009
The underlying document provides the most current adequacy and independence criteria for the
Pb-PEP. It is used to help monitoring organization decide to allow for federal implementation of
this program or to self-implement.
This attachment is a living document which will be reviewed annually and revised as needed.
Subsequent revisions will be posted as separate documents on AMTIC at
. A revision may not be necessary every year. Each
subsequent memo that announce the opportunity for monitoring organizations to assume their
performance evaluation programs will reference the most current revision to the Pb-PEP
Adequacy Document. Questions and Comments on this Document may be sent to Dennis
Grumpier, OAQPS lead for the PM Performance Evaluation Program.
crumpler.dennis@epa.gov . Please send a courtesy copy of your communication to your
respective EPA Regional Pb-PEP lead or Quality Assurance Manager.
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Pb-PEP Program Adequacy and Independence Criteria:
Monitoring Rule Requirements and Supplemental Guidance
Glossary (taken from the Current Field and Laboratory Operating Procedures)
AQS Air Quality System (EPA data base for ambient monitoring data)
COC Chain of Custody form
COR For EPA, the Contracting Officer's Representative on a given contract; he or she could be
a Work Assignment Manager (WAM), Task Order Delivery Officer (TOPO), or Delivery
Order Project Officer (DOPO)
ESAT Environmental Services Assistance Team
FS A field scientist is a person certified by the U.S. Environmental Protection Agency (EPA)
as completing a required training program as being capable and responsible for
conducting FRM PEs. That person would have a 2- or 4- year college degree in a
physical or life science or scientific instrumentation or have equivalent training or work
experience.
FRM Federal Reference Method
NIST National Institute of Standards and Technology
OAQPS Office of Air Quality Planning and Standards
Pb-PEP PM2.5 Federal Reference Method Performance Evaluation Program
PQAO Primary Quality Assurance Organization
QAPP Quality Assurance Project Plan
SOP Standard Operating Procedures
Overview of Monitoring Rule Requirements
• Monitoring plans or the QAPP shall provide for the implementation of a program of
independent and adequate audits of all monitors providing data for SLAMS and PSD,
including provisions of adequate resources for such audit programs. (40 CFR 58
Appendix A section 2.4). Starting January 1, 2009, this requirement also applies to SPM
monitors using FRM, FEM, or ARM methods which also meet the requirements of
Appendix E of 40 CFR 58, unless alternative QA procedures are approved by the
Regional Administrator. (Appendix A, section 1; 40 CFR 58.20; and 40 CFR
58.1 l(a)(2)) EPA interprets this requirement to apply only to SLAMS, PSD, and SPM
monitors that measure NAAQS pollutants.)
• Primary quality assurance organizations with 5 or fewer Pb monitoring sites are required
to have 5 valid independent audits per year; primary quality assurance organizations with
greater than 5 sites are required to have 8 valid audits per year. The implementation of an
audit similar to the PM2.5 Performance Evaluation program (PEP) is a new requirement
and it provides some assessment of overall bias but will be a mix of one or two Pb-PEP
audits with additional collocated sampling. The number of audits required is based on the
number of routine sites within a primary quality assurance organization PQAO. The
program will require the same number of audit samples as required for PM2.5 meaning:
o PQAOs with < 5 sites require 5 audits (1 Pb-PEP, 4 collocated)
o PQAOs with > 5 sites require 8 audits (2 Pb-PEP, 6 collocated)
• The regulation requires 100 percent completeness (meaning whatever it takes to get 5 or 8
valid samples).
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Guidance - General
• The general requirement for a program of independent and adequate audits means that
any monitoring organization implementing a Pb-PEP program must provide for
independence and adequacy for both field and lab implementation elements of the Pb-
PEP program.
• QAPP and SOPs for implementation will be reviewed and approved by the EPA Region.
• monitoring organization Pb-PEPs should have an adequate number of audit samplers,
including back-ups.
• If equipment is borrowed from the Regional Pb-PEP program, there must be some formal
agreement that the monitoring organization agency will repair or replace damaged
equipment in a timely manner.
• Since only 1 or 2 Pb-PEP-like audits are required, these will be scheduled as appropriate
throughout the year. However EPA would like to have the collocated samples collected
on a quarterly bases so at a minimum, 4 collocated samples would be collected quarterly
and if 6 are required, they would be interspersed in 2 of the 4 quarters.
• The implementation of the Pb-PEP program by monitoring organizations requires an
enhanced QA system for the Pb-PEP. Comparability between Federally-conducted and
monitoring organization Pb-PEPs is essential. Biannual collocations of all Pb-PEP
samplers in each Region are one of the critical QC activities in the Pb-PEP. These
"parking lot studies" provide
o First, a comparison of sampler performance;
o Second, a comparison of the technical performances of the monitoring
organization and the Region's personnel, and
o Third, a comparison of all Regions at the National level.
In addition to the collocations, annual TSAs of the monitoring organization programs will
be necessary, just as TSAs are necessary for EPA's ESAT-run Pb-PEP in each Region.
The EPA, via contractor support, will compile a nationwide Pb-PEP QA summary report
each year and will compile a 3-year report in the fourth year. These reports will include
comparisons of the collocations and TSAs Regionally and nationally as well as results of
the audits of the FRM network. The frequency of these reports will be re-evaluated
annually.
Independence of the monitoring organization Pb-PEP Program
40 CRF part 58 Appendix Section 2.2 states: "The monitoring organization must provide for a
quality assurance management function — that aspect of the overall management system of the
organization that determines and implements the quality policy defined in a monitoring
organization's QMP.. .The quality assurance management function must have sufficient
technical expertise and management authority to conduct independent oversight and assure the
implementation of the organization's quality system relative to the ambient air quality
monitoring program and should be organizationally independent of environmental data
generation activities." (EPA has a good example of a QMP for OAQPS
http://www.epa.gov/oar/oaqps/qa/qmp.pdf. In the preamble to the October 17, 2006, Federal
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Register that promulgated the recent revisions of the aforementioned monitoring regulations,
EPA explained that "An independent organization could be another unit of the same agency that
is sufficiently separated in terms of organizational reporting and which can provide for
independent filter weighing and performance evaluation auditing." Independent assessment, as
defined in Figure 1, is required to ensure that an appropriate level of independence is maintained
during monitoring organization implementation of the Pb-PEP.
Figure 1. Independent assessment
Independent assessment - an assessment performed by a qualified individual, group, or
organization that is not part of the organization directly performing and accountable for the
work being assessed. This auditing organization must not be involved with the generation
of the routine ambient air monitoring data. An organization can conduct the Pb-PEP if it
can meet this definition 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 below. In addition, the sample analysis of audit filters must be
performed by separate laboratory facility using separate laboratory equipment. Field and
laboratory personnel would be required to meet the Pb-PEP Audit field and laboratory
training and certification requirements. The monitoring organizations will be required to
participate in the centralized field and laboratory standards certification and comparison
processes to establish comparability to federally implemented programs.
Organization
3rd Level
Supervision
Organization
2nd Level
Supervision
Organization
2nd Level
Supervision
Organization
1 st Level
Supervision
Organization
1st Level
Supervision
Organization
1st Level
Supervision
Organization
1st Level
Supervision
Organization
Personnel
QA Lab Analysis
Organization
Personnel
QA Field Sampling
Organization
Personnel
Routine Lab Ana lysis
Organization
Personnel
Routine Field Sampling
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Adequacy of the monitoring organization Pb-PEP Program
The field and lab SOPs will be the primary source for the adequacy requirements. Basically,
monitoring organizations deciding to self-implement the Pb-PEP will have to maintain a
comparable program. The elements reported below are considered the important aspects for
maintaining comparability. The SOPs will be revised annually. The revision process begins
with a discussion of operational issues during the certification and recertification courses.
Necessary revisions are drafted and then vetted again through a semiformal review process
including public comment period. Consequently, the monitoring organizations that conduct
Pb-PEP are encouraged to participate in the training and SOP review process
Pb-PEP Field Operations ~ Critical Steps and Activities
The Pb-PP Field SOP will contain following requirements:
1. Initial training and certification of audit personnel through EPA's federally-implemented
Pb-PEP Field scientist course prior to an Agency's implementation of the program.
a. The Pb-PEP is the "Gold Standard" for network bias (and relative accuracy on a local
basis); therefore, uniform and consistent implementation remains a primary objective.
Operator and sampler performance are held to high standards. Comprehensive record
keeping, the quality control of the filter exposure and handling, and careful data
validation are critical activities. EPA will provide the initial training in a timely
manner for every monitoring organization that needs to get certified to self-implement
their program. We will tailor the course to the specific roles that the monitoring
organization is assuming—field operations, lab operations, or both. The course may be
as much a forum for a given agency to fine tune their Pb-PEP QAPPs as it is for
training. Monitoring organization Field Lab Scientist may also attend EPA national
training and recertification courses.
2. Annual recertification of audit personnel either by
a. Attending an annual Pb-PEP certification or recertification course;
b. Attending a Regionally implemented recertification course conducted by a certified,
EPA regional or OAQPS trainer;
c. Local recertification conducted by an independent organization (contractor) that has
been certified by OAQPS and commissioned by the respective EPA Regional Office;
see alternative during collocation events—element 13 below.
3. Existence of a back-up sampler, for the circumstance of having a sampler failure near the
end of a quarter or year; which would otherwise jeopardize completeness. These may be
made available from the federally run Pb-PEP program.
4. Performance leak check, pressure, temperature, time and flow rate check at every audit.
Data recorded and available upon request.
5. The frequency for field blanks is one per year which would be performed during actual
collocation with the Pb-PEP audit sampler.
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6. Generation of one trip blank per year during the same trip as the field blank. The trip blank
would be valid only if it is associated with a valid Pb-PEP audit.
7. Pb-PEP sampler should be positioned horizontally within 2-4 meters of the target routine
sampler and any other sampler in the vicinity and 1 meter vertically, of primary sampler's
(monitor's) inlet.
8. Use of antistatic bags and corrugated (stiff) shipping envelopes to reduce sample
bending/mutilation during storage and shipping.
9. The exposed filter shipment and delivery goal is to recover it within 8-48 hours of the end
of the sampling event, and shipped the same day via Fedex or other service, delivery to
laboratory with next day "morning" delivery, unless the sample is collected on Friday. A
more rapid delivery is always acceptable. A 48-hour collection is permissible if the site is
inaccessible on holidays and weekends; however, Friday audits or Thursdays before Friday
Holidays should be avoided if at all possible.
10. Monitoring organization-operated Pb-PEPs will implement a chain of custody protocol and
require completed field data sheets for each Pb-PEP event. EPA will furnish Chain of
Custody (COCs) and Field Data Sheets (FDSs) to those agencies that utilize the Federal
Pb-PEP lab service. COCs and FDSs and all QA/QC data should be filed and made
available upon request. As a general rule, Pb-PEP files should be held for 4 years plus the
current calendar year in order to address any regulatory data-driven decision appeals.
Electronic files of the forms will be available to fully self implementing programs upon
request and are encouraged for the sake of consistency in reporting.
11. Audit samplers must be inspected and cleaned, if necessary, on quarterly basis or more
frequently if circumstances dictate—Pb-PEP equipment must be pristine. An example
would be an audit conducted during a period when a dust storm occurred
12. The Pb-PEP sampler requires an annual multi-point verification and /or calibration for all
parameters (pressure, temperature, flow) using an NIST traceable standard that is
independent from the routine operational verification standard.
13. To accommodate monitoring organization Pb-PEP programs which may be limited by
travel budgets or policies of their agencies, the EPA has modified several QA oversight
activities for monitoring organization that are self-implementing : (a) Periodic Sampling
events using collocated Pb-PEP Samplers; (b) Technical Systems Audits of Pb-PEP field
scientists and supporting gravimetric laboratories, and (c) on-site recertification for
monitoring organization Field Scientists.
a. Collocations: In those Regions where monitoring organizations assume the
responsibilities associated with the Pb-PEP, collocations will serve as an assessment of
the comparability of Federal/State/Tribal/Local programs and the resulting Pb-PEP
data.
i. Each monitoring organization-run Pb-PEP shall participate in one collocation
joint activity with the respective Region's ESAT-run Pb-PEP field operations.
The schedule will be worked out through the EPA Regional Office.
ii. Each Regional and monitoring organization program needs to set-up and operate
the collocation through all measurement phases as if it were performing a routine
audit. After considerable deliberation among the monitoring organization
agencies and EPA Regions who have been participating in collocations, it was
determined that monitoring organization employees are required to conduct all the
necessary procedures in joint collocation studies. (This is the only way one would
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capture all potential sources of measurement error that might cause a program to
be dissimilar to the federally implemented Pb-PEP.)
iii. It is important that the monitoring organization have a back-up operator in case
the primary operator cannot perform all the requisite functions during the
collocation, e.g., due to an unforeseen emergency the monitoring organization
employees must return to home or office.
b. Technical Systems Audits—monitoring organization- implemented Pb-PEPs will be
subject to one annual technical systems audit of the field activities and support
laboratories. These audits will typically be conducted by the Regional Pb-PEP Lead
and will involve an on-site review of field and or lab activities, a review of data
acquisition, management and record keeping and relevant QA/QC procedures.
i. The EPA Regional Pb-PEP Lead may use the collocation events to conduct
audits. The review would also qualify as a recertification of the monitoring
organization field scientist(s).
ii. The EPA Regional Pb-PEP Lead will specify that paperwork for at least one
quarter of Pb-PEP activity, be submitted by the monitoring organization Pb-PEP
for a TSA review.
c. Recertifications of Field scientists—The EPA Regional Pb-PEP Lead may, at their
discretion, utilize the field activity reviews and TSAs to recertify monitoring
organization Pb-PEP field personnel.
i. The TSA and evaluation forms will be reported to OAQPS for compiling in a
national oversight record. OAQPS will compile an annual summary and include
the summaries in a detailed Triennial Pb-PEP QA Report.
ii. These forms are in the currently approved QAPP, which is available on AMTIC at
http://www.epa.gov/ttn/amtic/pmpep.html, or they can be requested from the
National Pb-PEP Lead at OAQPS.
Pb-PEP Laboratory (Lab) ~ Critical Steps and Activities
Monitoring organizations that are self implementing Pb-PEP must use laboratory
services that are independent of the laboratory performing routine data analysis.
Monitoring organizations who self-implement field activities can still utilize the
Region 9 Pb-PEP analytical services and are encouraged to do so. If not the
independent laboratory will be required to adhere to the following:
1. The Pb-PEP Lab's QAPP and SOPs should be available, reviewed, and approved by the
respective Regional Pb-PEP Lead or QA manager prior to implementation; then
subsequently, made available upon request. Their elements, specifications and QA/QA
criteria should be equivalent to those of the federally implemented Pb-PEP.
2. Initial training through Federal Pb-PEP sanctioned course prior to implementation.
a. Operational differences can exist between lab procedures of thee monitoring
organizations independent laboratory and the federally-run Pb-PEP. However the
operational difference should not affect data quality. EPA will require the
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monitoring organizations independent laboratory labs to retain the same levels of
QA/QC.
3. The Pb-PEP Lab must be independent of the monitoring organization's laboratory
performing routine FRM routine analysis.
4. The Pb-PEP Lab and analyst will be audited annually by the EPA Region or OAQPS;
recertification of lab technicians is part of the process.
5. All Pb-PEP Labs must meet QC requirements as described in Pb-PEP lab SOPs
6. Reagents and laboratory standards should be of the same quality as the federally
implemented Pb-PEP laboratory.
7. COCs and Field Data Sheets should be recorded and stored and made available upon
request, according to the schedule laid out in the Field and Lab SOPs. Digital versions are
available on the AMTIC website.
8. The Pb-PEP lab will archive extracts for current year plus last calendar year in cold
storage.
9. The Pb-PEP Lab will follow AQS format for reporting QA data to appropriate fields in
AQS.
10. The Pb-PEP Lab will load data into AQS within 15 days of analysis
11. The Pb-PEP Lab will participate in any Pb-PEP sanctioned performance evaluations that
may occur to test laboratory comparability (round robins, proficiency tests etc.).
12. The Pb-PEP Lab (or in the case of an monitoring organization Pb-PEP program, it might
be the client PQAO) submits annual report of results to EPA in format specified by EPA.
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Appendix B
Pb-PEP Field Data Sheet and Chain of Custody Form
The following two forms will be used by:
1. Personnel providing federal implementation of the Pb-PEP program,
2. monitoring organizations using the federal program and shipping the collocated filters to the
Pb-PEP National Laboratory in Region 9, and
3. any monitoring organization that is self implementing and utilizing the Pb-PEP National
Laboratory in Region 9.
For the field data sheet, monitoring organizations shipping the collocated samples and self-
implementing monitoring organizations using the Region 9 laboratory are required to complete, at a
minimum, the following information in the "Sampling Event" section:
• AQS Site ID
• Setup Date
• Site Name
• Primary Monitor Sampler Serial Number
• PEP Sampler (or collocated sampler) serial number
• Field Scientist (person either conducting sampling or retrieving filters)
and the following information in the "PB-PEP Exposure Data" section:
• Filter ID
• Elapsed time
• Total Volume
• Start Date/Time
• Stop Date Time
• Filter Integrity
• Sampler Flags
• Field Flags
These fields have been highlighted on the form.
All information on the Chain of Custody Form should be completed. There should be a one-to-one
match of forms (two forms) to sample filters shipped.
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Pb-PEP Field Data Sheet
Highlighted areas are minimum completion requirements for monitoring organizations submitting filters
to the Region 9 National Laboratory
Sampling Event Information
AQS Site ID
Site Name
Field Scientist
Pb-PEP Audit or Collocation
Setup Date
Primary SLT Sampler Serial No.
Pb-PEP TSP (or collocated
sampler) Serial No.
Parameter Check Device
Multi-Standard1
Temperature Standard
Barometric Pressure Standard
Flow Rate Standard
Time Checks OK?
Monitoring Site Criteria OK?
Make/ Model
Serial No.
n Yes n No (describe)
n Yes n No (describe)
; Use this line for multi-standard instruments (e.g., BGI TriCal andDeltaCal) when used for all three checks.
Pb-PEP Sampler Verification Checks 2
Leak Check
2-Minute Interval
Bar. Pressure
Ambient
Temperature
Ambient Sensor
Criteria
Change < 5 cmH2O
Criteria
±10 mmHg
Criteria
±2°C
Beginning P
cmH2O
Ref Standard
mmHg
Ref Standard
°C
Ending P
cmH2O
Sampler
mmHg
Sampler
°C
Date:
Verification OK?
DYes n No
Verification OK?
DYes n No
Verification OK?
DYes DNo
Flow Rate Verification
Audit Standard
FR (Cal.) Check
Design Flow Rate
"Q" Check
Criteria
< 4% difference
Criteria (±4%)
38.4 to 41 .6 CFM
Ref Standard
CFM
Ref Standard
CFM
Sampler
CFM
Design
40 CFM
Verification OK?
DYes DNo
Verification OK?
DYes n No
2 Indicate only the final result of the check after all troubleshooting has been done. Document troubleshooting in the
"Notes " section below and/or in the field notebook. If troubleshooting is unsuccessful, the sampler must be recalibrated or
repaired before conducting a sampling event. Fill out a new Field Data Sheet for the replacement sampler.
Pb-PEP Exposure Data
Filter ID
Elapsed Time (ET)
Total Volume (m3)
Flow Rate (CFM)
Start Date/Time
Stop Date/Time
Temperature (°C)
Bar. Pressure (mm Hg)
Field Blank ID
Trip Blank ID
Collocated Filter ID(s)4
Filter Retrieval Date/Time:
Filter Integrity OK?
Q: Avg:
Data Download OK?
Max: Min:
Max: Min:
n Yes n No (describe)
CV: ??
n Yes n No (describe)
Avg:
Avg:
Sampler Flags3:
Field Flags:
Make sure to add (EST) flag in "Sampler Flags" if runtime is outside of 1380- 1500 minute range.
4 For parking lot studies, all the IDs can be listed on one form
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PEP Chain-of-Custody Form for Pb-PEP
This COC form will be used for the transportation/tracking of both the Pb-PEP samples
collected by ESAT contractors and the collocated filters from monitoring organizations
utilizing federal implementation AND by monitoring organizations that are self- implementing
the program but using the Region 9 laboratory for analytical services.
PART I-FIELD SITE
Sampling Event Information
Filter ID
Primary Quality Assurance
Org. (PQAO)
Arrival Date at Site
Site Name & Description
Primary SLT Sampler
AQS Site ID
Other Operators or Observers
Sampler Operator:
Make/Model: Serial No.:
Sampling Event Filter Data
Sampling Date: Retrieval Date:
Time:
Sample Type
DRO- Routine D FB - Field Blank (RO Filter ID: ) D
D CO - Collocated D TB - Trip Blank (RO Filter ID )
Other (describe)
Event Filter Integrity (after sampling): n OK n Reject (describe) Integrity Flag:
PART II - FIELD FILTER SHIPPING TO LAB
Shipment Date
Shipped by
Airbill No.
Affiliation:
Shipping Destination:
Shipped via: n Federal Express
n Other
On completion of Part I-II, the field scientist keeps one copy and sends the top (original) copy to the laboratory with the
filter.
PART III - LABORATORY
Date Received
Shipment
Integrity OK?
n Yes n No
Received by:
Integrity Flag:
The analytical laboratory will DATE-STAMP and attach the COC form to the receiving log-book, in which same info is
recorded.
Notes:
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