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US Environmental Protection Agency
Office of Pesticide Programs
Office of Pesticide Programs
Microbiology Laboratory
Environmental Science Center, Ft. Meade, MD
Standard Operating Procedure for
OPP Microbiology Laboratory Personnel Training
SOP Number: ADM-04-05
Date Revised: 04-30-18

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SOP No. ADM-04-05
Date Revised 04-30-18
Page 1 of 7
SOP Number
ADM-04-05
Title
OPP Microbiology Laboratory Personnel Training
Scope
This SOP describes the Microbiology Laboratory Branch (MLB)
requirements for training for individuals working in the laboratory.
Application
The training requirements described in this SOP are applicable to all
positions in the Microbiology Laboratory.


Approval Date
SOP Developer:

Print Name:
SOP Reviewer

Print Name:
Quality Assurance Unit

Print Name:
Branch Chief

Print Name:


Date SOP issued:

Controlled copy
number:

Date SOP withdrawn:


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SOP No. ADM-04-05
Date Revised 04-30-18
Page 2 of 7
TABLE OF CONTENTS
Contents	Page Number
1.
DEFINITIONS
3
2.
HEALTH AND SAFETY
3
3.
PERSONNEL QUALIFICATIONS AND TRAINING
3
4.
INSTRUMENT CALIBRATION
4
5.
SAMPLE HANDLING AND STORAGE
4
6.
QUALITY CONTROL
4
7.
INTERFERENCES
4
8. NON-CONFORMING DATA
4
9.
DATA MANAGEMENT
4
10.
CAUTIONS
4
11.
SPECIAL APPARATUS AND MATERIALS
4
12.
PROCEDURE AND ANALYSIS
4
13.
DATA ANALYSIS/CALCULATIONS
7
14.
FORMS AND DATA SHEETS
7
15.
REFERENCES
7

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SOP No. ADM-04-05
Date Revised 04-30-18
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1. Definitions
Additional abbreviations/definitions are provided in the text.
1.	EPA Good Laboratory Practices (GLP) = 40 CFR Part 160
2.	Quality Assurance Unit (QAU) = Comprised of the Quality Assurance
Officer (QAO), who serves as the quality manager for the laboratory
and the alternate QAO.
3.	Trainee = A staff member being trained on technical methods,
equipment, and quality assurance practices as well as other required
training.
4.	Technical Trainer = A staff member qualified and competent to train
others in microbiological methods and operation, maintenance and
calibration of equipment.
5.	Quality Assurance Trainer = MLB staff member qualified, competent
and authorized by the Branch Chief in quality assurance practices and
requirements of GLP and ISO-17025 international standards. The QAU
provides training on GLP and ISO-17025 standards.
6.	External Trainer = Equipment vendors (e.g., Vitek, Confocal
microscope) from an external organization may serve as trainers.
7.	SOP Lead Author/Method Developer = individuals qualified to train
other staff members.
2. Health and
Safety
See details in specific SOPs.
3. Personnel
Qualifications
and Training
1.	Branch Chief or designee has the overall responsibility to ensure that
personnel are adequately trained for their assigned tasks, using current
SOPs and other appropriate training materials, (see ref. 15.3).
2.	Oualified Technical Trainers provide training for SOPs, new techniques
and quality assurance practices on an ongoing basis. Trainers must verify
the competency of trainees and update the MLB training spreadsheet
within 3-5 business days of training completion. A trainer must have the
following:
a.	A complete and thorough understanding of the current SOP, hands-
on experience and a working knowledge of the procedure.
b.	The lead author (the developer) of an SOP is automatically deemed
as a trainer for the SOP.
c.	The trainers are identified in the training spreadsheet by SOP.
3.	Trainees must familiarize themselves with the relevant SOP (s) and
associated procedures prior to receiving hands-on training in the

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SOP No. ADM-04-05
Date Revised 04-30-18
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laboratory. This step should be documented in the training spreadsheet.
4. Calibration
Not applicable.
5. Sample Handling
and Storage
Not applicable.
6. Quality Control
1.	On a bi-annual basis, the QAU will verify and update the assigned list of
qualified trainers.
2.	The QAU will verify staff training periodically (e.g., quarterly) by
reviewing the training spreadsheet.
3.	The QAU will review the status of the employee's training prior to sign-
off on study protocols.
4.	Training using a draft SOP is permissible; the QAU should be informed
of this action and noted in the training spreadsheet.
7. Interferences
1. Training using outdated SOPs will not be permitted.
8. Non-conforming
Data
Management of non-conformances will be consistent with SOP ADM-07,
Non-Conformance Reports.
9. Data
Management
1.	Training records are maintained and archived consistent with SOP ADM-
03, Maintaining, Tracking and Archiving of Records.
2.	Training is documented in the MLB training spreadsheet located on the
shared drive. The MLB training spreadsheet is archived quarterly by the
QAU.
3.	Position descriptions, vendor training certificates, and group training
records for all personnel are maintained in the current Personnel Training
Record Book stored in the D corridor near room D206.
4.	Training records, for employees no longer in MLB, are retired to an
archived training binder in the file room (D217).
10. Cautions
Not applicable.
11. Special
Apparatus and
Materials
Not applicable.
12. Procedure and
Analysis

12.1 New Employee
Training
a.	New employees must complete the initial 24-hour laboratory safety
training and provide the printout from the training modules to the
ESC safety manager and the Branch Chief.
b.	New employees are provided with a comprehensive introduction to

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SOP No. ADM-04-05
Date Revised 04-30-18
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the EPA and the Microbiology Laboratory Branch, overview of
administrative procedures, introduction to testing and laboratory
equipment, a tour of the Environmental Science Center, training on
MB-01 (biosafety), and an overview of the Quality Assurance Unit,
Good Laboratory Practice Standards, and ISO 17025 standard
during the first several weeks of their employment.
c.	The lab biosafety officer, QA trainer, Branch Chief and the trainee
complete the New Employee Training section of the training
spreadsheet. The Branch Chief places a copy of the position
description for the new employee in the training notebook.
d.	The employee reads the basic SOPs assigned to them and updates
the training spreadsheet once the SOPs are read.
12.2 Continuing
Training for
Employees
a.	Individuals participate in the 8-hour ESC annual safety refresher
training.
b.	As SOPs are updated, group training sessions are held to review the
changes to each SOP. The overview of the changes to the SOP are
covered by the lead author or technical reviewer for the SOP. The
employees update their records on the training spreadsheet within 5
business days of SOP overview completion. The training materials
are archived in the training notebook.
c.	Based on assigned projects, individuals receive specialized technical
training.
d.	Individuals attend training provided by vendors as necessary to
perform their duties. The training is noted by the individual on the
training spreadsheet. Certificates issued by the vendor are
maintained in the training notebook.
12.3 Technical,
Method or
Equipment
Training
a. Technical training for laboratory procedures encompass the
following steps:
i.	The trainee reviews the SOP and applicable forms and
documents that he/she is familiar with the SOP on the MLB
training spreadsheet within 5 business days.
ii.	The trainee observes in-lab demonstration of the procedure
by a qualified trainer.
iii.	The trainee performs the procedure under the observation of
a qualified trainer. Multiple observations may be necessary
and finally, the trainee performs the procedure
independently.
iv.	Trainee successfully completes the procedure and updates

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SOP No. ADM-04-05
Date Revised 04-30-18
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the "Completion of Training" field on the MLB Training
Spreadsheet within 5 business days after completion.
v. The trainee may be required to participate in proficiency
testing as determined by management. See section 12.5.
12.4 Quality
Assurance Unit
Training
Requirements
a.	Review of Agencv Oualitv Documents: The OAU must review the
following required documents located at the EPA Quality website,
as assigned by the OPP QA Director.
EPA Oualitv website: httD://www.eDa.gov/aualitv/aa docs.html
i.	Overview of the EPA Quality System
ii.	Introduction to EPA Quality System Requirements
iii.	Introduction to Data Quality Assessment
iv.	EPA Quality Policy CIO 2106
b.	Review of Guidance Documents: The OAU must review the
following guidance documents available at the EPA Quality
website, https://www.epa.gov/qualitv, as needed
i.	Quality Assurance Project Plans (QAPPs)
ii.	Quality Management Plans (QMP)
iii.	Standard Operating Procedures (SOPs).
c.	Internal Auditor Training: OAU should complete this training
available through the EPA quality website upon serving as a
member of the QAU. Continued ongoing training of the QAU
through A2LA or other similar organizations is encouraged by
management. The training for these modules will be tracked for
individuals serving in the QAU on the training spreadsheet.
EPA Quality training website:
httD://intranet.eDa.gov/aualitv/training.html
12.5 Proficiency
Testing (PT)
a. Proficiencv testing (PT): The laboratory uses internal PT to
determine the effectiveness of technical training of personnel. The
QAU, in consultation with the branch chief, arranges targeted PT
exercises per year to cover important technical aspects based on the
scope of accreditation for the ISO-17025 standard.
i.	PT may be required prior to performance of certain tasks.
ii.	The results from the PT exercises are used to assess
employees' additional training needs and guidance.
iii.	The successful completion of PT is noted in the MLB

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SOP No. ADM-04-05
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Training spreadsheet by individuals within 5 business days.
iv. If PT results are unsatisfactory, additional training is
required for analysts and is conducted by a qualified trainer.
12.6 Other Agency
Training
Requirements
a. Mandatory Agencv training: On an annual basis, several mandatory
training sessions are required by the Agency for all employees,
(e.g. ethics, information security, environmental justice,
confidential business, email records etc.).
i.	Training sessions are listed on the e-skillport portal for each
employee and must be completed by all employees within
the suggested time frames.
ii.	Upon completion of Agency required training, file the
certificates in the current Personnel Training Record Book
under employee's name.
13. Data Analysis/
Calculations
None
14. Forms and Data
Sheets
MLB Training Spreadsheet ADM-04-05 F2.docx
15. References
1.	US EPA Good Laboratory Practice Standards, Title 40 Code of Federal
Regulations (CFR) Part 160.
2.	ISO/IEC: 17025 (2017): General Requirements for the Competence of
Testing and Calibration Laboratories.
3.	Quality Management Plan (QMP) for the Office of Pesticide Programs.
(2016) and Appendix B-2 (QMP for Microbiology Laboratory Branch;
2018), US Environmental Protection Agency, Environmental Science
Center, Fort Meade, MD.

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