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-04-04

Date Revised: 2-10-15

 SOP No. ADM-04-04
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SOP Number ADM-04-04

Title OPP Microbiology Laboratory Personnel Training
Scope This SOP describes the Microbiology Laboratory Branch (MLB)
requirements for education, experience, and training of each
employee in order to ensure that testing and other laboratory
procedures are performed by qualified individuals.
Application The training and authorization 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Date SOP withdrawn:
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TABLE OF CONTENTS

Contents Page Number

1. DEFINITIONS 3

2. HEALTH AND SAFETY 3

3. PERSONNEL QUALIFICATIONS AND TRAINING 3

4. INSTRUMENT CALIBRATION 3

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 9

14. FORMS AND DATA SHEETS 9

15. REFERENCES 9
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1. Definitions Additional abbreviations/definitions are provided in the text.

1. A2LA= American Association for Laboratory Accreditation
2. MLB= Microbiology Laboratory Branch
3. EPA Good Laboratory Practices (GLP)= 40 CFR Part 160
4. Quality Assurance Unit (QAU) = Comprised of the Quality Assurance
Officer (QAO), who serves as the quality manager for the laboratory
and the alternate QAO.
5. Trainee= A staff member being trained for technical methods,
equipment use and calibration, and quality assurance practices and other
required training.
6. Technical Trainer= A staff member who is considered qualified,
competent and authorized by the Branch Chief and able to train others
in microbiological methods and operation, maintenance and calibration
of equipment.
7. Quality Assurance Trainer= MLB staff member who is considered
qualified, competent and authorized by the Branch Chief in quality
assurance practices and requirements of GLP and ISO-17025
international standards.
8. Special Trainer= Equipment vendors (e.g., Vitek, Confocal microscope)
from an external organization may serve as trainers. Additionally, GLP
and A2LA trainers may serve as trainers for GLP and ISO-17025
standards.
9. SOP Lead Author/Method Developer= MLB staff member who can
serve in training capacity for other staff.
2. Health and None.
Safety

3. Personnel 1. Branch Chief assigns trainers for specific activities.

Qualifications 2. Update Trainer Qualification Forms for Technical or Quality Assurance
and Training activities (see section 14), as a staff member is authorized to be a trainer.
3. Equipment vendors may serve as trainers for specific equipment (e.g.,
Vitek, Leica)
4. Standard operating procedure/method developer may serve as a trainer
for other staff members. As other staff members gain expertise in
specific laboratory practices, they may serve as qualified trainers.
4. Calibration Not applicable.
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5. Sample Handling Not applicable.

and Storage
6. Quality Control For quality control purposes, document the required information on the
appropriate form(s) (see section 14).
7. Interferences 1. All training must be conducted by qualified trainers.
2. Qualified Trainers must be approved and authorized by Branch Chief to
conduct training on a particular technical procedure, equipment, or
quality assurance practice.
3. The trainer must ensure that the most current version of the SOP along
with the appropriate forms are used when training.
8. Non-conforming 1. Management of non-conformances will be consistent with SOP ADM-07,
Data Non-Conformance Reports.
9. Data 1. Training records are maintained and archived consistent with SOP ADM-
Management 03, Maintaining, Tracking and Archiving of Records.
a. Training records for all current personnel are stored in a labeled
binder in the D corridor near room D206.
b. Training records, for employees no longer in MLB, are retired to an
archived training binder in secure file cabinets in file room D217.
10. Cautions None.
11. Special None.
Apparatus and
Materials
12. Procedure and 1. Position descriptions are filed in the current Personnel Training Records
Analysis Book.
2. All staff must undergo Good Laboratory Practices (see ref. 15.1) and
ISO-17025 (General requirements for the competence of testing and
calibration laboratories) training (see 15.5).
3. An employee should not perform any procedure or method until all
applicable training has been completed and competency demonstrated.
4. Laboratory based training is required for all testing procedures,
operation, calibration and maintenance of equipment, test related quality
control activities, sample-log-in and chain-of-custody procedures.
5. Upon completion of training, file documentation for each employee in
the Personnel Training Records Book.
12.1 Use of PT to a. The laboratory uses internal Proficiency Testing (PT) to determine
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determine the effectiveness of technical training for personnel. PT may be

Effectiveness of required prior to performance of certain tasks.
Training
b. The laboratory QAU arranges PT exercises throughout the year to
cover important technical areas.
c. The successful completion of PT is noted in the Personnel Training
Records Book.
d. If PT provides non-conforming data, additional training is
recommended for analysts and is conducted by a qualified trainer.
12.2 Qualifications of a. To train another employee on a technical procedure, equipment use
trainers and calibration, and MLB quality assurance requirements, a trainer
must have the following:
i. A complete and thorough understanding of the SOP and
hands-on, working knowledge of the procedure and must be
an approved trainer for the method.
ii. A current sign-off as a Qualified Trainer in the Personnel
Training Record Book (see 14.3) for the technical method or
quality assurance requirements (see 14.4).
iii. Branch Chief evaluates and approves individuals as Trainers
for test procedures or QA activities based on their
current/relevant experience.
b. Company representatives (vendors e.g., Vitek) may serve as trainers
for the use and operation of specialized equipment.
c. In the process of developing new methods and SOPs, the lead
author automatically serves as the trainer for other staff members.
12.3 Training a. The Branch Chief has overall responsibility to ensure that the
Responsibilities personnel in the Laboratory are adequately trained for their assigned
tasks. The Branch Chief or his/her designee manages training
requirements for employees to perform assays and other procedures
using the laboratory’s current SOPs and other appropriate training
materials (see ref. 15.2).
b. Upon hire, and as needed, the Branch Chief or his/her designee
identifies and documents the training needs of each employee (see
14.1 for New Employee Training Checklist).
c. Training for revised SOPs, new techniques and quality assurance is
arranged on an ongoing basis by qualified trainers.
d. Trainers must verify the competency of individuals they train and
document this competency by initialing the trainee’s Personnel
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Training Record Form (14.2), which is kept in the Personnel

Training Record Book.
e. Trainees must ensure that they understand the information being
communicated to them. They are encouraged to ask questions about
specific procedures.
f. Signatures of the trainee in the “Training Complete” box on the
Personnel Training Record Form (see 14.2) means the employee
fully understands the procedure and can perform it independently
without supervision.
g. The trainer who signs the Personnel Training Record Form (see
14.2) of a trainee for a particular SOP/ procedure is responsible for
verifying the competency of that person to perform the procedure.
A trainee should request a sign off on an SOP when he/she is fully
confident of the ability to perform the procedure without
supervision.
12.4 Health and a. Analysts must complete an initial 24 hour laboratory safety training
Safety provided by the Safety Health and Environmental Manager (SHEM)
and subsequently an 8 hour refresher course, every year thereafter,
is required.
b. If specific personal protective equipment, such as a respirator, is
required, the analyst must be certified each year per SHEM
requirements.
12.5 Training a. New employees receive a comprehensive introduction to the EPA
Requirements and the Microbiology Laboratory Branch during the first several
for New weeks of their employment.
Employees b. Qualified Trainers provide bio-safety, MLB quality assurance, GLP
and ISO-17025 training to new employees.
c. Complete the New Employee Training Checklist (see 14.1). The lab
bio-safety officer, QA trainer, Branch Chief and trainee initial the
New Employee Training Form and file it in the Personnel Training
Record Book.
12.6 Training a. Review of Agency Quality Documents. The QAU must review the
Requirements following documents found at the EPA Quality website:
for Quality http://www.epa.gov/quality/internal.html.
Assurance
i. Overview of the EPA Quality System
Officer
ii. Introduction to EPA Quality System Requirements
iii. Introduction to Data Quality Assessment
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iv. EPA Quality Policy CIO 2106

b. Training and review of guidance documents available at the EPA
Quality website: http://www.epa.gov/quality/train.html
i. Quality Assurance Project Plans (QAPPs)
ii. Quality Management Plans (QMP)
iii. Standard Operating Procedures (SOPs).
c. Quality Assurance Annual Reports and Workplan (QAARWP)
Training. The QAU must be familiar with preparation of
QAARWP, following Agency Guidelines for QAARWP reports.
d. Internal Auditor: Training is available through the EPA quality
website, http://www.epa.gov/quality/train.html, A2LA or other
similar organization. The QAU must be authorized by the Branch
Chief to serve as an auditor after successful completion of auditor
training.
e. GLP and ISO-17025 Training: MLB Quality Assurance Unit
personnel must have GLP and ISO-17025 training (arranged
internally or externally) in order to comply with the GLP and ISO-
17025 standards.
f. QAO and alternate QAO must be signed off as qualified trainers for
QA activities, to train other laboratory personnel.
g. QAO and alternate QAO must be proficient in the review of
antimicrobial product efficacy reports (ATP), summary memoranda
and review of data associated with microbiological research
projects.
h. Document QA Training for QAO (and alternate) in the Trainer
Qualification Form/QA (see 14.4), and file in the Personnel
Training Record Book including certificates (if available), related to
training.
12.7 Technical a. Technical training for laboratory procedures encompasses the
Method or following steps:
Equipment
i. The trainee reads the SOP and other applicable documents.
Training
ii. The trainee observes demonstration of the procedure by a
qualified trainer.
iii. The trainee performs the procedure under observation by a
qualified trainer as many times as necessary to become
proficient.
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iv. Trainee successfully completes the procedure and signs the

“Completion of Training” box on the Personnel Training
Record Form (see 14.2).
v. If necessary, the trainee may be required to perform a
proficiency test as determined by laboratory management.
12.8 Assessment of a. Observation of Procedure: Internal auditing is used to observe
Ongoing employees during testing and conduct of a procedure.
Training Needs b. Proficiency testing: Analysts participate in multiple proficiency
testing exercises per year, the results from PT are used to assess
employee needs for additional training.
c. Familiarity with current versions of SOPs: Analysts are required to
be familiar with current versions of SOPs. In addition, SOP
revisions are discussed in a formal setting to ensure that each
analyst is aware of new practices and procedures.
i. When new or newly revised SOPs are issued, copies are
issued and made available to all employees.
ii. Each employee is required to participate in the SOP training
for revised SOPs. A copy of the presentation, along with
names of attendees, is maintained as documentation of
training in the Personnel Training Record Book under yearly
Group Training Records.
12.9 Verification of a. The trainee and the trainer sign the Personnel Training Record Form
Competency (see 14.2) and forward it to the QAU and Branch Chief. Signatures
and of Branch Chief on the training form serve as authorization for the
Authorization trainee to independently perform procedures.
12.10 Other Agency a. Several on-line core training sessions are recommended by the
Requirements agency for each employee on an annual basis, (e.g. ethics,
information security, environmental justice, confidential business,
email records etc.)
b. These are listed on the e-skillport for each employee.
c. Purchase card holder undertakes refresher training annually.
d. The employee must take the required training within the specified
time period, as directed.
e. Upon completion of training, file the certificates in current
Personnel Training Record Book under employee’s name.
12.11 Documentation a. When new protocols are launched, training records are reviewed by
of Training and the QAU to ensure the analysts have valid training records for the
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Records methods listed in the protocol.

b. All training records are filed in the current employees’ Personnel
Training Record Book.
c. An electronic, quarterly Analyst Training List (see 14.5) is
maintained by the QAU for each employee, which is updated each
quarter during the fiscal year.
13. Data Analysis/ None
Calculations
14. Forms and Data Test Sheets. Test sheets are stored separately from the SOP under the
Sheets following file names:
New employee training checklist ADM-04-04_F1.docx
Personnel Training Record Form ADM-04-04_F2.docx
Trainer Qualification Form: Technical ADM-04-04_F3.docx
Trainer Qualification Form: Quality Assurance ADM-04-04_F4.docx
Analyst Training List (Updated quarterly): ADM-04-04_F5.docx
15. References 1. US EPA Good Laboratory Practice Standards, Title 40 Code of
Federal Regulations (CFR) Part 160.
2. Quality Management Plan (QMP) for the Office of Pesticide
Programs. (2015) and Appendix B-3 (QMP for Microbiology
Laboratory Branch), US Environmental Protection Agency,
Environmental Science Center, Fort Meade, MD.
3. Centers for Disease Control and Prevention and National Institutes of
Health, 2007. Biosafety in Microbiological and Biomedical
Laboratories, 5th Edition. U.S. Department of Health and Human
Services. U.S. Government Printing Office, Washington, D.C.
4. U.S. Office of Personnel Management. Operating Manual for
Qualification Standards for General Schedule Positions. OPM
Publication No. HX 118.
http://www.opm.gov/qualifications/index.asp.
5. ISO/IEC: 17025 (2005): General Requirements for the Competence
of Testing and Calibration Laboratories.