HIV Drug Resistance Training
Module 10
Standard Operating
Procedures (SOPs)
1
A Systems Approach to Laboratory Quality
Organization
Personnel
Equipment
Stock
Management
Quality Control
Data
Management
SOP,
Documents &
Records
Occurrence
Management
Assessment
Process
Improvement
Specimen
Management
Safety &
Waste
Management
2
A Systems Approach to Laboratory Quality
Organization
Personnel
Equipment
Stock
Management
Quality Control
Data
Management
SOP,
Documents &
Records
Occurrence
Management
Assessment
Process
Improvement
Specimen
Management
Safety &
Waste
Management
3
Topics




Processes and Procedures
Documenting Processes and Procedures
Forms, Manuals, and Job Aids
Managing Documents
4
Objectives





Identify purpose of SOPs and related
documentation.
Identify components of SOPs.
Identify the SOPs that are needed to ensure the
quality of testing.
Given a procedure, demonstrate how to write an
SOP.
Describe how to manage SOPs and related
documents in the lab.
5
processes and procedures
What is a process?
What is a procedure?
Why do we need to document both?
6
Path of Workflow
Sample
collection
Personnel
competency
testing
Reporting
Record keeping
and data
management
• Data and Lab
Management
• Safety
• Customer Service
QA and QC
Genotype
testing
Sample receipt
and
accessioning
7
Each Process Has Procedures
Sample
collection
Personnel
competency
testing
Reporting
Start
Record keeping
and data
management
Step 1
Step 2
• Data and Lab
Management
• Safety
• Customer Service
QA and QC
Genotype
testing
More
steps…
Finish
Sample receipt
and
accessioning
8
Procedures Must Be Documented—in SOPs
Sample
collection
Start
Step 1
Step 2
Standard
Operating
Procedures
(SOPs)
More
steps…
Finish
9
Process and Procedure


Process documents:
–
–
–
–
Show how everything fits together
Flow of work
Across procedures
Across time
–
–
–
–
Directions on how to perform a task
One task
Clear and accurate
What the operator needs to do and how
Procedure documents:
10
Why Processes and Procedures are Needed
Can be used for training and competence
assessment programs
 Personnel can become competent more quickly
 Way to identify, label, and correct process
problems

11
Standard Operating Procedures

Purpose: to ensure reproducible and correct
performance of laboratory tests
– Reduce inter-operator and inter-run variation


Made specific for each laboratory
Controlled document: need a regulated system
for
–
–
–
–
–
Preparation
Approval
Distribution
Revision
Training
12
Discussion



What is a process?
What is a procedure?
Why do we need to document both?
13
documenting processes and
procedures
What should a process document include?
What types of SOPs are there?
What SOPs does a genotyping lab need?
How can each lab write SOPs that work for it?
14
Essential Process Documents
for HIV DR Labs





Document approval process
Document management process
New assay validation process
New employee training process
Genotyping process
15
Template for Process Documents

Title
– Clearly states the intent of the document
– Include the word “process”

Purpose
– State purpose of document (optional: rationale,
theory, or historical background)

Process: Flowchart or Table
– Main part of document
– Shows/describes sequence of activities and
outcome

Supporting Documents
– Related procedures (SOPs)
16
Procedures (SOPs)
Process
Procedure
Procedure
Procedure
Procedure
Purpose
Purpose
Equipment
& Supplies
Equipment
& Supplies
Safety
Precautions
Safety
Precautions
Step-bystep
instructions
Step-bystep
instructions
Other
information
Other
information
17
Pretesting Phase
Sample
collection
Personnel
competency
testing
Reporting
Record keeping
and data
management
• Data and Lab
Management
• Safety
• Customer Service
QA and QC
Genotype
testing
Sample receipt
and
accessioning
18
Pretesting Procedures

Essential for HIV DR Labs:
– Specimen management: collection, labelling, receipt,
assessment, storage and shipping
• Criteria for unacceptable samples and follow up action
• Any storage or processing before the test
• Any preparations for samples transported to other
laboratories for testing
– Equipment maintenance

Other Helpful Procedures:
– Test requesting
– Sample collection and labeling
– Sample transport
19
Testing Phase
Sample
collection
Personnel
competency
testing
Reporting
Record keeping
and data
management
• Data and Lab
Management
• Safety
• Customer Service
QA and QC
Genotype
testing
Sample receipt
and
accessioning
20
Testing Procedures

Essential for HIV DR Labs:
– Unidirectional Laboratory workflow
– Properly Handling and manipulation of infectious
human material and biohazardous waste disposal
– All steps of sequencing procedure, including editing
and interpretation
– Internal quality control
• For commercial tests, can use manufacturer’s manuals or
write own procedures Copied from previous slide.
• If manufacturer’s procedures are modified:
Document changes
Verify adapted procedure
21
Post-testing Phase
Sample
collection
Personnel
competency
testing
Reporting
Record keeping
and data
management
• Data and Lab
Management
• Safety
• Customer Service
QA and QC
Genotype
testing
Sample receipt
and
accessioning
22
Post-testing Procedures

Essential for HIV DR Labs:
– Detection of containments
• Negative controls and what to do if they are positive
• Phylogenetic testing for cross-contamination (SQUAT)
• Decontamination procedures
– Data management
• Archiving sequence data and report documents
• Data storage and retrieval procedures
23
Post-testing Procedures

Other Helpful Procedures (Data Management):
– Electronic transfer of data from an instrument into a
computer system
– Manual entry of data into a computer system
– Manually reporting results on paper report forms
– Entering test results into the laboratory’s information
system (include each prompt in the computer program
sequence)
– Correcting results: how to change results that have
been erroneously entered into the reporting system
and are thus available for review and use by clinicians
and caregivers.
– Supervisory and/or medical review of examination
24
results, where such review is required.
Post-testing Procedures

Other Helpful Procedures (cont):
– Sample retention:
• Post-examination procedures for sample retention need
to include step-by-step instructions for archiving sample
materials in such a way as to be readily retrievable when
needed.
• Schedule for the duration of sample retention as defined
by regulatory or accreditation requirements, and
organizational needs.
• Disposal of samples after they have exceeded their
established retention times.
25
Template for Procedures
Title
Purpose
Equipment
Supplies
Sample (for testing
procedures only)
 Special Safety
Precautions












Standard
Operating
Procedures
(SOPs)
Procedure
Troubleshooting
Calculations
Interpretation/ Results
References
Related Documents
Appendices
26
Discussion




What should a process document include?
What types of SOPs are there?
What SOPs does a genotyping lab need?
How can each lab write SOPs that work for it?
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forms, manuals, and job aids
What other types of documents help with process control?
28
Form Documents



Blank documents (paper or computer)
Record results of a given procedure
Forms include:
–
–
–
–
–
Title that describes the form’s purpose
Facility name and location
Effective Date
Fields for information
Identifying information to link it to a procedure
• Form ABC-100-F01 is with Procedure ABC-100-P01)

Guidelines:
– Include properly completed in procedures manual
– Note needed forms in Appendices section of SOPs
29
Recommended Forms for Genotyping Labs




QC form(s) for genotyping
Document approval request form
Lab reagent inventory form
Flowchart for sample management
30
Procedure Manuals

Procedure manuals should be organized in a way
that can be easily followed by laboratory
personnel and should contain the following
elements:
–
–
–
–
Table of contents
Process descriptions (optional)
Procedures
Associated Forms
31
Job Aids

Examples:
– Instruction sheets
– Wall charts
– Instructions posted on equipment

Qualities of good job aids:
– 3 C’s: Current, complete, and correct
– Traceable to the “parent” document
– Effective date is listed.

If some of the above qualities are missing, start
the document change process.
32
Discussion

Besides SOPs, what other types of documents
help with process control?
33
managing documents
Why is it important to control how documents are created,
updated, copied, and stored?
What are some general guidelines for document management?
34
Document Management

A Document Management System ensures
– Approved format
– Current, approved version
Quality Assurance Manager is responsible for the
assignment and tracking of all documentation
 System may be

– Paper-based
– Electronic-based
35
Document Management System: Purpose



Keep everyone up to date
Get rid of old, outdated information
Standardize procedures

Maintain quality of laboratory services and results
36
Document Identification (example)


Name of lab or institution (e.g. ABC)
Numbers for type of procedure
– 100 = General Laboratory
– 200 = Molecular

Document type and procedure number
–
–
–
–
–

F = Form
P = Procedure
G = Guidance or Job Aid Documents
T = Table (process)
C = Flowchart (process)
ABC –
Revision number
100 – P08
37
Review and Approval of New Documents
Requestor completes approval request form
Lab supervisor(s) reviews document
Lab Director approves all new procedures and
any major modifications.
 The Quality Assurance Manager maintains review
and approval documentation in the master file
hard copy binder



38
Archiving, Storage, and Retention of
Documents

Master file:
–
–
–
–
Stored by the Quality Assurance Manager
Electronic
Current version
All previous versions , clearly identified
• RETIRED in bold on the upper right hand corner of the
header OR
• Watermarked diagonally across the page in order

Hard copy
– Stored by the Quality Assurance Manager
– In Master File Hard Copy Binder
39
Discussion
Why is it important to control how documents are
created, updated, copied, and stored?
 What are some general guidelines for document
management?

40
Reflection
What are the strengths and weaknesses of our
current processes and procedures?
 Where are we vulnerable to errors?
 How can we improve our documentation to
reduce errors?

41
Summary




Processes and Procedures
Documenting Processes and Procedures
Forms, Manuals, and Job Aids
Managing Documents
42
Practice: Create an SOP for Making Coffee
43
Summary
Process
• Identify
• Create
• Validate
• Approve
List
SOPs
SOP for
SOPs
• Pre-test
• Test
• Post-test
• Who
• What
• When
44