HIV Drug Resistance Training

Module 10
Standard Operating
Procedures (SOPs)

1
A Systems Approach to Laboratory Quality

Organization Personnel Equipment

Stock Data
Quality Control
Management Management

SOP,
Occurrence
Documents & Assessment
Management
Records

Safety &
Process Specimen
Waste
Improvement Management
Management 2
A Systems Approach to Laboratory Quality

Organization Personnel Equipment

Stock Data
Quality Control
Management Management

SOP,
Occurrence
Documents & Assessment
Management
Records

Safety &
Process Specimen
Waste
Improvement Management
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?

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 Path of Workflow

Sample
collection

Personnel
Reporting competency
testing

• Data and Lab

Management
Record keeping • Safety Sample receipt
and data • Customer Service and
management accessioning

Genotype
QA and QC
testing 7
Each Process Has Procedures

Sample
collection

Personnel
Reporting competency
testing
More
Start Step 1 Step 2 Finish
steps…
• Data and Lab
Management
• Safety
Record keeping • Customer Service Sample receipt
and data and
management accessioning

Genotype
QA and QC
testing 8
Procedures Must Be Documented—in SOPs

Sample
collection

More
Start Step 1 Step 2 Finish
steps…

Standard
Operating
Procedures
(SOPs) 9
 Process and Procedure

 Process documents:
– Show how everything fits together
– Flow of work
– Across procedures
– Across time
 Procedure documents:
– Directions on how to perform a task
– One task
– Clear and accurate
– What the operator needs to do and how

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

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 Discussion

 What is a process?
 What is a procedure?
 Why do we need to document both?

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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?

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 Essential Process Documents
for HIV DR Labs

 Document approval process

 Document management process
 New assay validation process
 New employee training process
 Genotyping process

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 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)
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Procedures (SOPs)

Process

Procedure
Procedure Procedure
Procedure

Purpose Purpose

Equipment Equipment
& Supplies & Supplies

Safety Safety
Precautions Precautions

Step-by- Step-by-
step step
instructions instructions

Other Other 17
information information
 Pretesting Phase

Sample
collection

Personnel
Reporting competency
testing

• Data and Lab

Management
• Safety
Record keeping • Customer Service Sample receipt
and data and
management accessioning

Genotype
QA and QC
testing 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
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 Testing Phase

Sample
collection

Personnel
Reporting competency
testing

• Data and Lab

Management
• Safety
Record keeping • Customer Service Sample receipt
and data and
management accessioning

Genotype
QA and QC
testing 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

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 Post-testing Phase

Sample
collection

Personnel
Reporting competency
testing

• Data and Lab

Management
• Safety
Record keeping • Customer Service Sample receipt
and data and
management accessioning

Genotype
QA and QC
testing 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

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 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
results, where such review is required. 24
 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.

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 Template for Procedures

 Title  Procedure
 Purpose  Troubleshooting
 Equipment  Calculations
 Supplies  Interpretation/ Results
 Sample (for testing  References
procedures only)  Related Documents
 Special Safety  Appendices
Precautions
Standard
Operating
Procedures
(SOPs) 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?

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 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
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Recommended Forms for Genotyping Labs

 QC form(s) for genotyping

 Document approval request form
 Lab reagent inventory form
 Flowchart for sample management

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 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

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 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.

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 Discussion

 Besides SOPs, what other types of documents

help with process control?

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managing documents

Why is it important to control how documents are created,

updated, copied, and stored?
What are some general guidelines for document management?

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 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

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Document Management System: Purpose

 Keep everyone up to date

 Get rid of old, outdated information
 Standardize procedures

 Maintain quality of laboratory services and results

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 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 – 100 – P08
 Revision number
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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

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 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

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 Discussion

 Why is it important to control how documents are

created, updated, copied, and stored?
 What are some general guidelines for document
management?

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 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?

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 Summary

 Processes and Procedures

 Documenting Processes and Procedures
 Forms, Manuals, and Job Aids
 Managing Documents

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Practice: Create an SOP for Making Coffee

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 Summary

Process List SOP for

• Identify SOPs SOPs
• Create • Pre-test • Who
• Validate • Test • What
• Approve • Post-test • When

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