Transcript HIV Drug Resistance Training Module 10 Standard Operating Procedures (SOPs) 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.

HIV Drug Resistance Training
Module 10
Standard Operating
Procedures (SOPs)
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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
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Processes and Procedures
Documenting Processes and Procedures
Forms, Manuals, and Job Aids
Managing Documents
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Objectives
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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.
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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
competency
testing
Reporting
Record keeping
and data
management
• Data and Lab
Management
• Safety
• Customer Service
QA and QC
Genotype
testing
Sample receipt
and
accessioning
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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
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Procedures Must Be Documented—in SOPs
Sample
collection
Start
Step 1
Step 2
Standard
Operating
Procedures
(SOPs)
More
steps…
Finish
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Process and Procedure
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
Process documents:
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–
–
–
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:
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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
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Standard Operating Procedures
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Purpose: to ensure reproducible and correct
performance of laboratory tests
– Reduce inter-operator and inter-run variation
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Made specific for each laboratory
Controlled document: need a regulated system
for
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–
–
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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
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Document approval process
Document management process
New assay validation process
New employee training process
Genotyping process
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Template for Process Documents
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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
& Supplies
Equipment
& Supplies
Safety
Precautions
Safety
Precautions
Step-bystep
instructions
Step-bystep
instructions
Other
information
Other
information
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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
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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
competency
testing
Reporting
Record keeping
and data
management
• Data and Lab
Management
• Safety
• Customer Service
QA and QC
Genotype
testing
Sample receipt
and
accessioning
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Testing Procedures
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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
competency
testing
Reporting
Record keeping
and data
management
• Data and Lab
Management
• Safety
• Customer Service
QA and QC
Genotype
testing
Sample receipt
and
accessioning
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Post-testing Procedures
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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
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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
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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.
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Template for Procedures
Title
Purpose
Equipment
Supplies
Sample (for testing
procedures only)
 Special Safety
Precautions
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Standard
Operating
Procedures
(SOPs)
Procedure
Troubleshooting
Calculations
Interpretation/ Results
References
Related Documents
Appendices
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Discussion
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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
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Blank documents (paper or computer)
Record results of a given procedure
Forms include:
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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)
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Guidelines:
– Include properly completed in procedures manual
– Note needed forms in Appendices section of SOPs
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Recommended Forms for Genotyping Labs
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QC form(s) for genotyping
Document approval request form
Lab reagent inventory form
Flowchart for sample management
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Procedure Manuals
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Procedure manuals should be organized in a way
that can be easily followed by laboratory
personnel and should contain the following
elements:
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Table of contents
Process descriptions (optional)
Procedures
Associated Forms
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Job Aids
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Examples:
– Instruction sheets
– Wall charts
– Instructions posted on equipment
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Qualities of good job aids:
– 3 C’s: Current, complete, and correct
– Traceable to the “parent” document
– Effective date is listed.
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If some of the above qualities are missing, start
the document change process.
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Discussion
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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
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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
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Keep everyone up to date
Get rid of old, outdated information
Standardize procedures
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Maintain quality of laboratory services and results
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Document Identification (example)
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Name of lab or institution (e.g. ABC)
Numbers for type of procedure
– 100 = General Laboratory
– 200 = Molecular
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Document type and procedure number
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F = Form
P = Procedure
G = Guidance or Job Aid Documents
T = Table (process)
C = Flowchart (process)
ABC –
Revision number
100 – P08
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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
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Master file:
–
–
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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
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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
• Identify
• Create
• Validate
• Approve
List
SOPs
SOP for
SOPs
• Pre-test
• Test
• Post-test
• Who
• What
• When
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