standard operating procedures writing - …...• standard operating procedure • recognized...
TRANSCRIPT
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Standard Operating Procedures (SOPs) Writing
Dr Naheda AlkazemiJuly 2018
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Content
• What is an SOP?• SOP benefits• Tips before creating SOP• When do we review SOPs?• SOP Structure
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What is an SOP?
• Standard Operating Procedure• Recognized internationally as a vital part of a laboratory quality
assurance program• Part of successful quality system in the laboratory• Step-by-step detailed instructions on how to perform a
laboratory assay/ procedures, including: • Pre-analytical [Specimen receipt & processing]• Analytical [Testing procedures (e.g. CBC)]• Post-analytical [Interpreting & reporting test results]
• Made specific to each laboratoryStandard Operating Procedure (SOP) writing - Dr Naheda Alkazemi - 2018
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What is an SOP? … cont
• Ensure reproducible and correct performance of laboratory tests• Requires a system for:
• Preparation• Approval• Distribution• Revision• Training
• Uniform • Accurate• Ensures results validityStandard Operating Procedure (SOP) writing - Dr Naheda Alkazemi - 2018
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Content
• What is an SOP?• SOP benefits
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SOP benefits
• Important for training new staff• Efficient workflow• Address safety and quality concerns• Minimize opportunities for
misunderstanding/miscommunication• Minimize variability in test results• Minimize failed test runs
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Content
• What is an SOP?• SOP benefits• Tips before creating SOP
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Tips before creating SOP
• SOP’s should be concise, step-by-step, and easy to read• Include pre-analytical, analytical and post-analytical phases• Use active voice and present verb tense (Never use “you”) (e.g.
Add 5ml of H20 and vortex)• Avoid using names; instead use titles if possible• Abbreviated step-by-step instructions• Consider using illustrations if possible• You can use pictures, tables & flowcharts to illustrate actions
• Especially useful for software instructionsStandard Operating Procedure (SOP) writing - Dr Naheda Alkazemi - 2018
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Tips creating SOP … cont
• Drafts should be reviewed by testing staff • Avoid unnecessary details• Document all dates (issue, review)• Kit/package inserts are NOT SOP’s• Never rely solely on manufacturer’s instructions for SOP’s• Information from the kit/package insert can help in the writing
of SOP.• Illustrations from kit/package inserts can be used/attached to
SOPsStandard Operating Procedure (SOP) writing - Dr Naheda Alkazemi - 2018
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Content
• What is an SOP?• SOP benefits• Tips before creating SOP• When do we review SOPs?
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When do we review SOPs?
• Regular update• Improvements in workflow• Change of reagents• Changes in reporting• Revised kit package inserts
IMPORTANT NOTE:When SOPs are revised, you must document these changes!Standard Operating Procedure (SOP) writing - Dr Naheda Alkazemi - 2018
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Content
• What is an SOP?• SOP benefits• Tips before creating SOP• When do we review SOPs?• SOP Structure
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SOP Manual Table of Contents
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SOP Structure
The SOP should include the following information• Title• Introduction/Purpose• Definitions• Equipment• Supplies• Sample (for testing procedures only)• Safety / Quality• Procedure
• Troubleshooting• Calculations • Interpretation/ Results• References• Related Documents• Appendices
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• Font: Times New Roman• Font size:
• Titles: 12 BOLD• Paragraphs: 12• Footer: 10
• Line Spacing: 1.5 Line
SOP Template
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Header / Footer
Title: Code:Section: Issue date:Issued by: Revision date:Approved by: Approved by:
• Header
• Footer:
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Introduction / Purpose
• Background information about the assay / machine / process
• Sensitivity/specificity data if appropriate• Diagnostic information • Justification of importance (include references)• Don’t forget citation!
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Definitions
• Abbreviations• e.g. CBC: Complete Blood Count
• Scientific terms
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Equipment / Supplies
• List all the equipment used• List all supplies needed
• Tables attached / index • Reagents used preparation recipe (if any)
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Sample
• Specimen collection • Acceptable specimen criteria; including:
• Received after collection time• Transportation• Storage
• Specimen rejection criteria• Biosafety
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Safety / Quality
• Quality • Quality controls
• Positive, negative, extraction, controls• Define acceptable/failure criteria• Define actions taken following test results (if any)
• Safety• Equipment needed• Important precautions• Test environment
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Procedure
• Step-by-step detailed instructions (simple & concise)• Sample processing• Sample testing• Data acquisition, calculations, software
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Troubleshooting
• Equipment• Refer to the manufacturer manual
• Test• Refer to the kit/package insert
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Calculations
• Results• Reporting • Dilutions
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Interpretation criteria
• Define positive, negative and equivocal/inconclusive results
• Define other tests needed (if any)• Table format?
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Resulting & Reporting
• When to report the results• How to report the test performed• Who has the authority to report• Documentation storage and retention (how, when,
where, who)• Electronic• Manual
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References / Related Documents
• Literatures cited (e.g. in the introduction)• Package inserts (if any)• Any document that interfaces with the SOP
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Appendices
• Package inserts• Flowcharts• Tables• Instrument operation & maintenance• Supporting documents
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Questions?
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References
• CLSI (2006) Laboratory Documents: Development and Control; Approved guideline-5thEdition. GP2-A5
• WHO (2011) Laboratory Quality Standards and their Implementation. Available at: http://www.searo.who.int/LinkFiles/Publications_Laboratory_Quality_Standards_and_Impl.pdf
• WHO (n.d.) Laboratory Quality Management System Tool Kit. Available at: http://www.who.int/ihr/training/laboratory_quality/documents/en/index.html
• ISO 15189 (2007) Medical Laboratory Standards-2ndEdition• Rick Alexander-Orange County (CA) Public Health Lab• Erik Reisdorf (2012) Standard Operating Procedures (SOPs). Surveillance & Team
Leader-Virology Laboratory
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