Standard Operating Procedures Writing - …...• Standard Operating Procedure • Recognized...

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Standard Operating Procedures (SOPs) Writing

Dr Naheda AlkazemiJuly 2018

Content

• What is an SOP?• SOP benefits• Tips before creating SOP• When do we review SOPs?• SOP Structure

Standard Operating Procedure (SOP) writing - Dr Naheda Alkazemi - 2018

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

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

Content

• What is an SOP?• SOP benefits

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

Content

• What is an SOP?• SOP benefits• Tips before creating SOP

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

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

Content

• What is an SOP?• SOP benefits• Tips before creating SOP• When do we review SOPs?

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

Content

• What is an SOP?• SOP benefits• Tips before creating SOP• When do we review SOPs?• SOP Structure

SOP Manual Table of Contents

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

• Font: Times New Roman• Font size:

• Titles: 12 BOLD• Paragraphs: 12• Footer: 10

• Line Spacing: 1.5 Line

SOP Template

Header / Footer

Title: Code:Section: Issue date:Issued by: Revision date:Approved by: Approved by:

• Header

• Footer:

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!

Definitions

• Abbreviations• e.g. CBC: Complete Blood Count

• Scientific terms

Equipment / Supplies

• List all the equipment used• List all supplies needed

• Tables attached / index • Reagents used preparation recipe (if any)

Sample

• Specimen collection • Acceptable specimen criteria; including:

• Received after collection time• Transportation• Storage

• Specimen rejection criteria• Biosafety

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

Procedure

• Step-by-step detailed instructions (simple & concise)• Sample processing• Sample testing• Data acquisition, calculations, software

Troubleshooting

• Equipment• Refer to the manufacturer manual

• Test• Refer to the kit/package insert

Calculations

• Results• Reporting • Dilutions

Interpretation criteria

• Define positive, negative and equivocal/inconclusive results

• Define other tests needed (if any)• Table format?

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

References / Related Documents

• Literatures cited (e.g. in the introduction)• Package inserts (if any)• Any document that interfaces with the SOP

Appendices

• Package inserts• Flowcharts• Tables• Instrument operation & maintenance• Supporting documents

Questions?

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