Standard Operating Procedures (SOP’s) Erik Reisdorf, MPH, M(ASCP)CM Surveillance & Team Leader-Virology Laboratory Improving Influenza Laboratory Management Practices February 27-March 2, 2012
Improving Influenza Laboratory Management Practices Bangkok, Thailand m February 27 th to March 2 nd , 2012
Learning Objectives
Differences between processes and procedures Importance of SOP’s Describe the key elements of an SOP Differences between SOP and a job aid Understand principles of document control Create an SOP
* Citations, references, and credits – Myriad Pro, 11pt
Standard Operating Procedure (SOP)
What is an SOP? Step-by-step instructions on how to perform a laboratory assay Includes: • Pre-analytical [Specimen receipt & processing] • Analytical [Testing procedures (e.g. PCR)] • Post-analytical [Interpreting & reporting test results (When, Who, How)] • References
SOP’s are specific for your laboratory!
* Citations, references, and credits – Myriad Pro, 11pt
Standard Operating Procedure (SOP)
What is an SOP important? Ensures that assays are performed the same way every time by
every one Ensures:
* Citations, references, and credits – Myriad Pro, 11pt
Standard Operating Procedure (SOP)
What is an SOP important? Ensures that assays are performed the same way every time by
every one Ensures: • Accuracy
* Citations, references, and credits – Myriad Pro, 11pt
Standard Operating Procedure (SOP)
What is an SOP important? Ensures that assays are performed the same way every time by
every one Ensures: • Accuracy • Reproducibility
* Citations, references, and credits – Myriad Pro, 11pt
Standard Operating Procedure (SOP)
What is an SOP important? Ensures that assays are performed the same way every time by
every one--UNIFORMITY Ensures: • Accuracy • Reproducibility • Validity of results
SOPs are an integral part of a successful total qualit y system in the laboratory
* Citations, references, and credits – Myriad Pro, 11pt
Development of a Total Quality System Quality Policies
Mission statements
Quality Plan
Implementation of Policies
Quality Manual
Application of Standards
Procedures
Development of SOPs
Training
Implementation of quality systems & use of SOPs
Monitoring and Evaluation
Documenting Failures
Quality Improvements
Corrective Actions
* Citations, references, and credits – Myriad Pro, 11pt
Development of a Total Quality System Quality Policies
Mission statements
Quality Plan
Implementation of Policies
Quality Manual
Application of Standards
Procedures
Development of SOPs
Training
Implementation of quality systems & use of SOPs
Monitoring and Evaluation
Documenting Failures
Quality Improvements
Corrective Actions
* Citations, references, and credits – Myriad Pro, 11pt
Exercise I:
What should be included in this SOP specifically for your lab? A. Acceptable specimen types B. Use of positive/negative controls C. Result interpretation D. Reporting results
* Citations, references, and credits – Myriad Pro, 11pt
Exercise I:
What should be included in this SOP specifically for your lab? A. Materials required B. Use of positive/negative controls C. Result interpretation D. Reporting results When Who How * Citations, references, and credits – Myriad Pro, 11pt
Standard Operating Procedure (SOP)
What are the benefits to your lab?
Important for training new staff Efficient workflow Address safety concerns Minimize opportunities for miscommunication Minimize variability in test results Minimize failed test runs Recognized internationally as a vital part of a laboratory quality assurance program
* Citations, references, and credits – Myriad Pro, 11pt
Standard Operating Procedure (SOP)
SOPs are “ living” documents!! Reviewed annually by supervisors Updated as needed • New catalog numbers • Improvements in workflow • Change or location of reagents • Changes in reporting • Revised kit package inserts Etc…
When SOPs are revised, you must document these changes!
* Citations, references, and credits – Myriad Pro, 11pt
SOP’s are Necessary Even When Utilizing Published Methods SOP’s specify procedures in greater details SOP’s are specific to the laboratory SOP’s should detail how (if at all) it differs from the published or standard methods “a significant part of the variabilit y of results generated by different laboratories analyzing the same samples and citing the same general reference is due to differences in the way the analytical test methods and procedures are actually performed by each laboratory. These differences are often caused by slight changes or adjustments allowed (or not detailed) by the general reference.” * Standard Guide for Documenting the Standard Operating Procedures used for Analysis of Water. 2004 ASTM
Package inserts are NOT SOP’s
Package inserts do NOT include specific information that pertains to your laboratory Do NOT rely solely on manufacturer’s package inserts for SOP’s DO use information from the package insert to include in the SOP. DO use illustrations from package inserts
* Standard Guide for Documenting the Standard Operating Procedures used for Analysis of Water. 2004 ASTM
Exercise II
Your laboratory sends out an external qualit y assessment panel for Influenza to 5 regional labs
Specimen ID
Expected Results Lab 1
Lab 2
Lab 3
Lab 4
Lab 5
Mean Ct High Ct Low Ct
Inf A
17.14
19.3
20.5
21.02
30.6
22.1
30.6
17.14
Inf B
21.76
23.2
22.6
20.26
36.7
25.48
36.7
20.26
11 WI 011
NEG
NEG
NEG
NEG
NEG
NEG
11 WI 012
Inf A
19.07
20.4
21.1
20.33
30.3
22.525
30.3
19.07
11 WI 013
Inf B
21.09
21.8
22.0
21.81
37.3
25.5
11 WI 014
Inf A
26.9
27
26.0
27.12
39
27.485
11 WI 010
37.3 39
21.09 18.82
Exercise II … it ’s all in the details!
Lab 1 Method/Target Extraction Method
Lab 2
Lab 3
CDC Real-time CDC Real-time CDC Real-time PCR PCR PCR
Lab 4 CDC Real-time PCR
Lab 5 CDC Real-time PCR
BM easyMAG
Qiagen Viral RNA
Qiagen Viral RNA BM easyMAG
Qiagen Viral RNA
PCR Mix Vendor
Ambion AgPath
Invitrogen Superscript
Invitrogen Superscript
AB TaqMan onestep
PCR Platform
AB7500Fast DX AB7500Fast DX AB7500Fast DX AB7500Fast DX AB7500Fast DX
Invitrogen Superscript
Creating an SOP
SOP’s should be concise, step-by-step, and easy to read Use active voice and present verb tense; Avoid using “ you” —implied Examples: Add 5ul of taq polymerase; Add 1.0ml H20 and vortex You should now add 1.0ml and then you should vortex
Avoid using names; instead use titles if possible Should be available in local language Simplify when possible Consider using job aids
• Abbreviated step-by-step instructions • Should be in accordance with SOP • Should be included as an appendix * Citations, references, and credits – Myriad Pro, 11pt • Consider using illustrations if possible
Exercise III: SOP or Job Aid
A. B.
Would the following be considered an SOP or Job Aid? SOP Job Aid
* Citations, references, and credits – Myriad Pro, 11pt
Exercise III: SOP or Job Aid
A. B.
Would the following be considered an SOP or Job Aid? SOP Job Aid
* Citations, references, and credits – Myriad Pro, 11pt
Exercise III: SOP or Job Aid
A. B.
Would the following be considered an SOP or Job Aid? SOP Job Aid
* Citations, references, and credits – Myriad Pro, 11pt
Exercise III: SOP or Job Aid
A. B.
Would the following be considered an SOP or Job Aid? SOP Job Aid
* Citations, references, and credits – Myriad Pro, 11pt
Exercise III: SOP or Job Aid
A. B.
Would the following be considered an SOP or Job Aid? SOP Job Aid
* Citations, references, and credits – Myriad Pro, 11pt
Exercise III: SOP or Job Aid
A. B.
Would the following be considered an SOP or Job Aid? SOP Job Aid
* Citations, references, and credits – Myriad Pro, 11pt
Use pictures, tables & flowcharts to illustrate actions
* Citations, references, and credits – Myriad Pro, 11pt
Use pictures, tables & flowcharts to illustrate actions Especially useful when writing procedures for using complex software to illustrate “ how to” Example 1
* Citations, references, and credits – Myriad Pro, 11pt
Example 2
Writing an SOP: Step 1
Table of Contents ISO 15189
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Writing an SOP: Step 1 Table of Contents Clinical Laboratory Standards Institute
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Writing an SOP: Step 2
Tracking documentation Header example
Change (Revision) Log
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References Appendix
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information Title and test code (if applicable)—Influenza A Antiviral Resistance Test (Test# 3122) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References Appendix
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References Appendix
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information Title and test code (if applicable) Introduction/Purpose • • • • •
Background information about assay Sensitivity/specificity data if appropriate Target sequences Surveillance or diagnostic Justification of importance (include references)
Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References * Citations, references, and credits – Myriad Pro, 11pt Appendix
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References Appendix
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria • • • • • •
Acceptable specimens include… Specim ens m ust be received ≤72hours post collection;lableling (DOC) Specimens stored at 4C or -80C Residual specimens archived indefinitely Reject leaking specimens Biosafety
Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting * Citations, references, and credits – Myriad Pro, 11pt References
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References Appendix
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog#
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References Appendix
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance • • • •
Control material (e.g. patient specimen, isolates, NA) Positive, Negative, Extraction, NTC controls Define acceptable/failure criteria Define actions taken
Procedure Interpretation criteria Resulting & reporting References Appendix * Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References Appendix
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure • • • • •
Step-by-step detailed instructions (simple & concise) Reagent recipes Sample processing Testing Data acquisition, calculations, software
Interpretation criteria Resulting & reporting References * Citations, references, and credits – Myriad Pro, 11pt Appendix
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References Appendix
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria • Define positive, negative and equivocal/inconclusive results • Consider table format
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References Appendix
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting • • • •
When to report How to report Who to report Documentation and retention
References Appendix * Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References Appendix
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References • Peer reviewed literature cited in Introduction • Package insert information (if applicable) • Any document that interfaces with the SOP
Appendix * Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References Appendix
* Citations, references, and credits – Myriad Pro, 11pt
Writing an SOP: Step 3
The SOP should include the following information
Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog# Quality assurance Procedure Interpretation criteria Resulting & reporting References Appendix—Job aids, package inserts, flowcharts, tables, instrument operation & maintenance
* Citations, references, and credits – Myriad Pro, 11pt
Key Points
Prepared in local language Include pre-analytical, analytical and post-analytical phases Concise & easy to follow; step-by-step Include document tracking and change log Include illustrations, flowcharts, and tables to illustrate procedures Drafts should be reviewed by testing staff Include job aids Annual review (including staff ) and when revised Only one master copy (can be electronic) Avoid using package inserts as SOP’s!
* Citations, references, and credits – Myriad Pro, 11pt
Key Points Avoid too much detail!
BAD EXAMPLE: “ The purpose of this procedure is to document the aforementioned activities, herein after referred to as the prescribed tasks in terms that preclude their execution in an inconsistent manner, wherein such inconsistency may potentially result in the prescribed tasks delivering a result that is not repeatable or reproducible” …
* Citations, references, and credits – Myriad Pro, 11pt
References
CLSI (2006) Laboratory Documents: Development and Control; Approved guideline-5th Edition. GP2-A5 WHO (2011) Laboratory Quality Standards and their Implementation . Available at: http://www.searo.who.int/LinkFiles/Publications_Labor atory_Qualit y_Standards_and_Impl.pdf WHO (n.d.) Laboratory Quality Management System Tool Kit. Available at: http://www.who.int/ihr/training/laboratory_qualit y/do cuments/en/index.html ISO 15189 (2007) Medical Laboratory Standards-2nd
Edition * Citations, Rickreferences, Alexander-Orange and creditsw– Myriad Pro, 11pt County (CA) Public Health Lab
Group Exercise (20min)
Break into groups of 4 Prepare a brief SOP from the package insert
Group Exercise (20min)
Title (Header)
National Influenza Chapter # 3 Center-Location
Approved By: Lab Director
Page 1 of 5
Section: Influenza testing manual
Accepted: December 10, 2011
Revision Date:
Title: Binax NOW Influenza A & B Rapid Test
Annual Review:
Group Exercise (20min)
Introduction
Description of assay
Target The BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal wash/aspirate specimens. It is intended to aid in Use the rapid differential diagnosis of influenza A and B viral infections. Rapid diagnosis of influenza can be important in cases of severe Importance disease warranting the use of antiviral therapies [2]. This assay has been shown to be reactive to seasonal H1, seasonal H3, 2009 H1N1 and Influenza B. However, sensitivity is less than culture or PCR. Sensitivity/specificity Negative test results should be confirmed by cell culture or PCR.
Group Exercise (20min)
Specimen criteria
Acceptable specimens include nasal washes/aspirates and NP or nasal swabs collected in VTM and received at the laboratory within 24 hours of collection.
Specimens should be labeled with patient name, location, DOC and transported at refrigerated temperatures.
Leaking specimens, non-respiratory specimens and unlabeled specimens will be rejected.
Specimens will be processed in a ClassII Biosafety Cabinet
Group Exercise (20min)
Reagents
Item description
Manufacturer
Catalog #
VTM
In-house
NA
Dacron swabs
Sigma
1234
Binax NOW Rapid influenza detection kit
Inverness Medical
5678
Group Exercise (20min)
Qualit y Control Each new testing kit lot# should be tested with an Influenza A, Influenza B and negative specimen controls. Failure of the testing kit to produce reactions consistent with the manufacturers specifications will be rejected and the manufacturer will be contacted.
Group Exercise (20min) 1.
Procedure Specimen processing details steps A. Place swab in elution buffer vial B. Rotate vigorously 3X C. Discard swab
2.
Testing procedure steps A. Remove sample with pipette B. Place entire contents (~100ul) on test device (illustration) C. Incubate 15 minutes at ambient temperature
Result Interpretation A. B. C. D.
Negative specimen will have a pink control line ONLY Flu A positive will have a ….. (illustration) Flu B positive will have a …. (illustration) Invalid will have no control line. Test will be repeated with a new test device.
Group Exercise (20min)
Reporting 1. Test results will be recorded in specimen logbook (location) and retained for a period of at least 5 years. 2. Test result reports will be sent daily by FAX to submitter 3. Weekly testing data (# tested/# positives by type) will be uploaded to WHO FluNET and be provided to the MOH Director. 1.
Include detailed procedure
Group Exercise (20min)
References 1. Binax NOW Rapid Influenza A & B package insert (Revised 12/19/2006. 2. Clinical Virology textbook
Group Exercise (20min)
Appendix Include package insert Include job aid Revision log
Influenza A Positive
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