standard operating procedures (sop’s) -...

Erik Reisdorf, MPH, M(ASCP)CM

Surveillance & Team Leader-Virology Laboratory

Improving Influenza Laboratory Management PracticesFebruary 27-March 2, 2012

Standard Operat ing Procedures (SOP’s)

Bangkok, Thailand m February 27th to March 2nd, 2012Improving Influenza Laboratory Management Practices

Learning Object ives

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 Operat ing 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!


What is an SOP important? Ensures that assays are performed the same way every t ime by

every one Ensures:




every one Ensures:

• Accuracy




every one Ensures:

• Accuracy• Reproducibility




every one--UNIFORMITY Ensures:

• Accuracy• Reproducibility• Validity of results

SOPs are an integral part of a successful total quality system in the laboratory


Development of a Total Quality System


Quality Policies Mission statements

Quality Plan

Quality Manual

Training

Procedures

Monitoring and Evaluation

Quality Improvements

Implementation of Policies

Application of Standards

Development of SOPs

Implementation of quality systems & use of SOPs

Documenting Failures

Corrective Actions

Exercise I:

What should be included in this SOP specifically for your lab?A. Acceptable specimen

typesB. Use of posit ive/negative

controlsC. Result interpretat ion D. Report ing results


Exercise I:

What should be included in this SOP specifically for your lab?A. Materials requiredB. Use of posit ive/negative

controlsC. Result interpretat ion D. Report ing results


When

Who

How


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



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 insertsEtc…


When SOPs are revised, you must document these changes!

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 variability of results generated

by different laboratories analyzing the same samples and cit ing the same general reference is due to differences in the way the analyt ical 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 illustrat ions 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 quality assessment panel for Influenza to 5 regional labs

Specimen IDExpected Results Lab 1 Lab 2 Lab 3 Lab 4 Lab 5 Mean Ct High Ct Low Ct

11 WI 010 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 37.3 21.09

11 WI 014 Inf A 26.9 27 26.0 27.12 39 27.485 39 18.82

Exercise II

… it ’s all in the details!

Lab 1 Lab 2 Lab 3 Lab 4 Lab 5

Method/TargetCDC Real-time PCR

CDC Real-time PCR

CDC Real-time PCR

CDC Real-time PCR

CDC Real-time PCR

Extraction Method BM easyMAG

Qiagen Viral RNA Qiagen Viral RNA BM easyMAG

Qiagen Viral RNA

PCR Mix VendorAmbion AgPath

InvitrogenSuperscript



AB TaqMan one-step

PCR Platform AB7500Fast DX AB7500Fast DX AB7500Fast DX AB7500Fast DX AB7500Fast DX

Creating an SOP

SOP’s should be concise, step-by-step, and easy to read Use act ive 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 t it les 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• Consider using illustrations if possible


Exercise III: SOP or Job Aid Would the following be considered an SOP or Job Aid?

A. SOPB. Job Aid


Exercise III: SOP or Job Aid

Would the following be considered an SOP or Job Aid?

A. SOPB. Job Aid


Use pictures, tables & flowcharts to illustrate act ions


Use pictures, tables & flowcharts to illustrate act ions

Especially useful when writ ing procedures for using complex software to illustrate “how to”

Example 1 Example 2


Writ ing an SOP: Step 1

Table of Contents ISO 15189


Writ ing an SOP: Step 1

Table of Contents Clinical LaboratoryStandards Inst itute


Writ ing an SOP: Step 2 Tracking documentat ion

Header example


Change (Revision) Log

Writ ing 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



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



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 Appendix



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 References Appendix



Title and test code (if applicable) Introduction/Purpose Specimen collection, transport, storage and rejection criteria Reagents/materials/equipment– include catalog#



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


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 Appendix



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



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


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


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


Key Points Prepared in local language Include pre-analyt ical, analyt ical and post-analyt ical

phases Concise & easy to follow; step-by-step Include document tracking and change log Include illustrat ions, flowcharts, and tables to illustrate

procedures Drafts should be reviewed by test ing 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!


Key Points

Avoid too much detail!

BAD EXAMPLE: “ The purpose of this procedure is to document the aforementioned act ivit ies, herein after referred to as the prescribed tasks in terms that preclude their execut ion in an inconsistent manner, wherein such inconsistency may potent ially result in the prescribed tasks delivering a result that is not repeatable or reproducible”…


References

CLSI (2006) Laboratory Documents: Development and Control; Approved guideline-5th Edit ion. GP2-A5

WHO (2011) Laboratory Quality Standards and their Implementat ion. Available at: ht tp://www.searo.who.int /LinkFiles/Publicat ions_Laboratory_Quality_Standards_and_Impl.pdf

WHO (n.d.) Laboratory Quality Management System Tool Kit . Available at: ht tp://www.who.int /ihr/t raining/laboratory_quality/documents/en/index.html

ISO 15189 (2007) Medical Laboratory Standards-2nd

Edit ion Rick Alexander-Orange County (CA) Public Health Lab* Citations, references, and creditsw– Myriad Pro, 11pt

http://www.searo.who.int/LinkFiles/Publications_Laboratory_Quality_Standards_and_Impl.pdf�

http://www.searo.who.int/LinkFiles/Publications_Laboratory_Quality_Standards_and_Impl.pdf�

http://www.who.int/ihr/training/laboratory_quality/documents/en/index.html�

http://www.who.int/ihr/training/laboratory_quality/documents/en/index.html�

Group Exercise (20min)

Break into groups of 4 Prepare a brief SOP from the package insert


Tit le (Header)

National Influenza Center-Locat ion

Chapter # 3 Approved By:Lab Director

Page 1 of 5

Section:Influenza testing manual

Title: Binax NOW Influenza A & B Rapid Test

Accepted:December 10, 2011

Revision Date:

Annual Review:


Introduct ion

The BinaxNOW®Influenza A & BTest is an in vitroimmunochromatographic 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 the rapid differential diagnosis of influenza A and B viral infections.

Rapid diagnosis of influenza can be important in cases of severe 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.

Negative test results should be confirmed by cell culture or PCR.

Description of assay

Importance

Target

Sensitivity/specificity

Use


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


Reagents

Item descript ion Manufacturer Catalog #VTM In-house NADacron swabs Sigma 1234Binax NOW Rapidinfluenza detection kit

Inverness Medical 5678


Quality 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) Procedure1. Specimen processing details steps

A. Place swab in elution buffer vialB. Rotate vigorously 3XC. Discard swab

2. Test ing procedure stepsA. Remove sample with pipetteB. Place entire contents (~100ul) on test device (illustration)C. Incubate 15 minutes at ambient temperature

Result Interpretat ionA. Negative specimen will have a pink control line ONLYB. Flu A positive will have a ….. (illustration)C. Flu B positive will have a …. (illustration)D. Invalid will have no control line. Test will be repeated with a new

test device.

Group Exercise (20min) Report ing

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 submitter3. Weekly testing data (# tested/# positives by type) will be

uploaded to WHO FluNETand 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 insertInclude job aidRevision log

Influenza A Positive

Image: www.remel.com