Standard Operating Procedures (SOP’s) - flu

1 Er i k Rei sd o r f , M PH, M (A SCP)CMSurveillance & Team Leader-Virology LaboratoryImp rovi ng Influenza Lab orat or y Management Pract icesFe b r u ar y 2 7-March 2, 2012St andard Operat ing Procedures ( SOP s)Bangkok, Thailand mFeb ruary 27tht o Ma rc h 2nd, 2012 Improving Influenza Laboratory Management PracticesLearning Obj ect ives Dif ferences bet ween processes and Procedures Im p o r t an ce o f SOP s Describe t he key element s of an SOP Dif ferences bet ween SOP and a j ob aid Understand principles of document control Creat e an SOP* Cit at ions, references, and credit s Myriad Pro, 11ptSt andard Operat ing Procedure (SOP) What is an SOP? St e p-by-step instructions on how to perform a laboratory assay In cl u d es: Pr e-analytical [Specimen receipt & processing] Analytical [Testing Procedures ( PCR)] Po st-analytical [Interpreting & reporting test results (When, Who, How)] References* Cit at ions, references, and credit s Myriad Pro, 11ptSOP s are specif ic for your laborat or y!

2 St andard Operat ing Procedure (SOP) What is an SOP important? En su r es t h at assays ar e p er f o r m ed t h e sam e w ay ever y t ime by ever y one En su r es:* Cit at ions, references, and credit s Myriad Pro, 11ptSt andard Operat ing Procedure (SOP) What is an SOP important? En su r es t h at assays ar e p er f o r m ed t h e sam e w ay ever y t ime by ever y one En su r es: Accuracy* Cit at ions, references, and credit s Myriad Pro, 11ptSt andard Operat ing Procedure (SOP) What is an SOP important? En su r es t h at assays ar e p er f o r m ed t h e sam e w ay ever y t ime by ever y one En su r es: Accuracy Reproducibility* Cit at ions, references, and credit s Myriad Pro, 11ptSt andard Operat ing Procedure (SOP) What is an SOP important? En su r es t h at assays ar e p er f o r m ed t h e sam e w ay ever y t ime by ever y one--UNIFORMITY En su r es: Accuracy Reproducibility Validity of resultsSOPs are an int egral par t of a successf ul t ot al qualit y syst em in t he laboratory* Cit at ions, references, and credit s Myriad Pro, 11ptDevelopment of a Tot al Qualit y Syst em* Cit at ions, references, and credit s Myriad Pro, 11ptQuality PoliciesM i ssi o n st at em en t sQuality PlanQualit y ManualTrainingProceduresMonitoring and EvaluationQualit y Improvement sImplementation of PoliciesAp p licat ion of St and ard sDevelopment of SOPsImplementation of quality systems & u se o f SO PsDocumenting FailuresCorrect ive Act ionsDevelopment of a Tot al Qualit y Syst em* Cit at ions, references, and credit s Myriad Pro.

3 11ptQuality PoliciesM i ssi o n st at em en t sQuality PlanQualit y ManualTrainingProceduresMonitoring and EvaluationQualit y Improvement sImplementation of PoliciesAp p licat ion of St and ard sDevelopment of SOPsImplementation of quality systems & u se o f SO PsDocumenting FailuresCorrect ive Act ionsExercise I: What should be included in this SOP specifically for yourlab? able specimen t of posit ive/negat ive int erpret at ion results* Cit at ions, references, and credit s Myriad Pro, 11ptExercise I: What should be included in this SOP specifically for yourlab? erials of posit ive/negat ive int erpret at ion results* Cit at ions, references, and credit s Myriad Pro, 11ptWh enWh oHowSt andard Operat ing Procedure (SOP) What are t he benef it s t o your lab? Important for training new staff Efficient workflow Ad d r ess saf et y co n cer n s Minimize opportunities for miscommunication Minimize variability in test results Minimize failed test runs Recog nized int ernat ionally as a vit al p ar t of a lab orat or y q ualit y assurance p rog ram* Cit at ions, references, and credit s Myriad Pro, 11ptSt andard Operat ing Procedure (SOP) SOPs are living documents!

4 ! Reviewed annually by supervisors Updat ed as needed New cat alog numb ers Improvement s in workflow Change or location of reagents Changes in reporting Revi sed kit package insert sEt c ..* Cit at ions, references, and credit s Myriad Pro, 11ptWhen SOPs are revised, you must documentt hese changes!SOP s are Necessar y Even When Ut ilizing Published Methods SOP s specif y Procedures in great er det ails SOP s are specif ic t o t he laborat or y SOP s should detail how (if at all) it differs from the published or Standard methods a signif icant par t of t he variabilit y of result s generat ed by dif ferent laborat ories analyzing t he same samples and cit ing t he same general reference is due t o dif ferences in t he way t he analyt ical t est met hods and Procedures are act ually per formed by each laborat or y. These dif ferences are of t en caused by slight changes or adj ust ment s allowed (or not det ailed) by t he general reference.

5 * Standard Guide for Documenting the Standard Operating Procedures used for Analysis of Water. 2004 ASTMP ackage inser t s are NOT SOP s Package inser t s do NOTinclude specific information that pertains to your laboratory Do NOTrely solely on manuf act urer s package inser t s f o r SOP s DOuse information from the package insert to include in the SOP. DOuse illust rat ions f rom package inser t s* Standard Guide for Documenting the Standard Operating Procedures used for Analysis of Water. 2004 ASTME xercise II Your laborat or y sends out an ext ernal qualit y assessment panel for Inf luenza t o 5 regional labsSpecimen IDExpect ed Re su l t sLab 1 Lab 2 Lab 3 Lab 4 Lab 5 Mean CtHigh CtLo w Ct11 WI WI 011N EGN EGN EGN EGN EGN EG11 WI WI WI it s all in the details!Lab1 Lab 2 Lab 3 Lab 4 Lab 5 Met hod/ TargetCDC Real-t ime PCRCDC Real-t ime PCRCDC Real-t ime PCRCDC Real-t ime PCRCDC Real-t ime PCRE xtraction MethodBM easyM AGQiagenViral RN AQiagenViral RNABM easyM AGQiagenViral RN APCR Mix VendorAmbion A g Pat hInvi t rogenSuperscriptInvi t rogenSuperscriptInvi t rogenSuperscriptAB TaqManone-st epPCR Pl a t f o r mAB7500 Fast DXAB7500 Fast DXAB7500 Fast DXAB7500 Fast DXAB7500 Fast DXCreating an SOP SOP s sh o u l d b e co n ci se, st ep-by-st ep, and easy t o read Use act ive voice and present verb t ense; Avoid using you implied Examples: Add 5ul of taqpolymerase; Add H20 and vortexYo ushould now add and thenyou should vortex Avoid using names.

6 Instead use titles if possible Should be available in local language Simplify when possible Co n si d er u si n g j ob aids Abbrevi at ed st ep-by-step instructions Should be in accordance with SOP Should be included as an appendix Consider using illustrations if possible* Cit at ions, references, and credit s Myriad Pro, 11ptExercise III: SOP or Job Aid Would the following be considered an SOP or Job Aid? b Ai d* Cit at ions, references, and credit s Myriad Pro, 11ptExercise III: SOP or Job Aid Would the following be considered an SOP or Job Aid? b Ai d* Cit at ions, references, and credit s Myriad Pro, 11ptExercise III: SOP or Job Aid Would the following be considered an SOP or Job Aid? b Ai d* Cit at ions, references, and credit s Myriad Pro, 11ptExercise III: SOP or Job Aid Would the following be considered an SOP or Job Aid? b Ai d* Cit at ions, references, and credit s Myriad Pro, 11ptExercise III: SOP or Job Aid Would the following be considered an SOP or Job Aid?

7 B Ai d* Cit at ions, references, and credit s Myriad Pro, 11ptExercise III: SOP or Job Aid Would the following be considered an SOP or Job Aid? b Ai d* Cit at ions, references, and credit s Myriad Pro, 11ptUse pict ures, t ables & f lowchar t s t o illust rat e act ions* Cit at ions, references, and credit s Myriad Pro, 11ptUse pict ures, t ables & f lowchar t s t o illustrate actionsEspecially useful when writing Procedures for using co m p l ex so f t w ar eto illustrate how to Example 1 Example 2* Cit at ions, references, and credit s Myriad Pro, 11ptWriting an SOP: Step 1 Table of Contents ISO 15189* Cit at ions, references, and credit s Myriad Pro, 11ptWriting an SOP: Step 1 Table of Contents Clinical LaboratorySt andards Institute* Cit at ions, references, and credit s Myriad Pro, 11ptWriting an SOP: Step 2 Tracking documentation Header example* Cit at ions, references, and credit s Myriad Pro, 11ptChange (Revision) LogWriting an SOP.

8 Step 3 The SOP should include the following information Title and test code (if applicable) Introduction/Purpose Specimen collect ion, t ransport , st orage and reject ion crit eria Reagent s/ mat erials/ equipment include catalog# Qualit y assurance Procedure Int erpret at ion crit eria Resulting & reporting References Appendix* Cit at ions, references, and credit s Myriad Pro, 11ptWriting 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 collect ion, t ransport , st orage and reject ion crit eria Reagent s/ mat erials/ equipment include catalog# Qualit y assurance Procedure Int erpret at ion crit eria Resulting & reporting References Appendix* Cit at ions, references, and credit s Myriad Pro, 11ptWriting an SOP: Step 3 The SOP should include the following information Title and test code (if applicable) Introduction/Purpose Specimen collect ion, t ransport , st orage and reject ion crit eria Reagent s/ mat erials/ equipment include catalog# Qualit y assurance Procedure Int erpret at ion crit eria Resulting & reporting References Appendix* Cit at ions, references, and credit s Myriad Pro, 11ptWriting an SOP.

9 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 Just ificat ion of import ance (include references) Specimen collect ion, t ransport , st orage and reject ion crit eria Reagent s/ mat erials/ equipment include catalog# Qualit y assurance Procedure Int erpret at ion crit eria Resulting & reporting References Appendix* Cit at ions, references, and credit s Myriad Pro, 11ptWriting an SOP: Step 3 The SOP should include the following information Title and test code (if applicable) Introduction/Purpose Specimen collect ion, t ransport , st orage and reject ion crit eria Reagent s/ mat erials/ equipment include catalog# Qualit y assurance Procedure Int erpret at ion crit eria Resulting & reporting References Appendix* Cit at ions, references, and credit s Myriad Pro, 11ptWriting an SOP: Step 3 The SOP should include the following information Title and test code (if applicable) Introduction/Purpose Specimen collect ion, t ransport , st orage and reject ion crit eria Accept able specimens Specim ens m ust be received 72hours post collection.

10 La b le lin g(DOC) Specimens stored at 4C or -80C Re sid u a l sp e cim e n s a rch ive d in d e fin it e ly Reject leaking specimens Bio s a fe t y Reagents/materials/equipment in clu d e ca t a lo g # Quality assurance Proce d ure In t e rp re t a t io n crit e ria Re su lt in g & re p o rt in g References Appendix* Citations, references, and credits Myriad Pro, 11p tWriting an SOP: Step 3 The SOP should include the following information Title and test code (if applicable) Introduction/Purpose Specimen collect ion, t ransport , st orage and reject ion crit eria Reagent s/ mat erials/ equipment include catalog# Qualit y assurance Procedure Int erpret at ion crit eria Resulting & reporting References Appendix* Cit at ions, references, and credit s Myriad Pro, 11ptWriting an SOP: Step 3 The SOP should include the following information Title and test code (if applicable) Introduction/Purpose Specimen collect ion, t ransport , st orage and reject ion crit eria Reagent s/ mat erials/ equipment include catalog#* Cit at ions, references, and credit s Myriad Pro, 11ptWriting an SOP: Step 3 The SOP should include the following information Title and test code (if applicable) Introduction/Purpose Specimen collect ion, t ransport , st orage and reject ion crit eria Reagent s/ mat erials/ equipment include catalog# Qualit y assurance Procedure Int erpret at ion crit eria Resulting & reporting References Appendix* Cit at ions, references, and credit s Myriad Pro, 11ptWriting an SOP.