1. This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201200009C, entitled NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS). Records and Reports Version 5.0 August 2012

2.  Describe the hierarchy of laboratory documentation  Describe the procedures for records maintenance and management  List and describe the information required on laboratory forms and reports  Describe the procedures for amending records  List the requirements for data retention Objectives 2

3. Why are records essential? A.For continuous monitoring of quality systems B.For specimen tracking throughout process (from cradle to grave) C.To identify failures in equipment D.To revisit information for reference E.For use as a management tool F.All of the above Pre-Assessment Question #1 3

4. The following are Good Clinical Laboratory Practice (GCLP) requirements of all laboratory handwritten records: A.Entries should be made in pencil B.White-out (erasing liquid) may be used C.Entries should be accompanied by undated signatures D.A temperature reading noted at 08:00 in the morning may be recorded later in the day E.A result may be scribbled in the technologist’s personal notebook and then transferred onto the worksheet afterwards F.None of the above Pre-Assessment Question #2 4

5. Per Clinical Laboratory Standards Institute (CLSI) guidelines, which of the following should be included in laboratory forms? A.Effective date B.Facility address C.Title that describes the purpose of the form D.A link to the applicable procedure document E.A and C only F.A, C and D G.All of the above Pre-Assessment Question #3 5

6. Is it acceptable to use correction fluid when correcting laboratory records? A.Yes B.No Pre-Assessment Question #4 6

7. How long should laboratory study records be kept? A.Two years, per College of American Pathologists (CAP) guidelines B.Five years C.Fifteen years D.Indefinitely E.Consult with the sponsor via the network laboratory Pre-Assessment Question #5 7

8. Approach to Laboratory Documentation Policies Procedures Working Instructions Forms and Records 8

9. Policies Procedures Working Instructions Forms and Records 9 Practical way in which a policy is translated into action to carry out an intent Provide information to carry out an intent Called SOPs Procedures can refer to working instructions Practical day to day instructions Can be embedded in a procedure Can be referred to in the procedure Provide evidence of fulfillment of intent Provide a statement of intent that an organization will follow a particular course of action Approach to Laboratory Documentation

10. Records Should easily demonstrate… why how when by whom …was the test performed Who was in charge? Were any problems encountered? How were they resolved? 10

11. Forms The title that describes the form purpose Facility name Effective date Fields to record information generated from performing the procedure A means to link the form to its respective procedure document Per CLSI (NCCLS), form documents need to include: 11

12. Records and Reports Tracking  Specimen tracking forms  External Quality Assurance (EQA) data  Laboratory requisitions  Laboratory reports  Quality control data  Assay validation data  Equipment service/maintenance logs  Analyte results with reference intervals  Analyzer printouts, raw data, worksheets  Specimen tracking forms  External Quality Assurance (EQA) data  Laboratory requisitions  Laboratory reports  Quality control data  Assay validation data  Equipment service/maintenance logs  Analyte results with reference intervals  Analyzer printouts, raw data, worksheets Systematic approach to management of: 12

13. Records and Reports Maintenance Records must be filed in a manner that allows for prompt retrieval (within 24 hours) when required. 13

14.  Readily available  Access limited to authorized individuals  Protection of records from fire and floods Records and Reports Tracking 14

15. Records and Reports Retention ….may be governed by multiple authorities: the sponsor (DAIDS), accreditation bodies (e.g., CAP), and local IRBs Follow the most stringent requirements when establishing retention times for laboratory records and reports Link to DAIDS Records Retention Policy 15

16. Handwritten Records Signed and dated by personnel making the entry Legible Indelible Recorded promptly 16

17.  No revision of reports received by referring laboratory  Referring laboratory must maintain copies of testing reports  Laboratory reports must identify the laboratory performing the testing Referring Specimens/Testing A referring laboratory is a facility that is a primary receiving laboratory for protocol specimens, but refers some or all of the specimens received to another laboratory for testing. 17

18. Results Reporting Information on Laboratory Reports Laboratory name Specimen collection date and time Participant ID Test identification Demographics Primary sample type 18

19. Study ID Visit ID Unit of measurement Date/Time of Specimen Receipt Result flag Result Reference intervals Results Reporting (cont’d) Information on Laboratory Reports 19

20. Results Reporting (cont’d) Date and time of report release ID of reporting tech Comments Information on Laboratory Reports 20

21. Data Corrections Draw a single line through the original entry Record correct value Sign and date change Document reason for change Do not use correction fluid Do not use pencil 1 1 2 2 3 3 4 4 5 5 6 6 Procedure for amending data 21

22. Testing Activities A list of testing activities performed in the laboratory A list of assay turnaround times (TAT) (Defined as the interval between specimen receipt by laboratory personnel and result reporting) TAT monitoring Maintain: 22

23. Skill Check The auditor requested evidence of review of the freezer temperature records that were maintained on the temperature monitoring system software. The Laboratory Supervisor insisted that she checks the records online weekly for trends, but was not able to print data as the records would be too bulky. The review was, however, not documented. 23

24. Skill Check (cont’d) As a quality improvement measure, how should the review be documented? A.Maintain a separate log that would be initialed each time the records are reviewed B.Maintain a separate log that would be initialed each time the records are reviewed and amend the SOP to reflect this change C.Print the data anyway to satisfy the auditor’s craving for initialing and dating every document in the laboratory D.None of the above 24

25. Skill Check (cont’d) A site laboratory receives an original requisition form with each sample collected for testing. After analysis, analyzer result printouts are stapled to the requisition forms and dispatched to the clinic. A duplicate analyzer printout is retained in the laboratory as a record of testing performed. Is the laboratory GCLP compliant? A.Yes B.No 25

26. Skill Check (cont’d) A DAIDS auditor sent out to a site laboratory has requested documented evidence of assay validation for an HIV-1 DNA PCR method. The Laboratory Supervisor prints a spreadsheet with results data for a comparison study that was performed the previous year and provides it to the auditor for verification. Is this good practice? A.Yes B.No 26

27. Why are records essential? A.For continuous monitoring of quality systems B.For specimen tracking throughout process (from cradle to grave) C.To identify failures in equipment D.To revisit information for reference E.For use as a management tool F.All of the above Post-Assessment Question #1 27

28. The following are GCLP requirements of all laboratory handwritten records: A.Entries should be made in pencil B.White-out (erasing liquid) may be used C.Entries should be accompanied by undated signatures D.A temperature reading noted at 08:00 in the morning may be recorded later in the day E.A result may be scribbled in the technologist’s personal notebook and then transferred onto the worksheet afterwards F.None of the above Post-Assessment Question #2 28

29. Per CLSI guidelines, which of the following should be included in laboratory forms? A.Effective date B.Facility address C.Title that describes the purpose of the form D.A link to the applicable procedure document E.A and C only F.A, C and D G.All of the above Post-Assessment Question #3 29

30. Is it acceptable to use correction fluid when correcting laboratory records? A.Yes B.No Post-Assessment Question #4 30

31. How long should laboratory study records be kept? A.Two years, per CAP guidelines B.Five years C.Fifteen years D.Indefinitely E.Consult with the sponsor via the network laboratory Post-Assessment Question #5 31

32.  Clinical Pathology Accreditation UK (www.cpa-uk.com)www.cpa-uk.com  ICON Laboratories Investigator Manuals  DAIDS Guidelines for Good Clinical Laboratory Practice Standards  CapioDiagnostic Laboratory Manual  CLSI Guideline GP02A5E: Laboratory Documents: Development and Control  DAIDS LMS (https://daidslms.plateau.com/)https://daidslms.plateau.com/  Source Documentation  Essential Documentation References/Resources 32

33. Wrap Up 33