Records and Reports

1. Records and Reports Version 5.0 August 2012

2. Objectives • 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

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

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

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

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

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

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

9. Approach to Laboratory Documentation Policies Provide a statement of intent that an organization will follow a particular course of action Procedures Practical way in which a policy is translated into action to carry out an intent Provide information to carry out an intent Called SOPs Working Instructions Forms and Records 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

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?

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

12. Records and Reports Tracking Systematic approach to management of: • 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

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

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

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

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

17. Referring Specimens/Testing • 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 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.

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

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

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

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

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:

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? Maintain a separate log that would be initialed each time the records are reviewed Maintain a separate log that would be initialed each time the records are reviewed and amend the SOP to reflect this change Print the data anyway to satisfy the auditor’s craving for initialing and dating every document in the laboratory None of the above

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 GCLPcompliant? Yes No

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? Yes No

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

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

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

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

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

32. References/Resources • Clinical Pathology Accreditation UK(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/) • Source Documentation • Essential Documentation

33. Wrap Up