Laboratory Information Systems

1. Laboratory Information Systems Version 5.0, August 2012

2. Objectives • Define a Laboratory Information System (LIS) and describe its purpose • Describe validation processes and what they accomplish • List processes to ensure secure LIS access • Describe requirements for altered records in an LIS • Describe LIS emergency preparedness processes • Describe the purpose of an audit trail

3. Pre-Assessment Question #1 A LIS performs or assists with the following laboratory functions: • Report generation • Documentation of safety incidents • Test ordering • A and C • A and B

4. Pre-Assessment Question #2 Which statement(s) below is⁄are true regarding LISvalidation? • If the system is purchased, validation is not required • Validation is necessary for implementation of all laboratory information systems • Re-validation is required for upgrades and changes to the systems • B and C

5. Pre-Assessment Question #3 Policies and procedures regarding use of the LISshould address the following: • All members of the laboratory team should have the same level of access within the LIS to ensure proper coverage during holidays and time off • Passwords should be real words as they are easier to remember • Passwords should require renewal periodically

6. Pre-Assessment Question #4 Which of the following are requirements for altered records in an LIS? • For revised reports, the laboratory is required to only include corrected results • Maintain a documented system to ensure that all revised reports are identified as revised, corrected, or amended on the laboratory reports • None of the above

7. Pre-Assessment Question #5 Emergency preparedness requires processes to be in place for: • Continuity of operations • Recovery of current data • Retrieval of archived data • All of the above

8. Pre-Assessment Question #6 Audit trails should capture the following information: • Time/date stamps of all data entry/manipulation • Individual performing task • Sequential edits performed on information • All of the above

9. Topics of Discussion

10. Laboratory Information Systems • What is a LIS? • What is its purpose? • How do you use your LIS?

11. Validation Frequency • Prior to implementation • Changes to “dictionaries” • Upgrades, overlays, software/programming changes Documentation

12. Validation (cont’d) Process Normal Ages, Genders Abnormal Absurd Reports Interfaces Reference Ranges Calculations

13. LIS – Altered Records • Maintain a documented system to ensure that all revised reports are identified as revised, corrected, or amended. • For revised reports, the laboratory must ensure both previously incorrect and new results are reported together.

14. Electronic Records Must be able to print complete copies of participant records • Original reference ranges • Flags or comments • Date of original report • Equipment or method used to produce results Retrieval time allowances

15. Audit Trails Information that must be associatedwith activities performed: Date Individual performing task Sequential edits performed on information Time

16. Skill Check When revised reports are issued, should the laboratory ensure that both the new result and the previous incorrect result are reported together? A. Yes B. No

17. Protection of Electronic Records

18. Elements of LIS SOPs End-user operation of LIS Emergency procedures Preservation of data and equipment Reporting archived data during downtime System maintenance and documentation

19. Protection of Electronic Records:Written Procedures The laboratory should maintain the following procedures for the preservation of data and equipment in case of: Unexpected destructive event (e.g., fire, flood) Hardware failure Software failure

20. More LIS Procedures Protection of Electronic Records: Written Procedures (cont’d) Protocols for periodic backing up and storing of information Protocols/procedures for restoring information from backed up media • Procedures for off-sitestorage of backup data

21. Protection of Electronic Records: Backup • How often should you backup? • Archival of backup materials • Organization and duplication

22. Protection of Electronic Records: Data Retrieval and Storage Stored study participant results data and archival information must be easily and readily retrievable. The LIS must be able to reproduce archived test results completely, including the reference range originally given for that test, and any flags, footnotes, or interpretive comments that were attached to that result at the time of the original report.

23. Protection of Electronic Records: Data Retrieval and Storage (cont’d) When multiple identical analyzers are used for reporting study participant test results, there should be the ability to trace results back to the original instrument on which the test was performed. The data storage capacity of the LIS should be sufficient to meet the needs of the sponsor.

24. Protection of Electronic Records: Data Retrieval and Storage (cont’d) Data storage media, such as tapes, disks, etc., must be properly labeled, stored, and protected from damage or unauthorized use. Documented procedures must allow for timely restoration of services utilizing the data storage media after an unexpected destructive event.

25. Protection of Electronic Records: System Maintenance There must be documented procedures for handling the shutdown and restarting of the LIS to ensure integrity of the data and uninterrupted delivery of laboratory services.

26. Protection of Electronic Records: System Maintenance (cont’d) All unscheduled computer downtime periods and other computer problems must be documented, including the reasons for failure and corrective actions taken.

27. Protection of Electronic Records: System Maintenance (cont’d) • Documented contingency plans must be developed to handle services in the event of a computer system failure such that study participant results are reported promptly. • Records must be maintained to document regular maintenance of the LIS.

28. Protection of Electronic Records: Hardware and Software • A documented procedure and a complete, up-to-date record of preventive maintenance must be readily available for all computer hardware. • There must be active review of computer system maintenance records by the laboratory manager or designee.

29. Protection of Electronic Records: Hardware and Software (cont’d) Errors detected during computer system usage or backup must be documented along with corrective action taken.

30. 21 CFR Part 11 Access to the LIS must be limited to authorized individuals Sec. 11.10 (d)

31. Access levels should identify who is authorized to: Access study participant data Enter study participant results System Access and Security Change results Alter computer programs Policies must be established stating who may use the computer system. Report results

32. System Access and Security (cont’d) Security (user) codes should be established such that only specifically authorized individuals may access study participant data or alter programs.

33. Access Codes Access codes and passwords should be used in such a manner that they are able to effectively control access to the system: Include numbers, not real words Inactivate when employees leave Do not post on terminals Do not give to other personnel

34. Audit Trails The LIS must provide secure, computer generated time stamped audit trails that record date and time of operator entries and actions that: Modify Create Delete

35. Audit Trails (cont’d) The LIS should maintain an audit trail ofall activities Identification of all personnel responsible for performance and verification of tests should be available on the system Time/date stamps of all data entry/manipulation

36. Audit Trails (cont’d) There must be an audit mechanism that allows the laboratory to identify all individuals who have modified study participant data, results, control files, or computer programs.

37. Training of Personnel There should be documentation that all appropriate users of the computer system have received adequate training initially and whenever the computer system is modified.

38. Timeline for Implementation Review of Available Systems/Selection Acquisition Training: System Admin and Key User(s) Installation of Hardware, Server, Uploading of Software UAT, OQ, IQ UAT, OQ, IQ Configuration/Database Creations End-user Training Testing Announcements GO LIVE!

39. Story Time! Does anyone have a laboratory system implementation experience they would like to share?

40. Post-Assessment Question #1 A LIS performs or assists with the following laboratory functions: • Report generation • Documentation of safety incidents • Test ordering • A and C • A and B

41. Post-Assessment Question #2 Which statement(s) below is⁄are true regarding LISvalidation? • If the system is purchased, validation is not required • Validation is necessary for implementation of all laboratory information systems • Re-validation is required for upgrades and changes to the systems • B and C

42. Post-Assessment Question #3 Policies and procedures regarding use of the LISshould address the following: • All members of the laboratory team should have the same level of access within the LIS to ensure proper coverage during holidays and time off • Passwords should be real words as they are easier to remember • Passwords should require renewal periodically

43. Post-Assessment Question #4 Which of the following are requirements for altered records in an LIS? • For revised reports, the laboratory is required to only include corrected results • Maintain a documented system to ensure that all revised reports are identified as revised, corrected, or amended on the laboratory reports • None of the above

44. Post-Assessment Question #5 Emergency preparedness requires processes to be in place for: • Continuity of operations • Recovery of current data • Retrieval of archived data • All of the above

45. Post-Assessment Question #6 Audit trails should capture the following information: • Time/date stamps of all data entry/manipulation • Individual performing task • Sequential edits performed on information • All of the above

46. References • Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application (August 2003). (www.fda.gov) • LIS Fundamentals (www.cap.org) • A Validation Approach for Laboratory Information Management Systems. (http://www.gxpandjvt.com/ivtnews/pdf/Nov03.pdf)

47. Wrap Up