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). Laboratory Information Systems Version 5.0, August 2012

2.  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 Objectives 2

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

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

5. Policies and procedures regarding use of the LIS should address the following: A.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 B.Passwords should be real words as they are easier to remember C.Passwords should require renewal periodically Pre-Assessment Question #3 5

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

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

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

9. Topics of Discussion Policies/Security/ Access Codes Auto-Verification Procedures/ Procedure Manuals Validation Data Entry/ReportsData Retrieval/Storage Hardware and SoftwareRegulations Systems MaintenanceEnvironment 9

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

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

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

13.  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. LIS – Altered Records 13

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

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

16. 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 Skill Check 16

17. Protection of Electronic Records 17

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

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

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

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

22. 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. Protection of Electronic Records: Data Retrieval and Storage 22

23. 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. Protection of Electronic Records: Data Retrieval and Storage (cont’d) 23

24. 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. Protection of Electronic Records: Data Retrieval and Storage (cont’d) 24

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. 25

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. 26

27.  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. Protection of Electronic Records: System Maintenance (cont’d) 27

28.  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. Protection of Electronic Records: Hardware and Software 28

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. 29

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

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

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. 32

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

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

35. Audit Trails (cont’d) The LIS should maintain an audit trail of all 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 35

36. 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. Audit Trails (cont’d) 36

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. 37

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

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

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

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

42. Policies and procedures regarding use of the LIS should address the following: A.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 B.Passwords should be real words as they are easier to remember C.Passwords should require renewal periodically Post-Assessment Question #3 42

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

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

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

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

47. Wrap Up 47