Purchase and Validation of a Blood Bank Immunoanalyser

1. D. Keane Sept. 2005 1 Purchase and Validation of a Blood Bank Immunoanalyser

2. D. Keane Sept. 2005 2 Key Processes Change Control Project Team Developing a User Requirement Specification Validation of the Analyser Installation Qualification Operational Qualification Performance Qualification – Test Method Validation

3. D. Keane Sept. 2005 3 Change Control Describe your proposal for new equipment Give reasons and outline benefits Major change State impact and implications Approval of proposed change

4. D. Keane Sept. 2005 4 Project Team Management lead Identify resource requirements for the project Clear roles Management of timelines for key milestones

5. D. Keane Sept. 2005 5 Project Team Project team members:- Management Quality Assurance IT Scientific Medical

6. D. Keane Sept. 2005 6 Project Team Project milestones and deliverables:- Develop a project plan with timelines Develop and approve the URS Site visits and reports Issue to tender Review tender documentation and selection

7. D. Keane Sept. 2005 7 Project Team Project milestones and deliverables:- Delivery of equipment Validation Review and release of equipment for use Have weekly meetings to manage project versus plan

8. D. Keane Sept. 2005 8 Developing a User Requirement Specification (URS) Defining what you want the analyser to do and what it is meant to do. Use the URS template provided in previous workshop.

9. D. Keane Sept. 2005 9 Developing a User Requirement Specification (URS) Standard format for URS:- Introduction Objective Scope Responsibilities Detailed Requirements

10. D. Keane Sept. 2005 10 Standard Format of URS Introduction (Section 1) Brief summary of what you want the automated system to do Benefits Describe your current systems - ABO Rh typing - Compatibility testing, Antibody Screening, Direct Coombs Tests - QC testing Annual workload and projected demand

11. D. Keane Sept. 2005 11 Standard Format for URS Objective (Section 2) Clear statement that the objective of the document is to define prospectively the detailed requirements of the proposed automation.

12. D. Keane Sept. 2005 12 Standard Format for URS Scope (Section 3) Scope of operation of the instrument - 24 hour use - Meeting transfusion requirements of your Laboratory and others - Back up for the instrument (old manual system)

13. D. Keane Sept. 2005 13 Standard Format for URS Responsibilities (Section 4) Define who is responsible for:- - writing the URS - reviewing the URS - Approving the URS - Reviewing the suppliers response to the URS

14. D. Keane Sept. 2005 14 Standard Format for URS Detailed Requirements (Section 5) General requirements/ quality requirements including documentation Information technology requirements Maintenance breakdown and repair requirements Environmental requirements

15. D. Keane Sept. 2005 15 Standard Format for URS Detailed Requirements (Section 5) Functional requirements (analyser, reagents, cards and reports) Calibration requirements

16. D. Keane Sept. 2005 16 Template for Detailed Requirements General Requirements The analyser must be capable of carrying out groups, antibody screens and crossmatches. The analyser should be fully validated at factory level. Results for quality assessment schemes such as UK NEQAS should be consistent and reliable. Previous NEQAS performance must be used to demonstrate this.

17. D. Keane Sept. 2005 17 Template for Detailed Requirements General Requirements The manufacturer/ supplier must be accredited to a recognised Quality Management System. Forward evidence of same. The supplier will agree to a supplier audit or site visits to locations using their equipment. A technical specification for the unit must be provided covering all major components of the system.

18. D. Keane Sept. 2005 18 Template for Detailed Requirements General Requirements A training course on the use, maintenance and operation of the analyser should be provided in advance of in-house validation. Certification of training must be provided. A list of users must be made available.

19. D. Keane Sept. 2005 19 General Requirements The analyser must have an audible alarm system which responds to:- out of specification temperature readings misalignment Template for Detailed Requirements

20. D. Keane Sept. 2005 20 Template for Detailed Requirements General Requirements A system of ongoing communication must be available between the supplying company and the users. Issues arising may then be communicated to all users. Describe your communication systems and response system.

21. D. Keane Sept. 2005 21 Template for Detailed Requirements General Requirements The following documentation must be supplied with the analyser:- User manual including detailed design specification and calibration procedures Factory acceptance tests for analyser and its essential components Calibration certificates for analsyser and its essential components

22. D. Keane Sept. 2005 22 Template for Detailed Requirements General Requirements The following documentation must be supplied with the analyser:- Certificate of electrical conformance Certificate of CE conformance Cleaning procedures

23. D. Keane Sept. 2005 23 Template for Detailed Requirements General Requirements The supplier will provide any if all technical backup required in the installation, parameterisation and testing of the system. The supplier must demonstrate their ability and competence in the validation of the unit. Please provide a copy of your equipment validation plan.

24. D. Keane Sept. 2005 24 Template for Detailed Requirements Information Technology Requirements The analyser must be capable of interfacing with Laboratory systems xyz. The supplier must make available:- Source code for review File transfer protocols for transfer of data to host system All relevant shell programs required for data transfer to host system files.

25. D. Keane Sept. 2005 25 Template for Detailed Requirements Information Technology Requirements The system must provide for backup of data and QC results preferably on the Laboratory system. Data/ results from the analyser must be accessed through the network either through Thin Clients or PC.

26. D. Keane Sept. 2005 26 Template for Detailed Requirements Information Technology Requirements The supplier to identify the category of software supporting the software as 1, 2, 3, 4 and 5 as well as the version. The analyser should provide security against unauthorised access to data. Password levels should be available to access various components of the system particularly for modification of data or results.

27. D. Keane Sept. 2005 27 Template for Detailed Requirements Information Technology Requirements The analyser bar code reader must be capable of reading symbologies e.g. ISBT 128, Codabar but not code 39. All software upgrades must be made available as soon as it possible. Such software should be validated prior to installation and validation post installation.

28. D. Keane Sept. 2005 28 Template for Detailed Requirements Information Technology Requirements The supplier/ manufacturer must document all changes from previous software versions. Formal notification of change must be passed on to the Laboratory Manager.

29. D. Keane Sept. 2005 29 Template for Detailed Requirements Information Technology Requirements The following hardware must be supplied with the analyser:- PC (compatible) Laser printer (compatible) Light pen Scanner UPS in support of power failure, surges and spikes

30. D. Keane Sept. 2005 30 Template for Detailed Requirements Maintenance Breakdown and Repair Requirements The suppliers or their agents must have the capability to implement routine preventative maintenance protocols including calibration of equipment components. There should be a comprehensive maintenance program available. A detailed user manual must be available.

31. D. Keane Sept. 2005 31 Template for Detailed Requirements Maintenance Breakdown and Repair Requirements Should there be a breakdown of the analyser, immediate access to an experienced and qualified Service Technician must be available. The Service Technician must be available on the day of the breakdown to perform necessary repairs.

32. D. Keane Sept. 2005 32 Template for Detailed Requirements Maintenance Breakdown and Repair Requirements A backup analyser must be available should it not be possible to repair the analyser in a timely manner.

33. D. Keane Sept. 2005 33 Template for Detailed Requirements Environmental Requirements The equipment must operate as per specification in an uncontrolled environment and in a temperature range of 100C to 300C.

34. D. Keane Sept. 2005 34 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports The analyser must be capable of handling different size sample tubes. Forward details of compatible tube sizes. It must be possible to group paediatric samples on the analyser.

35. D. Keane Sept. 2005 35 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports The analyser should conform with BCSH Guidelines and the test reagents should also conform with BCSH Guidelines. The analyser must offer positive identification of samples and reagents. The lot number and expiry date of reagents should be stored for future reference.

36. D. Keane Sept. 2005 36 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports The analyser must offer a clot detection system at the pipetting stage. There must be continuous monitoring of diluent and reagent levels as well as wash solutions. The centrifuge must centrifuge tests at the designated speed for the length of time specified.

37. D. Keane Sept. 2005 37 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports It must not be possible to open the door of the machine whilst parts are moving and it is in operation. It must be a fully enclosed system. User access to the analyser must be software controlled. The incubation time must be of the intended length of time for the tests.

38. D. Keane Sept. 2005 38 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports The throughput of the analyser should be at least x samples in x hours. Results for group and antibody screen should be available within this time frame. The heating block must be maintained as the designated temperature for tests.

39. D. Keane Sept. 2005 39 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports A compatible barcode printer must be supplied with the analyser. This will facilitate the compatibility testing.

40. D. Keane Sept. 2005 40 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports The optical autoreader must read all tests accurately. Results to be graded. Undetermined results must be held for operator review. Mixed field tests and haemolysed results should also be held. Reagent red cells must be agitated prior to their addition to tests.

41. D. Keane Sept. 2005 41 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports The analyser should be capable of handling packed red cell, serum, plasma and centrifuged whole blood samples. The analyser should be capable of operating 24 hours a day and must be adaptable for use by many operators.

42. D. Keane Sept. 2005 42 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports The testing process must identify all sub groups of A. Grouping anomalies traceable to ABO, reverse, and Rh typing must be identified at testing. The methodology should be sensitive to Anti D level of 0.05 iu/ml.

43. D. Keane Sept. 2005 43 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports All reagents and test cards supplied must be stable and suitable for use on the analyser. CE marked in compliance with the Invitro Diagnostic Device Directive. Results got when testing on the analyser must be equal to or better than the current manual system.

44. D. Keane Sept. 2005 44 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports All reagents and test cards must have passed internal Quality Assurance at the site manufacture. Certificates indicating that they have passed testing must be supplied with each new batch.

45. D. Keane Sept. 2005 45 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports The supplier must have a system in place to deal with complaints and problems as they arise.

46. D. Keane Sept. 2005 46 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports The reports generated by the analyser should be clear and identify by whom and when the test was performed. Test reports must be compatible with the requirements of ISO 15189 section 5.8.

47. D. Keane Sept. 2005 47 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports For blood groups, the report should show the reference number, reactions and group interpretation. Inconclusive results will be clearly identified or highlighted to the user. Reference numbers and test interpretation should be in barcode.

48. D. Keane Sept. 2005 48 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports For antibody screen, the report should print the unique sample reference number and results for each test performed. An interpretation of positive or negative should also be on the report. Reference numbers and test interpretation should be in barcode.

49. D. Keane Sept. 2005 49 Template for Detailed Requirements Functional Requirements for Analyser Reagents, Cards and Reports For Crossmatches the report should print the unique sample reference number, results for each unit of blood tested and interpretation of compatible or incompatible for each test. Reference numbers and test interpretation should be in barcode.

50. D. Keane Sept. 2005 50 Template for Detailed Requirements Calibration Requirements It must be possible to calibrate all essential elements of the analyser over the prescribed range of operation (3 point calibration) that is:- Incubator (0C) Pipette Volume (ul) and Pipette position Centrifuge (RPM and time) Auto Reader (nM) Timers (Time)

51. D. Keane Sept. 2005 51 Template for Detailed Requirements Calibration Requirements The analyser must provide volume verification and a check to ensure that the appropriate components of each test have been added.

52. D. Keane Sept. 2005 52 Process for Verifying User Requirement Specifications The output of the review process will be to verify using the objective evidence provided in the response, that each user requirement can be:- Fully met Partially met Not met Based on the above and cost, the Project Team makes a decision which system to purchase.

53. D. Keane Sept. 2005 53 Validation of the Automated Analsyser Purpose of the validation Draw up plans as per the templates supplied for validation. The output of the validation:- Equipment file Method file

54. D. Keane Sept. 2005 54 Notes for Validation of the Automated Analsyser The Engineer normally performs 80% of the IQ/ OQ testing (equipment). The Laboratory must approve the manufacturers validation plan (equipment). The Laboratory normally performs the PQ or method validation using test or QC samples. The IQ/ OQ must be performed before the method validation.

55. D. Keane Sept. 2005 55 Notes for Validation of the Automated Analsyser Before starting equipment validation:- Know the critical control systems Read the provided manuals Book the Engineer’s time and understand your instrument No payment until equipment is validated and meets your requirements (URS).

56. D. Keane Sept. 2005 56 Notes for Validation of the Automated Analsyser The validation plan for the equipment will be:- Based on supplier equipment validation plan Based on your additional validation requirements The Engineer may not perform all tests defined by the manufacturer’s validation plan.

57. D. Keane Sept. 2005 57 Notes for Validation of the Automated Analsyser When serious non conforming issues arise during validation, what happens? Beware of changes made during the validation process e.g. software upgrades.

58. D. Keane Sept. 2005 58 Equipment Validation (IQ/ OQ) Equipment validation includes software. Follow the standard template in writing the validation plan:- Introduction Objectives Scope The Validation Procedures including acceptance criteria Executive Summary

59. D. Keane Sept. 2005 59 Equipment Validation (IQ/ OQ) Focus on:- Objective (IQ/ OQ) Validation procedures including acceptance criteria Objectives (IQ/ OQ) Verify installation of the automated system is in accordance with manufacturers specifications.

60. D. Keane Sept. 2005 60 Equipment Validation (IQ/ OQ) Objectives (IQ/ OQ) The equipment meets the requirements specified in the URS including computer/ software elements. Statement verifying that when the equipment validation is ok then proceed to PQ or method validation.

61. D. Keane Sept. 2005 61 Validation Procedure (IQ/ OQ) Need to identify a system to record validation deviations:- Use your non conformance system Use a project specific deviation form (D.I.R.) (Deviation Incident Report) For each test on the equipment, the validation plan will define:- The method The acceptance criteria

62. D. Keane Sept. 2005 62 Validation Procedure (IQ/ OQ) The IQ/ OQ equipment validation plan may include the following:-

63. D. Keane Sept. 2005 63 Validation Procedure (IQ/ OQ)

64. D. Keane Sept. 2005 64 Validation Procedure (IQ/ OQ)

65. D. Keane Sept. 2005 65 Validation Procedure (IQ/ OQ)

66. D. Keane Sept. 2005 66 Validation Procedure (IQ/ OQ)

67. D. Keane Sept. 2005 67 Validation Procedure (IQ/ OQ)

68. D. Keane Sept. 2005 68 Validation Procedure (IQ/ OQ)

69. D. Keane Sept. 2005 69 Validation Procedure (IQ/ OQ)

70. D. Keane Sept. 2005 70 Validation Procedure (IQ/ OQ)

71. D. Keane Sept. 2005 71 Validation Procedure (IQ/ OQ)

72. D. Keane Sept. 2005 72 Validation Procedure (IQ/ OQ)

73. D. Keane Sept. 2005 73 Validation Procedure (IQ/ OQ)

74. D. Keane Sept. 2005 74 Validation Procedure (IQ/ OQ)

75. D. Keane Sept. 2005 75 Validation Procedure (IQ/ OQ)

76. D. Keane Sept. 2005 76 Validation Procedure (IQ/ OQ)

77. D. Keane Sept. 2005 77 Validation Procedure (IQ/ OQ)

78. D. Keane Sept. 2005 78 Validation Procedure (IQ/ OQ)

79. D. Keane Sept. 2005 79 Validation Procedure (IQ/ OQ)

80. D. Keane Sept. 2005 80 Executive Summary All data reviewed and authorised. Executive Summary report written/ authorised. Master list of non conformances with status Bottom line statement:- - Proceed with PQ - Repeat the OQ process or components thereof.

81. D. Keane Sept. 2005 81 Method Validation of Automated Analyser Pre Requisites for Method Validation Comparative testing (manual card versus automated card method) Detailed procedures in place and followed exactly All results must be recorded:- Manual – worksheets (including grades) Automated – printed reports (including grades)

82. D. Keane Sept. 2005 82 Method Validation of Automated Analyser Pre Requisites for Method Validation All batch number of materials and samples used must be recorded and traceable. Controls must be set-up and recorded at least daily during the validation exercise for both manual and automated methods. The test method validation must be authorised before you start. Do not make it up as you go along.

83. D. Keane Sept. 2005 83 Method Validation of Automated Analyser Pre Requisites for Method Validation Think of worse case scenarios. Keep a stock of sera with irregular antibodies.

84. D. Keane Sept. 2005 84 Method Validation

85. D. Keane Sept. 2005 85 Method Validation

86. D. Keane Sept. 2005 86 Method Validation

87. D. Keane Sept. 2005 87 Method Validation

88. D. Keane Sept. 2005 88 Method Validation

89. D. Keane Sept. 2005 89 Method Validation

90. D. Keane Sept. 2005 90 Method Validation

91. D. Keane Sept. 2005 91 Method Validation

92. D. Keane Sept. 2005 92 Method Validation

93. D. Keane Sept. 2005 93 Method Validation

94. D. Keane Sept. 2005 94 Method Validation

95. D. Keane Sept. 2005 95 Method Validation

96. D. Keane Sept. 2005 96 Method Validation – Parallel Testing 3 days testing (3 batches) on both systems Method Validation

97. D. Keane Sept. 2005 97 Executive Summary Signed statement confirming whether or not to go live with the automated system. Method Validation