Facilities and Equipment

1. Facilities and Equipment Version 5.0, August 2012

2. Objectives • List the requirements of laboratory facilities with regard to work space • Describe the importance of appropriate facility maintenance • Describe the importance of maintaining accurate laboratory equipment • Describe methods used to verify accuracy of laboratory equipment • Describe procedure for documenting maintenance, calibration, and corrective actions • Describe optimal maintenance of reagents

3. Overview Laboratory Facilities Data Storage Facilities Environmental Control Equipment Maintenance Equipment Inventory Reagents Reagents Inventory

4. Pre-Assessment Question #1 Which of the following are necessary for laboratory facilities to ensure high standards of quality work, data and safety? • Spills should be cleaned when convenient • Provide a safe environment for personnel • Proper lighting should be provided to ensure sufficient visibility • A and B only • B and C only • A and C only

5. Pre-Assessment Question #2 The following can occur in facilities with inadequate laboratory space: • Frequent laboratory accidents • Increased incidences of specimen loss or mix-ups • Sub-optimal equipment performance • Likelihood of incorrect results being reported • All of the above • A and B only

6. Pre-Assessment Question #3 Maintaining accurate laboratory equipment is important for: • Generation of accurate results • Minimizing the costs of repair • Reporting results in a timely manner • All of the above

7. Pre-Assessment Question #4 DAIDS Good Clinical Laboratory Practices (GCLP) requires that pipettes are checked for volumetric accuracy and reproducibility and recalibrated at what defined frequency? • Monthly • Annually • At minimum every 6 months • Every 2 months

8. Pre-Assessment Question #5 Why is it important for clinical research laboratories to document temperature monitoring and maintenance activities for laboratory equipment, including calibration and quality control (QC) testing? • It is a GCLP requirement • It ensures maintenance of an effective Quality Management systems • It provides evidence of compliance to documented procedures and policies • It assists in easy identification and corrections of problems associated with inadequate performance of these activities • All of the above • A and B only

9. Pre-Assessment Question #6 Which of the following are required for reagent labeling per GCLP guidelines? • Lot number and expiration date • Open and reconstitution date • Date received from manufacturer • A and B • B and C • A and C

10. Facilities DAIDS GCLP Guidelines Laboratories should be designed so that safety of employees and quality of work are not compromised.

11. Laboratory Facilities Access restriction to authorized personnel Availability of break rooms and office areas Data storage areas Evacuation plans Specimen integrity

12. Fixtures

13. Safety Signage Should be placed in relevant laboratory areas and be visible First Aid Escape Route Hazardous Corrosive Explosive Fire Extinguisher Flammable Toxic Biohazard Eyewash

14. Document daily cleaning activities • Clean spills immediately Work Areas • Adequate for proper specimen handling • Provide safe environment for personnel Housekeeping • Ensure sufficient visibility Work Space Lighting • Provide logical flow of work to prevent mix-ups and specimen loss Personnel Traffic • Limit personnel traffic • Maintain unobstructed walkways Segregation of Testing Activities

15. Facilities Sample integrity Equipment performance Unsuitable facilities affect Personnel safety and competency Compliance conditions set in the test

16. Data Storage Facilities • Separate areas should be provided for data storage. • Adequate security - unauthorized personnel should not have access to archived data. • Archive should be secure. • Facilities should be flood-proofed, fire-proofed, fire resistant, and protected from rodent infestation.

17. Environmental Control Humidity Temperature Dust Interferences

18. Temperature Recording Temperature Control • Temperature monitoring activities should be documented Tolerance Limits • Established by determining the minimum range of values common to the defined tolerance limits for reagents in storage or the recommended incubation temperature for the assays being performed Temperature Review • Monthly review of temperature charts

19. Temperature Logs

20. Temperature Logs (cont.)

21. Skill Check You are required to store in the refrigerator reagent kits with the following manufacturer recommended storage temperature ranges: • 2°C to 8°C • 0°C to 25°C • 3°C to 8°C • 3°C to 10°C • 3°C to 6°C • 3°C to 10°C • ALT: 0°C to 8°C • Pregnancy test: 2°C to 25°C • Rapid HIV: 3°C to 10°C • Chemistry Controls: -10°C to 6°C The optimal refrigerator temperature storage range would be defined as:

22. Skill Check The refrigerator where reagent test kits are stored malfunctioned over the weekend. The laboratory personnel are not sure what to do with all the refrigerator contents; they worry that if they discard everything, huge losses would be incurred. How would you advise them as the Laboratory Director? • Not to take a chance, but discard all contents • Mark affected materials to indicate possible quality problems • Continue using the reagents and kits as long as the QC is acceptable • Perform parallel testing with new batches • Shorten the expiration dates of the reagents and kits • B and D

23. Skill Check The following cannot be performed in the laboratory with a defined ambient room temperature range of 16°C to 28°C: • 14°C to 28°C incubation temperature range for the HBsAgMonolisa test • 2°C to 25°C storage temperature range of the FACSCalibur reagents • 2°C to 27°C storage temperature range of the HIV Determine kits • 25± 2°C incubation temperature range for the Vironostica HIV EIA test • B, C and D • A and E

24. Equipment Optimal working laboratory instrumentation is vital for: • Maintenance of productivity • Generation of accurate results • Lowering the incidents of equipment malfunctions • Minimizing the costs of repairs • Reporting results in a timely manner

25. Equipment Per DAIDS GCLP Guidelines, the laboratory should maintain documentation to support that equipment is properly: • Validated • Operated • Inspected • Maintained • Tested • Calibrated

26. Equipment Documentation Scheduled Preventative Maintenance Unscheduled Maintenance Service Calibration

27. Equipment Management Monitoring of equipment management activities through: Training and evaluation of competency Review of maintenance, service, calibration, and QC records Review of procedures and updating, as required Ensuring compliance with documented procedures

28. Preventive Maintenance/Calibration Plan • An equipment service schedule should be maintained • The list should include all equipment and the accompanying due dates of service and calibration • Ideally, the equipment list should be displayed

29. Preventive Maintenance/Calibration Plan

30. Pipettes Adjustable and Fixed-volume • Before placing into service • Minimally, every six months Frequency of checks for accuracy and precision:

31. Refrigerators and Freezers Establish maintenance program Establish tolerance limits Monitor temperature Check for ice build-up regularly Document corrective action for equipment failures Establish backup plan for malfunctions

32. Incubators and Water Baths • Temperature tolerance limits • Periodic preventative maintenance • Temperature monitoring • Corrective Actions

33. Centrifuges Equipped with safety buckets to minimize exposure to aerosols Centrifuges Adequately maintained (regular service) Should be kept clean

34. Centrifuges • Measurement of operating speeds, centrifugation temperature and time • Frequency • Tolerance limits • Maintenance records • Corrective actions

35. Autoclaves Verification of processing with each batch Verification of sterilization weekly Performance and documentation of maintenance Verification of timing

36. Timers Frequency Verification Known standard

37. Analytical Balances • Check accuracy with standard weights • Frequency determined by manufacturer • Service/maintenance performance and documentation • Placement of balance

38. Analytical Balances Activity Design a balance calibration verification log

39. Weight Verification Log

40. Biosafety Cabinets Verification/ visual checks Certification before use and annually Daily air flow checks Cleaning UV Lamp Documentation

41. Microscopes • Cleaning of eyepiece, objectives, stage, condenser, and light source • Documentation of cleaning activities • Scheduled service, where applicable • Use of dust covers

42. Analyzers Document a QC program for the analyzer Maintenance program developed according to manufacturer specifications All maintenance activities should be documented; review preventive maintenance (PM) logs Analyzer calibration performed at intervals specified by manufacturer

43. Generators Maintenance and load testing Documentation

44. Skill Check Select the best answer regarding laboratory equipment: • Equipment SOPs may not be required if operator manuals are available for use in the laboratory • Each equipment shall have an SOP that describes the use, preventative maintenance, cleaning, and calibration • The laboratory should maintain documented evidence of personnel training for the use, operation, and maintenance of all laboratory equipment • B and C only • All of the above

45. Documentation of the entire process: failure through resolution Equipment: Corrective Actions • How should failures and corresponding corrective/preventative actions be captured?

46. Corrective Action Reports

47. Corrective Action Logs

48. Inventory Electronic All laboratory equipment should be managed by an inventory system. Manual

49. Equipment make and model Equipment Inventory Log • Facility ID number • Serial number; acquisition date • Disposition information • Location • Service contact information

50. Skill Check Can a biosafety cabinet certification sticker displayed on the unit be used as a substitute for certification documents? A. YES B. NO