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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,

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Presentation on theme: "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,"— Presentation transcript:

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. HHSN C, entitled NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS). Facilities and Equipment Version 5.0, August 2012

2  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 Objectives 2

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

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

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

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

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

8 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? A.It is a GCLP requirement B.It ensures maintenance of an effective Quality Management systems C.It provides evidence of compliance to documented procedures and policies D.It assists in easy identification and corrections of problems associated with inadequate performance of these activities E.All of the above F.A and B only Pre-Assessment Question #5 8

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

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

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

12 Fixtures Bench Space Safety Equipment PlumbingShelving  Should be impervious to spillages and disinfectants  Should include fire extinguishers, eyewash, emergency showers, smoke detectors, fire alarms, etc.  Should have sinks with elbow taps  Should prevent containers from falling  Should never store liquid or corrosive chemicals on shelves above eye-level 12

13 Safety Signage CorrosiveExplosiveFlammableHazardousToxicEyewashBiohazardFirst AidFire ExtinguisherEscape Route Should be placed in relevant laboratory areas and be visible 13

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

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

16  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. Data Storage Facilities 16

17 Environmental Control Interferences Temperature Humidity Dust 17

18 Temperature Recording  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 Temperature Control 18

19 19 Temperature Logs Temperature records should include the following information: Specific equipment being monitored for temperature Temperature values Date when the temperature was read Initials of laboratory personnel monitoring and recording the temperature A section to record corrective action for out-of-range limits Space to record supervisor review signature and date

20 20 Temperature Logs (cont.)

21 A.2°C to 8°C B.0°C to 25°C C.3°C to 8°C D.3°C to 10°C E.3°C to 6°C F.3°C to 10°C You are required to store in the refrigerator reagent kits with the following manufacturer recommended storage temperature ranges:  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: Skill Check 21

22 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? A.Not to take a chance, but discard all contents B.Mark affected materials to indicate possible quality problems C.Continue using the reagents and kits as long as the QC is acceptable D.Perform parallel testing with new batches E.Shorten the expiration dates of the reagents and kits F.B and D 22 Skill Check

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

24 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 Equipment 24

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

26 Equipment Documentation Scheduled Preventative Maintenance Service Unscheduled Maintenance Calibration 26

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 27

28  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 Preventive Maintenance/Calibration Plan 28

29 Preventive Maintenance/Calibration Plan 29

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

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 31

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

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

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

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

36 Timers Frequency Known standard 36

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

38 Design a balance calibration verification log Analytical Balances 38

39 Weight Verification Log 39

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

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

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 42

43 Generators Maintenance and load testing Documentation 43

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

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

46 Corrective Action Reports 46

47 Corrective Action Logs 47

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

49 Equipment Inventory Log Equipment make and modelSerial number; acquisition dateFacility ID number Location Disposition information Service contact information 49

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

51 Reagents 51

52 Reagent Labeling Adequate labeling Lot # and expiration date Open reconstitution date ID of staff reconstituting reagent Storage requirements Contents 52

53 Certificates of Analysis A document issued by the manufacturer confirming the quality and composition of each batch and lot of reagents, chemicals or media prepared Therefore Laboratories should obtain Certificates of Analysis (COAs) with each new batch of critical reagents purchased (cell culture media and solutions) 53

54 Certificates of Analysis List tests performed, the tolerance, or outcome allowed for each test, results of the tests on a sample of that lot, and lot expiration date Describe specific tests performed to confirm the quality of the reagent lot Should be verified to check the quality and consistency of purchased media and solutions 54

55 Reagent Inventory Uninterrupted availability of reagents and supplies: Ensures laboratory efficiency and cost effectiveness Prevents costly, disruptive, and/or wasteful steps that hinder study progress 55

56 Help in ordering needs Help in identifying expired reagents Make reagent management easier Inventory Control Inventories 56

57 Inventory Control Monitoring Determine the frequency Determine the method Inventory control policy 57

58 Choose the most true statement: A.Expired reagents may be used if QC values are within acceptable limits B.The Laboratory may extend the expiration dates of reagents and controls if QC is within acceptable range C.Expired reagents required for use in training should be labeled ‘EXPIRED – FOR TRAINING PURPOSES ONLY’ D.None are true Skill Check 58

59 Water  Schedules and methods for monitoring water quality Policies  Document corrective action taken when tolerance limits are exceeded Quality Checks 59

60 Whatever you do in the laboratory, PLEASE Remember….. 60

61 Which of the following are necessary for laboratory facilities to ensure high standards of quality work, data and safety? A.Spills should be cleaned when convenient B.Provide a safe environment for personnel C.Proper lighting should be provided to ensure sufficient visibility D.A and B only E.B and C only F.A and C only Post-Assessment Question #1 61

62 The following can occur in facilities with inadequate laboratory space: A.Frequent laboratory accidents B.Increased incidences of specimen loss or mix-ups C.Sub-optimal equipment performance D.Likelihood of incorrect results being reported E.All of the above F.A and B only Post-Assessment Question #2 62

63 Maintaining accurate laboratory equipment is important for: A.Generation of accurate results B.Minimizing the costs of repair C.Reporting results in a timely manner D.All of the above Post-Assessment Question #3 63

64 DAIDS GCLP requires that pipettes are checked for volumetric accuracy and reproducibility and recalibrated at what defined frequency? A.Monthly B.Annually C.At minimum every 6 months D.Every 2 months Post-Assessment Question #4 64

65 Why is it important for clinical research laboratories to document temperature monitoring and maintenance activities for laboratory equipment, including calibration and QC testing? A.It is a GCLP requirement B.It ensures maintenance of an effective Quality Management systems C.It provides evidence of compliance to documented procedures and policies D.It assists in easy identification and corrections of problems associated with inadequate performance of these activities E.All of the above F.A and B only Post-Assessment Question #5 65

66 Which of the following are required for reagent labeling per GCLP guidelines? A.Lot number and expiration date B.Open and reconstitution date C.Date received from manufacturer D.A and B E.B and C F.A and C Post-Assessment Question #6 66

67 “Maintaining your equipment is paramount in maintaining the quality of your product.” Frank Rabey 67

68 Wrap Up 68


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