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1 Management of Laboratory Equipment. 2 Purchasing & Inventory Assessment Occurrence Management Information Management Process Improvement Customer Service.

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Presentation on theme: "1 Management of Laboratory Equipment. 2 Purchasing & Inventory Assessment Occurrence Management Information Management Process Improvement Customer Service."— Presentation transcript:

1 1 Management of Laboratory Equipment

2 2 Purchasing & Inventory Assessment Occurrence Management Information Management Process Improvement Customer Service Facilities & Safety The Quality System Organization Personnel Documents & Records Equipment Process Control (QC & EQA) & Specimen Management

3 3 Problem Scenario #1 Youre in the middle of performing ELISAs and the reader fails. You dont have a documented procedure for troubleshooting, the maintenance log has not been updated for 2 years, and the manufacturers instructions are missing. What should you do? Why? Youre in the middle of performing ELISAs and the reader fails. You dont have a documented procedure for troubleshooting, the maintenance log has not been updated for 2 years, and the manufacturers instructions are missing. What should you do? Why?

4 4 Functioning Equipment is Vital for: Producing reliable test results Minimizing instrument breakdown Lowering repair costs Preventing delays in reporting test results Maintaining productivity Producing reliable test results Minimizing instrument breakdown Lowering repair costs Preventing delays in reporting test results Maintaining productivity

5 5 A Good Equipment Program Achieves Maintaining a high level of performance Lengthening instrument life Reducing interruption of services due to breakdowns and failures Improving customer satisfaction Improving the technologists confidence and knowledge Maintaining a high level of performance Lengthening instrument life Reducing interruption of services due to breakdowns and failures Improving customer satisfaction Improving the technologists confidence and knowledge

6 6 Basic Laboratory Equipment Microscope Balance/scale Centrifuge Micropipette Spectrophotometer Refrigerator Freezer Microscope Balance/scale Centrifuge Micropipette Spectrophotometer Refrigerator Freezer Autoclave Hot air oven Incubator pH Meter Water bath Washer Shaker / rotator Vortex

7 7 Equipment Management Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition

8 8 Equipment Management Oversight Assign responsibilities for all activities Train all personnel on equipment management requirements and responsibilities Monitor equipment management activities by: Routinely reviewing all records Ensuring all procedures are followed Updating procedures, if necessary Assign responsibilities for all activities Train all personnel on equipment management requirements and responsibilities Monitor equipment management activities by: Routinely reviewing all records Ensuring all procedures are followed Updating procedures, if necessary

9 9 Equipment Management Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition

10 10 Selection Criteria Use Matching equipment with service provided Performance characteristics Facility requirements Cost Supply of reagents Ease of operation Warranty Availability of manufacturer technical support Service Contracts Use Matching equipment with service provided Performance characteristics Facility requirements Cost Supply of reagents Ease of operation Warranty Availability of manufacturer technical support Service Contracts

11 11 Selection Criteria Location in the laboratory available space, accessibility Safety Location in the laboratory available space, accessibility Safety

12 12 Equipment Management Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition

13 13 Acquiring Equipment Purchase, Lease, or Rent Central acquisition Bulk procurement Donor provided Conditions of contract Purchase, Lease, or Rent Central acquisition Bulk procurement Donor provided Conditions of contract

14 14 Acquiring Equipment Contract considerations: Parts Manual Installation Operators Manual Trial period Contents of service contracts Contract considerations: Parts Manual Installation Operators Manual Trial period Contents of service contracts

15 15 Equipment Management Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition

16 16 Installation Checklist Prior to installation: verify physical requirements have been met Safety checks, electrical, space, ventilation, water supply, ambient temperature, etc. confirm responsibility for installation Prior to installation: verify physical requirements have been met Safety checks, electrical, space, ventilation, water supply, ambient temperature, etc. confirm responsibility for installation

17 17 Installation Upon receipt: verify package contents do not attempt to use prior to proper installation If required, ensure the equipment is installed by the manufacturer Upon receipt: verify package contents do not attempt to use prior to proper installation If required, ensure the equipment is installed by the manufacturer

18 18 Installation After installation Establish inventory record Define conditions Develop and implement protocols for calibration, performance verification, and operating procedures Establish maintenance program Provide training for all operators After installation Establish inventory record Define conditions Develop and implement protocols for calibration, performance verification, and operating procedures Establish maintenance program Provide training for all operators

19 19 Equipment Management Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition

20 20 Equipment Calibration Perform initial calibration Calibrators or standards Follow manufacturers instructions Determine frequency of routine calibrations Perform initial calibration Calibrators or standards Follow manufacturers instructions Determine frequency of routine calibrations

21 21 Performance Validation Validate the performance of new equipment prior to use Test known samples, analyze data Establish stability/uniformity temperature controlled equipment Check accuracy/precision for pipettors Check centrifuge rpms Validate the performance of new equipment prior to use Test known samples, analyze data Establish stability/uniformity temperature controlled equipment Check accuracy/precision for pipettors Check centrifuge rpms

22 22 Equipment Management Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition

23 23 Maintenance Program Systematic and routine cleaning, adjustment, or replacement of instrument and equipment parts Performed periodically, daily, weekly, monthly Example: Cleaning optical lenses Thermostat adjustments Changing motor brushes Systematic and routine cleaning, adjustment, or replacement of instrument and equipment parts Performed periodically, daily, weekly, monthly Example: Cleaning optical lenses Thermostat adjustments Changing motor brushes

24 24 Function Checks Monitoring of instrument parameters to verify that that your equipment is working according to the manufacturers specification Performed periodically- daily, weekly, monthly Performed after major instrument repair Example: Daily monitoring of temperatures Checking wavelength calibration Checking autoclave indicator paper Monitoring of instrument parameters to verify that that your equipment is working according to the manufacturers specification Performed periodically- daily, weekly, monthly Performed after major instrument repair Example: Daily monitoring of temperatures Checking wavelength calibration Checking autoclave indicator paper

25 25 Implementing a Maintenance Program Assign responsibility Oversight of all laboratory equipment Individual responsibilities Develop written policies and procedures Train staff Keep records Assign responsibility Oversight of all laboratory equipment Individual responsibilities Develop written policies and procedures Train staff Keep records

26 26 Implementing a Maintenance Program Create a record for equipment inventory Name, Model #, Serial # Location in lab Date purchased Manufacturer and vendor contact information Warranty, expiration date Spare parts Create a record for equipment inventory Name, Model #, Serial # Location in lab Date purchased Manufacturer and vendor contact information Warranty, expiration date Spare parts

27 27 Implementing a Maintenance Program For each piece of equipment: Establish routine maintenance plan Establish required function checks Develop a list of spare parts For each piece of equipment: Establish routine maintenance plan Establish required function checks Develop a list of spare parts

28 28 Implementing a Maintenance Program: Spare Parts Establish and maintain an inventory of most frequently used spare parts. Include in record of inventory: Spare parts per equipment Part number Average use Minimal # of items to be stored Cost and date of ordering Dates of entry and issuance of part from inventory stock Balance of items remaining in inventory Establish and maintain an inventory of most frequently used spare parts. Include in record of inventory: Spare parts per equipment Part number Average use Minimal # of items to be stored Cost and date of ordering Dates of entry and issuance of part from inventory stock Balance of items remaining in inventory

29 29 Implementing a Maintenance Program: Documents Develop written procedures for all equipment Concise step-by-step instructions for performing maintenance and function checks Include guide for troubleshooting Establish maintenance records to track: function checks and routine maintenance calibration manufacturers service Develop written procedures for all equipment Concise step-by-step instructions for performing maintenance and function checks Include guide for troubleshooting Establish maintenance records to track: function checks and routine maintenance calibration manufacturers service

30 30 Sample Records Charts Logs Checklists Graphs Service Reports Charts Logs Checklists Graphs Service Reports

31 31

32 32 Equipment Management Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition

33 33 Troubleshooting Check manufacturers instructions Determine source of problem Sample problem Reagent problem Equipment problem Check electrical supply Check water supply Make one change at a time Check manufacturers instructions Determine source of problem Sample problem Reagent problem Equipment problem Check electrical supply Check water supply Make one change at a time

34 34 When In-house efforts fail: Do NOT use equipment that does not function properly Options for testing: Refer to nearby laboratory Obtain backup instrument from central stores Store samples appropriately Seek help from manufacturer or other technical expert Place a malfunction notice on equipment Do NOT use equipment that does not function properly Options for testing: Refer to nearby laboratory Obtain backup instrument from central stores Store samples appropriately Seek help from manufacturer or other technical expert Place a malfunction notice on equipment

35 35 Equipment Management Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition

36 36 Service and Repair Schedule service that must be periodically performed by the manufacturer Options Centrally service small equipment, e.g., microscopes, washers, pipettes Team of biomedical service technicians Schedule service that must be periodically performed by the manufacturer Options Centrally service small equipment, e.g., microscopes, washers, pipettes Team of biomedical service technicians

37 37 Equipment Documentation Develop a problem log record for each piece of equipment Date problem occurred, removed from service Reason for breakdown or failure Corrective action taken Date returned to use Change in maintenance or function checks Develop a problem log record for each piece of equipment Date problem occurred, removed from service Reason for breakdown or failure Corrective action taken Date returned to use Change in maintenance or function checks

38 38 Equipment Management Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition Selection Acquisition Installation Calibration / Validation Maintenance Troubleshooting Service and repair Retiring equipment / disposition

39 39

40 40 Retiring Equipment / Disposition When? When experts indicate not repairable Outmoded, will replace with new equipment Why? Prevent inaccurate test results Free up valuable space Hazardous How? Salvage any useable parts Consider biohazard, follow safety disposal procedures When? When experts indicate not repairable Outmoded, will replace with new equipment Why? Prevent inaccurate test results Free up valuable space Hazardous How? Salvage any useable parts Consider biohazard, follow safety disposal procedures

41 41 Benefits of a Maintenance Program Safety Fewer interruptions of work Lower repair costs Elimination of premature replacement Less standby equipment Identification of high maintenance cost Reduction of variation in test results Greater confidence in the reliability of results Safety Fewer interruptions of work Lower repair costs Elimination of premature replacement Less standby equipment Identification of high maintenance cost Reduction of variation in test results Greater confidence in the reliability of results

42 42 Function Checks Verify that Equipment is Working Properly Performed routinely Daily, weekly, monthly After adjustment or repair Example: Monitoring refrigerator temperatures Verifying pipette accuracy Checking centrifuge speed Performed routinely Daily, weekly, monthly After adjustment or repair Example: Monitoring refrigerator temperatures Verifying pipette accuracy Checking centrifuge speed

43 43 Refrigerator and Freezer: Use and Care Keep organized Periodically clean inside and outside Ensure door is completed sealed when closing CAUTION! – DO NOT store food items or beverages in laboratory refrigerator or freezer Keep organized Periodically clean inside and outside Ensure door is completed sealed when closing CAUTION! – DO NOT store food items or beverages in laboratory refrigerator or freezer

44 44 Refrigerator & Freezer: Temperature Checks Monitor daily Refrigerator: 2 o C to 8 o C Freezer: -20 o C, -40 o C, or -80 o C Monitor daily Refrigerator: 2 o C to 8 o C Freezer: -20 o C, -40 o C, or -80 o C

45 45 Refrigerator & Freezer: Temperature Log

46 46 Types of Pipettes Precision pipettes (Not disposable) Precise and accurate volumes (e.g., 50 µl for Determine) Use disposable, single-use, pipette tips Graduated plastic bulb pipettes (Disposable) Dispenses approximate volume Easy to use Precision pipettes (Not disposable) Precise and accurate volumes (e.g., 50 µl for Determine) Use disposable, single-use, pipette tips Graduated plastic bulb pipettes (Disposable) Dispenses approximate volume Easy to use

47 47 Pipette: Use and Care Select the appropriate pipette for the volume required Ensure that the pipettor, tips, and specimen are at the same temperature Firmly attach tip Select the appropriate pipette for the volume required Ensure that the pipettor, tips, and specimen are at the same temperature Firmly attach tip

48 48 Pipette: Use and Care (Contd) Hold the pipette vertically when aspirating Place tip just below the sample Avoid air bubbles Discard contaminated tips in appropriate container after completion of task Hold the pipette vertically when aspirating Place tip just below the sample Avoid air bubbles Discard contaminated tips in appropriate container after completion of task DO NOT RE-USE - Pipette tips - Graduated plastic bulb pipettes

49 49 Precision Pipettes Require Performance Checks Performed periodically Required supplies: Pipette Pipette tips Analytical balance Weigh boats Distilled or deionzed water Performed periodically Required supplies: Pipette Pipette tips Analytical balance Weigh boats Distilled or deionzed water

50 50 1. Pipette a series of 10 samples into a weigh boat on an analytical scale 2. Record weight of each sample to calculate calibration results 3. Verify calculated results are within limits RangeMax/Min Accuracy 10 µl µl10% 100 µl µ l10% 200 µl µ l10 % 4. If the results are not within limits, remove from service until appropriate adjustment can be made 5. Decontaminate pipette and scale after use 1. Pipette a series of 10 samples into a weigh boat on an analytical scale 2. Record weight of each sample to calculate calibration results 3. Verify calculated results are within limits RangeMax/Min Accuracy 10 µl µl10% 100 µl µ l10% 200 µl µ l10 % 4. If the results are not within limits, remove from service until appropriate adjustment can be made 5. Decontaminate pipette and scale after use Pipette: Steps for Checking Reproducibility

51 51 Pipette: Troubleshooting Leakage ProblemPotential CauseAction Tip(s) incorrectly attached Attach firmly Foreign articles between the tip and cone O-ring damaged Clean tip cones Change the O-ring Incorrect operation Tip incorrectly attached Follow manufacturers instructions carefully Firmly attach tip Inaccurate dispensing

52 52 Centrifuge: Use and Care Always operate with the lid closed Balance contents before turning on Check for vibration Do not open the lid until the rotor has come to a complete stop Keep lids on tubes when spinning Always operate with the lid closed Balance contents before turning on Check for vibration Do not open the lid until the rotor has come to a complete stop Keep lids on tubes when spinning

53 53 Centrifuges: Function Checks Proper balance Proper balance Lubrication Lubrication Rotor function Rotor function Proper balance Proper balance Lubrication Lubrication Rotor function Rotor function

54 54 Centrifuge: Routine Maintenance Clean interior, condenser coils, fan, and screens Clean interior, condenser coils, fan, and screens Investigate unusual noises or vibrations Investigate unusual noises or vibrations Inspect for evidence of wear, cracks in fitting, corrosion, uneven wear, or signs of fatigue: Inspect for evidence of wear, cracks in fitting, corrosion, uneven wear, or signs of fatigue: Head, shaft head and coupling Head, shaft head and coupling Rotor Rotor Brushes and bearings Brushes and bearings Power supply Power supply Motor and lubricant Motor and lubricant Gaskets, seals, mounts and lubricants Gaskets, seals, mounts and lubricants Calibrate speed Calibrate speed Clean interior, condenser coils, fan, and screens Clean interior, condenser coils, fan, and screens Investigate unusual noises or vibrations Investigate unusual noises or vibrations Inspect for evidence of wear, cracks in fitting, corrosion, uneven wear, or signs of fatigue: Inspect for evidence of wear, cracks in fitting, corrosion, uneven wear, or signs of fatigue: Head, shaft head and coupling Head, shaft head and coupling Rotor Rotor Brushes and bearings Brushes and bearings Power supply Power supply Motor and lubricant Motor and lubricant Gaskets, seals, mounts and lubricants Gaskets, seals, mounts and lubricants Calibrate speed Calibrate speed

55 55 Centrifuge Safety Increase the speed slowly until optimal speed is reached Increase the speed slowly until optimal speed is reached Disconnect the centrifuge from the electrical source before preventive maintenance, cleaning or inspection Disconnect the centrifuge from the electrical source before preventive maintenance, cleaning or inspection Take caution when removing spills and broken specimen tubes after a run Take caution when removing spills and broken specimen tubes after a run If tubes are broken, keep the door closed and allow to sit undisturbed for 30 minutes before attempting to clean If tubes are broken, keep the door closed and allow to sit undisturbed for 30 minutes before attempting to clean Use tweezers to remove broken glass Use tweezers to remove broken glass Increase the speed slowly until optimal speed is reached Increase the speed slowly until optimal speed is reached Disconnect the centrifuge from the electrical source before preventive maintenance, cleaning or inspection Disconnect the centrifuge from the electrical source before preventive maintenance, cleaning or inspection Take caution when removing spills and broken specimen tubes after a run Take caution when removing spills and broken specimen tubes after a run If tubes are broken, keep the door closed and allow to sit undisturbed for 30 minutes before attempting to clean If tubes are broken, keep the door closed and allow to sit undisturbed for 30 minutes before attempting to clean Use tweezers to remove broken glass Use tweezers to remove broken glass

56 56 Keep a Log for All Maintenance Activities


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