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

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Management of Laboratory Equipment

Management of Laboratory Equipment

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Purchasing & Inventory

AssessmentOccurrence

Management

Information Management

Process Improvement

Customer Service

Facilities & Safety

The Quality SystemThe Quality System

Organization Personnel

Documents & Records

Equipment

Process Control (QC & EQA) &

Specimen Management

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Problem Scenario #1Problem Scenario #1

• You’re in the middle of performing ELISAs and the reader fails. You don’t have a documented procedure for troubleshooting, the maintenance log has not been updated for 2 years, and the manufacturer’s instructions are missing.

• What should you do? Why?

• You’re in the middle of performing ELISAs and the reader fails. You don’t have a documented procedure for troubleshooting, the maintenance log has not been updated for 2 years, and the manufacturer’s instructions are missing.

• What should you do? Why?

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Functioning Equipment is Vital for: 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

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A Good Equipment Program Achieves 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 technologist’s 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 technologist’s confidence and

knowledge

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Basic Laboratory EquipmentBasic 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

• Autoclave• Hot air oven• Incubator• pH Meter• Water bath• Washer• Shaker / rotator• Vortex

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Equipment Management Equipment Management

• Selection• Acquisition• Installation• Calibration / Validation• Maintenance • Troubleshooting • Service and repair• Retiring equipment / disposition


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Equipment Management OversightEquipment 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

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


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Selection CriteriaSelection 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

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Selection CriteriaSelection Criteria

• Location in the laboratory available space, accessibility

• Safety

• Location in the laboratory available space, accessibility

• Safety

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Acquiring EquipmentAcquiring 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

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Acquiring EquipmentAcquiring 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

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Equipment ManagementEquipment Management



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Installation ChecklistInstallation 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

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Installation 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

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InstallationInstallation

• 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

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Equipment CalibrationEquipment Calibration

• Perform initial calibration Calibrators or standards Follow manufacturer’s instructions

• Determine frequency of routine calibrations

• Perform initial calibration Calibrators or standards Follow manufacturer’s instructions

• Determine frequency of routine calibrations

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Performance ValidationPerformance 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

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Maintenance ProgramMaintenance 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

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Function ChecksFunction Checks

• Monitoring of instrument parameters to verify that that your equipment is working according to the manufacturer’s 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 manufacturer’s specification

• Performed periodically- daily, weekly, monthly• Performed after major instrument repair Example:

Daily monitoring of temperatures Checking wavelength calibration Checking autoclave indicator paper

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Implementing a Maintenance ProgramImplementing 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

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Implementing a Maintenance ProgramImplementing 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

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Implementing a Maintenance Program 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

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Implementing a Maintenance Program: Spare Parts

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

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Implementing a Maintenance Program: Documents

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 manufacturer’s 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 manufacturer’s service

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Sample RecordsSample Records

• Charts• Logs• Checklists• Graphs• Service Reports

• Charts• Logs• Checklists• Graphs• Service Reports

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TroubleshootingTroubleshooting

• Check manufacturer’s instructions• Determine source of problem

Sample problem Reagent problem Equipment problem Check electrical supply Check water supply

• Make one change at a time

• Check manufacturer’s instructions• Determine source of problem

Sample problem Reagent problem Equipment problem Check electrical supply Check water supply

• Make one change at a time

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When In-house efforts fail: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

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Service and RepairService 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

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Equipment DocumentationEquipment 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

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Retiring Equipment / DispositionRetiring 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

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Benefits of a Maintenance ProgramBenefits 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

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Function Checks Verify that Equipment is Working Properly

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

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Refrigerator and Freezer: Use and Care

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

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Refrigerator & Freezer:Temperature Checks

Refrigerator & Freezer:Temperature Checks

Monitor daily• Refrigerator: 2oC to 8oC • Freezer: -20oC, -40oC, or -80oC

Monitor daily• Refrigerator: 2oC to 8oC • Freezer: -20oC, -40oC, or -80oC

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Refrigerator & Freezer:Temperature LogRefrigerator & Freezer:Temperature Log

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Types of PipettesTypes 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

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Pipette: Use and CarePipette: 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


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Pipette: Use and Care (Cont’d)Pipette: Use and Care (Cont’d)

• 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 taskDO NOT RE-USE- Pipette tips - Graduated plastic bulb pipettes

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Precision Pipettes Require Performance Checks

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

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1. Pipette a series of 10 samples into a weigh boat on an analytical scale

2. Record weight of each sample to calculate calibration results3. Verify calculated results are within limits

Range Max/Min Accuracy 10 µl + 1.0 µl 10% 100 µl + 10.0 µ l 10% 200 µl + 20.0 µ l 10 %

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 results3. Verify calculated results are within limits

Range Max/Min Accuracy 10 µl + 1.0 µl 10% 100 µl + 10.0 µ l 10% 200 µl + 20.0 µ l 10 %

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

Pipette: Steps for Checking Reproducibility

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Pipette: TroubleshootingPipette: Troubleshooting

Leakage

Problem Potential Cause Action

• 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 manufacturer’s instructions carefully


Inaccurate dispensing

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Centrifuge: Use and CareCentrifuge: 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

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Centrifuges: Function ChecksCentrifuges: Function Checks

• Proper balanceProper balance• Lubrication Lubrication • Rotor functionRotor function

• Proper balanceProper balance• Lubrication Lubrication • Rotor functionRotor function

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Centrifuge: Routine MaintenanceCentrifuge: Routine Maintenance• Clean interior, condenser coils, fan, and screensClean 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 Inspect for evidence of wear, cracks in fitting, corrosion, uneven

wear, or signs of fatigue:wear, or signs of fatigue: Head, shaft head and couplingHead, shaft head and coupling RotorRotor Brushes and bearingsBrushes and bearings Power supplyPower supply Motor and lubricantMotor and lubricant Gaskets, seals, mounts and lubricantsGaskets, seals, mounts and lubricants

• Calibrate speedCalibrate speed

• Clean interior, condenser coils, fan, and screensClean 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 Inspect for evidence of wear, cracks in fitting, corrosion, uneven

wear, or signs of fatigue:wear, or signs of fatigue: Head, shaft head and couplingHead, shaft head and coupling RotorRotor Brushes and bearingsBrushes and bearings Power supplyPower supply Motor and lubricantMotor and lubricant Gaskets, seals, mounts and lubricantsGaskets, seals, mounts and lubricants

• Calibrate speedCalibrate speed

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Centrifuge SafetyCentrifuge Safety

• Increase the speed slowly until optimal speed is reachedIncrease the speed slowly until optimal speed is reached• Disconnect the centrifuge from the electrical source before Disconnect the centrifuge from the electrical source before

preventive maintenance, cleaning or inspectionpreventive maintenance, cleaning or inspection• Take caution when removing spills and broken specimen Take caution when removing spills and broken specimen

tubes after a run tubes after a run • If tubes are broken, keep the door closed and allow to sit If tubes are broken, keep the door closed and allow to sit

undisturbed for 30 minutes before attempting to clean undisturbed for 30 minutes before attempting to clean • Use tweezers to remove broken glassUse tweezers to remove broken glass

• Increase the speed slowly until optimal speed is reachedIncrease the speed slowly until optimal speed is reached• Disconnect the centrifuge from the electrical source before Disconnect the centrifuge from the electrical source before

preventive maintenance, cleaning or inspectionpreventive maintenance, cleaning or inspection• Take caution when removing spills and broken specimen Take caution when removing spills and broken specimen

tubes after a run tubes after a run • If tubes are broken, keep the door closed and allow to sit If tubes are broken, keep the door closed and allow to sit

undisturbed for 30 minutes before attempting to clean undisturbed for 30 minutes before attempting to clean • Use tweezers to remove broken glassUse tweezers to remove broken glass

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Keep a Log for All Maintenance ActivitiesKeep a Log for All Maintenance Activities