3Trainer’s Guide Module: Equipment Problem Scenario #1You’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?
4Functioning Equipment is Vital for: Trainer’s GuideModule: EquipmentFunctioning Equipment is Vital for:Producing reliable test resultsMinimizing instrument breakdownLowering repair costsPreventing delays in reporting test resultsMaintaining productivityMinimizing instrument breakdown that slows down the work, and reduce the number of costly services for instrument repair, through appropriate planning for maintenance and repair(Creates basis for improving selection and purchase policy)Reliable results aids clinical diagnosis. Unreliable results may result in incorrect diagnosis and treatment of the patient.If equipment is properly maintained, it is less likely to breakdown before its next service and is less likely to perform inadequately as a result of lack of maintenance.
5A Good Equipment Program Achieves Trainer’s GuideModule: EquipmentA Good Equipment Program AchievesMaintaining a high level of performanceLengthening instrument lifeReducing interruption of services due to breakdowns and failuresImproving customer satisfactionImproving the technologist’s confidence and knowledgeA good equipment program plays an important role in the quality assurance of a laboratory to be able to produce reliable results.
6Basic Laboratory Equipment Trainer’s GuideModule: EquipmentBasic Laboratory EquipmentMicroscopeBalance/scaleCentrifugeMicropipetteSpectrophotometerRefrigeratorFreezerAutoclaveHot air ovenIncubatorpH MeterWater bathWasherShaker / rotatorVortexHighly sophisticated laboratories such as central or reference may also have automated analysers e.g. for EIA, CD4, PCR.
7Trainer’s Guide Module: Equipment Equipment ManagementSelectionAcquisitionInstallationCalibration / ValidationMaintenanceTroubleshootingService and repairRetiring equipment / dispositionIt is increasingly recognized that equipment management goes far beyond that of a person simply being able to operate the equipment. See list above.Equipment management also requires a specific person designated to deal with all aspects of equipment management.A Selection Criteria Check List will assist in purchasing the most appropriate piece of equipment to meet the laboratories needs, e.g.Cost, Manufacturer and Support, Availability, Model,
8Equipment Management Oversight Trainer’s GuideModule: EquipmentEquipment Management OversightAssign responsibilities for all activitiesTrain all personnel on equipment management requirements and responsibilitiesMonitor equipment management activities by:Routinely reviewing all recordsEnsuring all procedures are followedUpdating procedures, if necessaryTraining of laboratorians and monitoring of equipment are also important roles of the equipment manager.
10Trainer’s Guide Module: Equipment Selection CriteriaUseMatching equipment with service providedPerformance characteristicsFacility requirementsCostSupply of reagentsEase of operationWarrantyAvailability of manufacturer technical supportService ContractsPerformance characteristicsaccuracyprecisionsensitivityspecificityPhysical requirementselectrical, re-wiring, drains, plumbingSupply of reagentsAccess to reagentsAlternative sourcesFull support from manufacturers in terms of training, installation, service and repair are key points when checking the selection criteria.
11Trainer’s Guide Module: Equipment Selection CriteriaLocation in the laboratoryavailable space, accessibilitySafetyIs there a good laboratory infrastructure in place to accommodate the new piece of equipment.
13Trainer’s Guide Module: Equipment Acquiring EquipmentPurchase, Lease, or RentCentral acquisitionBulk procurementDonor providedConditions of contractPros and Cons of Purchase or RentPro Purchase VS Against PurchaseOwnership Total Responsibility
14Trainer’s Guide Module: Equipment Acquiring EquipmentContract considerations:Parts ManualInstallationOperators’ ManualTrial periodContents of service contracts
16Installation Checklist Trainer’s GuideModule: EquipmentInstallation ChecklistPrior to installation:verify physical requirements have been metSafety checks, electrical, space, ventilation, water supply, ambient temperature, etc.confirm responsibility for installation
17Trainer’s Guide Module: Equipment InstallationUpon receipt:verify package contentsdo not attempt to use prior to proper installationIf required, ensure the equipment is installed by the manufacturer
18Installation After installation Establish inventory record Define conditionsDevelop and implement protocols for calibration, performance verification, and operating proceduresEstablish maintenance programProvide training for all operators
20Equipment Calibration Trainer’s GuideModule: EquipmentEquipment CalibrationPerform initial calibrationCalibrators or standardsFollow manufacturer’s instructionsDetermine frequency of routine calibrations
21Performance Validation Trainer’s GuideModule: EquipmentPerformance ValidationValidate the performance of new equipment prior to useTest known samples, analyze dataEstablish stability/uniformity temperature controlled equipmentCheck accuracy/precision for pipettorsCheck centrifuge rpms
23Trainer’s Guide Module: Equipment Maintenance ProgramSystematic and routine cleaning, adjustment, or replacement of instrument and equipment partsPerformed periodically, daily, weekly, monthlyExample:Cleaning optical lensesThermostat adjustmentsChanging motor brushes
24Trainer’s Guide Module: Equipment Function ChecksMonitoring of instrument parameters to verify that that your equipment is working according to the manufacturer’s specificationPerformed periodically- daily, weekly, monthlyPerformed after major instrument repairExample:Daily monitoring of temperaturesChecking wavelength calibrationChecking autoclave indicator paper
25Implementing a Maintenance Program Trainer’s GuideModule: EquipmentImplementing a Maintenance ProgramAssign responsibilityOversight of all laboratory equipmentIndividual responsibilitiesDevelop written policies and proceduresTrain staffKeep records
26Implementing a Maintenance Program Trainer’s GuideModule: EquipmentImplementing a Maintenance ProgramCreate a record for equipment inventoryName, Model #, Serial #Location in labDate purchasedManufacturer and vendor contact informationWarranty, expiration dateSpare parts
27Implementing a Maintenance Program Trainer’s GuideModule: EquipmentImplementing a Maintenance ProgramFor each piece of equipment:Establish routine maintenance planEstablish required function checksDevelop a list of spare partsEach piece of equipment should have a label indicating the date in which the next service is dueFrequency of routine maintenance procedures and functions checks is an important part of the plan, and must be included in the documented procedure (daily, monthly, yearly)
28Implementing a Maintenance Program: Spare Parts Trainer’s GuideModule: EquipmentImplementing a Maintenance Program: Spare PartsEstablish and maintain an inventory of most frequently used spare parts. Include in record of inventory:Spare parts per equipmentPart numberAverage useMinimal # of items to be storedCost and date of orderingDates of entry and issuance of part from inventory stockBalance of items remaining in inventory
29Implementing a Maintenance Program: Documents Trainer’s GuideModule: EquipmentImplementing a Maintenance Program: DocumentsDevelop written procedures for all equipmentConcise step-by-step instructions for performing maintenance and function checksInclude guide for troubleshootingEstablish maintenance records to track:function checks and routine maintenancecalibrationmanufacturer’s service
33Trainer’s Guide Module: Equipment TroubleshootingCheck manufacturer’s instructionsDetermine source of problemSample problemReagent problemEquipment problemCheck electrical supplyCheck water supplyMake one change at a time
34When In-house efforts fail: Trainer’s GuideModule: EquipmentWhen In-house efforts fail:Do NOT use equipment that does not function properlyOptions for testing:Refer to nearby laboratoryObtain backup instrument from central storesStore samples appropriatelySeek help from manufacturer or other technical expertPlace a malfunction notice on equipment
36Trainer’s Guide Module: Equipment Service and RepairSchedule service that must be periodically performed by the manufacturerOptionsCentrally service small equipment, e.g., microscopes, washers, pipettesTeam of biomedical service techniciansSchedule service that must be periodically performed by the manufacturer - This service should have been part of the negotiated contract agreementTeam of biomedical service technicians – This trained team would service the entire country
37Equipment Documentation Trainer’s GuideModule: EquipmentEquipment DocumentationDevelop a problem log record for each piece of equipmentDate problem occurred, removed from serviceReason for breakdown or failureCorrective action takenDate returned to useChange in maintenance or function checks
40Retiring Equipment / Disposition Trainer’s GuideModule: EquipmentRetiring Equipment / DispositionWhen?When experts indicate not repairableOutmoded, will replace with new equipmentWhy?Prevent inaccurate test resultsFree up valuable spaceHazardousHow?Salvage any useable partsConsider biohazard, follow safety disposal procedures
41Benefits of a Maintenance Program Trainer’s GuideModule: EquipmentBenefits of a Maintenance ProgramSafetyFewer interruptions of workLower repair costsElimination of premature replacementLess standby equipmentIdentification of high maintenance costReduction of variation in test resultsGreater confidence in the reliability of results