laboratory management
TRANSCRIPT
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2Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
Essential to all aspects of health care are laboratory results that are: accuratereliabletimely
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Achieving a 99% level of qualitymeansaccepting a error rate1%4Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
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unnecessary treatment; treatment complicationsfailure to provide the proper treatmentdelay in correct diagnosisadditional and unnecessary diagnostic testing6Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
coordinated activities to direct and control an organization with regard to quality (ISO,CLSI)ALL aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality management system7Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
PreexaminationExaminationPostexamination
Data & Laboratory ManagementSafetyCustomer Service
Patient/Client PrepSample CollectionSample Receipt and AccessioningSample TransportQuality Control TestingRecord KeepingReporting
Personnel CompetencyTest Evaluations
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THE PATIENT Test selection
Sample CollectionSample TransportReport CreationReport Transport
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10The entire process of managing a sample must be considered:The beginning: sample collectionThe end: reporting and saving of resultsAll processes in betweenCompiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
human resourcesjob qualificationsjob descriptionsorientationtrainingcompetency assessmentprofessional development continuing education
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safe working environment transport managementcontainmentsecuritywaste managementlaboratory safetyergonomics
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acquisitioninstallationvalidationmaintenancecalibrationtroubleshootingservice and repairrecords
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quality controlsample managementmethod validationmethod verification
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confidentiality requisitions logs and recordsreportscomputerized laboratory information systems (LIS)
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creationrevisions and reviewcontrol and distribution
collectionreviewstorageretention
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complaintsmistakes and problemsdocumentationroot cause analysisimmediate actionscorrective actionspreventive actions
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INTERNALQuality IndicatorsAudit ProgramEXTERNALProficiency Testing (EQA)InspectionsAccreditationsAudit Review18Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
customer group identificationcustomer feedbackcustomer needs
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ImplementingQuality Managementdoes notguaranteeanERROR-FREELaboratory20Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
ISO International Organization for StandardizationCLSI Clinical and Laboratory Standards Institute(formerly known as NCCLS)Guidance for quality in manufacturing and service industriesStandards, guidelines, and best practices for quality in medical laboratory testingBroad applicability; used by many kinds of organizationsDetailed; applies specifically to medical laboratoriesUses consensus process in developing standardsUses consensus process in developing standards
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Leadershipexercising responsible authority, while providing motivation and visioninfluencing and encouraging staff to good performance
Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
establish a working structure thatensures sufficiency at all parts in thelaboratory work flowdesignate responsibilities and roles; develop an organization chartdesignate a Quality Managerallocate sufficient resources23Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
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NURSING DIRECTOR NURSING
HOSPITAL DIRECTOR24Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
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ISO 15189 requirementhas responsibility and authority to oversee compliancereports directly to the decision-making level of laboratory management
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monitor quality management systemassure compliancereview all recordsconduct, coordinate auditsinvestigate deficienciesCompiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
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test orderingsample managementtraining level (competence)of technical staffquality controlanalytical processrecording and reporting results
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relate how facility design impacts the efficiency and safety of laboratory workersdescribe practices to prevent or reduce risksdescribe steps to take in response to emergencies list personal protective equipment (PPE) that should be used routinelyCompiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
loss of staff confidence loss of reputationloss of customersincreased cost --- litigation, insurance
Negligence of laboratory safety is costly!
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Everyone31Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
path followed by the samplereception and registration of patientssampling roomsdispatch between different laboratoriesanalysis of samplesreport delivery, filingservice rooms32Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
Blood clottingHematologyBiochemistryWashroomBacteriologyGynaecological samplesBlood samplesCommon room, stairs to offices
Disinfection
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Blood clottingHematologyBiochemistryWashroomBacteriologyGynaecological samples collectionBlood samples collectionCommon room, stairs to offices
Disinfection
Waste
Reception
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high ceiling with good ventilationuse washable, glossy painteasy to clean and disinfectwalls and ceilingflooreasy to clean and disinfect
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non-porous covering, easy to clean, resistant to chemicals and disinfectantno wood, no steel
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dailybench topsfloorsweeklyceilings, wallsothersrefrigerators, freezers, storage areas
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showereye washer
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DO
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physicalchemicalbiological43Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
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do not recap needlesalways use puncture-resistant, leakproof, sharps containers always use specific waste disposal containers never directly handle broken glass45Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
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Do NOT reuse disposable injection equipment
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separate cabinets for storage spill containment cabinethazardous waste storageflammable liquids storage49Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
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aerosols and droplets
ocular invasioninhalationingestionskin penetration51Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
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laboratorys greatest assetcritical to qualitypartners in public healthqualified professionals
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Orientation
Competency Assessment
Task-specific TrainingCompetency Recognition
Job Description
Retraining
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EQUIPMENT
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Reduces interruption of services Increases safety Greater customer satisfaction
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easy to uselanguagewarrantysafetywill it fit?59Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
wiring diagramssoftware informationparts listoperator manualinstallation by manufacturertrial period
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confirm vendors responsibilities in writingestablish checklist
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when possible, have manufacturer install and set updo not attempt to use prior to proper installation
verify package contents copy software, if part of system62Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
Maintenance Program
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perform initial calibration use calibrators or standards follow manufacturers instructionsdetermine frequency of routine calibrations
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Test known samples, analyze dataEstablish stability for temperature- controlled equipmentValidate performance with parallel samplesNEW EQUIPMENT65Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
routine cleaningadjustment, replacement of equipment parts
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Monitor instrument parameters:periodically, daily, weekly, monthlyafter major instrument repair
Examples:incubator temperatureswavelength calibrationautoclave temperature chart
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instrument type, model number, serial numberlocation in laboratorydate purchasedmanufacturer and vendor contact infowarranty, spare parts
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What is the source of the problem?Sample?Reagent?Water, Electricity?Equipment?
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call manufacturer orother technical expert
look for options to continue service obtain back-up instrument from central stores or manufacturer refer sample to nearby laboratory
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manufacturerslaboratory must schedule routine manufacturers maintenancewarranty may require repair handled by manufacturerin-house biomedical service technicians
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date problem occurred, equipment removed from servicereason for breakdown or failurecorrective actions takendate returned to use change in maintenance or in function checks
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Quality Maintained
Minimize waste
Stay within budget
Supplies and reagents always available77Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
balance between stock availability and expiration dateslife-span of laboratory reagents varies
In-stockExpiry Date78Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
define criteria for supplies and services to be purchaseduse information from other laboratoriesevaluate before purchase and after receipt79Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
Determine payment mechanisms
Understand government requirements
Assure reliable availability, delivery80Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
INVENTORY CONTROL
Assign responsibilityAnalyze needsEstablish minimum stock needs
Develop forms and logsEstablish system for receiving, storingMaintain inventory system in all storage areas
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listing all tests in the laboratoryidentifying all supplies needed for each test using available information to estimate usage82Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
consumption-based methodmorbidity-based method83Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
based on actual usagemust take into account:health-supplies actually usedwaste: expired or spoiled suppliessupplies out of stock for more than 15 days during any time of year84Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
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based on actual number of episodesmust take into account:population sizedisease incidenceaccuracy of morbidity datatreatment guidelines86Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
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Maintain records:date receivedlot numberpass or fail acceptance criteriadate placed in service or disposition
May be useful to keep records in stockroom.
Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
Includes:name and signaturedate of receiptquantitydate of expiryminimum stockstock balanceOther information:shelf numberdestination
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inspect new orders at time of deliveryverify contentscheck integrityrecord date each item receivedrecord expiration datestore new shipment behind existing shipmentcreate or update records
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Use clearly visible dating labelsdate openeddate expired
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Inventory Control
Assign responsibilityMaintain inventory system in all storage areasConduct weekly physical counts Update records92Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
advantagesexact current state of stock management of expiration dates makes inventory tasks easierdrawbackson-site computer is needed requires trained staff93Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
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LaboratoryHandbookPolicies & Practices97Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000
contains information needed by those who collect samplesavailable to all sample collection areasmust be understood by all laboratory staffreferenced in the quality manual
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name and address of laboratorycontact names and telephone numbershours of operationlist of tests that can be orderedsample collection proceduressample transport proceduresexpected turn around times (TAT)how urgent requests are handled
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Define a good labeling systemAssess all samples -preexaminationProvide sample collection informationWhat- When- How
Provide appropriate containers and supplies
Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000