laboratory management

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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


Achieving a 99% level of qualitymeansaccepting a error rate1%4Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000


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


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


safe working environment transport managementcontainmentsecuritywaste managementlaboratory safetyergonomics


acquisitioninstallationvalidationmaintenancecalibrationtroubleshootingservice and repairrecords


quality controlsample managementmethod validationmethod verification


confidentiality requisitions logs and recordsreportscomputerized laboratory information systems (LIS)


creationrevisions and reviewcontrol and distribution

collectionreviewstorageretention


complaintsmistakes and problemsdocumentationroot cause analysisimmediate actionscorrective actionspreventive actions


INTERNALQuality IndicatorsAudit ProgramEXTERNALProficiency Testing (EQA)InspectionsAccreditationsAudit Review18Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000

customer group identificationcustomer feedbackcustomer needs


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


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!


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


non-porous covering, easy to clean, resistant to chemicals and disinfectantno wood, no steel


dailybench topsfloorsweeklyceilings, wallsothersrefrigerators, freezers, storage areas


showereye washer


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DO



physicalchemicalbiological43Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000


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



Do NOT reuse disposable injection equipment


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



laboratorys greatest assetcritical to qualitypartners in public healthqualified professionals



Orientation

Competency Assessment

Task-specific TrainingCompetency Recognition

Job Description

Retraining


EQUIPMENT

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Reduces interruption of services Increases safety Greater customer satisfaction


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


confirm vendors responsibilities in writingestablish checklist


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


perform initial calibration use calibrators or standards follow manufacturers instructionsdetermine frequency of routine calibrations


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


Monitor instrument parameters:periodically, daily, weekly, monthlyafter major instrument repair

Examples:incubator temperatureswavelength calibrationautoclave temperature chart


instrument type, model number, serial numberlocation in laboratorydate purchasedmanufacturer and vendor contact infowarranty, spare parts


What is the source of the problem?Sample?Reagent?Water, Electricity?Equipment?


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


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






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


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


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


Maintain records:date receivedlot numberpass or fail acceptance criteriadate placed in service or disposition

May be useful to keep records in stockroom.


Includes:name and signaturedate of receiptquantitydate of expiryminimum stockstock balanceOther information:shelf numberdestination


inspect new orders at time of deliveryverify contentscheck integrityrecord date each item receivedrecord expiration datestore new shipment behind existing shipmentcreate or update records


Use clearly visible dating labelsdate openeddate expired


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




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


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


Define a good labeling systemAssess all samples -preexaminationProvide sample collection informationWhat- When- How

Provide appropriate containers and supplies


laboratory management

Healthcare