Y khoa, dược - Laboratory and equipment safety
Certificate of Waiver Tests
Pose insignificant risk to the patient if they are performed or interpreted incorrectly
Simple and accurate, so the risk of obtaining incorrect results is minimal
Approved by the FDA for home use
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45Laboratory and Equipment Safety45-2Learning Outcomes45.1 Describe the purpose of the physician’s office laboratory.45.2 List the medical assistant’s duties in the physician’s office laboratory.45.3 Identify important pieces of laboratory equipment.45.4 Operate a microscope.45-3Learning Outcomes (cont.)45.5 Identify the regulatory controls governing procedures completed in the physician’s office laboratory.45.6 Identify measures to prevent accidents.45.7 Describe the goal of a quality assurance program in a physician’s office laboratory.45-4Learning Outcomes (cont.)45.8 Identify the medical assistant’s record-keeping responsibilities.45.9 Describe correct waste disposal procedures.45.10 Describe the need for quality assurance and quality control programs.45-5Learning Outcomes (cont.)45.11 Maintain accurate documentation, including all logs related to quality control.45.12 List common reference materials to consult for information on procedures performed in the physician’s office laboratory.45.13 Communicate with patients regarding test preparation and follow-up.45-6IntroductionLaboratory testing – integral part of patient care Medical assistant must know Common laboratory equipmentSafety in the laboratory Steps to prevent accidents CLIA ’88 – impact on laboratory settingQuality assuranceQuality control proceduresRequired record keeping45-7Role of Laboratory Testing in Patient CareAnalysis of blood, urine, and other body fluidsRegular monitoring to identify diseases or other problemsConfirm initial diagnosisDetermine and monitor dosage of a medication45-8Role of Laboratory Testing (cont.) Kinds of laboratoriesReference laboratory Owned and operated by an organization outside the practiceHave technological resources beyond the POLPOLQuicker turnaroundEliminates need for patient travel to other test location Some managed care companies require their subscribers to use a specific reference laboratory.45-9Role of Laboratory Testing (cont.)Purpose of POLAccurate and timely processing of routine testsReporting test results to physicianTestsChemical analysisHematologic tests Microbiologic testsUrinalysis 45-10Apply Your KnowledgeCompare a reference laboratory and the POL.ANSWER: A reference laboratory is a lab facility usually run by an organization separate from the practice. It has technologies beyond the POL. Patients have to travel to this facility. A POL provides quicker turnaround on results but is limited in the testing that can be performed. Patients are able to have testing done during an appointment without leaving the office.Super!45-11Medical Assistant’s RoleProcessing tests done in POLPreparing the patientCollecting the sampleCompleting the testReporting the resultsCommunicating information about the test45-12Medical Assistant’s Role (cont.)Additional responsibilitiesUnderstand regulationsAccident preventionWaste disposal Housekeeping and maintenanceQuality assurance and controlRecord keepingInventory and order equipment and suppliesUse reference materialsScreen and follow-up results45-13Apply Your KnowledgeWhat are the duties of a medical assistant related to testing done in the POL?ANSWER: The medical assistant duties may include preparing the patient, collecting the sample, running the test, reporting the results, and, once the physician has reviewed the results, communicating the results to the patient.Very Good!45-14Use of Laboratory Equipment You may routinely use the following: AutoclaveCentrifugeMicroscopeElectronic equipmentEquipment used for measurement45-15Use of Laboratory Equipment (cont.)Autoclave – sterilizes surfaces of instruments and equipmentCentrifuge – spins and separates specimen into its component parts45-16Use of Laboratory Equipment (cont.)Optical microscopeUses light, concentrated through a condenser and focused through the object, to project an imageCompound microscope – two lenses magnify the image created by condensed light45-17MicroscopeOcularsEyepieces MonocularBinocular Contain a magnifying lens – magnify image 10 times (10X lens)ObjectivesContain another magnifying lensMoved under ocular when neededThree objectivesTwo dry One oil-immersionMicroscope45-18Microscope (cont.)Arm and focus controlsArm – attaches oculars and objectives to bodyFocus controls – used to focus the objectLight source Under stage and substageAdjustable intensityStage and substage Stage – platform for slideSubstage – condenserSpecimen slides/ coverslipMicroscope45-19Parts of the MicroscopeEyepieces NosepieceObjectivesSlide Clips StageCondenserIrisLight SourceFine Adjustment Coarse AdjustmentBaseArm 5. 6. 7. 8. 9.10.11.12. 2. 3. 4. 1.Back45-20Use of Laboratory Equipment (cont.)Using an optical microscopeOperate correctlyCare and maintenanceClean after each useStore under plastic coverMove by holding arm and supporting the base45-21Use of Laboratory Equipment (cont.)Electronic equipment and softwareUsed to create and maintain clinical dataMore accurate, safer, and more efficient than manual methodsPhotometer – measures light intensityEquipment used for measurementPipettesFlasks or beakersHemocytometer Thermometers45-22Apply Your KnowledgeMatching:___ Measures light intensity A. Focus controls___ Platform for slide B. Hemocytometer___ Contains magnifying lens C. Stage___ One is an oil-immersion D. Photometer___ Condenser to concentrate light E. Ocular___ Move body tube up and down F. Substage___ Calibrated to count cells G. ObjectiveANSWER:GFEDCBANice Job!45-23Safety in the LaboratoryPrimary concernOSHA Protection of employees in the workplaceSpecific guidelines General duty clauseIf no specific guidelinesWorkplace free from recognized hazardsEnforces guidelines from CDC45-24OSHA GuidelinesStandard PrecautionsHazard communication standardsOSHA Bloodborne Pathogens StandardHazardous Waste Operations and Emergency Response Final RuleNeedlestick Safety and Prevention Act45-25Standard PrecautionsAssume that all blood, blood products, human tissue, and body fluids are contaminatedPPE guidelinesGlovesEye protectionUse equipment appropriatelyProper biohazard disposal45-26Hazard Communication Biohazard labelsMaterial Safety Data Sheets (MSDS)Hazard labelsName of materialHazardous effects45-27Safety in the Laboratory (cont.)OSHA Bloodborne Pathogens StandardWritten OSHA Exposure Control PlanTraining Blood-borne pathogensPPE Universal PrecautionsPrevention of exposureHepatitis B vaccination 45-28Safety in the Laboratory (cont.)Hazardous wasteDispose in proper containersSharps Other biohazardous wasteLocation of containersReduce spillageNeedlestick Safety and Prevention ActRevision of Bloodborne Pathogen StandardUse of devices to reduce risk45-29Accident Prevention GuidelinesPhysical safetyCommon sensePPEManufacturers’ guidelinesFire and electrical safetyFire drillsFire extinguishersReduce electrical hazards 45-30Safety in the Laboratory (cont.)Chemical safetyMSDSPPEBiologic safetyStandard PrecautionsDisinfection Waste disposalAccident reportingOffice proceduresEnsure safety/first aidClean up45-31Safety in the Laboratory (cont.)HousekeepingReduce risk of disease transmissionGuidelinesWritten policies and proceduresClean up spills/splashes immediatelyClean equipment after useDispose of waste correctly45-32Apply Your KnowledgeWhat information must be included on the MSDS?ANSWER: MSDS must include: Name of the product Chemical and common name of ingredients Chemical characteristics of the products Physical hazards Health hazards Guidelines for safe handling Emergency and first-aid procedures for exposureEXCELLENT!45-33Quality Assurance ProgramsMonitor the quality of patient careEnsure safety of workersAssess the quality of tests performed Clinical Laboratory Improvement Amendments (CLIA)Regulation of laboratoriesTest categoriesCertificate of WaiverModerate complexityHigh complexity45-34CLIACertificate of Waiver Tests Pose insignificant risk to the patient if they are performed or interpreted incorrectlySimple and accurate, so the risk of obtaining incorrect results is minimalApproved by the FDA for home use45-35CLIA (cont.)Moderate-complexity tests75% of testsQualified laboratory personnelRandom inspectionsHigh-complexity testsTests for specialties and subspecialties Qualified laboratory personnelRandom inspections45-36Components of Quality AssuranceQuality control programAdherence to proceduresCareful documentationInstrument and equipment maintenanceProficiency testingTraining and continuing educationStandard operating procedures documentation45-37Quality Control and MaintenanceEnsure accuracy in test results by carefully monitoring test proceduresProceduresEquipment calibrationUse control samplesPerform reagent controlsMaintain equipmentDocumentation of above procedures45-38Quality Control and Maintenance (cont.)Equipment maintenanceManufacturer’s guidelinesTroubleshooting a problem – investigating the cause using a systematic approachDocumentationQuality control logReagent control logEquipment maintenance logReference laboratory logDaily workload log45-39Proficiency TestingProficiency testing programAccuracy of test resultsAdherence to standard operating proceduresControl sample, documentation sent to proficiency testing organizationPass – continue performing testFail – discontinue performing tests45-40QA ProgramsTraining, continuing education, and documentationEmployer responsibilityReference materialMSDS/safety manuals/SOPsManufacturers’ user or reference guidesClinical Lab Technical Procedure ManualsRegulatory documentation (OSHA, CLIA ’88)Maintenance and housekeeping schedules45-41QA Programs (cont.)Requisition formsMedical assistant’s responsibilityComplete informationInclude with specimen or send with patient to laboratory45-42Apply Your KnowledgeWhat is the purpose of a quality assurance program for a laboratory?ANSWER: The purpose of a QA program for a lab is to monitor the quality of patient care, ensure safety of workers, and assess the quality of tests performed.QualityAnswer!45-43Communicating with the PatientBefore testingPatient preparationVerification of patient preparationDuring specimen collectionProper patient identificationVerbal and nonverbalAfter specimen collectionPostprocedure instructionsSchedule for further testing, if needed45-44Communicating with the Patient (cont.)Test resultsReport to physician for interpretationReport to patient, if instructed to by the physicianPatient questionsAnswer if within your scopeRefer to physician 45-45Record KeepingQuality control and equipment maintenanceInventory controlRecord test results in patient recordsTracking of specimens45-46Record Keeping (cont.)Patient recordsIdentify unusual findingsFollow office proceduresSpecimen identificationPatient informationPerson who collected specimenPhysicianPatient: Jason JonesDOB: 10/22/0000Date / time: 04/14/0000 @ 9:00 AMCollected by: shf Physician: M. Welby45-47Apply Your KnowledgeMr. Jones called for his laboratory results but the physician has not reviewed the results. What should the medical assistant do?ANSWER: The medical assistant should tell Mr. Jones that the physician has to review the results before releasing them to the patient. She should also tell Mr. Jones that she or the physician will call with the results once they are reviewed.When she reviews Mr. Jones’ laboratory results, she notes that his glucose is elevated. What should the medical assistant do?ANSWER: She should identify the test result that is out-of-range by circling or underlining it based on office policy.Bravo!45-48In Summary45.1 The physician’s office laboratory (POL) is responsible for accurate and timely processing of routine tests and for reporting test results to the physician.45.2 The medical assistant’s duties in an office laboratory include preparing the patient for the test, collecting the sample, completing the test, reporting the results to the physician, and communicating information about the test to the patient.45.3 Common laboratory equipment includes autoclaves, centrifuges, microscopes, electronic equipment and software, and equipment used for measurement.45-49In Summary (cont.)45.4 Follow specific steps for operating a microscope, including plugging it in, cleaning the lenses, placing the slide on the stage, adjusting the focus, examining the image, and cleaning the lens before storage. 45.5 Regulatory controls governing the physician’s office laboratory include Standard Precautions, Hazard Communication Standard, OSHA Bloodborne Pathogens Standard, Hazardous Waste Operations and Emergency Response Final Rule, and the Needlestick Safety and Prevention Act.45-50In Summary (cont.)45.6 Preventing accidents in the physician’s office laboratory should include physical, fire and electrical, chemical, and biologic safety measures.45.7 The goal of a quality assurance program in a physician’s office laboratory is to monitor the quality of the patient care that a medical laboratory provides.45.8 The medical assistant might be responsible for recording information about quality control and equipment maintenance, inventory control, test results in patient records, and tracking every specimen that he or she handles.45-51In Summary (cont.)45.9 Hazardous waste must be disposed of in properly constructed and labeled containers. Containers for sharps must be puncture-proof, leak-resistant, and rigid, and needles should be dropped into the sharps container without bending, breaking, or recapping them. 45.10 Quality assurance and quality control programs serve to reduce testing errors and provide for the safety of laboratory personnel.45.11 Accurate quality control documentation in a physician’s office laboratory includes a reference laboratory log and a daily workload log.45-52In Summary (cont.)45.12 Common reference materials used while performing procedures in a physician’s office laboratory include Material Safety Data Sheets, standard operating procedures, safety manuals, equipment manufacturers’ user or reference guides, Clinical Laboratory Technical Procedure Manuals, regulatory documentation, and maintenance and housekeeping schedules.45.13 It is the medical assistant’s responsibility to ensure that patients understand what is expected of them before a test. Providing clear pretest instructions in both oral and written form is an essential part of the test procedure. 45-53End of Chapter 45Quality is not an act, it is a habit. ~ Aristotle
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