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1、PointofCareTestingDepartmentFilenameNameofHospitalPage16of16DateofissueTRUSTLOGOQUALITYMANUALSUBSECTION-POINTOFCARETESTINGDRAFTDOCUMENTThisdocumenttogetherwiththePathologydirectorateQualityManualrepresentstheQualityManagementSystemofthePointofCaretestingdepartmen
2、tof(nameofhospital).IthasbeencompiledtomeettherequirementsoftheClinicalPathologyAccreditation(UK)Ltd(CPA)systemandappropriatenationalandinternationalstandards.AllproceduresspecifiedhereinaremandatorywithinthePointofCareTestingDepartment.Editionno.DateofIssueRevie
3、wIntervalStatefrequencyAuthorisedByAuthorHannahAlberyCopy1ofLocationofCopies1.2.3.DocumentReviewHistoryReviewDateReviewedBySignatureQUALITYMANUALPointofCareTestingDepartmentFilenameNameofHospitalPage16of16DateofissueCONTENTS1GENERALINFORMATION41.1TitleofLaborator
4、yorDepartment41.2TheQualityManual42MANAGEMENTCOMMITMENTTOQUALITY43ORGANISATIONANDMANAGEMENT43.1RelationshipwithintheOrganisation43.2POCTPolicy53.3POCTCommittee53.3.1MembershipofthePOCTCommittee53.3.2RemitofthePOCTCommittee53.3.2RelationshipofthePOCTCommitteewithi
5、ntheOrganisation64ORGANISATIONANDQUALITYMANAGEMENTSYSTEM64.1NeedsandRequirementsofUsers64.2QualityObjectivesandPlans74.3ControlofProcessandQualityRecords74.4ManagementReview85PERSONNEL85.1LaboratoryDirector85.2POCTCoordinator85.3StaffTrainingandEducation86PREMISE
6、SANDENVIRONMENT96.1PremisesandEnvironment96.2FacilitiesforStorage96.3HealthandSafety107EQUIPMENT,INFORMATIONSYSTEMSANDMATERIALS107.1ProcurementandManagementofEquipment107.2ManagementofDataandInformation107.3ManagementofMaterials108PRE-EXAMINATIONPROCESSES118.1Inf
7、ormationforUsers118.2SpecimenCollectionandHandling119EXAMINATIONPROCESS119.1SelectionandValidationofExaminationProcedures129.2ExaminationProcedures129.3AssuringtheQualityofExaminations1210THEPOST-EXAMINATIONPHASE1310.1ReportingResults1310.2ClinicalAdviceandInterp
8、retation13QUALITYMANUALPointofCareTestingDepartmentFilenameNameofHospitalPage16of16Dateofissue11EVALUATIONANDQUALITYASSURANCE1311.1EvaluationandImprovementProc
