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512 part v quality and compliance issues a quality

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512PART VQuality and Compliance IssuesA Quality Management System for the Blood BankBlood Bank Path of WorkflowComponent Collections, Preparation, Testing, Labeling, Distribution, Compatibility Testing*, Issue, AdministrationQuality System Essentials: The Building BlocksThe Blood BankThe WorkThe PerformanceOrganizationCustomer FocusFacilities & SafetyPersonnelPurchasing & InventoryEquipmentProcess ManagementDocuments & RecordsInformation ManagementNonconformance MgmtAssessmentsContinual Improvement*Links with Laboratory Path of Workflow, Figure 23-10QMS Essentials8OrganizationFacilities and safetyPersonnelPurchasing and inventoryEquipmentProcess managementDocuments and recordsNonconformancemanagementAssessmentsContinual improvementBlood Bank Operations8Donor qualificationAutologous donor qualificationApheresis donor qualificationBlood collectionCytapheresis collectionPreparation of componentsBOX 23–2QMS Essentials and Blood Bank OperationsTesting of donor bloodFinal labelingFinal inspection beforedistributionPatient samples and requestsSerologic confirmation ofdonor blood ABO/DPretransfusion testing ofpatient bloodSelection of compatibleblood and componentsfor transfusionCrossmatchSpecial considerations forneonatesSelection in special circum-stancesIssue for transfusionBlood administrationRh-immune globulinFigure 23–2.A quality system for the blood bank, showing the relationship of quality management system essentials to blood bank operations.
The important issue about having a customer focus is tounderstand the customer’s needs and design the workprocesses and procedures to meet those needs. In additionto fulfilling customer needs, the processes and proceduresmust also meet regulatory and accreditation requirements.Facilities and SafetyIn hospitals, the Joint Commission mandates an environ-mental control program that addresses all significant envi-ronmental issues for facility management and maintenancesuch as temperature control, electrical safety, fire protection,and so forth.4The Joint Commission also requires that hos-pital laboratories have training programs for all laboratorypersonnel on emergency preparedness, chemical hygiene,and infection control.4Therefore, hospital-based bloodbanks and transfusion services are already participating infacilities management and safety training. In addition, anyblood bank that performs irradiation of blood componentsmust also have a radiation safety program and documentappropriate training.A freestanding blood center must develop its own facilitymanagement program. All regulations and accreditationrequirements for emergency preparedness, chemical hygiene,infection control, and radiation safety training and documen-tation also apply.

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