LAB2 - Blood Bank Quality Management PDF

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BLOOD BANK QUALITY MANAGEMENT Blood banks must provide quality to their customers in many forms, including: • Safe, satisfying donation experiences for blood donors. • Accurately labeled and tested blood components provided to transfusion services. • Timely, accurate transfusion services provided to physicians and other health-care personnel. • Safe and efficacious blood transfusions to patients. The method for bringing this quality philosophy into all operations involves each facility developing a foundation of quality: • Quality control (QC) • Quality assurance (QA) • Quality management system (QMS) Blood bank compliance with federal regulations and accreditation standards is required by the following organizations: • United States Food and Drug Administration (FDA) • The Joint Commission • College of American Pathologists (CAP) • AABB (formerly known as American Association of Blood Banks) COMPLIANCE VS QUALITY MANAGEMENT  Compliance program – evaluate how effectively the facility meets regulatory and accreditation a requirements by detecting errors, deficiencies, and deviations  Compliance inspections – measure the state of the facility’s program with respect to the applicable requirements and are usually conducted every 2 years.  Quality management (QM) – Is actively and continuously practiced by blood bank leaders, managers, and staff throughout all blood bank operations.

QUALITY CONTROL • All blood bank medical laboratory scientists and technicians are familiar with routine blood bank QC procedures: ✓ Daily testing the reactivity of blood typing reagents. ✓ Calibrating serologic centrifuges; ✓ Timer checks ✓ Monitoring temperatures ✓ Manufacturers’ package inserts, ✓ Regular performance of QC QUALITY MANAGEMENT - Activities of the management function that determine the quality policy Organizational structure, QUALITY SYSTEM procedures, processes, and resources needed to implement quality management Planned, systematic QUALITY ASSURANCE activities implemented within the quality system to provide confidence that requirements for quality will be fulfilled Operational techniques QUALITY CONTROL and activities used to fulfill the requirements for quality Individualized Quality Control Plan (IQCP) • Laboratory’s Risk Assessment • Pre-analytic, Analytic, and Post-Analytic Processes • Customize its QC program Risk Assessment (RA)  SPECIMEN A. Patient Preparation B. Specimen Collection C. Specimen Labelling  REAGENT A. Shipping and Receiving B. Storage Condition C. Preparation

 TEST SYSTEM A. Failure of System Checks B. Detection of Clots, Hemolysis and Lipemia C. Transmission of Data to LIS  ENVIRONMENT A. Temperature B. Airflow/Ventilation C. Humidity  TESTING PERSONNEL A. Training – Philippine Blood Coordinating Council (PH) B. Competency C. Staffing Quality Control Plan (QCP) - CLIA – Clinical Laboratory Institute (Standard) • The number and type of QC testing materials • The frequency of testing • The criteria for acceptable QC results Quality Assessment • Proficiency testing records and QC results (Monitor effectiveness of Individualized Quality Control Plan – IQCP) • Turnaround time reports • Personnel competency record • Corrective action reports Quality Assurance - Set of planned actions that ensure that systems and elements will influence the quality of the product or service • Performance of a test method • Performance of an equipment Common QC Activities  Donor Collection • Microhematocrit instrument controls • Hemoglobin instrument controls • Apheresis equipment function check • Blood-weighing scales accuracy  Blood Components • Red blood cell hematocrit • Cryoprecipitated antihemophilic factor • Platelet counts in platelet units • Residual leukocyte counts in leukocytereduced components

Bacterial contamination of platelet units (Prone to contamination → room temperature only)  Reagent Controls • Copper sulfate • Reagent red blood cells • Reagent antisera • Test kits for infectious disease testing  Laboratory Equipment Function Checks • Heating instruments • Water bath • Thawing devices for blood components • pH meters • Cell counter • Centrifuges, refrigerated and serologic • Cell washers • Blood irradiators •

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Refrigerators Freezers Platelet incubators Blood warmers Shipping containers

QA Indicators ▪ Number of donor forms with incomplete or incorrect information ▪ Number and types of unusable units and blood components ▪ Number of blood typing discrepancies in donor and patients ▪ Number of and reasons for invalid tests ▪ Number of and reasons for labeling check failures ▪ Number and source of improper and incomplete request for blood components ▪ Number and location of patients without proper identification at time of specimen collection or transfusion ▪ Number of, source of, and reasons for unacceptable specimens ▪ Number of times wrong component or ABO was selected for crossmatch or use ▪ Number and type of transfusion complications ▪ Number of and reasons for turnaround tume failures

Quality Management System • Provides a framework for applying quality principles and practices uniformly across all blood bank operations, starting with donor selection and proceeding through transfusion outcomes. Quality Management System Essentials • Physical Facilities • • •

Hires Qualified Personnel Materials and Equipment Documents for Work Performance

QMS Essentials and Blood Bank Operations QMS Essentials • Organization • Resources • Equipment • Suppler and customer issues • Process control • Documents and records • Deviations, nonconformances, and adverse events • Assessments: Internal and external • Process improvement through corrective and preventive action • Facilities and safety Blood Bank Operations • Donor qualification • Autologous donor qualification • Apheresis donor qualification • Blood collection • Cytapheresis collection • Preoaration of components • Testing of donor blood • Final labeling • Final inspection before distribution • Patient samples and request • Serologic confirmation of donor blood ABO/D • Pretransfusion testing of patient blood • Selection of compatible blood and components for transfusion • Crossmatch • Special considerations for neonates • Selection in special circumstances • Issue for transfusion • Blood administration

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Organization • Relationships among blood bank personnel by job title • The blood bank’s link to the laboratory • The blood bank’s link to the hospital • How the blood bank links to the hospital’s quality function Customer Focus • Blood centers and transfusion services work on behalf of patients, the real customer of these facilities is the entity or person who receives and must be satisfied with a product or service. • For blood centers the customers are the donors, who want a safe and satisfying donation experience, and the transfusion services served by the blood center, that want properly tested and labeled blood components of the appropriate types on demand • For transfusion services, customers are the physicians, who want the blood transfusions they order to occur in a timely manner. • The nurses, who want the correctly issued blood components in a timely manner for administration to patients. • For all types of facilities, internal customers are the personnel Facilities and Safety - In hospital = Joint Commission • Temperature Control • Electrical Safety •

Fire Protection ✓ Emergency Preparedness ✓ Chemical Hygiene ✓ Infection Control

Personnel • Educational qualifications • Experience, and federal state • Local licensing requirements Competence assessment must include: 1. Direct observation of patient test performance. 2. Monitoring the recording and reporting of test results.

3. Review of test results or worksheets, QC records, proficiency testing results, and preventive maintenance records. 4. Direct observation of performance of instrument maintenance and function checks. 5. Assessment of test performance through testing previously analyzed specimens or external proficiency testing samples. 6. Assessment of problem-solving skills. Purchasing and Inventory • Inventories of reagents, supplies and blood components • Selecting vendors of equipment, supplies and services • Blood centers must also have processes for receipt, inspection, and testing Equipment • Installation qualification demonstrates that the equipment is correctly installed. • Operational qualification ensures the equipment operates as intended. • Performance qualification evaluates the personnel, procedures, and supplies in the facility work environment. • Schedules for calibration, preventive maintenance, RPM and timer checks, and monitoring of temperature-regulated equipment are required. Process Management • Process control- is a set of activities that ensures a given work process will keep operating in a state that is continuously able to meet process goals without compromising the process itself. • Total process control- is the evaluation of process performance, comparison of actual performance to a goal, and action taken on any significant difference...