IN THE NAME OF GOD Quality Assurance and Blood Bank S. AMINI KAFI ABAD CLINICAL AND ANATOMICAL PATHOLOGIST IRANIAN BLOOD TRANSFUSION ORGANIZATION(IBTO) RESEARCH CENTER 1387

Why do we need quality To ensure patients benefit not suffer from our products/ service To provide systems for ensuring products and services meet the customer's needs

Benefits of quality Reduce variation in processes Reduce rework Prevent problems occurring Generally improve what is done through the use of various measuring tools Reduce costs due to mistakes and errors Consistent and effective products

Quality is a processes Quality is an ongoing activity not a goal to be reached -quality is about continuous improvement -a continuous cycle -the deming cycle of Plan, Do, Check, Act -without continual improvement quality suffers

Who is responsible for Quality? EVERYONE IN THE LABORATORY! Laboratory management must commit to meeting quality needs Laboratory personnel must follow all quality assurance procedures

Quality Assurance & Quality Control Quality Assurance –Overall system wide quality process or program that includes: personnel, equipment, process control (QC), documents and records, etc. Quality Control –Monitoring a test system to determine if performance is within the established range of acceptability.

AABB Quality System EssentialsISO 9000/ Organization 4.1 Management responsibility 4.2 Quality system 2. Personnel4.18 Training 3. Equipment 4.11 Inspection, measuring, and test equipment 4. Supplier Issues 4.3 Contract review 4.6 Purchasing 4.7 Customer-supplied product 5. Process control, final inspection and handling 4.4 Design control 4.8 Productions identification and traceability 4.9 Process control 4.10 Inspection and testing 4.15 Handling, storage, packaging 6. Documents and records 4.5 Document and data control 4.16 Control of quality records 7. Incidents, errors, and accidents 4.13 Control of nonconforming product 8. Assessments: internal and external 4.17 Internal quality audits 9. Process improvement 4.14 Corrective and preventive action 10. Facilities and safety [4.9(b) Process control, inferred] 4.19 Servicing

99% Performance in the Blood Bank Examples of Errors 1.Patient sample labeling error 2.Blood issued to wrong patient 3.Incorrect grouping/typing due to technical error 4.Incorrect grouping/typing due to clerical error 5.Incomplete quality control of reagents

How do we reduce errors? CLIA ‘88 states that clinical laboratories must have a Quality Assurance Plan in place. Does a Quality Assurance Plan guarantee no technical errors or the production of blood components that will not transmit disease, etcetera? NO!! But, it does provide a mechanism to improve the quality of work performed and components produced.

Transfusion Centre Blood Supplied Laboratory Ordering Testing Storage Haemovigilance Adverse Reaction reporting Guidelines, Audit & review Hospital patient & sample Identification Patient Blood Administered Monitored Transfusion Chain

Value of Documentation Provides specific instructions Ensures processes and outcomes are traceable Processes can be audited and external assessments can therefore take place Tool for training

Types of Documentation Policies Standards Manuals Standard operating procedures Specifications Datasheets Forms Records Labels + Others ………………

SOPs Key element of documentation Define precisely how a procedure is to be performed Should be simple, logical and easy to follow

Key Points (SOP) (1) SOPs are an essential part of the quality system SOPs should be written for all the key procedures in an organization SOPs must be clear, concise and easy to follow SOPs should be used for staff training

Key Points (SOP) (2) SOPs should be validated SOPs should be living documents Staff must have easy access to the SOPs SOPs must be followed

Topics The need for assessment Elements of assessment –Evaluation –Validation –Monitoring –Quality assessment schemes –Errors and error management –Audits

Blood Bank Equipment Blood bank refrigerator Storage of RBC Freezer Storage of FFP, Cryo Refrigerator Storage of reagents, patients blood samples Platelet shaker incubator Serofuge Water bath Microscope Warmer

Equipment maintenance and calibration All equipment that has any impact upon the quality of the final product must have a comprehensive maintenance and calibration programme Maintenance and calibration -regular -appropriate -comprehensive

Reagent quality control is a constant in an evolving quality assurance program whose primary goal is to maintain consistent quality through process control. The primary goal of reagent QC is to establish that reagents are reacting appropriately each day of use or per run by the procedure recommended by the manufacturer

Reagents Frequency of Testing Requirements Reagent QCPositive controlNegative control ABO antisera Each day of use N/A Rh(D) antisera Each day of use Other antisera Each day of use AHG (antihuman globulin) Each day of use ABO reagents cells Each day of use N/A ABS (antibody screening cells) Each day of use N/A

Patient CellsPatient Serum Pt. #Anti-AAnti-BA Cells B Cells Interpret A 20 0B 3 00AB O

Cells v SerumSerum v Cells