in the name of god quality assurance and blood bank s. amini kafi abad clinical and anatomical...
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IN THE NAME OF GOD
Quality Assurance and Blood Bank
S. AMINI KAFI ABADCLINICAL AND ANATOMICAL PATHOLOGIST
IRANIAN BLOOD TRANSFUSION ORGANIZATION(IBTO) RESEARCH
CENTER1387
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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
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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
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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
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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
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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.
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AABB Quality System Essentials ISO 9000/9001
1. Organization4.1 Management responsibility
4.2 Quality system
2. Personnel 4.18 Training
3. Equipment4.11 Inspection, measuring, and test equipment
4. Supplier Issues4.3 Contract review4.6 Purchasing4.7 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 records4.5 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
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99% Performance in the Blood Bank
Examples of Errors
1. Patient sample labeling error2. Blood issued to wrong patient3. Incorrect grouping/typing due to
technical error4. Incorrect grouping/typing due to
clerical error5. Incomplete quality control of reagents
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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.
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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
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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
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Types of Documentation
• Policies
• Standards
• Manuals
• Standard operating procedures
• Specifications
• Datasheets
• Forms
• Records
• Labels
• + Others ………………
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SOPs
• Key element of documentation
• Define precisely how a procedure is to be performed
• Should be simple, logical and easy to follow
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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
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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
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Topics
• The need for assessment
• Elements of assessment– Evaluation– Validation– Monitoring– Quality assessment schemes– Errors and error management– Audits
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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
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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
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• 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
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Reagents Frequency of Testing Requirements
Reagent QC Positive control Negative control
ABO antisera Each day of use N/A
Rh(D) antisera Each day of use Each day of use
Other antisera Each day of use Each day of use
AHG (antihuman globulin) Each day of use Each day of use
ABO reagents cells Each day of use N/A
ABS (antibody screening cells) Each day of use N/A
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Patient Cells Patient Serum
Pt. # Anti-A Anti-B A CellsB
CellsInterpret
1 4+ 0 0 4+ A
2 0 4+ 4+ 0 B
3 4+ 4+ 0 0 AB
4 0 0 4+ 4+ O
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Cells v Serum Serum v Cells