QA Plan&Systems/Lookback Program
Records Keeping
Transfusion
Committee/MSBOS
Equipment Quality Control
Process Control and Validation
100
To improve overall quality of care and patient safety To protect donors, patients, and staff from harm when used in Transfusion Medicine To implement effective manufacturing processes and system control
What are goals of a Quality Assurance program
100
Record keeping practices ensure that each Blood Bank and transfusion service shall have a system of record-keeping: either manual, computerized or a combination of both.
What is Purpose of Record Keeping Practices
100
JCAHO
What is The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations
100
Quality Control includes measuring time required to warm to 37C, and testing and recording at a single point each day of use, the function of each piece of regulated equipment.
What is Water Bath
100
for new equipment and new procedures
What is Validation Plans
200
is the evaluation and monitoring of all aspects of a process or system to identify, correct, and prevent unacceptable results
What is Quality Assurance (QA)
200
“Cradle to grave”
What is General Requirements of Record Keeping Practices
200
Ensures that the most appropriate, efficient and safe use of the blood supply is achieved.
What is A Hospital Transfusion Committee
200
Temperature regulated equipment must be checked daily for correct temperature if used for storage of blood components and test reagents.
What is Basics for equipment monitoring
200
to validate procedures and ensure correct results are obtained using that test kit/SOP
What is Proficiency Testing
300
is to identify persons who may have received blood containing: HIV-1/2 HTLV-I/II HBsAg HCV CJD West Nile Virus Confirmed Syphilis (FTA-ABS)
What is the purpose of the Lookback program
300
must not be released or made available to unauthorized people.
What are Blood Bank records
300
Minimize excessive requests for crossmatches, to extend the shelf-life of unused units
What is an objective for the maximum surgical blood ordering schedule (MSBOS)
300
Sensors must be in containers with a heat transferable characteristic similar to those of blood and blood containers.(10% Glycerol and H2O). Volume of fluid must be equal to or smaller than volume of smallest component stored.
What are Refrigerators and freezers
300
is the evaluation of the performance of a process, comparison of actual performance with a goal, and the action taken on any significant difference.
What is Total Process Control
400
This involves examining past records of donor, and notifying (via recipient’s physician) all recipients of prior donations of the possibility of a transfusion associated with positive disease markers
What is Lookback Procedures
400
Reviewing records as part of pre-transfusion testing may prevent Delayed Hemolytic Transfusion Reactions in patients whose antibodies are undetectable at the time of testing. Keep permanent records on patients with un-expected antibodies readily available.
What is Use of Records
400
Reports cases of transfusion associated Acquired Immune Deficiency Syndrome (AIDS) to the blood collecting facility
What is Hospital Transfusion Committee
400
These are used for detection of warm Ab (37C).
What are Water baths, heat blocks, and incubators
400
is a set of interrelated resources and activities that transforms inputs into outputs.
What is Process
500
is a system of activities that assess, validate, review, and improve processes to provide confidence that requirements for quality are fulfilled . This allows a facility to identify problem areas and implement changes to ensure the quality and validity of results or products.
What is QA Plan
500
Records of donors and donor blood: Donors ABO/Rh Difficulty in blood typing Severe adverse reactions to donations Apheresis procedure clinical record Records of blood component inspection prior to issue
What is Minimum 5 year retention
500
This is achieved by calculating the normal blood component volume (by component type) for routine surgical capabilities of the facility. This allows a Transfusion Service to estimate quantities of blood components required to be available monthly
What is Decrease the Crossmatch-to-Transfusion ratio
500
Normal ranges for blood storage refrigerators
What is 1–6C
500
• Establish and document the following for each test method: accuracy sensitivity specificity reproducibility
What is Process Control—Validation
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