1. QUALITY ASSURANCE IN BLOOD BANKING
DR PINKY YADAV
MEDICAL SUPERINTENDENT

2. When discussing Quality Programs it includes:
Quality Control
Quality Assurance 
Quality Improvement 

3. For Blood Banking  Quality Programs are essential requirements of 2 Federal Agencies:
Centers for Medicare and Medicaid Systems (CMS), which covers all Clinical Laboratory activities and related federal payments
Food and Drug Administration that has the following concerns:
Responsibilities of the blood product requirements (anticoagulants and preservatives, shelf life etc.) 
Specific requirements related to independent quality control and quality assurance for overall quality of blood products and the processes related to dispersion of those products.

4. A number of accrediting agents have quality requirements as well:
American Association of Blood Banks (Blood Banks and Transfusion Services)
Joint Commission on the Accreditation of Healthcare Organizations 
College of American Pathologists
NABH standards for blood banks

5. Organization: active support of quality systems must be in place for the following procedures;
SOP's - Standard Operating Procedures
Training plans and development of procedures
Approval of lot release of reagents and quality control reagents
Review and approval of practices relating to personnel, equipment, selection of suppliers, process control, final inspection and handling nonconforming components, methods in place for handling incidents, errors, and accidents.

6. Personnel Practices
Methods for hiring of qualified personnel needs to be in place
Job descriptions for all positions need to exist and be available
Training program and full documentation of that training for new and continuous employees.  Whenever a new procedure or instrument is implemented a training program needs to be in place.
Regular competency evaluations including direct observation and documentation of such must occur.

7. Equipment Validation of new equipment
Calibration and preventative maintenance including  standard equipment like refrigerators, complex equipment and computer systems
Continual monitoring of blood bank refrigerators extremely important in both blood centers and transfusion services

8. Supplier issues 
The Food and Drug Administration licenses blood bank reagents, antisera, reagent cells, other commercial additives.  Specific criteria is set for both the specificity and the potency of the reagents.  For example, anti-A will only react with A cells and will demonstrate a 3-4+ reaction with A1reagent cells. 
Once the reagents have met the FDA criteria for specificity and potency, a license number is assigned.  Along with the license number and lot number an expiration date is also placed on the labeled.  Other than very rare antisera, routine blood bank reagents CANNOT be used after the expiration date. 
Daily quality control testing needs to be done for ABO, Rh, and Antibody Screening. 

9. Suppliers
Each manufacturer is required to provide a product insert for each reagent.  The product insert needs to include the following:
Reagent's description
Proper use procedures
What to expect in regards to performance
Limitations
When a new shipment of reagents is received, the product insert needs to be reviewed and any changes in the standard operating procedure needs to incorporated into the lab's procedure before the reagents are used by the laboratory.  Total compliance with the manufacturer's directions must be followed. 

10. According to AABB, the following criteria and documentation must be in place in the individual BLOOD BANK.
List of critical supplies and services
Clearly defined requirements
Evaluation of suppliers qualifications to meet requirements
Included: requirements for manufacturer mechanisms to notify facility of changes
Prior to use of incoming supplies they need to be tested.
Determination needs to be made relating to whether they are satisfactory for intended use. 
Documentation of package, storage and transportation
Documentation of testing needs to done by facility before being put into use and prior to each use for reagents related to ABO, Rh, antibody screening and infectious diseases before being used for patient or donor testing. (See attached worksheet for daily QC of blood bank reagents.) 

11. Process control, final inspection, and handling elements
Process control includes Development of SOP
Control of changes in policies, processes or procedures
Acceptance testing to new/revised software involved in blood bank procedures
Validation of new policies, processes or procedures
Monitoring and control of production processes
Participation in proficiency testing appropriate for each testing system in place
Established QC procedures for supplies and equipment
Supplier qualifications and product specification need to be in place
Control processes for nonconforming blood and blood components and products.

12. Documents and records (4 levels)
Documents and records have 4 levels
Policies (Level 1)  relate to "What to do" in response to various situations
Processes (Level 2) relate to "How it happens"
Procedures (Level 3) "How to do it"
Forms/Records, Supporting Documents etc. (Level 4) that need to be completed when you are performing the procedures and following the processes and policies.

13. Incidents, errors, and accidents
In order to continuous improve methods need to be in place to detect incidents, errors, and accidents.  Therefore the follow should be in place:
Process to capture incidents, errors etc.
If incident occurs, the severity of the incident is determined by the facility
If it is a one-time incident: "What is the likelihood it will happen again?" and what to do about it if it could happen again
If there are multiple similar incidents "What might be the root cause?"
Develop processes for continuous improvement to help eliminate both one-time incidents and multiple similar incidents.

14. Assessments: internal and external
A Quality Assessment Program includes both internal and external assessment:
Internal assessment includes blood usage review committees within a hospital (transfusion audits) or institutional QA teams
External assessments includes inspections, surveys, proficiency surveys performed by agencies like the FDA, AABB, CAP and NABH

15. Process improvement 
Corrective actions that are educational not punitive
Timely corrections
Yearly reports relating to QA and CQI committees

16. Facilities and safety 
Although both transfusion services and blood centers are primarily concern with safe transfusions and related issues, there also needs to be processes in place related to employee safety therefore the following needs should be met:
Compliance with OHSAS requirements: chemical and biologic
Disaster preparedness
Adequate space and ventilation
Adequate sanitation and water systems etc.
Evaluations of limitations of physical structure prior to implementation of new equipment or processes

17. THANKS