QUALITY ASSURANCE IN

BLOOD BANKING

DR PINKY YADAV
MEDICAL SUPERINTENDENT
WHEN DISCUSSING QUALITY PROGRAMS IT
INCLUDES:

 Quality Control
 Quality Assurance

 Quality Improvement
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.
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

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.
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.
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
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 A 1reagent
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.
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.
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.)
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.
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.
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.
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
PROCESS IMPROVEMENT

 Corrective actions that are educational not punitive

 Timely corrections

 Yearly reports relating to QA and CQI committees

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
THANKS