Unit 14 Quality Assurance in the Transfusion
Service
Terry Kotrla, MS, MT(ASCP)BB
History of Regulation in Blood Bank
 In the years before the HIV epidemic, blood banks were
perceived as organizations that provided a community service
 Increased occurrence of HIV and increased public scrutiny
resulted in stricter FDA regulations
 FDA regulatory oversight has resulted in an increased effort
to provide a safe, high-quality product at low cost
Overview
 Primary goal is transfusion of a safe unit of blood.
 To achieve quality must have:
 Well constructed SOPs.
 Well trained personnel who carefully adhere to SOPs.
 Comprehensive guidelines in compliance with Joint
Commission, FDA, AABB and CAP.
 Failure in the quality of blood collected, screening of
collected blood or failure to follow procedures in
transfusion protocols may result in fatal consequences.
Terms
 Quality control is the management of the testing process itself.
 Monitoring of equipment and instruments
 Determining that reagents are reacting appropriately.
 Quality Assurance includes the entire process of providing patient care, from
the time the physician orders the test until treatment of patient based on results
of test.
 Were appropriate lab tests ordered to determine the need for transfusion.
 Did the transfusion service perform appropriate testing of patient specimen and
preparation of the appropriate component
 Was the transfusion administered properly.
 Did the patient obtain the anticipated benefit.
 Utilization review is the process of monitoring the appropriateness of
transfusion.
 Continuous quality improvement involves reviewing the process of
providing patient care with the goal of reducing rework, waste and
inappropriate care.
Good Manufacturing Practices (cGMPs)
 cGMPs are legal requirements established by the FDA
 These regulations specify what needs to be done without
specifying how it needs to be done
 The cGMPs are only a part of the overall quality assurance
(QA) program
Quality Assurance Program (QA)
 QA comprises the combined activities performed by an
organization
 Ensures the quality of products and services offered
 Must include cGMPs
 Activities must be planned and documented by written
policies and procedures.
Records
 If it is not recorded it NEVER happened.
 Most common violation.
 Thorough record keeping essential.
 Recreates EVERY step related to production and distribution of blood
components including individuals involved.
 Creates an audit trail necessary to investigate errors.
 Original data CANNOT be obliterated, single line.
 Date and initial of changes required.
 NO white out or pencil is ever allowed.
 Document control essential as it specifies and describes: media to be
used, types of documents to keep and length of time.
Audit Trail
 A thorough record-keeping system recreates every step
related to:
 Production
 Distribution of a unit of blood
 This step is known as an audit trail
 An audit trail is important when investigating errors and
accidents
 Ability to trace back to the original entry and make
corrections is also necessary in computer systems.
Document Control
 Regulatory and accrediting agencies expect
documentation to be:
 Thorough
 Well organized
 Appropriately stored
 Retrievable in a reasonable amount of time
 Protected from unauthorized access
 Modification procedure in place
 Destruction procedure in place
Standard Operating Procedures (SOP)
 All record systems, including their control, handling, and
disposal, must be thoroughly described in the SOPs
 Describe how a particular task is to be accomplished
 Are important training tools for new employees
 Are written using a standard format
Change Control
 The blood industry is in a constant state of change
 Challenged routinely by new technologies and regulatory and
accrediting requirements
 Time consuming and requires money
 However, benefits outweigh costs
 Ensures that nothing “falls through the cracks
Personnel Qualifications
 Good employees are essential to the success of any
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organization
Hiring unqualified individuals can add significant cost to the
organization
Selection process must be thorough, and minimal preestablished criteria must be identified
Job descriptions list the tasks for each individual and are
essential
Once job is defined can then determine level of education
and training required.
Training
 A critical aspect of compliance with cGMPs
 Must define tasks performed and levels of competence
needed.
 Must have a written training program and assessment to
document and determine competency of the employee.
 Review of SOPs
 Trainer's demonstration of tasks or procedure
 Employee’s performance with trainer’s assistance
 Employee’s performance without assistance
Competency Assessment
 When documented evidence exists that the employee is able
to demonstrate knowledge and application of a new skill
 Initial competency assessment is done during training
 Periodic competency is used to determine that the employee
has maintained the skill
Proof of Competency Requirements
 The following agencies have established requirements for
proof of competency for personnel testing, twice the first
year of employment and annually thereafter:
 The Center for Medicare and Medicaid Services
 AABB
 CLIA
 Corrective actions needed for unacceptability
Proficiency Testing
 A required component of QA program
 Used to ensure that test methods and equipment are working correctly
 Ensures that staff members are following procedures
 Assigning external proficiency testing samples on a rotating basis.
 Proficiency testing may be internal, external or both.
 Observing employee performing assigned tasks.
 Reviewing documentation.
 Internal - Unknown samples prepared in house
 External - CAP survey is one example
 Written exams.
 Corrective action is implemented and monitored for improvement
when results are not acceptable
Supplier Qualifications
 The quality of any given product is as good as the quality of
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the raw materials
Supplier qualification has become standard practice in blood
banks
Written agreements between blood banks and suppliers are
common practice
Specific terms of product expectations
Course of action when criteria are not met
Error Management
 Part of a QA plan must include mechanisms for the detection
and management of errors and their consequences
 Errors, incidents, variances, and any nonconformance should
be documented and investigated
 Employees must involved in all aspects
 Root-cause analysis should be initiated
Recalls
 FDA requires that licensed and registered facilities report any
incidences of an error or accident
 If the investigation reveals that the root cause was due to an
error in manufacturing, a recall may take place
 Recalls are usually issued by manufacturers in an attempt to
remove products from the market
Validation
 A process that establishes documented evidence providing a
high degree of assurance that a specific product meets its preestablished quality and performance specifications
 Validation necessitates the commitment of time, resources,
and manpower
 Must be planned and thoroughly documented
Facilities and Equipment
 Facilities and equipment should be designed in compliance and support
of cGMPs
 Documentation must be made of routine maintenance, repairs and
testing performed on instruments from date of receipt to date
instrument is permanently removed from service.
 Temperature monitoring is critical for refrigerators, freezers,
incubators and waterbaths.
 Must be manually recorded daily.
 Refrigerators and freezers must have a device to record the temperature 24
hours a day.
 When temperature is out of range must have documentation of reason or
corrective action taken.
 Alarms on refrigerators and freezers must be tested periodically to make sure
they will sound at the appropriate temperature.
Quality Assessment of Supplies and
Reagents
 The following reagents must be tested each day of use:
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antihuman globulin serum
blood grouping anti-serums
lectins
antibody screening cells
reverse grouping cells
Enzymes
 For donor collection facilities the following must be tested with each
run:
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hepatitis testing reagents
HIV testing reagents
HTLV-I/II reagents
ALT testing reagents
syphilis serology reagents.
Quality Assessment of Supplies and
Reagents
 When reagents and supplies are received each of the following
must be documented during the log in process:
 date of receipt
 manufacturer
 lot number
 expiration date
 review of manufacturer's circular for changes
 leaking or damaged containers
Quality Assessment of Supplies and
Reagents
 Before being placed in use reagents are tested for
sensitivity and specificity.
 Daily testing is required to ensure the reagent has not lost
potency or reactivity.
 Can use a formand procedure created in-house or utilize QC kit
provided by a manufacturer.
 Lot numbers and expiration date of all reagents tested must be
on the form.
 Graded reactions recorded.
 Special typing sera need only be QCd when used.
 Final disposition of damaged or unsatisfactory reagents must
be documented.
Other Issues
 Lot release and label control to avoid product recall resulting
from mislabeling
 QA department to coordinate all activities related to QA
 Regulatory agencies include AABB and FDA; their
compliance standards should be known
 International Standards Organization 9000 provides guidance
in the development of standards; not specific for any product
or industry
Quality Assessment and Utilization
Review
 Most facilities use the 10 step process outlined by Joint
Commission
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Assign responsibility
Delineate the scope of care
Identify the most important aspect of care
Identify indicators
Establish thresholds
Collect and organize data
Evaluate data
Take corrective action
Assess actions and document improvement
Communicate.
Transfusion Committee
 Medical staff responsible for assessing adequacy of transfusion
services and proper use of blood components.
 Reviews usage of all components for appropriateness.
 Reviews records of all transfusion reactions.
 Reviews order practices.
Utilization Review
 Required by Joint Commission
 Used to assess the blood ordering and transfusion practices of
the medical staff.
 Crossmatch:transfusion ratio
 Number of units crossmatched divided by the actual number
transfused.
 Used as an indicator that too much blood is being requested to
be on hold.
 Could result in high outdate or waste.
 Number of autologous transfusions.
Utilization Review
 Number of emergency releases.
 Calculate statistics by physician.
 Review of records to determine if transfusion was justified.
 Audit criteria for transfusion must be defined:
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Hematocrit less than 24%
Hemoglobin of less than 8 gm/dL
Symptoms due to anemia
Recent estimated blood loss of greater than 10% of total blood
volume.
 If audit reveals unjustified transfusion physician is notified
and asked to respond.
Reference:
 Basic & Applied Concepts of Immunohematology, 2nd edition,
Blaney.
 Guide to the preparation, use and quality assurance of blood
components, 7th edition, Council of Europe Publishing
 Technical Manual American Association of Blood Banks, 11th
edition
 Quality Assurance in Blood Transfusion Service
http://www.bloodindex.net/quality_asssurance_intro.php