The document discusses the history and importance of quality assurance in blood banking. It outlines key aspects of an effective quality assurance program including standard operating procedures, trained personnel, comprehensive guidelines, thorough documentation and auditing. Ensuring the quality of blood products and transfusions is vital as failures can have fatal consequences. Strict regulation and oversight from organizations like the FDA have helped improve safety.

1. Terry Kotrla, MS, MT(ASCP)BB
Unit 14 Quality Assurance in the
Transfusion Service

2. 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

3. 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.

4. 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.

5. 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

7. 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.

9. 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.

10. 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.

12. 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

13. 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

15. 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

17. Personnel Qualifications
 Good employees are essential to the success of
any organization
 Hiring unqualified individuals can add significant
cost to the organization
 Selection process must be thorough, and minimal
pre-established 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.

18. 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

19. 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

20. 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

21. 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

22. Supplier Qualifications
 The quality of any given product is as good as the
quality of 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

23. 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

24. 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

25. Validation
 A process that establishes documented evidence
providing a high degree of assurance that a
specific product meets its pre-established quality
and performance specifications
 Validation necessitates the commitment of time,
resources, and manpower
 Must be planned and thoroughly documented

26. 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.

27. Quality Assessment of Supplies and
Reagents
 The following reagents must be tested each day of
use:
 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:
 hepatitis testing reagents
 HIV testing reagents
 HTLV-I/II reagents
 ALT testing reagents
 syphilis serology reagents.

28. 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

29. 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.

30. 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

31. Quality Assessment and Utilization
Review
 Most facilities use the 10 step process outlined by
Joint Commission
 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.

32. 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.

33. 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.

34. 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:
 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.

35. 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