QA

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