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
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.
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
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 pre-
established 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:
 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.
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
 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:
 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