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
6.
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.
8.
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.
11.
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
14.
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
16.
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
