Quality Assurance in the Transfusion Service

Dr. Bernard Natukunda

History of Regulation in the 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 regulations

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 one must have: Well constructed SOPs.
Well trained personnel who carefully adhere to the SOPs. Comprehensive guidelines in compliance with regulatory

agencies.
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 (GMPs)

GMPs are legal requirements established by the

regulators
These regulations specify what needs to be done without

specifying how it needs to be done

The GMPs 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 GMPs Activities must be planned and documented by written

policies and procedures.

Records
If it is not recorded then it NEVER happened.

This is the most common violation.

Thorough record keeping is 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 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 Be well organized Be appropriately stored Be retrievable in a reasonable amount of time

Be protected from unauthorized access

Have a modification procedure in place Have a destruction procedure in place

Standard Operating Procedures (SOPs)

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, the benefits outweigh the 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

Training
A critical aspect of compliance with GMPs 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 Employees performance with trainers assistance

Employees 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

Some agencies have established requirements for proof of

competency for personnel testing, twice the first year of employment and annually thereafter e.g.:
AABB

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 - a national survey may be carried out

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 non-conformances

should be documented and investigated

Employees must be involved in all aspects Root-cause analysis should be initiated

Recalls
Regulators require 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 GMPs
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-sera 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.

Hospital 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
Used to assess the blood ordering and transfusion

practices of the medical staff.

Cross-match:transfusion ratio
Number of units cross-matched 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:

Haematocrit [less than 24%] Haemoglobin [less than 8 gm/dL] Symptoms due to anaemia Recent estimated blood loss of greater than 10% of total blood volume.

If audit reveals unjustified transfusion, the physician is

notified and asked to respond.