Terry Kotrla, MS, MT(ASCP)BB

Unit 14 Quality Assurance in the Transfusion Service

History of Regulation in Blood BankIn 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

OverviewPrimary 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 instrumentsDetermining 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 componentWas 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 FDAThese 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 offeredMust include cGMPsActivities 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 TrailA thorough record-keeping system

recreates every step related to:ProductionDistribution of a unit of blood

This step is known as an audit trailAn audit trail is important when

investigating errors and accidentsAbility to trace back to the original entry

and make corrections is also necessary in computer systems.

Document ControlRegulatory and accrediting agencies

expect documentation to be:ThoroughWell organizedAppropriately storedRetrievable in a reasonable amount of timeProtected from unauthorized accessModification procedure in placeDestruction 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 ControlThe blood industry is in a constant state of

changeChallenged routinely by new technologies

and regulatory and accrediting requirements

Time consuming and requires moneyHowever, benefits outweigh costsEnsures that nothing “falls through the

cracks

Personnel QualificationsGood employees are essential to the

success of any organizationHiring unqualified individuals can add

significant cost to the organizationSelection 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.

TrainingA critical aspect of compliance with cGMPsMust 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 SOPsTrainer's demonstration of tasks or procedureEmployee’s performance with trainer’s

assistanceEmployee’s performance without assistance

Competency AssessmentWhen 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 RequirementsThe 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

ServicesAABBCLIA

Corrective actions needed for unacceptability

Proficiency TestingA required component of QA programUsed to ensure that test methods and equipment are

working correctlyEnsures that staff members are following proceduresAssigning 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 houseExternal - CAP survey is one exampleWritten exams.

Corrective action is implemented and monitored for improvement when results are not acceptable

Supplier QualificationsThe quality of any given product is as good

as the quality of the raw materialsSupplier qualification has become standard

practice in blood banksWritten agreements between blood banks

and suppliers are common practiceSpecific terms of product expectationsCourse of action when criteria are not met

Error ManagementPart 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 aspectsRoot-cause analysis should be initiated

RecallsFDA 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

ValidationA 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 EquipmentFacilities and equipment should be designed in

compliance and support of cGMPsDocumentation 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 ReagentsThe following reagents must be tested each

day of use:antihuman globulin serumblood grouping anti-serumslectinsantibody screening cellsreverse grouping cellsEnzymes

For donor collection facilities the following must be tested with each run:hepatitis testing reagentsHIV testing reagentsHTLV-I/II reagentsALT testing reagentssyphilis serology reagents.

Quality Assessment of Supplies and ReagentsWhen reagents and supplies are received

each of the following must be documented during the log in process:date of receiptmanufacturerlot numberexpiration datereview of manufacturer's circular for changesleaking or damaged containers

Quality Assessment of Supplies and ReagentsBefore 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 IssuesLot release and label control to avoid

product recall resulting from mislabelingQA department to coordinate all activities

related to QARegulatory 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 ReviewMost facilities use the 10 step process

outlined by Joint CommissionAssign responsibilityDelineate the scope of careIdentify the most important aspect of careIdentify indicatorsEstablish thresholdsCollect and organize dataEvaluate dataTake corrective actionAssess actions and document improvementCommunicate.

Transfusion CommitteeMedical 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 ReviewRequired by Joint CommissionUsed 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 ReviewNumber 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/dLSymptoms due to anemiaRecent 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