Quality Assurance in the Transfusion Service - Bernard

7/31/2019 Quality Assurance in the Transfusion Service - Bernard

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Dr. Bernard Natukunda

Quality Assurance in theTransfusion Service


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History of Regulation in theBlood 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


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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.


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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 onresults 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 oftransfusion.

Continuous quality improvement involves reviewing the process of

providing patient care with the goal of reducing rework, waste andinappropriate care.


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Good Manufacturing Practices (GMPs)

GMPs are legal requirements established by theregulators

These regulations specify what needsto be done withoutspecifying howit needs to be done

The GMPs are only a part of the overall quality

assurance (QA) program


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Quality Assurance Program (QA)

QA comprises the combined activities performed by anorganization

Ensures the quality of products and services offered

Must include GMPs

Activities must be planned and documented by writtenpolicies and procedures.


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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.


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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 makecorrections is also necessar in com uter s stems.


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Document Control

Regulatory and accrediting agencies expectdocumentation 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


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Standard Operating Procedures (SOPs)

All record systems, including their control, handling, anddisposal, 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


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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


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Personnel Qualifications

Good employees are essential to the success of anyorganization

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


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Training

A critical aspect of compliance with GMPs

Must definetasks performed and levels of competence

needed.

Must have a written training program and assessmentto

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


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Competency Assessment

When documented evidence exists that the employee isable 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


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Proof of Competency Requirements

Some agencies have established requirements for proof ofcompetency for personnel testing, twice the first year of

employment and annually thereafter e.g.:

AABB

Corrective actions needed for unacceptability


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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


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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


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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


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Recalls

Regulators require that licensed and registered facilitiesreport 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


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Validation

A process that establishes documented evidence providinga 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


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Facilities and Equipment Facilities and equipment should be designed in compliance and

support of GMPs

Documentation must be made of routine maintenance, repairs andtesting 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 temperature24 hours a day.

When temperature is out of range must have documentation of reason orcorrective action taken.

Alarms on refrigerators and freezers must be tested periodicallyto make

sure they will sound at the appropriate temperature.

l f l


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Quality Assessment of Suppliesand 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 witheach run: hepatitis testing reagents

HIV testing reagents HTLV-I/II reagents ALT testing reagents syphilis serology reagents.

Q li f li


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When reagents and supplies are received each of thefollowing 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

Q li A f S li


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Before being placed in use reagents aretested for sensitivity and specificity.

Daily testing is requiredto ensure the reagenthas not lost potency or reactivity.

Can use a formand procedure created in-house orutilize QC kit provided by a manufacturer.

Lot numbers and expiration date of all reagentstested must be on the form.

Graded reactions recorded.

Special typing sera need only be QCd when used.

Final disposition of damaged or unsatisfactoryreagents must be documented.


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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; theircompliance standards should be known

International Standards Organization 9000 provides

guidance in the development of standards; not specific for

any product or industry

Q lit A t d


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Quality Assessment andUtilization Review

Most facilities use the 10 step processoutlined by JointCommissionAssign 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.


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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.


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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.


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Utilization Review

Number of emergency releases.

Calculate statistics by physician.

Review of records to determine if transfusion wasjustified.

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 totalblood volume.

If audit reveals unjustified transfusion, the physician isnotified and asked to respond.

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Quality Assurance in the Transfusion Service - Bernard

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