Life's Blood
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QUALITY ASSURANCE IN BLOOD BANKING

Quality Programs 

When discussing Quality Programs  it includes:

  • Quality Control
  • Quality Assurance 
  • Quality Improvement 

For Blood Banking  Quality Programs are essential requirements of 2 Federal Agencies:

  1. Centers for Medicare and Medicaid Systems (CMS), formerly HCFA, under CLIA-88 which covers all Clinical Laboratory activities and related federal payments
  2. Food and Drug Administration that has the following concerns:
    1. Responsibilities of the blood product requirements (anticoagulants and preservatives, shelf life etc.) 
    2. Specific requirements related to independent quality control and quality assurance for overall quality of blood products and the processes related to dispersion of those products.

A number of accrediting agents have quality requirements as well: 

  1. American Association of Blood Banks (Blood Banks and Transfusion Services)
  2. Joint Commission on the Accreditation of Healthcare Organizations 
  3. College of American Pathologists

AABB Quality System Essentials & FDA Guidelines for Quality Assurance in Blood Establishments 

Organization: active support of quality systems must be place for the following procedures;

  • SOP's - Standard Operating Procedures
  • Training plans and development of procedures
  • Approval of lot release of reagents and quality control reagents
  • Review and approval of practices relating to personnel, equipment, selection of suppliers, process control, final inspection and handling nonconforming components, methods in place for handling incidents, errors, and accidents.

Personnel Practices

  • Methods for hiring of qualified personnel needs to be in place
  • Job descriptions for all positions need to exist and be available
  • Training program and full documentation of that training for new and continuous employees.  Whenever a new procedure or instrument is implemented a training program needs to be in place.
  • Regular competency evaluations including direct observation and documentation of such must occur.

Equipment 

  • Validation of new equipment
  • Calibration and preventative maintenance including  standard equipment like refrigerators, complex equipment and computer systems
  • Continual monitoring of blood bank refrigerators extremely important in both blood centers and transfusion services

Supplier issues 

The Food and Drug Administration licenses blood bank reagents, antisera, reagent cells, other commercial additives.  Specific criteria is set for both the specificity and the potency of the reagents.  For example, anti-A will only react with A cells and will demonstrate a 3-4+ reaction with A1 reagent cells.  Once the reagents have met the FDA criteria for specificity and potency, a license number is assigned.  Along with the license number and lot number an expiration date is also placed on the labeled.  Other than very rare antisera, routine blood bank reagents CANNOT be used after the expiration date.  Daily quality control testing needs to be done for ABO, Rh, and Antibody Screening.  Typing antisera for other red cell antigens will be tested when performing the antigen testing on the patient and donors since this test is not done each day.

Each manufacturer is required to provide a product insert for each reagent.  The product insert needs to include the following:

  • Reagent's description
  • Proper use procedures
  • What to expect in regards to performance
  • Limitations

When a new shipment of reagents is received, the product insert needs to be reviewed and any changes in the standard operating procedure needs to incorporated into the lab's procedure before the reagents are used by the laboratory.  Total compliance with the manufacturer's directions must be followed. 

According to AABB, the following criteria and documentation must be in place in the individual laboratory.

  • List of critical supplies and services
  • Clearly defined requirements
  • Evaluation of suppliers qualifications to meet requirements
  • Included: requirements for manufacturer mechanisms to notify facility of changes
  • Prior to use of incoming supplies they need to be tested.
  • Determination needs to be made relating to whether they are satisfactory for intended use. 
  • Documentation of package, storage and transportation
  • Documentation of testing needs to done by facility before being put into use and prior to each use for reagents related to ABO, Rh, antibody screening and infectious diseases before being used for patient or donor testing. (See attached worksheet for daily QC of blood bank reagents.) 

Process control, final inspection, and handling elements 

  • Process control includes
    Development of SOP
  • Control of changes in policies, processes or procedures
  • Acceptance testing to new/revised software involved in blood bank procedures
  • Validation of new policies, processes or procedures
  • Monitoring and control of production processes
  • Participation in proficiency testing appropriate for each testing system in place
  • Established QC procedures for supplies and equipment
  • Supplier qualifications and product specification need to be in place
  • Control processes for nonconforming blood and blood components and products. 

Documents and records (4 levels) 

Documents and records have 4 levels

  1. Policies (Level 1)  relate to "What to do" in response to various situations
  2. Processes (Level 2) relate to "How it happens"
  3. Procedures (Level 3) "How to do it"
  4. Forms/Records, Supporting Documents etc. (Level 4) that need to be completed when you are performing the procedures and following the processes and policies.

Incidents, errors, and accidents 

In order to continuous improve methods need to be in place to detect incidents, errors, and accidents.  Therefore the follow should be in place:

  • Process to capture incidents, errors etc.
  • If incident occurs, the severity of the incident is determined by the facility
  • If it is a one-time incident: "What is the likelihood it will happen again?" and what to do about it if it could happen again
  • If there are multiple similar incidents "What might be the root cause?"
  • Develop processes for continuous improvement to help eliminate both one-time incidents and multiple similar incidents.

Assessments: internal and external 

A Quality Assessment Program includes both internal and external assessment:

  • Internal assessment includes blood usage review committees within a hospital (transfusion audits) or institutional QA teams
  • External assessments includes inspections, surveys, proficiency surveys performed by agencies like the FDA, AABB, and CAP 

Process improvement 

  • Corrective actions that are educational not punitive
  • Timely corrections
  • Yearly reports relating to QA and CQI committees

Facilities and safety 

Although both transfusion services and blood centers are primarily concern with safe transfusions and related issues, there also needs to be processes in place related to employee safety therefore the following needs should be met:

  • Compliance with OSHA requirements: chemical and biologic
  • Disaster preparedness
  • Adequate space and ventilation
  • Adequate sanitation and water systems etc.
  • Evaluations of limitations of physical structure prior to implementation of new equipment or processes

OBJECTIVES - Quality Assurance in Blood Banking

  1. Identify the agencies having requirements for quality assurance in Blood Centers, Transfusion Centers and Blood Banks. 
  2. Explain the value of the following 

    a) SOP's 

    b) Personnel Policies 

    c) Standard Processes and their improvement 

    d) Equipment and supplies contracting, validation etc.
 

Clinical Microbiology Syllabus