A quality system for transfusion medicine ... and beyond.
America's blood banking system was subject to such increased scrutiny and higher expectations by the Food and Drug Administration that between Oct. 1, 1993, and Sept. 30, 1994, the agency issued 63 warning letters, six letters of intent to revoke a license, four suspension actions, four license revocations, three injunctions, and 469 recalls to blood centers, plasma centers, and hospital blood banks around the country. Clearly these facilities were not meeting the FDA's expectations for quality blood banking practices.
Stringent donor screening methods and new tests for transfusion-transmitted diseases were making the blood supply safer than ever before, but blood banks were still seriously missing the mark, says the FDA, the regulatory agency responsible for ensuring safe transfusion products. Further, while most of the nation's blood centers, hospital blood banks, and transfusion services are inspected and accredited by the American Association of Blood Banks (AABB), the FDA was threatening to close some of these facilities down. What follows is a sketch of the problems that have ensued over the past few years and of what the FDA and AABB did to make things better.
BRIEF HISTORY OF PROBLEM
During the late 1980s, FDA investigators began to view blood centers the way they viewed drug manufacturers during the inspection process. The Code of Federal Regulations (CFR), Parts 606-640, traditionally had been applied in the FDA Blood Bank Inspection Checklist. Now field investigators started applying the pharmaceutical Good Manufacturing Practice (GMP) regulations, Part 211, to blood centers. In doing so, surveyors were confronted by, among other problems, initial difficulty convincing blood center managers they are manufacturers (of a biological product).
In 1992 the FDA proposed a draft of a new guideline in its document "Quality Assurance in Blood Establishments." The essence of the document is that a facility's quality assurance (QA) program must include steps to prevent, detect, and correct deficiencies that may compromise blood product quality. The FDA released the revised draft document in 1993. The final version was published July 11, 1995.
Even before the 1992 FDA proposal, however, the AABB already had charged its new technical QA committee to:
* Produce a quality program applicable to all blood drawing and transfusion facilities
* Educate AABB members on the quality program
* Help improve the inspection and accreditation process.
After three years of meetings, conference calls, and volunteer work, The Quality Program was finally released and presented to the membership during the summer of 1994.
BLOOD BANKING MEETS GMP
The AABB's The Quality Program combines the elements of FDA GMP regulations with defined blood banking systems. The resulting grid in the accompanying figure forms a framework for blood centers, hospital blood banks, and transfusion services to define their quality programs.
Currently 10 systems (discrete collections of related processes) are included in the program. Five additional systems - autologous blood, apheresis, histocompatibility, tissue storage, and peripheral blood progenitor cells - are being reviewed by corresponding AABB committees and are scheduled for release to the membership shortly.
Within each system are critical control points (CCPs). These are steps that, if not performed or functioning correctly, could affect the safety and quality of the outcome. Each system has three or more CCPs, depending on its complexity. CCPs represent good starting points for flow charting steps, within a facility's major processes, where error prevention and detection can be built in.
Each CCP has one or more key elements (KE) - specific steps within the CCP. In many cases, KEs require written standard operating procedures (SOPs). Appropriate selection, training, and education of personnel in SOPs help reduce error and variation within KEs.
KEs are associated with monitors known as system checks (SCs) - similar to QA monitors used in the clinical lab. SCs help you tell if your systems, CCPs, and KEs are in control.
Once a facility identifies the systems, CCPs, KEs, and SCs best representing its scope of practice, employees can begin collecting performance data. The AABB plan provides sample data collection and scoring forms for a facility to conduct self-assessments, identifying areas for improvement. (The flowchart shown in the figure shows the relationship among systems, CCPs, KEs, and SCs.)
HOW TO TRACK SYSTEMS
The grid contained in the figure depicts GMPs down the left side and blood banking operational systems across the top. This visual, which shows the entire quality program for blood banking, can be used to track documents required for each system.
Every system contains its own CCPs (derived from FDA GMPs, AABB standards, and AABB inspection report form statements) and KEs. Both the AABB and the FDA require written QA plans. CCPs, on the left side of the grid, are the subheads of the written quality plan. (CCPs carry across all operational systems).
The AABB program includes Volume 1, the Quality Plan Manual, and Volume 2, the Self-Assessment Manual, in two loose-leaf binders. Each CCP of The Quality Program has a tabbed section into which a facility can file a description of its activities and a listing or copies of related documents. Following are suggestions of what to include in each of your facility's quality program system CCPs.
Organizational issues. Incorporate a written statement about your blood bank's quality goals, and appoint someone to act as director of all quality assurance efforts. Copies of your facility's organizational chart and a description of employee reporting relationships are beneficial. Also, describe how assessment findings and follow-up actions are communicated to top management.
Personnel. Provide a summary statement for each position in your department. This statement should include job description, orientation program, training verification documents, performance standards, competence assessments, performance appraisals, procedure change training verification, and continuing education program. Copies of these documents or their policy/procedure numbers and locations also are suggested. Finally, identify how selection, training, and education of staff are carried out in each of its systems.
Validation, calibration, PM, PT. Document a specific process will consistently produce a result or product that meets preestablished quality and performance specifications with a validation protocol. At a minimum, describe standard operating procedures for equipment, processes, and computer validation. Some examples of blood banking activities requiring validation are use of a sterile connection device or irradiator, platelet concentrate preparation, and the blood bank computer system.
Describe calibration, quality control (QC), and preventive maintenance (PM) requirements and schedules as well as how employees document findings, take action, and follow up on problems. Additionally, CLIA requires facilities to participate in proficiency testing (PT) for all analytes for which PT is available. Because the AABB has deemed status as an inspecting body for CLIA, your facility must meet these requirements. Be sure to include documentation that states:
* All testing personnel will be involved in PT
* Routine testing methods will be used in proficiency testing
* Corrective action will be taken and an improvement plan implemented when results are found out of control
* All relevant documents will be reviewed periodically.
Incorporate a documented rotation schedule for staff. Include a summary showing the number of challenges and variances seen in each proficiency testing event.
Supplier qualification. Identify critical supplies and reagents that could potentially affect quality and safety in your lab and define their specifications. Incorporate a procedure describing how new materials are validated and evaluated. Implement defined procedures for tracking supplies, and describe how your department inspects, documents, and ensures appropriate storage of incoming materials.
Process control. To minimize variation and error, all processes should be defined, standardized, and supported by written SOPs. Build acceptance and rejection criteria into processes wherever needed and monitor results. (A complete description of the process control is beyond the intent of this discussion; for more information, see the references at the end of this article.) Furthermore, describe how you use process control to reduce error and variation within your systems.
Documents, records, reviews. Define what records are kept in your facility as well as how they are reviewed, stored (and for how long), and retrieved. Write a second SOP for developing, maintaining, and disposing (archiving) outdated documents and a third SOP to outline when and how records are reviewed. One SOP for all three areas is also acceptable.
Describe actions taken in your facility once recurring problems are identified. The procedure for ongoing review should include instructions on how record reviews are documented and audited for completeness as well as a statement that unusual occurrences should be reviewed. Keep an up-to-date index of all SOPs. Records subject to these actions include:
* Personnel records (for training, competence assessment, and performance appraisals)
* SOPs (approved, revised, removed, and archived)
* Validated processes (procedures, computer)
* Tracking and tracing supplies, reagents, and equipment
* Equipment calibration, QC, repair, and post-repair QC.
Label control. Include a description of procedures for label control, including both labels for component production (on the donor side) and component modification (on the patient side). Maintain and archive a master label set.
Incidents, errors, accidents. Describe how your facility uses an error management system to monitor procedures and detect, report, and categorize incidents, errors, and accidents. Your institution must have a system to ensure timely notification of FDA-reportable events, such as donor or patient fatalities, mislabeling, and the inadvertent release of unsuitable blood. In addition, in this section you should include a written description for the notification and follow-up of any adverse effect of transfusion, such as immediate or delayed reactions, transfusion-transmitted disease, and look-back. Maintain your error and accident records separately from the internal audit.
Internal assessment. The Self-Assessment Manual defines a facility's internal assessment process by describing which systems are in use and by writing a procedure on how an internal assessment will be conducted. Designated personnel use the already-defined system checks for each KE and CCP, perform audits, record results, and prepare reports. They identify weak areas for follow-up corrective action and further monitoring. Reports of blood center audits must be made to the facility's top management; in hospital blood banks and transfusion services, audit results are part of the lab's QA report to the hospital QA committee.
Process improvement. Describe how the results of your facility's internal assessments will be used to improve performance. Outline the TQM/CQI process most commonly used by staff and how employees are trained in the use of these tools. Additionally, document how laboratorians have decreased rework and errors, improved customer satisfaction, optimized resources, and complied with regulations.
BEYOND BLOOD BANKING
Other sections of the clinical lab can use the AABB plan as well. Rather than listing blood bank systems across the top of the chart, you can list major preanalytic, analytic, and postanalytic functions: order handling, specimen procurement/transport, testing, and results reporting. CCPs, KEs, and system checks can be defined easily for each system.
Many CLIA requirements are identical to the FDA GMP regulations listed on the left side of the chart. A lab, therefore, can follow the suggestions in this article to develop a comprehensive QA plan. Labs already have much of this work done as policies and procedures to comply with various CAP, JCAHO, and CLIA requirements; the table format simply allows a better framework for organizing the information in a meaningful fashion.
In addition, using the AABB's Quality Program to write a QA plan and design a self-assessment program will enable your department to identify its strong and weak points. From there, your team can devise an action plan, prioritizing the weak areas that should be improved first. Bottom line: A well-written quality plan with documented findings, actions, and improvements will enable your employees to stand proud as your facility passes the toughest of inspections. The time frame will be determined by whether or not you draw and test blood and how comprehensive are your transfusion services.
The AABB Transfusion Service committee is preparing generic versions of the documents required for quality program CCPs. You will be able to tailor them to their needs. The documents are expected to be available next year.
1. Zoon K. Address on the state of the Center for Biologics Evaluation and Research. Washington, DC; January 27, 1995.
2. Code of Federal Regulations. Washington, DC: Food and Drag Administration; 1994. Parts 606-640; CFR Section 21.
3. Good Manufacturing Practice Regulations. Washington, DC: Food and Drug Administration; 1995. Parts 210-211, CFR Section 21.
4. Guideline for Quality Assurance in Blood Establishments. Washington, DC: Food and Drug Administration; 1995.
5. The Quality Program. Bethesda, Md; American Association of Blood Banks; 1994.
6. FDA Memorandum: Responsibilities of Blood Establishments Related to Errors and Accidents in the Manufacture of Blood and Blood Components. Washington, DC: Food and Drug Administration; March 20, 1991.
Berte LM. Managing quality in hospital transfusion medicine. Lab Med. February 1994; 25(2): 118-123.
GMP Fundamentals. Raritan, NJ: Ortho Diagnostics; 1994.
Quality Systems in the Blood Bank and Laboratory Environment. Bethesda, Md: American Association of Blood Banks; 1994
Lucia M. Berte, a member of MLO's Editorial Advisory Board, is director of information management at Elmhurst Memorial Hospital, Elmhurst, Ill.
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|Title Annotation:||American Association of Blood Banks devises quality program for blood banking systems|
|Author:||Berte, Lucia M.|
|Publication:||Medical Laboratory Observer|
|Date:||Oct 1, 1995|
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