Accreditation/Regulation

AABB

AABB develops standards that promote patient safety and quality. Combining internationally accepted quality management system essentials with technical requirements appropriate for each discipline, these standards form the basis for AABB’s internationally recognized accreditation program. Select resources:

CAP

College of American PathologistsUtilizing inspection teams of practicing laboratory professionals, the internationally recognized College of American Pathologists Laboratory Accreditation Program goes well beyond regulatory compliance to help laboratories achieve the highest standards of excellence. Rigorous accreditation standards are translated into detailed checklist requirements that give laboratories a quality practice blueprint to follow. The CAP Program meets the needs of diverse laboratory settings, from complex university medical centers to physician office laboratories, and covers a complete array of disciplines and testing procedures. Granted deeming authority by the Centers for Medicare and Medicaid Services (CMS), the CAP Program is recognized by The Joint Commission and can be used to meet many state certification requirements. CAP also accredits forensic urine drug testing and reproductive laboratories in concert with the American Society for Reproductive Medicine.

Download 2015 CAP Accreditation Checklist.

CLIA 88

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure accuracy, reliability and timeliness of patient test results regardless of where the test was performed.

The “Individualized Quality Control Plan” (IQCP) is the CLIA Quality Control policy currently under development as an alternate QC option allowed by 42CFR493.1250.  The guidance and concepts for IQCP are a formal representation and compilation of many things laboratories already do to ensure quality test results. IQCP permits the laboratory to customize its QC plan according to test method and use, environment, and personnel competency while providing for equivalent quality testing.

CLSI

A not-for-profit membership organization, the Clinical and Laboratory Standards Institute is based in Wayne, Penn. CLSI brings together the global laboratory community for a common cause: fostering excellence in laboratory medicine. They do so by facilitating a unique process of developing clinical laboratory testing standards based on input from and consensus among industry, government, and health care professionals.

In March 2015, CLSI published a new document titled “Process Management” (QMS18-Ed1), describing four requirements for managing laboratory processes and providing suggestions for effectively meeting regulatory and accreditation requirements, optimizing efficient use of resources, and contributing to patient safety and positive outcomes.

FDA

The FDA’s Center for Biologics Evaluation and Research regulates collection of blood and blood components used for transfusion or manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves. FDA/CBER also regulates related products—such as cell separation devices, blood collection containers and HIV screening tests—used to prepare blood products or ensure blood supply safety. CBER develops and enforces quality standards, inspects blood establishments, and monitors reports of errors, accidents and adverse clinical events. Selected resources:

HTA

To help ensure human tissue is used safely, ethically and with proper consent, the Human Tissue Authority regulates organizations that remove, store and use tissue for research, medical treatment, postmortem examination, teaching and display in public. They also give approval for organ and bone marrow donations from living people. Learn about HTA’s system for reporting serious adverse events linked to tissue and cell procurement, testing, processing, preservation, storage and distribution.

ICCBA

To enhance patient safety, the International Council for Commonality in Blood Banking Automation (ICCBBA) promotes global adoption of the ISBT 128 international information standard for identifying, labeling, and information processing of products of human origin. See ISBT 128 & Blood Transfusion and ISBT 128 database 6.6.0.

International Organization for Standardization (ISO)

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. It can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

Joint Commission

The gold standard in healthcare accreditation, the Joint Commission accredits more than 20,000 healthcare organizations, and has been accrediting hospital laboratory services since 1979, freestanding laboratories since 1995. They now accredit more than 1700 laboratories around the world—this represents almost 2500 CLIA*-certified laboratories, including freestanding reference labs and in vitro fertilization labs, and those connected with hospitals, ambulatory surgical centers, etc. (See Joint Commission/Labs and 2014 National Patient Safety Goals for Laboratory Services.) Since they began tracking sentinel events in 1996, their Accreditation Committee has reviewed a number of transfusion-error-related cases and completed a root cause analysis for each (see Sentinel Event Alert, Issue 10: Blood Transfusion Errors: Preventing Future Occurrences).

*Clinical Laboratory Improvement Amendment

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