QC Documents

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Quality Specifications

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International Regulatory

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Laboratory Practice and Quality












Quality Specifications

Biological Variation Values  This table provides desirable analytical quality specifications for imprecision, bias and total error based upon biological variation.

CLIA Proficiency Limits  This table provides CLIA's criteria for acceptable proficiency performance per 42 CFR Ch. IV (10-1-03 Edition).

US Regulations

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The final CLIA regulations were published on February 28, 1992 and are based on the complexity of the test method; thus, the more complicated the test, the more stringent the requirements. CLIA specifies quality standards for proficiency testing (PT), patient test management, quality control, personnel qualifications and quality assurance, as applicable.

Public Health Practice Program Office (PHPPO) Homepage:

NEW FINAL CLIA RULE! Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule January 24, 2003

PARTIAL SUMMARY FINAL RULE This summary is for informational purposes only, is not comprehensive, focuses primarily on general and special chemistry, hematology and virology requirements and not intended to be used as a guide for achieving compliance.

CLIA Chronology - CLIA-related publications from the Federal Register Code of Federal Regulations.

CLIA Fee Schedule Revision

Clinical Laboratory Improvement Advisory Committee. (CLIAC) Opening meeting, charter, committee meeting minutes

Simplifying CLIA Regulations Relating to Accreditation, Exemption of Laboratories Under a State Licensure

International Regulatory

The German Medical Association Directive on Quality Assurance of Quantitative Laboratory Tests for Medical Purposes as published in Deutsches Ärzteblatt, Vol. 98, No. 42, 19 October 2001, pp. A 2747 to A2759.

The European Committee for Standardization Homepage: CEN documents and updates; European conferences, Annual Report and more.

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from some 130 countries, one from each country. The homepage contains information about standards, News, FAQs, contacts and more.

Australia/New Zealand

AACB Australasian Association of Clinical Biochemists,Inc.

AIMS Australian Institute of Medical Scientists

RCPA The Royal College of Pathologists Australasian

RCPAQAP The Royal College of Pathologists Australasian - Quality Assurance Program

NATA National Association of Testing Authorities, Australia

NZIMLS New Zealand Institute of Medical Laboratory Science,Inc.

IANZ International Accreditation New Zealand


The American Association for Clinical Chemistry Homepage.

The College of American Pathologists Homepage:  Information about CAP Laboratory Improvement Programs, Reference and Standard Materials, News and more.

The Joint Commission on Accreditation of Healthcare Organizations Homepage. The mission of the Joint Commission on Accreditation of Healthcare Organizations is to improve the quality of care provided to the public through the provision of health care accreditation and related services that support performance improvement in health care organizations. The Joint Commission evaluates and accredits more than 19,500 health care organizations in the United States, including hospitals, health care networks, managed care organizations, and health care organizations that provide home care, long term care, behavioral health care, laboratory, and ambulatory care services.

The National Committee for Clinical Laboratory Standards Homepage. NCCLS is a globally recognized, voluntary consensus standards-developing organization that enhances the value of medical testing within the healthcare community through the development and dissemination of standards, guidelines, and best practices.

Laboratory Practice and Quality

Dr. James Westgard Homepage: Tools, technology and training for quality management in healthcare laboratories. Articles on QC and lab quality, continuing education, online course: "QC Planning for Healthcare Laboratories", offered by the American Association for Clinical Chemistry (AACC), a cource about figuring out what amount of QC is necessary to assure the desired quality will be achieved for the methods in your laboratory. This course is intended for clinical laboratory scientists who have an interest in or responsibility for technical quality management of laboratory testing processes. 

Private Office Laboratories: Coping With Federal Guidelines By Ira Schwartz, MD, PhD, The Hospital of The University of Pennsylvania. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) mandated that all laboratory testing in the US come under regulation by the Health Care Financing Administration. Congress enacted this law to safeguard the public. Physician office laboratories run by urologists are included in these regulations. Noncompliance affects Medicare and Medicaid reimbursements.

The Division of Laboratory Systems Public Health Practice Program Office



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