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
The Clinical Laboratory Improvement Act (CLIA) and the Physician's Office Laboratory:
A Computer-Assisted CME Course. The Virtual Hospital &University of Iowa, Heatl Care.The Clinical Laboratory Improvement Act of 1988 (CLIA '88) has drastically altered the management and use of the physician's office laboratory. The level of regulation was determined by the complexity of the tests performed. Physicians' office laboratories, dialysis units, health fairs, and nursing homes were all covered under the new law along with other previously exempt and non-exempt laboratories.
Quality Control Quality control (QC) is a process for assessing the accuracy and reliability of a test system. In clinical laboratories this is usually accomplished by running specimens with known values or outcomes along with patient unknowns to determine if the analytical system is functioning within prescribed boundaries.
Quality Assurance Quality assurance (QA) is a system for ensuring the quality of all facets of a laboratory's technical and non-technical function. QA is much broader in its scope than quality control which is mostly concerned with the analytical process. Quality assurance includes the evaluation of patient preparation and specimen collection, as well as the preanalytical, analytical, and postanalytical phases of laboratory testing.
The Clinical Laboratory Improvement Act (CLIA) and the Physician's Office Laboratory: Personnel Regulations By Marian Schwabbauer, Ph.D., CLDir(NCA). Physician office laboratories (POLs) perform more than half of all laboratory tests. Poor laboratory results can place patients in jeopardy. Physician office laboratory personnel are the critical ingredient in achieving accurate, reliable laboratory data. CLIA '88 established minimum qualifications for personnel based upon the complexity level of the testing being performed. In the process, new, descriptive personnel categories or classifications using completely revised nomenclature were defined that differ significantly from other commonly used personnel certifications or classifications.
Quality Control For Tests of Moderate or High Complexity, or Both Guidelines by Ronald D. Feld, Ph.D., Marian Schwabbauer, Ph.D., CLDir(NCA), John D. Olson, M.D., Ph.D.The laboratory must meet the applicable quality control requirements in ¤¤493.1201 through 493.1221 and in ¤¤493.1227 through 493.1235 of this subpart for the subspecialties for which it is certified under the specialty of microbiology.
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
Organizations
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