Title 42 Part 493 of the Code of Federal Regulations titled, "Standards and Certification: Laboratory Requirements," is issued by the Centers for Medicare & Medicaid Services (CMS) to enact the CLIA law passed by Congress (see below). In general terms, the CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. The final CLIA '88 regulations were first published in 1992, phased in through 1994, and amended in 1993, 1995, and 2003.
The interpretive guidelines to the CLIA regulations are published in the Centers for Medicare and Medicaid Services (CMS) State Operations Manual (SOM). The SOM is a source of guidance to laboratories for interpreting the CLIA regulations. It is also used by state offices to administer various federal programs, such as clinical laboratory certification under the CLIA regulations, and enforced by CMS.
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The Outcome-Oriented Survey Process
I. Identifying Sources of Information
II. Entrance Interview
III. Information Gathering
IV. Assessing Outcome or Potential Outcome
V. Regulatory Compliance Decision
VI. Exit Conference
VII. Development of the Statement of Deficiencies
VIII. Survey Report Documentation and Data Entry
IX. Additional Information
X. Reporting Complaints
REGULATIONS AND INTERPRETIVE GUIDELINES FOR LABORATORIES AND LABORATORY SERVICES
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