{"product_id":"book-28-2026-clinical-laboratory-improvement-amendments-of-1988-clia-survey-procedures-and-interpretive-guidelines","title":"Book 28: Clinical Laboratory Improvement Amendments of 1988 (CLIA): Survey Procedures and Interpretive Guidelines","description":"\u003cdiv id=\"tabs\"\u003e\n\u003cul\u003e\n\u003cli\u003e\u003ca href=\"#tabs-1\"\u003eDescription\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#tabs-2\"\u003eContents\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#tabs-3\"\u003eCover\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cdiv id=\"tabs-1\"\u003e\n\u003cp class=\"bigblacktext\" align=\"left\"\u003e\u003cspan\u003eTitle 42 Part 493 of the Code of Federal Regulations titled, \"Standards and Certification: Laboratory Requirements,\" is issued by the Centers for Medicare \u0026amp; 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, 2003, \u003cstrong\u003eand 2023 (effective December 28, 2024)\u003c\/strong\u003e. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"bigblacktext\" align=\"left\"\u003e\u003cspan\u003eThe 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.  \u003cbr\u003e\u003cbr\u003eThis book consists of the State Operations Manual, Appendix C interpretive guidance on the laboratory requirements at 42 CFR Part 493, including updates based on the December 2023 revisions to Part 493 that went into effect on December 28, 2024.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"bigblacktext\" align=\"left\"\u003e\u003cspan style=\"color: #000099;\"\u003eWhat's the Price?\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"smallblack\" align=\"left\"\u003e\u003cspan class=\"smallgray\"\u003e• 1-249 copies:  $24.95             • 250-499 copies:  $23.95\u003cbr\u003e• 500-749 copies: $22.95          • 750+ copies:  $21.95\u003cbr\u003e\u003cspan style=\"color: #000099;\" color=\"#000099\"\u003e\u003cbr\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000099;\" color=\"#000099\"\u003eCustom Cover Prices*?\u003c\/span\u003e\u003cspan class=\"smallgray\"\u003e\u003cbr\u003e• 1-24 copies:  unavailable             • 25-100 copies:  $2.00\/book\u003cbr\u003e• 100-249 copies: $1.00\/book        • 250+ copies:  No charge \u003cspan style=\"color: #000099;\" color=\"#000099\"\u003e\u003c\/span\u003e\u003cbr\u003e\u003cbr\u003e\u003cspan style=\"color: #000099;\" color=\"#000099\"\u003e* Based on quantities of a single book title\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv id=\"tabs-2\"\u003e\n\u003cp class=\"smallblack\" align=\"left\"\u003e\u003cstrong\u003eSURVEY PROTOCOLS\u003c\/strong\u003e\u003cbr\u003eIntroduction\u003cbr\u003eThe Outcome-Oriented Survey Process\u003c\/p\u003e\n\u003cp class=\"smallblack\" align=\"left\"\u003eI. Identifying Sources of Information\u003cbr\u003eII. Entrance Interview\u003cbr\u003eIII. Information Gathering\u003cbr\u003eIV. Assessing Outcome or Potential Outcome\u003cbr\u003eV. Regulatory Compliance Decision\u003cbr\u003eVI. Exit Conference\u003cbr\u003eVII. Development of the Statement of Deficiencies\u003cbr\u003eVIII. Survey Report Documentation and Data Entry\u003cbr\u003eIX. Additional Information\u003cbr\u003eX. Reporting Complaints\u003c\/p\u003e\n\u003cp class=\"smallblack\" align=\"left\"\u003e\u003cstrong\u003eB. INDEX\u003c\/strong\u003e\u003cbr\u003e\u003cstrong\u003eREGULATIONS AND INTERPRETIVE GUIDELINES FOR LABORATORIES AND LABORATORY SERVICES\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp class=\"smallblack\" align=\"left\"\u003e \u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv id=\"tabs-3\"\u003e\n\u003cp\u003eClick \u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0856\/8592\/files\/book28coiled.pdf?v=1747321122\" rel=\"noopener\" target=\"_blank\"\u003ehere\u003c\/a\u003e to see an enlarged pdf cover\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"Clinical Research Resources, LLC","offers":[{"title":"Default Title","offer_id":44561131274355,"sku":null,"price":24.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0856\/8592\/files\/2026book28coiled.png?v=1775165061","url":"https:\/\/www.clinicalresearchresources.com\/products\/book-28-2026-clinical-laboratory-improvement-amendments-of-1988-clia-survey-procedures-and-interpretive-guidelines","provider":"Clinical Research Resources, LLC","version":"1.0","type":"link"}