Equivalent Quality Control

Extract

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) were passed overwhelmingly by Congress in 1988 in response to public and media concerns about the quality of laboratory testing. There were media stories about misread PAP smears, inaccurate cholesterol testing, and concerns about unregulated laboratories' performance. The original legislation was generally worded and declared the intent that testing would be reliable and accurate regardless of where it was performed. The Centers for Medicare and Medicaid Services (CMS), then known as the Health Care Financing Agency (HCFA) was authorized to write regulations to administer the law. Because of many concerns and comments about provisions of the first draft of proposed regulations, the first final rule, containing most of the provisions that we still practice under today, was published on February 28, 1992. Additional changes and extensions to deadlines or phase-in periods were published in final rules on December 6, 1994, May 12, 1997, October 14, 1998, and December 29, 2000.

On January 24, 2003, CMS published revisions to the Final Rule that included substantive changes in quality control practices, among other changes. (The final Rule may be accessed at www.phppo.cdc.gov/clia/regs/toc.aspx.) This necessitated a revision of the interpretive guidelines in the State Operations Manual (SOM), used by laboratories to prepare for inspections and by state department of health surveyors to perform inspections. That revision was published on January 12, 2004, and can be found at www.cms.gov/clia/appendc.asp.

The revised CLIA regulation published on January 24, 2003, states in section 493.1256 (d) “Unless CMS approves…