The clinical laboratory improvement amendments of 1988 clia section 353 of the public health service act, codified at 42 u. Select updates for recommendations for clinical laboratory. Congress passed the clinical laboratory improve ment amendments clia in 1988, establishing quality standards for all nonresearch laboratory test. The objective of the clia program is to ensure accurate and reliable laboratory testing. Cms116 clinical laboratory improvement amendements.
This is the first of two articles summarizing federal regulations applicable to clinical laboratories and emphasizing pertinent features of the clinical laboratory improvement amendments of. This process involves compliance with the federal clinical laboratory improvement amendments clia of 1988, which requires. Clia abbreviation stands for clinical laboratory improvement amendments of. The amendments to the act also provide that quality control program standards for clinical laboratories shall not exceed the standards set forth in the federal regulations promulgated.
The clinical laboratory improvement amendments clia of 1988 are federal regulatory standards that apply to all clinical laboratory testing performed on humans in the united states. In recognition of the fact that the clinical laboratory reference system has requirements that are equal to or more stringentthan the clinical laboratory improvement amendments of 1988. The clinical laboratory improvement amendments clia regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the center for medicare and medicaid services cms before they can accept human samples for diagnostic testing. Federal regulation of clinical laboratories and the. Clinical laboratory improvement amendments clia toolkit. Clinical laboratory improvement amendments clia section. Genetic testing and the clinical laboratory improvement. The clinical laboratory improvement act of 1988 clia 88 mandates strict, new qualitycontrol measures for laboratories that interpret cervical cytology smears. The clinical laboratory improvement amendments of 1988 clia were established to strengthen federal oversight of clinical laboratories to. The certificate of a laboratory which has been excluded from participation under the medicare program under title xviii of the social security act because of actions relating to the quality of the laboratory shall be suspended for the period the laboratory is so excluded. The clinical laboratory improvement amendments of 1988 mandate pt for external quality assessment as part of the laboratory accreditation process, 2,3 although the precise rules. Clinical laboratory regulation under the clinical laboratory.
What is the abbreviation for clinical laboratory improvement amendments of 1988. Clinical laboratory improvement amendments wikipedia. Clia requires all entities that perform even one test, including waived tests on materials derived. The united states code is meant to be an organized, logical compilation of the laws passed by congress. This final rule amends the clinical laboratory improvement amendments of 1988 clia regulations to clarify that the waived test categorization applies only to nonautomated. Laboratories must comply with the clinical laboratory improvement amendments of 1988. Department of defense and hhs on the clinical laboratory improvement amendments of 1988 within dod, public law 100578, and part 493 of title 42, code of federal regulations. Clinical laboratory improvement amendments of 1988 survey results as a guide for clinical laboratory consultation, laboratory medicine, vo we use. The clinical laboratory improvement amendments of 1988 were passed into law on october 31, 1988. Research testing and clinical laboratory improvement.
The clinical laboratory improvement amendments of 1988 clia regulations include federal standards applicable to all u. The clinical laboratory improvement amendments of 1988. Cdc, in partnership with cms and fda, supports the clia program and clinical laboratory quality. Clia fees on october 31, 1988, congress enacted the clinical laboratory improvement amendments of 1988 clia pub. The clinical laboratory improvement amendments clia were established in 1988 to create standards and monitor quality for all laboratory testing regardless of where the test was. Claims that are submitted for laboratory services subject to the clinical laboratory improvement amendments clia 1988 federal statute and. The clinical laboratory improvement amendments of 1988 statute is an amendment to the public health services act in which congress revised the federal program for certification and oversight of clinical laboratory testing.
Clinical laboratory improvement amendments of 1988 changes. Clinical laboratory improvement amendments clia cdc. Clinical laboratory improvement amendments of 1988 survey. These comments are generally focused on the rfis policy proposals specific to. Clinical laboratory improvement amendments clia id.
Research testing and clinical laboratory improvement amendments of 1988 clia regulations the clinical laboratory improvement amendments of 1988 clia were established to. Clia clinical laboratory improvement amendments of 1988. In response to our request for input, cliac established a pt workgroup that included laboratory experts, representatives from accreditation. The clinical laboratory improvement amendments clia regulate laboratory testing and. Description contents cover title 42 part 493 of the code of federal regulations titled, standards and certification. Clinical laboratory improvement amendments clia icn 006270 july 2014. Laboratories clinical laboratory improvement amendments. Effect of the clinical laboratory improvement amendments of 1988 clia 88 on the incidence of invasive cervical cancer mark helfand, gerald t. Clinical laboratory improvement amendments of 1988 clia proficiency testing regulations related to analytes and acceptable performance, 15361567 201828363. Access to paid content on this site is currently suspended due to excessive activity being detected from your ip address 40. Research testing and clinical laboratory improvement amendments of 1988 clia regulations the clinical laboratory improvement amendments of 1988 clia were established to strengthen federal oversight of clinical laboratories to ensure the accuracy and reliability of patient test results. In total, clia covers approximately 260,000 laboratory entities. At its top level, it divides the world of legislation into fifty topicallyorganized titles. Clinical laboratory improvement amendments clia fda.
Clinical laboratory improvement amendments 42 usc 263a pdf icon external icon source. Staff pdf 124kb recommendations for clinical laboratory improvement amendments of 1988 clia waiver applications for. This proposed rule would update proficiency testing pt regulations under the clinical laboratory improvement amendments of 1988 clia to address current analytes that is, substances or constituents for which the laboratory conducts testing and newer technologies. Select updates for recommendations for clinical laboratory improvement amendments of 1988 clia waiver applications for manufacturers of in vitro diagnostic devices guidance for industry and food and drug administration staff november 2018. Clinical laboratory improvement amendments clia cms. Effect of the clinical laboratory improvement amendments.
The clinical laboratory improvement amendments clia of 1988 are united states federal regulatory standards that apply to all clinical laboratory testing performed on humans in the. Clinical laboratory improvement amendments of 1988. Understanding the clinical laboratory improvement amendments clia of 1988 is designed to clearly explain the complex federal regulations implementing clia. Government printing office gpo federal digital system external icon. This policy describes the information that is required on certain claims that are reported for laboratory services under the clinical laboratory improvement amendment clia 1988. Clinical laboratory improvement amendments of 1988 how. The clinical laboratory improvement amendments of 1988 statute is an. Clinical laboratory improvement amendments of 1988 clia 88 standards set for all laboratories to ensure quality patient care. Clinical laboratory improvement amendments claims that are submitted for laboratory services subject to the clinical laboratory improvement amendments of 1988 clia statute and. The law continues to be cited as clia 88 as named in legislation. Clinical laboratory improvement amendments of 1988 clia. This report examines logical but not yet widely recognized ramifications of the clinical laboratory improvement amendments of 1988 clia88, federal legislation that.
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