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 United States, except clinical trials and basic research.
In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for:
- diagnosis, prevention, or treatment of disease or impairment
- health assessments
An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. Most Laboratory Developed Tests have been regulated under this program. In 2014 the FDA started a public discussion about regulating some LDTs.
Per CLIA, each specific laboratory system, assay, examination is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the following seven criteria. A score of 1 is the lowest level of complexity, and a score of 3 indicates the highest level. Score 2 is assigned when the characteristics for a particular test are intermediate between the descriptions listed for scores of 1 and 3.
Criteria for categorization:
- Training and experience
- Reagents and materials preparation
- Characteristics of operational steps
- Calibration, quality control, and proficiency testing materials
- Test system troubleshooting and equipment maintenance
- Interpretation and judgment
Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, and the Division of Laboratory Services.
The CLIA Program is funded by user fees collected from approximately 200,000 laboratories, most located in the United States.
Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver. In November 2007, the CLIA waiver provisions were revised by the United States Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver, although many waived tests are not done according to designed protocols – more than 50% of such tests are done incorrectly – and result in medical errors, some with fatal consequences.
Minimum periods of retention
CLIA and the College of American Pathologists (CAP) have written policies for the minimum period of that laboratories should keep laboratory records and materials, with some examples as follows:
|Microscopy slides||Histology and non-forensic autopsy||10 years|
|Cytology, fine needle aspiration||10 years|
|Cytology, apart from fine needle aspiration||5 years|
|Paraffin-embedded blocks||Non-forensic||2 or 10 years|
|Requisition form and test report||Pathology reports||10 years|
|Blood bank records||Quality control records||5 years|
|Donor and recipient records||10 years|
|Records of indefinitely deferred donors||Indefinitely|
|Wet tissues||Until report is completed or 2 weeks thereafter|
|Proficiency testing records and quality management/quality control records||2 years|
|Discontinued procedures||2 years|
|Blood smears and other body fluid smears, microbiology slides (including Gram stains)||7 days|
|Flow cytometry plots||10 years|
The origins of CLIA can be traced back to the late 1960s, when cytology laboratories faced issues due to overworked personnel and a high incidence of errors in reading PAP smears. In response to these concerns, the Clinical Laboratory Improvement Amendment was introduced in 1967, which laid down the first set of regulations for laboratory standards, focusing mainly on independent and hospital laboratories.
The Clinical Laboratory Improvement Act of 1988 (CLIA 88) was passed in the USA subsequent to the publication of an article in November 1987 in The Wall Street Journal entitled "Lax Laboratories: The Pap Test Misses Much Cervical Cancer Through Labs Errors", which alerted the public to the fact that a pap smear may be falsely negative. The article implied that false negative tests resulted largely from the carelessness of doctors. Subsequent to this, claims involving pap smears showed an alarming growth. The Act aimed at a comprehensive regulation of gynecologic cytology laboratories.
- ^ CLIA related Federal Register and Code of Federal Regulation Announcements, and the FDA's Clinical Laboratory Improvement Amendments (CLIA). Accessed Nov. 14, 2015.
- ^ CLIA Program homepage
- ^ a b "CLIA Overview". CMS. 11 April 2018.
- ^ "Laboratory Developed Tests". FDA. 26 March 2018.
- ^ CLIA Categorization Criteria (December 2012)
- ^ "CLIA Waived Testing booklet" (PDF). December 2012.
- ^ "CLIA Waived IVD Regulatory Assistance". November 2007. Archived from the original on 2012-12-05. Retrieved 2012-12-10.
- ^ Gabler, Ellen (2015-10-31). "Hidden Errors – A Watchdog Report – Common medical tests escape scrutiny but often fall short". Milwaukee Journal Sentinel. Retrieved 2017-10-10.
- ^ a b c d e f g h i j k "42 CFR § 493.1105 - Standard: Retention requirements". Cornell Law School. [68 FR 3703, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]
- ^ a b c d e f g h i "CAP Policy Manual - Policy PP. Minimum Period of Retention of Laboratory Records and Materials" (PDF). CAP.org. Adopted August 1995. Revised September 2020
- ^ "Clinical Laboratory Improvement Act (CLIA)". New Mexico Department of Health. Retrieved 2023-04-18.
- ^ Anderson, Richard E. (May 2005). Medical Malpractice - A Physician's Sourcebook. Totowa, New Jersey: Humana Press. pp. 168–169. ISBN 1-58829-389-0.