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.[1]

CLIA Program

In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing.[2] 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.[3] In 2014 the FDA started a public discussion about regulating some LDTs.[4]

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 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.[5]

Criteria for categorization:

  1. Knowledge
  2. Training and experience
  3. Reagents and materials preparation
  4. Characteristics of operational steps
  5. Calibration, quality control, and proficiency testing materials
  6. Test system troubleshooting and equipment maintenance
  7. 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.[3]

CLIA-waived tests

Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver.[6] 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,[7] 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.[8]

Minimum periods of retention

CLIA[9] and the College of American Pathologists (CAP)[10] 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 autopsy10 years[9]
Forensic autopsyIndefinitely[9]
Cytology, fine needle aspiration10 years[10]
Cytology, apart from fine needle aspiration5 years[9]
Paraffin-embedded blocks Non-forensic2[9] or 10 years[10]
ForensicIndefinitely[9]
Requisition form and test report Pathology reports10 years[9]
Other2 years[9]
Blood bank records Quality control records5 years[10]
Donor and recipient records10 years[10]
Records of indefinitely deferred donorsIndefinitely[10]
Wet tissues Until report is completed[9] or 2 weeks thereafter[10]
Proficiency testing records and quality management/quality control records 2 years[9]
Discontinued procedures 2 years[9]
Blood smears and other body fluid smears, microbiology slides (including Gram stains) 7 days[10]
Flow cytometry plots 10 years[10]

See also

References
  1. CLIA related Federal Register and Code of Federal Regulation Announcements, and the FDA's Clinical Laboratory Improvement Amendments (CLIA). Accessed Nov. 14, 2015.
  2. CLIA Program homepage
  3. "CLIA Overview". CMS. 11 April 2018.
  4. "Laboratory Developed Tests". FDA. 26 March 2018.
  5. CLIA Categorization Criteria (December 2012)
  6. "CLIA Waived Testing booklet" (PDF). December 2012.
  7. "CLIA Waived IVD Regulatory Assistance". November 2007. Archived from the original on 2012-12-05. Retrieved 2012-12-10.
  8. 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.
  9. "42 CFR § 493.1105 - Standard: Retention requirements". Cornell Law School. [68 FR 3703, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]
  10. "CAP Policy Manual - Policy PP. Minimum Period of Retention of Laboratory Records and Materials" (PDF). CAP.org. Adopted August 1995. Revised September 2020
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