Английская Википедия:Clinical Laboratory Improvement Amendments

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Шаблон:Short description 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:Шаблон:Citation needed

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]

Test Complexity

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.[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.

List of CLIA test complexity categorizations:

  • Waived
  • Moderate
  • Provider-performed Microscopy (PPM)
  • High
    • Laboratory Devolped Test (LDT)s

Fees/Funding

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 autopsy 10 years[9]
Forensic autopsy Indefinitely[9]
Cytology, fine needle aspiration 10 years[10]
Cytology, apart from fine needle aspiration 5 years[9]
Paraffin-embedded blocks Non-forensic 2[9] or 10 years[10]
Forensic Indefinitely[9]
Requisition form and test report Pathology reports 10 years[9]
Other 2 years[9]
Blood bank records Quality control records 5 years[10]
Donor and recipient records 10 years[10]
Records of indefinitely deferred donors Indefinitely[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]

History

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.[11]

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.[12]

CLIA certificates

Types of CLIA certificates[13]
Acronym Certificate Notes
CoW Certificate of Waiver Issued to a laboratory that performs only waived tests.
PPM Certificate for Provider-performed Microscopy procedures Issued to a laboratory in which a physician, midlevel practitioner or dentist performs specific microscopy procedures during the course of a patient’s visit. A limited list of provider-performed microscopy procedures is included under this certificate type, which are categorized as moderate complexity testing.
Certificate of Registration ssued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration.
CoC Certificate of Compliance Issued to a laboratory once the State Agency or CMS surveyors conduct a survey (inspection) and determine that the laboratory is compliant with the applicable CLIA requirements. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing.
COA Certificate of Accreditation Issued to a laboratory on the basis of the laboratory’s accreditation by an accreditation organization approved by CMS. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing.

Accrediting organizations

For CLIA laboratories licensed under a Certificate of Accreditation (CoA), bi-annual inspections are conducted by an third-party accreditation organization (AO) that meets or exceeds the CLIA requirements.

CLIA Accreditation organizations (AO)
Acronym Accrediting Organization Notes
AABB Association for the Advancement of Blood & Biotherapies (formerly American Association of Blood Banks)
A2LA American Association for Laboratory Accreditation
(AAHHS/HFAP) Accreditation Association for Hospitals and Health Systems/ Healthcare Facilities Accreditation Program
ASHI American Society for Histocompatibility and Immunogenetics
COLA Commission on Office Laboratory Accreditation
CAP College of American Pathologists
TJC The Joint Commission

Laboratory directors

Clinical laboratories in the US that perform high complexity testing require a high complexity laboratory director (HCLD) that has earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS. The current approved boards are the following:

Certifying Boards for a high complexity laboratory director (HCLD)[14]
Acronym Name Notes
ABB American Board of Bioanalysis
ABCC American Board of Clinical Chemistry
ABFT American Board of Forensic Toxicology (limited to individuals with a doctoral degree with Fellow status)
ABMGG American Board of Medical Genetics and Genomics (formerly known as American Board of Medical Genetics (ABMG))
ABMLI American Board of Medical Laboratory Immunology no longer accepting new exam applicants
ABMM American Board of Medical Microbiology
ACHI American College of Histocompatibility and Immunogenetics (formerly known as American Board of Histocompatibility and Immunogenetics (ABHI))
NRCC National Registry of Certified Chemists
ASCP American Society for Clinical Pathology Diplomate in Medical Laboratory Immunology (DMLI)


See also

References

Шаблон:Reflist