Английская Википедия:Clinical Laboratory Improvement Amendments
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
- 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]
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:
- Knowledge
- 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.
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
| 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.
| 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:
| 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
- ↑ 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
- ↑ 3,0 3,1 Шаблон:Cite web
- ↑ Шаблон:Cite news
- ↑ CLIA Categorization Criteria (December 2012)
- ↑ Шаблон:Cite web
- ↑ Шаблон:Cite web
- ↑ Шаблон:Cite web
- ↑ 9,00 9,01 9,02 9,03 9,04 9,05 9,06 9,07 9,08 9,09 9,10 Шаблон:Cite web [68 FR 3703, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]
- ↑ 10,0 10,1 10,2 10,3 10,4 10,5 10,6 10,7 10,8 Шаблон:Cite web Adopted August 1995. Revised September 2020
- ↑ Шаблон:Cite web
- ↑ Шаблон:Cite book
- ↑ Шаблон:Cite webШаблон:Source-attribution
- ↑ Шаблон:Cite webШаблон:Source-attribution
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