Clinical Laboratory Improvement Amendments program
E116581
The Clinical Laboratory Improvement Amendments program is a U.S. federal regulatory framework that sets quality standards for laboratory testing on human specimens to ensure accurate, reliable, and timely patient test results.
All labels observed (5)
| Label | Occurrences |
|---|---|
| Clinical Laboratory Improvement Amendments program canonical | 2 |
| CLIA | 1 |
| CLIA program | 1 |
| Clinical Laboratory Improvement Amendments | 1 |
| Clinical Laboratory Improvement Amendments of 1988 | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T986265 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: Clinical Laboratory Improvement Amendments program Context triple: [Centers for Medicare & Medicaid Services, overseesProgram, Clinical Laboratory Improvement Amendments program]
-
A.
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is the U.S. regulatory body responsible for overseeing the safety, efficacy, and quality of biological products such as vaccines, blood products, and gene therapies.
-
B.
Clinical and Translational Science Awards Program
The Clinical and Translational Science Awards Program is a U.S. national consortium that supports academic medical institutions in accelerating the translation of scientific discoveries into improved patient care and public health.
-
C.
Hygienic Laboratory
Hygienic Laboratory was the early federal biomedical research facility that evolved into what is now the National Institutes of Health (NIH).
-
D.
Center for Devices and Radiological Health
The Center for Devices and Radiological Health is the U.S. FDA division responsible for regulating medical devices and radiation-emitting products to ensure their safety and effectiveness.
-
E.
NCI-Designated Cancer Centers Program
The NCI-Designated Cancer Centers Program is a U.S. network of leading academic and research institutions recognized for excellence in cancer research, treatment, and prevention.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: Clinical Laboratory Improvement Amendments program Target entity description: The Clinical Laboratory Improvement Amendments program is a U.S. federal regulatory framework that sets quality standards for laboratory testing on human specimens to ensure accurate, reliable, and timely patient test results.
-
A.
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is the U.S. regulatory body responsible for overseeing the safety, efficacy, and quality of biological products such as vaccines, blood products, and gene therapies.
-
B.
Clinical and Translational Science Awards Program
The Clinical and Translational Science Awards Program is a U.S. national consortium that supports academic medical institutions in accelerating the translation of scientific discoveries into improved patient care and public health.
-
C.
Hygienic Laboratory
Hygienic Laboratory was the early federal biomedical research facility that evolved into what is now the National Institutes of Health (NIH).
-
D.
Center for Devices and Radiological Health
The Center for Devices and Radiological Health is the U.S. FDA division responsible for regulating medical devices and radiation-emitting products to ensure their safety and effectiveness.
-
E.
NCI-Designated Cancer Centers Program
The NCI-Designated Cancer Centers Program is a U.S. network of leading academic and research institutions recognized for excellence in cancer research, treatment, and prevention.
- F. None of above. chosen
Statements (53)
| Predicate | Object |
|---|---|
| instanceOf |
U.S. federal regulatory program
ⓘ
laboratory quality standards framework ⓘ |
| abbreviation | CLIA ⓘ |
| administeredBy | Centers for Medicare & Medicaid Services ⓘ |
| administeredByAbbreviation | CMS ⓘ |
| appliesTo |
laboratories performing testing on human specimens for diagnosis, prevention, or treatment of disease
ⓘ
laboratories performing testing on human specimens for health assessment ⓘ |
| appliesToSettings |
hospital laboratories
ⓘ
independent laboratories ⓘ nursing facility laboratories ⓘ other sites performing testing on human specimens for clinical purposes ⓘ physician office laboratories ⓘ |
| authorizedBy | Clinical Laboratory Improvement Amendments of 1988 ⓘ |
| basisFor | quality standards for clinical laboratory testing ⓘ |
| CDCRole | provides scientific and technical support for CLIA standards ⓘ |
| certificateTypesInclude |
Certificate of Accreditation
ⓘ
Certificate of Compliance ⓘ Certificate of Provider-Performed Microscopy Procedures ⓘ Certificate of Registration ⓘ Certificate of Waiver ⓘ |
| collaboratesWith |
Centers for Disease Control and Prevention
ⓘ
Food and Drug Administration ⓘ |
| collaboratesWithAbbreviation |
CDC
ⓘ
linked to:
Centers for Disease Control and Prevention
FDA ⓘ
linked to:
Food and Drug Administration
|
| country |
United States
ⓘ
linked to:
United States of America
|
| enforcementMechanism |
laboratory inspections
ⓘ
proficiency testing review ⓘ sanctions for noncompliance ⓘ |
| excludes | laboratories performing testing for research only and not reporting patient-specific results ⓘ |
| FDARole | regulates test systems and reagents used in CLIA-regulated laboratories ⓘ |
| fullName | Clinical Laboratory Improvement Amendments program ⓘ |
| jurisdiction | federal ⓘ |
| legalBasis | Public Health Service Act authority for laboratory regulation ⓘ |
| overseenBy |
Centers for Medicare & Medicaid Services Survey and Certification Group
ⓘ
linked to:
Centers for Medicare & Medicaid Services
|
| purpose |
to ensure accurate patient test results
ⓘ
to ensure reliable patient test results ⓘ to ensure timely patient test results ⓘ |
| regulates | clinical laboratory testing on human specimens ⓘ |
| requires | CLIA certificate for laboratories performing non-exempt human testing ⓘ |
| sanctionsInclude |
civil monetary penalties
ⓘ
directed plans of correction ⓘ suspension or revocation of CLIA certificate ⓘ |
| sector | health care ⓘ |
| setsStandardsFor |
laboratory facility and safety requirements
ⓘ
patient test management in clinical laboratories ⓘ personnel qualifications in clinical laboratories ⓘ proficiency testing in clinical laboratories ⓘ quality assurance in clinical laboratories ⓘ quality control procedures in clinical laboratories ⓘ |
| shortName | CLIA program ⓘ |
| testComplexityCategories |
high complexity tests
ⓘ
moderate complexity tests ⓘ waived tests ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Clinical Laboratory Improvement Amendments program Description of subject: The Clinical Laboratory Improvement Amendments program is a U.S. federal regulatory framework that sets quality standards for laboratory testing on human specimens to ensure accurate, reliable, and timely patient test results.
Referenced by (6)
Full triples — surface form annotated when it differs from this entity's canonical label.
Centers for Medicare & Medicaid Services
→
overseesProgram
→
Clinical Laboratory Improvement Amendments program
ⓘ
Clinical Laboratory Improvement Amendments program
→
fullName
→
Clinical Laboratory Improvement Amendments program
ⓘ
linked to: Clinical Laboratory Improvement Amendments program
Clinical Laboratory Improvement Amendments program
→
authorizedBy
→
Clinical Laboratory Improvement Amendments of 1988
ⓘ
linked to: Clinical Laboratory Improvement Amendments program
linked to: Clinical Laboratory Improvement Amendments program
linked to: Clinical Laboratory Improvement Amendments program