Is histology considered high complexity testing?
Review of the CLIA categories of tests by complexity indicates that many tasks and tests performed in the histopathology laboratory are in fact of high complexity (CFR 42 §493.5, CFR 42 §493.17).
Who is subject to CLIA regulations?
CLIA applies to all laboratories that examine “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.” (see 42 U.S.C.
Who is required to have a CLIA certification?
1. Who must apply for a CLIA ’88 certificate? Anyone who performs testing of human specimens for the diagnosis, prevention or treatment of disease or health problems must apply for a CLIA certificate. This includes physicians who operate their own in-office laboratories.
Is histology moderate complexity testing?
According to CLIA standards, histology is considered “processing”, not testing. It is not considered testing because we do not provide any sort of interpretation.
What are CLIA regulations?
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.
Who is exempt from CLIA?
“CLIA-exempt” formally refers to a laboratory (not a test system) and means a laboratory that has been licensed or approved by a state where CMS has determined that the state has enacted laws relating to laboratory requirements that are equal to or more stringent than CLIA requirements, and the State licensure program …
What are the CLIA regulations and Federal Register documents?
CLIA Regulations and Federal Register Documents CLIA Related Hearing Decisions and Compliance Topics Cytology Proficiency Testing Individualized Quality Control Plan (IQCP) Interpretive Guidelines for Laboratories
How many clinical labs are covered by CLIA?
In total, CLIA covers approximately 260,000 laboratory entities. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program.
Who is responsible for the CLIA Program?
The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program. The objective of the CLIA program is to ensure quality laboratory testing.
How do I obtain a CLIA certificate for my laboratory?
Select the State agency based on the physical location of the laboratory. The State agency maintains the certificate information for new and existing laboratory providers within their state. For a list of our State agency CLIA contacts (PDF), please visit our website at /Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf (PDF)