What are the major components included in the CLIA 1988 regulations?
CLIA ’88 established requirements to improve the quality of laboratory testing, including standards for the performance of Proficiency Testing (PT), Quality Control (QC), QA, patient-test management and personnel requirements.
What impact did CLIA 88 have on the laboratory?
Results: More than 64% of physicians surveyed cited CLIA ’88 as a factor in their decision to reduce or eliminate in-office testing. The most striking effect of CLIA ’88 appears to be on pediatric practices and practices in rural areas, of which more than 70% have reduced or eliminated onsite testing.
What are the three categories of testing per CLIA 88?
Current Regulation: CLIA established three categories of tests: waived tests, moderate complexity tests, and high complexity tests.
What is considered a clinical laboratory according to the CLIA?
CLIA RESEARCH 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” (42 Code of Federal Regulations [CFR] § 493.2).
What is the purpose of CLIA 88?
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) were established to strengthen federal oversight of clinical laboratories to ensure the accuracy and reliability of patient test results.
What are laboratory standards?
This regulation, commonly known as the Laboratory Standard, was designed to ensure that laboratory workers are informed about the physical and chemical hazards of chemicals in their workplace and are protected from chemical exposures exceeding allowable levels.
What are the three most common specimens collected for the clinical laboratory?
The types of biological samples accepted in most clinical laboratories are: serum samples, virology swab samples, biopsy and necropsy tissue, cerebrospinal fluid, whole blood for PCR, and urine samples. These are collected in specific containers for successful processing in the laboratory.
What is CLIA and what is its purpose?
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Each agency has a unique role in assuring quality laboratory testing.
How many CLIA labs are there in the US?
260,000 laboratory entities
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 260,000 laboratory entities.
What are CLIA requirements?
CLIA Requirements for Lab Personnel. The CLIA personnel requirements are found in Subpart M of the Code of Federal Regulations. This subpart addresses qualifications and responsibilities for provider performed microscopy (PPM), moderate complexity, and high complexity laboratories.
What is the CLIA 88?
CLIA LAW. The Clinical Laboratory Improvement Amendments of 1988 statute is an amendment to the Public Health Services Act in which Congress revised the federal program for certification and oversight of clinical laboratory testing. Two subsequent amendments were made after 1988. The law continues to be cited as CLIA ’88 as named in legislation.
Which is true about CLIA?
Travel Agent Accreditation.
What are clinical laboratory requirements?
Clinical laboratory technologists must hold a bachelor’s degree in medical technology or one of the life sciences. Topics of instruction include chemistry, mathematics and microbiology.