What are the requirements for a CLIA waived laboratory director?
The CAP requires a minimum of doctoral level training for all laboratory medical directors regardless of testing complexity. By law, a director can direct up to five nonwaived laboratories, though some states restrict that to only three.
Which United States law sets standards for laboratory testing classifications and requirements based on the complexity of the test?
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 USC 263a) and the associated regulations (42 CFR 493) provide the authority for certification and oversight of clinical laboratories and laboratory testing.
What does 42 CFR Part 2 require written consent that contains?
Part 2s consent provision requires that a consent form include the specific name or general designation of the program or person permitted to make the disclosure [42 CFR Part 2, 2.31(a)(1)].
Can PT samples be sent to another laboratory?
Never send your PT samples to another laboratory, even if you send your patient specimens to another laboratory. Carefully read the PT results sheet. Select Would refer or Test not performed in these instances.
What are the cap requirements for lab director?
Updated Degree Requirements: Nursing Degrees No Longer Accepted for High-Complexity Testing Oversight. One of the more notable changes is that nursing degrees will no longer be recognized as valid for laboratory director roles in high-complexity labs.
What are the qualifications for a laboratory director under 42 CFR 493.1405 standard?
The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part.
What are the qualifications of a lab director?
Hold a masters degree in lab science and one year lab training or experience and one year experience supervising non-waived tests. Hold a bachelors degree in lab science and two years lab training or experience and two years experience supervising non-waived testing.
Related links
42 CFR 493.801 - Enrollment and testing of samples.
Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS.
42 CFR 493.801 - Condition: Enrollment and testing of
(1) The samples must be examined or tested with the laboratorys regular patient workload by personnel who routinely perform the testing in the laboratory,
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