What is 42cfr493?

What is 42cfr493?

§ 493.43. Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate of compliance. § 493.45. Requirements for a registration certificate. § 493.47.

Does CLIA require proficiency testing?

Proficiency testing is the only external performance indicator required by CLIA.

What is the purpose of CLIA?

The Clinical Laboratory Improvement Amendments (CLIA) Program regulates labs testing human specimens and ensures they provide accurate, reliable, and timely patient test results no matter where the test is done.

What is the difference between CLIA and CLSI?

CLIA – more specific in some areas, e.g. ISO/CLSI – more comprehensive and general, e.g. CLIA – more specific in some areas, e.g. ISO/CLSI – more comprehensive and general, e.g.

When did the 42 CFR Part 493 go into effect?

For laboratories subject to 42 CFR part 493published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994.

Is the laboratory required to comply with the requirements of Fr 493?

However, the laboratory must comply with the requirements in §§ 493.15(e), 493.1773, and 493.1775. [60 FR 20044, Apr. 24, 1995, as amended at 68 FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003] § 493.25 Laboratories performing tests of high complexity.

What happens if I don’t meet the requirements of part 493?

(e)Failure to meet the applicable requirements of part 493, will result in an action by HHS to suspend, revoke or limit the certificate of accreditation. HHS will –

What is § 493 1351 general?

§ 493.1351 General. This subpart consists of the personnel requirements that must be met by laboratories performing moderate complexity testing, PPM procedures, high complexity testing, or any combination of these tests. [60 FR 20049, Apr. 24, 1995]