[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR493.20]



[Page 988]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 493_LABORATORY REQUIREMENTS--Table of Contents

 

                      Subpart A_General Provisions

 

Sec.  493.20  Laboratories performing tests of moderate complexity.



    (a) A laboratory may qualify for a certificate to perform tests of 

moderate complexity provided that it restricts its test performance to 

waived tests or examinations and one or more tests or examinations 

meeting criteria for tests of moderate complexity including the 

subcategory of PPM procedures.

    (b) A laboratory that performs tests or examinations of moderate 

complexity must meet the applicable requirements in subpart C or subpart 

D, and subparts F, H, J, K, M, and Q of this part. Under a registration 

certificate or certificate of compliance, laboratories also performing 

PPM procedures must meet the inspection requirements at Sec. Sec.  

493.1773 and 493.1777.

    (c) If the laboratory also performs waived tests, compliance with 

subparts H, J, K, and M of this part is not applicable to the waived 

tests. However, the laboratory must comply with the requirements in 

Sec. Sec.  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]