[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: 42CFR493.25]



[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.  493.25  Laboratories performing tests of high complexity.



    (a) A laboratory must obtain a certificate for tests of high 

complexity if it performs one or more tests that meet the criteria for 

tests of high complexity as specified in Sec.  493.17(a).

    (b) A laboratory performing one or more tests of high complexity 

must meet the applicable requirements of subpart C or subpart D, and 

subparts F, H, J, K, M, and Q of this part.

    (c) If the laboratory also performs tests of moderate complexity, 

the applicable requirements of subparts H, J, K, M, and Q of this part 

must be met. Under a registration certificate or certificate of 

compliance, PPM procedures must meet the inspection requirements at 

Sec. Sec.  493.1773 and 493.1777.

    (d) If the laboratory also performs waived tests, the requirements 

of subparts H, J, K, and M are 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.



[57 FR 7139, Feb. 28, 1992, as amended at 60 FR 20044, Apr. 24, 1995; 68 

FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]