[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.25]

[Page 980]
 
                         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]