[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: 42CFR493.20]

[Page 979-980]
 
                         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. 493.20  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

[[Page 980]]

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]