[Code of Federal Regulations]
[Title 12, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.47]

[Page 983]
 
                         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 C--Registration Certificate, Certificate for Provider-performed 
          Microscopy Procedures, and Certificate of Compliance
 
Sec. 493.47  Requirements for a certificate for provider-performed microscopy (PPM) procedures.

    (a) A certificate for PPM procedures is required--
    (1) Initially for all laboratories performing test procedures 
specified as PPM procedures; and
    (2) For all certificate of waiver laboratories that intend to 
perform only test procedures specified as PPM procedures in addition to 
those tests listed in Sec. 493.15(c).
    (b) HHS will issue a certificate for PPM procedures if the 
laboratory--
    (1) Complies with the requirements of Sec. 493.43; and
    (2) Remits the fee for the certificate, as specified in subpart F of 
this part.
    (c) Laboratories issued a certificate for PPM procedures are subject 
to--
    (1) The notification requirements of Sec. 493.53;
    (2) The applicable requirements of this subpart and subparts H, J, 
K, and M of this part; and
    (3) Inspection only under the circumstances specified under Sec.Sec. 
493.1773 and 493.1775, but are not routinely inspected to determine 
compliance with the requirements specified in paragraphs (c) (1) and (2) 
of this section.
    (d) In accordance with subpart R of this part, HHS will initiate 
suspension, limitation, or revocation of a laboratory's certificate for 
PPM procedures for failure to comply with the applicable requirements 
set forth in this subpart. HHS may also impose certain alternative 
sanctions. In addition, failure to meet the requirements of this subpart 
may result in suspension of all or part of payments under Medicare and 
Medicaid, as specified in subpart R of this part.
    (e) A certificate for PPM procedures is valid for a period of no 
more than 2 years.

[58 FR 5223, Jan. 19, 1993, as amended at 60 FR 20045, Apr. 24, 1995; 68 
FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]