[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: 42CFR493.47]



[Page 992]

 

                         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]