[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: 42CFR493.45]



[Page 991-992]

 

                         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.  493.45  Requirements for a registration certificate.



    Laboratories performing only waived tests, PPM procedures, or any 

combination of these tests, are not required to obtain a registration 

certificate.

    (a) A registration certificate is required--(1) Initially for all 

laboratories performing test procedures of moderate complexity (other 

than the subcategory of PPM procedures) or high complexity, or both; and

    (2) For all laboratories that have been issued a certificate of 

waiver or certificate for PPM procedures that intend to perform tests of 

moderate or high complexity, or both, in addition to those tests listed 

in Sec.  493.15(c) or specified as PPM procedures.

    (b) HHS will issue a registration certificate if the laboratory--

    (1) Complies with the requirements of Sec.  493.43;

    (2) Agrees to notify HHS or its designee within 30 days of any 

changes in ownership, name, location, director or technical supervisor 

(laboratories performing high complexity testing only);

    (3) Agrees to treat proficiency testing samples in the same manner 

as it treats patient specimens; and

    (4) Remits the fee for the registration certificate, as specified in 

subpart F of this part.

    (c) Prior to the expiration of the registration certificate, a 

laboratory must--

    (1) Remit the certificate fee specified in subpart F of this part;

    (2) Be inspected by HHS as specified in subpart Q of this part; and

    (3) Demonstrate compliance with the applicable requirements of this 

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

    (d) In accordance with subpart R of this part, HHS will initiate 

suspension or revocation of a laboratory's registration certificate and 

will deny the laboratory's application for a certificate of compliance 

for failure to comply with the requirements set forth in this subpart. 

HHS may also impose certain alternative sanctions. In addition, failure 

to meet the requirements of this subpart will result in suspension of 

payments under Medicare and Medicaid as specified in subpart R of this 

part.

    (e) A registration certificate is--

    (1) Valid for a period of no more than two years or until such time 

as an inspection to determine program compliance can be conducted, 

whichever is shorter; and

    (2) Not renewable; however, the registration certificate may be 

reissued if compliance has not been determined by HHS prior to the 

expiration date of the registration certificate.

    (f) In the event of a noncompliance determination resulting in an 

HHS denial of a laboratory's certificate of compliance application, HHS 

will provide the laboratory with a statement of grounds on which the 

noncompliance determination is based and offer an opportunity for appeal 

as provided in subpart R.

    (g) If the laboratory requests a hearing within the time specified 

by HHS, it retains its registration certificate or reissued registration 

certificate until a decision is made by an administrative law judge as 

provided in subpart R of this part, except when HHS finds that 

conditions at the laboratory pose an imminent and serious risk to human 

health.

    (h) For laboratories receiving payment from the Medicare or Medicaid 

program, such payments will be suspended on the effective date specified



[[Page 992]]



in the notice to the laboratory of denial of the certificate application 

even if there has been no appeals decision issued.



[57 FR 7143, Feb. 28, 1992, as amended at 58 FR 5223, Jan. 19, 1993; 60 

FR 20045, Apr. 24, 1995; 68 FR 3702, Jan. 24, 2003]