[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: 42CFR493.45]

[Page 982-983]
 
                         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. 493.45  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

[[Page 983]]

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 
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]