[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.49]

[Page 972-973]
 
                         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. 493.49  Requirements for a certificate of compliance.

    A certificate of compliance may include any combination of tests 
categorized as high complexity or moderate complexity or listed in 
Sec. 493.15(c) as waived tests. Moderate complexity tests may include 
those specified as PPM procedures.
    (a) HHS will issue a certificate of compliance to a laboratory only 
if the laboratory--
    (1) Meets the requirements of Secs. 493.43 and 493.45;
    (2) Remits the certificate fee specified in subpart F of this part; 
and
    (3) Meets the applicable requirements of this subpart and subparts 
H, J, K, M, P, and Q of this part.
    (b) Laboratories issued a certificate of compliance--
    (1) Are subject to the notification requirements of Sec. 493.51; and
    (2) Must permit announced or unannounced inspections by HHS in 
accordance with subpart Q of this part--
    (i) To determine compliance with the applicable requirements of this 
part;
    (ii) To evaluate complaints;
    (iii) When HHS has substantive reason to believe that tests are 
being performed, or the laboratory is being operated in a manner that 
constitutes an imminent and serious risk to human health; and
    (iv) To collect information regarding the appropriateness of tests 
listed in Sec. 493.15 or tests categorized as moderate complexity 
(including the subcategory) or high complexity.
    (c) Failure to comply with the requirements of this subpart will 
result in--
    (1) Suspension, revocation or limitation of a laboratory's 
certificate of compliance in accordance with subpart R of this part; and
    (2) Suspension or denial of payments under Medicare and Medicaid in 
accordance with subpart R of this part.
    (d) A certificate of compliance issued under this subpart is valid 
for no more than 2 years.
    (e) In the event of a noncompliance determination resulting in an 
HHS action to revoke, suspend or limit the laboratory's certificate of 
compliance, HHS will--
    (1) Provide the laboratory with a statement of grounds on which the 
determination of noncompliance is based; and
    (2) Offer an opportunity for appeal as provided in subpart R of this 
part. If the laboratory requests a hearing within 60 days of the notice 
of sanction, it retains its certificate of compliance or reissued 
certificate of compliance until a decision is made by an administrative 
law judge (ALJ) 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 or when the criteria at Sec. 493.1840(a) (4) and 
(5) are met.
    (f) 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 a noncompliance determination even if 
there has been no appeals decision issued.
    (g) A laboratory seeking to renew its certificate of compliance 
must--
    (1) Complete and return the renewal application to HHS 9 to 12 
months prior to the expiration of the certificate of compliance; and
    (2) Meet the requirements of Sec. 493.43 and paragraphs (a)(2) and 
(b)(2) of this section.

[[Page 973]]

    (h) If HHS determines that the application for the renewal of a 
certificate of compliance must be denied or limited, HHS will notify the 
laboratory in writing of the--
    (1) Basis for denial of the application; and
    (2) Opportunity for appeal as provided in subpart R of this part.
    (i) If the laboratory requests a hearing within the time period 
specified by HHS, the laboratory retains its certificate of compliance 
or reissued certificate of compliance until a decision is made by an ALJ 
as provided in subpart R, except when HHS finds that conditions at the 
laboratory pose an imminent and serious risk to human health.
    (j) 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 nonrenewal of the certificate of 
compliance even if there has been no appeals decision issued.

[60 FR 20045, Apr. 24, 1995]