[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: 42CFR493.49]



[Page 992-993]

 

                         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 Sec. Sec.  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, 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--



[[Page 993]]



    (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.

    (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, as amended at 68 FR 3702, Jan. 24, 2003]