[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: 42CFR493.57]



[Page 994-995]

 

                         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 D_Certificate of Accreditation

 

Sec.  493.57  Requirements for a registration certificate.



    A registration certificate is required for all laboratories seeking 

a certificate of accreditation, unless the laboratory holds a valid 

certificate of compliance issued by HHS.

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

    (1) Complies with the requirements of Sec.  493.55;

    (2) Agrees to notify HHS within 30 days of any changes in ownership, 

name, location, director, or 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 specified in 

subpart F of this part.

    (b)(1) The laboratory must provide HHS with proof of accreditation 

by an approved accreditation program--

    (i) Within 11 months of issuance of the registration certificate; or

    (ii) Prior to the expiration of the certificate of compliance.

    (2) If such proof of accreditation is not supplied within this 

timeframe, the laboratory must meet, or continue to meet, the 

requirements of Sec.  493.49.



[[Page 995]]



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

suspension, revocation, or limitation of a laboratory's registration 

certificate and will deny the laboratory's application for a certificate 

of accreditation for failure to comply with the requirements set forth 

in this subpart. In addition, failure to meet the requirements of this 

subpart will result in suspension or denial of payments under Medicare 

and Medicaid as specified in subpart R of this part.

    (d) A registration certificate is valid for a period of no more than 

2 years. However, it may be reissued if the laboratory is subject to 

subpart C of this part, as specified in Sec.  493.57(b)(2) and 

compliance has not been determined by HHS before the expiration date of 

the registration certificate.

    (e) In the event that the laboratory does not meet the requirements 

of this subpart, HHS will--

    (1) Deny a laboratory's request for certificate of accreditation;

    (2) Notify the laboratory if it must meet the requirements for a 

certificate as defined in subpart C of this part;

    (3) Provide the laboratory with a statement of grounds on which the 

application denial is based;

    (4) Offer an opportunity for appeal on the application denial as 

provided in subpart R of this part. If the laboratory requests a hearing 

within the time specified by HHS, the laboratory will retain its 

registration certificate or reissued registration certificate until a 

decision is made by an administrative law judge as provided in subpart 

R, unless HHS finds that conditions at the laboratory pose an imminent 

and serious risk to human health; and

    (5) For those 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 request even 

if there has been no appeals decision issued.



[57 FR 7144, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]