[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: 42CFR493.61]



[Page 995-996]

 

                         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.  493.61  Requirements for a certificate of accreditation.



    (a) HHS will issue a certificate of accreditation to a laboratory if 

the laboratory--

    (1) Meets the requirements of Sec.  493.57 or, if applicable, Sec.  

493.49 of subpart C of this part; and

    (2) Remits the certificate of accreditation fee specified in subpart 

F of this part.

    (b) Laboratories issued a certificate of accreditation must--

    (1) Treat proficiency testing samples in the same manner as patient 

samples;

    (2) Meet the requirements of Sec.  493.63;

    (3) Comply with the requirements of the approved accreditation 

program;

    (4) Permit random sample validation and complaint inspections as 

required in subpart Q of this part;

    (5) Permit HHS to monitor the correction of any deficiencies found 

through the inspections specified in paragraph (b)(4) of this section;

    (6) Authorize the accreditation program to release to HHS the 

laboratory's inspection findings whenever HHS conducts random sample or 

complaint inspections; and

    (7) Authorize its accreditation program to submit to HHS the results 

of the laboratory's proficiency testing.

    (c) A laboratory failing to meet the requirements of this section--

    (1) Will no longer meet the requirements of this part by virtue of 

its accreditation in an approved accreditation program;

    (2) Will be subject to full determination of compliance by HHS;

    (3) May be subject to suspension, revocation or limitation of the 

laboratory's certificate of accreditation or certain alternative 

sanctions; and

    (4) May be subject to suspension of payments under Medicare and 

Medicaid as specified in subpart R.

    (d) A certificate of accreditation issued under this subpart is 

valid for no more than 2 years. In the event of a non-compliance 

determination as a result of a random sample validation or complaint 

inspection, a laboratory will be subject to a full review by HHS in 

accordance with Sec.  488.11 of this chapter.

    (e) Failure to meet the applicable requirements of part 493, will 

result in an action by HHS to suspend, revoke or limit the certificate 

of accreditation. HHS will--

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

determination of noncompliance is based;



[[Page 996]]



    (2) Notify the laboratory if it is eligible to apply for a 

certificate as defined in subpart C of this part; and

    (3) Offer an opportunity for appeal as provided in subpart R of this 

part.

    (f) If the laboratory requests a hearing within the time frame 

specified by HHS--

    (1) It retains its certificate of accreditation or reissued 

certificate of accreditation until a decision is made by an 

administrative law judge as provided in subpart R of this part, unless 

HHS finds that conditions at the laboratory pose an imminent and serious 

risk to human health; and

    (2) For those laboratories receiving payments from the Medicare or 

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

specified in the notice to the laboratory even if there has been no 

appeals decision issued.

    (g) In the event the accreditation organization's approval is 

removed by HHS, the laboratory will be subject to the applicable 

requirements of subpart C of this part or Sec.  493.57.

    (h) A laboratory seeking to renew its certificate of accreditation 

must--

    (1) Complete and return the renewal application to HHS 9 to 12 

months prior to the expiration of the certificate of accreditation;

    (2) Meet the requirements of this subpart; and

    (3) Submit the certificate of accreditation fee specified in subpart 

F of this part.

    (i) If HHS determines that the renewal application for a certificate 

of accreditation is to be denied or limited, HHS will notify the 

laboratory in writing of--

    (1) The basis for denial of the application;

    (2) Whether the laboratory is eligible for a certificate as defined 

in subpart C of this part;

    (3) The opportunity for appeal on HHS's action to deny the renewal 

application for certificate of accreditation as provided in subpart R of 

this part. If the laboratory requests a hearing within the time frame 

specified by HHS, it retains its certificate of accreditation or 

reissued certificate of accreditation until a decision is made by an 

administrative law judge as provided in subpart R of this part, unless 

HHS finds that conditions at the laboratory pose an imminent and serious 

risk to human health; and

    (4) Suspension of payments under Medicare or Medicaid for those 

laboratories receiving payments under the Medicare or Medicaid programs.



[57 FR 7144, Feb. 28, 1992, as amended at 58 FR 5224, Jan. 19, 1993]