493.61—Requirements for a certificate of accreditation.
(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.
(1)
Will no longer meet the requirements of this part by virtue of its accreditation in an approved accreditation program;
(3)
May be subject to suspension, revocation or limitation of the laboratory's certificate of accreditation or certain alternative sanctions; and
(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 § 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;
(2)
Notify the laboratory if it is eligible to apply for a certificate as defined in subpart C of this part; and
(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 § 493.57.
(1)
Complete and return the renewal application to HHS 9 to 12 months prior to the expiration of the certificate of accreditation;
(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—
(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]