Subpart D--Certificate of Accreditation
Source: 57 FR 7144, Feb. 28, 1992, unless otherwise noted.
Sec. 493.55 Application for registration certificate and certificate of
accreditation.
(a) Filing of application. A laboratory may be issued a certificate
of accreditation in lieu of the applicable certificate specified in
subpart B or subpart C of this part provided the laboratory--
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(1) Meets the standards of a private non-profit accreditation
program approved by HHS in accordance with subpart E; and
(2) Files a separate application for each location, except as
specified in paragraph (b) of this section.
(b) Exceptions. (1) Laboratories that are not at fixed locations,
that is, laboratories that move from testing site to testing site, such
as mobile units providing laboratory testing, health screening fairs, or
other temporary testing locations may be covered under the certificate
of the designated primary site or home base, using its address.
(2) Not-for-profit or Federal, State, or local government
laboratories that engage in limited (not more than a combination of 15
moderately complex or waived tests per certificate) public health
testing may file a single application.
(3) Laboratories within a hospital that are located at contiguous
buildings on the same campus and under common direction may file a
single application or multiple applications for the laboratory sites
within the same physical location or street address.
(c) Application format and contents. The application must--(1) Be
made to HHS on a form or forms prescribed by HHS;
(2) Be signed by an owner or authorized representative of the
laboratory who attests that the laboratory will be operated in
accordance with the requirements established by the Secretary under
section 353 of the Public Health Service Act; and
(3) Describe the characteristics of the laboratory operation and the
examinations and other test procedures performed by the laboratory
including--
(i) The name and total number of tests and examinations performed
annually (excluding waived tests and tests for quality control, quality
assurance or proficiency testing purposes);
(ii) The methodologies for each laboratory test procedure or
examination performed, or both; and
(iii) The qualifications (educational background, training, and
experience) of the personnel directing and supervising the laboratory
and performing the laboratory examinations and test procedures.
(d) Access and reporting requirements. All laboratories must make
records available and submit reports to HHS as HHS may reasonably
require to determine compliance with this section.
[57 FR 7144, Feb. 28, 1992, as amended at 58 FR 5224, Jan. 19, 1993; 58
FR 39155, July 22, 1993; 60 FR 20046, Apr. 24, 1995]
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.
(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.
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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]
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;
(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
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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]
Sec. 493.63 Notification requirements for laboratories issued a
certificate of accreditation.
Laboratories issued a certificate of accreditation must:
(a) Notify HHS and the approved accreditation program within 30 days
of any changes in--
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
(b) Notify the approved accreditation program no later than 6 months
after performing any test or examination within a specialty or
subspecialty area that is not included in the laboratory's
accreditation, so that the accreditation organization can determine
compliance and a new certificate of accreditation can be issued.
(c) Notify the accreditation program no later than 6 months after of
any deletions or changes in test methodologies for any test or
examination included in a specialty or subspecialty, or both, for which
the laboratory has been issued a certificate of accreditation.
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