Subpart B--Certificate of Waiver
Source: 57 FR 7142, Feb. 28, 1992, unless otherwise noted.
Sec. 493.35 Application for a certificate of waiver.
(a) Filing of application. Except as specified in paragraph (b) of
this section, a laboratory performing only one or more waived tests
listed in Sec. 493.15 must file a separate application for each
laboratory location.
(b) Exceptions. (1) Laboratories that are not at a fixed location,
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 or its designee on a form or forms prescribed by
HHS;
(2) Be signed by an owner, or by an authorized representative of the
laboratory who attests that the laboratory will be operated in
accordance with requirements established by the Secretary under section
353 of the PHS 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 the total number of test procedures and
examinations performed annually (excluding tests the laboratory may run
for quality control, quality assurance or proficiency testing purposes;
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(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 requirements. Laboratories that perform one or more
waived tests listed in Sec. 493.15(c) and no other tests must meet the
following conditions:
(1) Make records available and submit reports to HHS as HHS may
reasonably require to determine compliance with this section and
Sec. 493.15(e);
(2) Agree to permit announced and unannounced inspections by HHS in
accordance with subpart Q of this part under the following
circumstances:
(i) When HHS has substantive reason to believe that the laboratory
is being operated in a manner that constitutes an imminent and serious
risk to human health.
(ii) To evaluate complaints from the public.
(iii) On a random basis to determine whether the laboratory is
performing tests not listed in Sec. 493.15.
(iv) To collect information regarding the appropriateness of waiver
of tests listed in Sec. 493.15.
(e) Denial of application. If HHS determines that the application
for a certificate of waiver is to be denied, HHS will--
(1) Provide the laboratory with a written statement of the grounds
on which the denial is based and an opportunity for appeal, in
accordance with the procedures set forth in subpart R of this part;
(2) Notify a laboratory that has its application for a certificate
of waiver denied that it cannot operate as a laboratory under the PHS
Act unless the denial is overturned at the conclusion of the
administrative appeals process provided by subpart R; and
(3) Notify the laboratory that it is not eligible for payment under
the Medicare and Medicaid programs.
[57 FR 7142, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 60
FR 20044, Apr. 24, 1995]
Sec. 493.37 Requirements for a certificate of waiver.
(a) HHS will issue a certificate of waiver to a laboratory only if
the laboratory meets the requirements of Sec. 493.35.
(b) Laboratories issued a certificate of waiver--
(1) Are subject to the requirements of this subpart and
Sec. 493.15(e) of subpart A of this part; and
(2) Must permit announced or unannounced inspections by HHS in
accordance with subpart Q of this part.
(c) Laboratories must remit the certificate of waiver fee specified
in subpart F of this part.
(d) In accordance with subpart R of this part, HHS will suspend or
revoke or limit a laboratory's certificate of waiver for failure to
comply with the requirements of this subpart. In addition, failure to
meet the requirements of this subpart will result in suspension or
denial of payments under Medicare and Medicaid in accordance with
subpart R of this part.
(e)(1) A certificate of waiver issued under this subpart is valid
for no more than 2 years. In the event of a non-compliance determination
resulting in HHS action to revoke, suspend, or limit the laboratory's
certificate of waiver, HHS will provide the laboratory with a statement
of grounds on which the determination of non-compliance is based and
offer an opportunity for appeal as provided in subpart R of this part.
(2) If the laboratory requests a hearing within the time specified
by HHS, it retains its certificate of waiver or reissued certificate of
waiver until a decision is made by an administrative law judge, as
specified in subpart R of this part, except when HHS finds that
conditions at the laboratory pose an imminent and serious risk to human
health.
(3) 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 non-compliance determination even
if there has been no appeals decision issued.
(f) A laboratory seeking to renew its certificate of waiver must--
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(1) Complete the renewal application prescribed by HHS and return it
to HHS not less than 9 months nor more than 1 year before the expiration
of the certificate; and
(2) Meet the requirements of Secs. 493.35 and 493.37.
(g) A laboratory with a certificate of waiver that wishes to perform
examinations or tests not listed in the waiver test category must meet
the requirements set forth in subpart C or subpart D of this part, as
applicable.
[57 FR 7142, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 60
FR 20045, Apr. 24, 1995]
Sec. 493.39 Notification requirements for laboratories issued a
certificate of waiver.
Laboratories performing one or more tests listed in Sec. 493.15 and
no others must notify HHS or its designee--
(a) Before performing and reporting results for any test or
examination that is not specified under Sec. 493.15 for which the
laboratory does not have the appropriate certificate as required in
subpart C or subpart D of this part, as applicable; and
(b) Within 30 days of any change(s) in--
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
[57 FR 7142, Feb. 28, 1992, as amended at 60 FR 20045, Apr. 24, 1995]
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