Subpart C--Registration Certificate, Certificate for Provider-performed
Microscopy Procedures, and Certificate of Compliance
Source: 57 FR 7143, Feb. 28, 1992, unless otherwise noted.
Sec. 493.43 Application for registration certificate, certificate for
provider-performed microscopy (PPM) procedures, and
certificate of compliance.
(a) Filing of application. Except as specified in paragraph (b) of
this section, all laboratories performing nonwaived testing,
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 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 test procedures and examinations
performed annually (excluding waived tests or tests for quality control,
quality assurance or proficiency testing purposes);
(ii) The methodologies for each laboratory test procedure or
examination performed, or both;
(iii) The qualifications (educational background, training, and
experience) of the personnel directing and supervising the laboratory
and performing the examinations and test procedures.
(d) Access and reporting requirements. All laboratories must make
records available and submit reports to HHS as
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HHS may reasonably require to determine compliance with this section.
[57 FR 7143, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 58
FR 39155, July 22, 1993; 60 FR 20045, Apr. 24, 1995]
Sec. 493.45 Requirements for a registration certificate.
Laboratories performing only waived tests, PPM procedures, or any
combination of these tests, are not required to obtain a registration
certificate.
(a) A registration certificate is required--(1) Initially for all
laboratories performing test procedures of moderate complexity (other
than the subcategory of PPM procedures) or high complexity, or both; and
(2) For all laboratories that have been issued a certificate of
waiver or certificate for PPM procedures that intend to perform tests of
moderate or high complexity, or both, in addition to those tests listed
in Sec. 493.15(c) or specified as PPM procedures.
(b) HHS will issue a registration certificate if the laboratory--
(1) Complies with the requirements of Sec. 493.43;
(2) Agrees to notify HHS or its designee within 30 days of any
changes in ownership, name, location, director or technical 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, as specified in
subpart F of this part.
(c) Prior to the expiration of the registration certificate, a
laboratory must--
(1) Remit the certificate fee specified in subpart F of this part;
(2) Be inspected by HHS as specified in subpart Q of this part; and
(3) Demonstrate compliance with the applicable requirements of this
subpart and subparts H, J, K, M, and Q of this part.
(d) In accordance with subpart R of this part, HHS will initiate
suspension or revocation of a laboratory's registration certificate and
will deny the laboratory's application for a certificate of compliance
for failure to comply with the requirements set forth in this subpart.
HHS may also impose certain alternative sanctions. In addition, failure
to meet the requirements of this subpart will result in suspension of
payments under Medicare and Medicaid as specified in subpart R of this
part.
(e) A registration certificate is--
(1) Valid for a period of no more than two years or until such time
as an inspection to determine program compliance can be conducted,
whichever is shorter; and
(2) Not renewable; however, the registration certificate may be
reissued if compliance has not been determined by HHS prior to the
expiration date of the registration certificate.
(f) In the event of a noncompliance determination resulting in an
HHS denial of a laboratory's certificate of compliance application, HHS
will provide the laboratory with a statement of grounds on which the
noncompliance determination is based and offer an opportunity for appeal
as provided in subpart R.
(g) If the laboratory requests a hearing within the time specified
by HHS, it retains its registration certificate or reissued registration
certificate until a decision is made by an administrative law judge as
provided in subpart R of this part, except when HHS finds that
conditions at the laboratory pose an imminent and serious risk to human
health.
(h) 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 denial of the certificate application
even if there has been no appeals decision issued.
[57 FR 7143, Feb. 28, 1992, as amended at 58 FR 5223, Jan. 19, 1993; 60
FR 20045, Apr. 24, 1995]
Sec. 493.47 Requirements for a certificate for provider-performed
microscopy (PPM) procedures.
(a) A certificate for PPM procedures is required--
(1) Initially for all laboratories performing test procedures
specified as PPM procedures; and
(2) For all certificate of waiver laboratories that intend to
perform only
[[Page 894]]
test procedures specified as PPM procedures in addition to those tests
listed in Sec. 493.15(c).
(b) HHS will issue a certificate for PPM procedures if the
laboratory--
(1) Complies with the requirements of Sec. 493.43; and
(2) Remits the fee for the certificate, as specified in subpart F of
this part.
(c) Laboratories issued a certificate for PPM procedures are subject
to--
(1) The notification requirements of Sec. 493.53;
(2) The applicable requirements of this subpart and subparts H, J,
K, and M of this part; and
(3) Inspection only under the circumstances specified under
Sec. Sec. 493.1773 and 493.1775, but are not routinely inspected to
determine compliance with the requirements specified in paragraphs
(c) (1) and (2) of this section.
(d) In accordance with subpart R of this part, HHS will initiate
suspension, limitation, or revocation of a laboratory's certificate for
PPM procedures for failure to comply with the applicable requirements
set forth in this subpart. HHS may also impose certain alternative
sanctions. In addition, failure to meet the requirements of this subpart
may result in suspension of all or part of payments under Medicare and
Medicaid, as specified in subpart R of this part.
(e) A certificate for PPM procedures is valid for a period of no
more than 2 years.
[58 FR 5223, Jan. 19, 1993, as amended at 60 FR 20045, Apr. 24, 1995]
Sec. 493.49 Requirements for a certificate of compliance.
A certificate of compliance may include any combination of tests
categorized as high complexity or moderate complexity or listed in
Sec. 493.15(c) as waived tests. Moderate complexity tests may include
those specified as PPM procedures.
(a) HHS will issue a certificate of compliance to a laboratory only
if the laboratory--
(1) Meets the requirements of Secs. 493.43 and 493.45;
(2) Remits the certificate fee specified in subpart F of this part;
and
(3) Meets the applicable requirements of this subpart and subparts
H, J, K, M, and Q of this part.
(b) Laboratories issued a certificate of compliance--
(1) Are subject to the notification requirements of Sec. 493.51; and
(2) Must permit announced or unannounced inspections by HHS in
accordance with subpart Q of this part--
(i) To determine compliance with the applicable requirements of this
part;
(ii) To evaluate complaints;
(iii) When HHS has substantive reason to believe that tests are
being performed, or the laboratory is being operated in a manner that
constitutes an imminent and serious risk to human health; and
(iv) To collect information regarding the appropriateness of tests
listed in Sec. 493.15 or tests categorized as moderate complexity
(including the subcategory) or high complexity.
(c) Failure to comply with the requirements of this subpart will
result in--
(1) Suspension, revocation or limitation of a laboratory's
certificate of compliance in accordance with subpart R of this part; and
(2) Suspension or denial of payments under Medicare and Medicaid in
accordance with subpart R of this part.
(d) A certificate of compliance issued under this subpart is valid
for no more than 2 years.
(e) In the event of a noncompliance determination resulting in an
HHS action to revoke, suspend or limit the laboratory's certificate of
compliance, HHS will--
(1) Provide the laboratory with a statement of grounds on which the
determination of noncompliance is based; and
(2) Offer an opportunity for appeal as provided in subpart R of this
part. If the laboratory requests a hearing within 60 days of the notice
of sanction, it retains its certificate of compliance or reissued
certificate of compliance until a decision is made by an administrative
law judge (ALJ) as provided in subpart R of this part, except when HHS
finds that conditions at the laboratory pose an imminent and serious
risk to human health or when the criteria at Sec. 493.1840(a) (4) and
(5) are met.
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(f) 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 noncompliance determination even if
there has been no appeals decision issued.
(g) A laboratory seeking to renew its certificate of compliance
must--
(1) Complete and return the renewal application to HHS 9 to 12
months prior to the expiration of the certificate of compliance; and
(2) Meet the requirements of Sec. 493.43 and paragraphs (a)(2) and
(b)(2) of this section.
(h) If HHS determines that the application for the renewal of a
certificate of compliance must be denied or limited, HHS will notify the
laboratory in writing of the--
(1) Basis for denial of the application; and
(2) Opportunity for appeal as provided in subpart R of this part.
(i) If the laboratory requests a hearing within the time period
specified by HHS, the laboratory retains its certificate of compliance
or reissued certificate of compliance until a decision is made by an ALJ
as provided in subpart R, except when HHS finds that conditions at the
laboratory pose an imminent and serious risk to human health.
(j) 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 nonrenewal of the certificate of
compliance even if there has been no appeals decision issued.
[60 FR 20045, Apr. 24, 1995]
Sec. 493.51 Notification requirements for laboratories issued a
certificate of compliance.
Laboratories issued a certificate of compliance must meet the
following conditions:
(a) Notify HHS or its designee within 30 days of any change in--
(1) Ownership;
(2) Name;
(3) Location;
(4) Director; or
(5) Technical supervisor (laboratories performing high complexity
only).
(b) Notify HHS no later than 6 months after performing any test or
examination within a specialty or subspecialty area that is not included
on the laboratory's certificate of compliance, so that compliance with
requirements can be determined.
(c) Notify HHS no later than 6 months after 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 compliance.
[57 FR 7143, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]
Sec. 493.53 Notification requirements for laboratories issued a
certificate for provider-performed microscopy (PPM)
procedures.
Laboratories issued a certificate for PPM procedures must notify HHS
or its designee--
(a) Before performing and reporting results for any test of moderate
or high complexity, or both, in addition to tests specified as PPM
procedures or any test or examination that is not specified under
Sec. 493.15(c), for which it does not have a registration certificate as
required in subpart C or subpart D, as applicable, of this part; and
(b) Within 30 days of any change in--
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
[58 FR 5224, Jan. 19, 1993, as amended at 60 FR 20046, Apr. 24, 1995]
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