CHAPTER 4
REGISTRATION CERTIFICATE, CERTIFICATE FOR PROVIDER-PERFORMED
MICROSCOPY PROCEDURES, AND CERTIFICATE OF COMPLIANCE
4-1. Application for registration certificate, certificate for provider-performed
microscopy (PPM) procedures,and certificate of compliance (§493.43)
a. Except as specified in paragraph b below, all laboratories performing
tests of moderate complexity (including the subcategory), or high complexity,
or any combination of these tests, 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) DoD laboratories that engage in limited (not more than a combination of 15 moderately or minimally complex tests per certificate) public health testing may file a single certificate.
(3) DoD laboratories under the jurisdiction of a single hospital or clinic commander and that are supervised by a single laboratory director may file a single application, or multiple applications, for the laboratory sites under their command.
c. The application must:
(1) Be made to TSG or their designee on a form or forms prescribed by OASD(HA).
(2) Be signed by the laboratory director and the commander of the hospital or clinic who attests that the laboratory will be operated in accordance with requirements established in this Publication.
(3) Describe the characteristics of the laboratory operation and the examinations and other test procedures performed by the laboratory including:
(a) The name and total number of test procedures and examinations performed annually (excluding minimally complex tests or tests for quality control, quality assurance or proficiency testing purposes).
(b) The methodologies for each laboratory test procedure or examination performed, or both.
(c) The qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and test procedures.
d. All laboratories must make records available and submit reports through
command channels to TSG as TSG may reasonably require to determine compliance
with this chapter.
4-2. Requirements for a registration certificate (§493.45)
a. A registration certificate issued by TSG is required in the following
cases:
(1) Initially for all laboratories performing test procedures of moderate complexity (other than the subcategory of PPM procedures) or high complexity, or both.
(2) For all laboratories that have been issued a certificate for minimal complexity testing, or certificate for PPM procedures that intend to perform tests of moderate or high complexity, or both, in addition to those tests listed in paragraph 2-3 or specified as PPM procedures.
b. TSG will issue a registration certificate if the laboratory:
(1) Complies with the requirements of paragraph 4-1.
(2) Agrees to notify TSG or their designee within 30 days of any changes in name, location or director.
(3) Agrees to treat proficiency testing samples in the same manner as it treats patient specimens.
c. Prior to the expiration of the registration certificate, a laboratory
must:
(1) Be inspected as specified in Chapter 13 by TSG, or their designee, or by a private nonprofit accrediting agency approved by OASD(HA).
(2) Demonstrate compliance with the applicable requirements of this chapter and Chapters 6, 7, 8, 9, 10,11, 12 and 13.
d. In accordance with Chapter 14, TSG, through command channels, 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 chapter. TSG,
or their designee may also impose certain alternative sanctions.
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.
(2) Not renewable; however, a registration certificate may be extended if compliance has not been determined by TSG or their designee prior to the expiration date of the registration certificate.
f. In the event of a non-compliance determination resulting in a TSG denial
of a laboratory's certificate of compliance application, TSG, through command
channels, will provide the laboratory with a statement of grounds on which
the non-compliance determination is based, and offer an opportunity for
re-review as provided in Chapter 14.
4-3. Requirements for a certificate for provider-performed microscopy
(PPM) procedures (§493.47)
a. A certificate for provider-performed microscopy procedures is required:
(1) Initially for all laboratories performing test procedures specified as PPM procedures.
(2) For all certificate of minimal complexity laboratories that intend to perform only test procedures specified as PPM procedures in addition to those listed in paragraph 2-3.
b. TSG will issue a certificate for provider-performed microscopy procedures
if the laboratory complies with the requirements of paragraph 4-1.
c. Laboratories issued a certificate for provider-performed microscopy procedures
are subject to:
(1) The notification requirements of paragraph 4-6.
(2) The applicable requirements of this Chapter and Chapters 6, 7, 8, 9, 10, 11, and 12.
(3) Inspection only under the circumstances specified under paragraph 13-2, but are not routinely inspected to determine compliance with the requirements specified in paragraphs c(1) and (2) above.
d. In accordance with Chapter 14, TSG will initiate suspension, limitation,
or revocation of a laboratory's certificate for provider-performed microscopy
procedures for failure to comply with the applicable requirements set forth
in this chapter. TSG, or their designee, may also impose alternative sanctions.
e. A certificate for provider-performed microscopy (PPM) procedures is valid
for a period no more than 2 years.
4-4. Requirements for a certificate of compliance (§493.49)
A certificate of compliance may include any combination of tests categorized
as moderate complexity or high complexity or listed in paragraph 2-3 as
minimally complex tests. Moderate complexity tests may include those specified
as PPM procedures.
a. TSG will issue a certificate of compliance to a laboratory only if the
laboratory:
(1) Meets the requirements of paragraphs 4-1 and 4-2 above.
(2) Meets the applicable requirements of this chapter and Chapters 6, 7, 8, 9, 10, 11, 12, and 13.
b. Laboratories issued a certificate of compliance:
(1) Are subject to the notification requirements of paragraph 4-5 below.
(2) Must permit announced or unannounced inspections by TSG, or their designee, in accordance with Chapter 13:
(a) To determine compliance with the requirements of this program.
(b) To evaluate complaints from health care beneficiaries or MTF/Clinic commanders;
(c) When TSG has substantive reason to believe that any tests are being performed, or the laboratory is being operated in a manner that constitutes an imminent and serious risk to human health.
(d) To collect information regarding the addition, deletion, or continued inclusion of tests listed in paragraph 2-3 or tests categorized as moderate complexity (including the subcategory) or high complexity.
c. Failure to comply with the requirements of this chapter will result in
suspension, revocation or limitation of a laboratory's certificate in accordance
with Chapter 14.
d. A certificate issued under this Chapter is valid for no more than 2 years.
e. In the event of a non-compliance determination resulting in a TSG action
to revoke, suspend or limit the laboratory's certificate, TSG will:
(1) Provide the laboratory with a statement of grounds on which the determination of non-compliance is based.
(2) Offer an opportunity for review as provided in Chapter 14. If the laboratory requests a hearing within 60 days of the notice of sanction, it retains its certificate until a decision is made by TSG, except when TSG finds that conditions at the laboratory pose a serious risk to human health, or when criteria at paragraph 14-12a(4) are met.
f. A laboratory seeking to renew its certificate of compliance must:
(1) Complete and return the renewal application through command channels to TSG not less than 3 months, nor more than 6 months prior to the expiration date of the certificate.
(2) Meet the requirements of paragraph 4-1and paragraphs a(2) and b(2) above.
g. If TSG determines that the application for the renewal of a certificate
of compliance is to be denied or limited, TSG, utilizing command channels,
will notify the laboratory in writing of the:
(1) Basis for denial of the application.
(2) Opportunity for re-review as provided in Chapter 14.
4-5. Notification requirements for laboratories issued a certificate
of compliance (§493.51)
Laboratories issued a certificate must:
a. Notify TSG or their designee within 30 days of any change in:
(1) Name;
(2) Location; or
(3) Director.
b. Notify TSG 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 OASD(HA) or its designee 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.
4-6. Notification requirements for laboratories issued a certificate
for physician-performed microscopy procedures (§493.53)
Laboratories issued a certificate for provider-performed microscopy (PPM)
procedures must notify TSG or their 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 in paragraph 2-4c for which
it does not have a registration certificate, as required in Chapter 4 or
Chapter 5.
b. Within 30 days of any change in:
(1) Name;
(2) Location; or
(3) Director.Return to Table of Contents