CHAPTER 3
CERTIFICATE FOR MINIMAL COMPLEXITY
3-1. Application for a certificate for minimal complexity testing (§493.35)
a. Filing of application. Except as specified in paragraph b below, a laboratory
performing only one or more minimally complex tests listed in paragraph
2-3 must file a separate application for each laboratory location.
b. Exceptions
(1) Each laboratory not in a fixed location except as otherwise exempted under paragraph 2-1 must file an application using the address of the home base, including:
(a) A laboratory that moves from testing site to testing site or has a temporary testing location, such as a health screening fair; and
(b) Each mobile van providing lab services.
(2) DoD laboratories that engage in limited (not more than 15 waived or moderate) public health testing may file a single application.
(3) DoD laboratories under the jurisdiction of a single hospital or clinic commander that provide services limited to minimally complex tests may file a single application or multiple applications for the Certificate of Minimal Complexity testing laboratory sites under their command.
c. Application format and contents. 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 commander of the hospital or clinic who attests that the laboratory will be operated in accordance with requirements established in these Regulations.
(3) Describe the characteristics of the laboratory operation and the examinations and other test procedures performed by the laboratory including:
(a) 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).
(b) Where required, 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. Laboratories that perform one or more minimally complex tests listed
in paragraph 2-3c and no other tests must:
(1) Make records available and submit reports through command channels to TSG as TSG may reasonably require to determine compliance with this chapter and paragraph 2-3e.
(2) Agree to permit announced and unannounced inspections by TSG or their designee in accordance with Chapter 13 under the following circumstances:
(a) When TSG has substantive reason to believe that the laboratory is being operated in a manner that constitutes an imminent and serious risk to human health.(b) To evaluate complaints from health care beneficiaries or MTF/Clinic commanders.
(c) On a random basis to determine whether the laboratory is performing tests not listed in paragraph 2-3.
(d) To collect information for the addition, deletion, or continued inclusion of tests listed in paragraph 2-3.
e. If TSG determines that the application for a certificate of minimal complexity
testing is to be denied, TSG will, through command channels, provide the
laboratory with a written statement of the grounds on which the denial is
based and an opportunity for re-review, in accordance with Chapter 14.
3-2. Requirements for a certificate for minimal complexity testing (§493.37)
a. TSG will issue a certificate for minimal complexity testing to a laboratory
only if the laboratory meets the requirements of paragraph 3-1.
b. Laboratories issued a certificate for minimal complexity testing:
(1) Are subject to the requirements of this chapter and paragraph 2-3e.
(2) May undergo unannounced inspections by TSG or their designee in accordance with Chapter 13.
c. In accordance with Chapter 14, TSG will suspend, revoke, or limit a laboratory's
certificate for minimal complexity testing for failure to comply with the
requirements of this chapter.
d. A certificate for minimal complexity testing issued under this chapter
is valid for no more than 2 years. In the event of a noncompliance determination
resulting in TSG action to revoke, suspend, or limit the laboratory's certificate
for minimal complexity testing, TSG will, through command channels, provide
the laboratory with a statement of grounds on which the determination of
noncompliance is based, and offer an opportunity for review as provided
in Chapter 14.
e. A laboratory seeking to renew its certificate for minimal complexity
testing must:
(1) Complete the renewal application prescribed by OASD(HA) and return it through command channels to TSG not less than 3 months nor more than 6 months before the expiration of the certificate.
(2) Meet the requirements of paragraphs 3-1 and 3-2.
f. A laboratory with a certificate for minimal complexity testing that wishes
to perform examinations or test procedures not listed in the minimal complexity
test category must meet the requirements set forth in Chapter 4 or
Chapter 5.
3-3. Notification requirements for laboratories issued a certificate
for minimal complexity testing (§493.37)
Laboratories performing one or more tests listed in paragraph 2-3 and no
others must notify TSG or their designee if any of the following occur:
a. Before performing and reporting results for any test or examination that
is not specified under paragraph 2-3 for which it does not have the appropriate
certificate as required in Chapter 4 or Chapter 5.
b. Within 30 days of any change(s) in:
(1) Name;
(2) Location; or
(3) Director.Return to Table of Contents