CHAPTER 5
CERTIFICATE OF ACCREDITATION
5-1. Application for registration certificate and certificate of accreditation
(§493.55)
a. A laboratory may be issued a certificate of accreditation in lieu of
the applicable certificate specified in Chapter 3 or Chapter 4 provided
the laboratory:
(1) Meets the standards of a private non-profit accreditation program approved by OASD(HA). In order for an accreditation program to receive OASD(HA) approval, the program must be offered by a private non-profit organization, and the program must submit to OASD(HA) written evidence that the program has been approved by HHS.
(2) Files a separate application for each location, except as specified in paragraph b below.
b. Exceptions
(1) Each laboratory that is not in a fixed location except as otherwise exempted under paragraph 2-1 must file a single application using the address of the home base, including:
(a) A laboratory that moves from testing site to testing site or uses a temporary testing location, such as a health screening fair.
(b) Each mobile van providing laboratory testing.
(2) DoD laboratories that engage in limited (not more than 15 moderately complex or minimally complex tests per certificate) public health testing may file a single application.
(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 tests and examinations performed annually (excluding 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 section.
5-2. Requirements for a registration certificate (§493.57)
A registration certificate is required for all laboratories seeking a certificate
of accreditation, unless the laboratory holds a valid certificate issued
by TSG.
a. TSG will issue a registration certificate if the laboratory:
(1) Complies with the requirements of paragraph 5-1.
(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.
b. The laboratory must provide TSG with proof of accreditation by an approved
accreditation program:
(1) Within 11 months of issuance of the registration certificate; or
(2) Prior to the expiration of the certificate of compliance.
c. If such proof of accreditation is not supplied within this time frame,
the laboratory must meet, or continue to meet, the requirements of paragraph
4-4.
d. In accordance with Chapter 14, TSG, through command channels, 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 Chapter. TSG,
or their designee, may also impose certain alternative sanctions.
e. A registration certificate is valid for a period of no more than 2 years.
However, it may be extended if the laboratory is subject to paragraph 5-2c
above, and compliance has not been determined by TSG before the expiration
date of the registration certificate.
f. In the event that the laboratory does not meet the requirements of this
Chapter, TSG 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 Chapter 4.
5-3. Requirements for a certificate of accreditation (§493.61)
a. TSG will issue a certificate of accreditation to a laboratory if the
laboratory meets the requirements of paragraph 5-2 or, if applicable, paragraph
4-4.
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 paragraph 5-4.
(3) Comply with the requirements of the approved accreditation program.
(4) Permit random sample validation and complaint inspections as required in Chapter 13.
(5) Permit OASD(HA), TSG, or their designee to monitor the correction of any deficiencies found through the inspections specified in paragraph b(4) above.
c. A laboratory failing to meet the requirements of this chapter:
(1) Will no longer meet the requirements of CLIP by virtue of its accreditation in an approved accreditation program;
(2) Will be subject to full determination of compliance by TSG, and reviewed by OASD(HA);
(3) May be subject to suspension, revocation, or limitation of the laboratory's certificate of accreditation,or certain alternative sanctions.
d. A certificate of accreditation issued under this chapter 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 TSG or their designee.
e. Failure to meet the applicable requirements of these regulations, will
result in an action by TSG to suspend,revoke or limit the certificate of
accreditation. TSG or their designee 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 Chapter 4.
(3) Offer an opportunity for re-review as provided in Chapter 14.
f. In the event the accreditation organization's approval is removed by
OASD(HA), the laboratory will be subject to the applicable requirements
of Chapter 4 or paragraph 5-2 above.
g. A laboratory seeking to renew its certificate of accreditation must:
(1) Complete and return the renewal application through command channels to TSG no less than 6 months,no more than 9 months prior to the expiration of the certificate of accreditation.
(2) Meet the requirements of this chapter.
h. If TSG determines that the renewal application for a certificate of accreditation
is to be denied or limited,TSG, utilizing command channels, 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 Chapter 4.
(3) The opportunity for re-review on TSG's action to deny the renewal application for certificate of accreditation as provided in Chapter 14.
5-4. Notification requirements for laboratories issued a certificate
of accreditation (§493.63)
Laboratories issued a certificate of accreditation must:
a. Notify TSG or their designee and the approved accreditation program within
30 days of any changes in:
(1) Name.
(2) Location.
(3) 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 the certificate of accreditation
can be amended.
c. Notify the accreditation program 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 accreditation.
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