Haw. Code R. § 11-113-8 - Licensing of laboratories
(a) Laboratories in
this State performing substance abuse testing shall be licensed by the
department for that purpose.
(b) A
laboratory seeking a license shall submit to the department a request in
writing for an application form.
(c) Each license issued pursuant to this
chapter shall be issued to the owner of the laboratory and shall expire within
twenty-four months from the date of issuance.
(d) A laboratory must meet all of the
following provisions to qualify for a license:
(1) The laboratory is located in this
State.
(2) Laboratory personnel
meet the qualifications specified in section §
11-113-15.
(3) The laboratory facility performing
substance abuse testing shall be secured.
(4) The laboratory shall use proper chain of
custody procedures.
(5) The
laboratory shall use screening or confirmatory testing procedures, or both,
which are acceptable to the director.
(6) The laboratory shall have a quality
assurance program which is acceptable to the director.
(7) The laboratory must be enrolled in a
performance testing program which is acceptable to the director, at no cost to
the department.
(e) As
conditions to obtaining the license, the laboratory must agree to and execute
the following:
(1) Submit to the department
all results of performance testing in a timely manner;
(2) Receive, test, and submit reports to the
department on performance testing samples which may be supplied by the
department, at no cost to the department.
(3) Notify the department within thirty days
of any significant change in personnel, procedures, or operations which may
affect the reliability and accuracy of testing and the accurate reporting of
test results.
(4) Submit to onsite
inspections by the director or the director's representative. A laboratory will
be given at least twenty- four hours' oral or written notice, or both, before
any inspection.
(f) The
director may issue a license to any laboratory that meets the provisions of
subsections (d) and (e) and passes:
(1) An
official laboratory inspection conducted by the department, and
(2) A performance test acceptable to the
director.
(g) Under
interim conditions, the director may issue a provisional license of limited
duration to any laboratory in the State which meets the provisions of
subsection (d).
(h) A license shall
be forfeited prior to its expiration date if one or more of the following
occurs:
(1) The owner sells or otherwise
transfers the ownership of the laboratory.
(2) There is a change in the location of the
laboratory or structural alteration without prior written approval by the
department, which may affect adversely the quality of testing.
(3) The license holder surrenders the license
to the department.
(4) The license
holder fails to make full payment of the license fee.
(i) Upon any change in the ownership of a
laboratory, the director may issue a provisional license, upon written
application by the new owner pursuant to subsection (b);
(1) For a period not to exceed ninety days
from the date of the change in the ownership of the laboratory;
(2) Upon written assurance by the new owner
that the operation of the laboratory will continue to meet all provisions of
subsection (d); and
(3) Upon onsite
inspection by the director or the director's representative.
(j) The license shall specify the
name and address of the laboratory, the name of the owner, types of specimens
and tests which the licensee is allowed to perform and the substances of abuse
for which the licensee is allowed to analyze, and the designated cutoff levels.
The licensee must apply to the director of health for written approval of any
changes or additions of tests of substances of abuse.
(k) The director shall keep a current listing
of all laboratories performing substance abuse tests in the State. This listing
may be sent to any third party upon written request.
Notes
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