Ga. Comp. R. & Regs. R. 111-8-10-.04 - License
(1) Clinical
Laboratory License.
(a) No clinical
laboratory shall be operated without a license issued pursuant to these rules
and regulations and without a licensed director. All laboratory activities,
which are not specifically exempted by these regulations, must be performed in
a license laboratory. Provided, however, a facility or part of a facility in
which laboratory testing is done may qualify for exemption from personnel
requirements when only specific tests or techniques, designated by the
Department and used for screening and monitoring purposes only, are performed,
and the facility or part of the facility is under the supervision of the
laboratory as outlined in Rule
111-8-10-.16.
(b) A license shall be issued by the
Department to a clinical laboratory after all requirements for licensure are
met.
(c) A provisional license may
be issued as an authorization to operate a clinical laboratory for a limited
and specified period of time under the following conditions:
1. After a review of an application and
on-site inspection of a new laboratory has indicated that the laboratory has
the potential to meet required standards and appears to be in substantial
compliance with the requirements of these rules and regulations; or
2. An inspection or review of a licensed
laboratory reveals only correctable deficiencies for which an acceptable plan
of correction has been provided to Licensure of Clinical Laboratories Chapter
111-8-10 the Department and where the deficiencies do not constitute imminent
hazards to patients or to laboratory personnel.
(d) A license shall authorize the performance
of one or more categories, subcategories and/or test procedures and shall be
valid for one year from the date of issue unless sooner canceled, suspended or
revoked. Renewal of a license is subject to continued conformance with all
rules and regulations.
(e) A
license shall specify the names of the owner and director, categories and
subcategories of tests, and the location of the laboratory. The laboratory
license must be displayed at all times in view of the public.
(f) A license shall be valid only for the
clinical laboratory (as defined at
111-8-10-.03(c))
at the stated location and shall not be subject of sale or transfer to any
premises other than those for which it was issued. Should the laboratory change
its location, or ownership, a new application shall be made.
(g) Laboratory licenses shall be maintained
current and changes in categories/subcatogories of tests or off site locations
shall not be implemented without prior notification to and approval by the
Department.
(h) Specimen collection
stations which have a parent clinical laboratory which is licensed by the State
of Georgia may be considered by the Department to be a part of that laboratory;
but subject to all other applicable regulations.
(2)
Director's License.
(a) A director's license shall be issued by
the Department to persons meeting the requirements stated in these rules and
regulations. Applications for licensure or renewal as a director shall be made
on a form provided by the Department accompanied by the non-refundable fee, and
provide pertinent information as deemed necessary by the Department.
(b) The director's license shall be
maintained current and changes in the required information shall be reported to
the Department when they occur. Application shall be made and approved by the
Department prior to assumption of duties as a laboratory director.
(c) Any licensed laboratory director who is
convicted, pleads guilty or nolo contendere or receives first offender
treatment under the laws of this state, the United States, or any other state
of any criminal offense involving the manufacture, distribution, trafficking,
sale, or possession of a controlled substance or marijuana shall notify the
Department of the conviction within ten days following the conviction, plea or
first offender treatment.
Notes
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No prior version found.