Current through September 18, 2024
A. No less than
thirty (30) days after receipt of an application for an initial license, the
licensing agency shall issue a license, if the applicant meets the requirements
of the Act and this Part. Said license, unless sooner suspended or revoked,
shall expire on the 30th day of December of every other the year following the
date of license.
B. A license shall
be issued only for the premises and persons named in the application and shall
not be transferable.
C. The license
issued to a clinical laboratory shall clearly identify the specialty(ies) the
laboratory is licensed to provide. Such specialties shall include, but not be
limited to, the following:
1. Microbiology,
including bacteriology, virology, mycology and parasitology;
2. Immunohematology, including blood group
and Rh typing and crossmatching;
3.
Diagnostic immunology, including syphilis serology and general
immunology;
4. Pathology, including
tissue, oral and cytology;
5.
Hematology, including coagulation;
6. Clinical chemistry, including urinalysis,
endocrinology, and toxicology;
7.
Radiobioassay techniques; and
8.
Other specialties and subspecialties as recognized by the U.S. Department of
Health and Human Services.
D. Prior to issuing a license, the licensing
agency shall review the following documents required to be provided by a
laboratory prior to licensure:
1. Laboratory
Director: provide documentation of the qualifications of the individual
designated as laboratory director and a copy of that individual's
resume;
2. Laboratory staff:
provide a list of technical personnel that includes qualification designations
(MT, MLT, etc); also designate the individuals' primary special area(s), if the
application is for more than one specialty area;
3. Hours of operation: provide a statement
about the laboratory hours of operation;
4. Laboratory facility: provide floor plans
or a description of the facility that supports a statement that the facility is
adequate for the scope of services for which licensure is requested;
5. Equipment: provide a current equipment
list representing all of the testing equipment for the specialty area(s) for
which licensure is requested;
6.
Summary of tests performed: provide a list of all the tests for which licensure
is requested;
7. Proficiency
testing program: identify the proficiency testing program(s) for each
specialty, subspecialty, or analyte for which licensure is requested;
8. Quality control program: provide
information regarding how the daily quality control program is achieved and
used to ensure accurate testing;
9.
Quality assurance: provide a description of the laboratory's quality assurance
program or a copy of the quality assurance plan;
10. Fees: see §§
4.4(A)(1) and
(2) of this Part and the Fee Structure for
Licensing, Laboratory and Administrative Services Provided by the Department of
Health (Part 10-05-2 of this Title).
E. A license issued under this Part shall be
the property of the state and loaned to the licensee and shall be kept posted
in a conspicuous place on the licensed premises.
F. Out-of-State Laboratories
1. In addition to meeting the requirements
stated in §§
4.5(A) through
(E) of this Part, an out-of-state laboratory
shall be required to meet the additional requirements stated in §
4.5(F)(3) of
this Part.
2. Notwithstanding the
foregoing, upon payment of any applicable license fees, the Director may grant
immediate licensure to any clinical laboratory licensed as such in another
state and certified under the Clinical Laboratory Improvements Act of 1988,
when such clinical laboratory has been asked to perform a clinical laboratory
service which is not offered by any other clinical laboratory then licensed in
this state.
3. Any out-of-state
laboratory performing clinical laboratory tests on specimens collected in Rhode
Island shall be licensed in accordance with the requirements stated in this
Part.
a. Prior to issuing a license, the
licensing agency shall review documentation of certification/licensure status
supplied by the out-of-state laboratory to determine if the laboratory is:
(1) Certified by a federal agency in the
specialties for which it is seeking licensure; and/or
(2) Licensed in good standing by the state
agency in which the laboratory is located, and provided the laws, rules and
regulations for licensure of said state are deemed equivalent to or exceed the
laws, rules and regulations in this Part as determined by the Director of
Health.
4. If
an out-of-state laboratory meets the all of the requirements stated in this
Part, the licensing agency shall issue a license.
