RELATES TO: KRS Chapter 333
NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 authorizes
the Cabinet for Human Resources to periodically inspect medical laboratories in
Kentucky and to withhold the issuance of a license to the medical laboratory
until the cabinet determines that the laboratory is adequately staffed and
equipped to operate in conformity with the requirements of KRS Chapter 333 and
the administrative regulations promulgated thereunder. KRS Chapter 333 directs
the Secretary for Human Resources to adopt rules and regulations to effectuate
the purposes of KRS Chapter 333 including the licensure of medical
laboratories, standards of performance in the examination of specimens, and the
operation by the cabinet of a medical laboratory evaluation program. This
administrative regulation describes the proficiency test program which shall be
employed by the cabinet to evaluate the work of medical laboratories.
Section 1. Definitions.
(1) "Reference laboratory" means a laboratory
designated by the cabinet to authenticate the identification, content, or titer
of samples and other materials used in proficiency testing.
(2) "Referee laboratory" means a laboratory
designated by the cabinet to examine specimens or other materials for
proficiency testing using the time schedule allowed for licensed laboratories
and under conditions similar to those under which licensed laboratories examine
materials.
Section 2.
Proficiency Testing; Procedures, Samples, Test Conditions. Applicants and
licensees shall be subject to a proficiency testing program approved by the
cabinet, to aid in assessing the competency of laboratory staff and the
adequacy and quality of facilities, equipment, reagents, working conditions,
and procedures. Testing may be carried out during on-site inspections by the
cabinet or by submittal to laboratories of samples for examination. In
conducting testing, the following rules shall apply:
(1) The laboratory shall be tested only in
those procedures or specialties of procedures for which a license application,
original or renewal, has been filed with the cabinet, or for which the cabinet
has issued a license.
(2) Samples
shall be examined by regularly assigned personnel using the laboratory's
routine methods.
(3) Samples to be
tested may be provided prior to, during, or subsequent to
inspections.
(4) Time allowed for
testing of samples shall be the time required under conditions of normal
laboratory operations, as determined by the cabinet.
(5) Laboratory personnel shall enter the date
and time of receipt of samples, results of tests, and other information
required by the cabinet, on forms provided or required by the
cabinet.
Section 3.
Proficiency Testing; Reference Laboratories and Referee Laboratories. Samples
identical to those submitted to the applicant or licensee laboratory shall be
submitted to reference or referee laboratories designated by the
cabinet.
Section 4. Proficiency
Testing; Reporting of Test Scores.
(1) If
laboratory reports reflect a lack of proficiency, the cabinet may recommend
corrective measures, consultation, or training in an appropriate laboratory and
may, upon written request of the laboratory director, furnish the laboratory
with additional samples after corrective measures have been taken.
(2) Results reflecting a lack of proficiency
may constitute a basis for denial, revocation, suspension, or limitation of the
laboratory license, as provided by
KRS
333.190(3).
