Kansas Hospital Laboratory Regulations


28-34-11

Laboratory. (a) Definitions.
(1) ''CLIA'' means Public Law 100-578 implemented
by 42 CFR 493 issued Feb. 28, 1992, as
in effect on Sept. 1, 1992; changes in subparts H,
R and preamble to the Feb. 28, 1992 final rule
issued Aug. 11, 1992, as in effect on Sept. 1, 1992;
technical corrections made in subparts T, F, A, K,
C, Q, M and R issued Jan. 19, 1993, as in effect
on Sept. 1, 1992; and changes in subparts M and
K issued July 22, 1993, as in effect on Jan. 19,
1993.
(2) ''Clinical consultant'' means the individual
or individuals in the laboratory defined by 42 CFR
493.1417(b), as in effect on Sept. 1, 1992 or
493.1455(b), as in effect on Sept. 1, 1992.
(b) The laboratory or laboratories performing
analytical tests within the hospital shall hold a
valid CLIA certificate for the type and complexity
of all tests performed.
(c) Clinical laboratory services shall be available
on the hospital premises or provided by a
CLIA certified laboratory.
(d) An ''authorized individual'' shall, through
written or electronic means, request all tests performed
by the laboratory. The individual or individuals
serving as the laboratory's clinical consultant
or consultants, defined by 42 CFR
493.1417(b), as in effect on Sept. 1, 1992 or 493.
1455(b), as in effect on Sept. 1, 1992, shall clearly
define in writing an ''authorized individual.''
(e) All tissues removed shall be macroscopically
examined. If deemed necessary, by written
hospital policies and procedures, tissues shall then
be microscopically examined. A list of all tissues
which routinely do not require microscopic examination
shall be developed in writing by a pathologist
and approved by the medical staff of
each hospital.
(f) The original report or duplicate copies of
written tests reports and supporting records shall
be retained in a readily retrievable form by the
laboratory for a period of at least:
(1) two years for routine test reports;
(2) five years for blood banking test reports;
and
(3) ten years for histologic or cytologic test reports.
(g) Facilities for procurement, safekeeping,
and transfusion of blood, blood products or both
shall be provided or readily available. If blood
products or transfusion services are provided by
sources outside the hospital, they shall be provided
by a CLIA certified laboratory. The source
shall be certified for the scope of testing performed
or products provided.
(h) Laboratories shall release all proficiency
test results to KDHE within seven days of a written
request. (Authorized by and implementing
K.S.A. 65-431; effective Jan. 1, 1969; amended
Jan. 1, 1974; amended May 3, 1996.)