RELATES TO: KRS Chapter 333
NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 requires
medical laboratories in Kentucky to keep records involving medical laboratory
services and copies of reports of laboratory tests for the period of time and
in a manner prescribed by administrative regulation. KRS Chapter 333 authorizes
the Secretary for Human Resources to adopt rules and regulations to effectuate
the purposes and provisions of the chapter. This administrative regulation
describes the contents of test and specimen records to be maintained by the
medical laboratories.
Section 1.
Records of Observations. Records of observations shall be made by the medical
laboratory concurrently with the performance of each step in the examination of
specimens.
(1) The records shall reflect the
actual results of all control procedures.
(2) Pursuant to
KRS 333.180(1), all pertinent
laboratory records shall be made available to inspection, examination, and
copying as the cabinet may direct.
(3) All records shall be retained for a
period of at least two (2) years after the date of submittal of the report,
except as otherwise prescribed by law.
Section 2. Specimen Records. Daily accession
records shall be maintained containing the following information:
(1) Laboratory number of the specimen or
other means of identification;
(2)
Name and other identification of the person from whom the specimen was taken,
if available;
(3) Name of the
licensed physician or other person or laboratory submitting the
specimen;
(4) Date the specimen was
collected by the physician or other authorized person, if available;
(5) Date the specimen was received in the
laboratory;
(6) Condition of
unsatisfactory specimens and packages if received (e.g., broken, leaked,
hemo-lyzed, or turbid);
(7) Type of
test performed;
(8) Result of the
laboratory test; and
(9) Date the
test was completed.
