Title 902 | Chapter 011 | Regulation 045


902 KAR 11:045.Test and specimen records.

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, hemolyzed, or turbid);

(7)

Type of test performed;

(8)

Result of the laboratory test; and

(9)

Date the test was completed.

HISTORY: (3 Ky.R. 203; eff. 5-4-1977; 20 Ky.R. 2188; eff. 3-14-1994; Crt eff. 3-22-2019.)

7-Year Expiration: 3/22/2026

Last Action: 12/15/2021


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