S.L. 458.25 Art. 8Registers and records.

(1) The licensee shall keep and maintain an updated register in connection with all tests carried out at the laboratory, which register shall, in respect of each patient, include the following information:

(a) the name and surname, (or initials), a legally valid identification document number, sex, address and date of birth of the patient;

(b) the name, surname, address and medical registration number of the referring medical practitioner;

(c) the date when the request was received at the laboratory;

(d) the type of test requested by the referring medical practitioner;

(e) the type of test carried out at the laboratory and methods used;

(f) the name of the microbiologist, biochemist or other pathologist, or toxicologist responsible for the test, as well as the technical person who carried out the test;

(g) where practicable, the result of the test: Provided that the requirements in respect of the identity of the patient shall not apply when the blood of a patient is taken for testing for the human immunodeficiency virus, so that this test is carried out in a government laboratory.

(2) The licensee shall also keep records of reports of all results of tests carried out at his laboratory.

(3) (a) The licensee shall require all persons to whom Part II and Part V of the Act refers, to register their attendance at the laboratory, indicating date and time and whether entering or leaving the laboratory, immediately on entering and immediately before leaving the laboratory, in a register kept for the purpose. The licensee shall transmit the contents of such register to the Ministry or department in such manner as specified by the Minister.

(4) The Minister may from time to time prescribe that additional registers be kept as may be deemed necessary to ensure good laboratory practice.