Md. Code Regs. 10.18.02.06

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.18.02.06 - Responsibilities of Laboratory Directors

A. Except as provided in Regulations .01C and .02 of this chapter, the director of a medical laboratory shall:

(1) Submit a report to the health officer for the jurisdiction where the laboratory is located, within 48 hours after an examination of a specimen from a human body shows one of the following:

(a) A result on a test designed to detect in a sample the presence of HIV in accordance with Health-General Article, § 18-207(b)(1), Annotated Code of Maryland, including negative results;

(b) A quantitative or qualitative HIV viral load test result, including undetectable;

(c) A CD4+ cell test result, count, or percentage in an individual not known to be HIV negative; or II

(d) An HIV genotype sequence test result;

(2) Use the form provided by the Department in making the report required under §A(1) of this regulation;

(3) Include all of the following information in the report required under §A(1) of this regulation:

(a) Name and address of laboratory or assigned laboratory number;

(b) Date the specimen was obtained from the patient;

(c) Type and result of laboratory test, that is, HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence;

(d) Name, date of birth, race, ethnicity, and gender of the patient;

(e) Street address, city, state, and zip code of the patient's residence;

(f) Name of the physician authorizing the laboratory examination; and

(g) Address and telephone number of the physician authorizing the laboratory examination; and

(4) Contact the physician authorizing the laboratory examination to obtain any of the information, as required by §A(3) of this regulation, that is not provided on the laboratory examination order.

B. A laboratory director may not transmit to the health officer or the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method.

C. The laboratory director shall, at the request of the Secretary, make available to the Secretary any remaining clinical material from tested individuals.

D. This regulation does not relieve a physician of the duty to report as set forth in Health-General Article, §§18-201.1 and 18-202.1, Annotated Code of Maryland.

Md. Code Regs. 10.18.02.06

Regulation .06 amended effective 47:10 Md. R. 515, eff. 5/18/2020