Md. Code Regs. 10.51.05.03

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

Section 10.51.05.03 - Quality Assurance - Specific for Postmortem Forensic Toxicology

A. In addition to any applicable requirement in this chapter, a forensic laboratory performing postmortem forensic toxicology shall establish a:

(1) Procedure for responding to requests for the laboratory's information and documentation; and

(2) Policy for:

(a) Retention and release of laboratory information;

(b) Addressing the confidentiality of laboratory data; and

(c) Identifying:

(i) The extent to which interpretations may be provided with test results; and

(ii) Who is authorized to provide interpretations.

B. Specimen Collection and Handling.

(1) A laboratory director shall develop and provide, to all agencies or parties that submit or request postmortem toxicology analyses, instructions that include the specific requirements for the:

(a) Type and minimum amount of specimen needed to perform the:

(i) Requested analysis; and

(ii) Subsequent interpretations;

(b) Type and size of specimen container;

(c) Type and amount of preservative to be added to biological fluids, when applicable;

(d) Labeling of each individual specimen container;

(e) Packaging and transport of a specimen;

(f) Submission of relevant medical history on decedents who may carry a highly infectious disease, such as tuberculosis, hepatitis, or human immunodeficiency virus (HIV);

(g) Labeling of each specimen as to type and source, if applicable; and

(h) Proper sealing of containers to prevent:

(i) Leakage of the specimen container; and

(ii) Cross-contamination between specimens.

(2) A licensee shall ensure that a specimen submitted for postmortem toxicology testing includes documentation that provides pertinent case information, including the:

(a) Name of decedent;

(b) Date of specimen collection; and

(c) Pertinent history of the case.

(3) For a specimen received for postmortem toxicology testing, a laboratory shall maintain a written or electronic record documenting the:

(a) Condition of the specimen;

(b) Handwritten initials or electronic signature of the individual who received the specimen;

(c) Date the specimen was received;

(d) Name of the decedent;

(e) Unique identifier assigned to the specimen;

(f) Specimen type;

(g) Date the specimen was collected; and

(h) Identification of the individual who collected the specimen.

(4) A licensee shall develop and follow a policy for the retention, release, and disposal of specimens submitted for postmortem toxicology testing.

Md. Code Regs. 10.51.05.03