Regulation .03 Quality Assurance — Specific for Postmortem Forensic Toxicology.
Regulation .03 Quality Assurance — Specific for Postmortem Forensic Toxicology.LinkCopy Citation
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.