10.51.05.02

.02 Quality Assurance — Specific.

A. Policies and Procedure.

(1) A licensee shall develop, establish, maintain, implement, and follow quality assurance policies and procedures that ensure that the laboratory’s quality system is maintained.

(2) A licensee shall ensure that the laboratory has a clear procedure describing the process to uniquely identify evidence.

(3) Chain of Custody. The licensee shall:

(a) Maintain a record of chain of custody in written or electronic form in order to maintain accurate tracking of all evidence; and

(b) Document each transfer of evidence with the date of transfer and the signature of the person receiving the evidence at the time of transfer.

B. Identifying and Handling Evidence. A licensee shall:

(1) Ensure that each item of evidence received by the forensic laboratory:

(a) Is permanently marked and includes a unique identifier either on the:

(i) Evidence itself; or

(ii) Proximal container of the evidence; and

(b) Has a documented record that includes the:

(i) Identity of the evidence submitter;

(ii) Date the item of evidence was submitted; and

(iii) Description of the item of evidence submitted;

(2) Establish and follow a procedure to identify evidence that cannot be marked or identified as set forth in §B(1) of this regulation;

(3) Ensure all items produced during a forensic analysis or examination are:

(a) Marked with a unique identifier that can be traced back to the original evidence;

(b) Appropriately packaged;

(c) Documented in case notes, reports, and the evidence tracking system; and

(d) Packed with the original evidence when applicable or a disposition will be noted;

(4) Ensure documentation of the date of receipt of each test item and evidence;

(5) Establish, maintain, and follow a procedure to define proper packaging and sealing of evidence requiring that:

(a) Evidentiary seals:

(i) Are initialed or marked by the person sealing the evidence; and

(ii) Prevent the evidence from being removed, lost, altered, or contaminated; and

(b) Evidence is protected from:

(i) Loss;

(ii) Cross-contamination; and

(iii) Any harmful change; and

(6) Consider evidence containers properly sealed only if:

(a) The contents cannot readily escape; and

(b) Entering the container results in obvious damage or alteration to the container or the container’s seal.

C. Deficiencies, Errors, and Corrective Actions. A licensee shall have:

(1) A procedure for corrective actions to be taken when a deficiency or error is identified with:

(a) A forensic analysis procedure or method; or

(b) The casework or proficiency testing of a forensic analyst or examiner; and

(2) The procedure and required documentation for the corrective actions include:

(a) A determination of the cause of the deficiency or error;

(b) An evaluation of the deficiency or error to determine if the deficiency or error causes or has caused an adverse effect on the quality of a forensic analysis;

(c) An indication of the individual responsible for corrective action;

(d) A timeline of corrective action or actions; and

(e) Verification that the corrective action was:

(i) Implemented; and

(ii) Monitored for effectiveness in correcting the deficiency or error.

D. A licensee shall designate a quality assurance manager to oversee and ensure that the quality assurance program is implemented, maintained, and routinely evaluated.

E. A licensee shall ensure that a change to an entry on an examination document, whether written or electronic, is:

(1) Trackable to the person who made the change; and

(2) Not erased, hidden, obscured, disguised, or obliterated.

F. A licensee shall establish and follow a procedure to document any:

(1) Evidence discrepancies;

(2) Compromise of evidence integrity; or

(3) Lost or misplaced evidence.

G. A licensee shall document all quality assurance and quality control activities as set forth in this subtitle.

H. A licensee shall establish a procedure to:

(1) Investigate, resolve, and document a forensic analysis discrepancy; and

(2) Allow for a request and approval from the director or designee for a deviation from standard operating procedures.

I. Public Record.

(1) A licensee shall establish and follow a procedure to make discrepancy logs, contamination records, and test results available to the public within 30 days of a written request.

(2) A contamination record shall include the following information:

(a) Unique case identifier;

(b) Encoded sample identification;

(c) Description of results; and

(d) Identifiers that led to an incident report.