Md. Code Regs. 10.51.05.02

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.51.05.02 - 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) (text unchanged)

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.

Md. Code Regs. 10.51.05.02

Regulation .02 amended effective 42:14 Md. R. 880, eff.7/20/2015