Md. Code Regs. 10.51.06.07

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

Section 10.51.06.07 - Director - Specific Duties and Responsibilities

A forensic laboratory director shall:

A. Be accessible to forensic laboratory employees to provide on-site, telephonic, or electronic consultation as needed;

B. Ensure that:

(1) Forensic testing and examination systems developed and used for each forensic analysis performed in the laboratory provide quality laboratory services for all aspects of test and examination performance including the pre-analytic, analytic, and post-analytic phases of the forensic analysis;

(2) The physical plant and environmental conditions of the forensic laboratory are appropriate for the testing performed;

(3) Forensic laboratory employees are provided a safe work environment and are protected from physical, chemical, and biological hazards;

(4) A forensic analysis method selected for use in the laboratory has the capability of providing an accurate and reliable result with known or defined uncertainty;

(5) Verification procedures used are adequate to determine the accuracy, precision, uncertainty, and other pertinent performance characteristics of each forensic analysis method;

(6) Forensic analysis employees perform the forensic analysis methods as required by the laboratory's established procedures to assure accurate and reliable results;

(7) The forensic laboratory participates in and uses a Department-approved proficiency testing provider as set forth in this subtitle, for each forensic analysis the laboratory performs or offers to perform;

(8) Received proficiency test reports are reviewed by the appropriate forensic analysis employees to:

(a) Evaluate the laboratory's performance; and

(b) Identify any problems which require corrective action;

(9) A corrective action plan is followed when a proficiency test result is found to be unacceptable or unsatisfactory;

(10) Quality control, quality assurance and assessment, and ethics and data integrity programs are established, maintained, and followed as set forth in this subtitle;

(11) A case file is maintained for a minimum of 10 years after the case is received;

(12) Acceptable levels of analytical performance for each forensic analysis are established and maintained;

(13) Remedial actions are taken and documented if a deviation from the forensic laboratory's established performance characteristics is identified;

(14) Procedures and mechanisms are established, maintained, and followed to preserve evidentiary sample and specimen integrity and identity throughout the forensic analysis process;

(15) Forensic test and examination results are reported only when the forensic analysis system is functioning properly;

(16) Reports of forensic analysis results include pertinent information required for correct interpretation;

(17) Consultation is available to the forensic laboratory's clients on matters relating to the quality of the reported forensic analysis results and interpretation;

(18) There is on-site supervision of forensic analyses and examinations being performed;

(19) An employee has sufficient education and experience related to the forensic analyses and examinations being performed, has completed the training for the type and complexity of tests and examinations performed, and has demonstrated reliable test performance and examination operations to provide and report accurate results;

(20) Before performing a forensic analysis on an evidentiary sample or specimen, an employee has demonstrated reliable and proficient analysis and the providing and reporting of accurate results;

(21) Policies and procedures are established for monitoring the performance of employees who conduct pre-analytical, analytical, and post-analytical phases of the forensic analysis process to assure that:

(a) Employees are competent and maintain competency to:

(i) Process samples and specimens;

(ii) Perform forensic tests and examinations; and

(iii) Report forensic analysis results promptly and proficiently; and

(b) Employee needs for remedial training or continuing education to improve skills are identified, when necessary; and

(22) A procedure manual is available to and followed by all employees responsible for any aspect of the forensic analysis process;

C. Employ a sufficient number of forensic laboratory employees with the required education, experience, and training, and in accordance with the employee responsibilities set forth in this chapter to:

(1) Provide consultation and court testimony;

(2) Supervise the performance of forensic analyses;

(3) Collect, process, and store evidentiary samples and specimens;

(4) Perform forensic analysis procedures; and

(5) Report forensic analysis results promptly and proficiently;

D. Establish and specify, in writing, the duties and responsibilities of each:

(1) Consultant;

(2) Technical leader; and

(3) Individual engaged in the performance of the pre-analytic, analytic, and post-analytic phases of a forensic analysis;

E. Identify in the written duties and responsibilities required in §D of this regulation:

(1) What forensic tests, examinations, and procedures each individual is authorized to perform;

(2) The competencies required to perform each forensic test, examination, and procedure;

(3) Whether supervision is required for specimen and sample processing, forensic analysis performance, or result reporting; and

(4) If review by a technical leader or director is required before reporting a forensic analysis result; and

F. Have the authority to initiate, suspend, and resume forensic analysis operations for:

(1) The laboratory; or

(2) An individual analyst or examiner.

Md. Code Regs. 10.51.06.07

Regulation .07 amended effective 42:14 Md. R. 880, eff.7/20/2015