Md. Code Regs. 10.51.05.01

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

Section 10.51.05.01 - Quality Assurance - General

To obtain or maintain a permit to operate a forensic laboratory, a person or licensee shall ensure that the forensic laboratory:

A. Establishes and follows policies and procedures for a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality and safety of the total examination and forensic analysis process;

B. Maintains a quality assurance program that:

(1) Continually evaluates the effectiveness of the laboratory's policies and procedures;

(2) Routinely revises policies and procedures based on the results of ongoing evaluation;

(3) Identifies and corrects problems;

(4) Assures:

(a) Accurate, complete, and reliable reporting of results of examinations and analyses;

(b) Technical procedures are validated and are accepted practice in the forensic discipline; and

(c) Adequate and competent employees;

(5) Requires documentation of all quality assurance and quality control activities; and

(6) Includes policies and procedures for:

(a) Handling and preservation of evidence;

(b) Calibration and maintenance of equipment;

(c) Handling, maintaining, and securing laboratory records including case records and reports;

(d) Evaluation and approval of employees;

(e) Laboratory security;

(f) Identifying and implementing corrective actions;

(g) Documenting and investigating complaints;

(h) The operation of individual characteristic databases, where appropriate; and

(i) Data integrity and ethics;

C. Develops and maintains:

(1) An organizational chart of all employees;

(2) Job requirements and a job description for each contractor; and

(3) Employee records that include, but are not limited to:

(a) Job requirements and a job description for each employee;

(b) Educational background and qualifications;

(c) Curriculum vitae;

(d) Court testimony evaluations and a record that the evaluations are reviewed with each examiner and analyst;

(e) Documentation of successful completion of a training program set forth by the laboratory, including competency testing;

(f) Authorization to perform independent casework; and

(g) Performance evaluations;

D. Establishes and maintains a forensic laboratory safety program;

E. Employs appropriately trained employees and possesses equipment to conduct the scope of forensic services offered;

F. Maintains reference literature in physical or electronic form that covers all disciplines and subdisciplines for which services are offered;

G. Designates an individual as the quality assurance manager;

H. Defines and maintains a document retention policy;

I. Maintains a facility that is designed to ensure the integrity of the forensic analyses and the evidence;

J. Conducts:

(1) Administrative review of all cases and reports before issuing a report; and

(2) Technical review, of no less than 5 percent of cases as determined by the laboratory director or designee, to ensure conclusions and supporting data are within the constraints of scientific knowledge; and

K. Establishes a mechanism to address unresolved discrepant conclusions between an analyst and the technical reviewer.

Md. Code Regs. 10.51.05.01

Regulation .01 amended effective 42:14 Md. R. 880, eff.7/20/2015