Current through Register Vol. 51, No. 25, December 13, 2024
Section 10.51.05.01 - Quality Assurance - GeneralTo 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;(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;(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; andK. 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