1. A. Under the authority of the director, and operating independently of casework, a quality assurance manager shall be responsible for:

   1. (1) Establishing:

      1. (a) A comprehensive quality assessment system that includes quality control and quality assessment programs that cover the forensic analyses performed; and
      2. (b) Parameters for necessary levels of performance for forensic analyses;
   2. (2) The overall maintenance and operation of the laboratory’s quality assurance program; and
   3. (3) Maintaining pertinent documentation and records of quality assurance activities.

2. B. The quality assurance manager shall:

   1. (1) Oversee the:

      1. (a) Participation and usage of an approved proficiency test provider commensurate with the licensed forensic analysis services;
      2. (b) Administration of proficiency testing; and
      3. (c) Evaluation of proficiency test results;

   2. (2) Maintain the forensic laboratory’s quality assurance:

      1. (a) Program; and
      2. (b) Program manual;

   3. (3) Evaluate instrument records for:

      1. (a) Calibration;
      2. (b) Validation; and
      3. (c) Maintenance;

   4. (4) Review:

      1. (a) Standard operating procedures;
      2. (b) Internal audit records;
      3. (c) Training records;
      4. (d) Competency records;
      5. (e) Proficiency tests;
      6. (f) Management reviews; and
      7. (g) Quality assurance documentation;
   5. (5) Ensure all methods, including new methods and modifications to current methods, are validated;
   6. (6) Select, train, and evaluate internal auditors;
   7. (7) Investigate technical problems;
   8. (8) Propose corrective or remedial actions;

   9. (9) Verify that corrective or remedial actions:

      1. (a) Are implemented; and
      2. (b) Correct the identified problem;

   10. (10) Assess the adequacy of record review activities, including but not limited to:

       1. (a) Reports; and
       2. (b) Case records;
   11. (11) Document all corrective actions taken when forensic analysis systems and procedures deviate from the forensic laboratory’s established performance specifications; and
   12. (12) Maintain records that demonstrate that proficiency testing samples are analyzed in the same manner as any other evidentiary specimen or sample received by the forensic laboratory for forensic analysis.

Authority: Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland

Effective date: May 28, 2012 (39:10 Md. R. 660)

Regulation .07B amended effective July 20, 2015 (42:14 Md. R. 880)

Regulation .14 amended effective July 20, 2015 (42:14 Md. R. 880)

Regulation .17E amended effective July 20, 2015 (42:14 Md. R. 880)