Maryland Administrative Code

.04 Incorporation by Reference. In this subtitle, the following documents are incorporated by reference: A. 42 U.S.C. §14131, as amended; and B. Quality Assurance Standards for DNA Testing Laboratories, September 2011, Federal Bureau of Investigation.

.01 Responsibilities of the Department. A. The Department shall conduct audits, as set forth in this chapter, of forensic laboratories that obtain or retain a license. B. Audits. The Department shall: (1) Conduct or oversee an announced or unannounced audit of a forensic laborato…

.02 Accredited Forensic Laboratory and Accrediting Organization. A. Accredited Forensic Laboratory — Determination. The Secretary shall accept as meeting the audit requirements of this subtitle a forensic laboratory accredited by an organization approved by the Secretary, as set …

.03 Audits. A. General. (1) A licensee shall allow an on-site audit by the Department and, when applicable, by the forensic laboratory’s accreditation organization, at any time during the forensic laboratory’s normal hours of operation, to evaluate the forensic laboratory’s compl…

.01 License — General. A. General Requirements. (1) A person shall obtain a license from the Secretary before performing or offering to perform a forensic analysis in this State. (2) A person may not perform or offer to perform forensic analysis without first obtaining a forensic…

.02 License — Requirements. A. Requirements. A person operating a forensic laboratory that performs one or more forensic analyses shall: (1) Obtain, complete, and submit written or electronic permit applications as prescribed in this subtitle; (2) Obtain a forensic laboratory lic…

.03 License — Administrative Procedures. A. Application — Filing. (1) A person shall: (a) Apply for a license for each forensic laboratory location; (b) File an application for a license using written or electronic forms provided by the Department; and (c) Include in the applicat…

.01 Proficiency Testing — General. A. Proficiency Testing. Each year a licensee shall participate in an external proficiency testing program for each forensic science discipline in which the laboratory performs forensic tests and examinations, including but not limited to: (1) Fi…

.02 Proficiency Testing — Forensic DNA Analysis. Regardless of whether the individual provides results or conclusions, an individual who provides technical support for DNA analysis, performs DNA analysis, or is designated by the technical leader as a participant in DNA casework, …

.03 Proficiency Testing Provider Approval. A. Approval Required. A private, nonprofit, or commercial organization or government agency may not provide a proficiency test in this State for use by a forensic laboratory without first obtaining proficiency testing approval from the D…

.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 a…

.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 lab…

.03 Quality Assurance — Specific for Postmortem Forensic Toxicology. A. In addition to any applicable requirement in this chapter, a forensic laboratory performing postmortem forensic toxicology shall establish a: (1) Procedure for responding to requests for the laboratory’s info…

.04 Quality Control Program. A. A licensee shall: (1) Develop, establish, maintain, implement, and follow quality control policies and procedures that ensure accurate and reliable: (a) Forensic analysis results; and (b) Case reports; (2) Ensure that all quality control activities…

.05 Standard Operating Procedures Manual (SOPM). A. Policies and Procedures. A licensee shall ensure that all policies and procedures affecting the scope of activities performed in the laboratory are: (1) Documented; and (2) Communicated to, understood by, available to, and imple…

.06 Calibration — General. A. A licensee shall develop, establish, implement, maintain, and follow calibration procedures. (1) If computers or automated equipment are used for the processing, recording, reporting, storage, or retrieval of calibration data, the licensee shall ensu…

.07 Validation and Performance Checks. A. The licensee shall: (1) Separately perform a validation or conduct a performance check on standard methods before use; (2) Validate non-standard methods, laboratory designed methods, laboratory designed tests, and modifications of standar…

.08 Examination and Analysis. A. A licensee shall develop, establish, maintain, implement, and follow examination and analysis procedures. B. A licensee shall: (1) Ensure that all evidence is given a unique identifier; (2) Ensure that, when computers or automated equipment are us…

.09 Test Reports — General. A. A licensee shall ensure that a test report includes but is not limited to the following: (1) Name and physical address of the laboratory; (2) A unique identifier on each page of the report; (3) Identification of the forensic analysis method used; (4…

.10 Employee Training and Competency. A. A licensee shall develop, establish, maintain, implement, and follow a written training program for all technical skills in each discipline and subdiscipline for each new or untrained employee and employees who need remedial training. B. A…

.11 Equipment Maintenance. A. General. The laboratory shall develop, establish, maintain, implement, and follow an equipment calibration and maintenance procedure and policy. B. A licensee shall ensure that equipment, before being placed into use, is calibrated or checked to esta…

.12 Case Records. A. A licensee shall create and maintain a unique identifier system for all administrative and examination documents originating from or received by the laboratory for each case by: (1) Writing all documents in permanent ink and defining exceptions in the laborat…

.13 Complaints. A. A licensee shall retain all complaint records and documentation of the investigations and corrective actions taken by the laboratory. B. A licensee shall ensure that complaint documents include at least the: (1) Name and organization of complainant, if applicab…

.14 Subcontractors. A licensee shall: A. Maintain a list of all subcontractors to which forensic analyses are referred; B. Be responsible for the subcontractor’s forensic analysis or examination; C. Ensure that forensic analysis results from the subcontractor are written or in a …

.15 Facilities. A. Facility Administration. A licensee shall ensure that a laboratory: (1) Is adequate for the testing services offered; (2) Has lighting, plumbing, wiring, ventilation, heat, air conditioning, and humidity to meet the laboratory’s requirements; and (3) Has the re…

.16 Ethics and Data Integrity Policy — Requirement. A. A licensee shall: (1) Establish and maintain a written ethics and data integrity policy to be followed by all forensic laboratory employees, which includes the items set forth in §B of this regulation; (2) Provide access to t…

.17 Nonretaliation. A. A licensee shall establish, maintain, and follow a nonretaliation policy that ensures that an employee who in good faith reports to the Secretary or the Department an issue related to data integrity or unethical or fraudulent conduct will not be subject to …

.01 Employees — Required. A. A licensee operating a forensic laboratory shall employ or otherwise engage the services of qualified employees, including: (1) A director; (2) A technical leader; (3) A quality assurance manager; and (4) Forensic analysts and examiners. B. Based on t…

.02 Employees — Character and Education Verification. A. A licensee shall establish and follow written procedures for verifying the background and education of forensic laboratory employees. B. A licensee shall verify the background and education of an individual by a: (1) Backgr…

.03 Employees — Qualification Effective Dates. A. Regardless of how an individual’s role, position, or title is identified by a licensee, on or after January 1, 2012, an individual who begins employment with a licensee in a forensic laboratory shall meet the appropriate employee …

.04 Director — Requirement. A licensee shall employ a forensic laboratory director who: A. Meets the qualifications set forth in this chapter; and B. Is responsible for the overall operation and administration of the laboratory.

.05 Director — Qualifications. A director of a forensic laboratory shall: A. Hold an earned master’s or doctoral degree from an accredited institution in: (1) Forensic science; (2) A natural science such as chemistry, physics, or biology; or (3) A subspecialty of a natural scienc…

.06 Director — General Duties and Responsibilities. A. A director of a forensic laboratory is responsible for the overall operation and administration of the forensic laboratory. B. A director of a forensic laboratory shall participate in and actively oversee the planning, organi…

.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 develope…

.08 Quality Assurance Manager — Requirements. A. A director of a forensic laboratory shall designate a qualified individual as a quality assurance manager to be responsible for coordinating the activities required to ensure quality forensic analysis services. B. A quality assuran…

.09 Quality Assurance Manager — Qualifications. A quality assurance manager of a forensic laboratory shall: A. Hold an earned baccalaureate or advanced degree from an accredited institution in: (1) Forensic science; (2) A natural science such as: (a) Chemistry; (b) Physics; or (c…

.10 Quality Assurance Manager — Duties and Responsibilities. A. Under the authority of the director, and operating independently of casework, a quality assurance manager shall be responsible for: (1) Establishing: (a) A comprehensive quality assessment system that includes qualit…

.11 Technical Leader — Requirements. A. If a licensee performs or offers to perform forensic analyses in the discipline of Biology-DNA analysis, a forensic laboratory shall have a technical leader who: (1) Meets the qualifications set forth in this chapter; and (2) Is responsible…

.12 Technical Leader — Qualifications. A. General. Except for the discipline of Biology-DNA analysis, a technical leader in a discipline or subdiscipline of a forensic laboratory shall: (1) Hold an earned baccalaureate or advanced degree from an accredited institution in: (a) For…

.13 Technical Leader — Responsibilities. A. Authority. A licensee may authorize a technical leader to initiate, suspend, and resume a forensic analysis or forensic analyses operations for: (1) The laboratory, if assigned to the technical leader; (2) The forensic analysis section …

.14 Forensic Analysis Employees — Requirement. A licensee shall ensure: A. The forensic laboratory has at least one individual who meets the employee qualification requirements of this chapter, to perform the functions set forth in this chapter, for the type of forensic tests and…

.15 Forensic Analysis Employees — Qualifications. A. Forensic Analysis Employees — Qualifications for Toxicology and Trace Evidence Disciplines. (1) A forensic analyst working in toxicology or trace evidence disciplines of a forensic laboratory shall: (a) Possess a baccalaureate …

.16 Forensic Analysis Employee Responsibilities — General. A licensee shall ensure that: A. A forensic analysis employee is responsible for: (1) Specimen and sample processing; (2) Performing forensic analyses; and (3) Reporting forensic analysis results; and B. An individual per…

.17 Forensic Analysis Employee Responsibilities — Specific. Regardless of the forensic analysis category, an individual who performs a forensic analysis shall: A. Follow the forensic laboratory's approved procedures for: (1) Specimen and sample handling and processing; (2) Perfor…

.01 Sanctions — General. A. Authority and Types. (1) The Secretary may impose one or more principal or alternative sanctions if a forensic laboratory or the laboratory’s director or other employees fail to meet the standards of this subtitle and Health–General Article, Title 17, …

.02 Sanctions — Departmental Actions. A. Deficiency Posing Immediate Jeopardy. (1) If a forensic laboratory’s deficiency poses immediate jeopardy to public safety or individual rights, the Secretary shall take one or more of the actions listed in §A(2) and (3) of this regulation.…

.03 Principal Sanctions — Departmental Actions. A. Hearing Requirement. (1) Except when the Secretary finds that a danger to public safety imperatively requires that emergency action be taken to correct a deficiency, the Secretary shall inform the licensee in writing: (a) If a su…