A licensee operating a forensic laboratory shall employ or otherwise engage the services of qualified employees, including: A director; A technical leader; A quality assurance manager; and Forensic analysts and examiners. Based on the scope of forensic testing services or categories offered or performed by the forensic laboratory, a licensee: Shall employ a sufficient number of qualified forensic analysts and examiners to: Accomplish the forensic laboratory’s mission and goals as determined by the director; Meet the forensic laboratory’s established priority protocols for a forensic analysis; and Ensure that the quality of forensic testing services is not jeopardized; and May employ more than one technical leader. The laboratory director may identify or designate an individual in an equivalent role, position, or title for an employee required in §A of this regulation if the individual: Meets the qualifications for the position; and Fulfills the responsibilities of the designated required employees as set forth in this subtitle. An individual employed by a licensee may serve in one or more roles or positions of the employees required in §A of this regulation if the: Individual meets the qualifications for and fulfills the responsibilities of the required employees as set forth in this subtitle; and Duties and responsibilities are delegated in writing to the assigned individual. A licensee shall establish and follow written procedures for verifying the background and education of forensic laboratory employees. A licensee shall verify the background and education of an individual by a: Background investigation; Review of the individual’s grade transcript from the college or university that the individual attended, that is: The original record or transcript document; or An official certified copy of the transcript; Test for abuse of controlled dangerous substances; and Polygraph examination, if available. 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 qualifications and requirements as set forth in this subtitle for a: Director; Technical leader; Quality assurance manager; Forensic analyst or examiner; and Person in the chain of casework who could affect the forensic analysis results, including technicians. A licensee shall deem an individual who is performing the function of a forensic laboratory director, as set forth in this chapter, on or before December 31, 2011, as: Meeting the qualifications of a forensic laboratory director; and Fulfilling the duties and responsibilities of the director as set forth in this subtitle. A licensee shall deem an individual, other than the director, who is performing the function of one or more of the required employees, as set forth in Regulation .01 of this chapter, on or before December 31, 2011, as: Meeting the qualifications for the designated role, position, or title if the individual is authorized in writing by the director; and Fulfilling the duties and responsibilities of the designated position as set forth in this subtitle. Deemed Qualification. The deemed qualification for forensic laboratory employees as set forth in §§B and C of this regulation is limited to the specific role or function of an individual on or before December 31, 2011. The deemed qualification of an individual in a specific role or function as set forth in §§B and C of this regulation is permanent and portable. If the role of an individual employed by a licensee changes, the individual, before serving in the new role, shall: Meet the appropriate qualifications for the role as set forth in this chapter; or From January 1, 2012, through December 31, 2018, meet the employee qualifications established by the laboratory director for a forensic non-Biology-DNA: Technical leader; Quality assurance manager; or Analyst or examiner. Sunset of Deemed Qualifications. The deemed qualification of an individual in a specific role or function as set forth in §D(3)(b) of this regulation: Is not permanent; and Expires on December 31, 2018. A licensee shall employ a forensic laboratory director who: Meets the qualifications set forth in this chapter; and Is responsible for the overall operation and administration of the laboratory. A director of a forensic laboratory shall: Hold an earned master’s or doctoral degree from an accredited institution in: Forensic science; A natural science such as chemistry, physics, or biology; or A subspecialty of a natural science such as organic chemistry, biochemistry, or molecular biology; and Have at least: 3 years of documented forensic laboratory experience; and 2 years of managerial or supervisory experience. A director of a forensic laboratory is responsible for the overall operation and administration of the forensic laboratory. A director of a forensic laboratory shall participate in and actively oversee the planning, organization, direction, and review of all laboratory operations, including but not limited to: Employing individuals who are competent to: Perform a forensic analysis; and Record and report a forensic analysis: Promptly within the priority protocols established by the director; Accurately; and Proficiently; and Ensuring compliance with the requirements set forth in this subtitle. A forensic laboratory director may: If qualified, perform the duties of a: Technical leader; Quality assurance manager; and Forensic analysis employee; and Delegate a duty or responsibility set forth in this subtitle to an employee who is qualified to carry out the delegated duty or responsibility. If a forensic laboratory director delegates the performance of the director’s duties or responsibilities as set forth in this subtitle, the forensic laboratory director shall ensure that the delegated duties and responsibilities are properly performed as required by this subtitle and Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland. A forensic laboratory director shall: Be accessible to forensic laboratory employees to provide on-site, telephonic, or electronic consultation as needed; Ensure that: 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; The physical plant and environmental conditions of the forensic laboratory are appropriate for the testing performed; Forensic laboratory employees are provided a safe work environment and are protected from physical, chemical, and biological hazards; 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; Verification procedures used are adequate to determine the accuracy, precision, uncertainty, and other pertinent performance characteristics of each forensic analysis method; Forensic analysis employees perform the forensic analysis methods as required by the laboratory’s established procedures to assure accurate and reliable results; 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; Received proficiency test reports are reviewed by the appropriate forensic analysis employees to: Evaluate the laboratory’s performance; and Identify any problems which require corrective action; A corrective action plan is followed when a proficiency test result is found to be unacceptable or unsatisfactory; Quality control, quality assurance and assessment, and ethics and data integrity programs are established, maintained, and followed as set forth in this subtitle; A case file is maintained for a minimum of 10 years after the case is received; Acceptable levels of analytical performance for each forensic analysis are established and maintained; Remedial actions are taken and documented if a deviation from the forensic laboratory’s established performance characteristics is identified; Procedures and mechanisms are established, maintained, and followed to preserve evidentiary sample and specimen integrity and identity throughout the forensic analysis process; Forensic test and examination results are reported only when the forensic analysis system is functioning properly; Reports of forensic analysis results include pertinent information required for correct interpretation; Consultation is available to the forensic laboratory’s clients on matters relating to the quality of the reported forensic analysis results and interpretation; There is on-site supervision of forensic analyses and examinations being performed; 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; 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; 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: Employees are competent and maintain competency to: Process samples and specimens; Perform forensic tests and examinations; and Report forensic analysis results promptly and proficiently; and Employee needs for remedial training or continuing education to improve skills are identified, when necessary; and A procedure manual is available to and followed by all employees responsible for any aspect of the forensic analysis process; 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: Provide consultation and court testimony; Supervise the performance of forensic analyses; Collect, process, and store evidentiary samples and specimens; Perform forensic analysis procedures; and Report forensic analysis results promptly and proficiently; Establish and specify, in writing, the duties and responsibilities of each: Consultant; Technical leader; and Individual engaged in the performance of the pre-analytic, analytic, and post-analytic phases of a forensic analysis; Identify in the written duties and responsibilities required in §D of this regulation: What forensic tests, examinations, and procedures each individual is authorized to perform; The competencies required to perform each forensic test, examination, and procedure; Whether supervision is required for specimen and sample processing, forensic analysis performance, or result reporting; and If review by a technical leader or director is required before reporting a forensic analysis result; and Have the authority to initiate, suspend, and resume forensic analysis operations for: The laboratory; or An individual analyst or examiner. 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. A quality assurance manager may be employed full-time or part-time as appropriate for the scope of forensic analysis services offered or performed. A quality assurance manager of a forensic laboratory shall: Hold an earned baccalaureate or advanced degree from an accredited institution in: Forensic science; A natural science such as: Chemistry; Physics; or Biology; or A subspecialty of a natural science such as: Organic chemistry; Biochemistry; or Molecular biology; and Complete a training program as determined by the laboratory director. Under the authority of the director, and operating independently of casework, a quality assurance manager shall be responsible for: Establishing: A comprehensive quality assessment system that includes quality control and quality assessment programs that cover the forensic analyses performed; and Parameters for necessary levels of performance for forensic analyses; The overall maintenance and operation of the laboratory’s quality assurance program; and Maintaining pertinent documentation and records of quality assurance activities. The quality assurance manager shall: Oversee the: Participation and usage of an approved proficiency test provider commensurate with the licensed forensic analysis services; Administration of proficiency testing; and Evaluation of proficiency test results; Maintain the forensic laboratory’s quality assurance: Program; and Program manual; Evaluate instrument records for: Calibration; Validation; and Maintenance; Review: Standard operating procedures; Internal audit records; Training records; Competency records; Proficiency tests; Management reviews; and Quality assurance documentation; Ensure all methods, including new methods and modifications to current methods, are validated; Select, train, and evaluate internal auditors; Investigate technical problems; Propose corrective or remedial actions; Verify that corrective or remedial actions: Are implemented; and Correct the identified problem; Assess the adequacy of record review activities, including but not limited to: Reports; and Case records; Document all corrective actions taken when forensic analysis systems and procedures deviate from the forensic laboratory’s established performance specifications; and 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. 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: Meets the qualifications set forth in this chapter; and Is responsible for the technical and scientific oversight of the section or unit in a forensic laboratory that performs forensic analyses for DNA. Based on the scope of forensic analysis services, a licensee may employ one or more technical leaders who: Meet the qualifications of this chapter; and Are responsible for the technical and scientific oversight of: The forensic laboratory; or A specific section or forensic science discipline in a forensic laboratory. A technical leader: Is not required to be on-site in the forensic laboratory at all times forensic analyses are performed; and Shall be: Available to forensic laboratory employees as needed to provide technical and scientific oversight and assistance; and Accessible to forensic laboratory employees to provide on-site, telephonic, or electronic consultation. General. Except for the discipline of Biology-DNA analysis, a technical leader in a discipline or subdiscipline of a forensic laboratory shall: Hold an earned baccalaureate or advanced degree from an accredited institution in: Forensic science; A natural science such as: Chemistry; Physics; or Biology; or A subspecialty of a natural science such as: Organic chemistry; Biochemistry; or Molecular biology; and Have documented post-degree experience in the forensic discipline or subdiscipline in which the individual will be a technical leader, as follows: 4 years with a baccalaureate degree; 3 years with a master’s degree; or 2 years with a doctoral degree. Except for Biology-DNA analysis and forensic toxicology, a director may establish alternate qualifications for a technical leader in a discipline or subdiscipline of a forensic laboratory if the individual: Has 9 or more years of documented experience in the forensic discipline or subdiscipline in which the individual will be a technical leader; and Is able to demonstrate competency under the laboratory’s competency procedures in the forensic discipline or subdiscipline in which the individual will be a technical leader. Forensic Toxicology. In addition to the requirements set forth in §A of this regulation, a technical leader in the discipline of forensic toxicology shall meet the requirements of and be certified under COMAR 10.10.09. Forensic Biology—DNA Analysis. If a forensic laboratory performs or offers to perform tests in the discipline of forensic DNA analysis, the technical leader shall meet the employee qualifications for a technical leader and be authorized by the licensee to carry out the duties and responsibilities of a technical leader, as set forth in Quality Assurance Standards for Forensic DNA Testing Laboratories, which is incorporated by reference. Authority. A licensee may authorize a technical leader to initiate, suspend, and resume a forensic analysis or forensic analyses operations for: The laboratory, if assigned to the technical leader; The forensic analysis section or unit of the laboratory assigned to the technical leader; or An individual in the technical leader’s assigned forensic analysis section or unit of the laboratory. A technical leader shall be responsible for: Selection of the test method, in concert with the laboratory director, that is appropriate, depending on the type of evidence, for forensic use and for reporting forensic analysis results; Validation of each forensic analysis procedure performed; Establishing the forensic laboratory’s forensic analysis performance specifications, including: Precision; Accuracy; and Uncertainty of measurement, where applicable; Maintaining instrument records for: Calibration; Validation; and Maintenance; Ensuring that: The performance levels established in §B of this regulation are maintained throughout the entire forensic analysis process: From initial receipt of the sample or specimen; Through testing and examination; and Through reporting of the forensic analysis results; and Forensic analysis results are not reported until all corrective actions have been taken and the forensic analysis system is functioning properly; Resolving technical problems and ensuring that remedial actions are taken whenever a forensic analysis procedure or system deviates from the forensic laboratory’s established performance specifications; and Re-evaluating employee performance, before reporting forensic analysis results, to include the use of a new test method or instrumentation when a forensic analysis method or instrumentation changes. A licensee shall ensure: 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 examinations performed in the laboratory; and Technical reviews of case files and reports are conducted as determined by the Director or applicable standards. Forensic Analysis Employees — Qualifications for Toxicology and Trace Evidence Disciplines. A forensic analyst working in toxicology or trace evidence disciplines of a forensic laboratory shall: Possess a baccalaureate or advanced degree in a natural science, forensic science, or a closely related field of science; and Have successfully completed a training program in forensic toxicology or forensic analysis of trace evidence, as determined by the laboratory director. An individual whose degree is in a field other than a natural science, forensic science, or a closely related field, may meet the educational requirements, as determined by the director and technical leader, if the individual has: Successfully completed 12 or more semester or credit hours of course work in biology, physics, or chemistry; and Successfully completed a training program in forensic toxicology, or forensic analysis of trace evidence, as determined by the laboratory director. Forensic Analysis Employees — Qualifications for Controlled Dangerous Substances. An individual performing forensic laboratory analyses for controlled dangerous substances shall meet the pertinent employee qualifications and certification requirements set forth in COMAR 10.10.09. Forensic Analysis Employees — Qualifications for Biology Discipline of Forensic Science. A forensic analyst working in the biology discipline of forensic science shall: Possess a baccalaureate or advanced degree in a natural science, forensic science, or a closely related field of science; and Have successfully completed a training program in the biology discipline of forensic science, as determined by the laboratory director. An individual whose degree is in a field other than a natural science, forensic science, or a closely related field, may meet the educational requirements, as determined by the director and technical leader, if the individual has: Taken 12 or more semester or credit hours of course work in biology, physics, or chemistry; and At least 2 years of training in the category of forensic analysis performed for the identification and evaluation of evidence in criminal matters. Forensic Analysis Employees — Qualifications for Forensic DNA Analysis. A forensic analyst working in the forensic science discipline of biology who performs a DNA analysis shall meet the FBI standards for performing DNA analysis, as set forth in the Quality Assurance Standards for Forensic DNA Testing Laboratories, which is incorporated by reference. Forensic Analysis Employees — Qualifications for Firearms and Toolmarks Examinations. An individual employed by a licensee to perform examinations of firearms and toolmarks evidence shall: Possess a baccalaureate degree in: A biological or physical science; Criminal justice; Law enforcement; or A related field; or Have successfully completed a training program, as determined by the laboratory director and technical leader, in the fields of: Firearms; Processing or examination of forensic evidence; and Laboratory testing of materials. Forensic Analysis Employees — Qualifications for Latent Examinations. An individual who classifies fingerprints or other friction-ridge prints or performs impression examinations shall: Possess a high school diploma or equivalent; and Have successfully completed a training program, as determined by the laboratory director and technical leader, including: 1 year performing duties related to: Law enforcement activities; or Forensic laboratory services; and 1 year performing: Fingerprint classification; or Latent examinations. Forensic Analysis Employees — Qualifications for Forensic Document Examiner. An individual employed by a licensee to examine questioned documents or to be a forensic document examiner shall: Possess a baccalaureate degree or advanced degree in a natural science, forensic science, or a closely related field of science; Have successfully completed a formal training program in the field of forensic document examination, as determined by the laboratory director; and Have at least 1 year of experience performing forensic analyses for the identification and evaluation of evidence in criminal matters. A licensee shall ensure that: A forensic analysis employee is responsible for: Specimen and sample processing; Performing forensic analyses; and Reporting forensic analysis results; and An individual performs only those forensic analyses that: Are authorized by the forensic laboratory director for the individual to perform; and Require a degree of skill commensurate with the individual's education, training, experience, and technical abilities. Regardless of the forensic analysis category, an individual who performs a forensic analysis shall: Follow the forensic laboratory's approved procedures for: Specimen and sample handling and processing; Performing the forensic analysis; and Reporting and maintaining records of forensic analysis results; Adhere to the forensic laboratory's policies and procedures for: Quality control; Quality assurance; and Ethics and data integrity; Document all activities related to: Quality assurance; Quality control; Ethics and data integrity; Calibration of forensic analysis: Equipment; Instruments; and Procedures; and Performance of maintenance and repair of forensic: Equipment; and Instruments; Follow the forensic laboratory's established policies and procedures if forensic analysis systems are not within the established specifications for acceptable performance; and Be capable of: Identifying a problem that may adversely affect performance of a forensic analysis or reporting of a forensic analysis result; and Following the laboratory policy and procedure for addressing nonconforming testing. 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)