The intent of this subtitle is to require a forensic laboratory to: Employ qualified employees; and Operate and perform forensic analyses under: Reliable procedures; Effective quality control and quality assurance programs; and Qualified supervision. This subtitle contains the standards and requirements that a forensic laboratory shall meet to obtain and retain a license to perform or offer to perform forensic analyses. This subtitle does not apply to a: Forensic laboratory operated by the federal government; or Laboratory licensed or certified by the Maryland Department of Agriculture. Forensic analysis does not include: A test of a specimen of breath or blood to determine alcohol concentration or controlled dangerous substance content; Forensic information technology; A presumptive test performed at a crime scene; A presumptive test performed for the purpose of determining compliance with a term or condition of community supervision or parole and conducted by or under contract with a county department of corrections or the Department of Public Safety and Correctional Services; or An expert examination or test conducted principally for the purpose of scientific research, medical practice, civil or administrative litigation, or any purpose other than determining the connection of physical evidence to a criminal act. In this subtitle, the following terms have the meanings indicated. Terms Defined. Accuracy. “Accuracy” means the degree of agreement between the determination of a quantity and the quantity’s true value. “Accuracy” includes the quality of a test result as it relates to the analytic phase of the testing process when the test result: Conforms exactly to a standard; or Deviates only within established limits from a standard. Administrative Documentation. “Administrative documentation” means a type of laboratory record. “Administrative documentation” includes but is not limited to: Case-related conversations and communications; Evidence receipts; Description of evidence packaging and seals; Incident reports; Service request documentation; Case-related correspondence including emails and letters; Interim and preliminary reports; Case-related database search documentation; and Other pertinent information pertaining to a forensic analysis, a forensic analysis report, or an analyst’s conclusion. “Administrative review” means an evaluation of a report and supporting documentation for editorial correctness and consistency with laboratory policies. “Alternative sanction” means a sanction that is: Not a principal sanction; and Imposed by the Secretary against a forensic laboratory and includes a directed plan of correction or a limitation on testing services. “Analyst” means an individual who: Performs casework-related duties on items of evidence within the laboratory and issues reports containing opinions or interpretations concerning the resulting findings and observations; or Conducts or directs the analysis of forensic casework samples, interprets data, and reaches conclusions. “Analyte” means a substance or constituent for which a forensic laboratory conducts testing. “Approved proficiency test provider” means an external proficiency test provider who has been approved by the Department as set forth in COMAR 10.51.04.03. “Assessment” means a review of a laboratory’s activities to determine compliance with a set of requirements established by an accrediting organization. Audit. “Audit” means an on-site visit to or survey of a forensic laboratory by the Department to determine a forensic laboratory’s compliance with: Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland; and The applicable regulations of this subtitle. “Audit” includes but is not limited to: An inspection; A follow-up inspection; A complaint investigation; and On-site monitoring. “Calibration” means the set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material and the corresponding known values of the material. “Calibrator” means a material having a known value or concentration that is traceable to the International System of Units standard, if available, as required by the: Manufacturer of the instrumentation; or Forensic laboratory’s quality assurance program. “Case file” means the part of the case record that is a file containing administrative and examination documentation generated or received by laboratory employees pertaining to a uniquely identified case. Case Notes. “Case notes” means the component of examination documents that is used to support an analyst’s conclusions. “Case notes” includes, but is not limited to, notes, charts, graphs, photographs, and other documents created for documenting the: Procedures, standards, controls, and instruments used for a forensic analysis; Observations made for a forensic analysis or examination; Basis or grounds for an analyst’s conclusions; and Results of performed forensic analyses. Case Record. “Case record” means examination and administration documentation received or generated by the laboratory pertaining to a uniquely identified case. “Case record” includes a case file and other laboratory records that are pertinent to forensic analyses and conclusions of a particular case. “Case record” is not limited to a case file. “Case report” means a final, formal report that is signed by the analyst or examiner and issued by a forensic laboratory. “Casework” means the forensic analysis of evidence submitted to a forensic laboratory. “Chain of custody” means the documented movement and location, including the custody, control, and transfer, of physical evidence, from the time the evidence is received until the final disposition of the evidence by the forensic laboratory. “Comparative analyses” means the examination of two or more items to determine the commonality of physical or chemical characteristics of the items. Competency. “Competency” means the: Demonstrated and documented ability of an individual to perform assigned work in a discipline or subdiscipline, in accordance with a licensee’s technical procedures and training manuals, before the performance of independent casework under the authorization of a forensic laboratory director; and State or quality of being qualified and having the ability to perform a specific task, job, or role. “Competency” includes: Possessing the requisite knowledge, skills, and abilities to perform a task, job, or role; and Utilizing the requisite combination of knowledge, skill, and demonstration of knowledge necessary to produce satisfactory performance. “Competency assessment” means a formal, standardized evaluation of an individual’s ability to perform a specific assigned task, job, or role. “Complaint investigation” means an investigation of a forensic laboratory, which may include an on-site audit conducted by the Department, based on a complaint or allegation of regulatory noncompliance. Contamination Record. “Contamination record” means a record of contamination as defined in the Quality Assurance Standards for Forensic DNA Testing Laboratories, which is incorporated by reference. “Contamination record” includes: A unique case identifier; Encoded sample identification; A description of results; and Identifiers that led to an incident report. “Controlled dangerous substance” means any drug, substance, or immediate precursor in Schedules I through V as set forth in Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland. “Customer” means a person authorized by statute, which includes a law enforcement agency, prosecutor, criminal suspect, defendant or defendant’s legal representative, or court, making a request for forensic laboratory services. “Data integrity” means the condition existing when data is unchanged from its source and has not been accidentally or maliciously modified, altered, or destroyed during any operation, such as transfer, storage, or retrieval. “Deficiency” means a finding of statutory or regulatory noncompliance. “Deficiency statement” means a report provided to a forensic laboratory subsequent to an audit conducted by: The forensic laboratory’s accrediting organization; or The Department. “Department” means the Maryland Department of Health. “Department of Agriculture” means the Maryland Department of Agriculture. “Directed plan of correction” means a sanction that consists of a set of corrective actions stipulated by the Secretary for a forensic laboratory to implement to effect statutory or regulatory compliance. Discipline. “Discipline” means a major area of forensic science in which a forensic laboratory is licensed to perform or offers to perform forensic analyses. “Discipline” includes: Controlled dangerous substances, including the subdisciplines of pharmaceutical and illicit drugs and other controlled dangerous substances; Toxicology, including the subdisciplines of forensic toxicology and postmortem toxicology; Biology, including the subdisciplines of DNA analysis and serology; Trace evidence, including but not limited to the subdisciplines of adhesives, analysis of unknowns, explosives and explosive debris, fuels, hairs, fibers and textiles, polymers, fire debris, glass, gunshot residue, metal and alloys, paint, and physical comparisons; Firearms and toolmarks, including all subdisciplines of firearms and toolmarks examinations; Latent prints, including the subdisciplines of latent print processing, latent print comparison, and impressions; Questioned documents, including the subdisciplines of handwriting, paper, and questioned documents; Forensic pathology; Forensic entomology; and Forensic odontology. “Discrepancy logs” means a system used by a forensic laboratory to document administrative or processing errors related to evidence and tracked within a case record. Discriminate or Retaliate. “Discriminate or retaliate” means any adverse action taken by a licensee or a licensee’s employee against a forensic laboratory employee who in good faith reports a data integrity issue or unethical or fraudulent conduct, as set forth in this subtitle and Health-General Article, §17–2A–10, Annotated Code of Maryland. “Discriminate or retaliate” includes, but is not limited to: Failing to promote an individual or provide another employment-related benefit for which the individual would otherwise be eligible; Making an adverse evaluation or decision in relation to accreditation, certification, credentialing, or licensing of the individual; or Taking a personnel action that is adverse to the individual concerned. “DNA” means deoxyribonucleic acid. “Document” means a written, printed, or electronic format. Electronic Record. “Electronic record” means a record created, generated, sent, communicated, received, or stored by electronic means in a format that may be: Optical; Magnetic; or Digital. “Electronic record” includes any record that contains information readable by a computer or machine rather than an individual. “Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record. “Evidence” means a thing or component of a thing that: Is detectable by sensory, physical, chemical, optical, or electronic means; and Provides factual information related to a crime. “Examination” means an analysis of evidence, which may include a visual, physical, or chemical analysis. “Examination documentation” means notes, including a description of the evidence, reference to procedures followed, tests conducted, standards and controls used, diagrams, printouts, photographs, observations, and results of examinations. “Examiner” means an individual who: Performs casework-related duties on items of evidence within the laboratory and issues reports containing opinions or interpretations concerning the resulting findings and observations; or Conducts or directs the analysis of forensic casework samples, interprets data, and reaches conclusions. External Control. “External control” means a test or examination performed on an external test sample to demonstrate a procedure is working correctly. “External control” uses an external test sample that: Is not part of the analytical system; Contains a known quantity of the analyte being tested; Is similar in its physical characteristics and constituents to samples tested by the system; and Reacts with all system components in the same way as a test sample. “External proficiency test” means an analysis performed on a proficiency testing sample provided to a forensic laboratory by an approved proficiency testing provider external to the laboratory or laboratory system. Forensic Analysis. “Forensic analysis” means a medical, chemical, toxicological, firearms, or other expert examination or test performed on physical evidence, including DNA evidence, for the purpose of determining the connection of the evidence to a criminal act. “Forensic analysis” includes an examination or test required by a: Law enforcement agency; Prosecutor; Criminal suspect, defendant, or defendant’s legal representative; or Court. “Forensic analysis” does not include: A test of a specimen of breath or blood to determine alcohol concentration or controlled dangerous substance content; Forensic information technology; A presumptive test performed at a crime scene; A presumptive test performed for the purpose of determining compliance with a term or condition of community supervision or parole and conducted by or under contract with a county department of corrections or the Department of Public Safety and Correctional Services; or An expert examination or test conducted principally for the purpose of scientific research, medical practice, civil or administrative litigation, or any purpose other than determining the connection of physical evidence to a criminal act. “Forensic information technology” means digital or electronic evidence that is stored or transmitted electronically. Forensic Laboratory. “Forensic laboratory” means a facility, entity, or site that performs or offers to perform a forensic analysis. “Forensic laboratory” includes a laboratory owned or operated by the State, a county or municipal corporation in the State, or another governmental entity. “Forensic laboratory” does not include: A forensic laboratory operated by the federal government; or A laboratory licensed or certified by the Maryland Department of Agriculture. Incident Report. “Incident report” means a record used by a forensic laboratory to document procedural or policy noncompliance or unexpected outcomes. “Incident report” includes: Identification of the procedural or policy noncompliance or unexpected outcome; Elimination steps taken, when applicable; and Related documentation such as discrepancy logs and contamination records, when applicable. “Internal audit” means a licensee’s self-inspection, based on standards defined by the laboratory’s director and quality assurance manager, to evaluate, confirm, or verify the forensic laboratory’s activities related to quality control. “Internal proficiency tests” means samples or specimens developed by the laboratory director or the director’s designee and administered to an analyst or examiner for analysis or examination as unknown samples or specimens. “Internal validation” means the in-house demonstration of the accuracy, reliability, and limitations of a technical procedure or analysis. “Laboratory designed tests” means test procedures developed and subjected to validation within the forensic laboratory. “Laboratory director” means an individual who: Meets the education and experience requirements set forth in this subtitle for a laboratory director; and Participates in and actively oversees the planning, direction, organization, and review of all forensic laboratory operations to the extent necessary to ensure compliance with this subtitle. “Laboratory system” is an organization having at least two physically separate forensic laboratory facilities that are independently managed under the direction of a single individual in the chain of command. “Letter of permit exception” means a letter granting limited authority to an individual not associated with a public or commercial laboratory, who reviews results or conclusions of the original forensic analysis performed by a licensed forensic laboratory solely for the purpose of assessing the original opinion, interpretation, or conclusion of the licensed forensic laboratory. “License” means a permit, letter of exception, certificate, or other document issued by the Secretary granting approval or authority to a forensic laboratory to perform or offer to perform forensic analyses in the State. “Licensed forensic laboratory” means a forensic laboratory operating under a license issued by the Department. “Licensee” means a person who holds a license under this subtitle to maintain and operate a forensic laboratory. “Limited access” means employees are restricted from accessing or entering a specific area of the laboratory unless authorized by the laboratory director. “Limited forensic analysis” means performing a forensic laboratory test or analysis in a single discipline or subdiscipline. “Office of Health Care Quality” means the Office of Health Care Quality of the Maryland Department of Health. “Owner” means a person who possesses a financial interest in a forensic laboratory. “Performance check” means an evaluation of a test system by assessing the functionality of system components in total, including but not limited to, assessment of the test system’s: Accuracy; Precision; and Reagents. “Permitted forensic laboratory” means a licensed forensic laboratory operating under a permit issued by the Department. “Physical evidence” means any object, thing, or substance relating to a criminal act. “Plan of correction” means a post-audit report created by a forensic laboratory in response to a deficiency statement received from: The forensic laboratory’s accrediting organization; or The Department. “Policy” means a written document that outlines a principle, plan, or course of action in regard to the operation of a forensic laboratory, including but not limited to: Quality assurance; Data integrity and ethics; Quality control; Safety; and Training. “Precision” means the agreement of results among themselves when a specimen or sample is tested multiple times. “Presumptive test” means a test that does not provide a conclusive result, but is used to screen for the presence of a substance. “Principal sanction” means the denial, suspension, or revocation of a license. “Procedure” means a way of doing something that is set down in a written or electronic document that details the sequence of actions or step-by-step instructions to be followed to accomplish an administrative or technical task. “Proficiency testing” means determining the ability of an individual or a forensic laboratory to perform a forensic analysis to obtain a correct test result by: Performing a forensic analysis on a sample provided by a proficiency testing provider or laboratory director; and Reporting the results of the forensic analysis to the proficiency testing provider or laboratory director for evaluation. “Proficiency testing provider” means an entity external to the participating forensic laboratory that: Has one or more samples with values initially known only by the proficiency testing provider; Sends one or more samples to a participating forensic laboratory to perform forensic analyses; and Reports the results to the provider. “Qualitative” means relating to or involving comparisons based on the attributes or qualities of an item or thing. “Quality assurance” means a system of established policies and procedures designed to monitor, review, evaluate, and improve the ongoing and overall quality aspects of the forensic laboratory. “Quality assurance manager” means an individual designated by a director who is responsible for ensuring the requirements for a forensic laboratory’s quality assurance program are: Established; Implemented; Followed; and Maintained. Quality Control. “Quality control” means the established policies and procedures designed and used to ensure the quality of results obtained from the analytic phase of a testing process. “Quality control” includes, but is not limited to, activities that detect, monitor, review, and evaluate the: Accuracy, reliability, and precision of the analytic phase of a testing process; Changes in the chemical, electronic, optical, or mechanical components of a test system; Deterioration of reagents, materials, or supplies used in a testing process; and Employee practices during the testing process. “Quality control testing” means analyses or examinations performed on quality control samples as part of the laboratory’s quality assurance program to demonstrate that a forensic analysis: Is performed correctly; and The test system is working properly to obtain a known result. “Quantitative” means expressible as a quantity or relating to measurement or a determination of the amounts and proportions of the chemical constituents of a substance or mixture. “Reagent” means a substance or mixture of substances used in a chemical or biological test to detect, measure, or examine physical evidence or produce other substances. “Records” means both examination and administrative documents. “Reference standard” means a material or sample with known properties that is acquired or prepared to: Calibrate analytical equipment; or Use as an external quality control. “Reliability” means the consistency of a measurement, that is, the degree to which an instrument or test system measures the same way each time it is used under the same set of conditions. “Reproducibility” means the ability of a test method or test system to produce consistent results if replicated by analysts or examiners working independent of one another. “Safeguard” means a person, procedure, or mechanism that protects and ensures the integrity of: Evidence; Test methods and test systems; Examinations; and Documents. “Safety program” means the policies and procedures that describe the various elements of a forensic laboratory’s safety system. Sanction. “Sanction” means an adverse action against a forensic laboratory that the Secretary may impose to effect statutory or regulatory compliance. “Sanction” includes both principal and alternative sanctions. “Secretary” means the Secretary of Health or the Secretary’s designee, including the Department. “Security” means the policies and procedures implemented and followed by a licensee to ensure the protection, integrity, and prevention of contamination of the forensic evidence, data, and case records. “SOPM” means a standard operating procedures manual. “Standard” means one or more specific technical, procedural, fiscal, or other regulatory requirements that a forensic laboratory or individual shall meet to comply with this subtitle. “Subcontractor” means a person contracted by a licensee to perform a specific forensic analysis or other task related to the operation of the forensic laboratory. “Subdiscipline” means a specific type of analysis or analyses within a discipline of forensic science as set forth in this regulation. “Technical leader” means an individual who is qualified by education and experience and is accountable for the technical operations of the forensic laboratory analyses in a specific discipline or subdiscipline of forensic science. “Technical procedure” means a set of directions or step-by-step instructions for performing a forensic analysis or examination. “Technical review” means an evaluation of reports, notes, data, and other documents to ensure there is an appropriate and sufficient basis for the reported scientific conclusions. “Technical reviewer” means an employee or other individual who performs a technical review of a report and is: A current or previously qualified analyst in the discipline, subdiscipline, or method being reviewed; and Not an author or co-author of the report being reviewed. “Technician” means an individual who performs analytical techniques on evidence samples under the supervision of a qualified forensic analyst or examiner and who does not issue a report for the work performed. “Traceable” or “traceability” means the property of a measurement result by which the measurement can be related to appropriate standards through an unbroken chain of comparisons. Validation. “Validation” means a process by which a forensic analysis method or procedure is evaluated to determine the accuracy, reliability, and limitations of the test method or procedure for forensic casework. “Validation” applies to both new and modified existing forensic analysis methods and procedures and includes: Developmental validation, which is the review of acquired test data and determination of conditions and limitations of a new or novel method or procedure for use on forensic samples; and Internal validation, which is a review of accumulated test data within the laboratory to demonstrate that an established method or procedure performs as expected in the laboratory and to specify laboratory interpretation guidelines. “Verification” means a documented check of a comparison made between known and questioned specimens or samples by a second qualified forensic examiner. In this subtitle, the following documents are incorporated by reference: 42 U.S.C. §14131, as amended; and Quality Assurance Standards for DNA Testing Laboratories, September 2011, Federal Bureau of Investigation. Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland Effective date: May 28, 2012 (39:10 Md. R. 660)