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) The Department shall conduct audits, as set forth in this chapter, of forensic laboratories that obtain or retain a license. Audits. The Department shall: Conduct or oversee an announced or unannounced audit of a forensic laboratory, at any time during a forensic laboratory’s hours of operation, to assess compliance with applicable sections of Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, and this subtitle; and Examine, as part of an audit, a forensic laboratory’s facilities, equipment, quality assurance records and procedures, operating procedures, employees, employee records, proficiency testing, results and reports of forensic analyses, and other records and files pertinent and subject to this subtitle. Issuance of Licensing Documents. The Department shall: License a person to operate a forensic laboratory by issuing a license when the forensic laboratory is in compliance with the applicable standards set forth in this subtitle; and Issue a license that includes the: Name of the forensic laboratory; Name of the licensee or owner; Name of the forensic laboratory director; Expiration date of the license; and Forensic science disciplines and subdisciplines in which the forensic laboratory is authorized to perform forensic analyses. Administration and Information Management. The Department shall: Maintain a list of licensed forensic laboratories; Document information regarding denial, suspension, or revocation of a license and submit this documentation to the Secretary; Monitor the proficiency testing performance of a forensic laboratory required to participate in proficiency testing; Impose alternative sanctions and initiate actions leading to imposition of principal sanctions against a forensic laboratory under the appropriate provisions of this subtitle and Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland. Forensic Laboratory Advisory Committee. The Secretary shall provide staff for the Forensic Laboratory Advisory Committee established by the Governor pursuant to Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland. The Forensic Laboratory Advisory Committee: Shall advise the Secretary on matters relating to forensic laboratories as set forth in Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland; and May make recommendations to the Secretary concerning the: Implementation of the requirements for forensic laboratories set forth in Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland; Regulations required by Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland; and Department’s oversight and licensing of forensic laboratories. 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 forth in §C of this regulation, if the Department determines that the standards of the forensic laboratory’s accreditation organization are equivalent to those under this subtitle. Accredited Forensic Laboratory — Requirements. In addition to meeting the requirements for obtaining and maintaining a certificate of accreditation, as set forth by the forensic laboratory’s accrediting organization, an accredited forensic laboratory shall: Obtain and maintain a valid license issued by the Department; and Be subject to audit by the Department as set forth in COMAR 10.51.02.03. Accreditation Organization. A private, nonprofit forensic laboratory accreditation organization may inspect and accredit forensic laboratories in the State for the purpose of State licensure only after applying for and receiving approval of the Department, as the Secretary’s designee. The Department shall base approval of a forensic laboratory accreditation organization on a review of information provided by that organization, including but not limited to: Data collection and data sharing and reporting policies; Accreditation policies, procedures, and standards; Assessment forms and guidelines; Assessment and deficiency writing policies and procedures; Assessor and technical expert qualifications; Complaint investigation policies and procedures; Proficiency test monitoring policies and procedures; and Procedures the accreditation organization will follow when notifying the Department that the accreditation organization: Is denying, withdrawing, suspending, revoking, or otherwise limiting a forensic laboratory’s accreditation; Finds serious jeopardy to individual rights or identifies a hazard to public safety; Accredits a new forensic laboratory; Imposes an adverse or corrective action on a forensic laboratory; or Is initiating a complaint investigation. In addition to requirements set forth elsewhere in this subtitle, an accreditation organization shall: Provide to the Department: Annually, an updated list containing the names, addresses, and accreditation expiration dates of forensic laboratories in the State that are accredited by the organization; Within 30 days after conducting an assessment, a certified written or electronic copy of each assessment report covering each forensic laboratory applying for or maintaining accreditation in the State; Written notice of any proposed change to requirements for forensic laboratory accreditation, at least 30 days before the effective date of the change; Within 10 days after a forensic laboratory’s certificate of accreditation expires, written or electronic notice when the forensic laboratory does not renew an accreditation certificate; and Within 24 hours after taking an action, telephonic or electronic notice when an accredited forensic laboratory’s certificate of accreditation is suspended, revoked, surrendered, or otherwise limited; Evaluate compliance, when applicable, with State regulations pertaining to: Forensic analyses; Reporting of forensic analysis results as required by law or regulation; and Proficiency testing; Evaluate compliance with State regulations by: Incorporating an evaluation of compliance with State regulatory requirements into the accreditation organization’s own assessment process; or Demonstrating that the accreditation organization’s existing assessment process adequately evaluates compliance with State regulations; and On request, provide to the Department a copy of: A complaint investigation; Assessor qualifications; A change in a forensic laboratory’s forensic disciplines or subdisciplines; or Other information the Department may require relating to approval of a forensic laboratory accreditation organization. General. 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 compliance with the applicable requirements, conditions, and standards of this subtitle. An audit may include but is not limited to observation and examination of: Laboratory facilities; Equipment; Quality assurance and quality control program records; Operating procedures; Employees; Employee records; Proficiency testing; Forensic analysis reports; and Other records and files pertinent to this subtitle. Forensic laboratory employees shall make data and records accessible during an on-site audit. Permitted Forensic Laboratory. A licensee operating a forensic laboratory under a permit shall: Be subject to routine audits conducted by the Department; Undergo a routine audit within 6 months after the forensic laboratory: Begins operating; Undergoes a change in ownership; or Has had a principal or alternative sanction imposed; and Undergo a routine triennial audit after meeting the audit requirements set forth in §B(2) of this regulation. Accredited Forensic Laboratory. An accredited forensic laboratory is: Not subject to routine audits conducted by the Department as set forth in §B of this regulation if the accredited forensic laboratory is undergoing routine on-site assessment conducted by an accreditation organization approved by the Secretary, except as provided in §C(2) of this regulation; and Subject to audits conducted by the Department to: Investigate a complaint; Determine regulatory compliance with any quality requirement; Follow up on any serious problem identified by an accreditation organization; or Validate an accreditation organization’s assessment of a forensic laboratory. Public Record. A forensic laboratory shall make discrepancy logs, contamination records, test results, and final inspection reports, including deficiency statements and plans of correction, available to the public within 30 business days of a written request for these public documents. Except as identified in this section or as otherwise provided by law, the proceedings, records, and files of an organization or State agency responsible for assuring compliance with this subtitle shall be confidential and may not be discoverable or admissible as evidence in a civil or criminal action. Internal Audits. A forensic laboratory shall conduct and document an annual audit of the overall operations of the forensic laboratory and generate a written audit report that identifies the finding and the corrective action taken to address the noncompliance. The forensic laboratory shall: Report the audit documentation to the Department within 4 months of the audit date; Make the audit documentation available on-site for inspection by the Department or its designee; Conduct an audit in each discipline in which the laboratory performs forensic analyses, using the quality assurance program policies, procedures, and protocols currently in use during the auditing cycle; and Conduct a comprehensive evaluation of the overall quality assurance program that includes both administrative and technical services. Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland Effective date: May 28, 2012 (39:10 Md. R. 660) Regulation .01D amended effective August 29, 2016 (43:17 Md. R. 953) General Requirements. A person shall obtain a license from the Secretary before performing or offering to perform a forensic analysis in this State. A person may not perform or offer to perform forensic analysis without first obtaining a forensic laboratory license from the Secretary. Letter of Permit Exception. The Secretary may grant an individual a letter of permit exception if: The individual is not affiliated with a public or commercial laboratory that performs forensic analyses; The application for the letter of permit exception is limited to an individual performing limited forensic analysis in a discipline or subdiscipline; and The individual applying for the letter of permit exception has documentation that demonstrates the individual’s competency and experience in the specific forensic discipline or subdiscipline in which the forensic analysis will be performed. The individual who will perform the forensic analysis shall: Submit an application for a letter of permit exception to the Department for approval; Renew a letter of permit exception every 3 years from the date of issuance, if renewal is desired; Be subject to oversight by the Department; and Be subject to the sanctions set forth in COMAR 10.51.07. Waiver. The Secretary may grant to a forensic laboratory not located in this State, a waiver from the licensing requirements of this subtitle if: The forensic analysis or examination is not performed by a licensee; The waiver is limited to a single case or related cases; and The person requesting the waiver has documentation that demonstrates the forensic laboratory’s competency and quality. A licensee, a party to a criminal case or related cases, or the forensic laboratory that has been requested to perform a forensic analysis shall: Submit a request for a waiver for approval by the Department; and Make requests in accordance with the process established by the Department. The Department may require an out-of-State laboratory that has been waived for licensure to apply for licensure based on the number of waivers issued to that laboratory by the Department. The Department may deny a waiver if: The Department determines the laboratory has been the subject of frequent waiver requests and the laboratory has failed to apply for licensure; or The laboratory’s license application was denied or its license was suspended or revoked by the Department. Prohibited Analyses. The Secretary may impose principal and alternative sanctions as set forth in this subtitle if a person performs or offers to perform a forensic analysis or part of a forensic analysis, including the use of a reagent, supply, procedure, method, technique, kit, or equipment, that: Does not produce accurate or reliable forensic analysis results as evidenced by documented, independent scientific testing and evaluation; or Lacks proof of efficacy substantiated by independently conducted and documented scientifically based evidence. Limitation. A person may not operate a forensic laboratory in a forensic science discipline or subdiscipline other than what is listed on the license unless it is a discipline or subdiscipline listed under COMAR 10.51.01.02C . Application Eligibility. A person meeting the requirements and standards of this subtitle and the requirements set forth in Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, may apply for a forensic laboratory permit. Issuance. Permit. The Secretary may issue a permit that: Is valid for not more than 3 years from the date of issue; and Shall be renewed before the date of expiration if a person intends to operate the forensic laboratory in the succeeding permit period. Site License Required. A person shall obtain a separate license for each location at which the person maintains a site to perform forensic analyses. In order to maintain a State license issued by the Department pursuant to this subtitle, a licensee shall be in compliance with all applicable federal, State, and local requirements. Requirements. A person operating a forensic laboratory that performs one or more forensic analyses shall: Obtain, complete, and submit written or electronic permit applications as prescribed in this subtitle; Obtain a forensic laboratory license as required in this subtitle; and Renew a forensic laboratory license as required in this subtitle. Regulatory Requirements. A person operating a forensic laboratory under a license shall comply with the: Audit requirements set forth in COMAR 10.51.02.03; Applicable proficiency testing requirements set forth in COMAR 10.51.04; Applicable ethics, data integrity, and non-retaliation requirements set forth in COMAR 10.51.05.16 and .17; Applicable quality systems, quality assurance, and quality control requirements set forth in COMAR 10.51.05; Applicable employee requirements set forth in COMAR 10.51.06; and Applicable federal, State, and local requirements regarding the operation of forensic laboratories. Application — Filing. A person shall: Apply for a license for each forensic laboratory location; File an application for a license using written or electronic forms provided by the Department; and Include in the application a description of forensic laboratory services, which includes but is not limited to: Types of forensic analyses performed or to be performed; Total number of individuals who perform forensic analyses for each forensic science discipline; and Qualifications of employees who direct, supervise, and perform forensic analyses. The forensic laboratory director shall sign the application forms attesting that the: Information provided in the application is accurate; and Forensic laboratory is or will be operated in accordance with the requirements and standards set forth in this subtitle. Application — Evaluation and Billing. The Department shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if the: Application is complete; and Forensic laboratory is eligible for a license. Application — Denial of License. If the Department determines that a forensic laboratory is not in compliance with the requirements of this subtitle and therefore cannot be issued a license, the Department shall provide to the forensic laboratory: A written statement of the grounds on which the denial is based; and The opportunity to: Amend and resubmit the application; or Request, in writing, an opportunity for a hearing as provided in the Administrative Procedure Act, State Government Article, §§10-201 — 10-226, and Health-General Article, §17-2A-09, Annotated Code of Maryland. Notification Requirements. A licensee shall notify the Department within 30 days of a change in forensic laboratory: Ownership; Name; Location; or Director. Amending a License. Except as prescribed in §D of this regulation, a licensee holding an unexpired license who wishes to have a permit amended shall: Submit a written request to amend the license to the Department; Remit to the Department a $50 relicensing fee; and Obtain written approval from the Department before implementing the change to the forensic laboratory’s operation or forensic analysis that is affected by the amendment. Expiration and Renewal. A license expires on the date shown on the license. The Department shall provide a renewal application to a forensic laboratory not less than 30 days before the expiration date shown on the license. In order to renew a license, a licensee shall file an application to renew the license using written or electronic forms provided by the Department and following the same procedures prescribed in §§A and B of this regulation. A licensee who fails to submit a completed renewal application before the expiration date may not operate the forensic laboratory after the permit expiration date. Non-Transferability. A license is not transferable. Addition of a New Discipline, Subdiscipline, or Forensic Analysis. A licensee shall: Apply for a provisional license for each new discipline, subdiscipline, or forensic analysis the licensee wishes to perform; File an application for a provisional license using forms provided by the Department; Include in the application a description of each new discipline, subdiscipline, or forensic analysis; and Make payment of any fees associated with each new addition. A licensee shall provide documentation of: Validation for the new discipline, subdiscipline, or forensic analysis; and Completion of training to include competency tests, and if applicable, proficiency tests of individuals who perform analyses within each new discipline, subdiscipline, or forensic analysis. An accredited licensee shall be subject to review by the Department until the new discipline, subdiscipline, or forensic analysis is accredited. Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland Effective date: May 28, 2012 (39:10 Md. R. 660) Chapter, Licenses and Fees renamed Licenses effective August 29, 2016 (43:17 Md. R. 953) Regulation .02A amended effective August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292) Regulation .03 amended effective August 29, 2016 (43:17 Md. R. 953) Regulation .03A, F amended effective March 13, 2017 (44:5 Md. R. 292) Regulation .04 repealed effective August 29, 2016 (43:17 Md. R. 953) 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: Firearms and toolmarks; Questioned documents; Latent prints; Trace evidence; Biology; Controlled dangerous substances; and Toxicology. Proficiency Testing Performance and Participation Requirements. Annually, a forensic analyst shall: Participate in a proficiency test for each discipline for which the forensic analyst is qualified to perform tests or examinations for casework; and Perform the proficiency testing analysis using the same methods and procedures routinely used for performing the forensic analysis of casework. For each subdiscipline for which a forensic analyst performs casework, the forensic analyst shall perform proficiency testing at least once in the 3-year license period or if applicable within the required time period outlined by the accreditation organization. Proficiency Testing Performance, Participation Schedule, and Documentation. The quality assurance manager or technical leader, as designated by the director, shall: Establish a formal, written proficiency testing protocol covering both external and internal proficiency tests for each forensic science discipline and subdiscipline in which the laboratory performs tests and examinations; and Document and maintain all records of proficiency testing and results for each individual forensic analyst required to participate in proficiency testing. 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, shall meet the proficiency testing requirements set forth in 42 U.S.C. §14131, which is incorporated by reference. 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 Department. Approval Granted by the Secretary. The Department may approve a proficiency testing provider for a forensic science discipline or subdiscipline, if the proficiency testing provider: Provides reliable, documented evidence to the Department that the proficiency test is technically and administratively able to meet the applicable requirements of this chapter; and Submits directly to the Department evaluations of all proficiency test results from each laboratory that holds a Maryland forensic laboratory permit. Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland Effective date: May 28, 2012 (39:10 Md. R. 660) To obtain or maintain a permit to operate a forensic laboratory, a person or licensee shall ensure that the forensic laboratory: 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; Maintains a quality assurance program that: Continually evaluates the effectiveness of the laboratory’s policies and procedures; Routinely revises policies and procedures based on the results of ongoing evaluation; Identifies and corrects problems; Assures: Accurate, complete, and reliable reporting of results of examinations and analyses; Technical procedures are validated and are accepted practice in the forensic discipline; and Adequate and competent employees; Requires documentation of all quality assurance and quality control activities; and Includes policies and procedures for: Handling and preservation of evidence; Calibration and maintenance of equipment; Handling, maintaining, and securing laboratory records including case records and reports; Evaluation and approval of employees; Laboratory security; Identifying and implementing corrective actions; Documenting and investigating complaints; The operation of individual characteristic databases, where appropriate; and Data integrity and ethics; Develops and maintains: An organizational chart of all employees; Job requirements and a job description for each contractor; and Employee records that include, but are not limited to: Job requirements and a job description for each employee; Educational background and qualifications; Curriculum vitae; Court testimony evaluations and a record that the evaluations are reviewed with each examiner and analyst; Documentation of successful completion of a training program set forth by the laboratory, including competency testing; Authorization to perform independent casework; and Performance evaluations; Establishes and maintains a forensic laboratory safety program; Employs appropriately trained employees and possesses equipment to conduct the scope of forensic services offered; Maintains reference literature in physical or electronic form that covers all disciplines and subdisciplines for which services are offered; Designates an individual as the quality assurance manager; Defines and maintains a document retention policy; Maintains a facility that is designed to ensure the integrity of the forensic analyses and the evidence; Conducts: Administrative review of all cases and reports before issuing a report; and 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; and Establishes a mechanism to address unresolved discrepant conclusions between an analyst and the technical reviewer. Policies and Procedure. A licensee shall develop, establish, maintain, implement, and follow quality assurance policies and procedures that ensure that the laboratory’s quality system is maintained. A licensee shall ensure that the laboratory has a clear procedure describing the process to uniquely identify evidence. Chain of Custody. The licensee shall: Maintain a record of chain of custody in written or electronic form in order to maintain accurate tracking of all evidence; and Document each transfer of evidence with the date of transfer and the signature of the person receiving the evidence at the time of transfer. Identifying and Handling Evidence. A licensee shall: Ensure that each item of evidence received by the forensic laboratory: Is permanently marked and includes a unique identifier either on the: Evidence itself; or Proximal container of the evidence; and Has a documented record that includes the: Identity of the evidence submitter; Date the item of evidence was submitted; and Description of the item of evidence submitted; Establish and follow a procedure to identify evidence that cannot be marked or identified as set forth in §B(1) of this regulation; Ensure all items produced during a forensic analysis or examination are: Marked with a unique identifier that can be traced back to the original evidence; Appropriately packaged; Documented in case notes, reports, and the evidence tracking system; and Packed with the original evidence when applicable or a disposition will be noted; Ensure documentation of the date of receipt of each test item and evidence; Establish, maintain, and follow a procedure to define proper packaging and sealing of evidence requiring that: Evidentiary seals: Are initialed or marked by the person sealing the evidence; and Prevent the evidence from being removed, lost, altered, or contaminated; and Evidence is protected from: Loss; Cross-contamination; and Any harmful change; and Consider evidence containers properly sealed only if: The contents cannot readily escape; and Entering the container results in obvious damage or alteration to the container or the container’s seal. Deficiencies, Errors, and Corrective Actions. A licensee shall have: A procedure for corrective actions to be taken when a deficiency or error is identified with: A forensic analysis procedure or method; or The casework or proficiency testing of a forensic analyst or examiner; and The procedure and required documentation for the corrective actions include: A determination of the cause of the deficiency or error; An evaluation of the deficiency or error to determine if the deficiency or error causes or has caused an adverse effect on the quality of a forensic analysis; An indication of the individual responsible for corrective action; A timeline of corrective action or actions; and Verification that the corrective action was: Implemented; and Monitored for effectiveness in correcting the deficiency or error. A licensee shall designate a quality assurance manager to oversee and ensure that the quality assurance program is implemented, maintained, and routinely evaluated. A licensee shall ensure that a change to an entry on an examination document, whether written or electronic, is: Trackable to the person who made the change; and Not erased, hidden, obscured, disguised, or obliterated. A licensee shall establish and follow a procedure to document any: Evidence discrepancies; Compromise of evidence integrity; or Lost or misplaced evidence. A licensee shall document all quality assurance and quality control activities as set forth in this subtitle. A licensee shall establish a procedure to: Investigate, resolve, and document a forensic analysis discrepancy; and Allow for a request and approval from the director or designee for a deviation from standard operating procedures. Public Record. A licensee shall establish and follow a procedure to make discrepancy logs, contamination records, and test results available to the public within 30 days of a written request. A contamination record shall include the following information: Unique case identifier; Encoded sample identification; Description of results; and Identifiers that led to an incident report. In addition to any applicable requirement in this chapter, a forensic laboratory performing postmortem forensic toxicology shall establish a: Procedure for responding to requests for the laboratory’s information and documentation; and Policy for: Retention and release of laboratory information; Addressing the confidentiality of laboratory data; and Identifying: The extent to which interpretations may be provided with test results; and Who is authorized to provide interpretations. Specimen Collection and Handling. A laboratory director shall develop and provide, to all agencies or parties that submit or request postmortem toxicology analyses, instructions that include the specific requirements for the: Type and minimum amount of specimen needed to perform the: Requested analysis; and Subsequent interpretations; Type and size of specimen container; Type and amount of preservative to be added to biological fluids, when applicable; Labeling of each individual specimen container; Packaging and transport of a specimen; Submission of relevant medical history on decedents who may carry a highly infectious disease, such as tuberculosis, hepatitis, or human immunodeficiency virus (HIV); Labeling of each specimen as to type and source, if applicable; and Proper sealing of containers to prevent: Leakage of the specimen container; and Cross-contamination between specimens. A licensee shall ensure that a specimen submitted for postmortem toxicology testing includes documentation that provides pertinent case information, including the: Name of decedent; Date of specimen collection; and Pertinent history of the case. For a specimen received for postmortem toxicology testing, a laboratory shall maintain a written or electronic record documenting the: Condition of the specimen; Handwritten initials or electronic signature of the individual who received the specimen; Date the specimen was received; Name of the decedent; Unique identifier assigned to the specimen; Specimen type; Date the specimen was collected; and Identification of the individual who collected the specimen. A licensee shall develop and follow a policy for the retention, release, and disposal of specimens submitted for postmortem toxicology testing. A licensee shall: Develop, establish, maintain, implement, and follow quality control policies and procedures that ensure accurate and reliable: Forensic analysis results; and Case reports; Ensure that all quality control activities set forth in this chapter are documented; Ensure that the quality control program is able to detect shifts and trends that could result in an adverse impact on the quality of forensic analysis results; Ensure that quality control data are evaluated routinely and when found to be contaminated, out of range, incorrect, or otherwise unacceptable: Corrective actions are taken; and Incorrect results are not reported; Ensure that quality control material and reference standards are specified in the SOPM and the results of quality control testing are documented in the case record; Ensure that a reagent used for a forensic analysis: Is tested for reliability before being put into use; Is identified with the: Name of the reagent; Lot number or date the reagent was prepared; and Expiration date; Is checked for reliability on a cycle determined by the technical leader; Has a record documenting: Who prepared the reagent; and Completion of a reliability check before use; and Has storage, safety, and handling requirements specified; Ensure that a reagent that is not used for a forensic analysis on a regular basis is tested for reliability before each use; Discard a reagent, make a new reagent, and check the new reagent’s reliability before any casework being performed, if the reagent reliability is found to be compromised; Use reagents that are suitable for the forensic analysis methods employed; Have procedures for tracking the receipt and use of commercial reagents; Have procedures for the formulation of in-house reagents in the SOPM; and Test the forensic analysis method, before reporting a forensic analysis result, using: A positive and negative external control for a qualitative forensic analysis; and Known levels of external controls for each analyte in a quantitative forensic analysis. Postmortem Forensic Toxicology. In addition to applicable requirements of this regulation, a laboratory performing postmortem forensic toxicology shall meet the requirements of this section. Screening Tests. A licensee shall: Ensure a postmortem toxicology screening test is appropriate and validated for the type of biological specimen being analyzed; and Perform and document precision studies for a method that uses cut-off values for analyte concentrations. Confirmatory Tests. A licensee shall: Confirm, if possible, the detection or initial identification of controlled dangerous substances or other toxicants by a second method based on a different chemical principle; and Ensure the confirmatory test is more specific than the initial test for the target analyte, if possible. Immunoassay. A laboratory shall: Be able to demonstrate sufficient separation in the response between a negative and positive specimen at the cut-off concentration of the immunoassay; Validate the use of an immunoassay method or procedure on a specimen if the method or procedure is not recommended by the manufacturer of the immunoassay; and Use matrix-matched quality control materials for each batch of specimens analyzed with the immunoassay. Chromatography. A laboratory shall: Analyze calibrators or controls with each batch of specimens for qualitative and quantitative chromatography assays; Establish an acceptable range for each quantitative quality control material; and Use a suitable internal reference standard, when available. Spectrophotometry. A laboratory shall maintain cuvettes used for spectrophotometry in good optical condition. Mass Spectrometry. A laboratory shall: Establish and adhere to criteria for acceptable mass spectrometric tune; Have written criteria for full scan mass spectrometric identification through library searching; and Compare ion ratios and retention times between reference standards, calibrators, quality control materials, and case specimens when using selected ion monitoring or selected reaction monitoring. Policies and Procedures. A licensee shall ensure that all policies and procedures affecting the scope of activities performed in the laboratory are: Documented; and Communicated to, understood by, available to, and implemented by employees performing the activities. A licensee shall ensure that: Documents issued to employees are reviewed and approved for use by authorized employees before issue; The current revision status and distribution of documents is established to preclude use of archived documents; Authorized documents are available at all locations where casework is performed; Archived documents are promptly removed from access or otherwise identified to ensure against unintended use; Documents are uniquely identified, including date of issue or version, page numbering, total number of pages or a mark to signify the end of the document, and the issuing authority; Changes to documents are approved by the same authority that issued the document and altered or new text is clearly identified; and Documents in computerized systems have equivalent procedures. A licensee shall develop, establish, maintain, implement, and require that technical procedures meet the following: The procedures included are: Generally accepted in the appropriate forensic field or supported by data gathered and recorded in a scientific manner; Available to all appropriate employees; Able to produce valid and accurate results; and Reviewed annually by the director or the director’s designee and this review shall be documented; All procedures include, at a minimum: Sample or specimen preparation, as needed for the method; Required quality control, standard, and reference material; Calibration requirements and instructions; Interfering substances and potential sources of error; Literature references; Special analytical and safety precautions; Step-by-step instructions; and Calculations, if required; The laboratory has a document control procedure to determine when the technical procedure has been discontinued or retired. A laboratory procedure identifies which documents are to be maintained in the case file; All changes to a procedure are approved and signed by the director; The SOPM is available to all forensic analysts and examiners; A departure from the SOPM is: Approved by the laboratory director or qualified designee before implementation; Scientifically validated before implementation; Written; and Communicated to the quality assurance manager; The laboratory has a procedure for determining the reasons, criteria, or conditions for when a report is not produced; The laboratory has a procedure or policy for technical review of reports that: Defines criteria for the technical review, for example, number or percent of case reports reviewed or corrective action protocol if discrepancies are found; Ensures that a review cannot be performed by the examiner or analyst who prepared the report; and Ensures that a technical review of a one-individual unit is performed at a review percentage determined by the laboratory director by an analyst or examiner of another licensed forensic laboratory, who is qualified within the same disciplines or subdisciplines; and The laboratory has a procedure for administrative review that: Requires that reviews be performed on all case reports; Specifies who may perform the administrative review; Clearly defines how the administrative review is documented; and Requires that reviews be performed before case reports are issued. A licensee shall ensure that the laboratory has a policy and procedure for the handling of written or oral complaints received from customers, laboratory employees, or other parties. Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall have: A record of sample signatures and initials of all employees handling specimens and performing analytical work; and A procedure: For periodically monitoring the purity of chemicals used as reference standards; and That defines which postmortem forensic toxicology tests are to be performed on each type of case. A licensee shall develop, establish, implement, maintain, and follow calibration procedures. If computers or automated equipment are used for the processing, recording, reporting, storage, or retrieval of calibration data, the licensee shall ensure that: Computer software is performance checked after updates occur or validated; Procedures are established, maintained, and followed to protect and secure the data; and Computers and automated equipment are maintained to ensure proper functioning. A licensee shall ensure that: Reference standards are calibrated by an entity that can provide traceability; Measuring devices including rulers, weights, pipettes, balances, thermometers, and other devices that affect a forensic analysis result are calibrated against a reference standard traceable to the International System of Units, if available, as required by the manufacturer or forensic laboratory’s quality assurance program; Calibration, if applicable, is performed: Before initial use and before the recalibrated item is returned to service; Following service or maintenance; and At intervals specified by the manufacturer or more frequently as determined by the technical leader or quality assurance manager; and All calibration activities are documented. Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall: Include in the method calibration: A sufficient number of calibrators and quality control samples in each batch that are consistent with the analysis being performed; and Analyses being performed on unusual specimens that: Use appropriate matrix-matched calibrators, when possible; and Are prepared and tested concurrently with the specimen; and Have a policy that defines a specimen that has a unique matrix. The licensee shall: Separately perform a validation or conduct a performance check on standard methods before use; Validate non-standard methods, laboratory designed methods, laboratory designed tests, and modifications of standard methods before use; and Maintain documentation of all method validation and performance check activities. A licensee shall ensure that validation includes, but is not limited to: Literature references; Limitations of the method; Sources of error; Specificity; Sensitivity; Accuracy; and Reproducibility. A licensee shall ensure that performance checks, if applicable, are performed: Before: Initial use of computers and automated equipment; and Computers or automated equipment are returned to use for casework; Following servicing or maintenance; At intervals specified by the manufacturer; and As needed as determined by the laboratory director or the laboratory director’s designee. A technical leader and a laboratory director shall approve all testing methods before the testing methods are put into use. A licensee shall ensure that: Reference samples are used for method validation and performance checks; Validation and performance checks include a statement as to whether the method is fit for the intended use; and All new procedures and modifications of current procedures are validated and documented before being used in case work. A licensee shall develop, establish, maintain, implement, and follow examination and analysis procedures. A licensee shall: Ensure that all evidence is given a unique identifier; Ensure that, when computers or automated equipment are used for the processing, recording, reporting, storage, or retrieval of examination or analysis data: Computer software is validated; Procedures are established and maintained to protect and secure the data; and Computers and automated equipment are maintained to ensure proper functioning; Have a policy for securing short-term and long-term storage of documents, evidence, and reports, which includes: Limited access; and Environmental controls; Ensure each individual sub-sample has a unique identifier, when evidentiary samples are subdivided; Ensure that all positive comparative analyses are verified by a second independent qualified examiner or analyst who has documented expertise in the examination that was performed, and the verification is documented; and Have a policy for securing evidence that is in the process of being examined or analyzed. Examinations and Analysis by Subcontractors. All subcontractors shall be licensed as a forensic laboratory in the State, regardless of location, unless a waiver has been obtained for a rare or unique test as required by COMAR 10.51.03.01A(4). A licensee shall ensure: The customer who ordered the analyses is notified of the laboratory’s intention to subcontract specific services for testing; All subcontractors issue reports only to the forensic laboratory that ordered the testing; and All remaining evidence is returned to the forensic laboratory by the subcontractor. A licensee shall ensure that a test report includes but is not limited to the following: Name and physical address of the laboratory; A unique identifier on each page of the report; Identification of the forensic analysis method used; A clear identification of each item tested including a description of the item’s condition; The date each forensic analysis was completed; Units of measurement, if applicable; The name and written or electronic signature of the examiner or analyst responsible for: Performance of the forensic analysis; Interpretations of forensic analysis results; and Opinions; Opinions and interpretations; When applicable, a statement of uncertainty of measurement if the uncertainty of measurement may affect the interpretation of the results of the forensic analysis; The date report was generated; The indication of the end of the report on the report’s last page; and If applicable, a statement that the analysis was performed by another laboratory and identifies the facility that actually performed the analysis. A licensee shall ensure that any information from §A(1)—(12) of this regulation that is not included in the test report is documented in the case record. A licensee shall ensure that test reports: Are produced when analytical testing is performed on evidence; Contain opinions and conclusions and the name of the report’s author; Report results accurately, clearly, unambiguously, and objectively; and Utilize a page numbering system that includes either the total number of pages or a mark to signify the end of the document. A licensee shall ensure that amended reports: Clearly state that the report has been amended; Reference the original report; Are placed or associated with the original report in the case file; and Are provided to the customers. Reports — Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall: Have a procedure or policy for technical review of reports, which includes at a minimum: Chain of custody documentation; Validity of analytical data; and Quality control data; Include on the test report the name of the submitting agency or individual; Indicate qualitative test results using the: Term “Positive” if the test result is positive for the presence of the substance tested; and Term “None detected” if the test result is negative for the presence of the substance tested; Have quantitative results identified using correct nomenclature; Have preliminary reports clearly indicate that the: Results are unconfirmed and subject to verification; Testing is incomplete; and Subsequent results, where appropriate, may affect the final report and interpretation of the report; Clearly identify test results performed by a subcontractor; Clearly identify revised reports or addenda using the same identifying information as the original report, for reports that contain additional testing after the original test results were reported; and Indicate on the final report the name of the laboratory that actually performed the test if specimens were referred to another laboratory for analysis. 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. A licensee shall ensure that available to all technical employees is a discipline-specific training program that includes: All aspects of the work being performed by the laboratory for each discipline and subdiscipline in which the laboratory performs case work; Ethics and data integrity; Criminal and civil law procedures; Criteria or requirements to demonstrate competence; Moot court training if court testimony may be required; and Expert witness training if expert witness testimony may be required. A licensee shall ensure that training records include at least: Competency assessments; Proficiency testing results; Documentation of all training; Documentation of training that occurred at a previous job, if applicable; Written authorization by the laboratory director and technical leader to conduct independent casework in each type of testing assigned; and Documentation of all continuing education. General. The laboratory shall develop, establish, maintain, implement, and follow an equipment calibration and maintenance procedure and policy. A licensee shall ensure that equipment, before being placed into use, is calibrated or checked to establish that the equipment meets either the laboratory’s or manufacturer’s specifications, or both, as determined by the director. A licensee shall ensure that records are maintained on all items of equipment including at a minimum: Identity of the item of equipment and the equipment’s ancillary parts; Manufacturer’s name and serial number or other unique identifier; Performance checks ensuring the equipment complies with the manufacturer’s specifications; Current location, if applicable; Manufacturer’s instructions or operating manual; Dates and results of calibrations, adjustments, and service and date of next calibration; Documentation of all maintenance performed, including date and signature of the individual performing the maintenance; and Documentation of any damage, malfunction, modification, or repair to the equipment. A licensee shall ensure that any equipment that gives questionable results or is not functioning properly is immediately taken out of use and the equipment: Is clearly labeled as out of service; Is examined and repaired or retired; Is calibrated or shown to perform correctly before being put back into service; and Has forensic analysis results on previously examined evidence evaluated for accuracy back to the previous calibration. A licensee shall ensure that the equipment, including both hardware and software, is safeguarded from adjustments that invalidate or alter calibrations or test examinations and analyses. A licensee shall ensure that operator’s manuals for all equipment and instruments are available to all examiners and analysts who use the equipment or instruments. 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: Writing all documents in permanent ink and defining exceptions in the laboratory SOPM; Using electronic signatures only if a security protocol is in place; Having a tracking policy and system for electronic record changes, when the electronic document is complete; and Identifying all administrative documents with a unique identifier and signing or initialing by the individual who prepared or received the document. In regard to examination documents, a licensee shall ensure that: If information is recorded on both sides, each side of a page is considered a separate page; If examination documents consist of multiple pages, a page numbering system that includes either the total number of pages or a mark signifying the end of the document is used; In the absence of the examiner or analyst, another competent examiner or analyst is able to evaluate and interpret the data; An examination document: Includes details to support the conclusions and opinions reported by each examiner or analyst; Is free of erasures or obliterations; Is marked with a unique identifier and the examiner’s or analyst’s handwritten initials or electronic signature; and Includes each date casework or an analysis was performed; If an individual in addition to the examiner or analyst interprets or reports the results, both individuals initial or electronically sign each page of the examination documents; Abbreviations and symbols are defined in the SOPM; Erroneous results, corrections, and amendments: Are crossed out with a single line, not erased, and not deleted or made illegible; and Have corrections entered beside the erroneous result; All corrections and amendments are initialed and dated; If electronically signed, measures are taken to ensure the signature is secure; and There is no loss or change of the original documents. A licensee shall retain all complaint records and documentation of the investigations and corrective actions taken by the laboratory. A licensee shall ensure that complaint documents include at least the: Name and organization of complainant, if applicable; Date of complaint; Details of complaint; Corrective action and resolution; and Notification of the complainant as to the resolution of the complaint. A licensee shall forward all complaints to the laboratory director. A licensee shall: Maintain a list of all subcontractors to which forensic analyses are referred; Be responsible for the subcontractor’s forensic analysis or examination; Ensure that forensic analysis results from the subcontractor are written or in a secured electronic form; Ensure that if alternative methods are used, the customer is notified before performing the examination or analysis; Establish and use appropriate review procedures to ensure the integrity of: Outsourced samples; and Data received from the subcontractor; and Establish and use appropriate review procedures to verify compliance with applicable State regulations. Facility Administration. A licensee shall ensure that a laboratory: Is adequate for the testing services offered; Has lighting, plumbing, wiring, ventilation, heat, air conditioning, and humidity to meet the laboratory’s requirements; and Has the required safety equipment as defined by the laboratory SOPM. Security. A licensee shall: Control and limit access to areas of the laboratory to those persons who regularly work in an area or are designated by the laboratory director as having access to an area; and Ensure that: Entrances and exits have adequate security measures; Internal areas that are required to have controlled or limited access are protected by a locked system; The distribution of all keys, magnetic cards, and entry devices is documented and authorized by the director; The facility is secure; and All short-term and long-term storage areas have controlled or limited access and have a lock system in place. Safety. A licensee shall: Have a safety policy and procedure, that is reviewed annually; Designate an employee as the safety officer with responsibilities defined by the licensee; Have appropriate safety policies and procedures; Demonstrate appropriate safety policies and procedures; Have appropriate safety devices and equipment available and in close proximity to the appropriate areas; and Be in compliance with all federal, State, and local regulations regarding the handling and disposal of infectious materials, chemicals, radioactive materials, sharps, and glassware. A licensee shall: 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; Provide access to the information, training, and resources needed by all forensic laboratory employees to comply with applicable federal and State laws, including ethics laws and regulations and the ethics and data integrity policy required in §A(1) of this regulation; Provide formal ethics and data integrity training: As part of new employee orientation; and On an annual basis for all current employees; Develop and utilize an employee ethics and data integrity agreement, for each employee to sign annually after training, acknowledging, and certifying that the employee has read, understands, and will follow the forensic laboratory ethics and data integrity policy; and Provide a working environment in the forensic laboratory that: Prevents employees from being subject to inappropriate pressures, coercion, intimidation, unethical laboratory dilemmas, or bribery from internal or external sources; and Promotes and maintains effective bilateral communication through the chain-of-command, regarding concerns, inquiries, and allegations pertaining to: Suspected or actual unethical conduct; Data integrity issues; Questionable practices; or Questions concerning forensic analysis procedures or results. A licensee shall ensure that a licensee’s ethics and data integrity policy includes at least the following topics, requirements, and procedures: An employee’s responsibility to report any activity or behavior by any other employee, subcontractor, or vendor that the employee has reason to believe violates applicable laws, rules, and regulations or the forensic laboratory’s ethics and data integrity policy; The disciplinary action an employee will be subject to if the employee: Makes or produces a report that the employee knows to be false or misleading; Is found falsifying, short-cutting, camouflaging, or misrepresenting any information or facts about forensic analysis procedure, result, reports, or data management; or Otherwise engages in conduct or behavior that violates the: Forensic laboratory’s ethics and data integrity policy; or Established forensic laboratory practices; Procedures for reporting, handling, and investigating complaints of unethical conduct and violations or suspected violations of the forensic laboratory’s ethics and data integrity policy; Requiring employees to: Act impartially and not give preferential treatment to any person; Exhibit exemplary conduct and use honest efforts in the performance of duties and responsibilities; Perform a forensic analysis in a manner that: Is independent of internal and external influences; Is objective; and Assures that results are accurate, precise, and of known and documented quality; and Understand the: Serious implications and consequences of unethical conduct, intent to defraud, or any impropriety in performing forensic analyses; and Zero tolerance policy regarding an employee who engages in any form of conduct or behavior that is a violation of the ethics and data integrity policy required in §A of this regulation or any forensic laboratory practice that is not authorized by a licensee’s established procedures; and Prohibiting an employee from: Soliciting or accepting any gift of goods or services or other benefit of value from a person or entity: Seeking action from or doing business with the forensic laboratory; or Whose interests may be substantially affected by the performance or nonperformance of the employee’s duties and responsibilities; Holding a financial or personal interest that conflicts with the conscientious and ethical performance of duties and responsibilities; Engaging in a transaction allowing the improper use of confidential information to further a private interest; Conducting an action that violates the standards and requirements set forth in this subtitle or the licensee’s ethics and data integrity policy; and Engaging in outside employment or activities that conflict with the conscientious and ethical performance of duties and responsibilities. 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 any form of discrimination or retaliation. An employee who works in a forensic laboratory may disclose information to the Secretary that the employee believes evidences a violation or possible violation of a standard or requirement set forth in this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, including a standard or requirement related to data integrity or unethical or fraudulent conduct. A licensee shall post the document developed by the Secretary and approved by the Department informing employees of a forensic laboratory of the procedures to report instances of noncompliance or other violations of the standards and requirements set forth in this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland. The Department shall develop a forensic laboratory noncompliance document that: Has contact information for reporting violations of standards and requirements for forensic laboratories, including address, phone numbers, fax number, and website; Has a statement about nonretaliation and nondiscrimination against anyone reporting noncompliance or other violations for forensic laboratories; and Is signed by the director of the Office of Health Care Quality. The Department shall distribute to each quality assurance manager of a forensic laboratory the document referenced in §D of this regulation. A licensee shall ensure that the document referenced in §D of this regulation is posted in a conspicuous place visible to all forensic laboratory employees. A licensee may not discriminate or retaliate against an employee of a forensic laboratory who: In good faith makes a report to the Secretary as set forth in this regulation; or Has agreed to cooperate with an investigation of the forensic laboratory. A licensee may be subject to the sanctions set forth in this subtitle and Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, if the licensee discriminates or retaliates against an employee who in good faith makes a report to the Secretary as set forth in this regulation, including: Failing to promote the employee or provide an employment-related benefit for which the employee would otherwise be eligible; Making an adverse evaluation or decision in relation to accreditation, certification, credentialing, or licensing of the employee; or Taking a personnel action that is retaliatory to the employee. An employee of a forensic laboratory who has been discriminated or retaliated against in violation of this regulation or Health-General Article, §17–2A–10, Annotated Code of Maryland, may initiate an action within 2 years of the discrimination or retaliation that is the basis for the action, and, on prevailing, shall be entitled to: Reinstatement; Reimbursement for lost wages; Work benefits lost as a result of the unlawful acts of the licensee; and Reasonable attorney’s fees and costs associated with pursuing the action. Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland Effective date: May 28, 2012 (39:10 Md. R. 660) Regulation .01K amended effective July 20, 2015 (42:14 Md R. 880) Regulation .02A, B amended effective July 20, 2015 (42:14 Md R. 880) Regulation .05C amended effective July 20, 2015 (42:14 Md R. 880) Regulation .07C amended effective July 20, 2015 (42:14 Md R. 880) Regulation .09C, D amended effective July 20, 2015 (42:14 Md R. 880) Regulation .10B amended effective July 20, 2015 (42:14 Md R. 880) Regulation .12B amended effective July 20, 2015 (42:14 Md R. 880) Regulation .15A, C amended effective July 20, 2015 (42:14 Md R. 880) 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) Authority and Types. 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, Subtitle 2A, Annotated Code of Maryland. Principal Sanctions. The Secretary may impose the following principal sanctions: Denial of a license; Suspension of a license; or Revocation of a license. Alternative Sanctions. Instead of or in conjunction with withdrawing a principal sanction, the Secretary may impose one or more of the following alternative sanctions: A directed plan of correction; Limitation on forensic analyses; or Training and technical assistance. Reasons for Imposition. The Secretary may impose on a forensic laboratory one or more sanctions if the Secretary finds: A deficiency identified through: An on-site audit; or A review of materials submitted by a forensic laboratory that shows a problem with: Application data; Employee qualification materials; or Internal audits; Unsuccessful proficiency test performance; Demonstrated incompetence, such as showing consistent or repetitive errors in: Operating forensic laboratory equipment; or Performing a forensic analysis; False statements made on an application, allegation of compliance, or other form submitted to the Department; Misrepresentation in obtaining a license or in operating a forensic laboratory; Submission of a sample or specimen by a forensic laboratory inside the State to another laboratory that does not possess a license or a waiver as set forth in this subtitle; or A violation of a law of the State pertaining to a forensic laboratory. Factors Affecting Choice of Sanctions. The Secretary shall choose which sanctions to apply to a forensic laboratory based on, but not limited to, the following: Whether a deficiency poses immediate jeopardy to public safety or individual rights; The nature, incidence, severity, and duration of the deficiency; Whether a deficiency has been identified repeatedly; Whether the Department can determine the laboratory’s compliance due to inaccurate record keeping or the licensee’s lack of documentation or laboratory records, including those required for quality assurance and quality control; Failure to make records available to the Department; The relationship of one deficiency or group of deficiencies to another deficiency; The overall compliance history of a forensic laboratory, including but not limited to any period of noncompliance that occurred between the Secretary’s determinations of compliance; The corrective and long-term compliance outcomes the Secretary intends to effect through application of the sanction; and The progress a forensic laboratory has made toward regulatory compliance following a reasonable opportunity to correct a deficiency. Improper Referral of Proficiency Testing Samples. If the Department determines that a forensic laboratory has intentionally referred a proficiency testing sample to another laboratory for analysis, the Secretary: Shall revoke the forensic laboratory’s license for a period of 1 year; and May also impose one or more alternative sanctions. Owning and Operating Prohibition Following Revocation. A person who has owned, operated, or directed a forensic laboratory that has had the laboratory’s license revoked may not, within 1 year of the revocation, apply for a license for or own, operate, or direct a forensic laboratory. Deficiency Posing Immediate Jeopardy. 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. Initial Actions. When a deficiency involving immediate jeopardy is first identified, the Secretary shall: Require the forensic laboratory to take immediate action to remove the jeopardy; and Impose: A principal sanction after giving the forensic laboratory at least 24 hours’ notice; or One or more alternative sanctions. Follow-up Actions. If the Department finds, in a follow-up audit of a forensic laboratory under an alternative sanction, that the forensic laboratory has not eliminated the immediate jeopardy, the Secretary shall impose a principal sanction after giving the forensic laboratory at least 24 hours’ notice. Deficiency Not Posing Immediate Jeopardy. If a forensic laboratory’s deficiency does not pose immediate jeopardy to personal or public safety, the Secretary may take one or more of the actions listed in §B(2)—(4) of this regulation. Initial Actions. When a deficiency is first identified, the Secretary may impose one or more alternative sanctions or a principal sanction. Unsuccessful Proficiency Testing Participation. If a forensic laboratory exhibits unsuccessful proficiency testing, as set forth in this subtitle, the Secretary may impose the training and technical assistance requirements set forth in Regulation .04 of this chapter as a directed plan of correction, as well as any other sanction. Follow-up Actions. If the Department finds in a follow-up audit, that a forensic laboratory has not initiated a corrective action for a deficiency within 30 days after the deficiency was identified, the Secretary may: Impose, or continue if already imposed, one or more sanctions; Conduct one or more on-site audits to evaluate progress in the correction of a deficiency; and Conduct an additional follow-up on-site audit to determine whether all corrections have been made. Duration of a Sanction. A sanction shall remain in force until: A forensic laboratory corrects the deficiency; or A forensic laboratory’s license is revoked. Withdrawal of a Sanction. General. The Secretary may not withdraw a sanction until the Secretary verifies regulatory compliance with this subtitle. Credible Allegation of Compliance. When a sanctioned forensic laboratory submits a credible allegation of compliance, the Secretary may determine compliance through one or more of the following ways: On the basis of the evidence submitted by the forensic laboratory in the allegation; or A follow-up audit to verify whether the forensic laboratory has achieved compliance. If a forensic laboratory does not correct all deficiencies within 30 days after imposition of a sanction, the Secretary may initiate action to suspend or revoke the license. Hearing Requirement. 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: If a suspension or revocation of the licensee’s license takes effect; The reason for the suspension or revocation; and That the licensee has an opportunity for a hearing on the matter before the suspension or revocation takes effect, as provided in State Government Article, §10-226, Annotated Code of Maryland. If the Secretary finds a condition that imperatively requires emergency or immediate action to preserve public safety or individual rights, the Secretary shall inform the licensee in writing: When a suspension or revocation of the licensee’s license takes effect; The reason for the suspension or revocation; and That the licensee has an opportunity for a hearing on the matter, as provided in State Government Article, §10-226, Annotated Code of Maryland, after the suspension or revocation. Notice. Contents. In cases involving a principal sanction, the Secretary shall give written notice to a licensee of the: Deficiency identified; Sanction proposed for imposition; Reason for the proposed sanction; Projected effective date and duration of the proposed sanction; Authority for the proposed sanction; and Time allowed for a forensic laboratory to respond to the notice. Opportunity to Respond. During the time allowed and stated in the written notice, a forensic laboratory may submit to the Secretary written evidence or other information against imposition of the proposed sanction or sanctions. Notice Times. If a deficiency is found that imperatively requires emergency or immediate action, the Secretary shall provide notice at least 24 hours before the effective date of the sanction, unless conditions warrant immediate suspension. If a deficiency is found to warrant a principal sanction, but does not imperatively require emergency or immediate action, the Secretary shall provide notice at least 10 days before the effective date of sanction. To preserve a right to a hearing, a licensee shall request a hearing within 10 days of the licensee’s receipt of the notice of the pending sanction. Application. If a forensic laboratory’s performance in proficiency testing is unsatisfactory, as set forth in this subtitle, the Secretary may require the forensic laboratory to undertake the directed plan of correction of training the forensic laboratory employees or obtaining technical assistance, or both, in order to meet the proficiency testing requirements of this subtitle. Procedures. A forensic laboratory required to undertake training of employees or to obtain necessary technical assistance shall: Document the training or assistance, or both, using a form provided by the Department; and Submit the completed form to the Department. If the Department determines that a licensee has reported an erroneous test result that threatens the safety or rights of an individual, the Secretary may order the licensee, within a specified period of time, to: Give prompt notice of the erroneous test result to: The person who ordered the forensic analysis be performed; Any other person to whom the forensic laboratory has previously sent a report that contained the erroneous test result; The Office of Public Defender or counsel of record; and The State’s Attorney; Provide corrected reports to the persons notified in §A(1) of this regulation; Maintain a duplicate copy of both the original report and the corrected report; Conduct a quality assessment of all phases of the testing or examination process to determine the cause of the erroneous forensic analysis test result; Take the necessary remedial or corrective action to prevent recurrence of the problem; and Take any additional measures necessary to reduce or eliminate the threat to public safety or individual rights. Civil Money Penalty for Failure to Comply with Order. A forensic laboratory that fails to comply with an order issued by the Secretary under §A of this regulation is subject to a civil money penalty of up to $1,000 for each day of noncompliance, up to a maximum of $50,000. The Secretary may impose the civil money penalty instead of, or in addition to, any other sanction imposed under this chapter. Notice and Hearing. Notice. Before the Secretary imposes a civil money penalty for noncompliance as provided in §B of this regulation, the Secretary shall give written notice to a licensee: Of the intent to impose a civil money penalty; and That the licensee has an opportunity for a hearing on the matter before the civil money penalty is imposed. Content. The Secretary shall give written notice to the licensee of the: Reason for the imposition of the civil money penalty; Amount of the civil money penalty; Effective date of the imposition of the civil money penalty; Time allowed for the licensee to respond to the notice; and Authority for imposing the civil money penalty. Opportunity to Respond. During the time allowed and stated in the written notice from the Secretary, the licensee may submit to the Secretary written evidence or other information to support the position that the licensee has not violated the requirements of this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland. To preserve the right to a hearing, the licensee shall request a hearing within 10 days of receipt of the notice of the Secretary’s intent to impose the civil money penalty. Factors to Be Considered in the Assessment of Penalties. In cases in which the Secretary determines that the imposition of a civil money penalty is appropriate, the Secretary shall consider the following factors in determining the amount of the penalty: The extent to which the licensee derived any financial or other benefit from reporting erroneous forensic analysis results; The willfulness on the part of the licensee to violate this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland; The extent of actual or potential harm caused by the reporting of erroneous forensic analysis results; The cost of investigating and prosecuting the case against the licensee; The licensee’s history of previous failure to meet the standards of this subtitle; and The existence of mitigating factors. Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland Effective date: May 28, 2012 (39:10 Md. R. 660) Effective date: July 1, 2000 (27:12 Md. R. 1141) Regulation .03A amended effective January 19, 2004 (31:1 Md. R. 31) Chapter repealed effective July 2, 2007 (34:13 Md. R. 1151) Effective date: July 1, 2000 (27:12 Md. R. 1141) Chapter repealed effective July 2, 2007 (34:13 Md. R. 1151) Effective date: July 1, 2000 (27:12 Md. R. 1141) Regulation .02A, C amended effective January 19, 2004 (31:1 Md. R. 31) Chapter repealed effective July 2, 2007 (34:13 Md. R. 1151) Effective date: July 1, 2000 (27:12 Md. R. 1141) Chapter repealed effective July 2, 2007 (34:13 Md. R. 1151)