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10.51.05.00.htm 10.51.05.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 51 FORENSIC LABORATORIES Chapter 05 Quality Assurance Authority: Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland
10.51.05.01.htm 10.51.05.01. 01 Quality Assurance ― General.. To obtain or maintain a permit to operate a forensic laboratory, a person or licensee shall ensure that the forensic laboratory:A. Establishes and follows policies and procedures for a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality and safety of the total examination and forensic analysis process;B. Maintains a quality assurance program that:.
10.51.05.02.htm 10.51.05.02. 02 Quality Assurance ― Specific.. A. Policies and Procedure.. 1) A licensee shall develop, establish, maintain, implement, and follow quality assurance policies and procedures that ensure that the laboratory’s quality system is maintained.2) A licensee shall ensure that the laboratory has a clear procedure describing the process to uniquely identify evidence.3) Chain of Custody. The licensee shall:. a) Maintain a record of chain of custody in written or electronic form in o
10.51.05.03.htm 10.51.05.03. 03 Quality Assurance ― Specific for Postmortem Forensic Toxicology.. A. In addition to any applicable requirement in this chapter, a forensic laboratory performing postmortem forensic toxicology shall establish a:1) Procedure for responding to requests for the laboratory’s information and documentation; and. 2) Policy for:. a) Retention and release of laboratory information;. b) Addressing the confidentiality of laboratory data; and. c) Identifying:.
10.51.05.04.htm 10.51.05.04. 04 Quality Control Program.. A. A licensee shall:. 1) Develop, establish, maintain, implement, and follow quality control policies and procedures that ensure accurate and reliable:a) Forensic analysis results; and. b) Case reports;. 2) Ensure that all quality control activities set forth in this chapter are documented;. 3) 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;
10.51.05.05.htm 10.51.05.05. 05 Standard Operating Procedures Manual (SOPM). A. Policies and Procedures. A licensee shall ensure that all policies and procedures affecting the scope of activities performed in the laboratory are:1) Documented; and. 2) Communicated to, understood by, available to, and implemented by employees performing the activities.B. A licensee shall ensure that:. 1) Documents issued to employees are reviewed and approved for use by authorized employees before issue;2) The current revision s
10.51.05.06.htm 10.51.05.06. 06 Calibration ― General.. A. A licensee shall develop, establish, implement, maintain, and follow calibration procedures.. 1) If computers or automated equipment are used for the processing, recording, reporting, storage, or retrieval of calibration data, the licensee shall ensure that:a) Computer software is performance checked after updates occur or validated;. b) Procedures are established, maintained, and followed to protect and secure the data; and.
10.51.05.07.htm 10.51.05.07. 07 Validation and Performance Checks.. A. The licensee shall:. 1) Separately perform a validation or conduct a performance check on standard methods before use;. 2) Validate non-standard methods, laboratory designed methods, laboratory designed tests, and modifications of standard methods before use; and3) Maintain documentation of all method validation and performance check activities.. B. A licensee shall ensure that validation includes, but is not limited to:.
10.51.05.08.htm 10.51.05.08. 08 Examination and Analysis.. A. A licensee shall develop, establish, maintain, implement, and follow examination and analysis procedures.B. A licensee shall:. 1) Ensure that all evidence is given a unique identifier;. 2) Ensure that, when computers or automated equipment are used for the processing, recording, reporting, storage, or retrieval of examination or analysis data:a) Computer software is validated;.
10.51.05.09.htm 10.51.05.09. 09 Test Reports ― General.. A. A licensee shall ensure that a test report includes but is not limited to the following:. 1) Name and physical address of the laboratory;. 2) A unique identifier on each page of the report;. 3) Identification of the forensic analysis method used;. 4) A clear identification of each item tested including a description of the item’s condition;. 5) The date each forensic analysis was completed;. 6) Units of measurement, if applicable;.
10.51.05.10.htm 10.51.05.10. 10 Employee Training and Competency.. A. A licensee shall develop, establish, maintain, implement, and follow a written training program for all technical skills in each discipline and subdiscipline for each new or untrained employee and employees who need remedial training.B. A licensee shall ensure that available to all technical employees is a discipline-specific training program that includes:1) All aspects of the work being performed by the laboratory for each disci
10.51.05.11.htm 10.51.05.11. 11 Equipment Maintenance.. A. General. The laboratory shall develop, establish, maintain, implement, and follow an equipment calibration and maintenance procedure and policy.B. A licensee shall ensure that equipment, before being placed into use, is calibrated or checked to establish that the equipment meets either the laboratory’s or manufacturer’s specifications, or both, as determined by the director.C. A licensee shall ensure that records are maintained on all items of equi
10.51.05.12.htm 10.51.05.12. 12 Case Records.. A. A licensee shall create and maintain a unique identifier system for all administrative and examination documents originating from or received by the laboratory for each case by:1) Writing all documents in permanent ink and defining exceptions in the laboratory SOPM;. 2) Using electronic signatures only if a security protocol is in place;. 3) Having a tracking policy and system for electronic record changes, when the electronic document is complete; and
10.51.05.13.htm 10.51.05.13. 13 Complaints.. A. A licensee shall retain all complaint records and documentation of the investigations and corrective actions taken by the laboratory.B. A licensee shall ensure that complaint documents include at least the:. 1) Name and organization of complainant, if applicable;. 2) Date of complaint;. 3) Details of complaint;. 4) Corrective action and resolution; and. 5) Notification of the complainant as to the resolution of the complaint..
10.51.05.14.htm 10.51.05.14. 14 Subcontractors.. A licensee shall:. A. Maintain a list of all subcontractors to which forensic analyses are referred;. B. Be responsible for the subcontractor’s forensic analysis or examination;. C. Ensure that forensic analysis results from the subcontractor are written or in a secured electronic form;D. Ensure that if alternative methods are used, the customer is notified before performing the examination or analysis;
10.51.05.15.htm 10.51.05.15. 15 Facilities.. A. Facility Administration. A licensee shall ensure that a laboratory:. 1) Is adequate for the testing services offered;. 2) Has lighting, plumbing, wiring, ventilation, heat, air conditioning, and humidity to meet the laboratory’s requirements; and3) Has the required safety equipment as defined by the laboratory SOPM.. B. Security. A licensee shall:. 1) Control and limit access to areas of the laboratory to those persons who regularly work in an are
10.51.05.16.htm 10.51.05.16. 16 Ethics and Data Integrity Policy ― Requirement.. A. A licensee shall:. 1) Establish and maintain a written ethics and data integrity policy to be followed by all forensic laboratory employees, which includes the items set forth in §B of this regulation;2) Provide access to 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 integri
10.51.05.17.htm 10.51.05.17. 17 Nonretaliation.. A. A licensee shall establish, maintain, and follow a nonretaliation policy that ensures that an employee who in good faith reports to the Secretary or the Department an issue related to data integrity or unethical or fraudulent conduct will not be subject to any form of discrimination or retaliation.B. An employee who works in a forensic laboratory may disclose information to the Secretary that the employee believes evidences a violation or possib
10.51.05.9999.htm 10.51.05.9999. Administrative History 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).
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