Section 144-270-5 - Requirements For Testing Laboratories Laboratories conducting chemical tests for drugs other than alcohol must comply with the following:
A. Laboratory Accreditation Laboratories testing for substances of use under this rule must be accredited as a Forensic Testing Laboratory to ISO 17025 standards by an accrediting body, such as ANSI National Accreditation Board (ANAB).
B. Analyst Certification 1. Analysts testing for substances of use under this rule must be certified by the Department for such testing. Analysts seeking certification must demonstrate that they are under the control and supervision of an ISO 17025 accredited Forensic Testing Laboratory, as defined herein. Analyst certification is initially obtained by successful completion of a Health and Environmental Testing Laboratory Forensic Chemistry training program and the passing of a competency test, as described in the Forensic Chemistry Quality Manual. This certification is issued by the Department and signed by the Forensic Technical Laboratory Director and Associate Director of Laboratory Operations.2. The term of the analyst certificate may not exceed six months for blood alcohol analysis and one year for toxicology drug analysis, from the date of issue. To maintain certification, the successful completion of a discipline-specific proficiency test must occur prior to the expiration date of the current certification. If these requirements are met, a new certification will be issued for the next term. Records of this certification will be maintained by the Forensic Technical Laboratory Director and the certified analyst.C. Personnel 1. Laboratory Technical Director a. The forensic toxicology laboratory must be directed by a person who is qualified by reason of appropriate education and experience to assume the required professional, organizational, educational, managerial and administrative responsibilities.b. Alternative acceptable qualifications include a doctoral degree in one of the natural or physical sciences and at least three years of full-time laboratory experience in forensic toxicology; or a Master's degree in one of the natural or physical sciences and at least five years of full-time laboratory experience in forensic toxicology; or a Bachelor's degree in one of the natural sciences and at least seven years of full-time laboratory experience in forensic toxicology.c. The laboratory technical director must also have documented training and/or experience in the forensic applications of analytical toxicology (such as court testimony, research, participation in continuing education programs, and/or peer review of appropriate manuscripts in the field), including a knowledge of evidentiary procedures that apply when toxicological specimens are acquired, processed, and stored and when toxicological data are submitted as part of a legal proceeding.d. The laboratory technical director is responsible for ensuring that the laboratory personnel are adequately trained and experienced to conduct the work of the laboratory.e. The laboratory technical director is responsible for maintaining the competency of laboratory personnel by monitoring their work performance and verifying their skills. This training and experience must be documented.f. The laboratory technical director and/or section supervisor is responsible for the development of complete, up-to-date procedures and quality assurance manuals that are available to and followed by all personnel performing tests.2. Analyst a. Analysts must possess at least a baccalaureate degree in chemistry, biochemistry, or other physical or biological science, and received at least 20 semester hours of training in chemistry, and have experience comparable to that required by the laboratory's accrediting body.b. The analyst must have training in the theory and practice of the procedures used, and understanding of quality control concepts. In addition, the analyst must have had at least one year of experience in analytical chemistry, or have completed successfully special training provided or approved by the Department. Periodic verification of skills must be documented.D. Quality Assurance 1. The laboratory must have clear written procedures describing the chain of custody of all samples, the security requirements for all sections of the laboratory, including the security of record keeping, and for all laboratory testing procedures and quality assurance procedures. Screening and confirmatory methods of testing shall be as defined in Section 1(A)(5).2. The laboratory analyst must demonstrate satisfactory performance in the proficiency testing program of an approved vendor accredited to ISO 17043 for each discipline for which testing services are offered. Results must be reported to the accrediting body for each discipline listed on the scope of testing document. Satisfactory performance is defined as follows:
a. Qualitative proficiency tests will be evaluated by comparing the achieved result to the expected result. If a compound is part of the current testing menu, if applicable to the section, the test will be considered passing if all achieved results match expected results. If a compound is part of the current testing menu and is not identified by the analyst, the test will be considered failed unless a root cause investigation determines an acceptable reason for the missed compound. b. Blood alcohol quantitative proficiency tests will be evaluated by comparing the achieved quantitative values to the expected quantitative values. The test will be considered passing if all achieved quantitative values are within ±2 standard deviations or ±10% of the reported mean value. If a quantitative value falls outside of those ranges, the test is considered failed, unless a root cause investigation determines an acceptable reason for the difference.c. Records must be maintained indicating that proficiency samples are processed as routine specimens, identify the analyst performing the test, and indicate supervisory review and corrective action for unsatisfactory results.d. An analyst who does not perform satisfactorily, as defined in Subsection 5(D)(2) above, is subject to loss of certification to perform testing for substances of use. If authorization is revoked, the laboratory will perform remedial action in accordance with ISO 17025 Forensic Testing accreditation standards and the Department's Quality Manual.e. The laboratory must have a quality assurance program which encompasses all aspects of the testing process: specimen acquisition, chain of custody, security, and reporting of results, in addition to the screening and confirmation analytical procedures.i. Quality control procedures will be designed, implemented, and reviewed to monitor the conduct of each step of the process.ii. Quality control procedures must include validation of the performance of all equipment used to analyze samples and data processing equipment. Records must be maintained concerning the repair and maintenance of all equipment. Records shall be maintained for at least two years on site, and 18 years in long-term, offsite storage.f. All positive specimens must be retained in secure storage for at least six months. It is the burden of the party requesting longer retention of the sample(s) to make prior arrangements with the laboratory for the return of the sample to an appropriate agent and the Department may, upon request, store positive specimens beyond six months.g. All laboratory reports, including the screening, confirmation and quality control data must be reviewed before being certified as accurate. The report must identify the drugs confirmed in the sample.i. The results of all analyses must be recorded on a standard form approved by the Department.ii. A certified copy of the report must be sent to: the arresting or correctional officer, the appropriate District Attorney, the appropriate department (Department of Public Safety, Department of Inland, Fisheries or Wildlife, or Department of Marine Resources) or its agent, and to the Secretary of State. (29-A MRS §2431(2) (C.))E. A laboratory or analyst aggrieved by any decision of the Department regarding certification has the rights of appeal specified in The Maine Administrative Procedure Act, 5 MRS Ch. 375, and the Department's Administrative Hearings Regulations, 10-144 CMR Ch.1.10-144 C.M.R. ch. 270, § 5