Section 144-270-4 - Analytical ProceduresA. Standard operating procedure Manual The Department is authorized to perform chemical tests on blood and urine (29-A MRS §2524(4) and will comply with the following standard operating procedures when conducting testing of persons suspected of operating under the influence of intoxicating liquor or drugs to ensure results are reliable and legally defensible. Other laboratories must operate consistently with certification or licensing requirements (29-A MRS §2524(2) and also comply with the following operating standards when conducting testing of persons suspected of operating under the influence of intoxicating liquor or drugs to ensure results are reliable and legally defensible:
1. The laboratory must have a procedure manual(s) that are complete, up-to-date, and available to all personnel who are performing tests.2. The manual(s) must include detailed descriptions of procedures for sample receiving, chain-of-custody, analysis, quality assurance and quality control, review of data, and reporting.3. The manual(s) must include administrative procedures, as well as analytical methods and must be reviewed, signed, and dated whenever it is first placed into use or changed.4. The manual(s) must include the following: a. Control and maintenance of documentation of case records and procedure manuals;b. The laboratory's procedures for ensuring that measurements are traceable to appropriate standards, where available;c. The type and extent of examinations conducted by the laboratory;d. Validation of test procedures used;f. The use of standards and controls in laboratory procedures;g. Calibration and maintenance of equipment;h. Practices for ensuring continued competence of examiners including interlaboratory comparisons, proficiency testing programs, and internal quality control schemes (e.g. technical review);i. Corrective action taken whenever analytical discrepancies are detected;j. Laboratory protocol permitting departures from documented policies and procedures; andk. Audits and quality system review. Required documentation applicable to new assays must be added as each test is performed for the first time. The laboratory must maintain outdated copies of the procedure manual(s) and provide a means for their retrieval from archival storage.
B. Confirming the presence of a drug As a general matter of scientific and forensic principle, the analytical scheme will begin with a screening test. All positive screening results will be subject to confirmation (see Section 1(A)(5)(a) above). Only those results confirmed with GC/MS, LC/MS or other validated instrumentation will be reported as detected or confirmed in the sample. A negative test result will be reported when no compounds of interest are present or compounds are present but do not meet established acceptability criteria, based on the specific testing procedure being performed. Established acceptance criteria can be found in the specific testing procedure manuals maintained by the Department.
C. Analysis of blood for alcohol level1. Replicate analyses must be performed at different times to minimize the possibility of undetected errors. Results must be expressed in terms of % w/v, that is, grams of alcohol per 100 milliliters of blood, rounded downward. 2. Analytical procedure for determining alcohol in blood must meet the following performance requirements: a. The accuracy and sensitivity of the procedure must consistently attain results within 5% of the known value over the range of 0.10% and greater, or + 0.005 of the known value for values less than 0.10%, in the analysis of appropriate reference materials of known ethyl alcohol concentration for blood determinations.b. The blank values yielded by the procedure in analyses of alcohol - free blood specimen consistently may not be greater than 0.01%.10-144 C.M.R. ch. 270, § 4