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.