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;

(4) Ensure that quality control data are evaluated routinely and when found to be contaminated, out of range, incorrect, or otherwise unacceptable:

(a) Corrective actions are taken; and

(b) Incorrect results are not reported;

(5) 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;

(6) Ensure that a reagent used for a forensic analysis:

(a) Is tested for reliability before being put into use;

(b) Is identified with the:

(i) Name of the reagent;

(ii) Lot number or date the reagent was prepared; and

(iii) Expiration date;

(c) Is checked for reliability on a cycle determined by the technical leader;

(d) Has a record documenting:

(i) Who prepared the reagent; and

(ii) Completion of a reliability check before use; and

(e) Has storage, safety, and handling requirements specified;

(7) Ensure that a reagent that is not used for a forensic analysis on a regular basis is tested for reliability before each use;

(8) Discard a reagent, make a new reagent, and check the new reagentís reliability before any casework being performed, if the reagent reliability is found to be compromised;

(9) Use reagents that are suitable for the forensic analysis methods employed;

(10) Have procedures for tracking the receipt and use of commercial reagents;

(11) Have procedures for the formulation of in-house reagents in the SOPM; and

(12) Test the forensic analysis method, before reporting a forensic analysis result, using:

(a) A positive and negative external control for a qualitative forensic analysis; and

(b) Known levels of external controls for each analyte in a quantitative forensic analysis.

B. Postmortem Forensic Toxicology. In addition to applicable requirements of this regulation, a laboratory performing postmortem forensic toxicology shall meet the requirements of this section.

(1) Screening Tests. A licensee shall:

(a) Ensure a postmortem toxicology screening test is appropriate and validated for the type of biological specimen being analyzed; and

(b) Perform and document precision studies for a method that uses cut-off values for analyte concentrations.

(2) Confirmatory Tests. A licensee shall:

(a) 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

(b) Ensure the confirmatory test is more specific than the initial test for the target analyte, if possible.

(3) Immunoassay. A laboratory shall:

(a) Be able to demonstrate sufficient separation in the response between a negative and positive specimen at the cut-off concentration of the immunoassay;

(b) 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

(c) Use matrix-matched quality control materials for each batch of specimens analyzed with the immunoassay.

(4) Chromatography. A laboratory shall:

(a) Analyze calibrators or controls with each batch of specimens for qualitative and quantitative chromatography assays;

(b) Establish an acceptable range for each quantitative quality control material; and

(c) Use a suitable internal reference standard, when available.

(5) Spectrophotometry. A laboratory shall maintain cuvettes used for spectrophotometry in good optical condition.

(6) Mass Spectrometry. A laboratory shall:

(a) Establish and adhere to criteria for acceptable mass spectrometric tune;

(b) Have written criteria for full scan mass spectrometric identification through library searching; and

(c) 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.