Md. Code Regs. 10.51.05.04

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.51.05.04 - 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 reagent's 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.

Md. Code Regs. 10.51.05.04