Regulation .04 Quality Control Program.
Regulation .04 Quality Control Program.LinkCopy Citation
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.