1. (1) The Department approves the following test methods for determining blood alcohol level: Gas Chromatography.

2. (2) The Department shall approve gas chromatographic analytical procedures which meet the following specifications:

   1. (a) Includes the approved method used and a description of the method, and the equipment, reagents, standards, and controls used;
   2. (b) Uses commercially-prepared standards and controls certified by the manufacturer, or laboratory-prepared standards and controls verified using gas chromatography against certified standards. For commercially-prepared standards and controls, the manufacturer, lot number and expiration date must be documented for each sample or group of samples being analyzed. For laboratory-prepared standards and controls, date, person preparing the solution, method of preparation and verification must be documented;
   3. (c) A statement of the concentration range over which the procedure is calibrated. The calibration curve must be linear over the stated range;
   4. (d) Uses a new or existing calibration curve. A new calibration curve must be generated using at least three (3) standards: one at 0.05 g/100mL or less, one between 0.05 and 0.20 g/100mL (inclusive) and one at 0.20 g/100mL or higher, and must be verified using a minimum of two (2) controls, one at 0.05 g/100mL or less and one at 0.20g/100mL or higher. An existing calibration curve must be verified using a minimum of two (2) controls, one at 0.05 g/100mL or less and one at 0.20g/100mL or higher;
   5. (e) Includes the analysis of an alcohol-free control, and the analysis of a whole blood or serum control. The whole blood or serum control may be used to satisfy the control requirement(s) in paragraph (2)(d); and
   6. (f) The gas chromatographic analytical procedure must discriminate between methanol, ethanol, acetone and isopropanol and employ an internal standard technique.

3. (3) Any substantial change to the method or analytical procedure must receive prior approval by the Department before being used to determine the blood alcohol level of a sample submitted by an agency. The following changes are always deemed substantial:

   1. (a) A change in the type or thickness of the stationary phase in the analytical column(s);
   2. (b) A change in the nominal length of the analytical column(s);
   3. (c) A change in the injection port or inlet settings such as temperature or split ratio;
   4. (d) A change in the gas chromatograph oven temperature or temperature program;
   5. (e) A change in the type of carrier gas used; and

   6. (f) A change in the column flow or pressure settings.

      For changes not specifically listed above, the Department shall determine if the changes are substantial on a case-by-case basis.

4. (4) An analyst shall only use a Department-approved procedure to determine the blood alcohol level of samples submitted. Approval of blood alcohol analysis methods and procedures shall be based on rule requirements in effect at the time they were submitted for approval.

Rulemaking Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3., (d) FS. Law Implemented 316.1933(2)(b), 316.1934(3), 322.63(3)(b), 327.352(1)(e), 327.353(2), 327.354(3) FS. History–New 10-31-93, Amended 7-29-15, 7-17-25.