Current through Reg. 50, No. 249, December 24, 2024
(1)
The application for a permit to determine the alcohol level of a blood sample
shall be made on the Application for Permit to Conduct Blood Alcohol Analyses
FDLE/ATP Form 4, revised December 2014, effective date July 2015, hereby
incorporated by reference,
https://www.flrules.org/Gateway/reference.asp?No=Ref-05640,
provided by the Department and shall include the following information:
(a) Name and address of applicant;
(b) A copy of state license if licensed, or
college transcript;
(c) Name and
address of employer and laboratory facility where applicant performs
analyses;
(d) Identify at least one
Agency for which blood analyses are to be performed pursuant to chapters 316,
322 and 327, F.S.; and,
(e) A
complete description of proposed analytical procedure(s) to be used in
determining blood alcohol level.
(2) Qualifications for blood analyst permit -
To qualify, the applicant must meet all of the following requirements:
(a) Department approval of analytical
procedure(s). All proposed analytical procedures will be reviewed and a
determination of approval will be made by the Department;
(b) Satisfactory determination of blood
alcohol level in five proficiency samples provided by the Department using the
proposed analytical procedure. Satisfactory determination shall be made by
reporting results for blood alcohol proficiency samples within the acceptable
range for the samples. For blood alcohol testing, acceptable ranges shall mean
the calculated proficiency sample mean + or - 3 standard deviations iterated
twice. The mean and standard deviations will be calculated using the results
reported by the analysts and reference laboratories;
(c) Identify at least one Agency for which
blood analyses are to be performed pursuant to chapters 316, 322 and 327, F.S.;
and,
(d) Meet one of the following:
1. Possess a clinical laboratory license in
clinical chemistry as a technologist, supervisor or director, under chapter
483, F.S.; or
2. Be a licensed
physician pursuant to chapter 458, F.S.; or
3. Complete a minimum of 60 semester credit
hours or equivalent of college, at least 15 semester hours of which must be in
college chemistry.
(3) The department shall approve gas
chromatographic analytical procedures which meet the following requirements:
(a) Includes the approved method used and a
description of the method, and the equipment, reagents, standards, and controls
used;
(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;
(c) A statement of the concentration range
over which the procedure is calibrated. The calibration curve must be linear
over the stated range;
(d) Uses a
new or existing calibration curve. The 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. The 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;
(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 (d);
(f) A gas chromatographic analytical
procedure must discriminate between methanol, ethanol, acetone and isopropanol
and employ an internal standard technique;
(4) The permit shall be issued by the
Department for a specific method and procedure. 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 Department shall determine what constitutes a substantial
change.
(5) An analyst shall only
use a Department-approved procedure to determine the blood alcohol level of
samples submitted by an agency. 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.,
316.1933(2)(b), 316.1934(3) 322.63(3)(b), 327.352(1)(b)3. FS. Law Implemented
316.1932(1)(b),
316.1933(2)(b),
316.1934(3),
322.63(3)(b),
327.352(1)(b),
(e),
327.353(2),
327.354(3)
FS.
New 10-31-93, Amended 4-1-94, 2-1-95, 1-1-97, 11-5-02,
12-9-04, 7-29-15.
