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or higher.  All standards and controls analyzed must produce results within 0.005 g/100mL or 5%, whichever is greater, from the known standard or control value;

(e) No change.

(f) The A gas chromatographic analytical procedure must discriminate between methanol, ethanol, acetone and isopropanol and employ an internal standard technique;

(g) An enzymatic analytical procedure based on alcohol dehydrogenase must use the procedure recommended by the instrument manufacturer/test kit vendor for whole blood alcohol analysis, and the enzyme used must have sufficient selectivity to provide negligible cross-reactivity towards methanol, acetone and isopropanol.  The analytical  procedure must require the analyses of two separate samples from a blood tube, submitted by an agency, producing results within 0.010 grams of alcohol per 100 milliliters of blood (g/100mL) of each other.

(4) The permit shall be issued by the Department for a specific method and analytical procedure. An analyst shall only use a Department-approved analytical procedure to determine the blood alcohol level of samples submitted by an agency. Approval of blood alcohol analysis methods and analytical procedures shall be based on rule requirements in effect at the time they were submitted for approval.  Any substantial change to the method, analytical procedure, or laboratory facility 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) Any change to the method or analytical procedure must receive approval by the Department prior to being used to determine the blood alcohol level of a sample submitted by an agency. The analyst shall complete and submit an updated Blood Alcohol Analyses Analytical Procedures FDLE/ATP Form 43 – October 2007 and the Department shall ensure that the change(s) comply with all requirements of subsection (3).  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.  

SPECIFIC 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. History–New 10-31-93, Amended 4-1-94, 2-1-95, 1-1-97, 11-5-02, 12-9-04, __________.

11D-8.014 Blood Alcohol Permit - Analyst: Renewal.

(1) Permits to conduct blood alcohol analyses shall remain valid until otherwise suspended or revoked by the Department. In order to remain qualified for such permit, an analyst must satisfactorily determine the blood alcohol level of at least two (2) proficiency test samples provided by the Department each annual quarter semi-annually. 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. Satisfactory determination shall be made by reporting results for the analyses of two separate samples  from each proficiency test blood tube within its acceptable range.  The Department will use the results reported by the analysts and participating blood alcohol testing reference laboratories to calculate each sample level mean and standard deviation to attain the acceptable ranges for the proficiency test cycle.  For blood alcohol proficiency testing, the procedure to determine acceptable ranges shall be the following:

1. Calculate the mean plus or minus three (3) standard deviations of the results submitted for all five (5) sample levels of the proficiency test cycle,

2. Remove any results that fall outside this initial range,

3. Calcluate the new mean plus or minus three (3) standard deviations of the remaining results for all five (5) sample levels of the proficiency test cycle.  

These final calculations become the acceptable ranges for the proficiency test cycle.  

(2) An analyst, who is in good standing, may elect to not participate in one proficiency test cycle each calendar year. The analyst must notify the Department in writing, of his/her election prior to the date the proficiency test results must be reported to the Department.  

(2) (3) Upon notification by the Department that an analyst has failed to satisfactorily determine the blood alcohol level on any the set of two (2) proficiency samples, the analyst shall be required to not conduct the duties authorized by the permit.  Before resuming the duties authorized by the permit, the analyst must satisfactorily determine the blood alcohol level of an additional second set of five (5) proficiency test samples provided by the Department in the current proficiency test cycle.  Satisfactory determination of the blood alcohol level of the additional set of five (5) samples consitutes satisfactory determination for the proficiency test cycle.

(3) (4) Upon notification by the Department that an analyst has failed to satisfactorily determine the blood alcohol level on a second the additional set of five (5) proficiency samples, the analyst shall not perform any duties authorized by the analyst’s permit until the analyst satisfactorily determines the blood alcohol level of a subsequent set of proficiency samples provided by the Department in the next scheduled proficiency test cycle referenced above. This section shall not preclude the Department from taking further action in accordance with Rule 11D-8.015, F.A.C.

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