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person observing collection and receiving the blood sample on Certification of Blood Collection and Labeling FDLE/ATP Form 42 –  New October 2007.

(6)  (5) Blood samples need not be refrigerated if submitted for analysis within for up to seven (7) days of after collection, or during transportation, examination or analysis. Blood samples must be otherwise refrigerated, except that refrigeration is not required subsequent to the initial analysis.

(7) (6) Blood samples must be hand-delivered or mailed for initial analysis within thirty days of collection, and must be initially analyzed within sixty days of receipt by the facility conducting the analysis. Blood samples which are not hand-delivered must be sent by priority mail, overnight delivery service, or other equivalent delivery service.

(8) (7) Notwithstanding any requirements in Chapter 11D-8, F.A.C., any blood analysis results obtained, if proved to be reliable, shall be acceptable as a valid blood alcohol level.

SPECIFIC 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 7-29-01, __________.

11D-8.013 Blood Alcohol Permit - Analyst.  

(1) The An application for a permit to determine the alcohol level of a blood sample shall be made on a form provided by to the Department and shall include the following information:

(a) through (d) No change.

(e) A completed description of proposed Blood Alcohol Analyses Analytical Procedures FDLE/ATP Form 43 – New October 2007.

(2) Qualifications for blood analyst permit – To qualify, the applicant must meet all of the following requirements:

(a) Department approval of analytical procedure(s). The Department shall approve analytical procedure(s) described in the Blood Alcohol Analyses Analytical Procedures FDLE/ATP Form 43 – New October 2007 which meet the requirements of subsection (3);  All proposed analytical procedures will be reviewed and a determination of approval will be made by the Department;

(b) Satisfactory determination of  the blood alcohol level in five (5) proficiency test 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 Satisfactory determination shall be made by reporting results for the analyses of two separate samples of each proficiency test blood tube within its acceptable range.  The Department will provide the proficiency test samples and 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.  

(c) No change.

(d) Meet one of the following:

1. through 2. No change.

3. Complete with a C- or better a minimum of 60 semester credit hours or equivalent of college, at least 15 semester credit hours of which must be in college chemistry.

(3) The department shall approve gas chromatographic analytical procedures and enzymatic analytical procedures based on alcohol dehydrogenase which meet the following requirements as described on Blood Alcohol Analyses Analytical Procedures FDLE/ATP Form 43 – New October 2007:

(a) No change.

(b) Uses commercially-prepared standards and controls certified by the manufacturer, or laboratory-prepared standards and controls.  Standards and controls must either be certified by the manufacturer or 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,  the preparation date, person preparing the solution, method of preparation and verification must be documented;

(c) No change.

(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

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