Blood Test Regulations

11D-8.011. Approval of Blood Alcohol Test Methods

The Department approves the following test methods for determining blood alcohol level:

Gas Chromatography.

11D-8.012. Blood Samples - Labeling and Collection

(1) Before collecting a sample of blood, the skin puncture area must be cleansed with an antiseptic that does not contain alcohol.

(2) Blood samples must be collected in a glass evacuation tube that contains a preservative such as sodium fluoride and an anticoagulant such as potassium oxalate or EDTA (ethylenediaminetetraacetic acid). Compliance with this section can be established by the stopper or label on the collection tube, documentation from the manufacturer or distributor, or other evidence.

(3) Immediately after collection, the tube must be inverted several times to mix the blood with the preservative and anticoagulant.

(4) Blood collection tubes must be labeled with the following information: name of person tested, date and time sample was collected, and initials of the person who collected the sample.

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

(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.

(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.

11D-8.013. Blood Alcohol Permit - Analyst

(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;

(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.

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 2 proficiency samples provided by the Department semiannually. 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.

(2) Upon notification by the Department that an analyst has failed to satisfactorily determine the blood alcohol level on any set of proficiency samples, the analyst shall be required to satisfactorily determine the blood alcohol level of a second set of five proficiency samples provided by the Department.

(3) Upon notification by the Department that an analyst has failed to satisfactorily determine the blood alcohol level on a second set of 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. This section shall not preclude the Department from taking further action in accordance with Rule 11D-8.015, F.A.C.

(4) Failure to satisfactorily determine the blood alcohol level of any 4 sets of proficiency samples provided by the Department within a 12-month period shall result in revocation of the blood analyst permit.

11D-8.015. Denial, Revocation, and Suspension of Permits

(1) Notwithstanding an applicant’s qualifications, the Department shall deny an application for an original permit where the applicant:

(a) Fails to meet the permit qualifications under these rules.

(b) Has been convicted of any of the following offenses in any federal or state court:

1. Any felony;

2. Any misdemeanor involving perjury, false statements or falsification of records;

3. Criminal conviction for any violation of Chapter 893, F.S.;

4. Driving under the influence of alcoholic beverages or drugs during the five years prior to submitting the application;

5. Leaving the scene of a crash involving death or serious bodily injury.

(c) Knowingly performing the duties of a breath test operator, agency inspector, breath test instructor, or analyst without a valid applicable permit.

(d) Had the permit previously revoked under subsection (3) below.

(2) The Department is authorized to suspend any permit for any of the following reasons:

(a) Failure to prepare and maintain breath or blood testing records as required by these rules.

(b) Failure to continue to meet the qualifications for such permit.

(3) The Department is authorized to revoke any permit for any of the following reasons:

(a) Knowingly making a false statement or providing false information on any agency document or on any document required by these rules.

(b) Knowingly making a false statement or providing false information on any application for permit submitted to the Department.

1. Any felony;

2. Any misdemeanor involving perjury, false statements or falsification of records;

3. Driving under the influence of alcoholic beverages or drugs;

4. Leaving the scene of a crash involving death or serious bodily injury;

5. Any criminal violation of Chapter 893, F.S.

(d) Performing the duties of a breath test operator, agency inspector, or analyst with knowledge that the applicable permit is suspended or in violation of continuing education requirements.

(e) Having had the permit previously suspended for any violation of these rules.

(4) The Department is authorized to require a breath test operator, agency inspector, breath test instructor, or analyst who violates any of these rules to attend additional training or education related to their certification or permit.

(5) The Department is authorized to invalidate the registration of any evidential instrument for a violation of any rule relating to the use, custody and care of such instrument.

(6) All permits and registrations which have been suspended, revoked or invalidated must be surrendered to the Department upon demand.

11D-8.016. Administrative Hearings

All proceedings concerning the revocation, suspension, or denial of permits shall be conducted in accordance with Chapter 120, F.S., and the Florida Administrative Code.

11D-8.0035. Approval of Alcohol Reference Solution and Sources

(1) The Department shall approve a source of alcohol reference solution for use by agencies in the State of Florida. The source approved by the Department shall be an entity that manufactures alcohol reference solutions and meets the following requirements:

(a) The source must prepare alcohol reference solution, and be capable of producing a minimum batch volume of 800 bottles, each containing at least 500 milliliters, to produce the following vapor alcohol concentrations: 0.05 g/210L, 0.08 g/210L, and 0.20g/210L;

(b) The source must have performed and documented tests that demonstrate that the alcohol reference solutions are reliable for at least two years from the date of manufacture.

(2) The Department shall approve each lot of alcohol reference solution prior to distribution for use in Florida.

(a) The Department shall determine the alcohol concentration in a minimum of ten (10) sample bottles of each lot of alcohol reference solution using gas chromatography or other scientifically accepted method at the time such lots are submitted for approval. Duplicate analyses will be performed on each sample bottle of alcohol reference solution. If any result falls outside the alcohol reference solution acceptable range, a second set of analyses will be performed. If the second set of results are within the alcohol reference solution acceptable range, the alcohol reference solution shall be approved. If any of the results fall outside the alcohol reference solution acceptable range a second time, the alcohol reference solution shall be disapproved.

(b) The Department shall notify the source that the approved lots may be distributed for use in Florida, and shall issue a Certificate of Assurance, FDLE/ATP Form 32 revised March 2001, effective date July 2015, hereby incorporated by reference, https://www.flrules.org/Gateway/reference.asp?No=Ref-05643 This form may be obtained by contacting the Florida Department of Law Enforcement, Alcohol Testing Program, P.O.Box 1489, Tallahassee, Florida 32302.

(3) Alcohol reference solution lots approved by the Department shall be used in agency or Department inspections within two (2) years of the date of manufacture.

11D-8.0036. Approval of Dry Gas Standards Source

(1) The Department shall approve a source of dry gas standards for use by agencies in the State of Florida. The source approved by the Department shall be an entity that manufactures dry gas standards and meets the following requirements:

(a) The source must produce dry gas standards which are traceable to the National Institute of Standards and Technology.

(b) Each dry gas standard lot produced by the source must be certified by the source as to its contents and alcohol vapor concentration.

(c) The source must be capable of producing a minimum of 300 cylinders of dry gas standard during a thirty day period at an alcohol vapor concentration of 0.08 g/210L.

(d) The source must have performed and documented tests that demonstrate that the source’s dry gas standards are reliable for at least two years from the date of manufacture.

(2) Dry gas standard cylinders produced by the approved source must not be used beyond the expiration date.

11D-8.0075. Agency Retention of Records

(1) Each agency shall maintain the following records for at least three years from the last entry date: agency inspection reports and breath test instrument repair records. The breath test instrument registration shall be retained by an agency for at least three years after the instrument is removed from evidentiary use. Dry gas standard certificates of analysis shall be retained by an agency for at least three years after receipt. These records shall be accessible to the Department upon request.

(2) At least once each calendar month each agency shall electronically transmit to the Department all breath tests conducted on that agency’s Intoxilyzer 8000 evidentiary breath test instruments.

(3) The purpose of this section is solely for regulatory and administrative use, and any violation of this section shall not affect the admissibility, validity or reliability of breath test results.