To conform and comply with new developments in the field of alcohol testing and with the needs of those affected by these rules.

DEPARTMENT OF LAW ENFORCEMENT
Division of Local Law Enforcement Assistance

RULE NO: RULE TITLE
11D-8.002: Definitions
11D-8.003: Approval of Breath Test Methods and Instruments
11D-8.0035: Approval of Alcohol Reference Solution and Sources
11D-8.004: Department Inspection and Registration of Breath Test Instruments
11D-8.006: Agency Inspection of Breath Test Instruments
11D-8.007: Approved Breath Test Instruments - Access, Facility Requirements, Observation Period, and Operational Procedures
11D-8.0075: Agency Retention of Records
11D-8.008: Breath Test Operator and Agency Inspector
11D-8.011: Approval of Blood Alcohol Test Methods
11D-8.012: Blood Samples - Labeling and Collection
11D-8.013: Blood Alcohol Permit - Analyst
11D-8.014: Blood Alcohol Permit - Analyst: Renewal
11D-8.015: Denial, Revocation, and Suspension of Permits
11D-8.017: Forms
PURPOSE AND EFFECT: To conform and comply with new developments in the field of alcohol testing and with the needs of those affected by these rules.
SUMMARY: Rule revisions pertain to the regulation and implementation of Florida's implied consent and alcohol testing program. The proposed revisions govern definitions of terminology; regulation of and qualifications for alcohol test permit holders; and use and maintenance of breath test instruments.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 316.1932(1)(a)2., 316.1932(1)(f)1., 322.63(3)(a), 327.352(1)(b)3., 327.352(1)(d) FS.
LAW IMPLEMENTED: 316.1932(1)(b), 316.1933(2)(b), 316.1934(3), 322.63(3), 327.352(1)(e), 327.353(2)(b), 327.354(3) FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):
DATE AND TIME: Wednesday, April 2, 2008, 10:00 a.m.
PLACE: 2331 Phillips Road, Tallahassee, Florida 32308-1489
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 5 days before the workshop/meeting by contacting: Sharon S. Traxler at [phone]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Sharon S. Traxler, Florida Department of Law Enforcement, 2331 Phillips Road, Tallahassee, FL 32308, [phone]

THE FULL TEXT OF THE PROPOSED RULE IS:

11D-8.002 Definitions.

(1) through (4) No change.

(5) Agency Inspection – the periodic testing of the calibration and operation of an evidentiary breath test instrument, including all required preventive maintenance, in accordance with Rule 11D-8.006, F.A.C., and performed by an Agency Inspector a person authorized by the Department.

(6) through (8) No change.

(9)  Alcohol Reference Solution – a standard used to verify the calibration of a breath test instrument consisting of a mixture of alcohol and distilled or deionized water that will produce a known alcohol vapor concentration at a specific temperature, used to verify the accuracy of an evidentiary breath test instrument.

(10) No change.

(11) Approved Blood Alcohol Test – the analyses of two separate portions of the same blood sample using a Department-approved blood alcohol test method and a Department-approved analytical procedure, with results within 0.010 grams of alcohol per 100 milliliters of blood (g/100mL), and reported as the blood alcohol level.

(12)  Approved Breath Alcohol Test – conducted in accordance with Operational Procedures – Intoxilyzer 8000 FDLE/ATP Form 37, Rev. October 2007, a minimum of two evidentiary breath samples, as defined in paragraph (18) of this section, of breath collected within fifteen minutes of each other, analyzed using an evidentiary approved breath test instrument, producing two results within 0.020 g/210L, and reported as the breath alcohol level. If the results of the first and second evidentiary breath samples are more than 0.020 g/210L apart, a third evidentiary breath sample shall be analyzed. Refusal or failure to provide the required number of valid breath samples constitutes a refusal to submit to the breath test. Notwithstanding the foregoing sentence, the result(s) obtained, if proved to be reliable, shall be acceptable as a valid breath alcohol level.

(13) Authorized Repair Facility – the Department, the breath test instrument manufacturer, or an entity authorized by the breath test instrument manufacturer to service and repair such breath test instrument.

(14) through (15) No change.

(16) Blood Alcohol Testing Reference Laboratory – a laboratory which conducts blood alcohol analyses, and participates in a proficiency test cycle for their quality control purposes. To become qualified, the blood alcohol testing reference laboratory’s analytical procedure must meet the requirements of subsection 11D-8.013(3), F.A.C. before the Department will use their proficiency test results for a blood alcohol proficiency test cycle.

(17)(16) Breath Alcohol Level – the alcohol concentration by weight in a person’s breath based upon grams of alcohol per 210 liters of breath (g/210L).

(18)(17) Breath Test Instructor – a person who has been issued a Breath Test Instructor Certification by the Criminal Justice Standards and Training Commission.

(19)(18) Breath Test Operator – a person who has been issued a Breath Test Operator permit by the Department.

(20) Commission – Criminal Justice Standards and Training Commission

(21) Control Test – when conducted during a breath test, the verification of the accuracy of an evidentiary breath test instrument through the analysis of a 0.08 g/210L dry gas standard.

(22)(19) Department – the Florida Department of Law Enforcement.

(23) Diagnostic Check – an internal systems analyses conducted by an evidentiary breath test instrument to ensure operational requirements are met for functionality and performance.

(24)(20) Dry Gas Standard – a standard consisting of a mixture of alcohol and gas which produces a known alcohol vapor concentration, used to verify the accuracy calibration of a breath test instrument.

(25) Evidentiary Breath Sample – air expelled from the lung(s) in a single exhalation achieving slope as indicated by the instrument. Commonly referred to as “deep lung air” or “end expiratory air”.

(26)(21) Evidentiary Breath Test Instrument – a breath test instrument approved by the Department under Rule 11D-8.003, F.A.C., registered by the Department under Rule 11D-8.004, F.A.C., and used primarily to conduct breath alcohol breath tests pursuant to Florida law.

(27)(22) Methods – types of alcohol analyses approved by the Department to conduct chemical or physical tests of blood or breath.

(28)(23) Mouth Alcohol Solution – a mixture of alcohol and distilled or deionized water provided by the Department.

(29)(24) Permit – when issued by the Department, certifies that the holder has met all necessary qualifications, remains in full compliance with these rules and is authorized to perform all related duties. A permit is issued only to a qualified applicant and remains valid and in full effect until determined otherwise by the Department.

(30) Precision – the nearness of measurements to each other; expressed as a standard deviation.

(31)(25) Reference Sample Device – a device, also known as a simulator, that produces a known vapor concentration by the passage of air through a liquid.

(32)(26) Target Concentration – a gas chromatographic result equivalent to the following known alcohol vapor concentrations of alcohol reference solution: for 0.05 g/210L the target concentration is 0.0605 g/100mL; for 0.08 g/210L the target concentration is 0.0968 g/100mL; for 0.20 g/210L the target concentration is 0.2420 g/100mL.

Specific Authority 316.1932(1)(a)2., (f)1., 316.1933(2)(b), 316.1934(3), 322.63(3)(a), (b), 327.352(1)(b)3. FS. Law Implemented 316.1932(1)(b)2., 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 1-1-97, 7-6-99, 7-29-01, 11-5-02, 12-9-04, 3-27-06, _________.

 

11D-8.003 Approval of Breath Test Methods and Instruments.

(1) No change.

(2) The Department approves breath test methods and new instrumentation to ensure the accuracy and reliability of breath test results. An evaluation for approval of a new instrument shall be conducted by the Department in accordance with and meet the requirements of Instrument Evaluation Procedures FDLE/ATP Form 34 – Rev. October 2007. The Department has approved the following breath test instrumentation for evidentiary use: CMI, Inc. Intoxilyzer 5000 Series including any or all instruments using one of the following programs: 5000 Basic Software Program; Florida Software Program; R-Software Program; and CMI, Inc. Intoxilyzer 8000 using software evaluated by the Department in accordance with Instrument Evaluation Procedures FDLE/ATP Form 34 Rev. March 2004.

(3) The Department has approved the following breath test instrument for evidentiary use: CMI, Inc. Intoxilyzer 8000 using software evaluated by the Department. The Department has approved the following options for use with Intoxilyzer 5000 Series instruments: keyboard; simulator recirculation; sample capture; pressure switch setting at no less than two inches and no more than six inches of water.

(4) Evaluation(s) of software intended for evidentiary use and of approved breath test instrument(s) listed in subsection (3) shall be conducted in accordance with Instrument Evaluation Procedures FDLE/ATP Form 34 – Rev. October 2007. Evaluation(s) that meet the requirements of Instrument Evaluation Procedures FDLE/ATP Form 34 – Rev. October 2007 validate the approval, accuracy, precision and reliability of an evidentiary breath test instrument.

(5)(4) A Department inspection that complies performed in accordance with Rule 11D-8.004, F.A.C., validates the approval, calibration, accuracy, precision and reliability of an evidentiary breath test instrument.

(5) The Department shall conduct evaluations for approval of new instrumentation under subsection (2) in accordance with Instrument Evaluation Procedures FDLE/ATP Form 34 – Rev. March 2004.

(6) The availability or approval of new instruments, software, options or modifications does not negate the approval status of currently previously approved instruments, software, options or modifications. The evaluation of new software, options or modifications does not negate the use of previously evaluated software, options or modifications.

Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), (b), 327.352(1)(b)3. FS. Law Implemented 316.1932(1)(b)2., 316.1934(3), 322.63(3)(b), 327.352(1)(e), 327.354(3) FS. History– New 10-31-93, Amended 1-1-97, 7-29-01, 11-5-02, 12-9-04,__________.

 

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) through (b) No change.

(c) The source must produce alcohol reference solution lots which are traceable to the National Institute of Standards and Technology.

(d) Each alcohol reference solution lot produced by the source must be certified by the source as to its contents and alcohol vapor concentration.

(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. The Duplicate analyses will be performed on two separate samples from each sample bottle of alcohol reference solution. All analysis results shall fall within the alcohol reference solution acceptable range.

(b) No change.

(3) through (4) No change.

Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3., (d) FS. Law Implemented 316.1932(1)(b)2., 316.1934(3), 322.63(3)(b), 327.352(1)(e), 327.354(3) FS. History– New 7-6-99, Amended 7-29-01, 12-9-04,__________.

 

11D-8.004 Department Inspection and Registration of Breath Test Instruments.

(1) The Department shall register and inspect a breath test instrument prior to such instrument being initially placed into evidentiary use by an agency. The inspection which complies with Department Inspection Procedures – Intoxilyzer 8000 – FDLE/ATP Form 36 – Revised October 2007, validates the instrument’s approval for evidentiary use, and the registration denotes an evidentiary breath test instrument approved pursuant to these rules and shall reflect the registration date, the owner of the instrument, the instrument serial number, the manufacturer, and the model designation.

(2) Evidentiary Registered breath test instruments shall be inspected by the Department at least once each calendar year, and must be accessible to the Department for inspection. Any evidentiary breath test instrument returned from an authorized repair facility shall be inspected by the Department prior to being placed in evidentiary use. The Department inspection which complies with Department Inspection Procedures – Intoxilyzer 8000 – FDLE/ATP Form 36 – Revised October 2007, validates the instrument’s approval, calibration, accuracy, precision, and reliability of an evidentiary breath test instrument for evidentiary use.

(3) Department inspections shall be conducted in accordance with Department Inspection Procedures FDLE/ATP Form 35 – Rev. August 2005 for the Intoxilyzer 5000 Series, or Department Inspection Procedures – Intoxilyzer 8000 FDLE/ATP Form 36 – Rev. October 2007 August 2005 for the Intoxilyzer 8000; and the results reported on FDLE/ATP Form 26 – Department Inspection Report – Rev. March 2004 for the Intoxilyzer 5000 Series, or FDLE/ATP Form 41 – Department Inspection Report – Intoxilyzer 8000 – Rev. August 2005 for the Intoxilyzer 8000.

(4) As of January 2, 2009, an evidentiary breath test instrument owned by the Department must be calibrated by an authorized repair facility, as defined in subsection (13) of this section, at least once every two (2) calendar years. Compliance with this section can be established by the Certificate of Calibration issued by the authorized repair facility.

(5)(4) Department Inspectors shall be employed by the Department to register evidentiary breath test instruments, to conduct inspections and maintenance of breath test instruments and related equipment and facilities, to conduct and monitor training classes, and to otherwise ensure compliance with Chapter 11D-8, F.A.C.

Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3. FS. Law Implemented 316.1932(1)(b)2., 316.1934(3), 322.63(3)(b), 327.352(1)(e), 327.354(3) FS. History– New 10-31-93, Amended 1-1-97, 7-29-01, 11-5-02, 12-9-04, 3-27-06,__________.

 

11D-8.006 Agency Inspection of Breath Test Instruments.

(1) Evidentiary breath test instruments shall be inspected by an agency inspector at least once each calendar month. The agency inspection shall be conducted in accordance with Agency Inspection Procedures FDLE/ATP Form 16 – Rev. March 2004 for the Intoxilyzer 5000 Series, or Agency Inspection Procedures – Intoxilyzer 8000 FDLE/ATP Form 39 – Rev. October 2007 August 2005 for the Intoxilyzer 8000; and the results reported on FDLE/ATP Form 24 – Agency Inspection Report – Rev. March 2001 for the Intoxilyzer 5000 Series, or FDLE/ATP Form 40 – Agency Inspection Report – Intoxilyzer 8000 – March 2004 for the Intoxilyzer 8000.

(2) Whenever an agency relocates an Intoxilyzer 5000 evidentiary breath test instrument for use at another facility, an agency inspection shall be conducted prior to the instrument’s removal, and another inspection shall be conducted prior to the instrument’s use for evidentiary breath testing at the new facility. A mobile testing unit is considered an agency facility.

(2)(3) Whenever an instrument is taken out of evidentiary use, the agency shall conduct an agency inspection. The agency shall also conduct an agency inspection prior to returning an instrument to evidentiary use.

(3) As of January 2, 2009, an evidentiary breath test instrument must be calibrated by an authorized repair facility, as defined in subsection (13) of this section, at least once every two (2) calendar years. Compliance with this section can be established by the Certificate of Calibration issued by the authorized repair facility.

(4) Agency Inspectors are responsible for compliance with Chapter 11D-8, F.A.C., rules governing agency custody, care, and inspection of breath test instruments and records as defined in Rule 11D-8.0075, F.A.C.

Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3. FS. Law Implemented 316.1932(1)(b)2., 316.1934(3), 322.63(3)(b), 327.352(1)(e), 327.354(3) FS. History– New 10-31-93, Amended 1-1-97, 7-29-01, 11-5-02, 12-9-04, 3-27-06, ________.

 

11D-8.007 Approved Breath Test Instruments – Access, Facility Requirements, Observation Period, and Operational Procedures.

(1) Evidentiary breath test instruments shall only be accessible to a person issued a valid permit by the Department and to persons authorized by a permit holder. This section does not prohibit agencies from sending an evidentiary breath test instrument to an authorized repair facility. Only authorized repair facilities are authorized to remove the top cover of an Intoxilyzer 8000 evidentiary breath test instrument.

(2) through (3) No change.

(4) When operating an Intoxilyzer 5000 Series instrument, a breath test operator shall conduct a breath test in accordance with, and shall record the results on, the Breath Test Results Affidavit FDLE/ATP Form 14 Rev. March 2002. When operating an Intoxilyzer 8000 instrument, a breath test operator shall conduct a breath test in accordance with Operational Procedures – Intoxilyzer 8000 FDLE/ATP Form 37 – Rev. October 2007 August 2005, and the results of the test shall be recorded on the Breath Alcohol Test Affidavit – Intoxilyzer 8000 FDLE/ATP Form 38 – October, 2007 March 2004.

(5) Each agency shall record all breath tests conducted on a particular Intoxilyzer 5000 Series evidentiary breath test instrument on the Breath Test Log FDLE/ATP Form 13 – Effective January 1997. The breath test log shall be reviewed each calendar month by an agency inspector to ensure that the information is properly recorded and that all necessary corrections are made. The agency inspector’s signature on the breath test log shall signify compliance with this section.

Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3. FS. Law Implemented 316.1932(1)(b)2., 316.1934(3), 322.63(3)(b), 327.352(1)(e), 327.354(3) FS. History– New 10-31-93, Amended 1-1-97, 7-29-01, 11-5-02, 12-9-04, 3-27-06, ________.

 

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, copies of department inspection reports, evidentiary breath test instrument certificate(s) of calibration, and agency inspection print cards, breath test logs and evidentiary breath test instrument repair records. The evidentiary 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 the expiration date receipt.

(2) through (3) No change.

Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3. FS. Law Implemented 322.63(3), 327.354(3) FS. History–New 7-29-01, Amended 11-5-02, 12-9-04,__________.

 

11D-8.008 Breath Test Operator and Agency Inspector.

(1) through (2) No change.

(3) Breath Test Operators and Agency Inspectors must satisfy continuing education requirements in order to maintain valid permits. Continuing education requires successful completion of the applicable Commission-approved basic or renewal cCourse by June 30 following the fourth permit anniversary date, and during each subsequent four-year cycle. Successful completion of the Commission-approved Agency Inspector Course or Agency Inspector Renewal Course also satisfies an Agency Inspector’s breath test operator continuing education requirements.

(4) Any Breath Test Operator or Agency Inspector who fails to satisfy the continuing education requirements shall not perform any duties authorized by the permit until successful completion of the applicable Commission-approved basic or renewal course.

(5) A Breath Test Operator or Agency Inspector must be employed by an Agency in order to perform the duties authorized by the permit. Permits to conduct breath tests and inspect breath test instruments issued pursuant to former Rule 11D-8.008, F.A.C., shall remain valid until such permits expire or otherwise become invalid in accordance with those rules.

(6) Agency Inspectors are responsible for compliance with Chapter 11D-8, F.A.C., rules governing agency custody, care, and inspection of breath test instruments and related records.

(6)(7) Any Bbreath Ttest Ooperator or Aagency Iinspector who fails to successfully complete the Commission-approved renewal course shall not perform any duties authorized by the permit until successful completion of the Commission-approved basic course.

(7)(8) Members of the Department’s Alcohol Testing Program who instruct Commission-approved breath test courses may use such course instruction to satisfy their continuing education requirements under this section.

Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3. FS. Law Implemented 316.1934(3), 322.63(3)(b), 327.354(3) FS. History–New 10-31-93, Amended 1-1-97, 7-29-01, 11-5-02, 12-9-04, 3-27-06,__________.

 

11D-8.011 Approval of Blood Alcohol Test Methods.

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

(1) Alcohol Dehydrogenase (Enzymatic).

(2) Gas Chromatography.

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,__________.

 

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, such as povidone-iodine or benzalkonium chloride, that does not contain alcohol. Compliance with this section can be established by the information on the packaging of the antiseptic.

(2) Blood samples must be collected in an glass evacuatedion blood collection tube that is not expired and contains at least 2 mg/mL of the preservative such as sodium fluoride (NaF) and an at least 2 mg/mL of the anticoagulant such as potassium oxalate or at least 1 mg/mL of the anticoagulant EDTA (ethylenediaminetetraacetic acid). as listed on Compliance with this section can be established by the stopper or label of on the collection tube, documentation from the manufacturer or distributor, or by other evidence. Compliance with this section can be established by dividing the amount (in mg) of the preservative or anticoagulant by the volume (in mL) of the collection tube.

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

(4) No change.

(5) Compliance with the collection and labeling requirements of paragraphs (1) through (4) shall be documented by the 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 for up to if submitted for analysis within seven (7) days after 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.

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

(a) through (d) No change.

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

(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 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: 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

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 credit semester 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 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 semi-annually each annual quarter. 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: 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.

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 the any set of two (2) proficiency samples, the analyst shall not conduct the duties authorized by the permit. Before resuming the duties authorized by the permit, the analyst must be required to 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 the additional a second 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 in the next scheduled proficiency test cycle referenced above 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)(5) Failure to satisfactorily determine the blood alcohol level of any four (4) six (6) sets of proficiency test samples provided by the Department within a twelve (12) month period shall result in revocation of the blood analyst permit.

(5) An analyst may elect to not participate in one proficiency test cycle within a twelve month period. The analyst must notify the Department in writing, of his/her election prior to the date the proficiency test results are due. An analyst electing this option shall not perform the duties authorized by the permit until the analyst satisfactorily completes the renewal requirements of the permit. An analyst may either request samples for the current proficiency test cycle or wait until the next cycle. The Department will provide samples in the next proficiency test cycle, failure to participate in this proficiency test cycle will result in the Department taking action in accordance with Rule 11D-8.015, F.A.C.

Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 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)(e), 327.353(2), 327.354(3) FS. History–New 10-31-93, Amended 1-1-97, 11-5-02,__________.

 

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) No change.

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

1. through 2. No change.

3. Criminal conviction for any violation of controlled substance statutes found in Chapter 893, F.S., or violation of any federal controlled substance statute or violation of any other state’s controlled substance statutes;

4. through 5. No change.

(c) through (d) No change.

(2) No change.

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

(a) through (b) No change.

(c) Being convicted after issuance of the permit of any of the following offenses in any federal or state court:

1. through 4. No change.

5. Any criminal violation of controlled substance statutes found in Chapter 893, F.S., or federal controlled substance statute or violation of any other state’s controlled substance statutes;

(d) through (e) No change.

(4) No change.

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

(6) No change.

Specific Authority 316.1932(1)(a)2., (f)1., 316.1933(2)(b), 316.1934(3), 322.63(3)(a), (b), 327.352(1)(b)3. FS. Law Implemented 316.1933(2)(b), 316.1934(3), 322.63(3)(b), 327.353(2), 327.354(3) FS. History–New 10-31-93, Amended 1-1-97, 7-29-01, 11-5-02, 12-9-04, 3-27-06,________.

 

11D-8.017 Forms.

The following forms referenced in these rules are hereby incorporated by reference:

FDLE/ATP Form 13 – Breath Test Log – Effective January 1997.

FDLE/ATP Form 14 – Breath Test Result Affidavit – Revised March 2002.

FDLE/ATP Form 16 – Agency Inspection Procedures – Revised March 2004.

FDLE/ATP Form 24 – Agency Inspection Report – Revised March 2001.

FDLE/ATP Form 26 – Department Inspection Report – Revised March 2004.

FDLE/ATP Form 32 – Certificate of Assurance – Revised March 2001.

FDLE/ATP Form 34 – Instrument Evaluation Procedures – Revised October 2007 March 2004.

FDLE/ATP Form 35 – Department Inspection Procedures – Revised August 2005.

FDLE/ATP Form 36 – Department Inspection Procedures – Intoxilyzer 8000 – Revised October 2007 August 2005.

FDLE/ATP Form 37 – Operational Procedures – Intoxilyzer 8000 – Revised October 2007 August 2005.

FDLE/ATP Form 38 – Breath Alcohol Test Affidavit – Intoxilyzer 8000 – Revised October 2007 March 2004.

FDLE/ATP Form 39 – Agency Inspection Procedures – Intoxilyzer 8000 – Revised October 2007 August 2005.

FDLE/ATP Form 40 – Agency Inspection Report – Intoxilyzer 8000 – March 2004.

FDLE/ATP Form 41 – Department Inspection Report – Intoxilyzer 8000 – Revised October 2007 August 2005.

FDLE/ATP Form 42 – Certification of Blood Collection and Labeling – New October 2007.

FDLE/ATP Form 43 – Blood Alcohol Analyses Analytical Procedures – New October 2007.

These forms may be obtained by contacting the Florida Department of Law Enforcement, Alcohol Testing Program, P.O. Box 1489, Tallahassee, Florida 32302. Agencies will be provided blank forms upon request and without cost for their alcohol testing program use.

Specific Authority 316.1932(1)(a)2., (f)1., 316.1933(2)(b), 316.1934(3), 322.63(3)(a), (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)(e), 327.353(2)(b), 327.354(3) FS. History–New 10-31-93, Amended 2-1-95, 1-1-97, 7-29-01, 11-5-02, 12-9-04, 3-27-06, __________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Sharon S. Traxler, Florida Department of Law Enforcement, 2331 Phillips Road, Tallahassee, Florida 32308, [phone]
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Laura Barfield, [phone]
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 26, 2008
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: January 18, 2008