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FDLE's Blood Alcohol Testing Program

The FDLE's Alcohol Testing Program issues permits to blood analysts, conducts proficiency testing of blood analysts, and prescribes the approved methods of blood alcohol testing. The FDLE does not employ blood collection experts in the Alcohol Testing Program.

FDLE rules are meant to be a minimum framework for the blood analyst for does the testing of blood within the Alcohol Testing Program. Amazingly, FDLE does not regulate blood collection personnel and does not have the authority to prescribe blood collection practices.

Your DUI defense attorney should be familiar with FDLE's blood alcohol testing program. In a DUI cases involving a blood test, your attorney will have to have the blood excluded from evidence. In the event the blood and blood testing is admitted at trial, your attorney will show all of the problems with the accuracy and reliability.


Problems with the Rules for the Blood Analysts

Blood analysts must apply to FDLE for a permit to test blood under the implied consent laws. See Fla. Admin. Code R.11D-8.013(1). In addition to the applicant's qualifications, the application must include a complete description of the proposed analytical procedures that the analyst uses to test blood alcohol levels. See Fla. Admin. Code R. 11D-8.013(1).

The laboratories' proposed analytical procedures are also called standard operating procedures ("SOPs”). The analyst must also demonstrate proficiency in blood alcohol analysis by satisfactorily determining the blood alcohol level in five samples provided by the FDLE.

The FDLE rules do not require that the analysts' standard operating procedures include screening blood samples for irregularities. Those irregularities that can lead to problems with blood testing can include

  • clotting;
  • hemolysis; and
  • hemoconcentration.

No Procedures to Document Irregularities and Reject Compromise Samples

FDLE's rules do not require analysts to document irregularities and reject compromised samples. The FDLE's proficiency testing does not include any methods to exclude compromised samples. For example, an analyst does not document a compromised sample in the laboratory record. The standard operating procedures do not including any procedure for documenting irregularities and rejecting compromised samples.

Although blood analysis must be performed in an accredited laboratory, in accordance with good laboratory practices, to produce accurate and reliable results, the FDLE rules do not require that the laboratories where analysts work be accredited. The rules require that testing be performed in accordance with good laboratory practices, which would necessarily include practices not listed in the FDLE rules.

Problems include the fact that the analysts is not required to visually inspect samples or to document clotting or any other irregularity. The standard operating procedures do not require that blood samples be analyzed for the presence of hemolysis. FDLE has no records of any samples being rejected by an analyst because of an irregularity in the sample.

Despite the fact that a clotted sample is not whole blood, the FDLE lab will test clotted samples for blood alcohol content. Clotting increases blood alcohol levels. In some cases, the analyst will remove the clots and then analyzes the sample for blood alcohol level. The analysts will then report the results as whole blood analysis and consider the results to be accurate and reliable.

The analysis are not even required to make a note of the clot on the lab report. This is a problem because clotting can elevate blood alcohol content. The analyst cannot see every clot in a sample with the naked eye. It is important to test blood that is as close to the blood in circulation as possible when the results will be used in a DUI case. Some analysis do not even know what the term ‘hemolysisis” means and have never rejected a blood sample because of irregularities in the sample.

Blood samples should be visually inspected by an analyst before testing to look for clots and irregularities in color. Analysts should document abnormal findings during this examination because irregularities in the sample can render it unreliable. Rule 11D-8.013 does not require gross inspection of a blood sample before analysis or documentation of irregularities.

The standard operating procedures should include a written procedure for determining whether a blood sample is suitable for testing, and that analysist should document when a sample is not suitable for testing. If a blood sample is clotted, or shows evidence of tampering, decomposition, or any signs indicating that the integrity of the sample has not been maintained, should be rejected for blood alcohol testing. 


FDLE Lacks Authority to Regulate Blood Collection 

The FDLE lacks statutory authority to regulate blood collection, which is the subject of the regulations contained in rule 11D-8.012. FDLE lacks the authority to adopt rules regulating needle gauge and tourniquet use.

Rules 11D-8.012 and 11D-8.013 are invalid for failing to ensure that compromised samples are rejected. Although FDLE rules authorize two forms of blood alcohol testing—alcohol dehydrogenase (enzymatic) and gas chromatography, only one form of testing is used.

Clotting (sometimes called "coagulation") can occur even in glass evacuation tubes containing a preservative and an anticoagulant. Deficiencies in the collection process can lead to clotting. Clotting alters the ratio of liquid to solid in the blood sample, which can increase the concentration of alcohol in the liquid portion of the sample.

Hemolysis alters the concentration of alcohol within a subsample of a blood sample. A hemolyzed sample should be excluded from testing.


Challenges to Invalidate Administrative Rules for Blood Testing

In a recent case, the defendant petitioned to invalidate Florida Administrative Code Rules 11D-8.012 and llD-8.013. In the hearing, the FDLE conceded, and the relevant statutes make clear, that the FDLE lacks the authority to make rules governing blood collection, which is the subject of rule11D-8.012.

The argument has been made that if the FDLE has the authority to regulate blood collection, then rule 11D- 8.012 is invalid because it fails to set standards for proper needle and tourniquet use, both of which are necessary to ensure reliable blood alcohol test results.

Rule llD-8.013 is invalid because it fails to require blood analysts to screen blood samples for irregularities before testing, document irregularities, and reject compromised samples. Rules 11D-8.012 and 11D-8.013 fail to accomplish one of the primary goals of the FDLE's rules for blood alcohol testing - to ensure reliable scientific testing for use in criminal proceedings under the implied consent laws. The inadequacy of these rules calls into question the integrity of the criminal process and undermines confidence in the judicial system.


Florida's Implied Consent Laws for Blood Alcohol Concentration Testing

Florida's implied consent laws require all persons accepting a driver's license in Florida to consent to a blood or breath alcohol test upon being arrested for driving under the influence. See §§ 316.1932, 316.1933, 316.1934, Fla. Stat. (2013). The two "core policies" of testing under Florida's implied consent law include:

  1. ensuring reliable scientific testing for use in court proceedings by establishing uniform, approved testing procedures; and
  2. protecting the health of those being tested.

State v. Bender, 382 So. 2d 697, 699 (Fla. 1980)) and State v. Miles, 775 So. 2d 950, 953 (Fla. 2000). FDLE's authority to adopt rules governing testing under Florida's Implied Consent Laws Florida's implied consent statutes delegate to the FDLE the responsibility of formulating rules governing the process by which a person's blood is analyzed to determine alcohol content. See Miles, 115 So. 2d at 952.

The FDLE formulated the rules in chapter 11D-8—its "Alcohol Testing Program" —pursuant to this delegation of legislative authority. Administrative rulemaking is exclusively a legislative function. Save the Manatee Club, Inc., 773 So. 2d at 598 (citing Art. II, § 3, Fla. Const.).

"An administrative rule is valid only if adopted under a proper delegation of legislative authority." Id. To prescribe an administrative rule, an agency needs both statutory “rule making authority" and a "law implemented." See §§ 120.52(8), 120.536, Fla. Stat. (2013).

"Rulemaking authority" is a statute that "explicitly authorizes or requires an agency to adopt, develop, establish or otherwise create any statement coming within the definition of the term'rule.'" § 120.52(17). The definition of "law implemented" is "the language of the enabling statute being carried out or interpreted by an agency through rulemaking." §120.52(9).

If the State can demonstrate substantial compliance with the FDLE's rules, certain statutory presumptions arise in a criminal case, including the presumption of the integrity of the testing process and the presumption of impairment. See § 316.1934(2).


FDLE Rules for Blood Testing Cases to Determine Alcohol Concentration 

For this reason, it is critical that the FDLE's rules are sufficient to ensure reliable samples and accurate results. Two FDLE rules are at issue in blood testing cases to determine the alcohol concentration:


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 o f 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

(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.

llD-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 a form 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 o f 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.

(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

(3) The department shall approve gas chromatographic analytical procedures and enzymatic analytical procedures based on alcohol dehydrogenase 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/lOOmL or less, one between 0.05 and 0.20 g/lOOmL (inclusive) and one at 0.20 g/lOOmL or higher, and must be verified using a minimum of two (2) controls, one at 0.05 g/lOOmL 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/lOOmL 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;

(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, 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, 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) 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. 


Invalid exercise of delegated legislative authority in promulgating administrative rules

Section 120.52(8) defines "invalid exercise of legislative authority" as “action that goes beyond the powers, functions, and duties delegated by the Legislature."

Four of the six statutory grounds for declaring a rule invalid are at issue here:

(b) The agency has exceeded its grant of rulemaking authority, citation to which is required by s. 120.54(3)(a)l.;

(c) The rule enlarges, modifies, or contravenes the specific provisions of law implemented, citation to which is required by s. 120.54(3)(a)l.;

(d) The rule is vague, fails to establish adequate standards for agency decisions, or vests unbridled discretion in the agency;

(e) The rule is arbitrary or capricious. A rule is arbitrary if it is not supported by logic or the necessary facts; a rule is capricious if it is adopted without thought or reason or is irrational;

§ 120.52(8)(b)-(e).


Rule 11D-8.012 - FDLE Has No Authority to Prescribe Rules Governing the Collection of Blood

The FDLE had no authority to implement rule 11D-8.012, "Blood Samples- Labeling and Collection." The FDLE has admitted that no such authority exists. Rule 11D-8.012 is an invalid exercise of delegated legislative authority under section 120.52(8)(b) and (c) because it "exceeds [the FDLE's] grant of rulemaking authority" and "enlarges, modifies, or contravenes the specific provisions of law implemented." § 120.52(8)(b) & (c).

Rule 11D-8.012 regulates the manner in which blood is collected, labeled and transported for testing under the implied consent laws. The FDLE conceded that it lacks the statutory authority necessary to regulate blood collection.

FDLE's position is the agency lacks the delegated legislative authority to regulate blood collection. FDLE has the delegated legislative authority to regulate blood analysts and issue blood permits. 

For purposes of the implied consent laws, "[o]nly a physician, certified paramedic, registered nurse, licensed practical nurse, other personnel authorized by a hospital to draw blood, or duly licensed clinical laboratory director, supervisor, technologist, or technician . . . may withdraw blood for the purpose of determining the alcoholic content thereof " §316.1933(2)(a).

Despite FDLE's lack of authority to regulate blood collection techniques. FDLE takes the position that all of the existing regulations of blood collection in rule 11D-8.012 are unauthorized and, thus, invalid.

Those existing regulations include the type of antiseptic swab used to clean the skin, the type of preservative and anticoagulant in the glass collection tube, the procedure for inverting the sample of blood after collection, and refrigeration of the sample. See Fla. Admin. Code R. 11D-8.012. Nothing in the implied consent statutes gives the FDLE the authority to implement a rule regulating blood collection.

Rule 11D-8.012 cites, as rulemaking authority, three statutes: sections 316.1932(l)(a)2. and (l)(f)l., 322.63(3)(a), and 327.352(l)(b)3. & (l)(d), Florida Statutes (2013). None authorizes the FDLE to prescribe rules for the collection of blood.

Section 316.1932(l)(a)2. and 327.352(l)(b) state that the FDLE's Alcohol Testing Program is "responsible for the regulation of blood analysts who conduct blood testing to be utilized" under the implied consent laws.

A blood "analyst" is "a person who has been issued a permit by the [FDLE] to conduct blood alcohol analyses." Fla. Admin. Code R. 11D-8.002(10).

A blood analyst is not the same as a medical professional who collects blood. Compare § 316.1933(2)(a) (listing the medical professionals who are authorized to collect blood under the implied consent laws), with rule 11D-8.002, and rule 11D-8.013(2) (defining the qualifications for a blood analyst to receive a permit from FDLE). Section 327.352(l)(b)3. lists the responsibilities of the FDLE under the Alcohol Testing Program. None pertains to blood collection.

Sections 316.1932(l)(f)l. and 322.63(3)(a) require that the tests used to determine the amount of alcohol in the defendant's blood or breath be administered substantially in accordance with the rules implemented by the FDLE.

Section 327.352(1)(d) states that a person arrested for operating a vessel under the influence can request a blood or breath test. These statutes do not authorize the FDLE to regulate blood collection.

Rule 11D-8.012 cites sections 316.1933(2)(b), 316.1934(3), 322.63(3)(b), 327.352(l)(e), 327.353(2), and 327.354(3), Florida Statutes (2013), as "law implemented."

Just as with the rulemaking authority, none of these statutes provides the FDLE the authority to regulate blood collection. They provide only the authority to regulate chemical analysis of blood and to issue permits for blood analysts. The FDLE's authority to regulate blood analysts and blood tests does not, by extension, supply the authority to regulate blood collection.

Section 120.52(8) states that "[n]o agency shall have the authority to adopt a rule only because it is reasonably related to the purpose of the enabling legislation . . . ." Agencies are only authorized to promulgate rules that implement or interpret specific statutory powers or duties, "as opposed to improvising in an area that can be said to fall only generally within some class of powers or duties the Legislature has conferred on the agency." State, Bd. ofTrs. v. Day Cruise Ass 'n, 194 So. 2d 696, 700 (Fla. 1st DCA 2001); see also § 120.52(8), Fla. Stat. (2013); S W. Fla. Water Mgmt. Dist. v. Save the Manatee Club, Inc., 773 So. 2d 594, 599 (Fla. 1st DCA 2000) (stating that "specific" in the context of section 120.52(8) means "limiting or limited; specifying or specified; precise, definite, [or] explicit")."

The question is whether the statute contains a specific grant of legislative authority for the rule, not whether the grant of authority is specific enough" Save the Manatee Club, Inc., 773 So. 2d at 599 (emphasis in original). "Either the enabling statute authorizes the rule at issue or it does not." Id.

Here, there is no specific statutory authority for the FDLE to promulgate rules for the collection or labeling of blood.
Because of the FDLE's concession and the clear lack of delegated legislative authority, rule 11D-8.012 should be invalidated.

Rule 11D- 8.012 is invalid under section120.52(8)(b) and (c).


Arguments that Rules 11D-8.012 and llD-8.013 are Facially Invalid

Rule 11D-8.012 regulates blood collection, while rule llD-8.013 regulates the methods of blood alcohol testing and the permitting of blood analysts. Both rules are invalid under section 120.52(8)(c), (d) and (e). These rules fail to establish adequate standards to ensure scientifically reliable blood alcohol test results.

In a criminal proceeding, if the State can prove compliance with the FDLE's rules, it is entitled to the presumptions of the integrity of the testing process and impairment. See § 316.1934(2); State v. Miles, 775 So. 2d 950, 952 (Fla. 2000).

The trade-off for giving the State these presumptions is that the FDLE rules must ensure the reliable, consistent result. Thus, the FDLE rules must do the following:

  1. prescribe the blood collection techniques and standards that are necessary to ensure reliable samples; and
  2. require that blood analysts screen blood samples before testing, document irregularities, and reject compromised samples.

Rules 11D-8.012 and llD-8.013 are insufficient in both respects.

The Supreme Court addressed the FDLE's responsibility with respect to its Alcohol Testing Program in State v. Miles, 115 So. 2d 950 (Fla. 2000). In Miles, the Supreme Court made clear that the FDLE rules must ensure reliable test results, not just produce reliable results most of the time:

Without provisions for proper maintenance of a blood sample, the integrity of the sample is guaranteed only from the point of testing, regardless of the length of time that passes before the FDLE actually performs the testing.

In the instant case, we note the testing did not occur until some fourteen days after the blood draw. Under the evidence presented in the trial court, fourteen days without refrigeration may well have impacted the integrity of the blood sample.

Hence, as found by the trial court, the absence of maintenance standards renders rule 11D-8.012(3) inadequate and inconsistent with the purpose of the implied consent law as it relates to ensuring the reliability of test results. As such, the State is not entitled to the presumptions of impairment associated with the implied consent statutory scheme.

Id. at 955. The Court upheld the First District's holding that rule 11D-8.012 did not comply with the "core policies" of the implied consent laws, as stated in State v. Bender, 382 So. 2d 697, 699 (Fla. 1980). Miles, 775 So. 2d at 952, 953-54.

The Court's analysis in Miles is controlling here, where the evidence showed that Rules 11D-8.012 and 11D-8.013 fail to ensure scientifically reliable results. Although in Miles, the Supreme Court did not address the FDLE's authority to promulgate rules governing blood collection.

Rule 11D-8.012, if authorized, is invalid because it fails to set standards for proper needle gauge and tourniquet use, which are necessary to produce reliable blood samples for testing. Even if the Court finds that the FDLE has the authority to promulgate a rule on blood collection, then rule 11D-8.012 is facially invalid because it fails to set forth standards for proper needle gauge and tourniquet use.

These standards are necessary to ensure that a blood sample will produce scientifically reliable blood alcohol test results for use in a future criminal proceeding. There was no dispute over the importance of using proper blood collection techniques when drawing a sample for testing under the implied consent laws. Dr. Goldberger, the FDLE's expert in forensic toxicology, blood alcohol analysis and laboratory practices, agreed that proper collection techniques are necessary to ensure a scientifically reliable blood alcohol analysis.

Use of the correct needle and proper tourniquet use are critical to the blood collection process. Needles and tourniquets must be used properly to ensure accurate blood alcohol test results. Yet, rule 11D-8.012 does not set forth any standards for needles or tourniquet use.

Using the wrong needle  can cause irregularities such as clotting and hemolysis in the sample.


Clotting

Clots can form in the tubing apparatus of the butterfly needle and pass to the collection tube (Tl:172; T2:235-38; T3:310). The anticoagulant in the collection tube does not dissolve the clots.

Clots can also clog the pipette, the instrument used to withdraw a sub-sample from the sample for testing. Hemolysis occurs because the red blood cells collide as they enter the butterfly needle, causing those cells to rupture. In addition, improper tourniquet use can cause hemolysis and hemoconcentration.

Clotting increases blood alcohol levels under the gas chromatography testing method, the method currently used throughout Florida for testing under the implied consent laws. Clotting increases the blood alcohol content in the sample.

Clotting can occur for a variety of reasons, including the type of needle used in the collection process or the failure to mix the sample properly with the anticoagulant contained in the tube.

Clotting alters the ratio of liquid to solid in the sample and can increase the concentration of alcohol in the liquid portion of the sample.

Although the FDLE argues that the anticoagulant in the collection tube prevents clotting, ta blood sample can contain clots, even when the glass collection tube contains an anticoagulant, as required by rule 11D-8.012. The problems with clotting were sufficient to declare rule 11D-8.012 facially invalid for failing to set standards for use of the proper needle. See Miles, 775 So. 2d at 953-54 (holding that rule 11D-8.012 must ensure scientifically reliable analysis).

As to hemolysis, the omission from the rule of requirement related to needle gauge and tourniquet use is of no material consequence because the evidence did not establish that hemolysis affects testing under the gas chromatography method, the only blood alcohol testing method currently used in Florida. Hemolysis has an effect on the enzymatic method.

The enzymatic method is currently authorized by the FDLE rules and has been used in the past. See Fla. Admin. Code R. 11D-8.011. Some laboratories in Florida were still using the enzymatic test in mid-1990s.


Hemolysis

Use of the wrong needle and improper tourniquet use can cause hemolysis. Hemolysis artificially elevates blood alcohol content when blood is analyzed using the enzymatic test.

Hemolysis affects the color of the sample and, since the enzymatic method is color-dependent, affects the test results under that method. Although he rules must ensure that all authorized testing methods produce reliable results, the rules do not ensure reliable results.


Hemoconcentration

The impact of hemoconcentration on blood alcohol testing is well documented. Hemoconcentration changes the ratio of red blood cells to the watery portion of the blood, increasing the alcohol concentration.

Hemoconcentration can result from applying the tourniquet for too long, or from using the wrong needle.

Rule 11D-8.012 does not include adequate regulations of blood collection to ensure that blood samples are a representation of the "whole blood" in the individual's body.

Rule llD-8.013 is facially invalid because it fails to require permitted blood analysts to screen out compromised blood samples before testing the sample.

Screening blood samples before testing them and rejecting compromised samples are essential steps to ensuring that a blood alcohol test produces accurate results. Blood samples should be screened for irregularities, and that irregular samples should be excluded or at least documented in lab results. Yet, rule11D-8.013, which regulates blood

Yet, rule11D-8.013, which regulates blood analysts and the methods of blood analysis, does not require analysts to screen blood samples before testing, document any irregularities, or reject compromised samples. In practice, the evidence shows that the FDLE issues permits to laboratories and analysts whose standard operating procedures do not include these steps.

These insufficiencies render the rule invalid. See Miles, 775 So.2d at 595; § 120.52(8)(d). Standard A blood test that produces accurate results most of the time is insufficient. See Miles, 775 So. 2d at 955. The purpose of the rules "is to ensure reliable scientific evidence for use in future court proceedings." Bender, 382 So. 2d at 699; see also Miles, 115 So. 2d at 953-55.

To "ensure" means to make certain. See www.merriam-webster.com/dictionary/ensure.

Rule llD-8.013 does not meet the "core policies" of the implied consent law because it fails to ensure reliable test results. The FDLE rules need not require analysts to inspect samples, document irregularities, and reject compromised samples because analysts routinely do those things as a matter of standard laboratory practice.

The standard operating procedures of the crime labs in Florida do not require analysts to visually inspect samples or document irregularities. In fact, the analysts could not recall ever rejecting a sample because of irregularities within the sample. The lab procedures were approved by the FDLE under rule llD-8.013, even though they lack any requirement to inspect samples, document irregularities, or reject compromised samples.

By failing to require laboratories to inspect, document, and reject compromised samples, the FDLE fails to ensure that these laboratories are producing reliable blood alcohol test results.

In a criminal trial, to receive the presumptions of impairment and integrity of the testing process, the State need only prove that the test complied with the FDLE rules. If these rules are inadequate to ensure reliable samples, as the evidence demonstrates here, the presumptions are fundamentally flawed and ultimately could deprive the defendant of the opportunity to confront the blood test evidence offered against him.

Although FDLE must adopt a rule for every single step in the testing process, it does have the obligation to promulgate rules that are sufficient to ensure scientifically reliable results. Certainly, requiring

Although FDLE must adopt a rule for every single step in the testing process, it does have the obligation to promulgate rules that are sufficient to ensure scientifically reliable results. Certainly, requiring proper needle and tourniquet use and rejecting bad samples are the kinds of necessary steps that must be included in the rules. Their absence renders rules 11D-8.012 and llD-8.013 invalid.


This article was last updated on Friday, March 3, 2017.