John Goodman v. Florida Department of Law Enforcement , 238 So. 3d 102 ( 2018 )

Supreme Court of Florida
____________
No. SC16-1752
____________
JOHN GOODMAN,
Petitioner,
vs.
FLORIDA DEPARTMENT OF LAW ENFORCEMENT,
Respondent.
[February 1, 2018]
PER CURIAM.
This case is before the Court to review the decision of the Fourth District
Court of Appeal in Goodman v. Florida Department of Law Enforcement, 203 So.
3d 909 (Fla. 4th DCA 2016). In its decision, the district court ruled upon the
following questions, which the court certified to be of great public importance on
rehearing:
(1) ARE THE CURRENT RULES OF THE FLORIDA
DEPARTMENT OF LAW ENFORCEMENT (FDLE)
INADEQUATE UNDER STATE v. MILES, 775 So. 2d 950 (Fla.
2000), FOR PURPORTEDLY FAILING TO SUFFICIENTLY
REGULATE PROPER BLOOD DRAW PROCEDURES, AS WELL
AS THE HOMOGENIZATION PROCESS TO “CURE” A
CLOTTED BLOOD SAMPLE?
(2) ARE THE PRESENT RULES SIMILARLY INADEQUATE
FOR FAILING TO SPECIFICALLY REGULATE THE WORK OF
ANALYSTS IN SCREENING BLOOD SAMPLES,
DOCUMENTING IRREGULARITIES, AND REJECTING UNFIT
SAMPLES?
Id. at 916. We have jurisdiction. See art. V, § 3(b)(4), Fla. Const. For the
following reasons, we answer both certified questions in the negative.
FACTUAL AND PROCEDURAL BACKGROUND
In February 2010, Petitioner, John Goodman, was involved in a car accident,
which resulted in a death. Afterward, a nurse at Wellington Regional Hospital
drew Goodman’s blood for blood alcohol testing pursuant to Florida’s implied
consent law. Goodman was ultimately convicted of, and sentenced for, DUI
manslaughter/failure to render aid and vehicular homicide/failure to give
information or render aid.1
At trial, Goodman moved to exclude the blood alcohol test results based, in
part, on the blood collection method utilized. Goodman asserted that the nurse
who collected his blood substituted a 25-gauge butterfly needle for the 21-gauge
needle in the blood collection kit supplied by law enforcement. Essentially, this
challenge was directed to the sufficiency of Florida Administrative Code Rule
1. His criminal appeal proceeded separately. Recently, the Fourth District
affirmed Goodman’s DUI manslaughter conviction, but vacated his vehicular
homicide conviction on double jeopardy grounds. Goodman v. State (Goodman
II), 229 So. 3d 366 (Fla. 4th DCA 2017).
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11D-8.012.2 Thus, the trial court deferred ruling on the motion pending resolution
of the challenge at the Division of Administrative Hearings (DOAH).
In his DOAH petition, Goodman challenged the validity of an existing Rule
under section 120.56(3), Florida Statutes (2009). Specifically, he disputed whether
the Florida Department of Law Enforcement (FDLE) had the authority to
promulgate Rules related to blood collection, along with the sufficiency of Rules
11D-8.012 and 11D-8.013 to produce scientifically reliable results.3 The petition
alleged that these deficiencies amounted to an invalid exercise of delegated
legislative authority under various provisions of section 120.52(8), Florida Statutes
(2009).
Blood Collection Equipment at Issue
There are two relevant types of needles in this case: straight and butterfly
needles. Upon insertion, a straight needle evacuates blood directly into a
collection tube; whereas, a butterfly needle has plastic tubing which connects the
needle to the collection tube. Both needles are connected to vacuum collection
tubes. Although Rule 11D-8.012(2) requires collection tubes to contain an
2. Hereinafter, any reference to a “Rule” will be to those in chapter 11D-8
of the Florida Administrative Code, unless otherwise specified.
3. In this Court, Goodman abandoned his challenge of FDLE’s authority to
promulgate blood collection Rules. Therefore, it will not be addressed here.
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anticoagulant, there is no separate anticoagulant in the butterfly needle tubing
itself. Anticoagulant that is in the collection tube prevents clotting, but it will not
dissolve any already formed clots. Without anticoagulant, blood can begin to clot
within seconds after collection, depending on the patient.
Generally, law enforcement blood collection kits contain 21-gauge straight
needles. However, butterfly needles may be used for blood collection on certain
individuals with damaged veins or to allow movement without displacing the
needle and damaging the vein. Dr. Bruce Goldberger, an FDLE expert and the
Director of Toxicology at the University of Florida College of Medicine, noted that
he has seen butterfly needles substituted for the original needles in law
enforcement kits on occasion when his laboratory conducted blood alcohol testing.
Needle gauge refers to the size of the internal diameter of the needle, and it
is an important aspect of blood collection. The gauge and actual size of the needle
have an inverse relationship; thus, a higher gauge number translates to a smaller
diameter. According to Goodman’s blood collection expert, George Souza, the
standard needles recommended for blood collection are 21- and 22-gauge straight
needles. Experts from both sides disputed the suitability of collecting blood with a
25-gauge butterfly needle when the sample will be tested for alcohol. For
Goodman, Souza testified that use of a 25-gauge butterfly needle for blood
collection is below the standard of care. Conversely, for FDLE, Dr. Goldberger
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testified that he considered samples collected with 25-gauge butterfly needles as
valid for blood alcohol testing under the testing method used in Florida, which is
detailed below.
Both the Rules and relevant statutes are silent as to the appropriate needle
type or gauge. Instead, the Legislature restricted medical decisions regarding
blood collection to health professionals by statute:
Only 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, acting at the request of a law enforcement
officer, may withdraw blood for the purpose of determining its
alcoholic content . . . .
§ 316.1932(1)(f)2.a., Fla. Stat. (2009).
Potential Issues Affecting Reliability of Blood Alcohol Testing
Blood naturally clots through the coagulation of components in the blood.
As a result, clotting changes the composition of a blood sample, and it can
artificially increase the alcohol content in the sample. Alcohol is also water-
soluble; as clots form into solids, the alcohol follows the remaining liquid and
elevates the alcohol concentration in the testable, liquid portion of the sample.
However, whether clotting affects the test result depends on the degree of clotting.
For instance, a serum sample (fully clotted) could produce a result that is
approximately a sixteen percent higher alcohol reading than unclotted whole blood.
Whereas, microclots—clots that are nearly invisible to the naked eye—might have
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absolutely no effect on the test result. According to testimony, if a microclot is
large enough to prevent pipetting the sample, then it could impact the accuracy and
reliability of the test result.4
Testimony indicated that improper blood collection practices, such as using
the wrong needle or improperly applying a tourniquet, can increase the chance of a
sample having clotting or hemoconcentration. According to Souza, it would be
“very unlikely” for either clotting or hemoconcentration to occur in blood collected
with a 21-gauge straight needle and the proper tourniquet. Although butterfly
needles increase the time between removal of blood and mixture with the
anticoagulant compared with straight needles, Dr. Goldberger testified that such
time frame difference was “[n]othing significant.” Moreover, evidence showed
that despite the presence of anticoagulant, clots can still form within the collection
tube if the collector fails to properly invert the tube or the blood is improperly
collected.
Every blood analyst in this record testified that if a sample had an issue with
clotting it would be noted on the laboratory file. Goodman submitted an expert
witness on blood alcohol analysis who was a former manager of FDLE’s Alcohol
Testing Program (the Program). That witness testified that, while at FDLE, she
4. Pipetting is the process of a blood analyst drawing a subsample from the
collection tube to transfer it into a testing vial.
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would not make any notation of clotting on the toxicology report; rather, she would
make a note on the laboratory file, which was also available to defendants through
a public records request. Toxicology reports are sent to law enforcement after
testing, while laboratory files stay with the analysts and are not automatically sent
to defendants. Further, Goodman’s expert and Dr. Xiaoquin Shan, a Palm Beach
County Sheriff’s Office (PBSO) blood analyst, both confirmed that analysts can
calculate the correct corresponding whole blood alcohol content even if there are
clotted samples.
Neither party presented comprehensive data concerning the extent of any
perceived testing reliability issues across the State. Goodman’s expert had
conducted thousands of blood alcohol analyses during her three and a half years
performing blood alcohol analysis at FDLE and only encountered a “bad sample”
on approximately “10, 15 times maybe.” It should be noted that her definition of a
“bad sample” was far broader than merely clotted samples.
FDLE Rules and Blood Alcohol Testing
The two relevant Rules in this case are Rule 11D-8.012, which governs
labeling and collection of blood samples, and Rule 11D-8.013, which governs
permitting of blood alcohol analysts.
Rule 11D-8.012 sets forth the necessary procedures prior to a sample
arriving at a laboratory for analysis. The Rule states that the skin must be cleansed
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with an alcohol-free antiseptic, and the collection tube must contain anticoagulant
and preservative. Fla. Admin. Code R. 11D-8.012(1)-(2). Moreover, the
collection tube must be inverted following collection, labelled with certain
identifying information, and refrigerated at certain stages prior to testing. Id. 11D-
8.012(3)-(5).
To be permitted as a blood analyst under Rule 11D-8.013, an applicant must
have minimum qualifications and submit for approval a “complete description of
proposed analytical procedure(s),” or a standard operating procedure (SOP). Fla.
Admin. Code R. 11D-8.013(1)-(2). FDLE subjects these analysts to proficiency
testing to ensure that each analyst, using his or her SOP, can accurately determine
the alcohol content of five different samples. Id. 11D-8.013(2)(b). Subsequently,
analysts must renew their permits through proficiency testing. Id. 11D-8.014.
Rule 11D-8.002(14) requires the blood tested by the Program to be “whole
blood.” Essentially, whole blood is all of the blood together without any parts
removed. The only approved method for blood alcohol testing under the Program
is gas chromatography (GC), Fla. Admin. Code R. 11D-8.011, and Florida forensic
laboratories universally use headspace GC.
Under headspace GC, a blood analyst “thoroughly mix[es]” a sample before
pipetting a few drops for testing. Although mixing the sample prior to pipetting it
is “good laboratory practice,” the Rules do not explicitly require this action. Still,
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FDLE’s expert described mixing as “just part of the practice in the laboratory.”
After this sub-sample is separated into a specialized vial, it is mixed with internal
standard. Internal standard is a liquid that dilutes the blood and makes the blood
alcohol results quantifiable. While the Rules require the addition of an internal
standard, the exact amount is not prescribed. Next, the analyst places the prepared
sample into a headspace autosampler, which heats and pressurizes the sample.
This causes any alcohol contained in the sample to equilibrate in the headspace
above it. That headspace gas is then pushed through a transfer line into the gas
chromatograph, where the gas interacts with coated columns to give an alcohol
content reading.
Nothing in the Rules specifically requires analysts to screen for irregularities
such as clotting. Although the Rules do not require blood analysts to document
irregular samples, it is standard laboratory practice to do so. Some laboratories’
SOPs require analysts to make that notation; however, the PBSO SOP does not.
Regardless, the blood analysts from the PBSO testified that they would make a
notation of any clotting to place all parties on notice that the results should be
interpreted to take into account an irregularity such as clotting. Additionally,
Dustin Yeatman—the PBSO blood analyst who analyzed Goodman’s blood—
testified that any irregularities are always documented and reported. Also, he
stated that Goodman’s sample was thoroughly mixed prior to testing.
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Patrick Murphy, the FDLE manager of the Program, testified that the Rules
are intended to be a minimum framework for blood analysts. FDLE’s expert
opined that the Rules should be broad enough to allow laboratories to use their
own individualized methods if they conform to the framework of the Rules. One
reason for that is to ensure that the Rules are not “static” because if science
changes, the Rules will lag behind due to the strict statutory procedure for
amending or adopting Rules. Although Murphy expected that analysts would
document irregularities, he would not reject an SOP for failing to include that
requirement because it is not explicitly required by any Rule. Goodman’s expert
testified that analysts visually inspect the sample for irregularities prior to testing.
The expert conceded and agreed that gross examination of a sample is a “common
step” when analysts open and inventory the evidence, but the Rules do not
specifically require it.
DOAH Final Order
The administrative law judge (ALJ) denied all of Goodman’s challenges.
The ALJ found that despite Rule 11D-8.012 requiring that collection tubes contain
preservative and anticoagulant, blood samples “can, on occasion, include [clotted]
blood.” Moreover, he found that the type of needle used and a failure to properly
mix the blood with anticoagulant in the tube could both cause clotting. Finally, he
found that the “evidence fails to establish that the mere presence of [clotting]
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inevitably precludes the withdrawal of a subsample that properly reflects the
components of the whole blood contained in the collection tube.” An additional
finding supported that conclusion: “the accuracy of the blood alcohol level
reported by the subsample is related to the degree of [clotting] present in the
sample.” To this end, the ALJ concluded that the “omission from the rule of a
requirement related to needle gauge and tourniquet usage is of no material
consequence.” Further, the ALJ found that the evidence established that “analysts
routinely examine and document the condition of samples as a matter of standard
laboratory practice.” Therefore, the ALJ likewise concluded that the “omission of
such a requirement does not provide a basis to invalidate the rule.”
Appeal to the Fourth District
Goodman appealed the Final Order to the Fourth District, raising the same
challenges. Goodman, 203 So. 3d at 912. The Fourth District affirmed the ALJ’s
rejection of each challenge. Id. at 915.
As to Goodman’s challenge of Rule 11D-8.012, the Fourth District
concluded that the “testimony was sufficient for the ALJ to find that clotting, even
when increased by the use of a smaller butterfly needle, does not inherently render
blood alcohol testing inaccurate, as there were commonly known and utilized
curative procedures.” Id. at 914. The Fourth District noted that “clotting can
affect the accuracy of a blood alcohol test.” Id. at 913. However, it reasoned that
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it is still possible to obtain an accurate blood alcohol content (BAC) reading from a
clotted sample through a “homogenization process.” Id. at 913. Moreover, the
court stated that clotting problems are avoided by the standard practice of blood
analysts mixing a sample prior to testing. Id. at 914. Distinguishing Miles, the
Fourth District concluded that “clotting is notably different than the flaws caused
by the lack of refrigeration in Miles, which could not be rectified after the fact.”
Goodman, 203 So. 3d at 914.
Pertaining to Goodman’s challenge of Rule 11D-8.013, the Fourth District
noted testimony that blood analysts routinely document “any irregularities in blood
samples,” which supported the ALJ’s finding that “analysts routinely examine and
document the condition of samples as a matter of standard laboratory practice.” Id.
at 914-15. The court explained that Rule 11D-8.013 is “not meant to be the only
source of guidance for analysts, but is instead meant to supplement and reinforce
sound scientific principles and laboratory practices.” Id. The Fourth District
concluded that the Rules, in conjunction “with basic laboratory practices, are
sufficient to protect the safety and interests of the court system and defendants
alike.” Id. at 915.
Subsequently, the Fourth District denied Goodman’s motion for rehearing,
but certified the two questions of great public importance. Id. at 916.
This review follows.
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ANALYSIS
Section 120.68(1)(a), Florida Statutes (2009), authorizes judicial review of
final administrative orders. “If an administrative law judge’s final order depends
on any fact found by the administrative law judge, the court shall not substitute its
judgment for that of the administrative law judge as to the weight of the evidence
on any disputed finding of fact.” § 120.68(10), Fla. Stat. Accordingly, this court
reviews factual findings on administrative rule challenges for competent,
substantial evidence. See § 120.68(7)(b), Fla. Stat.; Dep’t of Health v. Bayfront
Med. Ctr., Inc., 134 So. 3d 1017, 1018 (Fla. 1st DCA 2012). Whereas, conclusions
of law are reviewed de novo. Volusia Cty. Sch. Bd. v. Volusia Homes Builders
Ass’n, Inc., 946 So. 2d 1084, 1089 (Fla. 5th DCA 2006).
When challenging an administrative rule, the “petitioner has a burden of
proving by a preponderance of the evidence that the existing rule is an invalid
exercise of delegated legislative authority.” § 120.56(3)(a), Fla. Stat. (2009). This
is because “duly promulgated agency rules” are “presumptively valid until
invalidated.” See City of Palm Bay v. State Dep’t of Transp., 588 So. 2d 624, 628
(Fla. 1st DCA 1991). For these reasons, the “challenging party bears a heavy
burden.” State Bd. of Optometry v. Fla. Soc’y of Ophthalmology, 538 So. 2d 878,
884 (Fla. 1st DCA 1988).
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The Implied Consent Law, Bender,5 and Miles
To address drunk driving in Florida, the Legislature enacted the implied
consent law. See §§ 316.1932, 316.1933, 316.1934, Fla. Stat. (2009). One
function of this statutory scheme is to imply the consent for a blood alcohol test of
any driver arrested under suspicion of driving under the influence. Id.
§ 316.1932(1)(a)1.a. If properly administered, the test results give rise to criminal
presumptions of impairment. See id. § 316.1934(2)(c) (making a BAC of 0.08 or
higher prima facie evidence of impairment). Thus, the tests must be scientifically
reliable and accurate. See Bender, 382 So. 2d at 699. However, the presumptions
are rebuttable and a defendant may introduce “competent evidence bearing upon
the question of whether [they were] under the influence of alcoholic beverages.” §
316.1934(2), Fla. Stat.; Bender, 382 So. 2d at 699 (“[A] defendant may in any
proceeding attack the reliability of the testing procedures, the qualifications of the
operator, and the standards establishing the zones of intoxicant levels.”).
Through various statutes, the Legislature delegated authority to FDLE for
“formulating and approving the process in which a person’s blood is analyzed in
determining its alcoholic content.” Miles, 775 So. 2d at 952; see §§
316.1932(1)(a)2., (f)1., Fla. Stat.; § 316.1933(2)(b), Fla. Stat. The delegated
5. State v. Bender, 382 So. 2d 697 (Fla. 1980).
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authority under the implied consent law to FDLE’s predecessor agencies was
constitutionally tested in Bender. 382 So. 2d at 698-99. There, we approved the
Legislature’s delegation of authority for “breath- and blood-testing” as “proper and
allowable.” Id. at 700. In doing so, the Court stated the underlying purpose of the
implied consent law, otherwise known as the “core policies”:
The purpose of those portions of sections 322.261 and 322.262[6]
which direct law enforcement to use only approved techniques and
methods is to ensure reliable scientific evidence for use in future court
proceedings and to protect the health of those persons being tested,
who by this statute have given their implied consent to these tests.
Id. at 699 (emphasis added). Although the adequacy of the Rules was not at issue
in Bender, the Court concluded that compliance with the Rules is essential for
reliable procedures and that “[n]one of the statutory presumptions can apply in the
absence of compliance with the administrative rules.” See id. at 699-700. Without
compliance with the Rules, the presumptions would not apply; but the State could
seek to admit the test results by laying the common law three-prong predicate
explained in Robertson v. State, 604 So. 2d 783 (Fla. 1992).
Later, in Miles, this Court considered a certified question regarding the
State’s entitlement to the presumptions—in the absence of compliance with the
implied consent law—by laying the admissibility predicate under Robertson.
6. The statutes were amended and renumbered after Bender.
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Miles, 775 So. 2d at 955-57. This Court’s discussion of that certified question is
not particularly relevant here; however, before reaching that issue, we addressed
the adequacy of Rule 11D-8.012 for the first and only time. 775 So. 2d at 953-55.
There, this Court affirmed a finding that Rule 11D-8.012 was inadequate for
failing to include requirements for a preservative inside collection tubes or
refrigeration of samples prior to testing. See 775 So. 2d at 951-53.
Testimony in Miles established that “proper preservation of a blood sample
was fundamental to any quality control scheme.” Id. at 954. There, FDLE experts
testified that requiring a preservative or refrigeration was “so fundamental that it
did not need to be in a rule because anyone dealing with blood samples would be
aware of the need for proper preservation.” Id. All of the experts in Miles agreed
that the absence of a preservative or refrigeration could impact the alcohol content
of a blood sample over time. See id. As to the adequacy of Rule 11D-8.012, this
Court held that there was “no error in the First District’s approval of the trial
court’s finding.” Id. at 955. We explained that lack of maintenance standards in
Miles only assured the integrity of blood samples “from the point of testing.” Id.
Moreover, the blood test at issue took place fourteen days after collection, and the
evidence showed that “fourteen days without refrigeration may well have impacted
the integrity of the blood sample.” Id. Concluding, this Court reiterated its
agreement that the absence of those particular maintenance standards rendered
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Rule 11D-8.012 inadequate and inconsistent with the purpose of the implied
consent law to ensure reliable test results. Id.
The present case is unique “in that the adequacy of the rule itself was
challenged . . . as opposed to the noncompliance with a rule.” Id. at 954 n.4 (citing
Albritton v. State, 561 So. 2d 19 (Fla. 5th DCA 1990); Donaldson v. State, 561 So.
2d 648 (Fla. 4th DCA 1990)). Such circumstances amount to a facial challenge to
the sufficiency of two agency rules. See Fairfield Communities v. Fla. Land &
Water Adjudicatory Comm’n, 522 So. 2d 1012, 1014 (Fla. 1st DCA 1988); cf.
Butler v. State Dep’t of Ins., 680 So. 2d 1103 (Fla. 1st DCA 1996) (addressing a
facial challenge to the constitutionality of the statutory delegation of authority to
an agency); Sw. Fla. Water Mgmt. Dist. v. Save the Manatee Club, Inc., 773 So. 2d
594 (Fla. 1st DCA 2000) (addressing a challenge to an agency’s authority to
implement or promulgate rules pursuant to the enabling statute).
Sufficiency of Rule 11D-8.012
Goodman argues that Rule 11D-8.012 is inadequate because it fails to
prescribe any requirements for needle gauge or tourniquet usage. We disagree.
It is undisputed that Rule 11D-8.012 governs blood labeling and collection
and that the Rule does not specify a needle or the tourniquet techniques to be used.
In its entirety, Rule 11D-8.012 follows:
11D-8.012 Blood Samples – Labeling and Collection
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(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.
Fla. Admin. Code R. 11D-8.012. Because Rule 11D-8.012 does not specifically
address the blood collection standards that are challenged here, this Court must
decide if the absence of those standards renders the Rule facially inadequate in
light of the core policies of the implied consent law. See Goodman, 203 So. 3d at
916; Miles, 775 So. 2d at 955; Bender, 382 So. 2d at 699-700.
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In the Final Order, the ALJ found that blood 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.” The ALJ
also found that 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.” Both of
these findings were supported by competent, substantial evidence from experts on
both sides. The ALJ did not specifically make findings as to needle gauge;
however, the record demonstrated that clotting may be more likely to occur in
blood draws using smaller needles (i.e., 25-gauge needles). Relatedly, butterfly
needles increase the time between evacuation of blood from the body and mixture
with the anticoagulant in the collection tube. Souza and Dr. Goldberger disputed
the relevance of that fact. The ALJ did not make any findings on
hemoconcentration. The record contains scant evidence of hemoconcentration
except a cursory indication that it can increase the alcohol content of a sample if a
tourniquet is applied for too long prior to blood collection.
The ALJ further found that “analysts routinely examine and document the
condition of samples as a matter of standard laboratory practice.” In fact, checking
for blood clots is an incidental requirement of headspace GC testing because
analysts must pipette the sample prior to analysis. Competent, substantial evidence
supported this finding through every blood analyst’s testimony. Importantly, the
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ALJ determined that the “evidence fails to establish that the mere presence of
[clotting] inevitably precludes the withdrawal of a subsample that properly reflects
the components of the whole blood contained in the collection tube.” He
explained, noting that “the accuracy of the blood alcohol level reported by the
subsample is related to the degree of [clotting] present in the sample.” As detailed
below, these last two findings were supported by competent, substantial evidence
and supported the ALJ’s final determination.
Goodman argues that the ALJ’s finding that clotting does not “inevitably
preclude” an accurate result indicates that the ALJ failed to take Miles and the core
policies into account; however, Goodman fails to grasp the relationship between
the ALJ’s two findings on clotting. The ALJ correctly identified that there are
various degrees of blood clotting, and the accuracy of a result directly relates to
that degree. According to evidence, that spectrum of blood clotting in samples
could range anywhere from invisible microclots to fully clotted serum. As FDLE’s
expert confirmed, microclots that do not affect a blood analyst’s ability to pipette a
sample have absolutely no effect on a test under headspace GC. Whereas, due to
clotting, the alcohol content in a serum sample is artificially elevated compared to
its whole blood alcohol content by approximately sixteen percent. As a result, the
ALJ correctly found that not all clotted blood samples present reliability issues.
This finding was a corollary to the immediately preceding finding: that clotting
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does not “inevitably preclude[] the withdrawal of a subsample that properly
reflects the components of the whole blood.”
Multiple portions of the record shed further light on the ALJ’s finding that
clotting does not “inevitably preclude” accurate results. First, unlike Miles where
an analyst had no way to know that a defect existed or any ability to rectify the
defect after the fact, analysts here check for blood clots as a matter of standard
laboratory practice prior to testing. Because analysts inspect and pipette samples
prior to testing, any clotting irregularities that could impact a result would be
evident. Second, Goodman’s witness and a PBSO blood analyst both testified that
analysts can perform simple calculations to account for clots and determine a
sample’s alcohol content without the clot. Fully clotted serum samples are not
valid for testing under Rule 11D-8.002(14). Regardless, this testimony
demonstrates that analysts theoretically work backwards to eliminate any effect of
clotting because—as the ALJ found—the degree of clotting has a direct
relationship to the accuracy of a test result. This evidence is in stark contrast to
Miles, where the potential effects of heat and bacteria were irreversible after the
fact and there was no way to account for the impact. See Miles, 775 So. 2d at 954-
55, 954 n.5. Finally, defendants are free to challenge the accuracy of their result in
any given case. § 316.1934(2), Fla. Stat.; Bender, 382 So. 2d at 699. Indeed,
defendants may dispute whether clotting affected their sample or an analyst erred
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in preparing the sample. However, Goodman failed to present any such challenge
or evidence.
What is more, we must recognize that Miles came to this Court with a
different procedural posture. There, as it pertained to the sufficiency of Rule 11D-
8.012, this Court affirmed the First District’s approval of a trial court finding that
Rule 11D-8.012 was inadequate. See Miles, 775 So. 2d at 953-55. Here, the ALJ
came to the opposite conclusion. This detail is particularly relevant in light of the
statutory limitation on judicial review of final administrative orders:
[T]he court shall not substitute its judgment for that of the
administrative law judge as to the weight of the evidence on any
disputed finding of fact.
§ 120.68(10), Fla. Stat. Despite the fact that clotting and hemoconcentration can
theoretically increase BAC, the ALJ made factual findings—supported by
competent, substantial evidence—to buttress his rejection of Goodman’s challenge.
The ALJ determined that Goodman failed to satisfy his burden and, based on this
record, we cannot disturb that conclusion.
However, whether Rule 11D-8.012 is facially adequate under Miles presents
a legal question, which the ALJ did not address and this Court reviews de novo.
See Volusia Home Builders, 946 So. 2d at 1089.
Goodman’s primary contention is that Miles and the core policies mandate
that the Rules ensure scientific reliability. Relatedly, he contends that the ALJ
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applied the wrong standard by finding that clotting does not “inevitably preclude”
a proper BAC result. The ALJ failed to cite Miles, or any other case for the matter.
However, as shown below, the ALJ correctly ruled that the absence of needle
gauge and tourniquet standards does not render Rule 11D-8.012 facially
inadequate. The limited law related to this question demonstrates that the facial
requirements of the Rules need not regulate every conceivable contingency to
comply with the core policy to ensure reliable results.
In Bender, after first announcing the core policies, we held that failing to
promulgate a Rule that incorporated breathalyzer manufacturers’ procedures for
operation and maintenance did not violate a defendant’s due process rights. 382
So. 2d at 700. The Rules there required the operation and maintenance to be in
accordance with the procedures, but the procedures were not specifically
enumerated. Id. We reasoned that the failure to provide those procedures was not
a constitutional infirmity because there was no showing that the documents were
unavailable. Id. Moreover, the defendants there had “the right in their individual
proceedings to attack the reliability of the testing procedures or the operator’s
qualifications.” Id. Thus, we already rejected a similar challenge to the absence of
an express Rule when the Rule and its incidental procedures, in conjunction,
facially ensure reliability and there is no evidence to the contrary. See id.
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Similarly, in State v. Friedrich, 681 So. 2d 1157 (Fla. 5th DCA 1996), the
Fifth District Court of Appeal reversed six orders granting defendants’ motions in
limine to exclude evidence of breath alcohol test results. Id. at 1159-60. Although
Friedrich did not present a direct Rule challenge, the Fifth District considered
whether a variation in the alcohol content of stock solution made breath test results
scientifically inaccurate or not in compliance with the Rules. Id. at 1162-64. As in
this case, in Friedrich, there were no Rules promulgated that concerned the
composition of stock solution, which was prepared by FDLE and used in Florida to
calibrate breathalyzers. Id. at 1163. Moreover, evidence demonstrated that there
was a theoretical, mathematical possibility that stock solution could fall within
FDLE’s accepted range of variance while allowing certain breathalyzers to
produce artificially higher alcohol content results. Id. at 1163-64. Because the
defendants there did not provide any evidence to show that their breath tests met
that possibility, the Fifth District rejected their claims as “speculative and
theoretical.” Id. at 1163. However, the Fifth District clarified that defendants
could challenge the validity of breath tests if their results were potentially impacted
by that variation. Id. at 1163-64. The court explained that when promulgating
Rules, FDLE “must do a competent job, but not a perfect one.” Id. at 1164.
Below, the Fourth District distinguished Miles by noting that clotting can be
“rectified after the fact,” unlike the lack of a preservative or refrigeration in Miles.
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Goodman, 203 So. 3d at 914. Although the Fourth District was wrong as to the
appropriate method to remedy clotting,7 the record demonstrates that clotted blood
can be identified and remedied to ensure reliable testing—a critical distinction
from the defect in Miles. Blood analysts routinely check for blood clots when they
prepare samples for testing under headspace GC. Conversely, in Miles, no
evidence suggested that there was any way for analysts to know if heat or bacteria
affected the sample. See Miles, 775 So. 2d at 951-55. We noted there that, absent
maintenance standards, “the integrity of the sample is guaranteed only from the
point of testing.” Id. at 955. Yet, here, we can be confident in the results because
analysts check for irregularities. Further, in Miles, an important consideration for
this Court was that the experts were in complete agreement that the lack of a
preservative or refrigeration could impact a blood sample. See id. Whereas, here,
there was a battle of the experts as to the exact effects of clotting on samples and
the proper scope of regulation. FDLE’s expert testified to microclots having no
effect on a sample under headspace GC and 25-gauge butterfly needles being
acceptable for blood draws. Goodman’s experts provided a blanket statement that
clotted samples are always unreliable and testified that using 25-gauge butterfly
needles is below the standard of care for blood draws. For these reasons, Miles is
7. The Fourth District misinterpreted Dr. Goldberger’s testimony
concerning homogenization.
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factually distinguishable from this case. See also Vuong v. Fla. Dep’t of Law
Enf’t, 149 So. 3d 174, 176-77 (Fla. 4th DCA 2014) (distinguishing Miles when
there was disputed evidence as to the effect of modifications to breathalyzers and
the ALJ found that “the evidence failed to establish the complained-of deficiencies
had any impact on the reliability of breath alcohol tests”).
Therefore, the core policy of the implied consent law to ensure scientifically
reliable test results cannot be interpreted as strictly as Goodman contends. Instead,
the core policy places on FDLE the “responsibility of establishing uniform and
reliable testing methods in this scientific area.” See Bender, 382 So. 2d at 700.
Although that responsibility is weighty, it does not oppress FDLE with the
impossible task of continuously regulating the potential existence of every
theoretical problem that could occur during a blood draw.
To be sure, there is no Rule regulating needle gauge or tourniquet usage;
still, Rule 11D-8.012 adequately ensures reliable results. Testimony established
that any issues would likely result from poor blood collection practices. The
Legislature provided for this concern by mandating that only medical experts such
as doctors, nurses, or paramedics can collect blood for the purposes of determining
its alcoholic content.8 § 316.1932(1)(f)2.a., Fla. Stat. Further, any clotting that
8. In fact, regulating needle gauge and type could conflict with the other
core policy: protecting the health of those tested. Bender, 382 So. 2d at 699.
Smaller needles may be necessary for certain people with severely damaged veins.
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could affect a test result would be noticeable when an analyst pipettes the sample
because the pipette would be unable to cleanly draw a subsample. All analysts
testified that they make a notation of any noticeable clotting on the laboratory file,
which defendants can obtain via a public records request. In any situation, a
defendant could challenge the accuracy of the test or qualifications of the analyst,
which has been the law in Florida for nearly forty years. See Bender, 382 So. 2d at
699. Accordingly, we conclude that Rule 11D-8.012 facially ensures reliable
blood test results and any question as to the accuracy of a particular test is best
determined on a case-by-case basis. See Vuong, 149 So. 3d 174; Wissel v. State,
691 So. 2d 507, 508 (Fla. 2d DCA 1997) (rejecting an “attack, based on the lack of
a rule or regulation to cover every step of the testing” because it was “not only
speculative and theoretical, but also hyper-technical”); Friedrich, 681 So. 2d 1157;
see also State v. Kleiber, 175 So. 3d 319, 321 (Fla. 5th DCA 2015) (“[M]inor
deviations from the rules will not prohibit the test results from being presented, as
long as ‘there is evidence from which the fact finder can conclude that the [test]
itself remained accurate.’ ” (quoting State v. Donaldson, 579 So. 2d 728, 729 (Fla.
1991))).
Likewise, as a practical matter, butterfly needles may be necessary for involuntary
blood draws on drunk drivers to allow movement without rupturing their veins. It
follows that both decisions are best made by medical professionals, not lawyers.
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Finally, Goodman looks to the implied consent laws from five other states in
an unpersuasive attempt to convince this Court that FDLE has an easy fix to
mandate the use of commercially available blood draw kits. Although other states’
rules are not controlling, it is telling that even some of those states provide latitude
for medical experts depending on the circumstances. See Ill. Admin. Code tit. 20,
§ 1286.320(d) (2015) (“Officers shall use DUI kits provided by the Department, if
possible. If kits are not available, officers may submit two standard grey top
vacuum tubes.”). Moreover, no party or court located any rule that prescribes a
needle gauge to use during blood alcohol draws. See Goodman, 203 So. 3d at 915
n.6 (surveying other states).9 The logic behind Goodman’s contention risks
locking scientific practices into today’s methodology. See 203 So. 3d at 915. For
example, testimony established that prior to the DOAH hearing, standard,
commercial law enforcement blood collection kits contained 21-gauge straight
needles, which Goodman reiterated at oral argument. However, Dr. Goldberger
testified that butterfly needles have been used in Florida, at least on some
occasions. Moreover, a recent Wisconsin Supreme Court decision suggests that
straight needle kits may not be ubiquitous, noting the “blood draw kits . . .
9. It is telling that we found a New Jersey regulation mandating a needle
gauge for body piercings, N.J. Admin. Code § 8:27-6.5(e); oddly, there is no
corresponding requirement for blood alcohol draw needles.
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contain[ed] a ‘butterfly needle.’ ” State v. Kozel, 889 N.W.2d 423, 428 (Wis.
2017). Therefore, Goodman’s argument regarding a DUI kit requirement is self-
defeating. Because the statutory process for amending or promulgating a Rule is
difficult, see § 120.54, Fla. Stat. (2017), the Rules set a due-process floor, while
allowing some flexibility for science to advance. See Bender, 382 So. 2d at 700
(requiring constant legislative supervision of the administration of FDLE’s
scientific methods was “neither practically possible nor required by our
constitution”). On this record, we cannot impede that legislatively created scheme
of FDLE oversight.
Resultantly, we conclude that Rule 11D-8.012 is not inadequate.
Sufficiency of Rule 11D-8.013
Goodman argues that Rule 11D-8.013 is inadequate because it fails to
specify that analysts must screen, document, and reject unfit samples. Again, we
disagree.
The ALJ found that blood “analysts routinely examine and document the
condition of samples as a matter of standard laboratory practice.” Concerning this
finding, the record is telling. All the blood analysts testified that they examine and
document if a sample is clotted. Goodman’s expert agreed and testified that
examining the sample is a “common step” when analysts open and inventory the
evidence. During this gross examination, analysts invert the collection tube and
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they would be able to “feel [large clots] going from one end to another.”
Moreover, analysts incidentally check for microclots due to the nature of
conducting a blood analysis under headspace GC. Analysts “thoroughly mix” each
sample before pipetting it for transfer to the testing vials. When the sample is
pipetted, “the presence of clots become[s] very evident” to an analyst.
Importantly, the laboratory file where all analysts note whether a sample exhibited
clotting is available to defendants. Because of this, the ALJ concluded that the
“omission of such a requirement [to examine and document the condition of
samples] does not provide a basis to invalidate the rule.” Clearly, competent,
substantial evidence supported that determination.
Notwithstanding the routine practice described above, Dr. Goldberger
testified that individual laboratories’ SOPs should prescribe a procedure for
screening, documenting, and rejecting unfit samples. SOPs must be approved by
FDLE under Rule 11D-8.013(2)(a), and FDLE would not reject an SOP solely
because it did not include these procedures. Moreover, the PBSO SOP does not
provide any specific requirements on the challenged procedures. However,
Yeatman, who tested Goodman’s blood, stated that the PBSO’s practice is that
“any time a sample is clotted, it is documented on the analyst’s case file and is also
reported.”
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Goodman argues that despite the established fact that blood analysts
routinely perform these procedures, Rule 11D-8.013 does not require them.
Therefore, he argues, the Rules cannot ensure reliable results.
In Miles, this Court rejected the argument that blood preservation and
maintenance steps were “so fundamental that [they] did not need to be in a rule
because anyone dealing with blood samples would be aware of the need for proper
preservation.” 775 So. 2d at 954. However, Goodman’s comparison—between
including a preservative inside collection tubes or refrigerating the sample in-
transit with requiring a trained scientist to record when the outcome of a test might
be inaccurate—is not persuasive. In Miles, the maintenance steps were not
incidental to transporting a sample and applied to every person in the chain of
custody, including potentially a mailman. See id. at 954-55; Rafferty v. State, 799
So. 2d 243, 247-48 (Fla. 2d DCA 2001). Whereas the challenged procedures here
are merely incidental to testing and include elementary steps applying only to
blood analysts—whom Rule 11D-8.013(2)(d) requires to be licensed clinical
chemists, college-educated in chemistry, or physicians. Further, nothing in Miles
suggested that blood samples were being properly preserved prior to the decision.
In fact, a case from the Second District Court of Appeal showed that improper
preservation and maintenance of blood samples was a problem in Florida prior to
Miles, which posed a statewide threat to test reliability. See Rafferty, 799 So. 2d at
- 31 -
247 (calling the case “a textbook example of how not to handle blood”). However,
here, the evidence demonstrates that there is no risk to the accuracy of blood tests
in the absence of a Rule on screening, documenting, and rejecting unfit samples,
because blood analysts are already doing this as a matter of standard laboratory
practice.
In Wissel, the Second District considered a Rule challenge for failing to
specify FDLE’s procedures in preparing stock solution to be used in breathalyzer
testing. 691 So. 2d at 507. The Second District held that “procedures that are
implicit and incidental to procedures otherwise explicitly provided for in a properly
adopted rule or regulation do not require further codification by a further adopted
rule or regulation.” Id. There, the defendant noted FDLE’s failure to promulgate a
procedure on how it mixed or produced stock solution, among other claims. Id. at
508. However, the court explained that “lack of a rule or regulation to cover every
step of the testing procedures for breath test instruments, is not only speculative
and theoretical, but also hyper-technical.” Id. Below, the Fourth District applied
Wissel to this case, noting that the “rules at issue, when combined with basic
laboratory practices, are sufficient to protect the safety and interests of the court
system and defendants alike.” Goodman, 203 So. 3d at 915. Similar to Wissel,
Goodman’s argument fails because blood analysts already screen, document, and
reject unfit samples as an implicit and incidental part of headspace GC testing.
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And—without more—Goodman’s position leaves him tilting at windmills. See
Goodman, 203 So. 3d at 912 (calling Goodman’s position “an overbroad solution
in search of a problem”); Vuong, 149 So. 3d at 176-77 (affirming an ALJ’s
rejection of a Rule challenge when the impact of a modification was disputed and
the evidence failed to establish that the test results were unreliable); Wissel, 691
So. 2d at 508 (repudiating a “speculative and theoretical, but also hyper-technical”
rule challenge); Friedrich, 681 So. 2d at 1163 (rejecting “speculative and
theoretical” claims).
Relatedly, in Miles, evidence showed that the blood sample was
unrefrigerated and without a preservative for fourteen days, which “may well have
impacted the integrity of the blood sample.” 775 So. 2d at 955. This Court relied
on that fact to justify its holding that Rule 11D-8.012 was “inadequate and
inconsistent with the purpose of the implied consent law.” Id. Whereas, here,
there is absolutely no indication that Goodman’s sample was clotted or exhibited
hemoconcentration. See Wissel, 691 So. 2d at 508 (repudiating a “speculative and
theoretical, but also hyper-technical” rule challenge); Friedrich, 681 So. 2d at 1163
(rejecting “speculative and theoretical” attack). In fact, Yeatman, who tested
Goodman’s blood, testified that he always documents clotting and he thoroughly
mixed Goodman’s blood, thereby demonstrating that there were no clotting issues
in this case and the record provides absolutely no evidence to the contrary.
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Taking Goodman’s contention to its logical conclusion, Rule 11D-8.013
could be inadequate for an unending litany of reasons. For example, the Rule does
not require blood analysts to wear rubber gloves to prevent contamination. Under
Goodman’s reasoning, even if it is conclusively proven that each and every blood
analyst in Florida wears rubber gloves when handling samples, the Rule would be
inadequate for failing to require them. Although it may be preferable for FDLE to
promulgate a Rule that specifically lays out every minute detail of a test, this Court
is not positioned to make that determination. Further, such an exercise “would
swiftly devolve into a hopeless endeavor and serve only to expand [FDLE’s]
regulations to epic lengths.” Goodman, 203 So. 3d at 915.
Based on the foregoing, we conclude that Rule 11D-8.013 is not inadequate.
CONCLUSION
Accordingly, we answer both certified questions in the negative and approve
the decision of the Fourth District.
It is so ordered.
PARIENTE, LEWIS, QUINCE, CANADY, POLSTON, and LAWSON, JJ.,
concur.
LABARGA, C.J., recused.
NOT FINAL UNTIL TIME EXPIRES TO FILE REHEARING MOTION AND,
IF FILED, DETERMINED.
Application for Review of the Decision of the District Court of Appeal – Certified
Great Public Importance
- 34 -
Fourth District - Case No. 4D14-3263
(Palm Beach County)
Jane Kreusler-Walsh, Rebecca Mercier Vargas, and Stephanie L. Serafin of Law
Office of Kreusler-Walsh Vargas & Serafin, P.A., West Palm Beach, Florida;
Brian A. Newman of Pennington, P.A., Tallahassee, Florida; and Elizabeth L.
Parker of Kaplan, Sconzo & Parker, P.A., Palm Beach Gardens, Florida,
for Petitioner
Pamela Jo Bondi, Attorney General, Amit Agarwal, Solicitor General, and Rachel
Nordby, Deputy Solicitor General, Tallahassee, Florida,
for Respondent
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