        DISTRICT COURT OF APPEAL OF THE STATE OF FLORIDA
                                FOURTH DISTRICT

                               JOHN GOODMAN,
                                  Appellant,

                                         v.

            FLORIDA DEPARTMENT OF LAW ENFORCEMENT,
                            Appellee.

                                 No. 4D14-3263

                                 [May 25, 2016]

   Appeal from the Florida Division of Administrative Hearings; L.T. Case
No. 14-1918RX.

   Jane Kreusler-Walsh and Stephanie L. Serafin of Kreusler-Walsh,
Compiani & Vargas, P.A., West Palm Beach; Brian A. Newman of
Pennington, P.A., Tallahassee; and Elizabeth L. Parker of Law Office of
Elizabeth Parker, P.A., Palm Beach Gardens; for appellant.

    Ann Marie Johnson, Tallahassee, for appellee.

FORST, J.

   Appellant John Goodman was involved in a vehicular collision that
resulted in the death of another individual. Appellant’s blood was drawn
after the accident for blood alcohol testing, pursuant to Florida’s implied
consent statutes. See §§ 316.1932-34, Fla. Stat. (2010). Ultimately,
Appellant was charged with DUI Manslaughter/Failed to Render Aid and
Vehicular Homicide/Failed to Give Information or Render Aid. As part of
his defense, Appellant moved to exclude the blood alcohol test results,
challenging Florida Administrative Code Rules 11D-8.012 and 11D-8.013
and the authority of the Florida Department of Law Enforcement (“FDLE”)
to promulgate these rules relating to the collection and labeling of blood
for blood alcohol content testing. The trial court deferred ruling on the
motion and transferred this issue to the Florida Division of Administrative
Hearings, under the doctrine of primary jurisdiction. 1 An administrative

1“The doctrine of primary jurisdiction dictates that when a party seeks to invoke
the original jurisdiction of a trial court by asserting an issue which is beyond the
ordinary experience of judges and juries, but within an administrative agency’s
law judge (“ALJ”) held an evidentiary hearing and dismissed Appellant’s
petition, finding that the challenged rules were valid exercises of delegated
legislative authority, i.e., FDLE has the authority to govern the collection
of blood and that Rule 11D-8.012 and Rule 11D-8.013 are valid exercises
of agency rulemaking that ensure reliable blood alcohol test results.

   Subsequently, the trial court denied Appellant’s motion to exclude the
blood test results. Appellant was ultimately convicted of the above-noted
charges and sentenced. 2

    Appellant now appeals the ALJ’s order and raises three issues: (1) the
FDLE lacked delegated authority to promulgate the rules at issue; (2) Rule
11D-8.012 constitutes an invalid exercise of delegated legislative authority
because it fails to establish standards for the method by which blood is
collected for chemical analysis; and (3) Rule 11D-8.013 constitutes an
invalid exercise of delegated legislative authority because it fails to
incorporate a process to identify and/or exclude unreliable blood samples
from the testing process. We affirm the first issue without further
comment. See State v. Bender, 382 So. 2d 697, 699 (Fla. 1980) (finding
that the pertinent statutes “direct law enforcement to use only approved
techniques and methods . . . to ensure reliable scientific evidence for use
in future court proceedings . . . .”). We write to explain our reasons for
affirming on the other two challenges to the rules.

                                BACKGROUND

   As noted above, Appellant challenges the legitimacy and sufficiency of
two FDLE regulations:         Rules 11D-8.012 and 11D-8.013.           These
regulations govern the collection and storage of blood samples for the
FDLE’s blood alcohol testing program, as well as regulate those persons
qualified to test the samples. Rule 8.012 specifies a number of steps that
must be taken during the blood collection and testing process, including,
inter alia, that the skin must be cleansed with a non-alcohol antiseptic
before collection, that the samples “must be collected in a glass evacuation
tube that contains a preservative,” that “the tube must be inverted several
times” and labelled properly, and that the samples must be refrigerated if
they are stored for more than seven days. However, the rule does not set
standards either for the type and size of needle to be used or the tourniquet
application protocol to be followed in the collection of a blood sample for

special competence, the court should refrain from exercising its jurisdiction over
that issue until such time as the issue has been ruled upon by the agency.” Flo-
Sun, Inc. v. Kirk, 783 So. 2d 1029, 1036-37 (Fla. 2001).
2 Appellant’s appeal of his conviction and sentence is proceeding separately.


                                        2
testing. Rule 8.013 lays out the requirements for a Florida blood analyst
permit, and further sets forth the blood alcohol testing analytical
procedures. This rule fails to explicitly require the analysts to screen for
and reject compromised blood samples, or to document irregularities in
the tested samples.

   These deficiencies, Appellant argues, render the regulatory scheme
insufficient to ensure the reliability of the blood alcohol test results.
However, as described below, Appellant’s argument is an overbroad
solution in search of a problem that does not exist.

                                ANALYSIS

A. Challenge to Rule 11D-8.012

    “In an appeal from final administrative action, this court reviews the
administrative agency’s findings of fact to determine whether they are
supported by competent, substantial evidence.” Dorcely v. State Dep’t of
Bus. & Prof. Regulation, 22 So. 3d 834, 836 (Fla. 4th DCA 2009). “We
review the agency’s conclusions of law de novo.” Id. In a challenge to an
existing rule, the burden is on the petitioner to demonstrate that the rule
is invalid. See § 120.56(3)(a), Fla. Stat. (2010); State Dep’t of Children &
Family Servs. v. I.B., 891 So. 2d 1168, 1171 (Fla. 1st DCA 2005).

    By law, persons accepting drivers’ licenses in the state are deemed to
consent to testing of their blood alcohol content. § 316.1932(1)(a)1.a., Fla.
Stat. (2010). The “underlying purpose of the implied consent law . . . ‘is to
ensure reliable scientific evidence for use in future court proceedings and
to protect the health of those persons being tested . . . .’” State v. Miles,
775 So. 2d 950, 953 (Fla. 2000) (emphasis omitted) (quoting Bender, 382
So. 2d at 699). Furthermore, compliance with the FDLE regulations gives
rise to various statutory presumptions for use in court proceedings. When
a regulation fails to meet the purposes of the implied consent program,
however, the statutory presumptions do not apply. See id. at 953-55
(holding that failure to require proper preservation of blood samples
rendered a prior version of Rule 8.102 “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 [was] not entitled to the
presumptions of impairment associated with the implied consent statutory
scheme.”).

   Appellant argues that Rule 8.012 is invalid for failure to specify a
required needle size for drawing blood. Specifically, he alleges that his
blood was drawn using a twenty-five gauge butterfly needle, rather than a

                                     3
“standard” twenty-one gauge straight needle. A twenty-five gauge needle
is narrower than a twenty-one, and, unlike a straight needle, which injects
blood directly into the vial, a butterfly needle delivers blood to the
collection vial via a small length of rubber tubing. Although the standard
kits used by law enforcement contain the twenty-one gauge straight
needles, the twenty-five gauge butterfly needles can be useful for certain
patients.

    At the proceedings below, the administrative law judge heard testimony
from seven expert witnesses, all of whom opined on the relative
effectiveness of this deviation in needle size and type and/or the
effectiveness of the procedures in place under the current regulations. The
testimony established that the use of a smaller butterfly needle to draw a
suspect’s blood can have several effects on a blood sample, such as
increased blood clotting or hemolysis (the release of the contents of red
blood cells into the surrounding plasma). 3 Experts for both parties
testified, and the administrative law judge found, that the use of a smaller
needle is more likely to cause blood to clot in the delivery from the donor
to the test tube in which the blood will be stored (at which point anti-
coagulation measures are employed to prevent new or further coagulation).
However, because the administrative law judge found that an accurate
result being obtained from clotted blood was not “inevitably precluded,” he
determined that Rule 11D-8.102 was valid.

   Although the testimony presented at the hearing was subject to
multiple conclusions on this point, there was sufficient evidence in the
record to support the ALJ’s findings of fact as to the effect of clotting on
the accuracy of blood testing. First, the testimony was clear that a smaller
needle can increase clotting, and that clotting can affect the accuracy of a
blood alcohol test. However, one expert testified that it is still possible to
get an accurate result from testing a properly prepared sample even after
clotting had occurred because the clot does not add or subtract anything
from the blood that would affect the test. 4          He referred to this
homogenization process as “[v]ery easy” and testified that a clotted sample
is neither “contaminated” nor necessarily an unreliable input into the


3 On appeal, Appellant has focused his arguments with respect to Rule 8.012
solely on the increase in clotting caused by a smaller needle and deficient
tourniquet usage.
4 See also Derrick J. Pounder & Alan Wayne Jones, Post-Mortem Alcohol —

Aspects of Interpretation, in FORENSIC ISSUES IN ALCOHOL TESTING 65, 66 (Steven
B. Karch ed. 2008) (“The presence of blood clots will not necessarily have a
negative influence on the accuracy of the blood alcohol analysis using headspace
gas chromatography.”).

                                       4
scientific analysis. Further testimony revealed that homogenization was
necessary only with larger clots, because “small clots . . . would have no
affect [sic] on the blood alcohol test.” These large clots would be easily
noticeable, based on the testimony that grossly clotted blood would be
difficult to move through the needles or pipettes. Regardless of the size of
the clot, testimony also revealed that standard practice is to “mix[ ] the
sample” prior to testing, in order to avoid problems such as those created
by clots.

    The takeaway point from this expert’s testimony is that “a sample
collected using a 25-gauge butterfly needle [is] valid for blood alcohol
determination using headspace gas chromatography” so long as proper
procedures are followed, and that Rule 8.012 is not invalid for failure to
specify a required needle size for drawing blood. See State v. Friedrich,
681 So. 2d 1157, 1161-63 (Fla. 5th DCA 1996) (finding that, so long as
the Intoxilyzer breath tests were made in substantial compliance with the
applicable statutes and rules and the results of the tests “are sufficiently
reliable so as to be generally acceptable in the scientific community,” the
court could not “say FDLE is remiss for not adopting rules or protocols in
this regard”). Thus, the testimony established that clotting is notably
different than the flaws caused by the lack of refrigeration in Miles, which
could not be rectified after the fact. Miles, 775 So. 2d at 954-55. This
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.

B. Challenge to Rule 11D-8.013

    Appellant also argues that Rule 8.013 improperly fails to require the
screening, removal, or documentation of flawed blood samples. FDLE
responds, and we agree, that Appellant has not established that the Rule
has failed to ensure the accuracy of the blood testing program. The Rule
itself, titled “Blood Alcohol Permit — Analyst,” sets out criteria to apply for
a permit to conduct blood alcohol analyses, including submission of an
application providing “[a] complete description of proposed analytical
procedure(s) to be used in determining blood alcohol level.”               The
applicant’s “proposed analytical procedures” are then reviewed by the
Department.

   Appellant called two witnesses who actually conducted blood tests for
the Palm Beach County Sheriff’s Office. Both testified that they routinely
documented any irregularities in blood samples. Another expert, who had
analyzed thousands of blood samples, stated that he always made written

                                      5
documentation if a sample was clotted and required analysts working
under him to do the same. That second expert, who was in fact the person
who tested Appellant’s blood in this case, specifically stated that “any time
a sample is clotted, it is documented on the analyst’s case file and is also
reported . . . [a]s additional remarks under the conclusions.” 5 Yet another
expert testified that in his tens-of-thousands of samples tested, he always
noted when a sample was clotted, but had also always been able to
properly test the blood after making that notation. This testimony
supports FDLE’s contention, both below and on appeal, that Rule 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. It also supports the ALJ’s conclusion that “analysts
routinely examine and document the condition of samples as a matter of
standard laboratory practice [and the] omission of such a requirement
does not provide a basis to invalidate [Rule 8.013].”

   Any attempt by FDLE to regulate for every possible contingency that
may arise in the collection or testing processes would swiftly devolve into
a hopeless endeavor and serve only to expand the Department’s
regulations to epic lengths. 6 Furthermore, such over-regulation would run
the risk of locking in today’s current scientific methodology, preventing the
evolution and improvement of the system. It would also deprive both the
State and criminal defendants of the expertise and discretion of the
analysts, as their training and practical experience is necessary to properly
address the wide variety of factual scenarios that may arise.7 For instance,

5 Appellant has failed to provide a copy of his report as part of the record on
appeal. We therefore do not know whether Appellant’s blood was in fact clotted.
6 No other state appears to have regulated to the extent that Appellant argues

Florida must. Appellant has not provided, and we have failed to locate, a single
rule across the country that regulates the exact size of needle that must be used.
Instead, the rules simply provide general guidance clearly intended to be
supplemented by standard best practices and medical knowledge. See, e.g., Miss.
Admin. Code 31-5-2:1750.000 et seq. (2016) (adopting rules regulating blood
collection without specifying a particular needle size to be used); § 577.029, Mo.
Rev. Stat. (2016) (requiring use of a “previously unused and sterile needle”); Mont.
Admin. R. 23.4.220 (2016) (adopting rule with similar requirements to FDLE
rule); N.H. Code Admin. R. Saf-C 6402.02 (2016) (same); Ohio Admin. Code 3701-
53-05 (2016) (requiring blood to be drawn “with a sterile dry needle”). With
regards to the screening of blood, we have found only one state—Maine—which
specifically requires analysts to document clots found in testing samples. See
10-144 Ch. 270 Me. Code. R. § B(3)(e) (2016).
7 See Edward J. Imwinkelried, Some Preliminary Thoughts on the Wisdom of

Governmental Prohibition or Regulation of Employee Urinalysis Testing, 11 Nova L.
Rev. 563, 596-97 (1987) (calling for government regulation of laboratories, but

                                         6
we would be loath to require the FDLE to mandate a single, one-size-fit-all
needle choice for blood collection, as the unique facts of each case may
require a different choice. This determination is best left for the trained
professionals on the ground, as are many of the choices made in the
testing laboratories across the State. 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. See Wissel v. State,
691 So. 2d 507, 507-08 (Fla. 2d DCA 1997) (holding “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 [and] to hold otherwise belies
statutory intent . . . .” and that such an argument, “based on the lack of a
rule or regulation to cover every step of the testing procedures . . . is not
only speculative and theoretical, but also hyper-technical.”).

                                 CONCLUSION

   Appellant has failed to show that Rules 8.012 and 8.013 do not ensure
the accuracy of the blood testing program. The ALJ’s and trial court’s
determinations that these rules adequately protect the reliability and
consistency of blood testing were supported by competent evidence in the
record on appeal. For these reasons, we affirm the administrative law
judge’s order.

   Affirmed.

WARNER and STEVENSON, JJ., concur.

                             *         *         *

Not final until disposition of timely filed motion for rehearing.




only going so far as to argue that the laboratories should themselves establish
specific internal quality control procedures based on more general regulations).

                                       7
