             IN THE SUPERIOR COURT OF THE STATE OF DELAWARE



                                          :
STATE OF DELAWARE                         :
                                          :
        v.                                :               I.D. No. 1411013133
                                          :
LAMONTRA R. FOUNTAIN,                     :
                                          :
                    Defendant.            :
                                          :




                              MEMORANDUM OPINION

                           Upon Defendant’s Motion to Suppress
                                       Granted


                                 Submitted: August 24, 2016
                                  Decided: August 30, 2016




      Rebecca Anderson, Esquire, Deputy Attorney General, 114 East Market Street,
Georgetown, DE 19947.

      Danielle Brennan, Esquire, Deputy Attorney General, 820 N. French Street, 7th Floor,
Wilmington, DE 19801.

      Michael Capasso, Esquire, Office of the Public Defender, 14 The Circle, 2nd Floor,
Georgetown, DE 19947.



STOKES, J.
                                        I. INTRODUCTION

       Defendant, Lamontra Fountain (“Defendant”), was arrested on November 21, 2014, and

charged with Driving Under the Influence of Alcohol.          Defendant moved to preclude the

admission of his blood test results based upon the failure of the State of Delaware (the “State”) to

demonstrate compliance with the instructions provided in the Delaware State Police Blood

Alcohol Evidence Collection Kit. At the pretrial hearing, the Court found the State laid the

proper foundation for the admission of Defendant‟s blood test results. However, after trial began

and upon hearing testimony from the State‟s chemist, the Court reversed its decision and

suppressed the blood test results based upon the fact that the tube used in Defendant‟s blood

draw was not filled to “maximum volume.” The State filed a motion for reargument contending

that, however interpreted, maximum volume does not require a full ten milliliters be drawn. The

motion was granted in order to clarify the significance and meaning of the direction. After

reconsideration, Defendant‟s Motion to Suppress is GRANTED.

                             II. FACTS AND PROCEDURAL POSTURE

       On November 21, 2014, Defendant was stopped while driving by Corporal Christopher

Miller (“Cpl. Miller”) of the Seaford Police Department. After speaking with Defendant, Cpl.

Miller detected a strong alcoholic odor on his breath and an odor of burnt marijuana from inside

his vehicle. Based on these observations, Cpl. Miller decided to subject Defendant to a battery

of field sobriety tests. From the results of the field tests, Defendant was arrested for Driving

Under the Influence and various other violations. Shortly thereafter, Cpl. Miller obtained a

search warrant for a sample of Defendant‟s blood and transported Defendant to Nanticoke

Memorial Hospital to execute the warrant.




                                                 2
        At the hospital, Cpl. Miller provided Jennifer Ganly (“Ganly”), a phlebotomist, with a

Delaware State Police Blood Alcohol Evidence Collection Kit (the “Kit”).1 Although Ganly

testified that a legal blood draw requires ten milliliters of blood,2 the sample she obtained from

Defendant was approximately six milliliters. The sample was then sealed and logged into

evidence at the Seaford Police Department.

        On December 11, 2014, Defendant‟s blood sample was transferred from the Seaford

Police Department to the Delaware State Police Crime Lab (“DSPCL”). The analysis performed

on the blood sample revealed that Defendant‟s blood alcohol content (“BAC”) was above the
               3
legal limit.       Defendant was charged by Information with Driving Under the Influence of

Alcohol and associated charges on January 21, 2015.

          On April 14, 2015, Defendant moved to preclude the admission of his blood test results

asserting breaks in the chain of custody. After a hearing, the Court found the State met the

necessary threshold in establishing that the evidence was what it purported to be, and

Defendant‟s Motion was denied. Trial was scheduled for July 15, 2015, but before trial began,

an evidentiary hearing was held to determine whether the manner in which Defendant‟s blood

was drawn complied with the instructions provided in the Kit. Ultimately, as discussed above,

the decision was reversed because the blood tube used was not filled to maximum volume. Step

2 of the Kit states: “Using normal procedures, withdraw blood from subject (allow tube to fill to

maximum volume).”           A mistrial was declared as the jury already heard evidence that

Defendant‟s BAC was above the legal limit, and the results could overwhelm the jurors‟ ability

to fairly decide the remaining issues in the case.

1
  Cpl. Miller also provided Ganly with a Suspect Drug Use Kit. Although Ganly used the tube provided in the
Suspect Drug Kit to collect Defendant‟s blood, the sample was not tested before trial.
2
  State v. Fountain, ID No. 1411013133, at A-40 (Del. Super. July 15, 2015) (TRANSCRIPT) [hereinafter “July
2015 Hr‟g”].
3
  See 21 Del. C. § 4177.
                                                       3
        Following the granting of the motion, an evidentiary hearing was held to consider the

State‟s position that “a tube less full than „maximum volume‟ does not affect the scientific

soundness and validity of a blood sample.”4 At the April 19, 2016 hearing, four witnesses

testified on behalf of the State. They were: Eric Barton, vice president of Tritech Forensics;5

Melvin Finke, product development engineer for Medtronic;6 Dr. Ana Stankovic, clinical

pathologist and vice president of Becton Dickinson (“BD”);7 and Julie Willey, Director of the

DSPCL. Additionally, the State submitted documentary evidence. Thereafter, the issue was

briefed by the parties.

        While preparing to render its decision, it became apparent to the Court that some

questions were left unanswered. Specifically, what effects, if any, a lower sample volume had

on the test‟s reliability? As a result, the parties were asked to present additional expert testimony

addressing that issue. The Court heard testimony from two experts on behalf of the State—Jack

Kalin (“Kalin”), Alabama‟s former Chief Toxicologist, and Alan Wayne Jones (“Jones”),

Sweden‟s former Chief Toxicologist. In rebuttal, Defendant offered testimony from Dr. Stefan

Rose (“Rose”), a forensic physician.

                                        III. PARTIES’ CONTENTIONS

                                            A. State’s Contentions
        The State argues “[b]ecause [the DSPCL Director] has validated the reliability of her

results with the gas chromatograph regardless of the number of mLs collected in the grey top



4
  State‟s Mot. for Rearg. at 6.
5
  Tritech Forensics manufactures evidence collection kits for law enforcement. The Kit used to collect Defendant‟s
blood was manufactured by Tritech.
6
  Medtronic, formerly known as Covidien, is a medical device company that manufactures and sells medical devices.
7
  BD is a medical device company that manufactures and sells medical devices. Although Tritech buys blood
collection tubes from Medtronic and BD, Tritech‟s vice president testified that the bulk of the tubes used for their
blood collection kits are manufactured by BD. See State v. Fountain, ID No. 1411013133, at 21 (Del. Super. Apr.
19, 2016) (TRANSCRIPT) [hereinafter “April Hr‟g”].
                                                         4
                              8
tube, Hunter [v. State] was not violated.”9 Essentially, the State contends strict compliance with

the manufacturer‟s protocol—as required under Hunter—chooses form over function and ignores

the scientific principles that support the test‟s reliability. Further, the language, “allow tube to

fill to maximum volume,” from Step 2 of the Kit‟s Instructions, “is satisfied when a sufficient

sample is collected to be tested.”10

                                     B. Defendant’s Contentions
         Defendant contends that by failing to exhaust the vacuum inside the blood collection
                                                                                                    11
tube, the DSPCL did not comply with the manufacturer‟s protocol, and the test is invalid.

Further, the State did not “demonstrate any valid scientific testing, or provide a qualified expert

opinion, to support its claim that the blood test should be admitted even though the State Crime
                                                                    12
Lab did not comply with the manufacturer‟s use requirements.”

                                        IV. APPLICABLE LAW

         Concerning the admissibility of scientific test results, Delaware law is clear. As stated by

our Supreme Court:

         In Clawson v. State, we stated that “the admissibility of intoxilyzer test results
         center on the State providing an adequate evidentiary foundation for the test
         result‟s admission.” We held that it was error for the trial court to admit into
         evidence the results of an Intoxilyzer 5000 test when it was determined that the
         manufacturer‟s protocol was not complied with before the test was administered.
         Following the manufacturer‟s use requirements ensures the reliability of the
         scientific test. It is this guarantee of reliability and accuracy that is the
         foundational cornerstone to the admissibility of the results of a scientific test.
         Without that guarantee of reliability, there exists too great a risk that a jury will be
         persuaded by scientific evidence that is unreliable.

         In Clawson, we held that “the admission of a test result that was not in
         compliance with the manufacturer‟s requirements jeopardized the fairness of [a]

8
  55 A.3d 360 (Del. 2012).
9
  State‟s Op. Br. at 22-23.
10
   Id. at 22.
11
   Def.‟s Ans. Br. at 12.
12
   Id. at 14.
                                                    5
         trial.” In Hunter‟s case, using the expired vacutainer tubes in the blood test kit
         was in direct contravention of the manufacturer‟s specification sheet for the
         vacutainer tubes. In Hunter‟s case, shaking the tubes vigorously was in direct
         violation of the manufacturer‟s instructions for use of the kit.

         In accordance with our holding in Clawson v. State, those two independent
         deviations from the manufacturer‟s required protocol, standing alone, each
         rendered the BAC test inadmissible due to the lack of a proper foundation. It was
         an abuse of discretion for the trial judge to deny Hunter‟s motion to suppress the
                                                                                       13
         results of the BAC test. Therefore, Hunter‟s DUI conviction must be reversed.

Straightforwardly, when performing a scientific test, deviations from protocol threaten the test‟s

validity where the result determines a central issue, i.e., a BAC above the legal limit, and it

cannot be based upon unreliable evidence. In that context, there can be no confidence in a jury

verdict or the fairness of a trial.

                                                 V. DISCUSSION

                                             A. Maximum Volume

         From the outset of this litigation, the meaning of the phrase, maximum volume, as stated

in the Kit‟s Instructions, has been the subject of much debate. At the pretrial hearing on

Defendant‟s Motion to Suppress, even though the issue was chain of custody, the Court heard

testimony from Ganly about Defendant‟s blood draw. When asked what maximum volume

meant to her, Ganly replied, “When the blood stops flowing into the tube. It has a vacuum in the
                                                          14
tube that allows the blood to go into the tube.”               Shortly after, when asked how full the blood
                                                                                                                     15
tube needed to be in order to obtain a viable sample, Ganly replied, “At least, up to the label.”

Ganly later testified that a legal blood draw requires ten milliliters but filling the tube with ten

milliliters is not possible because of the rubber stopper. Finally, Ganly explained that although



13
   Hunter, 55 A.3d at 365-66 (Del. 2012) (quoting Clawson v. State, 867 A.2d 187, 191-93 (Del. 2005)).
14
   July 2015 Hr‟g at A-16. Ganly explained that the amount that flows into the tube is the same for every patient.
Interestingly, Willey testified that the amount of blood drawn is patient specific. See infra, at 12.
15
   Id. at A-22.
                                                          6
the tube was designed to draw ten milliliters of blood, the most it could hold was approximately

eight milliliters.

        The Court initially found the State demonstrated compliance as required under Hunter

because the blood tube appeared to be filled all the way. However, upon closer examination, the

tube only appeared full because the sides were stained with blood. In fact, the tube was filled

approximately halfway. Furthermore, during trial, testimony from Whitney Smith (“Smith”), the

DSPCL chemist who tested Defendant‟s blood, revealed further confusion surrounding the

phrase maximum volume. Upon questioning Smith about its meaning, she replied, “I don‟t quite

understand the term, maximum volume.”16                    As a result, Defendant‟s BAC results were

suppressed.

        In its Motion for Reargument, the State argued maximum volume does not mean a full

tube of blood is required for testing, and testimony from Willey, Director of the DSPCL, would

support that contention. Consequently, while the State‟s Motion for Reargument was granted,

the State was required to proffer testimony from the blood tube manufacturer given the holding
            17
in Hunter.       At Defendant‟s April 19, 2016 hearing, the State proffered testimony from BD‟s

vice president and clinical pathologist, Dr. Stankovic.18 Dr. Stankovic explained BD‟s tubes can

hold a maximum of 10.7 milliliters of blood. Also, Dr. Stankovic testified that, concerning BD‟s

tubes, maximum volume means exhausting the vacuum completely “because only then will you

get the correct blood to additive ratio.           And that is important because we guarantee the




16
   July 2015 Hr‟g at B-63.
17
   See Fountain, 2015 WL 6437462, at *2.
18
   At Defendant‟s blood draw, both a Medtronic tube and a BD tube were used. Because both tubes comply with the
same FDA requirements, Dr. Stankovic‟s testimony is applicable to evacuated blood tubes manufactured by
Medtronic as well.
                                                       7
                                                             19
performance of the product in these circumstances.”                In other words, the reliability of the test

result is warranted as scientific tests were done to replicate consistent results.

        During Dr. Stankovic‟s direct examination, the State submitted instructions that BD

sends in every shipment of blood tubes. The instructions include several passages pertinent to

the issue at bar. One such passage, recognizing that limitations of the evacuated blood tube

system exist, states: “The quantity of blood drawn varies with altitude, ambient temperature,
                                                                                            20
barometric pressure, tube age, venous pressure, and filling technique, . . . .”                   Dr. Stankovic

confirmed this notion and explained, “[I]t‟s reasonable to assume that you might not be able to
                                                              21
get nine [m]Ls of blood minimum every single time.”

        The next witness called to testify on behalf of the State was Willey. As Willey began to

testify, it became clear that neither she nor any other current employee of the DSPCL drafted the

Kit‟s Instructions. In fact, Willey testified that the Kit‟s Instructions have remained unchanged

throughout her tenure as Director.22 Defining maximum volume proved to be an elusive affair.

The first time Willey was asked to define maximum volume, she responded, “[T]he maximum

volume is the maximum amount of blood that could be drawn into a specific tube that is utilized
                     23
for a blood draw.”        A few questions later, Willey testified that maximum volume was not a set

amount and was patient specific. In her final attempt to define maximum volume, Willey stated,

“Maximum volume to me means the sufficient amount of sample that can be tested so we can
                                                                                                       24
generate an accurate result and issue a report from the Delaware State Police Crime Lab.”




19
   April Hr‟g at 91.
20
   State‟s Ex. 9 at 2.
21
   April Hr‟g at 99.
22
   The language was developed by an earlier State examiner, however, and not by a manufacturer.
23
   Id. at 148.
24
   Id. at 173.
                                                        8
        Since the meaning of maximum volume was still unclear, additional attempts to define

the phrase were made. At the July 11, 2016 hearing, it was established that Kalin, former

Alabama Chief Toxicologist, drafted the instructions included inside Alabama‟s blood alcohol

evidence collection kit. Similar to Delaware, Alabama‟s instructions use the phrase, maximum

volume. When asked why he chose this language, Kalin explained:

        Because we were a full-service toxicology laboratory, we didn‟t know, when a
        case came in, what we would be doing with a sample. We may just do an ethanol
        determination and a drug screen that would require, oh, just a fraction of a
        milliliter to complete. On the other hand, we may have to do full confirmations,
        quantifications and we might need 10 to 15 milliliters in order to conduct all those
        tests. So the reason for that, [f]ill to maximum volume, is to, at least, have people
        give us enough sample in case we needed to do all the testing we might want to
        do.25

Kalin stated the only reason that he included the phrase maximum volume was to ensure he got

as much blood as possible. He did so because he recognized that tubes would be submitted with

varying volumes of blood. Additionally, he ascribed no weight to Dr. Stankovic‟s testimony that
                                                                                    26
a minimum of nine milliliters is required “[b]ecause that doesn‟t matter.”

        Jones, the State‟s next expert, was also asked to define maximum volume; he stated, “To
                                           27
try to get as much blood as possible.”          He also explained that some patients may have fragile or

collapsed veins which could affect the amount of blood drawn. When Defendant‟s expert, Rose,

was asked the same question, he explained that:

        [M]aximum volume means the amount of the maximum amount of blood that the
        tube will allow to be filled when it‟s collected properly from either an artery or
        vein, depending on what the tube use is for and if the vacuum is lost then the tube
        will not be filled to maximum volume or if the vacuum is intact and for whatever



25
   State v. Fountain, ID No. 1411013133, at 22-23 (Del. Super. July 11, 2016) (TRANSCRIPT) [hereinafter “July
2016 Hr‟g”].
26
   Id. at 100.
27
   State v. Fountain, ID No. 1411013133, at 32 (Del. Super. Aug. 11, 2016) (TRANSCRIPT) [hereinafter “Jones
Hr‟g”].
                                                       9
        reason the blood vessel that the needle is inserted into is not capable of delivering
        enough blood.28

        After reviewing the entire record, although several different interpretations of maximum

volume were proffered, all the interpretations shared a common thread; maximum volume will

vary from patient to patient. Given the number of external factors that could potentially affect

the amount of blood drawn, e.g., altitude, ambient temperature, barometric pressure etc.,

maximum volume will vary and will not be a specific amount each time. In light of that, the

most logical definition of maximum volume, in the context of the Kit‟s Instructions, is enough

blood to produce reliable results. As will be explained, .5 milliliters of blood or more can yield

reliable results. Therefore, maximum volume is satisfied when a phlebotomist, using normal

procedures, collects as much blood as reasonably possible in excess of .5 milliliters.

        Defining maximum volume this way is also supported by the following caveat in BD‟s

instructions:

        Whenever changing any manufacturer‟s blood collection tube type, size, handling,
        processing or storage condition for a particular laboratory assay, the laboratory
        personnel should review the tube manufacturer‟s data and their own data to
        establish/verify the reference range for specific instrument/reagent system. Based
                                                                                        29
        on such information, the laboratory can then decide if a change is appropriate.

Dr. Stankovic explained that this caveat was included to account for factors beyond their control

which could affect the amount of blood drawn.30 She further explained that the laboratory is free

to use the blood tubes to suit their needs so long as the results are validated. The above-

mentioned caveat anticipates end users developing their own instructions and protocol. Because

of this, a sample of blood less than nine milliliters would not be a deviation as contemplated

under Hunter.

28
   State v. Fountain, ID No. 1411013133, at 27 (Del. Super. Aug. 12, 2016) (TRANSCRIPT) [hereinafter “Rose
Hr‟g”].
29
   State‟s Ex. 9 at 4.
30
   April Hr‟g at 94.
                                                      10
        By way of comparison, in Hunter, the tube used for the defendant‟s blood draw was
           31
expired.         The Court found the results to be inadmissible even though the State proffered expert

testimony from a DSPCL chemist establishing that an expired tube would not affect the test‟s
                32                                                                                         33
reliability.         BD‟s instructions explicitly state: “Do not use tubes after their expiration date.”

Unlike the present case, BD‟s instructions do not include a caveat which allows for the use of an

expired tube even if the results are validated.

        Assuming arguendo that maximum volume means an amount between nine and 10.7

milliliters and that obtaining less would be a deviation from protocol, the State has demonstrated

that samples less than nine milliliters are reliable nonetheless. To better understand this, a brief

overview of the testing process is necessary.

                                            B. Blood Alcohol Testing

                                        1. Headspace Gas Chromatography

        Headspace gas chromatography (“HSGC”) is the method used by the DSPCL to analyze

BAC. HSGC measures the amount of gaseous alcohol in the headspace above the sample.

Because alcohol in blood is volatile, it partitions into the headspace above a blood sample in a

unique and consistent manner based on certain temperature and constant pressure. At a given

temperature, the amount of alcohol in the headspace is proportional to the concentration of
                                   34
alcohol in the blood sample.             The gaseous vapor is then introduced into a machine known as a

gas chromatograph. Ultimately, it will permit the calculation of the BAC of the blood sample at

the time of collection.35



31
   Hunter, 55 A.3d at 364.
32
   Id. at 364-66.
33
   State‟s Ex. 9 at 3.
34
   This phenomenon is known as “Henry‟s Law.”
35
   See generally, Harold M. McNair & James M. Miller, BASIC GAS CHROMATOGRAPHY (2d ed. 2009).
                                                       11
        Before the technician can run any tests, however, he or she must prepare the blood

sample. First, using a pipette,36 the technician transports .1 milliliter aliquot37 of blood from the

sample tube into a headspace vial. Next, the .1 milliliter sample is diluted ten times with an

internal standard (the “Dilution Process”). The Dilution Process is done irrespective of whether

the blood tube is full, half full, or barely full.38 It is this step in HSGC process which forms the

basis of the State‟s contention that a sample size of .5 milliliters is all that is required. Support
                                             39
for this notion originated from a paper           published by Jones, one of the State‟s experts. In order
                                                                                                     40
for this scientific evidence to be admissible, however, it must be relevant and reliable.

                                 2. The Dilution Process Under Daubert

        Delaware Rule of Evidence 702, which governs the admissibility of expert testimony or

evidence, provides:

        If scientific, technical or other specialized knowledge will assist the trier of fact to
        understand the evidence or to determine a fact in issue, a witness qualified as an
        expert by knowledge, skill, experience, training or education may testify thereto
        in the form of an opinion or otherwise, if (1) the testimony is based upon
        sufficient facts or data, (2) the testimony is the product of reliable principles and
        methods, and (3) the witness has applied the principles and methods reliably to
        the facts of the case.

D.R.E. 702 is identical to its federal counterpart, and the Delaware Supreme Court has adopted

the United States Supreme Court‟s rulings in Daubert v. Merrell Dow41 and Kumho Tire Co. v.

Carmichael42 “as the correct interpretation of Delaware Rule of Evidence 702.” 43 “Daubert

describes Rule 702‟s „overarching subject [a]s the scientific validity—and thus the evidentiary

36
   A pipette is a laboratory tool commonly used in chemistry to transport a measured volume of liquid.
37
   An aliquot is a portion of a larger whole.
38
   See McNair & Miller, supra note 35 at 141 (2d ed. 2009) (“The internal standard method does not require exact or
consistent sample volumes . . . .”).
39
   A.W. Jones, Blood Analysis by Headspace Gas Chromatography: Does a Deficient Sample Volume Distort
Ethanol Concentration?, 43 MED. SCI. LAW 241, 245 (2003).
40
   D.R.E. 702.
41
   509 U.S. (1993).
42
   526 U.S. (1999).
43
   M.G. Bancorporation, Inc. v. Le Beau, 737 A.2d 513 (Del. 1999).
                                                        12
relevance and reliability—of the principles that underlie the submission.‟ ”44 The trial judge acts

as a gatekeeper to determine whether the expert testimony or evidence is both relevant and

reliable.45

         Evidence is relevant if it relates to an “issue in the case”46 and “assist[s] the trier of fact to

understand the evidence or to determine a fact issue.”47 “To determine reliability under Daubert,

the trial court must consider a non-exhaustive list of factors.”48 Those factors include: (1)

whether the expert evidence or testimony “can be (and has been) tested,” (2) “whether it has

been subject to peer review and publication,” (3) “its known or potential error rate,” and (4)

“whether it has attracted widespread acceptance within a relevant scientific community.”49

While flexible, the focus of a Rule 702 analysis “must be solely on principles and methodology,

not on the conclusions that they generate.”50

         Both Kalin and Jones offered testimony regarding the scientific validity of the Dilution

Process. Since both opinions echo one another, the Court will focus upon Jones‟ testimony.

         Jones qualifies as an expert under D.R.E. 702.51 As one of the preeminent experts on

breath and blood alcohol testing, Jones is qualified by knowledge, skill, experience, training, and

education.52 He obtained a Ph.D. on the subject of measuring alcohol in breath and blood in

1974. Jones also received a Senior Doctorate of Science as a result of his numerous publications

on the subject of forensic alcohol analysis. For thirty years, Jones was a practicing forensic

toxicologist and retired as the head of Sweden‟s toxicology laboratory. Jones is not only a

44
   Tumlinson v. Advanced Micro Devices, Inc., 81 A.3d 1264 (Del. 2013) (emphasis in original).
45
   Id.
46
   Daubert, 509 U.S. at 591.
47
   Id.
48
   Tumlinson, 81 A.3d at 1269.
49
   Daubert, 509 U.S. at 580.
50
   Id. at 595.
51
   For a copy of Jones‟ curriculum vitae, see 1 Fitzgerald, Intoxication Test Evidence § 36.7 (2d ed.).
52
   See 1 Fitzgerald, Intoxication Test Evidence § 22:14 (2d ed.) (regarding Jones as one of the most prolific writers
and researchers in the field of forensic toxicology).
                                                          13
member of numerous professional associations, but also is a frequent presenter on the topic of

blood alcohol analysis. Throughout his career, Jones has testified as an expert in cases all over

the world.

        The evidence and testimony Jones presented is relevant to the facts and would be helpful

in resolving this issue. However, before the Court can accept Jones‟ testimony as scientifically

valid, it must determine if it is reliable.

        At the August 11, 2016 hearing, Jones testified that his research into whether the volume

of the blood sample collected affected the reliability of the results was motivated by a case in

England. In that case, the defendant, who was suspected of driving under the influence of

alcohol, was acquitted after an expert testified that a deficient volume of blood would artificially

increase the BAC detected. Jones disagreed with this conclusion and set out to refute this notion.

        To test his theory, Jones filled ten tubes with an identical amount of alcohol. Then, he

filled the tubes with varying amounts of his own blood to mimic a situation in which the

phlebotomist did not draw a full tube.               Jones testified that the results of this experiment

demonstrated that an over concentration of sodium fluoride in an under-filled tube did not cause

inflated BAC results. In fact, any effects that occurred were in a defendant‟s favor because the

BAC actually decreased.53 However, a decreased BAC only occurred when a sample size of .5

milliliters or less was collected.

        One of the Daubert factors is whether the expert‟s theory can and has been tested. Jones‟

theory can and has been tested. Not only did he test his theory, but his theory was also tested by

other scientists in the field. The study, “Absence of Salting out Effects in Forensic Blood

Alcohol Determination at Various Concentrations of Sodium Fluoride Using Semi-Automated

53
  See, Jones supra note 36 at 246 (“When a deficient volume of blood or urine is sent for determination of ethanol
by [Headspace Gas Chromatography], the drunk driver gains a slight advantage compared with a tube filled with
blood and no excess [sodium fluoride].”).
                                                        14
Headspace Gas Chromatography,” confirmed Jones‟ theory that despite an over concentration of
                                                           54
sodium fluoride, reliable results were still obtainable.

        Another factor of reliability under Daubert is whether the expert‟s methods were subject

to the rigors of peer review and publication. During his testimony, Jones explained that his

article was subjected to peer review and published in a medical journal. While relevant, peer

review and publication is not a sine qua non of admissibility as it does not necessarily correlate

with reliability.55

        In addition, Courts consider the known or potential error rate. Under Jones‟ theory, the

only known error rate is a 2-3% decrease in BAC. However, this only occurs when the volume

of the sample collected is .5 milliliters or less. If the DSPCL were to receive a blood tube with .5

milliliters or less, the specimen would be rejected and not subject to testing.

        Courts also consider whether the scientific theory has gained widespread acceptance in

the relevant scientific community. The article wherein Jones proposed this theory has been cited

numerous times by other experts in the field. Further, Jones, Kalin, and Willey testified that this

theory had gained general acceptance in the scientific community.

        Defendant‟s expert, Rose, was also qualified under D.R.E. 702. However, the Court was

not persuaded by his testimony. First and foremost, Rose recognized the Dilution Process as a

valid technique and conceded that he uses the method and will continue doing so.56 Second,

none of his opinions were supported by documentation. Finally, Rose opined that even if a tube

was filled between nine and 10.7 milliliters, there was still a potential for unreliable results. In

sum, Rose‟s testimony was speculative, contradictory, and unhelpful.

54
   B.A. Miller et al., Absence of Salting out Effects in Forensic Blood Alcohol Determination at Various
Concentrations of Sodium Fluoride Using Semi-Automated Headspace Gas Chromatography, 44 SCI. & JUST. 73, 76
(2004).
55
   Daubert, 509 U.S. at 593.
56
   Rose Hr‟g at 61.
                                                    15
        Essentially, Jones merely reconfirmed the use of the Dilution Process in the sample used

in the chromatograph. Kalin‟s testimony was particularly helpful to explain this situation. This

technique is commonly performed in forensic laboratories. When a tube is filled with varying

amounts of blood, there is the possibility that the preservatives in the tube, namely sodium

fluoride, will be over concentrated. If no precautions are taken, an over concentrated amount has

the potential to cause an over inflated presence of ethanol in the headspace tested in the

chromatograph.57         By diluting the sample taken from the collection tube, potential

inconsistencies caused by the “salting out” process are eliminated.

        Furthermore, if blood collection tubes are filled to nine milliliters or more, the

preservatives introduced by the manufacturer are effective to ensure against contamination and to

prevent enzyme activity that could result in the presence of more ethanol in the blood than was

present at the time of collection. The reference in the literature is the blood-to-additive ratio.

The tube tested, which was manufactured by Medtronic, had no instructions as to quantity. The

BD manual includes a commercial warranty for its tubes when nine or more milliliters of blood

is drawn. As BD‟s expert acknowledged, the guarantee does not mean that, in situations where

less blood is drawn, analytical results were unreliable.

        The sample in Defendant‟s case was clear. There was no clotting or smell that suggests

any red flags. The DSPCL followed the Dilution Process and Jones and Kalin found the

DSPCL‟s procedures appropriate.




57
 See generally A.W. Jones, Determination of Liquid/Air Partition Coefficients for Dilute Solutions of Ethanol in
Water, Whole Blood, and Plasma, 7 J. ANALYTICAL TOXICOLOGY 193 (1983).
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         In passing, the research done in this case indicates that many jurisdictions do not specify

any particular amount of blood that needs to be drawn.58 This reinforces the experience that an

exact amount of blood will not always be drawn in the best of conditions, setting aside the

challenges that blood draws may present in emergency rooms with defendants presenting in

difficult circumstances.        The research also reflects that consideration should be given to

formalize the directions by a regulatory process often done by agency action.59

                                           C. Defendant’s BAC Results

         Although the State has established that .5 milliliters of blood is all that is required for

 reliable BAC results, and that Defendant‟s blood sample was well above that at six milliliters,

 there is evidence in the record which necessitates suppression. At the July 15, 2015 evidentiary

 hearing, Ganly testified as to how she performed the blood draw. The following excerpt is from

 Ganly‟s testimony on cross-examination:

                  Ganly:            I put the needle on the tube and then I put the needle into
                                    his arm, but I cleaned it first.

                  Counsel:          Let me step back. So you cleaned the site?

                  Ganly:            Yes.

                  Counsel:          With—

                  Ganly:            Iodine.

                  Counsel:          And how can you be sure it‟s iodine?




58
   See e.g., Ohio Admin Code. 3701-52-05 (requiring blood to be drawn into a vacuum container without specifying
the volume); Mont. Admin. R. 23.4.220 (requiring samples of “sufficient volume” to provide accurate and
repeatable analyses); Miss. Admin. Code 31-5-2:1753.000 (indicating that a low sample volume will not preclude
testing).
59
   For a complete list of states that have adopted formal blood alcohol testing regulations, see 50 State Regulatory
Surveys: Criminal Laws: Blood Alcohol Testing (2016). Delaware is one of nine states without formal
administrative regulations.
                                                         17
                 Ganly:            I‟m positive it‟s iodine because it leaves a yellow tint to the
                                   skin and I always clean it with the stuff that the State Police
                                   provide us with.

                 Counsel:          So the very next thing is—I wish I had something to use for
                                   demonstration, but—you have the needle part—

                 Ganly:            Mm-hmm.

                 Counsel:          —and the tube. You put the tube on to the needle; is that
                                   what you said, correct?

                 Ganly:            The needle on to the vacuum container.

                 Counsel:          Yes, I‟m sorry. And then you place it into his arm?

                 Ganly:            Yes.60

        Ganly‟s testimony is problematic because puncturing the tube before the needle is in the

arm will not only degrade the vacuum prematurely but also compromise the tube‟s sterility. This

type of exposure could allow in contaminants that cause fermentation which could artificially

inflate BAC results. Ganly later tried to retract her statements. However, Ganly did not use

normal procedures.61 Adherence to these procedures ensures an aseptic collection environment.

Thus, the results were unreliable. Accordingly, the Court finds that the State did not establish a

sufficient foundation to admit the results of Defendant‟s BAC analysis.

                                              VI. CONCLUSION

        Considering the foregoing, Defendant‟s Motion to Suppress is GRANTED.

        IT IS SO ORDERED.




60
  July 2015 Hr‟g at A-24-25.
61
  In a Rule 104(a) determination, the proponent must establish the necessary foundational facts by a preponderance
of the evidence. A judge can consider credibility of evidence. Here, the foundation would need to show by a
preponderance that the needle was first placed in Defendant‟s arm before the stopper on the collection tube was
punctured. See Diana Garza & Kathleen Becan-McBride, PHLEBOTOMY HANDBOOK 337 (8th ed. 2010); see also 45
Am. Jur. Trials 1 § 64 (1992).
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