Texas Commission Reviews Expertox

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TABLE OF CONTENTS

I. COMMISSION BACKGROUND……………………………………………………………...1
A. History and Mission of the Texas Forensic Science Commission…………………….1
B. Commission Jurisdiction……………………………………………………………….1
1. Investigations of Professional Negligence or Professional Misconduct
Resulting from Complaints and Laboratory Self-Disclosures….. ……………..1
2. Accreditation Jurisdiction……………………………………………………...2
3. Licensing Jurisdiction………………………………………………………….2
C. Jurisdiction Applicable to this Complaint…………….………………………………..3
D. Limitations of this Report………….………………..…………………………………5
II. BACKGROUND AND SUMMARY OF THIS COMPLAINT……………………………….5
A. Complaint and Investigative Decision by the Commission…………..………………..5
B. Summary of the Complaint…….………………………………………………………6
C. Initial Response by Dr. Lykissa and his Pre-Investigation Appearance at the Texas
Forensic Science Commission Meeting January 29, 2021……..………………………7
D. Second “Forensically Validated” Report………………………………………………9
E. Facts of Underlying Criminal Investigation…………………..………………………10
III. INVESTIGATION………………………………………………………………………….11
A. Initial Document Request from the Commission to ExperTox………………………..11
B. Documents Reviewed and Interview Request…………………………………………12
C. Interview of Dr. Lykissa………..……………………………………………………...12
IV. ROHRIG REPORT FINDINGS AND OBSERVATIONS……….…………………………13
A. Expert Report Background….………………………………………………………...13
B. GHB Result…….……………………………………………………………………..14
C. Lidocaine Result……….……………………………………………………………...14
1. After-the-Fact Linearity Study (Lidocaine)……………………………………15
2. General Validation Issues……………………………………………………...16
D. THC Result……………….…………………………………………………………..16
E. Interpretive Toxicology Report…………..…………………………………………...16
F. Non-forensic v. Forensic Report………………………………………..…………….17

i
V. COMMISSION FINDINGS………………………………………………………………….19
A. Texas Licensing Requirement for Forensic Analysts……...…………………………19
B. Determination Regarding Professional Misconduct or Professional Negligence..…...20
C. Professional Negligence Finding: Lykissa Knowingly Performed Forensic
Analysis without a Forensic Analyst License………………………………………....21

D. Professional Misconduct Finding: Testing Report(s) and the Interpretive


Toxicology Report Lack Scientific Foundation………………..…….……………….22

E. Professional Negligence Finding:Against Dr. Lykissa for Charging Extra for a………..
“Forensic” Version of a Report Issued for Clinical Purposes…………………….…..24

VI. EXPERTOX CORRECTIVE MEASURES FOLLOWING THE COMMISSION…………


INVESTIGATION………………………………………………………………………..26

VII. COMMISSION CHANGE IN CAP ACCREDITATION RECOGNITION…………….26

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EXHIBIT INDEX

A. ExperTox Original Hair Analysis Report

B. ExperTox Interpretive Report

C. NMS Full Report on ExperTox Analysis

D. Link to January 2021 TFSC Quarterly Meeting

E. Affidavit of Rachel L. Black

F. ExperTox “Forensic” Hair Analysis Report

G. Letter dated March 22, 2021 from Smith to Lykissa Requesting Responses

H. ExperTox Response to March 22, 2021 Letter from Smith

I. List of Material Reviewed by TFSC for Complaint No. 20.55

J. CV of Dr. Timothy Rohrig, updated April 2023

K. Dr. Timothy Rohrig’s Final Report on ExperTox Analysis

L. ExperTox Baseline Hair Testing SOP

M. Transcript of Lykissa Testimony at January 29, 2021 Quarterly Meeting

N. Society of Forensic Toxicologists (SOFT) Guiding Principles of Professional


Responsibility

O. ExperTox Invoices to ARCPoint

iii
I. COMMISSION BACKGROUND

A. History and Mission of the Texas Forensic Science Commission

The Texas Forensic Science Commission (“Commission”) was created during the 79th

Legislative Session in 2005 with the passage of HB-1068. The Act amended the Code of Criminal

Procedure to add Article 38.01, which describes the composition and authority of the

Commission.1 During subsequent legislative sessions, the Texas Legislature further amended the

Code of Criminal Procedure to clarify and expand the Commission’s jurisdictional responsibilities

and authority.2

The Commission has nine members appointed by the Governor of Texas. 3 Seven of the

nine commissioners are scientists or medical doctors and two are attorneys (one prosecutor

nominated by the Texas District and County Attorney’s Association and one criminal defense

attorney nominated by the Texas Criminal Defense Lawyer’s Association). 4 The Commission’s

Presiding Officer is Jeffrey Barnard, MD. Dr. Barnard is the Chief Medical Examiner of Dallas

County and Director of the Southwestern Institute of Forensic Sciences in Dallas.

B. Commission Jurisdiction

1. Investigations of Professional Negligence or Professional Misconduct


Resulting from Complaints and Laboratory Self-Disclosures

Texas law requires the Commission to “investigate in a timely manner, any allegation of

professional negligence or professional misconduct that would substantially affect the integrity of

the results of a forensic analysis conducted by crime laboratory.” 5 The term “forensic analysis” is

1
TEX. CODE CRIM. PROC. art. 38.01.
2
See e.g., Acts 2013, 83rd Leg. ch. 782 (S.B. 1238) §§ 1-4 (2013); Acts 2015, 84th Leg. ch. 1276 (S.B. 1287) §§ 1-7
(2015); TEX. CODE CRIM. PROC. art 38.01 § 4-a(b).
3
TEX. CODE OF CRIM. PROC. art. 38.01 § 3.
4
Id.
5
TEX. CODE CRIM. PROC. art. 38.01 § 4(a)(3)(A).

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defined as a medical, chemical, toxicological, ballistic, or other examination or test performed on

physical evidence, including DNA evidence, for the purpose of determining the connection of the

evidence to a criminal action.6 The statute excludes certain types of analyses from the “forensic

analysis” definition, such as latent print analysis, a breath test specimen, and the portion of an

autopsy conducted by a medical examiner or licensed physician. 7

Crime laboratories must also report professional negligence or professional misconduct to

the Commission.8 The statute does not define the terms “professional negligence” and

“professional misconduct.” The Commission has defined those terms in its administrative rules. 9

2. Accreditation Jurisdiction

The Commission is charged with accrediting crime laboratories and other entities that

conduct forensic analyses of physical evidence for use in criminal proceedings. 10 The term “crime

laboratory” includes a public or private laboratory or other entity that conducts a forensic analysis

subject to the statute.11

3. Licensing Jurisdiction

Under Texas law, a person may not act or offer to act as a forensic analyst unless the person

holds a Forensic Analyst License issued by the Commission.12 While accreditation is granted to

the entities that perform forensic analysis, licensing is a credential obtained by the individuals who

practice the forensic analysis. The licensing program took effect on January 1, 2019.

6
TEX. CODE CRIM. PROC. art. 38.35(a)(4).
7
See, TEX. CODE CRIM. PROC. art. 38.35 (a)(4)(A)-(F) and (f) (for a complete list of statutory exclusions).
8
TEX. CODE CRIM. PROC. art. 38.01 § 4(a)(1)-(2). (Additionally, pursuant to the Forensic Analyst Licensing
Program Code of Professional Responsibility, members of crime lab management shall make timely and full disclosure
to the Texas Forensic Science Commission of any non-conformance that may rise to the level of professional
negligence or professional misconduct.) See, 37 Tex. Admin. Code § 651.219(c)(5) (2018).
9
37 Tex. Admin. Code § 651.302 (7) and (8) (2020).
10
TEX. CODE CRIM. PROC. art. 38.01 § 4-d(b).
11
TEX. CODE CRIM. PROC. art. 38.35 § (a)(1).
12
TEX. CODE CRIM. PROC. art. 38.01§ 4-a(b); 37 Tex. Admin Code § 651.201(c) (2018).

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The law defines the term “forensic analyst” as “a person who on behalf of a crime

laboratory [accredited by the Commission] technically reviews or performs a forensic

analysis or draws conclusions from or interprets a forensic analysis for a court or crime

laboratory.13 Pursuant to its licensing authority, the Commission may take disciplinary

action against a license holder or applicant for a license on a determination by the

Commission that a license holder or applicant for a license has committed professional

misconduct or has violated Texas Code of Criminal Procedure Article 38.01 or an

administrative rule or other order by the Commission.14 If the Commission determines a license

holder has committed professional misconduct or has violated an administrative rule or order by

the Commission, the Commission may: (1) revoke or suspend the person’s license; (2) refuse to

renew the person’s license; (3) reprimand the license holder; or (4) deny the person a license. 15

The Commission may place on probation a person whose license is suspended.16 Disciplinary

proceedings and the process for appealing a disciplinary action by the Commission are governed

by the Judicial Branch Certification Commission. 17

C. Jurisdiction Applicable to this Complaint.

The subject laboratory, ExperTox, Inc. (“ExperTox”) and the individual analyst, Dr. Ernest

Lykissa, (“Dr. Lykissa”), which are the subject of this complaint and investigation, were subject to

the Commission’s investigative, accreditation and licensing jurisdiction described above.

At the time of the forensic analysis that is the subject of this complaint and investigation

and during the course of the Commissions’ investigation in this matter, ExperTox was accredited

13
TEX. CODE CRIM. PROC. art. 38.01 § 4-a(a)(2).
14
TEX. CODE CRIM. PROC. art. 38.01 § 4-c; 37 Tex. Admin Code § 651.216(b) (2019).
15
Id. at 651.216(b)(1)-(4).
16
Id. at (c).
17
TEX. CODE CRIM. PROC. art. 38.01 § 4-c(e); 37 Tex. Admin. Code § 651.216(d) (2019).

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by the College of American Pathologists (“CAP”) under CAP’s Forensic Drug Testing Program,

a Commission-recognized accrediting body, and Dr. Lykissa served in the role of Vice President,

and Laboratory Director at ExperTox in Deer Park, Texas (the location where the forensic analysis

that is the subject of this complaint and investigation occurred). 18

On or about and between October 2—October 24, 2019, ExperTox performed the hair

analysis that is the subject of this report. Dr. Lykissa subsequently authored an interpretive opinion

regarding the hair analysis. Since the Commission’s investigation in this matter, ExperTox has

undergone significant changes in leadership and has changed the focus and scope of its laboratory

work, including accepting Dr. Lykissa’s resignation and hiring a new Laboratory Director and

Quality Director. ExperTox hired Dr. James Bourland, Ph.D., F-ABFT, NRCC-TC as the new

Laboratory Director on October 5, 2022. In addition, ExperTox created and filled the position of

Quality Supervisor to oversee validation studies, quality management and quality assurance

programs at the laboratory.

Dr. Lykissa never obtained his full forensic analyst license by the Commission at any time

relevant to this complaint, although he was allegedly performing forensic analysis and required to

be licensed prior to November 9, 2022, the date the Commission removed CAP as an accrediting

body. The Commission granted Dr. Lykissa a provisional license in the discipline of Toxicology

18
Effective November 9, 2022, the Commission withdrew its recognition of the national accrediting bodies CAP and
the Substance Abuse and Mental Health Services Administration (SAMHSA) for accreditation of crime laboratories
performing forensic analysis in criminal actions. As a result of the Commission’s withdrawal of recognition of CAP
and SAMHSA as accrediting bodies, ExperTox and four other Texas-accredited laboratories who were solely
accredited by CAP’s Forensic Drug Testing program were no longer recognized by the Commission to perform
forensic analysis for criminal actions (effective 11/9/2022) or were otherwise already exempt from accreditation and
licensing requirements in Texas. The Commission found the testing performed by CAP and SAMHSA laboratories
is typically not initiated for the principal purpose of determining the connection of physical evidence to a criminal
action, but rather is within contexts such as community supervision, clinical, medical practice or other purposes
unrelated to determining the connection of physical evidence to a criminal action. See, Section VII. of this report for
further description on the accreditation program changes. Neither CAP, SAMHSA, nor any of the affected laboratories
filed comments or otherwise objected to Commission’s rulemaking removing these accreditation programs.

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(Interpretive) on February 10, 2021, shortly after it discussed this complaint at the Commission’s

January 2021 quarterly meeting. Dr. Lykissa’s provisional license expired on February 9, 2022.

After the expiration of his provisional license, Dr. Lykissa completed a statistics course which is

required for full licensure. However, the course was insufficient to satisfy the requirement,19 and

this precluded Dr. Lykissa from obtaining a forensic analyst license.

D. Limitations of this Report

The Commission’s authority contains important statutory limitations. For example,

no finding by the Commission constitutes a comment upon the guilt or innocence of any

individual.20 The Commission’s written reports are not admissible in civil or criminal actions nor

does the Commission have the authority to subpoena documents or testimony. 21 Information the

Commission receives during any investigation is dependent upon the willingness of stakeholders

to submit relevant documents and respond to questions. The information gathered in this report is

not subject to the standards for admission of evidence in a courtroom. For example, no individual

testified under oath, was limited by either the Texas or Federal Rules of Evidence (e.g., against the

admission of hearsay) or was subject to cross-examination under a judge’s supervision.

II. BACKGROUND AND SUMMARY OF COMPLAINT

A. Complaint and Investigative Decision by the Commission

This report contains observations and recommendations regarding a complaint filed by

Assistant District Attorney Carrie Wood (“ADA Wood”), formerly a member of the Conviction

Integrity Unit of the Philadelphia District Attorney’s Office. The Commission accepted the

19
A three-semester credit hour (or equivalent) college-level statistics course is required by any applicant who applied
for licensure after January 1, 2019. The course Dr. Lykissa submitted for approval included less than the required
credit hours.
20
Id. at § 4(g) (2019).
21
Id. at § 11 (2019).

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complaint for investigation and formed an investigative panel at its January 29, 2021 quarterly

meeting. The Investigative Panel consists of Sarah Kerrigan, Ph.D., Nancy Downing, Ph.D., Mark

Daniel, Esq., and Brazos County Elected District Attorney Jarvis Parsons, Esq.

B. Summary of the Complaint

The complaint alleges that ExperTox, through an intermediary collection laboratory in

Philadelphia named Arcpoint, was engaged to conduct hair testing as part of an investigation into

sexual assault allegations and the potential pursuit of criminal charges. ExperTox produced a

laboratory report containing results of hair testing and a written interpretive report providing Dr.

Lykissa’s opinion on the pharmacological effects of detected substances. According to the

complaint, the Assistant District Attorney assigned to the criminal investigation, Rachel Black

(“ADA Black”), became concerned with quality and reliability of ExperTox’s work based on

telephone conversations with Dr. Lykissa, and contacted ADA Wood regarding her concerns.

ADA Wood instructed ADA Black to obtain documents regarding the analysis from ExperTox and

submit them to another laboratory, NMS Labs, Inc. in Horsham, Pennsylvania, for review. NMS

Labs, Inc. is also subject to the Commission’s jurisdiction, with laboratory facilities in

Pennsylvania and Texas.

The original ExperTox hair analysis report (“Original Report”) dated October 25, 2019,

was submitted to the Commission with ADA Wood’s complaint. ExperTox reported detecting

delta-9-tetrahydrocannabinol (THC) and lidocaine in the hair of the survivor. Of particular note,

the original hair analysis report contained a caveat statement that read: “Results are for CLINICAL

USE ONLY, NOT FOR FORENSIC PURPOSES.” (See, Exhibit A, ExperTox Original

Report.) The complaint also included a letter report (“Interpretive Toxicology Report”) dated

February 25, 2020, in which Dr. Lykissa provided the statement: “It is my professional opinion

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that these amounts of THC and lidocaine detected in [the survivor’s] hair, constitute evidence of

potential combined enhanced pharmacological effect to her ability to control her Mental and

Physical faculties. If these drugs were administered to her without her consent, then that could

constitute a drug facilitated assault by the perpetrator.” (See, Exhibit B, ExperTox Interpretive

Report.)

The complaint also included a draft report of observations by expert toxicologist Dr. Sherri

Kacinko from NMS Labs that strongly criticized various aspects of the testing, reports, and

statements made by Dr. Lykissa in the case. (See, Exhibit C, NMS Report.)

C. Initial Response by Dr. Lykissa and his Pre-Investigation Appearance at the


Texas Forensic Science Commission Quarterly Meeting January 29, 2021.

On January 12, 2021, Commission staff notified Dr. Lykissa of the complaint via email,

providing him a copy of the complaint and corresponding attachments. On January 13, 2021, Dr.

Lykissa responded by email stating it “is with great surprise” that he received notification from

the Commission that the Commission was involved in a case that “was clearly labeled as Only for

Clinical Purposes and not Forensic.” In the email reply, he further stated his intention to be

virtually present for the Commission’s hearing to discuss the complaint.

Dr. Lykissa appeared via Zoom at the quarterly Commission meeting held on January 29,

2021. (See, Exhibit D, Link to Quarterly Meeting Video.) In his statements at the Commission’s

meeting, Dr. Lykissa said he told prosecutors ExperTox did not have a validated method for

detecting lidocaine in hair, so any results would only indicate the presence of the substance, but

not the quantity. Dr. Lykissa stated the testing was positive for the presence of lidocaine, but that

he conducted the testing using “…a clinical method.”

Dr. Lykissa told the Commission that the baseline portion of the hair detected no THC and

a small amount of lidocaine, and that the portion of the hair tested for the presence of drugs detected

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THC and lidocaine. He further stated that he told the prosecutor, “I do not want to testify in this

case. I cannot offer you anything scientifically valid,” and claimed he stressed to the prosecutor to

“please read the caveat I bolded for you” that stated, “Results are for CLINICAL USE ONLY,

NOT FOR FORENSIC PURPOSES.” Lykissa and ADA Black’s respective recollection of events

differ. (See, Exhibit E, ADA Black Affidavit.)

During the meeting, the Commission’s General Counsel read Dr. Lykissa an excerpt from

the ExperTox Interpretive Report dated February 25, 2020, signed by Dr. Lykissa, that relayed his

professional opinion that the “amounts of THC and lidocaine detected in [the survivor’s] hair,

constitute evidence of potential serious combined enhanced pharmacological effect on her ability

to control her mental and physical faculties. If these drugs were administered to her without her

consent, then that could constitute a drug facilitated assault by the perpetrator.”

After some discussion of his overall experience and expertise in forensic toxicology and

pharmacology, Dr. Lykissa stated, “as far as I am concerned, this test should not have been

used…even though I wrote the report.”

Dr. Lykissa also stated that initially he was unaware the testing was requested in connection

with a criminal action because he received it from a collector, Arcpoint Laboratory in Philadelphia,

and was not informed about the purpose of the testing. The testing requested was described as a

“date rape panel” pursuant to court order, which should at least flag the possibility the request was

in the context of a criminal proceeding. To the extent there was a question, Dr. Lykissa’s

subsequent communications with the prosecutor removed all ambiguity. Indeed, until recently

ExperTox’s own website made the following claim: “Law enforcement, criminal justice and legal

professionals have found their single source forensic toxicology solution in ExperTox.”22 [The

22
https://www.expertox.com/html/services/legal.php (last accessed July 8, 2022).

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website’s express representation that criminal justice stakeholders were a key part of ExperTox’s

client base undermines Dr. Lykissa’s assertions that the laboratory’s testing sometimes “ended up”

in criminal proceedings, but that this was unbeknownst to him.]

The Commission notes the ExperTox website no longer makes the claim referenced above.

The current website emphasizes the purpose of the laboratory’s test results and removes confusion

about the purpose of the testing being criminal forensic analysis, viz: “ExperTox’s test results may

exclusively be used for diagnostic, clinical, or civil purposes. Nothing in our test results constitute

forensic analyses for use in criminal matters.”

D. Second “Forensically Validated” Report

At the time of Dr. Lykissa’s January 2021 quarterly meeting appearance, the Commission

was unaware that ExperTox produced a second version of the original report and subsequently

provided it to the District Attorney’s Office. Shortly after Dr. Lykissa’s appearance, however, the

Commission learned that the laboratory produced a “forensically validated” or “court admissible”

version of the Original Report for an additional fee.23 The District Attorney’s Office provided a

copy of the second “forensically validated” report to Commission staff. Commission staff closely

examined the second report and determined the only difference between the Original Report and

the second version was the omission of the phrase “CLINICAL USE ONLY, NOT FOR

FORENSIC PURPOSES.” (See, Exhibit F: ExperTox “Forensic” Report.) All other

information contained in the Original Report and second, “forensically validated” report, including

the dates of analysis, are identical. Both the Original Report and the “Forensic” Report include a

representation that the results were reviewed by Dr. Lykissa and another ExperTox analyst.

23
On February 1, 2021, Dr. Kacinko emailed ADA Black indicating she watched Dr. Lykissa’s appearance at the Jan.
2021 Commission quarterly meeting. She noted there was an additional ExperTox report without the disclaimer that
Lykissa did not mention.

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E. Facts of Underlying Criminal Investigation

Law enforcement arrested the suspect, a former Philadelphia police officer, in the

underlying criminal investigation on September 27, 2019, and charged him with sexual assault. In

a bail motion hearing on October 17, 2019, the prosecutor announced to the court a pending hair

analysis due to survivor allegations of drugging by the defendant.

In the next hearing on November 1, 2019, the prosecution stated the video of the episode

depicted a “visibly altered woman” and that a hair test dated October 25, 2019, “was positive for

more than one drug the complaining witness did not voluntarily consume.” The prosecutor noted

that one of those drugs (lidocaine) was found in a bottle in the suspect’s nightstand during a search

of his home. Based upon ExperTox’s hair test results, the prosecutor announced her intention to

amend the charges to include a more serious allegation of “rape by the administration of drugs and

intoxicants to the complainant without her knowledge for the purpose of preventing resistance,” a

first-degree felony.24

The court held a preliminary hearing on the case on January 15 and 16, 2020. During that

hearing, an investigating officer testified to finding a bottle of lidocaine in the suspect’s bedroom

nightstand. The prosecutor then offered the ExperTox “forensically validated” report and certified

in good faith that she would have a doctor testify to relevance of the scientific data at trial. As

noted, this version of the analytical report omitted the caveat “for clinical use only, not for forensic

purposes.”

The prosecutor stated the government’s theory was that, based on the hair test results, “the

defendant gave [the victim] THC in addition to the lidocaine.” The prosecutor acknowledged that

24
See, 18 Pa. C.S. § 3121(a)(4), A person commits a felony of the first degree when the person engages in sexual
intercourse with a complainant, “where the person has substantially impaired the complainant’s power to appraise or
control his or her conduct by administering or employing, without the knowledge of the complainant, drugs,
intoxicants or other means for the purpose of preventing resistance.”

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lidocaine is not typical in sexual assault cases (unlike GHB) but stated that this fact does not bar

prosecuting the defendant “if he put that in her drink, if he put that on a [sex toy] without her

knowledge and it increased her level of intoxication.”

The record indicates that the incident being prosecuted in the case was videotaped and,

following its viewing at the preliminary hearing, the court dismissed the charges for lack of

evidence.

III. INVESTIGATION

A. Initial Document Request from the Commission to ExperTox

On March 22, 2021, Commission staff requested Dr. Lykissa’s response to certain

questions regarding the frequency and content of ExperTox’s reports utilized in criminal

proceedings. Staff also requested a list of controlled substances for which ExperTox offers hair

analysis. (See, Exhibit G, Letter to Dr. Lykissa 3.22.21.) On March 29, 2021, Lykissa provided

the requested information. (See, Exhibit H, ExperTox Response to TFSC 3.29.21.) ExperTox

did not answer the questions directly:

For example, in the Wood Carrie case in Philadelphia, the DA asked me to testify on
this case for which I declined since the test had been performed for Clinical Use only.
The reason been [sic] that we did not have a Forensically validated hair testing
method for Lidocaine at this time, only for clinical testing. Then the DA literally
begged me to write something down hypothetically for the Lidocaine and THC
combined effect on someone’s mental state which reluctantly I did (my wrong
decision) sent her the standard report I issue to the Medical Centers in the Houston
area to Medical Doctors handling critical care patients. I also recall telling her that
the Lidocaine detected in the baseline segment was disproving the claim of the
plaintiff that the Lidocaine was administered by the defendant. Only the THC was
pertinent. I also advised her to talk to NMS for supportive testimony. The complaint
was filed with your Commission by the Defense Attorney who demanded from my
assistants, for me to consult with her which I declined.

B. Documents Reviewed and Interview Request

The Panel and Commission staff interviewed several witnesses, including:

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1. Rachel Black, the former Assistant District Attorney assigned to investigate and
prosecute the underlying criminal case.

2. Dr. Sherri Kacinko, a forensic toxicologist at NMS Labs, who was retained by the
District Attorney’s Office to examine the data underlying ExperTox’s report.

3. Dr. Khushroo Shroff, President and CEO of Arcpoint Laboratory in Philadelphia, a


facility used for the collection of the specimens used in the ExperTox analysis.

4. Dr. Ernest Lykissa, a toxicologist at ExperTox Laboratories in Deer Park, unlicensed


by the Commission at the time of the subject analysis of this complaint.

Commission staff reviewed various documents, correspondence, and transcripts of court

hearings (See, Exhibit I, List of Documents Reviewed.)

C. Interview of Dr. Lykissa

On July 12, 2022, Commission staff and the investigative panel members interviewed Dr.

Lykissa.25 He acknowledged the lidocaine results (3.9 pg/mg) were reported despite being well

below the laboratory SOP reporting cut-off of 100 pg/mg. He also acknowledged the single point

calibration used in the analysis violated the laboratory SOP requiring a five-point calibration curve

and admitted the single point calibration was not a scientifically valid method for obtaining a

quantitative result. Dr. Lykissa also discussed the laboratory’s prior validation of the method and

the lack of validation studies supplied despite numerous prior requests by the Commission. 26 After

the interview, a representative from ExperTox submitted a document entitled “Lidocaine Analysis

in Pharma Samples,” however, this document is not a validation study. To date, Dr. Lykissa has

not submitted any relevant validation studies for lidocaine performed before the hair testing was

25
Just prior to the interview, Dr. Lykissa was discharged from an eleven-day stay at Memorial Hermann Southeast
for treatment of residual health effects of a recent coronavirus infection, including acute atrial fibrillation, radiation
treatment, and sepsis. Dr. Lykissa was still convalescing at the time of the interview and was later re-admitted to
Memorial Hermann Southeast for the same medical concerns on August 4, 2022.
26
Before the interview, ExperTox submitted a 2017 and a 2018 “Acquisition Method Report” related to Agilent
Technologies’ “Masshunter” software as purported validation studies. Commission staff has repeatedly informed
ExperTox of the legal requirement that staff be copied on all substantive communications with the laboratory’s
accrediting body. As of this writing, ExperTox has yet to confirm that all required information has been provided.

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reported in this case. In response to a recent request from CAP, ExperTox provided documentation

purporting to relate to validation of hair analysis for lidocaine. However, the information provided

to CAP is incomplete and the validation summary is dated well after the testing discussed in this

report (June 30, 2022).

Dr. Lykissa maintained his original report with the “Clinical Use Only” caveat was

utilized because the request was not clearly forensic, despite being “Court Ordered” for a “Date

Rape.” The caveat was removed after discussions with the prosecutor, so it was clear at that time

it was to be used in connection with a criminal action. Dr. Lykissa admitted he was not licensed

by the Commission when any of the ExperTox reports in the Philadelphia case were issued.

IV. ROHRIG REPORT FINDINGS AND OBSERVATIONS

A. Expert Report Background

At its July 16, 2021 quarterly meeting, the Commission voted to retain forensic toxicology

expert Dr. Timothy Rohrig to review the case and issue a written report detailing his observations

and expert opinion on the complaint in this investigative matter. 27 (“Rohrig Report”). (See, Exhibit

K, Rohrig Report.)

The Commission provided Dr. Rohrig with all documentation supplied by ExperTox

during the investigation. Staff intentionally omitted the NMS report from materials sent to Dr.

Rohrig. All observations set forth in this report are the independent impressions of Dr. Rohrig,

based upon ExperTox’s records and reports provided to the Commission.

27
Dr. Rohrig is a forensic toxicologist who provides expert consultant services in forensic toxicology to a variety of
stakeholders in the criminal justice system. (See Rohrig CV at Exhibit J.) He is not a forensic practitioner employed
by an accredited crime laboratory in Texas, and thus he is neither required to be, nor is he eligible for, licensure under
Texas law. See, Tex. Code Crim. Proc. Art 38.01.

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After review of all materials provided to him, Dr. Rohrig’s expert opinion was that the

toxicology report should never have been issued, and that the “expert opinion” contained in the

interpretive toxicology report was not founded in or supported by current scientific literature.

A detailed description of Dr. Rohrig’s most pertinent findings and observations is outlined

below. As a threshold matter, Dr. Rohrig found the overall evaluation of the data challenging due

to illegible “screen shots” of sequence tables, poor quality chromatograms with difficult to read

numerical values, and the absence of key raw data (e.g., area counts of ions) provided by

ExperTox.

B. GHB Result

Dr. Lykissa reported Gamma-hydroxybutyrate (“GHB”) was detected at a concentration of

less than 50 pg/mg of hair. The analysis was conducted October 6-14, 2019. Dr. Rohrig’s review

revealed the following:

• Records for the GHB batch log do not indicate the GC/MS instrument used for the
analysis.

• GHB results reflected on the handwritten batch log was ZERO, as compared to the
reported result of “Detected” less than 50 pg.mg (suggesting the compound was
detected above the limit of detection (LOD) but below the limit of quantification
(LOQ) of 50 pg/mg).

• The GHB reported result of “Detected <50 pg/mg” is therefore in conflict with the
“ZERO” written on the confirmation batch log.

C. Lidocaine Result

Dr. Lykissa reported lidocaine was detected at 3.9 pg/mg of hair (with a baseline detection

at 0.43). The analysis was conducted October 16-24, 2019. Dr. Rohrig’s review revealed the

following:

• The effective date for the lidocaine Standard Operating Procedure (“SOP”) was
October 30, 2019, five days after the original testing was completed and the original

Page 14
report published. It therefore appears that the analytical work was performed under
an unapproved SOP.

• The laboratory’s SOP for lidocaine provided that a 5-point calibration curve,
including the origin, should be generated for each client sample. Instead, the
laboratory used a single point calibrator. This is not a forensically acceptable
method to produce a quantitative value.

• Dr. Lykissa did not follow the laboratory’s reporting criteria. Both case and
baseline samples should have been reported out as NEGATIVE, since both are
below the apparent LOD/LOQ of the method (as established in an after-the-fact
“Lidocaine Linearity Study” performed by ExperTox, discussed below).

• The laboratory did not validate the lidocaine method as required by CAP and
pursuant to proper forensic laboratory practice. Even though the reports state the
test was developed and validated by ExperTox, the laboratory used an assay that
had no validation, or any evidence indicating establishment of any validation
parameters for the batch containing the relevant case sample.

• Given the poor quality of the produced data and apparent missing key data points,
i.e., ion abundance, it is not possible to assess whether the ion ratios are acceptable
according to practice in forensic toxicology. The SOP states they must be within
+/-30%; the printout suggests they are. However, the +/-30 % may not be acceptable
given the abundances of the two ions are unknown.

• In both confirmation batches (case and baseline samples) the calibrators appear to
be overloaded. Additionally, neither of these batches analyzed QC samples.

1. After-the-Fact Linearity Study (Lidocaine)

Though the Commission requested the applicable validation study, the laboratory produced

a “Linearity Study” performed well after reported results in the case. The submitted study appears

to have been performed on LCMS#4 on or about September 10, 2021.

Several issues were noted with the “Linearity Study” including:

• The calibration curve did not include the origin, contrary to the SOP.

• Evaluation of the 100 pg/mg calibrator exhibited poor chromatography of the


transition ion with a significant trailing shoulder (~50%).

• The Linearity Study was not signed off on for acceptance and/or approval in case
work.

Page 15
Even assuming acceptable chromatography (which it is not), the Limit of Detection

(“LOD”) and Limit of Quantitation (“LOQ”) would be the lowest calibrator of 100 pg/mg. Results

of this study should have been rejected. But even setting this point aside, the LOD/LOQ for the

assay is 100pg/mg. Results reported in the instant case are far below the established limits of the

assay even according to the “Linearity Study” conducted after-the-fact.

2. General Validation Issues

Additionally, the study did not address other important parameters of a properly validated

method such as the precision and accuracy of the method, bias in the method, interference with

other compounds, and the ion suppression/enhancement in the LCMS method (matrix effects).

D. THC Result

The laboratory reported delta 9-THC was detected at 7.5 pg/mg of hair (not detected in the

baseline). Dr. Rohrig’s review revealed the following:

• The validation study did not have any supporting data for determination of accuracy
and precision of the method.

• The validation study lacked key components for a forensically accepted study,
specifically bias in the method, interference with other compounds, and the ion
suppression/enhancement in the LCMS method (matrix effects).

• Lykissa reported a quantitative result, with poor identification data for the case
sample.

• It is unclear what acceptable range for controls were utilized.

E. Interpretive Toxicology Report by Dr. Lykissa

The Interpretive Toxicology Report dated February 25, 2020, issued by Dr. Lykissa states:

“It is my professional opinion that these amounts of THC and Lidocaine detected in Ms. [redacted]

hair, constitute evidence of potential serious combined pharmacological effect to her ability to

control her Mental and Physical faculties.”

Page 16
Even assuming there were reliable data to indicate that THC and lidocaine were actually

present in the sample, the interpretation provided by Dr. Lykissa regarding impairment of the

complainant was not scientifically valid. THC may have a cognitive impact while the individual

is acutely intoxicated. The presence of a drug(s) in a hair sample, however, only indicates general

exposure to the drug and cannot be directly associated with intoxication on any particular day.

Lidocaine is a local anesthetic and antiarrhythmic drug and is generally not known for its

intoxicating or impairing effects. 28 It generally has low bioavailability, approximately 35%.

Therefore, with oral administration most of the drug will not reach systemic circulation and will

have little to no central effect. At high systemic intravenous (IV) doses, this medication may cause

some adverse side effects including dizziness, confusion, and loss of consciousness. The incidence

of CNS toxicity (i.e., depression) is dose-dependent and quite rare, with reported frequency of less

than 1% following IV administration. A review of the relevant scientific literature does not suggest

any clinically relevant potentiation, additive, or synergistic effect(s) of lidocaine with the co-

administration of THC.

F. Non-Forensic Report v. Forensic Report

On August 27, 2021, the Commission requested ExperTox’s policy related to the use of

the disclaimer language “Results are for CLINICAL USE ONLY, NOT FOR FORENSIC

PURPOSES.” On March 29, 2021, Dr. Lykissa responded that the statement “is used as a

disclaimer for establishing the validity of our published results only for the clinical practice that

28
An isolated report suggests that lidocaine has been used to facilitate sexual assault [Suchan and Adamowicz
2013]. Fathy et al [2019] suggest that IV lidocaine may cause post-operative cognitive impairment. In commenting
on Fathy et al [2019], van der Veen and Slagt [2019] states that the post-operative cognitive dysfunction is not due
to the anesthetic technique or drug, but patient characteristics, such as age and frailty. The presence of lidocaine
may be due to the sexual assault examination [coating of the speculum with lidocaine], topical treatment of minor
injuries sustained in the time frame in question, and/or as a lubricant used during the alleged assault.

Page 17
originally ordered these test reports…since they were not performed with forensic criteria. (i.e.,

valid forensic chain of custody, forensically validated methods).” (See, Exhibit L, ExperTox SOP

Response.)

On September 16, 2021, representatives from ExperTox produced an SOP for Non-

Forensic v. Forensic Reporting, purportedly signed by Dr. Lykissa on September 8, 2018, that

states in pertinent part:

“In our laboratory we find ourselves very often in situations where once we test a
sample for exclusively clinical use, the results of such a test become legally
significant and we are asked to elevate the status of a test from a clinical to a
forensic, court defensible evidence. Herein will be an attempt to address the
complexity that ensues once the drug test results become a legal issue, which is
referred to as a forensic drug test.”

“The stellar discrepancy of a clinical test v. forensic is the lack of a valid forensic
chain of custody. In addition, the original clinical report does not usually meet
forensic criteria. Therefore, in order to remedy these discrepancies, we will review
all documentation, received in the lab regarding the specimen, and generated by
instrumental analyses. We may then contact the sample collecting facility and
advise them that we need an affidavit signed by the collector that addresses the
omissions of the clinical requisition form, and the need to generate a forensic chain
of custody form. The sample tested needs to be retrieved if it resulted in positive
drug findings and retested under forensic protocol per our SOP and reported as
such.”

Dr. Rohrig reviewed the responses and SOP. He noted the only difference between the

original “non-forensic” laboratory report produced by ExperTox, and the “forensic report”

subsequently issued was the removal of the disclaimer language. All other information on the face

of the report was identical. The report without the disclaimer does not reflect an amended report.

Dr. Rohrig concluded: “This significant upcharge for a simple removal of the disclaimer,

without retesting or review and no indication of an amendment/addendum should raise some

ethical concerns.” The Commission concurs with Dr. Rohrig’s observations, both in terms of the

Page 18
scientific concerns cited and the disturbing lack of professional responsibility demonstrated by Dr.

Lykissa when he increased the fee charged in exchange for removal of disclaimer language.

V. COMMISSION FINDINGS

A. Texas Licensing Requirement for Forensic Analysts

Beginning on January 1, 2019, a person may not act or offer to act as a forensic analyst in

the State of Texas unless the person holds a forensic analyst license. 29 A “forensic analyst” is a

person who on behalf of an accredited crime laboratory technically reviews or performs a forensic

analysis or draws conclusions from or interprets a forensic analysis for a court or crime

laboratory.30

“Forensic analysis” means a medical, chemical, toxicologic, ballistic, or other expert

examination or test performed on physical evidence, including DNA evidence, for the purpose of

determining the connection of the evidence to a criminal action. 31

The hair analysis in this case occurred in October of 2019, well after the forensic analyst

licensing requirement took effect. The initial report with the caveat language indicating the report

was “not for forensic purposes” was released October 25, 2019. On or about and between October

2 to October 24, 2019, Dr. Lykissa conducted or reviewed the hair analysis in Deer Park, Texas

and was not licensed by the Commission at that time.

Dr. Lykissa maintains he was not aware that the hair testing was sought in connection with

a criminal matter because the sample was submitted by an intermediary collection agency and

forwarded to his laboratory without accompanying information, 32 even though the testing request

was for a “court ordered” “date rape” testing panel. For both the “forensic” report and the

29
TEX. CODE CRIM. PROC. art. 38.01 § 4-a(b); 37 Tex. Admin. Code §651.201(c) (2018).
30
See, Id. at § 4-a(a)(1).
31
TEX. CODE CRIM. PROC. art. 38.35 § (a)(4).
32
See, Exhibit M, Transcript of Dr. Lykissa at the January 29, 2021, Commission quarterly meeting.

Page 19
interpretive report, the record is clear Dr. Lykissa knew he was dealing with forensic analysis of

physical evidence and an interpretive opinion in connection with a criminal action. 33

Internal Commission email correspondence indicates staff communicated the Texas

licensing requirement both by email and in telephone conversation directly with Dr. Lykissa before

the January 1, 2019 effective date. Records indicate that no person employed with ExperTox

sought or received a license before engaging in the conduct discussed in this report despite

receiving notifications of the licensing requirement.

The Commission finds Dr. Lykissa acted as forensic analyst without a forensic analyst

license as required by Texas law during the period for which the analysis and interpretation was

performed in this case.

B. Determination Regarding Professional Misconduct or Professional


Negligence

“Professional misconduct” means the forensic analyst or crime laboratory, through a

material act or omission, deliberately failed to follow the standard of practice that an ordinary

forensic analyst or crime laboratory would have followed, and the deliberate act or omission would

substantially affect the integrity of the results of a forensic analysis. An act or omission was

deliberate if the forensic analyst or crime laboratory was aware of and consciously disregarded an

accepted standard of practice required for a forensic analysis.”

“Professional negligence” means the forensic analyst or crime laboratory, through a

material act or omission, negligently failed to follow the standard of practice that an ordinary

forensic analyst or crime laboratory would have followed, and the negligent act or omission would

substantially affect the integrity of the results of a forensic analysis. An act or omission was

33
“Criminal action” includes an investigation, complaint, arrest, bail, bond, trial, appeal, punishment, or other matter
related to conduct proscribed by a criminal offense. TEX. CODE CRIM. PROC. art. 38.35 § (a)(2).

Page 20
negligent if the forensic analyst or crime laboratory should have been but was not aware of an

accepted standard of practice.”

The term “would substantially affect the integrity of the results of a forensic

analysis” does not necessarily require that a criminal case be impacted or a report be issued to the

customer in error. The term includes acts or omissions that would call into question the integrity

of the forensic analysis, the forensic analyst or analysts, or the crime laboratory as a whole,

regardless of the ultimate outcome in the underlying criminal case. 34

C. Professional Negligence Finding Against Dr. Lykissa: Dr. Lykissa


Performed Forensic Analysis Without a Forensic Analyst License

The Commission finds Dr. Lykissa committed professional negligence by failing to follow

the standard of practice that an ordinary forensic analyst would have followed in obtaining a

forensic analyst license before performing forensic analysis in his laboratory located in Texas. This

standard of practice was codified by the Texas Legislature in Article 38.01 of the Texas Code of

Criminal Procedure, established by Commission rule in the Texas Administrative Code, and

communicated to Dr. Lykissa, though he asserts he did not fully appreciate that the requirement

applied to him until this investigation. The Commission finds Dr. Lykissa should have been aware

of the need to obtain a license to perform forensic analysis as that term is defined in Article 38.01

of the Texas Code of Criminal Procedure, and his failure to obtain a license as required by law

substantially affected the integrity of the results of the forensic analysis performed by Dr. Lykissa.

Dr. Lykissa represents and warrants that he will not, at any time now or in the future,

practice forensic analysis as that term is defined in Article 38.01 of the Texas Code of Criminal

Procedure from the date this report is finalized.

34
37 Tex. Admin. Code § 651.302 (10) (2020).

Page 21
D. Professional Misconduct Finding: Testing Report(s) and the Interpretive
Toxicology Report Issued by Dr. Lykissa Lack Scientific Foundation

Even more disturbing than the licensing violation is the poor quality of Dr. Lykissa’s

analytical and interpretive work. The hair testing results reported in the case discussed in this report

are not supported by the data provided by the laboratory and are not supported by accepted

scientific reporting criteria in the field of forensic toxicology. The reported results were not based

in any reliable validation work and should not have been issued and constitute professional

misconduct. The Commission further finds Dr. Lykissa’s interpretive toxicology opinion regarding

the pharmacological effects and implications for the suspect discussed in this report unfounded

and unsupported by accepted scientific principles and applicable scientific literature in forensic

toxicology.

The Texas Code of Professional Responsibility for Forensic Analysts and Crime

Laboratory Management defines a framework for promoting integrity and respect for the scientific

process and encouraging transparency in forensic analysis. The Code states that forensic analysts

shall promote validation and guard against the use of non-valid methods in casework and the

misapplication of validated methods.35 The Code also states forensic analysts shall present

accurate and complete data in reports, oral and written presentations and testimony based on good

scientific practices and valid methods. These principles are also embodied in the Society of

Forensic Toxicologists, Inc. Guiding Principles of Professional Responsibility. 36

ExperTox’s recognized accrediting body, CAP, performed a laboratory assessment of

ExperTox in June 2018 and, when reviewing information regarding a different analyte (THC),

CAP specifically advised Dr. Lykissa regarding the criteria that should be presented in a validation

35
37 Tex. Admin. Code § 651.219(b)(3), effective May 16, 2018.
36
See, Exhibit N, Society of Forensic Toxicologist Guiding Principles of Professional Responsibility.

Page 22
study. Dr. Lykissa was put on notice by CAP of issues with ExperTox’s validation studies (or the

lack thereof) for toxicology testing by the laboratory. CAP specifically required ExperTox to

correct its prior validations, yet Dr. Lykissa continued to perform a toxicological analysis without

appropriate validation of the method used in a felony criminal case where such factors as life,

liberty, public safety, and the overall integrity of the criminal justice system are at stake.

Dr. Lykissa publicly admitted that he did not have a validated method for detecting

lidocaine and would not be able to quantify the amount.37 He also admitted that he could not offer

“anything scientifically valid” with respect to the analysis. 38 “This test should not have been

used…even though I wrote the [interpretive toxicology] report.” 39 Dr. Lykissa reflected identical

sentiments in a written response to the Commission’s request for certain information by stating,

“we did not have a forensically validated method hair testing method for Lidocaine at th[e] time”

and when the “DA literally begged me to write something down hypothetically for the Lidocaine

and THC combined effect on someone’s mental state” …reluctantly I did (my wrong decision).”

The Commission finds Dr. Lykissa committed professional misconduct for deliberately

failing to follow a standard of practice an ordinary forensic analyst would have followed, by failing

to report forensic toxicology quantitative values utilizing a forensically validated method, contrary

to industry and national accrediting body standards and the laboratory’s own SOP.

The Commission further finds Dr. Lykissa committed professional misconduct by

deliberately providing an interpretive toxicology report including a statement about

pharmacological effects that lacked any scientific validity and by failing to show any

understanding or consideration of the serious impact his actions had on the outcome of the

37
See, Exhibit D, Link to January 2021 Quarterly Meeting at 52:00.
38
Id. at 54:35.
39
Id. at 58:15.

Page 23
criminal case. There is no scientific basis to support the interpretive opinion offered by Dr.

Lykissa regarding the so-called “serious combined enhanced pharmacological effects” of the

substances in question. As Dr. Rohrig stated in his report to the Commission, a review of the

relevant, published scientific literature does not suggest any clinically relevant potentiation,

additive, or synergistic effect(s) of lidocaine with the co-administration of THC.

The Commission encourages stakeholders in the criminal justice system to submit any

forensic analysis performed by Dr. Lykissa for review and re-analysis (where possible) by an

independent accredited laboratory if needed to confirm results are scientifically supported. A list

of ANSI National Accreditation Board (“ANAB”) and American Association for Laboratory

Accreditation (“A2LA”) accredited laboratories in the discipline of forensic toxicology is

maintained on the Commission’s website.

E. Professional Negligence Finding Against Dr. Lykissa: Charging Extra for a


“Forensic” Version of a Report Issued for Clinical Purposes

The Commission finds Dr. Lykissa committed professional negligence when he produced

a “forensic” version of a clinical result for the payment of an additional fee with no other changes

to the report. As detailed earlier in the report, the only difference between the original report and

the second “forensically validated” report was the removal of the disclaimer language that

potentially made the report inadmissible by a criminal court. All other information on the face of

the report is identical. Dr. Lykissa performed no retesting and gave no indication that he amended

or supplemented the report outside of removing the disclaimer.

In an email response to Dr. Rohrig’s report, Dr. Lykissa maintained that the additional

charge for the “forensically validated” report was attributable to “authoring the report, in lieu of a

generic report listing findings with no explanation, performing a Lidocaine validation in hair, and

Page 24
working with the DA for a period of 3 hours in preparation for the trial, and been (sic) available

for testimony, which never occurred.”

The response by Lykissa does not acknowledge that the invoice for the “Forensic Version

of Reported DFSA” was dated December 2, 2019. (See, Exhibit O, Invoice from ExperTox to

Arcpoint.) At that time, there had not been a report authored “in lieu of a generic report listing

findings with no explanation” (the Dr. Lykissa Interpretive Report was dated February 25, 2020).

Likewise, the laboratory had not performed a scientifically acceptable Lidocaine validation in hair

by the December date. Further, while it may be permissible to charge for consultations before trial,

those hours should not be hidden in a charge for the “forensic version” of a previously issued

report.

The removal of the “Clinical Use Only, Not for Forensic Purposes” disclaimer with no

substantive change to the forensic analysis or related method validation resulted in a misleading

representation of the analytical findings. By charging an additional fee for a “Forensic Version of

Reported DFSA”, Dr. Lykissa implied the analysis was conducted pursuant to heightened

requirements and oversight of the CAP Forensic Drug Testing Program, yet no such distinction

existed.40 The Commission recognizes that, since Dr. Lykissa was not licensed at the time of the

analysis in this matter, he may not have been aware of the professional standards of practice

articulated in the Texas Code of Professional Responsibility for Forensic Analysts that are

applicable to this conduct (e.g., disclosing limitations to guard against making invalid inferences

or misleading the judge or jury; not issuing reports or withholding information for strategic or

tactical litigation advantage; presenting accurate and complete data in reports, communicating

honestly and fully with all parties). For this reason, the Commission concludes Lykissa’s actions

40
DFSA refers to Drug Facilitated Sexual Assault.

Page 25
constituted professional negligence because he should have been aware (but perhaps was unaware)

that issuing a “forensic version” of the report for an additional fee without conducting any further

analytical work constituted a violation of the rules governing forensic analysts in Texas.

VI. EXPERTOX CORRECTIVE MEASURES FOLLOWING THE INVESTIGATION


BY THE COMMISSION

Subsequent to the adoption of a draft final report by the Commission at the July 19, 2022

quarterly meeting, Dr. Lykissa resigned from his capacity as Laboratory Director of ExperTox. As

of October 5, 2022, ExperTox hired Dr. James Bourland, PhD, F-ABFT, NRCC-TC as the new

laboratory director. In addition, ExperTox created and filled the position of Quality Supervisor to

oversee validation studies, quality management, and quality assurance programs at the laboratory.

The laboratory asserts that it has improved its review and completion process of method

validations as well as made various updates to its SOPs. ExperTox was also subsequently

inspected by the CAP program and has received an extension of accreditation from the CAP

Forensic Drug Testing Program.

VII. COMMISSION CHANGE IN CAP ACCREDITATION RECOGNITION

At its July 19, 2022 quarterly meeting, the Commission voted to remove both CAP and the

Substance Abuse and Mental Health Services Administration (“SAMHSA”) from the list of

accrediting bodies recognized by the Commission. This change was due to multiple factors. The

testing performed by CAP and SAMHSA laboratories is typically not for the principal purpose of

determining the connection of physical evidence to a criminal action, but rather is within contexts

like community supervision, clinical, medical practice, or other purpose unrelated to determining

the connection of physical evidence to a criminal action. The programs administered by CAP and

SAMHSA are fundamentally less rigorous in areas that are critical to the fair administration of

Page 26
justice than the forensic accreditation programs administered by ANAB and A2LA which have as

their primary purpose serving the needs of the criminal justice system.

Affected CAP and SAMHSA laboratories (including ExperTox) were notified of this

intended change and voiced no objection to the removal of these accrediting bodies from the

accrediting bodies recognized by the Commission. Effective November 9, 2022, CAP is no longer

recognized by the Commission as an accrediting body. This change is specific to forensic analysis

as that term is defined in the Code of Criminal Procedure. ExperTox, as well as other CAP and

SAMHSA laboratories, are no longer accredited by the Commission. Because of this change in

accreditation status, individuals who perform testing at ExperTox are no longer required to obtain

a forensic analyst license. Should ExperTox’s new scientific leadership seek to perform forensic

analysis in criminal actions and achieve accreditation by a recognized accrediting body (currently

ANAB or A2LA), the Commission will consider ExperTox’s application for accreditation (and

associated licensure) at that time.

Page 27
EXHIBIT A
EXHIBIT B
1430 Center Street
Deer Park, Texas 77536
Ph. 281-476-4600
Fx. 281-930-8856
www.expertox.com

Date: February 25, 2020

RE:

The undersigned has been practicing Clinical and Forensic Toxicology for the past
33 years. Presently I am in private practice in Deer Park, Texas. My educational
background consists of a Bachelors (1970) and Master of Science (1971) in Microbiology
from California State University at Long Beach. I was also awarded a Doctorate in
Medicine & Experimental Surgery, and Molecular Pharmacology from University of
Montreal (1979), Canada. I have taught Clinical and Forensic Toxicology for a number of
years as associate professor at Baylor College of Medicine. In this career I have pursued
the scientific study of drugs including their sources, appearance, chemistry, actions, and
uses including ethanol (alcohol).

I have assisted, in numerous occasions, medical teams as the clinical Toxicologist


in the diagnosis, treatment, and subsequent evaluation of patients through clinical
Toxicological testing and interpretation. I am also presently performing with my team of
scientists in our forensic laboratory, a number of daily evaluations and scientific
measurements, involving the detection and quantitation of therapeutic or illicit drugs, and
in assisting physicians involved in the critical care of head trauma patients, or patients that
are suffering from serious toxicity syndromes involving drugs of abuse, heavy metals, and
other toxins.

I have been asked to provide a professional opinion on the case of .

1. Expertox Hair Drug Test collected 09/30/2019

The hair test indicated an amount of D9-Tetra-Hydro-Cannabinol at the concentration of


7.5 pg/mg of hair. In addition, there was a positive finding of Lidocaine with the
concentration of 3.9 pg/mg

It is my professional opinion that these amounts of THC and Lidocaine detected in


Ms. hair, constitute evidence of potential serious combined enhanced
pharmacological effect to her ability to control her Mental and Physical faculties. If these
drugs were administered to her without her consent, then that could constitute a drug
facilitated assault by the perpetrator.
Ernest D. Lykissa Ph.D.
Molecular Pharmacology,
Medicine and Experimental Surgery
Clinical and Forensic Toxicologist
Expertox Laboratory Director

References:

1. Drug Abuse Handbook 2nd. Ed. Steven B. Karch M.D. Chapter CRC Press 2007.

2. Analytical and Practical Aspects of Drug Testing in Hair. Pascal Kintz Ed. 2007
EXHIBIT C
January 26, 2021

Rachel Black
District Attorney’s Office
Three South Penn Square
Philadelphia, PA 19107

RE: Commonwealth v. MC-51-CR-0025635-2019


NMS Expert Services Case No. 20311758

Dear Ms. Black:

You have retained National Medical Services, Inc., represented by Sherri L. Kacinko, Ph.D., as consultants in
toxicology in the captioned case. You have requested that I review pertinent documents and form conclusions
and opinions regarding the analysis, reporting, and interpretation of testing performed on a hair sample
collected from

In order to comply with your request, I reviewed a report and analytical data from ExperTox, Inc. (ExperTox).

Based on my review of these documents, it is my understanding that ExperTox performed testing on two
segments of hair, one which was calculated to include the date of an alleged sexual assault (case specimen) and
another from a separate time period which is referred to as “baseline”. The requisition form for testing indicated
that the client submitting the sample was ordering a miscellaneous test panel noted to be “Date Rape” and the
issued report indicated the reason for testing to be “Court Ordered”; additionally, the requisition form indicated
the client was interested in testing for lidocaine. The samples were tested for a variety of drugs by enzyme
immunoassay (EIA) and liquid-chromatography tandem-mass spectrometry (LC-MS/MS); the complete scope
of testing was not provided. The hair segment representing the date of interest was reported to contain <50
pg/mg Gamma-Hydroxy Butyric Acid (GHB), 7.5 pg/mg Delta-9 THC and 3.9 pg/mg lidocaine. The report
indicates that the baseline hair contained 0.43 pg/mg lidocaine and no Delta-9 THC.

The following deficiencies were noted in the provided paperwork:


1) The document labeled “ExperTox Date Rape/GHB Hair Batch Log” contains a column labeled
“Aliquot Date” but no date was indicated.
2) The only chromatography that was provided was for the lidocaine and Delta-9-THC analysis for
the patient specimens (case and baseline). No examples of calibrator or control chromatography
was provided.
3) No chromatography was provided for the GHB analysis.
4) The data provided for delta-9-THC does not include controls making it impossible to evaluate
the reliability of the reported result.
5) The chromatography that was provided appears to be a “print screen” from the instrument
software interface and is very difficult to read.

Based on the information provided above and my education, knowledge, training and experience, it is my
opinion that the reported results are not reliable because of the reasons described below:

200 Welsh Road, Horsham, Pennsylvania 19044 T 800.522.6671 F 215.657.2972 www.nmslabs.com


1) The testing performed does not align with the generally accepted requirements of forensic testing

Although the ExperTox report originally provided states “Results are for CLINICAL USE ONLY, NOT
FOR FORENSIC PURPOSES”, it is clear they knew that the results would be applied to a legal matter. The
analytical data refers to the requested testing as “Date Rape” and the report indicates that the reason for
testing is “Court Ordered”. A copy of the report without this statement was also provided upon request.
Therefore, the testing performed should adhere to the expectations of forensic testing.

2) The testing for lidocaine did not contain appropriate quality control (QC) samples

The data provided for the lidocaine testing (pages 19-21, 36-41) indicates that quantification of lidocaine in
hair was achieved using a single calibrator and at most, a single QC sample. In general, a minimum of two
QC samples should be run concurrently and the concentrations of these controls should encompass the
analytical measurement range (AMR) of the assay. For assays which only include a single calibrator, the
AMR should be established during validation and controls, with concentrations less than and greater than
the calibrator concentration, are required to ensure that the test is reliable at the time of patient sample
analysis.

Data for the analysis of the baseline sample for lidocaine can be found on pages 19-21 of the included
documentation. On page 19 it indicates that the analytical run included a negative control, the patient
baseline sample, a low calibrator and a high calibrator. The data on page 21 labels the high calibrator as a
QC and it was not used in the generation of the calibration curve. No QC sample with a concentration less
than the low calibrator was analyzed.

The data for the analysis of the case specimen is on pages 36-41. It appears the testing was performed twice
as there are two confirmation batch log documents. The confirmation batch log found on page 39 shows
three samples being analyzed – “neg”, the case specimen, and “cal”, but no chromatography was provided
from this batch. Handwritten notes show the results of this analysis as “0”, “Detected (0.5)” and “Pos” for
the three specimens, respectively. Despite no indication of a QC sample being included in this batch, the
document indicates the QC was “acceptable”.

The confirmation batch log for the reported lidocaine result (page 36) does not indicate that a QC was run,
however the analytical data (page 41) shows a QC sample noted to be Level 5 with an expected
concentration of “1000”. The expected calibrator concentration was “100”; like the baseline sample, no QC
sample with a concentration less than the calibrator concentration was included.

This is not only poor practice, it is specifically out of compliance with The College of American
Pathologists (CAP) Forensic Drug Testing accreditation, which ExperTox holds. Page 16 of the CAP
Chemistry and Toxicology checklist says:
Daily quality control must be run as follows:
1. Quantitative tests - two controls at different concentrations at least daily
2. Qualitative tests - a negative control and a positive control (when applicable) at least daily

3) The method used to quantify the baseline specimen and case specimen are inconsistent.

It is difficult to fully evaluate the data provided for the lidocaine quantification because it is unclear what
concentrations were used to calibrate the assays. Both the baseline specimen data (p. 21) and the case
specimen data (pg. 41) show that a single calibrator was employed and that a sample labeled “Cal” was used
as a QC. Although, the method used to quantify the baseline and case specimens appear to be different. In
Commonwealth v.
NMS Labs WO 20311758 2 of 4
both cases the calibrator and QC are labeled as “Level” 2 and 5 with expected concentrations of 100 and
1000 pg/mg, respectively.

However, for the baseline specimen it appears that the final results are reported as a “percent of” the actual
calibrator concentration, which appears to be 2 (no units provided, assuming pg/mg based on reported
results). This conclusion is based on the values found in the columns labeled “Calc Conc” and “Final Conc”.
Based on this assumption, the concentration of the QC sample is 5.1 pg/mg (254% of 2), which is consistent
with what appears on the data.

For the case specimen batch, the “Calc Conc” and “Final Conc” are identical. This suggests that in this case
the concentrations of the calibrator and QC sample are 100 and 1000 pg/mg, respectively.

4) The single-point calibration used to quantify lidocaine in the case specimen was not successful

Because it is not clear how quantification was performed for the case specimen, two scenarios were
considered. In either case, the batch should not have been considered acceptable.

1. The concentrations of the calibrator and QC were 100 and 1000 pg/mg, respectively.

This appears to be the case considering the reported result of 3.9 pg/mg. In this case the run should
have been rejected because the QC final concentration (427) was less than 50% of the expected
concentration. Further, a second sampled (labeled as a QC) with an expected concentration of 1000
also quantified at less than 50% of target and the notes on the confirmation batch log indicated that
the peak plateaued.

2. The concentrations of the calibrator and QC were 2 and 5 pg/mg, respectively (as appears to be the
case in the baseline specimen batch) and the analyst did not properly calculate the final results.

In this scenario, the final concentration of the QC would have been 8.5 pg/mg, which is 70% greater
than the expected concentration (5 pg/mg) and the patient specimen concentration would be 3.9% of
the calibrator concentration, or 0.08 pg/mg, for which there is no corresponding appropriate control.

It is clear that no matter how the results were calculated for the analysis of the patient specimen, the results
were unacceptable and no results should have been reported.

5) The analytical results do not support a positive identification of lidocaine in the baseline or case
specimen.

There are three essential parameters to positive identification by LC-MS/MS:


1) Chromatography
2) Transition ratios
3) Retention time (or relative retention time)

In this case, the transition ratios were all unacceptable, which is documented on the chromatography (pgs.
21 & 41). The instrument software (Agilent Masshunter) can be programmed to highlight elements of the
analytical data that do not meet pre-defined criteria. This is often used to quickly draw the analyst’s
attention to potential problems, but it is still vital for the analyst to evaluate each parameter. To determine if
a patient sample contains an analyte of interest, the transition ratio of the patient sample should be compared
to the transition ratio of the calibrator(s). The required agreement between the ratios can vary but usually
Commonwealth v.
NMS Labs WO 20311758 3 of 4
laboratories adhere to generally accepted guidance -- the agreement should be within ±50% at most (20-
30% is more commonly used). In this case, the transition ratios for the patient samples (baseline and case
specimen) were 0.7 while the calibrator transition ratios were 1.8 and 1.7. In other words, the patient
samples had a ratio that was >60% lower than the calibrator sample.

6) It is not appropriate to report GHB as <50 pg/mg when the confirmation cutoff concentration is 3000
pg/mg.

In qualitative tests the term “cutoff” is generally used to describe the concentration which differentiates a
positive sample from a sample that should be reported as “None Detected”. If the case specimen met all the
criteria to identify GHB as present but the concentration was determined to be less than the cutoff it may be
appropriate to report it as <3000 pg/mg but it is not acceptable to report it as <50 pg/mg.

********************
In summary, the analysis of hair performed by ExperTox, Inc. is scientifically inadequate and the
analytical data do not support the reported results. The data provided show a disregard for good
laboratory practices and calls into question the reliability of results generated by this laboratory. Because
the results are unreliable it would be inappropriate to offer interpretation on the clinical or forensic
impact of the reported compounds in an individual.

These conclusions are based on the information available for my review at this time. If additional
information becomes available, I will be happy to review this new information and re-evaluate my stated
opinions and conclusions.

Respectfully,

Sherri Kacinko, Ph.D., F-ABFT


Toxicologist

Commonwealth v.
NMS Labs WO 20311758 4 of 4
EXHIBIT D
Link to video of Texas Forensic Science Commission Quarterly Meeting, January 29, 2021; discussion of
the complaint against ExperTox begins at 49:10. Dr. Lykissa joins the meeting at 51:31.

https://txcourts.zoom.us/rec/play/NTFY1l54Fzw4pRO3lixys-
YwgLgaOKbE5wwz5vlaXzvd2FgyjIFAHQ2YN2MRmcKYF1WyUKMWGMcKlL1g.UWfYYaG2VPJnU4FJ?contin
ueMode=true& x zm rtaid=o5fj3Pd7Sdup5i5OnX3ugA.1659989596143.ea89d7a348e4a771b8fc3dd956
e6667d& x zm rhtaid=482
EXHIBIT E
EXHIBIT F
EXHIBIT G
EXHIBIT H
1430 Center Street
Deer Park, Texas 77536
Ph. 281-476-4600
Fx. 281-930-8532
www.expertox.com

Date: March 29, 2021

Robert Smith Esq.

1. In the last 3 years I can recall of five cases (see below) in which the Donors of
the Hair specimen submitted the reports of Expertox to authorities , as proof of
abstinence or adherence to Court dictates ( i.e. probation). To clarify, the report was
issued to the submitting collection facility, which forwarded the report to the Donor of
the Hair specimen

2. In the last 3 years and in at least 5 instances that I can recall, out of state
District Attorneys demanded phone interpretation of hair testing results. In every
occasion they also asked for written interpretational reports which I declined in every
case, and asked them to call NMS Labs in Pennsylvania.
For example, in the Wood Carrie case in Philadelphia, the DA asked me to testify on this
case for which I declined since the test had been performed for Clinical Use only. The
reason been that we did not have, a Forensically validated hair testing method for
Lidocaine at this time, only for clinical testing. Then the DA literally begged me to write
something down hypothetically for the Lidocaine and THC combined effect on
someone’s mental state which reluctantly I did (my wrong decision) send her the standard
report I issue to the Medical Centers in the Houston area to Medical Doctors handling
critical care patients.. I also recall telling her that the Lidocaine detected in the baseline
segment was disproving the claim of the plaintiff that the Lidocaine was administered by
the defendant. Only the THC was pertinent. I also advised her to talk to NMS for
supportive testimony. The complaint was filed with your Commission by the Defense
Attorney who demanded from my assistants, for me to consult with her which I declined.
Please note: In the last 3 years, there have been multiple phone consultations with
Medical Practitioners about the Clinical significance of the hair testing findings issued by
my Laboratory. In these cases, i.e. Memorial Hermann Prevention Facility for Substance
Abuse Rehabilitation, and for Critical Care patients in Hermann Hospital and Children’s
Hospital of Houston written interpretational reports were issued.

3.The statement on our reports, issued by our laboratory, “FOR CLINICAL USE
ONLY AND NOT FOR FORENSIC PURPOSES”, is utilized as a disclaimer for
establishing the validity of our published results only for the clinical practice that
originally ordered these test reports. No attorneys or prosecutors may issue subpoenas
for these tests since they were not performed with forensic criteria (i.e., valid Forensic
Chain of Custody, Forensically validated methods). The Forensic Mandates in
accordance to the mandates of our National Forensic Accreditation by the College of
American Pathologists, are only utilized for testing hair samples of, i.e., Houston Police
Deputies, and for Human Resources Entities, for Pre- Employment of new Hires, and or
for Cause on the job sites of Houston.

4.
Expertox List of Hair Drug Testing Confirmations by
GCMS/LCMSMS
Amphetamine, Methamphetamine, MDA, MDMA (Extasy), MDEA,
THC and metabolites,
Opiates, 6- Acetylmorphine,
Cocaine and metabolites,
PCP,
Benzodiazepines and metabolites,
Barbiturates,
Methadone and metabolite,
Propoxyphene and metabolite,
Meperidine and metabolite,
Tramadol and metabolite,
Fentanyl, Sufentanyl, Ketamine and metabolite,
Lidocaine,
Promethazine,
Amitriptyline, Nortriptyline, Imipramine, Desipramine, Doxepin, Desmethyl-Doxepin,
Buprenorphine and metabolite,
Chlorpheniramine,
Citalopram,
Sertraline,
Dextromethorphan,
Dimethyltryptamine,
Diphenhydramine,
Ethyl Glucuronide,
Fluoxetine,
Gabapentin,
GHB (Gamma Hydroxy Butyrate), 1,4 Butanediol
Mitragynine,7-Hydroxymitragynine,
LSD, 2-OXO-3-OH-LSD,
Methylphenidate,
Naltrexone,
Tizanidine,
Nicotine, Cotinine,
Psilocybin, Psilocin,
Scopolamine,
Tapentadol,
Doxylamine, Brompheniramine,
Carisoprodol, Meprobamate,
Cyclobenzaprine,
Methocarbamol,
Phentermine
Methaqualone,
Zolpidem, Zopiclon

Note: Dr. S. Vareed and myself have obtained Provisional Texas Forensic Analyst
Licenses at this time (early in March 2021). And need be by the commission we will seek
whatever additional accreditations will satisfy any requirements we must meet.

Ernest D. Lykissa Ph.D.


Molecular Pharmacology,
Medicine and Experimental Surgery
Clinical and Forensic Toxicologist
Expertox Laboratory Director
EXHIBIT I
EXHIBIT J
TIMOTHY P. ROHRIG, Ph.D., F-ABFT
Consultant in Pharmacology and Toxicology
2017 N. Castle Rock
Wichita, Kansas 67230

www.pharmacology-toxicologyconsultant.com

EDUCATION

University of Missouri-Kansas City


Kansas City, Missouri
Ph.D. degree awarded 1984
Pharmaceutical Science
Major Emphasis Area: Pharmacology/Toxicology

Rockhurst College
Kansas City, Missouri
B.S. degree awarded 1978
Major: Chemistry

Johnson County Community College


Overland Park, Kansas
Undergraduate: Non-degree course
Emergency Medical Technician – Fall 1979

BOARD CERTIFICATION American Board of Forensic Toxicology


Certificate Number 181/1267
Granted March 1989

LICENSE State of New York, Clinical Laboratory Director; CQ Number ROHRT1


September 1997 – September 2019
Inactive Status September 2019 - Present

New York State Department of Health


Blood and Urine Alcohol Analyst Permit
Gas Chromatography, Flame Ionization Detection, Headspace Sampling
January – December 2000

Kansas Emergency Medical Services Registry


Emergency Medical Technician [EMT] 1980 - 1983

ACADEMIC APPOINTMENTS

Principle Lecturer in Toxicology/Visiting Professor


Emporia State University
Emporia, Kansas 66801

January 2020 – Present

Visiting Professor of Forensic Toxicology


University of Lincoln
Lincoln LN6 7TS United Kingdom

February 2017 - Present


Timothy P. Rohrig, Ph.D.
Page 2

ACADEMIC APPOINTMENTS con’t

Adjunct Professor of Criminal Justice and Forensic Science


Wichita State University
Wichita, Kansas 67260

December 2003 – October 2019

Clinical Assistant Professor of Pathology


University of Kansas
School of Medicine-Wichita
Wichita, Kansas 67214

July 1, 2001 – June 30, 2012

Clinical Assistant Professor of Pathology


State University of New York
Upstate Medical University (formerly known as Health Science Center-Syracuse)
Syracuse, New York 13210

January 1, 1999 – July 31, 2000

Adjunct Assistant Professor of Pharmacology and Toxicology


University of Oklahoma, Health Sciences Center
College of Pharmacy
Oklahoma City, Oklahoma 73190

April 1989 - August 1994

EMPLOYMENT

Consultant in Pharmacology and Toxicology


2017 N. Castle Rock
Wichita, KS 67230

January 1989 – Present

Regional Forensic Science Center


1109 N. Minneapolis St.
Wichita, Kansas 67214

Present Position: Chief Toxicologist [Part-Time]

April 2020 – December 2022


Timothy P. Rohrig, Ph.D.
Page 3

EMPLOYMENT CONT.

Regional Forensic Science Center


1109 N. Minneapolis St.
Wichita, Kansas 67214

Position: Director

January 2007 – October 2019

Position: Director, Forensic Science Laboratories and Chief Toxicologist

August 2000 – October 2019

Center for Forensic Sciences


Onondaga County Health Department
100 Elizabeth Blackwell
Syracuse, New York 13210

Position: Director of Laboratories

August 1998 – July 2000

Osborn Laboratories, Inc.


14901 West 117th Street
Olathe, Kansas 66062

Position: Vice President and Director of Toxicology

August 1994 – July 1998

Office of the Chief Medical Examiner


901 North Stonewall
Oklahoma City, Oklahoma 73117

Position: Chief Forensic Toxicologist

June 1991 - August 1994

Position: Deputy Chief Forensic Toxicologist

August 1987 - May 1991

Kansas Bureau of Investigation


Forensic Science Laboratory
1620 Tyler
Topeka, Kansas 66612

Position: Chief Forensic Toxicologist

February 1986 - August 1987


Timothy P. Rohrig, Ph.D.
Page 4

EMPLOYMENT CONT.

Office of the Chief Medical Examiner


701 Jefferson Road
South Charleston, West Virginia 25309

Position: Toxicologist

August 1985 - February 1986

Kansas Bureau of Investigation


Forensic Science Laboratory
1620 Tyler
Topeka, Kansas 66612

Position: Forensic Toxicologist

September 1983 - August 1985

Rockhurst College
Department of Chemistry
5225 Troost Avenue
Kansas City, Missouri 64110

Position: Lecturer

August 1980 - May 1983

Midwest Research Institute


Organic and Radiochemical Synthesis Section
4225 Volker Boulevard
Kansas City, Missouri 64110

Position: Assistant Chemist/Supervisor, Analytical Support Group

June 1979 - August 1980

Position: Junior Chemist

May 1978 - May 1979


Timothy P. Rohrig, Ph.D.
Page 5

PROFESSIONAL ORGANIZATIONS

American Academy of Forensic Sciences

Toxicology Section – Provisional Member (1986 – 1989)


Member (1990 – 1993)
Fellow (1993 – present)
Toxicology Section – Workshop Chairman (2003)
Toxicology Section – Awards Committee (2002 – 2005)
Toxicology Section - Program Committee (2003 – 2004)
Toxicology Section – Membership Committee (2004 – 2006)
Toxicology Section – Continuing Education Committee (2004 – 2005)
Toxicology Section – Secretary (2004 – 2005)
Toxicology Section – Chairman (2005 - 2006)
AAFS Nominating Committee (2006)
Toxicology Section Nominating Committee – Chairman (2007), Member (2016-17)
Toxicology Section - Awards and Scholarship Committee Chairman (2018-2020)

Alcohol, Drugs and Impairment Division


[Previously known as Committee on Alcohol and Other Drugs]
National Safety Council

Member (1990 – Present)

International Association of Forensic Toxicologists

Member (1993 – Present)

Midwestern Association of Forensic Scientists

Member (1986 – Present)


Toxicology Section Coordinator (1987)

Society of Forensic Toxicologists

Member (1985 – Present)


Budget, Finance and Audit Committee (1989-1991)
Membership Committee (1991-1993)
Member of Board of Directors (2000-2002)
Guest Editor, SOFT/JAT October Special Issue (2001)
Drug Facilitated Sexual Assault [Crimes] Committee (2002 – 2022)
Treasurer (2002 – 2004)
Vice President (2005)
President (2006)
Ex-officio Member of Board of Directors (2007)
Nominating Committee – Chair (2007) and Member (2013)
Liaison to the National Association of Medical Examiners (2008 – 2009)
Drugs & Driving Committee; joint with AAFS (2016 – Present)
Oral Fluid Subcommittee (2016 – 2018; elevated to full committee)
Oral Fluid Committee (2019 – Present)
Awards Committee – Chairman (2021- Present), Member (2020 – Present)
Timothy P. Rohrig, Ph.D.
Page 6

PROFESSIONAL ORGANIZATIONS con’t

Southwestern Association of Toxicologists

Member (1987 – Present)


Counselor (1990-1991)
President-Elect (1991-1992)
President (1992-1993)
Board Member (1993-1994)
Secretary (1994-1998)

New York Crime Laboratory Advisory Committee

Member (1998 – 2000)


Assistant Chair (2000)

American Society of Crime Laboratory Directors

Member (2000 – Present)


Strategic Planning Committee (2003 – 2004)
Technical Advisory Committee – Toxicology (2005 – 2016)

American Board of Forensic Toxicologists

Nominating Committee (2002 – 2004)

OTHER PROFESSIONAL ACTIVITIES

Laboratory Inspector/Team Leader

DHHS (Known as the NIDA Program) National Laboratory Certification Program


November 1990 – June 2011

Laboratory Inspector

College of American Pathologists, Laboratory Accreditation Program


January 2003 – January 2005

Member

Oklahoma Partnership Against Inhalant Abuse Task Force


September 1993 - August 1994

Member

Sexual Assault Nurse Examiner Advisory Committee [New York]


December 1999 – July 2000
Timothy P. Rohrig, Ph.D.
Page 7

OTHER PROFESSIONAL ACTIVITIES con’t

Instructor

Forensic Medical Investigation Review Course


November 2000 – 2005

Member

Wichita SANE/SART [Sexual Assault Nurse Examiner/Response Team] Advisory Board


November 2000 – December 2011
January 2013 – October 2019

Board Member

Wichita Area Sexual Assault Center


January 2007 – December 2012

Expert Panel Member

Toxicology/Controlled Substance Expert Panel


NIJ: Forensic Science and Technology Transfer Project
January – March 2007

Task Force Member

NIJ: Training Task Force


March – July 2013

Invited Visiting Professor


Erasmus Mundus Masters Programme
University of Lincoln
Lincoln LN6 7TS United Kingdom

January 2013 – January 2017

External Examiner for Viva Voce – PhD Candidate


University of Lincoln
Lincoln LN6 7TS United Kingdom

January 2016

Forensic Laboratory Needs Technology Working Group [FLN-TWG]


Office of Justice Program’s (OJP) National Institute of Justice (NIJ)

Member

Aug 2018 - Present


Timothy P. Rohrig, Ph.D.
Page 8

OTHER PROFESSIONAL ACTIVITIES con’t

National Institute of Justice (NIJ) Steering Committee


National Opioid Response Policy and Practice Forum –
Reducing Crime, Informing Public Health and Safety, and Strengthening Communities

Member

Feb 2019

Consortium of Forensic Science Organizations

Board Member

January 2016 - Present

Vice Chair

February 2022 - Present

HONORS

Rho Chi National Honorary Pharmaceutical Society Alpha Omega Chapter Univ of MO-KC 1982

American Academy of Forensic Sciences General Section Award 1989 - 1990

Who's Who in Science and Engineering, 2nd Ed., 1994/1995

American Academy of Forensic Sciences - Rolla N. Harger Award 2009


Timothy P. Rohrig, Ph.D.
Page 9

PRESENTATIONS

T. Rohrig, “Drug Exposure in CINC Cases”

Invited presentation at Best Practices in Child Welfare Law Training sponsored by Office of
Judicial Administration-Kansas Judicial Center.

April 2023; Topeka, KS [virtual presentation]

T.P. Rohrig, “Etizolam: Toxicology Report to the Courtroom”

Presented at a workshop entitled “Driving Under the Influence: NPS Benzodiazepines” at the
Society of Forensic Toxicologists Annual Meeting

November 2022; Cleveland, OH

T.P. Rohrig, “Tales of the Dead and One that Wasn’t”

Invited lecture at the George Washington University Law School

October 2019; Washington DC

T.P. Rohrig, “Drug Facilitated Sexual Assault-Miscellaneous Therapeutics: OTC Antihistamines, Tricyclic
Antidepressants, and Carisoprodol”

Invited presentation at the California Association of Toxicologists Spring Meeting.

May 2019; Monteray, CA

T.P. Rohrig, “Alcohol, Memory and Alcohol-Induced Blackouts”

Invited presentation at the California Association of Toxicologists Spring Meeting.

May 2019; Monteray, CA

T.P. Rohrig, “Tales of the Dead and One that Wasn’t”

Invited lecture at Barts and The London School of Medicine and Dentistry, William Harvey
Research Institute, Cameron Forensic Medical Sciences, Queen Mary University of London

January 2019; London UK

T.P. Rohrig, “Road-Side Drug Testing: An Evaluation of the Alere DDS®2 Mobile Test System”

Invited presentation at the 12th Annual Joint LEO/Prosecutor: Impaired Driving Seminar

October 2017; Wichita KS


Timothy P. Rohrig, Ph.D.
Page 10

PRESENTATIONS con’t

T.P. Rohrig, “Social Drink and the Common Cold: Alcohol and Antihistamines in Drug Facilitated Sexual
Assault”

Invited presentation at the International Association of Forensic Nurses – Kansas Chapter


Meeting

August 2017; Wichita KS

T.P. Rohrig, “Driving Impairment Due To Inhalant Abuse”

Presented at the Graduate Seminar Series in Forensic Science at Emporia State University

April 2017; Emporia KS

T.P. Rohrig, “Carbon Monoxide Intoxications: Unusual Sources”

Presented at the Southwestern Association of Toxicologists Spring Meeting

April 2017; Wichita KS

S.A. Miller* and T.P. Rohrig, “U-47700: A Not So New Opioid”

Presented at the Southwestern Association of Toxicologists Spring Meeting

April 2017; Wichita KS

T.P. Rohrig, “Prescription Medications: They Can Impair Driving”

Invited Presentation at OSU Center for Health Sciences Friday Seminar Series

April 2017; Tulsa OK

T.P. Rohrig* and C.M. Moore, “Road-Side Drug Testing: An Evaluation of the Alere DDS®2 -A Pilot Study”

Presented at workshop held at the Kansas Drugged Driving Summit

October 2016; Topeka KS

T.P. Rohrig, “Oral Fluid: An Alternative Specimen for Drugged Driving Detection”

Presented at workshop held at the Annual Meeting of the Midwestern Association of Forensic
Scientists

October 2016; Branson MO


Timothy P. Rohrig, Ph.D.
Page 11

PRESENTATIONS con’t

T.P. Rohrig, “Drugs and Driving: Don’t Take the High Road”

Presented at workshop held at the Annual Meeting of the Midwestern Association of Forensic
Scientists

October 2016; Branson MO

T.P. Rohrig, “Interpretation of Hair and Urine Drug Test Results”

Presented at the Kansas Alliance for Drug Endangered Children- Sedgwick County seminar on
Drugs-Effects, Testing, Trends and Professional Safety

September 2015; Wichita KS

T.P. Rohrig, Postmortem Interpretation 1: Interpretive Considerations and Challenges”

Presented at a workshop entitled “Postmortem Toxicology: From Autopsy to Interpretation” at the


Society of Forensic Toxicologists Annual Meeting

October 2015; Atlanta GA

T.P. Rohrig, “Interpretation of Hair and Urine Drug Test Results”

Presented at the Kansas Alliance for Drug Endangered Children- Sedgwick County seminar on
Drugs-Effects, Testing, Trends and Professional Safety

September 2015; Wichita KS

T.P. Rohrig, “Alcohol Facilitated Sexual Assault”

Presented at the Graduate Seminar Series in Forensic Science at Emporia State University

September 2015; Emporia KS

T.P. Rohrig, “Oral Fluid: Utilization in Detecting Drugged Drivers”

Presented at Prosecuting Attorneys’ Seminar: 21 st Century Prosecution; The New and the Novel

October 2014; Wichita, KS

T.P. Rohrig, “Oral Fluid as a Test Specimen: Guidelines for Implementing a Data Collection Program”

Presented at IACP Training Conference

July 2014; Phoenix, AZ


Timothy P. Rohrig, Ph.D.
Page 12

PRESENTATIONS con’t

T.P. Rohrig, “Basic Pharmacology of the Synthetic Cannabinoids”

Presented at the Southwestern Association of Toxicologists Fall Meeting.

October 2012; Norman, Oklahoma

A.J. Whitaker*, L. Harryman and T.P. Rohrig, “Single Dose Urinary Kinetics of Carisoprodol”

Presented at the Southwestern Association of Toxicologists Fall Meeting.

October 2012; Norman, Oklahoma

T.P. Rohrig, “Toxicology for Kansas Prosecutors”

Invited presentation at the Trial Advocacy II for Kansas Prosecutors Workshop

August 2012; Wichita, KS

T.P. Rohrig, “Alcohol and Drug Facilitated Sexual Assaults”


T.P. Rohrig, “Pain Management Medications Utilized in Drug Facilitated Sexual Assaults”
T.P. Rohrig, “DFSA Applications and Interpretations – OTC Antihistamines”

Invited presentations at the Society of Forensic Toxicologists Continuing Education Workshop –


Drug Facilitated Sexual Assault

April 2012; Edmond, OK

L.E. Hume*, R.D. Fornshell, T.P. Rohrig, and J.G. Rankin, “New Gas Chromatography-Positive Chemical
Ionization Tandem Mass Spectrometric Method for the Determination of Methylenedioxypyrovalerone
(MDPV), 4-Methylmethcathinone (Mephedrone), and 4-Methoxymethcathinone (Methedrone)”

Presented at the American Academy of Forensic Sciences Annual Meeting

February 2012; Atlanta, GA

T.P. Rohrig, “Pharmacology of Cathinone Analogs aka Bath Salts”

Presented at the Southwestern Association of Toxicologists Fall Meeting.

Sept 2011; Wichita, KS

T.P. Rohrig, “But Judge It’s Therapeutic – Driving Under the Influence of Prescription Medications”

Presented at the Southwestern Association of Toxicologists Fall Meeting.

Sept 2011; Wichita, KS


Timothy P. Rohrig, Ph.D.
Page 13

PRESENTATIONS con’t

L. Harryman* and T.P. Rohrig, “Single Dose Urinary Kinetics of Cyclobenzaprine”

Presented at the Southwestern Association of Toxicologists Fall Meeting.

Sept 2011; Wichita, KS

K. Creamer* and T.P. Rohrig, “Methylenedioxypyrovalerone (MDPV): Method Development”

Presented at the Southwestern Association of Toxicologists Fall Meeting.

Sept 2011; Wichita, KS

T.P. Rohrig, “Pharmacology of Cathinone Analogs aka Bath Salts”

Invited presentation at the California Association of Toxicologists Spring Meeting.

May 2011; Napa, CA

T.P. Rohrig, “Marijuana Intoxication: Impact on Driving Performance”


T.P. Rohrig, “Driving Under the Influence of Stimulants”
T.P. Rohrig, “OTC Drugs and Driving: Antihistamines”
T.P. Rohrig, “Driving Impairment Due to Inhalant Abuse”
T.P. Rohrig, “Legal Challenges to Prosecuting a Driving Under the Influence of Inhalants Case”
T.P. Rohrig, “Benzodiazepines: Impact on Driving”
T.P. Rohrig, “But Judge…Its Therapeutic”

Presented at the “Symposium in Toxicology [DUID]”

January 2011; Ames, Iowa

T.P. Rohrig, “Drug Facilitated Sexual Assault (DFSA) Applications and Interpretations:
OTC Antihistamines”

Presented at the workshop entitled “Drug Facilitated Sexual Assault” at the Society of Forensic
Toxicologists Annual Meeting

October 2010; Richmond, VA

T.P. Rohrig, “Introduction to Analytical Techniques and Colorimetric Tests”

Presented at the “Symposium on Special Topics in Forensic Toxicology”

August 2008; Ames, Iowa

T.P. Rohrig, “Toxicological Challenges in Decomposed or Embalmed Bodies””

Presented at the “Symposium on Special Topics in Forensic Toxicology”

August 2008; Ames, Iowa


Timothy P. Rohrig, Ph.D.
Page 14

PRESENTATIONS con’t

T.P. Rohrig, “Interpretation of Postmortem Toxicology-Pitfalls to Avoid”

Presented at the “Symposium on Special Topics in Forensic Toxicology”

August 2008; Ames, Iowa

T.P. Rohrig, “Toxicology of Pain Management Drugs – An Overview”

Presented at the workshop entitled “Postmortem Toxicology: Interpretation of Drug


Concentrations in Hair” at the American Academy of Forensic Sciences Annual Meeting

February 2008; Washington, DC

T.P. Rohrig, “Toxicological Analysis of Drug Facilitated Crimes for Dummies…and Smarties, Too:
Hallucinogens”

Presented at the workshop entitled “Toxicological Analysis of Drug Facilitated Crimes for
Dummies…and Smarties, Too” at the Society of Forensic Toxicologists Annual Meeting

October 2007; Durham, NC

T.P. Rohrig, “Alcohol Biomarkers: Ethyl Glucuronide – Diagnostic and Forensic Utility”

Invited presentation at the Biological Science’s Departmental Seminar Series –


Wichita State University

March 2007; Wichita, KS

T.P. Rohrig, “Driving Under the Influence of Drugs: Forensic Implications – Pharmacology,
Pharmacokinetics and Interpretation”

Invited presentation at a workshop entitled “Apprehension and Prosecution of Drug Impaired


Drivers: The ABC’s of DRE”

September 2006; Wichita, KS

T.P. Rohrig, “Toxicological Determination of Children Exposed to a Methamphetamine Laboratory


Environment”

Invited presentation at a workshop entitled “Meth: What’s Cooking in Sedgwick County”

September 2006; Wichita, KS


Timothy P. Rohrig, Ph.D.
Page 15

PRESENTATIONS con’t

T.P. Rohrig, “Pharmacokinetics and Pharmacodynamics in the Geriatric Population: A Focus on


Psychotropic Medications”

Presented at the workshop entitled “Interpretation of Toxicological Analysis in the Elderly” at the
American Academy of Forensic Sciences Annual Meeting

February 2006; Seattle, WA

L.A. Harryman* and T.P. Rohrig, “Tramadol: A Forensic Toxicology Overview”

Presented at the Southwestern Association of Forensic Scientists Annual Meeting

October 2005; Wichita, KS

T.P. Rohrig, “Medical Implications of Children Exposed to a Methamphetamine Laboratory Environment”

Invited presentation at Kansas Alliance for Drug Endangered Children Seminar

September 2005; Junction City, KS

T.P. Rohrig, “Zolpidem: Forensic Implications – Pharmacokinetics and Pharmacodynamics”

Invited presentation at the Midwest Association for Toxicology and Therapeutic Drug Monitoring
Annual Meeting

May 2005; Kansas City, MO

C.L. Huber* and T.P. Rohrig, “Lamotrigine – A Forensic Toxicology Overview”

Presented at the Southwestern Association of Toxicologists Meeting

November 2004; Oklahoma City, OK

T.P. Rohrig, “Case Studies Illustrating Application of Principles of Pharmacokinetics”

Presented at the workshop entitled “Application of the Principles of Pharmacology and


Pharmacokinetics to the Interpretation of Drug Blood Levels” [co-chairman] at the American
Academy of Forensic Sciences Annual Meeting

February 2004; Dallas, TX

J. L. Oeberst* and T. P. Rohrig, “Comparison of the Distribution of Fentanyl in Deaths Related to Use and
Abuse of Duragesic® Patch and Intravenous Administration of Patch Contents”

Presented at the American Academy of Forensic Sciences Annual Meeting

February 2003; Chicago, IL


Timothy P. Rohrig, Ph.D.
Page 16

PRESENTATIONS con’t

T. Thompson* and T.P. Rohrig, “The Identification of Capsaicinoids in Pepper Spray Residues”

Presented at the Southwestern Association of Toxicologists Meeting

April 2002; Wichita, KS

T.P. Rohrig, “Interpretation of Postmortem Toxicology: Pitfalls to Avoid”

Presented at the Southwestern Association of Toxicologists Meeting

April 2002; Wichita, KS

C.L. Huber*, L.J. Goodson and T.P. Rohrig, “Oxycodone – An ELISA Method Validation”

Presented at the Southwestern Association of Toxicologists Meeting

April 2002; Wichita, KS

T.P. Rohrig, “Interpretation of Postmortem Toxicology: Pitfalls to Avoid”

Presented at the Kansas Coroner’s Association Meeting

July 2001; Wichita, KS

T.P. Rohrig, “Introduction to Pharmacology and Forensic Toxicology”

Presented at the DEA Basic Narcotic Investigator’s School

March 2001; Topeka, KS

J.L. Oeberst*, T.P. Rohrig, M. Wells, L. Sifford and M.H. Dudley,


“Fentanyl on the Internet and Other Creative Forms of Abuse Resulting in Death”

Presented at the Annual meeting of the American Academy of Forensic Sciences

February 2001; Seattle, WA

T.P. Rohrig, “Drug Facilitated Sexual Assault”

Presented at Syracuse University Health Services Continuing Education Day

August 1999; Syracuse, New York


Timothy P. Rohrig, Ph.D.
Page 17

PRESENTATIONS con’t

T.P. Rohrig, “Pharmacokinetics and Pharmacodynamics of Ethyl Alcohol”

Presented at the New York Prosecutors Training Institute

July 1999; Syracuse, New York

T.P. Rohrig, “Oral Fluid – An Alternative Specimen for Drug Analysis”

Presented in the SOFT/TIAFT workshop entitled “Pharmacology and


Analytical Toxicology of Drugs in Saliva”

October 1998; Albuquerque, New Mexico

T.P. Rohrig, “Complications in the Analyses of Embalmed Tissues”

Invited presentation and panel member at the New York State Toxicology Seminar

September 1998; Albany, New York

T.P. Rohrig, “An Introduction to Forensic Toxicology”

Invited presentation at Angelo State University

April 1998: San Angelo, Texas

J.C. Epley, J.L. Henry and T.P. Rohrig, “The Distribution of Zolpidem in Postmortem Cases”

Presented at the Spring Meeting of the Southwestern Association of Toxicologists

April 1998: Fort Worth, Texas

T.P. Rohrig, “Oral Fluid - An Alternative Specimen for Drug Analysis”

Invited presentation at University of Illinois - Chicago

March 1998: Chicago, Illinois

Invited presentation at the Quarterly Meeting of the California Association of Toxicologists

February 1998: San Francisco, California

T.P. Rohrig, “Confirmation of Cocaine Use in Oral Fluid”

Presented at DHHS Drug Testing Advisory Board - Scientific Meeting on Drug Testing of Alternative
Specimens and Technologies

April 1997: Rockville, Maryland


Timothy P. Rohrig, Ph.D.
Page 18

PRESENTATIONS con’t

T.P. Rohrig, “External Quality Assurance for An Oral Fluid Drug Testing Program”

Presented at DHHS Drug Testing Advisory Board - Scientific Meeting on Drug Testing of Alternative
Specimens and Technologies

April 1997: Rockville, Maryland

T.P. Rohrig, “Quality Assurance and Quality Control in a Postmortem Laboratory”

Presented at the Fall Meeting of the Southwestern Association of Toxicologists

November 1996: Oklahoma City, Oklahoma

T.P. Rohrig, “Urine Drug Testing: How is it done? What does it mean?”

Presented at the 24th Fall Educational Seminar of the Kansas State Society of the American
Medical Technologists

September 1996: Overland Park, Kansas

T.P. Rohrig, “Alcohol Pharmacokinetics”

Invited presentation at the Ethyl Alcohol Symposium. Sponsored by the Southwestern Association
of Toxicologists

November 1994: Fort Worth, Texas

L.E. Balding, F.B. Jordan, C.S. Choi and T.P. Rohrig*, "Gas Flames, Closed Spaces and Hypoxia"

Presented at the Spring Meeting of the Southwestern Association of Toxicologists

April 1994: Dallas, Texas

B. Snodgrass and T.P. Rohrig, "Postmortem Determination of Carteolol Administered


as a Topical Ophthalmic"

Presented at the Fall Meeting of the Southwestern Association of Toxicologists

November 1993: Arlington, Texas

L. Harty and T.P. Rohrig, "Postmortem Distribution of Mexiletine"

Presented at the Fall Meeting of the Southwestern Association of Toxicologists

November 1993: Arlington, Texas


Timothy P. Rohrig, Ph.D.
Page 19

PRESENTATIONS con’t

T.P. Rohrig, "Sudden Death Due to Butane Inhalation"

Presented at the Fall Meeting of the Southwestern Association of Toxicologists

November 1993: Arlington, Texas

T.P. Rohrig, "An Introduction to Forensic Toxicology"

Invited presentation at Angelo State University

November 1992: San Angelo, Texas

T.P. Rohrig, "Toxicology of Volatile Inhalants"

Invited presentation at the Inhalant Abuse Symposium. Sponsored by the Southwestern


Association of Toxicologists

November 1992: San Angelo, Texas

T.P. Rohrig and A.W. Mitchell, "An Accidental Argon Death"

Presented at the Fall Meeting of the Southwestern Association of Toxicologists

November 1992: San Angelo, Texas

T.P. Rohrig and N.G. Ray, "Tissue Distribution of Bupropion in a Fatal Overdose"

Presented at the Spring Meeting of the Southwestern Association of Toxicologists

April 1992: Shreveport, Louisiana

G.W. Kunsman, and T.P. Rohrig, "Tissue Distribution of Ibuprofen in a Fatal Overdose"

Presented at the Spring Meeting of the Southwestern Association of Toxicologists

April 1992: Shreveport, Louisiana

A.W. Mitchell, B.D. Curtis, and T.P. Rohrig, "Headspace Analysis of Toluene"

Presented at the Fall Meeting of the Southwestern Association of Toxicologists

October 1991: Oklahoma City, Oklahoma


Timothy P. Rohrig, Ph.D.
Page 20

PRESENTATIONS con’t

T.P. Rohrig*, L.E. Balding and R. W. Prouty, "Triazolam: Analysis and Case Studies"

Presented at the Spring Meeting of the Southwestern Association of Toxicologists.

October 1990: Santa Fe, New Mexico

R.W. Prouty* and T.P. Rohrig, "Forensic Considerations in the Evaluation and Interpretation of Postmortem
Blood Alcohol Results"

Presented at the 27th International Meeting of the International Association of Forensic


Toxicologists

October 1990: Perth, Australia

T.P. Rohrig and B.L. Snodgrass, "Analysis of 3-Hydroxybenzodiazepines by Gas Chromatography/Mass


Spectrometry"

Presented at the Spring Meeting of the Southwestern Association of Toxicologists

April 1990: Austin, Texas

E.F. Hatch, P.J. Cooper and T.P. Rohrig, "Amphetamine Screening in Medical Examiner Cases”

Presented at the Spring Meeting of the Southwestern Association of Toxicologists

April 1990: Austin, Texas

P.S. Mork and T.P. Rohrig, "Detection of Fentanyl in Postmortem Blood by Radioimmunoassay"

Presented at the Fall Meeting of the Southwestern Association of Toxicologists

November 1989: San Antonio, Texas

T.P. Rohrig, "Postmortem Formation of Ethanol - Interpretation of Results"

Presented at the 18th Annual Midwestern Association of Forensic Scientists Meeting

October 1989: Fairview Heights, Illinois

T.P. Rohrig, "Fluoxetine Overdose: A Case Report"

Presented at the Fall Meeting of the Southwestern Association of Toxicologists

November 1988: Shreveport, Louisiana


Timothy P. Rohrig, Ph.D.
Page 21

PRESENTATIONS con’t

T.P. Rohrig, "Current Drug Screening Methods - An Evaluation"

Invited presentation at the Laboratory Issues in Drugs of Abuse Testing Seminar; Sponsored by
Kansas City Scientific Inc. and the University of Missouri, School of Pharmacy

January 1987: Kansas City, Missouri

T.P. Rohrig, "Drugs and Driving"

Invited presentation at the Law Enforcement Seminar Series.

June 1985: Topeka and Wichita, Kansas

T.P. Rohrig* and D.M. Yourtee, "In Vitro Metabolic Turnover of Aflatoxin Q1 by Rat Liver"

Presented at the Annual Meeting of the Missouri Academy of Science

April 1983: St. Louis, Missouri

CONFERENCES/SYMPOSIUMS

Invited Participant at the "International Symposium on Driving Under the Influence of Alcohol and/or Drugs"

March 1986: Quantico, Virginia

Invited Participant at "An International Symposium on Forensic Toxicology"

June 1992: Quantico, Virginia

Mock Trial Witness at the Lethal Weapon/Vehicular Homicide Trial School

September 1995: Kansas City, Missouri

Invited Participant at “Improving Integration of DRE, Investigative and Toxicological Evidence in DUID
Prosecutions” Summit National Safety Council CAOD and National Highway Traffic Safety Administration

May 2004: Seattle, Washington

Invited Speaker at the Kansas Alliance for Drug Endangered Children Seminar. Presentation entitled
“Medical Implications of Children Exposed to a Methamphetamine Laboratory Environment” and member of
the panel discussion group.

September 2005: Junction City, Kansas


Timothy P. Rohrig, Ph.D.
Page 22

CONFERENCES/SYMPOSIUMS con’t

Invited participant and co-chairman; “Symposium on Special Topics in Forensic Toxicology”

August 2008: Ames, Iowa

Invited Instructor for the Ames Lab/Midwest Forensic Resource Center sponsored workshop [4.5 days] on
“General Principles of Drug Pharmacokinetics [ADME]”

March 2010; Wichita, KS


March 2011; Ames, IA

Invited Instructor for the Ames Lab/Midwest Forensic Resource Center sponsored workshop [4.5 days] on
“Advanced Pharmacokinetics for Toxicologists: P-450 Isozymes and Drug-Drug/Food Interactions”

July 2010; Ames, Iowa


July 2011; Ames, Iowa

Invited Instructor for the Ames Lab/Midwest Forensic Resource Center sponsored workshop [4.5 days] on
“Postmortem Toxicology: Interpretive Challenges and Considerations”

October 2010; Ames, Iowa


October 2011; Ames, Iowa

Invited participant and co-chairman for Ames Lab/Midwest Forensic Resource Center sponsored
conference entitled “Symposium in Toxicology [DUID]”

January 2011: Ames, Iowa

Invited Speaker at the DWI/Traffic Safety and DRE Recertification Conference.


Presentation entitled “DWI-D Value of Urine and/or Blood Toxicology”.

June 2012: Osage Beach, Missouri

Invited Instructor for the Midwestern Association of Forensic Scientists sponsored Spring Toxicology
workshop [2.5 days] on “Postmortem Toxicology: Interpretive Challenges and Considerations”

April 2015: Milwaukee, WI

Invited Speaker at the Kansas Alliance for Drug Endangered Children-Sedgwick County Seminar.
Presentation entitled, “Interpretation of Hair and Urine Drug Test Results”

September 2015; Wichita, KS

Invited Instructor for the Southwestern Association of Toxicologists sponsored Spring Workshop [2.5
hours] on “ADME: General Principles of Drug Pharmacokinetics”

April 2017; Wichita KS


Timothy P. Rohrig, Ph.D.
Page 23

BOOK CHAPTERS

Rohrig, TP, Gamble, M and Cox, K: Identification and Quantitation of Ketamine in Biological Matrices Using
Gas Chromatography-Mass spectrometry (GC-MS). In Clinical Applications of Mass Spectrometry: Methods
and Protocols, Ed U Garg and CA Hammett-Stabler, Humana Press, 2010

Rohrig, TP, Harryman, LA and Norton, MC: Identification and Quantitation of Zolpidem in Biological Matrices
Using Gas Chromatography-Mass spectrometry (GC-MS). In Clinical Applications of Mass Spectrometry:
Methods and Protocols, Ed U Garg and CA Hammett-Stabler, Humana Press, 2010

Rohrig, TP, Norton, MC and Harryman, LA: Identification and Quantitation of Zopiclone in Biological
Matrices Using Gas Chromatography-Mass spectrometry (GC-MS). In Clinical Applications of Mass
Spectrometry: Methods and Protocols, Ed U Garg and CA Hammett-Stabler, Humana Press, 2010

Marinetti, LJ and Rohrig, TP: Drug-Facilitated Sexual Assault (Chemical Sexual Assault). in The Clinical
Toxicology Laboratory: Contemporary Practice of Poisoning Evaluation, 2nd Edition, Ed TC Kwong,
B Magnani, TG Rosano and LM Shaw, AACC Press 2013

BOOKS

Rohrig, T.P. Postmortem Toxicology: Challenges and Interpretive Considerations. 1st Ed.,
Academic Press, 2019.
Timothy P. Rohrig, Ph.D.
Page 24

PUBLICATIONS

1. Youso K.B., Osawa K.A., Divine M.L., Rohrig T.P. “Driving Impairment Cases involving
Flualprazolam”

J. Analytical Toxicology 46:e191-e195, 2022


https://doi.org/10.1093/jat/bkac019

2. Tiscione N.B. and Rohrig T.P. “1,1-Difluoroethane Forensic Aspects for the Toxicologist and
Pathologist”

J. Analytical Toxicology 45:792-798, 2021


Advance Access Publication date: 21 May 2021;
https://doi.org/10.1093/jat/bkab054

3. Rohrig T.P., Nash E., Osawa K.A., Shan X., Scarneo C., Youso K.B., et al. “Fentanyl and Driving
Impairment”

J. Analytical Toxicology 45:389-396, 2021


Advance Access Publication date: 14 Aug 2020;
https://doi.org/10.1093/jat/bkaa105

4. Rohrig T.P., Osawa K.A., Baird T.R. and Youso K.B. “Driving Impairment Cases involving Etizolam
and Flubromazolam”

J. Analytical Toxicology 45:93-98, 2021


Advance Access Publication date: 13 May 2020; https://doi:10.1093/jat/bkaa050

5. Baron M.G., Rohrig T., Gonzalez-Rodriguez J. “Forensic Science in the UK. Part III. Regulation of
Forensic Science in England and Wales-The Role of the Forensic Science Regulator”

Forensic Science Review 32(1): 2-6, 2020

6. Rohrig TP, Miller SA and Baird TR. “U-47700: A Not So New Opioid”

J. Analytical Toxicology 42:e12-e14, 2018; https://doi.org/10.1093/jat/bkx081

7. Rohrig TP, Moore CM, Stephens K, et al. “Roadside drug testing: An evaluation of the Alere
DDS®2 mobile test system”

Drug Test Anal. 2017;1-8. https://doi.org/10.1002/dta.2297

8. Rohrig, T.P. and Hicks, C.A., “Brain Tissue: “A Viable Postmortem Toxicological Specimen”

J. Analytical Toxicology 39: 137-139, 2015

9. Stockham, T. and Rohrig, T.P., “The Use of “Z-Drugs” to Facilitate Sexual Assault”

Forensic Science Review 22(1):61-73, 2010


Timothy P. Rohrig, Ph.D.
Page 25

PUBLICATIONS CON’T

10. Rohrig, T.P., Huber, C., Goodson, L. and Ross, W. “Detection of Ethylglucuronide in Urine
following the Application of Germ-X”

J. Analytical Toxicology 30: 703-704, 2006

11. Rohrig, T.P. and Moore, C.M., “Zolpidem: Forensic Aspects for the Toxicologist and Pathologist”

Forensic Sci Med Pathol 1(2): 81-90, 2005

12. Rohrig, T.P. and Goodson, L.J., “A Sertraline Intoxicated Driver”

J. Analytical Toxicology 28:689-691, 2004

13. Rohrig, T.P. and Moore, C., “The Determination of Morphine in Urine and Oral Fluid following
Ingestion of Poppy Seeds”

J. Analytical Toxicology 27: 449-452, 2003

14. Henry, J., Epley, J., and Rohrig, T.P., “The Analysis and Distribution of Mescaline in Postmortem
Tissues”

J. Analytical Toxicology 27: 381-382, 2003

15. Epley, J.C., Henry, J.L., and Rohrig, T.P., “The Distribution of Zolpidem in Postmortem Cases”

Am. J. For Med. Path., accepted for publication - 1998

16. Rohrig, T.P., “Comparison of Fentanyl Concentrations in Unembalmed and Embalmed Liver
Samples”

J. Analytical Toxicology 22: 253, 1998

17. Rohrig, T.P., “Sudden Death Due to Butane Inhalation”

Am. J. For. Med. Path. 16(3): 229-302, 1997

18. Balding, L., F.B. Jordan, C.S. Choi and T.P. Rohrig, "Gas Flames, Closed Spaces and Hypoxia"

Am. J. For. Med. Path. 16(3): 229-231, 1995

19. Rohrig, T.P. and L.E. Harty, "Postmortem Distribution of Mexiletine in a Fatal Overdose"

J. Analytical Toxicology 18:354-356, 1994

20. Kunsman, G.W. and T.P. Rohrig, "Tissue Distribution of Ibuprofen in a Fatal Overdose"

Am. J. For. Med. Path: 14(1):48-50, 1993

21. Rohrig, T.P. and N.G. Ray, "Tissue Distribution of Bupropion in a Fatal Overdose"

J. Analytical Toxicology 16:343-345, 1992


Timothy P. Rohrig, Ph.D.
Page 26

PUBLICATIONS CON’T

22. Rohrig, T.P. and R.W. Prouty, "Tissue Distribution of Methylenedioxymethamphetamine".

J. Analytical Toxicology 16:52-53, 1992

23. Rohrig, T.P., "Ice: Methamphetamine of the 90's"

Medicolegal-Gram (State of Oklahoma) 9(3):7-8, 1990

24. Rohrig, T.P. and R.W. Prouty, "A Nortriptyline Death With Unusually High Tissue Concentrations"

J. Analytical Toxicology 13:303-304, 1989

25. Rohrig, T.P. and R.W. Prouty, "Fluoxetine Overdose: A Case Report"

J. Analytical Toxicology 13:305-307, 1989

26. Rohrig, T.P., "Alkyl Nitrites: Legal Street Drugs"

Medicolegal-Gram (State of Oklahoma) 8(4):8-10, 1989

27. Rohrig, T.P., D.A. Rundle and W.N. Leifer, "Fatality Resulting From Metoprolol Overdose"

J. Analytical Toxicology 11:231-232, 1987

28. Rohrig, T.P. and R.C. Backer, "Amoxapine Overdose: Report of Two Cases"

J. Analytical Toxicology 10:211-212, 1986

29. Yourtee, D.M. and T.P. Rohrig, "The In Vitro Metabolism of Aflatoxin Q1 by Mouse and Rabbit
Liver Preparations"

Research Communications in Chemical Pathology and Pharmacology


50:103-123, 1985

30. Rohrig, T.P. and D.M. Yourtee, "In Vitro Metabolism of Aflatoxin Q1 by Rat Liver
Postmitochondrial Homogenates"

Research Communications in Chemical Pathology and Pharmacology


40:457-464, 1983

31. Susan, A., T. Rohrig and J. Wiley, "Stability Upon Storage, Analysis, and Purifications of C-14
and H-3 Labeled Polycyclic Aromatic Hydrocarbons and
their Metabolites"

J. Labeled Compounds and Radiopharmaceuticals 18:1449-1455, 1981


EXHIBIT K
Timothy P. Rohrig, Ph.D., F-ABFT
Consultant in Pharmacology and Toxicology
2017 N. Castle Rock
Wichita, Kansas 67230

Email: [email protected]
Alt Email: [email protected]

4 December 2021

Lynn Garcia
Director/General Counsel
Texas Forensic Science Commission
Office of Court Administration
205 W. 14th St, Suite 600
Austin, TX 78701

Re: Matter of TX FSC Complaint #20.55

Dear Ms. Garcia:

At your request and supplied by your office, I have reviewed the following material in the
above captioned case.

 Texas Forensic Science Commission Complaint Form: ExperTox Lab


o ExperTox Forensic Chain of Custody and Control form; ID#192750040,
dated 30 September 2019
o Email correspondence between Brenda Rios [ExperTox] and KE Shroff,
PhD [Arcpoint Labs], dated 2 – 4 Oct 2019
o ExperTox Lab Report-Clinical [Accession #192750040] dated 25 Oct
2019, with limited supporting laboratory data documentation
o ExperTox opinion letter re: Hair Drug Test sample collected on 30
September 2019; authored by Laboratory Director Ernest D. Lykissa, PhD,
dated 25 February 2020
o NMS Draft Report referenced in Complaint was NOT provided/reviewed
 Email correspondence between Khushroo Shroff, PhD of ARCPOINT Labs of
Philadelphia and Philadelphia District Attorney’s Office; 16 August 2019 and 18
September 2019
o Invoices [31 Oct 2019 and 2 December 2019] and Payment receipts

Page | 1
 Apparent College of American Pathologists Inspection deficiency report, with
ExperTox Corrective Actions
 CAP Inspector’s Summation Report; Inspection Date 29 July 2020
 Texas Forensic Science Commission’s request for additional information re:
above captioned complaint, dated 22 March 2021, and ExperTox reply, dated 29
March 2021.
 Litigation Data Pack
o Containing some raw data
 Validation Studies for THC [Hair] and Lidocaine [Hair]
 SOP/Policy – “Non-Forensic Reporting” vs “Forensic Reporting”
 Baseline Hair Testing SOP
 ExperTox Lab Report without Non-Forensic Disclaimer [Accession #192750040]
dated 25 Oct 2019

My comments and opinions will be focused on the Reliability and Validity of Testing and
the Expert [Ernest D. Lykissa, PhD] opinion letter rendered in the above captioned
matter; specifically:

1. Are the hair testing results reported by ExperTox supported by the data
provided by the laboratory?
2. Are the hair testing results provided by ExperTox supported by accepted
scientific reporting criteria in forensic toxicology?
3. Was the interpretation provided by ExperTox regarding impairment of the
complainant (sic) scientifically valid?
4. Does Expert have any observations regarding the role of the accrediting
body (CAP) in providing oversight for any issues observed during the
course of Expert’s review?
5. Are there any other observations Expert believes would assist the FSC in
addressing the complaint filed in this matter?

The following facts and opinions are based upon my review of the aforementioned
material, the technical, scientific and medical literature and my education, training and
experience in the fields of pharmacology and toxicology.

 On 30 September 2019 at approximately 1215 hrs [12:15 pm], a hair sample was
collected from a donor [name and other identifying information was redacted] by
Arcpoint Labs, and sent via FedEx to ExperTox laboratory which received the
specimen on 2 Oct 2019.
 The requested testing to be performed was a “Date Rape” test and a specific
request to further test for lidocaine.

Page | 2
 ExperTox Laboratory reported [Accession #192750040] the following:

Hair:
 Gamma-Hydroxy Butyric Acid [GHB]: Detected - < 50 pg/mg
 Delta-9-THC: Detected - 7.5 pg/mg
 Lidocaine: Detected – 3.9 pg/mg

Baseline Findings:
Lidocaine: Detected at 0.43 pg/mg
Delta-9-THC: Not Detected

The following other drug/drug classes were reported non-detected:


 Barbiturates
 Benzodiazepines
 Opioids
 Sedative/Hypnotics
 Over-the-Counter drugs
 Muscle relaxants

Review of Analytical Data provided to support Reported Results [Accession #192750040]:

Overall evaluation of the data was challenging, given the “screen shots” of the sequence
tables, and chromatograms were of poor quality and difficult to read the numerical
values, along with the absence of key raw data [e.g. area counts of ions].

GHB:

The laboratory reported a GHB result of “DETECTED”, at a concentration of


less than 50 pg/mg of hair. The analysis was conducted 6 Oct – 14 Oct 2019.

The confirmation batch log for GHB does not indicate the GC/MS instrument
utilized for the analysis. The batch log [Batch #09301908, 10031908] reflects
that the Ion Ratios and Retention times [RT] for GHB case sample, calibrator, and
controls, both required for identification, were within specifications. However,
this could not be verified since the “Results Table” was not accompanied with
supporting data and chromatograms. The sequence table does reflect the
referenced sample [Line 43]; however the vial number [#6] does not match the
Sample number [#5] on the handwritten GHB confirmation Batch Log.

The batch log reflects that the same stock solution [Lot#073019Bc 1] was used to
make both the calibrator and controls.

The GHB result as reflected on the handwritten batch log was zero, as compared
to the reported result of “Detected”, less than 50 pg/mg. The detected less than
would suggest that the compound was detected above the Limit of Detection
[LOD], but was below the Limit of Quantitation [LOQ] of 50 pg/mg.

Page | 3
LIDOCAINE:

Lidocaine SOP

The lidocaine SOP provided for review was V2017-001 [assuming version date
unknown month in 2017]; annual review page reflects first date of review of 30
Oct 2019. An email from Dr. Shaiju Vareed dated 30 Sept 2021 stated that the
effective date for the Lidocaine SOP was 30 Oct 2019.

The SOP states that a 5-point calibration curve, including the origin, is generated
for each client samples. The qualifier ion (+ 30%) range is set by the threshold
[calibrator] standard (100 pg/mg for lidocaine). [Lido SOP pg 4 of 8]

The SOP reflects Lidocaine quality control [QC] concentrations were 350 pg/mg
[low QC] and 750 pg/mg [high QC]. The acceptance criteria [Lido SOP pg 4 of 8] for
controls are [abstracted]:

 Positive controls quantitative value MUST be within + 30% of established


mean.
 Negative control must demonstrate no drug present as defined by Limit of
Detection.
 Control has an unacceptable parameter (i.e. chromatographic quality).
 If the criteria are not met, “The run should be rejected”.

There is no mention of chromatographic quality as far as acceptance or not for a


calibration point. Case (Client) samples should have baseline resolution from any
interfering peaks.

The SOP states “Review of the data is documented by the Director or Certifying
Scientist’s initials on the chromatograms.” [Lido SOP pg 5 of 8]

The SOP further states that “Unknowns with values less than 100 pg/mg for
lidocaine is reported as Negative. [Lido SOP pg 5 of 8]

It should be noted that the references listed in the SOP have no direct connection
to lidocaine analyses, with a possible exception of the Baselt reference which I am
assuming is the lidocaine monograph [page is not provided] in the book.
[Lido SOP pg 6 of 8]

Lidocaine Linearity Study

Although a validation study for lidocaine was requested, the laboratory produced
a “Linearity Study”. The submitted study appears to be performed on LCMS#4;
however the acquisition date [assuming performance date] was 10 Sept 2021.

Page | 4
The study did not address other important parameters in a properly validated
method, such as the following; in a method which appears to have been use for
many years:

 Precision and Accuracy of the method


 Bias in the method
 Interferences by other compound with the method
 Ion suppression/enhancement in the LCMS method [matrix effects]

Case Data [#192750040]

The laboratory reported under additional findings a lidocaine result of “detected”,


at concentration of 3.9 pg/mg of hair. The report further indicates a “Baseline”
concentration of lidocaine at 0.43 pg/mg of hair.

The initial lidocaine confirmation batch log [#10031908] ran on 16 Oct 2019,
reflects the a negative control, case sample (192750040) and calibrator [Lot#
040819RH2 Exp date 4/21] and reports a lidocaine result of “detected”, with an
apparent concentration of 0.5 pg/mg, with the negative control as zero and the
calibrator as positive.

This information was provided with the Complaint, data was requested to support
the lidocaine testing, and this batch was NOT included in the data produced on 16
Sept 2021.

An additional confirmation lidocaine batch was run on 17 Oct 2019, and


interestingly had the same batch number [10031908] as the batch run on 16 Oct
2019. [See inserted data below] The batch log listed the samples as follows;
negative control, case sample, calibrator and calibrator 2. The worklist report
reflects the same order, with a blank in between the case sample and calibrator 1.
However, the Cal 1 and 2 lot numbers were different [Lot # 1019195V2 Exp
10/21 for both], as compared to the batch run on 16 Oct 2019. The batch log [17
Oct 2019] and result table, with the associated sample chromatogram, reflects a
lidocaine concentration of 3.9 pg/mg. The second calibrator was not used, the
batch log reflects a comment “NA (Peak Platued (sic))”, assumed author meant
the peak plateau; thus invalidating the calibrator for use.

Cal1 Lidocaine Peak also appears overloaded/saturated. Although the data


suggests [difficult to “see” the raw responses for the MRMs due to the poor
quality of the provided data], the transition ratio are acceptable for the
identification of lidocaine, using an overload peaks for the calibrator will skew
the results.

The chromatogram/calibration curve print out indicates a single point calibration


was used; with the 100 pg/mg data point, and the origin. This is contrary to the
stated SOP using four calibrators and the origin, as well as the presented linearity

Page | 6
The laboratory did NOT follow the presented SOP, as far as using a multi-point
calibrations curve; instead use a single point calibrator which is not a forensically
acceptable method to produce a quantitative value. Furthermore, the laboratory
did NOT follow its reporting criteria, in that the case sample and “baseline” result
should have both been reported out as NEGATIVE, since both results were below
the apparent LOD/LOQ of the method, and the questionable identification of
lidocaine based upon the presented data.

The laboratory did not validate the lidocaine method as required by CAP and
good forensic laboratory practice. The only presented “validation data” [minimal
at best] was generated AFTER a request for the validation study relating to the
captioned complaint.

In both confirmation batches, the calibrators appear to be overloaded, and in


neither of these batches were QC samples analyzed.

Delta-9-THC:

THC SOP

A 4-point calibration curve is generated; the SOP is silent on whether the origin is
included in the calibration curve. The SOP does not define the “Threshold
Standard”; in which the ion ratios of the controls and client [case] sample are
compared, although one may assume the reporting cut-off calibrator [5 pg/mg] is
the same as the threshold standard.

The acceptance criteria [THC SOP pg 4 of 8] for controls are [abstracted]:


 Negative control must demonstrate no drug present as defined by Limit of
Detection.
 The Positive Controls Quantitative Value must be within + 30% of the
established mean. However, under Calibration, the SOP states the QCs
should be within + 30% of the targeted values.
 The Retention Time must be within + 4% of the Threshold Standard.
 Control has an acceptable parameter (i.e. chromatographic quality).
 If the criteria are not met, “The run should be rejected”.

There is no mention of chromatographic quality as far as acceptance or not for a


calibration point and/or batch run.

The SOP states “Review of the data is documented by the Director or Certifying
Scientist’s initials on the chromatograms.”

Page | 9
THC Validation Study

An undated or signed summary of THC and Carboxy-THC validation parameters,


excluding ion suppression/enhancement results was presented.

The Accuracy and Precision Studies for THC and Carboxy-THC, with approval
sign-off [see below], were dated 21 May 2018.

Although the sign-off by unknown individual indicated the instrument was


cleared for use, it failed to identify the instrumental platform.

The above Accuracy and Precision Studies did not have supporting data for the
above approval.

Data for Interference Studies, and a Carry-Over Study had acquisition dates of 9
July 2018, and Additional Accuracy Studies with an acquisition date of 27 July
2018. The additional Accuracy study was approved on 30 July 2018 by Dr.
Lykissa. The Summary Table for Carry-Over reflects a 100 ng calibrator

Page | 10
followed by a 2.5 ng calibrator, whereas the sequence table appears to reflect a
1000 ng THC calibrator followed by 2.5 ng calibrator.

The THC Hair Validation study did not address other important parameters in a
properly validated method, such as the following; in a method which appears to
have been use for many years:

 Bias in the method


 Interferences by other compound with the method
o Although the method was challenged with a number of commonly
encountered compounds, it was not challenged with any synthetic
cannabinoids for interference.
 Ion suppression/enhancement in the LCMS method [matrix effects]

Case Data [#192750040]

The THC SOP states [THC SOP pg 4 of 8] “If the quantitative value for the positive
control is out of range or any other parameters are unacceptable (i.e. retention
time, ion ratios, chromatographic quality, etc.). The run is to be rejected.”

The Confirmation Batch Log Worksheet [Batch 10031904; 4 Oct 2019] does have
QC results “checked” as acceptable. However, the case data does not reflect the
established mean and/or range for the Controls. Although, if one relies upon the
target values, then it appears the QCs are within acceptable ranges.

The SOP states that any interfering peak on the case sample should have baseline
resolution. It is apparent, as shown below, that there is some interference with the
case sample chromatography, and thus calls into question of the identification
based upon transition ratios.

Page | 11
As a result of that complaint, I was asked to review and evaluate the case material and
provided a response to the below questions [my response is indicated briefly following
each question].

1. Are the hair testing results reported by ExperTox supported by the


data provided by the laboratory?

NO

2. Are the hair testing results provided by ExperTox supported by


accepted scientific reporting criteria in forensic toxicology?

NO

It is my opinion that the Toxicology Report should never have been issued, and the
“expert opinion” is not founded or support by the scientific literature.

My opinions and response to the posed questions are further supported by the following:

 GHB reported “Detected < 50 pg/mg” is in conflict with the result of zero written
on the confirmation batch log.
 Not following approved SOP or testing without approved SOP [Lidocaine]
 Ignoring poor quality of the raw data
 Using an assay [lidocaine] that had absolutely no validation or anything remotely
associated with establishing any validation parameters in the batch that the case
sample was run; and most disturbing when the validation study was asked for in
August 2021[relative to this inquiry], the laboratory finally produce the “Linearity
Study” which was run on or about 10 Sept 2021.
 Lab Report states “This test is developed and validated by ExperTox
Laboratory.”
 Reported lidocaine values were below the SOP stated reporting limit and should
have been reported as negative.
 In Dr. Lykissa’s letter of 29 March 2021 to Mr. Robert Smith, he states in
reference to this matter that the tests were not performed with forensic criteria.
 Given the poor quality of the produced data and apparent missing key data points,
i.e. ion abundances; one can’t assess whether or not the ion ratios are acceptable
according to standard forensic practices. The SOP states they must be within
+ 30%, the print out does suggest they are. However, +30% may not be
acceptable given the abundances of the two ions are unknown.

Page | 13
3. Was the interpretation provided by ExperTox regarding impairment
of the complainant (sic) scientifically valid?

NO

In Dr. Lykissa’s report [reference to ExperTox Hair Drug Test collected 30 September
2019], dated 25 February 2020 he states: “It is my professional opinion that these
amounts of THC and Lidocaine detected in Ms. (name redacted) hair, constitute evidence
of potential serious combined enhanced pharmacological effect to her ability to control
her Mental and Physical faculties.”

The following comments and opinions are assuming that the THC and Lidocaine were
actually present in the hair, as discussed previously, they results should have been
negative and hence there is nothing to interpret.

THC may have a cognitive impact while the individual is acutely intoxicated. However,
the presence of a drug(s) in a hair sample will only indicate exposure to the drug and
cannot be directly associated with intoxication, in isolation, on a particular day.

The ExperTox request form [A308361; collection date 30 Sept 2019] does ask that the
submitted hair sample be tested for lidocaine.

Lidocaine is a local anesthetic and antiarrhythmic drug and is generally not known for its
intoxicating or impairing effects. It has a generally low bioavailability, approximately
35%; therefore with oral administration most of the drug will not reach systemic
circulation and therefore will have little to no central effect. At high systemic [IV] doses,
this medication may cause some adverse side-effects; including CNS effects such as
dizziness, confusion and loss of consciousness. The incidence of CNS toxicity (i.e.
depression) is dose dependent and quite rare, with reported frequency of less than 1%
following IV administration.

An isolated report suggests that lidocaine has been used to facilitate a sexual assault
[Suchan and Adamowicz 2013]. Fathy et al [2019] suggest that IV lidocaine may cause
postoperative cognitive impairment. In commenting on Fathy et al [2019], van der Veen
and Slagt [2019] they state that the postoperative cognitive dysfunction is not due to the
anesthetic technique or drug, but patient characteristics; such as age and frailty.
The presence of lidocaine may be due to the sexual assault examination [coating of the
speculum with lidocaine], topical treatment of minor injuries sustain in the time frame in
question, and/or as a lubricant used during the alleged assault.

A review of the literature does not suggest any clinically relevant potentiation, additive or
synergistic effect(s) of lidocaine with the co-administration of THC.

Page | 14
4. Does the Expert have any observations regarding the role of the
accrediting body (CAP) in providing oversight for any issues observed
during the course of Expert’s review?

YES

CAP performed a laboratory assessment of ExperTox on or about 8 June 2018. One of


the deficiencies that related to this evaluation was TLC.10475.

TLC.10475 [Validation of LC (MSMS) 4]

In CAP’s 29 June 2018 letter to Dr. Lykissa, they listed criteria that should be presented
in a validation study; e.g. accuracy, precision, interferences, reportable range, and matrix
matched reference material. It appears this was provided by ExperTox for THC in hair to
CAP on or about 18 July 2018.

However, when the validation study was requested on or about 30 Aug 2021 from
ExperTox, as part of this review [TPR], it was received on 16 Sept 2021 key components
of a forensically acceptable validation study were still absent. As discussed previously,
the study did not address other important parameters in a properly validated method as
required by CAP; such as the following:

 Precision and Accuracy of the method


 Bias in the method
 Interferences by other compound with the method
 Ion suppression/enhancement in the LCMS method [matrix effects]

Comments and Conclusions

It appears that ExperTox was using an improperly validated method for lidocaine, and in
my opinion still is, after being put on notice and required to correct for another analyte
[THC] several years prior to the case specimen in question.

It appears that the absence of a validation study for Lidocaine was not noted by the CAP
inspection of 29 July 2020. The only deficiency reported was GEN.20450; the inspector
commented on “There were write-overs on temperature OCs. No correction of write-over
was observed.”

The CAP Inspector’s Summation Report for inspection date 29 July 2020 reflects no
deficiencies for the Forensic Drug Test Unit. Given the issues noted by my review, I am
assuming the CAP inspector only looked at the target analytes for their program, and not
additional compounds [i.e. lidocaine] tested in ExperTox’s “Date Rape Panel-Hair”
panel. I further suspect the possibility that the inspector was presented with limited and
“clean data” for review, or perhaps just data from urine specimens.

Page | 15
5. Are there any other observations Expert believes would assist the FSC
in addressing the complaint filed in this matter?

Yes

5.1: The overall quality of documentation was poor.

5.2: CAP initially advised EXPERTOX of validation deficiencies for LCMS#4 on 29


June 2018, and gave the laboratory a list of needed validation parameters. The laboratory
apparently ignored this advisory for lidocaine, in that a validation study was not
performed. Upon request [20 Aug 2021] for the validation studies, on 30 Aug 2021 Dr.
Lykissa asked for additional week to produce the required studies. However, they used
this time, on or about 10 Sept 2021, to conduct a “validation study” for lidocaine. These
were received on 16 September 2021. The Lidocaine study only addressed a few of the
criteria; i.e. linearity and apparent carry-over.

5.3: The data requested both by the Philadelphia DA and your Commission was of
such poor quality [legibility] that a review was difficult at best. Several data points were
missing so one could not verify [ion ratios] compliance with either EXPERTOX SOPs or
standard practice in the industry.

5.4: The use of the same stock solution for calibrator(s) and controls or the absence of
documentation of the lots numbers for the calibrators and controls.
 GHB: Issue discussed in prior GHB section.
 General “Date Rape” Screen [Batch 09301908/10031908] and
Fentanyl [Batch 10021904] had the same lot number and expiration
date [01032019 & 1/21] for ALL calibrators and controls.
 Opioid batch for Tramadol and Meperidine lacked documentation of
the Lot # and Expiration date for calibrator(s) and controls.

5.5: There was an overall perception of poor or non-existent management review and
approval of validation studies, SOPs and case data.

5.6: Non-Forensic Report v Forensic Report

On 22 March 2021, Staff Attorney Robert Smith inquired to ExperTox what their
policy relating to “Results are for CLINICAL USE ONLY, NOT FOR
FORENSIC PURPOSES”. ExperTox Laboratory Director Ernest Lykissa replied
that the statement is used as a disclaimer for establishing the validity of our
published results only for clinical practice. “….since the [tests] were not
performed with forensic criteria (i.e. valid Forensic Chain of Custody,
Forensically validated methods.)”

Page | 16
ExperTox SOP for Non-Forensic Reporting v Forensic Reporting, signed by
Ernest Lykisaa, PhD on 8 Sept 2018 states in part the following:

“The stellar discrepancy of a clinical test vs. forensic is the lack of a valid forensic
chain of custody. In addition, the original clinical report does not usually meet
forensic criteria. Therefore, in order to remedy these discrepancies, we will
review all documentation, received in the lab regarding the specimen, and
generated by instrumental analyses. We may then contact the sample collecting
facility and advise them that we need an affidavit signed by the collector that
addresses the omissions of the clinical requisition form, and the need to generate a
forensic chain of custody form. The sample tested needs to be retrieved if it
resulted in positive drug findings and retested under forensic protocol per our
SOP and reported as such.”

There does not appear to be data to support a retest, and the Lab Report without
the Clinical disclaimer does not reflect it is an amendment or addendum report.
In a comparison of the two reports, it appears that the only change/amendment
[not reflected on the report] was the removal of the Clinical Disclaimer statement.
There appears to be two invoices from ExperTox to ARCpoint [collection site] for
the “Date Rape Panel”; Invoice #81833 31 Oct 19 for Accession #1927550050,
with Donor Name redacted in the amount of $345.00 and the second Invoice
#82169 for a “Forensic Version” of the Report, with the donor name redacted in
the amount of $1,315.00.

The significant upcharge for a simple removal of the disclaimer, without retesting
or review and no indication of an amendment/addendum should raise some ethical
concerns.

I believe the review of the provided material is sufficient to call into question the
accuracy and quality of data in the matter at hand.

I reserve the right to review any additional information subsequently made available and
to modify, if necessary, my opinion based upon the new information.

If I may be of further assistance and/or you would like to discuss this report, please do
not hesitate to call.

Respectfully submitted,

/s/ Timothy P. Rohrig


Timothy P. Rohrig, Ph.D., F-ABFT
___________________________________________________________________
Suchan M, Adamowicz P. Problems of Forensic Sciences 2013:96 752-64.
Fathy W, Hussein M, Khalil, H. Local and Regional Anesthesia 2019:12 1-6.
Van der Veen GJ, Slagt C. Local and Regional Anesthesia 2019:12 27-28.

Page | 17
EXHIBIT L
1430 Center Street
Deer Park, Texas 77536
Ph. 281-476-4600
Fx. 281-930-8532
www.expertox.com

Date: March 29, 2021

Robert Smith Esq.

1. In the last 3 years I can recall of five cases (see below) in which the Donors of
the Hair specimen submitted the reports of Expertox to authorities , as proof of
abstinence or adherence to Court dictates ( i.e. probation). To clarify, the report was
issued to the submitting collection facility, which forwarded the report to the Donor of
the Hair specimen

2. In the last 3 years and in at least 5 instances that I can recall, out of state
District Attorneys demanded phone interpretation of hair testing results. In every
occasion they also asked for written interpretational reports which I declined in every
case, and asked them to call NMS Labs in Pennsylvania.
For example, in the Wood Carrie case in Philadelphia, the DA asked me to testify on this
case for which I declined since the test had been performed for Clinical Use only. The
reason been that we did not have, a Forensically validated hair testing method for
Lidocaine at this time, only for clinical testing. Then the DA literally begged me to write
something down hypothetically for the Lidocaine and THC combined effect on
someone’s mental state which reluctantly I did (my wrong decision) send her the standard
report I issue to the Medical Centers in the Houston area to Medical Doctors handling
critical care patients.. I also recall telling her that the Lidocaine detected in the baseline
segment was disproving the claim of the plaintiff that the Lidocaine was administered by
the defendant. Only the THC was pertinent. I also advised her to talk to NMS for
supportive testimony. The complaint was filed with your Commission by the Defense
Attorney who demanded from my assistants, for me to consult with her which I declined.
Please note: In the last 3 years, there have been multiple phone consultations with
Medical Practitioners about the Clinical significance of the hair testing findings issued by
my Laboratory. In these cases, i.e. Memorial Hermann Prevention Facility for Substance
Abuse Rehabilitation, and for Critical Care patients in Hermann Hospital and Children’s
Hospital of Houston written interpretational reports were issued.

3.The statement on our reports, issued by our laboratory, “FOR CLINICAL USE
ONLY AND NOT FOR FORENSIC PURPOSES”, is utilized as a disclaimer for
establishing the validity of our published results only for the clinical practice that
originally ordered these test reports. No attorneys or prosecutors may issue subpoenas
for these tests since they were not performed with forensic criteria (i.e., valid Forensic
Chain of Custody, Forensically validated methods). The Forensic Mandates in
accordance to the mandates of our National Forensic Accreditation by the College of
American Pathologists, are only utilized for testing hair samples of, i.e., Houston Police
Deputies, and for Human Resources Entities, for Pre- Employment of new Hires, and or
for Cause on the job sites of Houston.

4.
Expertox List of Hair Drug Testing Confirmations by
GCMS/LCMSMS
Amphetamine, Methamphetamine, MDA, MDMA (Extasy), MDEA,
THC and metabolites,
Opiates, 6- Acetylmorphine,
Cocaine and metabolites,
PCP,
Benzodiazepines and metabolites,
Barbiturates,
Methadone and metabolite,
Propoxyphene and metabolite,
Meperidine and metabolite,
Tramadol and metabolite,
Fentanyl, Sufentanyl, Ketamine and metabolite,
Lidocaine,
Promethazine,
Amitriptyline, Nortriptyline, Imipramine, Desipramine, Doxepin, Desmethyl-Doxepin,
Buprenorphine and metabolite,
Chlorpheniramine,
Citalopram,
Sertraline,
Dextromethorphan,
Dimethyltryptamine,
Diphenhydramine,
Ethyl Glucuronide,
Fluoxetine,
Gabapentin,
GHB (Gamma Hydroxy Butyrate), 1,4 Butanediol
Mitragynine,7-Hydroxymitragynine,
LSD, 2-OXO-3-OH-LSD,
Methylphenidate,
Naltrexone,
Tizanidine,
Nicotine, Cotinine,
Psilocybin, Psilocin,
Scopolamine,
Tapentadol,
Doxylamine, Brompheniramine,
Carisoprodol, Meprobamate,
Cyclobenzaprine,
Methocarbamol,
Phentermine
Methaqualone,
Zolpidem, Zopiclon

Note: Dr. S. Vareed and myself have obtained Provisional Texas Forensic Analyst
Licenses at this time (early in March 2021). And need be by the commission we will seek
whatever additional accreditations will satisfy any requirements we must meet.

Ernest D. Lykissa Ph.D.


Molecular Pharmacology,
Medicine and Experimental Surgery
Clinical and Forensic Toxicologist
Expertox Laboratory Director
EXHIBIT M
1

8 FORENSIC SCIENCE COMMISSION QUARTERLY MEETING

9 JANUARY 29, 2021

10 VIA ZOOM

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25
2

1 (Requested excerpt begins)

2 MARK DANIEL: Which brings us to

3 complaints, and our first is 20.55. It's brought by the

4 Philadelphia attorney's office that's making allegations

5 against ExperTox Lab concerning hair follicle testing.

6 They allege they conducted scientifically unreliable

7 testing on hair follicles on a sexual assault survivor.

8 The analysis of the hair was for the presence of

9 delta(9)-THC and also lidocaine. The district

10 attorney's office consulted and obtained NMS Labs to

11 review the case and offer opinions regarding the testing

12 of ExperTox.

13 We now have NMS's final report available to

14 us. It's consistent with their original draft. NMS

15 found the testing form did not align with generally

16 accepted requirements of forensics testing. It found

17 the testing for lidocaine did not contain the

18 appropriate quality control samples. It found the

19 method used to quantify the baseline specimen and the

20 case specimen were wholly inconsistent. It found the

21 single point calibration used to quantify lidocaine in

22 the case was not really successful, and then the

23 analytical result did not support a final indication of

24 lidocaine.

25 So with that being said, we reached out to


3

1 ExperTox and they had responded that this was for

2 clinical purposes only and not forensic. I understand

3 Dr. Ernest Lykissa -- I may have pronounced --

4 mispronounced that name -- is available today to respond

5 to that or enlighten us on what they mean on clinical

6 purpose versus forensic.

7 And, Lynn, maybe that might be -- make him

8 available for discussion. Questions about that might be

9 appropriate.

10 LYNN GARCIA: Yes, I believe they're on the

11 line.

12 So, Leigh, can you make sure that they can

13 unmute?

14 Let me see, I'm going to ask to unmute.

15 LEIGH TOMLIN: Yeah, they can.

16 LYNN GARCIA: Okay, super. Thank you.

17 ERNEST LYKISSA: Okay, can you hear us now?

18 LEIGH TOMLIN: Yes.

19 ERNEST LYKISSA: Okay. We're on.

20 MARK DANIEL: Let me begin with a question

21 if I may, Dr. Barnard. I saw the response that they

22 said that their work was for clinical purposes only and

23 not forensic, and that's fine, but I understood the

24 sample was submitted to them in connection with a sexual

25 assault matter. So I'm trying to understand that. If


4

1 y'all can help us, please.

2 ERNEST LYKISSA: Okay. We will tell you

3 that they were informed at the time because they had

4 written specifically for lidocaine. They were informed

5 at the time that the only method of lidocaine we had in

6 our laboratory validated -- it was not for a hair

7 lidocaine. We don't usually do hair with lidocaines.

8 They said, well, can you see it? If you -- if you see

9 it, that will be enough quantitatively. That's what we

10 were told by the -- the district attorney, okay, up

11 there.

12 And so we did find lidocaine, but it was in

13 a clinical method. We had no time to validate anything

14 here, okay. We were just going to tell them

15 quantitatively.

16 The THC was perfectly there, and it had not

17 been there on the baseline. The baseline refers to a

18 growth segment of the hair that does not correspond to

19 the growth of the -- of the incident date, something

20 from before, because we get long hair. So the -- the

21 most proximal ending is usually the one that they are

22 interested in. So we went before that and we tested,

23 believe it or not, in the baseline about one month's

24 worth of growth between June of 19 and 7 of 19, and what

25 we did obtain in this particular one -- no. No. No,


5

1 let me see here. Excuse me.

2 7-16. Yes, 7-16 to 8-13 was the incident

3 date. The baseline was 6-18 to 7-16. In that

4 particular one, we detected lidocaine in a very small

5 amount and then we detected no THC.

6 Now, the THC -- there's no problem with the

7 THC. They never mentioned anything about the THC. I

8 told them, I said, look -- when they called me, I said,

9 this test was done clinically. You can take it for

10 approximately, you know, and look at it, and we see a

11 3.9 showing up on the incident date. You see a .43.

12 Who tells you that she did no take it by herself. She

13 was taking it before. We don't have any evidence, okay.

14 I said, I do not want to testify on this case. I do

15 not -- I cannot offer you anything scientifically valid.

16 I said, and please read the caveat that I

17 bolded for you, you know, capitalized for you, clinical

18 use only, not for forensic purposes. I cannot say it

19 any louder and not clearly without being obnoxious.

20 LYNN GARCIA: So this is Lynn Garcia.

21 I'm -- I'm looking at a report that ExperTox released

22 February 25th of 2020, and it says, it is my

23 professional opinion that these amounts of THC and

24 lidocaine detected in the survivor's hair constitute

25 evidence of potential serious combined enhanced


6

1 pharmacological effect to her ability to control her

2 mental and physical faculties. If these drugs were

3 administered to her without her consent, then that could

4 constitute a drug facilitated assault by the

5 perpetrator.

6 ERNEST LYKISSA: Well --

7 LYNN GARCIA: And when I read that, what I

8 see is -- you know, setting aside whether that type of

9 statement is supportable just as a scientific matter --

10 ERNEST LYKISSA: Well, it's not an

11 absolute.

12 LYNN GARCIA: Well, what I am -- but let me

13 finish my statement.

14 So what I see there is what we would

15 classify under Texas law as interpretive toxicology. So

16 you're talking about pharmacological effects of drugs in

17 a person's system. This is clearly within the context

18 of a criminal action, and so my question is -- you know,

19 Texas law requires two things. One is accreditation of

20 the laboratory, and the second is licensing of analysts.

21 So under 38.01 of the Code of Criminal Procedure, it

22 states that a person may not act or offer to act as a

23 forensic analyst unless the person holds a forensic

24 analyst license.

25 So just to be really clear, there are a


7

1 number of concerns, I think, that we have about

2 ExperTox's -- I understand that you do a lot that does

3 not have to do with the criminal justice system, but to

4 the extent that the work you do does interface with the

5 criminal justice system, there are -- the legislature

6 has set forth very clear parameters within which people

7 are expected to operate and within which we have, you

8 know, many, many, many labs - small, large, public,

9 private, inside of Texas, outside of Texas - who comply

10 with all of these requirements.

11 So for me, there are multiple questions

12 that arise in reviewing this complaint that was filed by

13 the DA's office in Philadelphia.

14 ERNEST LYKISSA: Are you waiting for a

15 reply?

16 DR. BARNARD: Well, do you have a reply?

17 ERNEST LYKISSA: Well, yeah. I mean,

18 we -- I mean, if you look at my resume, sir, I was doing

19 forensic toxicology in California before there was such

20 a field. Okay. And -- with my other (unintelligible)

21 mass specs that we had there in SAMHSA labs both in Los

22 Angeles and in -- also in the Fresno, California area.

23 And I've testified in a lot of federal courts, and I

24 think with my 75 years on my head, I can tell you that I

25 have seen everything that the forensic arena can show,


8

1 okay, but I've been a professor at Baylor College of

2 Medicine in clinical and forensic toxicology, and as far

3 as I'm concerned, these tests should not have been used

4 because I did tell her finally, even though I wrote that

5 report, that it -- that those results, based on what

6 we -- we published on this report, are consistent with

7 someone having a -- because I also in my PhD, I have

8 experimental medicine and surgery and molecular

9 pharmacology. So I have a pharmacological professional

10 opinion, okay. So I'm not a chemist from somewhere,

11 okay, to put out in the protections that I know nothing

12 about the drugs.

13 So these drugs, if I find them in somebody

14 and I have validated methods -- the THC method was

15 validated. That was a validated method. And according

16 to the College of American Pathology forensic

17 accreditation, we are fully accredited to do things

18 outside of Texas because with Texas, you -- the Texas

19 Commission has put me on a -- on a watch list for not

20 doing anything forensic in Texas, and I have refused a

21 lot -- every day we are refusing specimens from Texas,

22 okay, when attorneys want to do secondary testing for

23 this and that, and I -- and I tell them, we cannot do

24 that in Texas.

25 And as far as I'm concerned, we also have


9

1 ISO 17025 in hair testing, and we are No. 3 laboratory

2 in the SAMHSA list of laboratories to be starting hair

3 testing for forensic purposes by SAMHSA, okay, in truck

4 drivers starting of this year.

5 So all I can tell you is I know what I'm

6 talking about, and I feel that my caveat at the bottom

7 of that result, clinical use only, not for forensic

8 purposes, was put there for only one reason, to absolve

9 me from having something like this happening to me,

10 okay. And I don't take it very nicely, obviously. I'm

11 sorry, but I'm suffering from some vaccine or COVID

12 low-grade fevers right now.

13 So anyway. So that's all I'm going to tell

14 you, and I find it completely -- I mean, the THC was

15 perfect. The only thing that we had was the lidocaine,

16 and the lidocaine, as far as I'm concerned, with one

17 standard in clinical practice with a calibrator on a LC

18 triple quad mass spec not only visualizes the molecule

19 for you, but also you can get some intensity of signal

20 that you can qualify over a -- another injection of a

21 standard. So that's all we did, okay.

22 LYNN GARCIA: So I just want to be clear

23 about something in terms of the law, which is that the

24 law defines what forensic analysis is, and forensic

25 analysis is an expert examination or test on physical


10

1 evidence for the purpose of connecting the evidence to a

2 criminal action. The term "criminal action" is broadly

3 defined under Texas law. What the law does not say is

4 that if you write a sentence in the bottom of your

5 report that says this is not intended for forensic

6 purposes but you know that the client is using it for

7 forensic purposes --

8 ERNEST LYKISSA: Oh, I did not at the time.

9 No, I did not. It came through a collector. Excuse me.

10 It came from our point in Philadelphia. I didn't know

11 why they were testing. The specimen showed up at our

12 door and we went ahead and test it, okay, but they were

13 also told that the lidocaine was only validated for

14 clinical purposes. So we put that caveat at the bottom

15 for that reason.

16 So I would like to beg you guys to look at

17 this, okay, from my position and understand that

18 sometimes between the collectors and the lady that went

19 to the collector with a self test that she paid them,

20 okay, and then I get the test and I'm not given any

21 knowledge like you have in your cases that you do in

22 your laboratories. You have officers testifying with

23 you telling you I arrested somebody for this, I

24 arrested -- I don't know anything about these people

25 that are sending the specimen to me.


11

1 LYNN GARCIA: So you --

2 ERNEST LYKISSA: Go ahead.

3 LYNN GARCIA: But it is quite clear from

4 everything that we have that you interacted directly

5 with the DA's office, and it's also quite clear that you

6 provided an opinion about drug-facilitated assault by

7 the perpetrator, your words. So I just want --

8 ERNEST LYKISSA: No, possible perpetrator.

9 Please, you're making the statement absolute when it's

10 not.

11 LYNN GARCIA: I'm reading your report.

12 That's all I'm doing. Word -- verbatim, the language

13 that is in your report.

14 So I guess what I would say is one of two

15 things, either -- if it is true that you don't do

16 criminal -- that you don't do forensic analysis as that

17 term is defined under the Code of Criminal Procedure,

18 then the best option is just to take you off the list of

19 accredited laboratories in Texas so that there's no

20 confusion among the criminal --

21 ERNEST LYKISSA: I don't see why my

22 accreditation in Texas has anything to do with something

23 that happened in Philadelphia.

24 LYNN GARCIA: The point is that if you are

25 doing -- if you are holding yourself out as a forensic


12

1 analyst and you're doing that work in Texas, you need to

2 be licensed and the lab needs to be accredited. That is

3 what the law says. So you can't have it both ways. And

4 that's what I think is -- is happening here, is that you

5 want to be able to caveat your way out of -- of the

6 requirements of state law, and that is not what any

7 other lab that works within our jurisdiction -- whether

8 physically located here or not, nobody else gets to do

9 that. No matter if they've been a PhD toxicologist for

10 60 years or 70 years, everybody is subjected to the same

11 requirements if you meet the statutory definition.

12 So what I would suggest is that one of two

13 things either is going to happen. One is that you

14 remove yourselves from our jurisdiction by getting off

15 the list of accredited laboratories for purposes of

16 being able to have your evidence entered in criminal

17 trials, or if you're going to be subject to our

18 jurisdiction because you want the ability to do that,

19 then that means that everything else that all -- every

20 other lab has to subject themselves to in terms of our

21 rules and our oversight and the licensing requirements,

22 then all of that applies. So it has to be one or the

23 other. It can't be both.

24 ERNEST LYKISSA: Well, we'll take the

25 second one. If you can give us probation in order to --


13

1 for some time, whatever you -- your members decide to

2 proceed with your guidance and try to achieve a

3 fulfillment. I'll be -- I'll be retired by next month,

4 so, you know, my -- Dr. Vareed next to me, he will make

5 sure that these things are taken care of.

6 LYNN GARCIA: Okay. So if that's the case,

7 then -- if they are going to be subject to -- like all

8 of the other accredited labs and labs that need to be

9 licensed, then my suggestion would be that a panel be

10 created in order to address all of these issues.

11 DR. BARNARD: Mr. Daniel?

12 MARK DANIEL: Well, Dr. Barnard, in light

13 of -- we appreciate Dr. Lykissa's response and comments.

14 (Requested excerpt concludes)

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14

1 REPORTER'S CERTIFICATE

3 STATE OF TEXAS )

4 COUNTY OF TRAVIS )

6 I, Shonna K. Castillo, Certified Shorthand

7 Reporter, certify that the foregoing is a correct

8 transcription, to the best of my ability, from the video

9 recording of the proceedings as provided to me in the

10 above-entitled matter.

11 I further certify that I am neither counsel for,

12 related to, nor employed by any of the parties to the

13 action in which this hearing was taken, and further that

14 I am not financially or otherwise interested in the

15 outcome of the action.

16 WITNESS MY OFFICIAL HAND this the 7th day of

17 June, 2021.

18 Original certified for Forensic Science Commission

19 /s/ Shonna K. Castillo


SHONNA K. CASTILLO
20 Certified Shorthand Reporter
Texas Merit Reporter
21 Registered Professional Reporter
Certification No. 4896
22 Expires: 10-31-21
(512) 589-3152
23 [email protected]

24

25
EXHIBIT N
ETHICS
Guiding Principles of Professional Responsibility
>> Download SOFT's Ethics Procedures <<
>> Download SOFT's Ethics Complaint Form<<

Society of Forensic Toxicologists (SOFT) Code of Ethics

As a Member of the Society of Forensic Toxicologists (the “Society”), I agree to conduct myself in a
professional manner, in accordance with the following ethical principles. I understand if I behave in a manner
detrimental to the organization or the profession of forensic toxicology in general, I may be censured or
expelled from membership.

Members agree to:

1. Perform professional activities with honesty, integrity and objectivity.

2. Refrain from knowingly misrepresenting professional qualifications including, but not limited to: education,
training, experience, certification, area of expertise, and professional memberships.

3. Hold in confidence and refrain from misuse of information obtained or received in the course of professional
activities.

4. Provide expert advice and opinions within the limits of individual competence and generally accepted
scientific principles.

5. Render testimony in a truthful manner without bias or misrepresentation.

6. Refrain from exercising professional or personal conduct adverse to the best interests and objectives of the
Society.

Guiding Principles Preamble

The Guiding Principles are intended to create a culture of ethical behavior and professional responsibility
among SOFT members and/or affiliates. The concepts presented here have been drawn from other
professional codes and suggestions made by leaders in the forensic community[1]. The Guiding Principles
have been vetted and adopted by the Society of Forensic Toxicologists (SOFT) Board of Directors with the
expectation that forensic toxicologists and forensic toxicology laboratory personnel and management will use
them in training sessions, performance evaluations, disciplinary decisions, and as guides in other professional
and management decisions. It is important that all individuals engaged in forensic toxicology are equally aware
of these Guiding Principles and incorporate the principles into their daily work.

These Guiding Principles provide a framework for describing ethical and professional responsibilities in the
forensic community. While not all inclusive, they describe key areas and provide some specific rules to
supplement the existing Code of Ethics adopted by SOFT.

Professionalism

The ethical and professionally responsible forensic toxicologist and forensic toxicology laboratory manager:
1. Are independent, impartial, detached, and objective, approaching all examinations with due diligence
and an open mind.
2. Conduct full and fair examinations. Conclusions are based on the evidence and reference material
relevant to the evidence, not on extraneous information, political pressure, or other outside influences.
3. Are aware of their limitations and only render conclusions that are within their area of expertise and
about matters which they have given formal consideration.
4. Honestly communicate with all parties (the investigator, prosecutor, defense, and other expert
witnesses) about all information relating to their analyses, when communications are permitted by law
and agency practice.
5. Report to the appropriate legal or administrative authorities unethical, illegal, scientifically questionable
conduct or impaired competence.
6. Take appropriate action if there is potential for, or there has been, a miscarriage of justice due to
circumstances that have come to light, incompetent practice or malpractice.
7. Report conflicts between their ethical/professional responsibilities and applicable agency policy, law,
regulation, or other legal authority, and attempt to resolve them.
8. Do not accept or participate in any case on a contingency fee basis or in which they have any other
personal or financial conflict of interest or an appearance of such a conflict.

Competency and Proficiency

The ethical and professionally responsible forensic toxicologist and forensic toxicology laboratory manager:

1. Are committed to career‐long learning in the forensic disciplines in which they practice and staying
abreast of new technologies and techniques. Conclusions and opinions are based on generally
accepted tests and procedures.
2. Are properly trained and determined to be competent through testing prior to undertaking the
examination of the evidence.
3. Give utmost care to the treatment of any samples or items of potential evidentiary value to avoid
tampering, adulteration, loss or unnecessary consumption.

Clear Communications

The ethical and professionally responsible forensic toxicologist and forensic toxicology laboratory manager:

1. Accurately represent their education, training, experience, and area of expertise.


2. Present accurate and complete data in reports, testimony, publications and oral presentations.
3. Make and retain full, contemporaneous, clear and accurate records of all examinations and tests
conducted, and conclusions drawn, in sufficient detail to allow meaningful review and assessment of
the conclusions by an independent person competent in the field.
4. Prepare reports in which facts, opinions and interpretations are clearly distinguishable, and which
clearly describe limitations on the methods, interpretations and opinions presented.
5. Do not alter reports or other records, or withhold information from reports for strategic or tactical
litigation advantage.
6. Support sound scientific techniques and practices and do not use their positions to pressure an
examiner or technician to arrive at conclusions or results that are not supported by data.
7. Testify to results obtained and conclusions reached only when they have confidence that the opinions
are based on good scientific principles and methods. Opinions are to be stated so as to be clear in
their meaning.

[1] The Guiding Principles of Professional Responsibility are based upon the ASCLD/LAB Guiding Principles of
Professional Responsibility for Crime Laboratories and Forensic Scientists. Prior to adoption, ASCLD/LAB
disseminated the Guiding Principles to thirty forensic science organizations (including the Society of Forensic
Toxicologists) for comment.
EXHIBIT O

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