Texas Commission Reviews Expertox
Texas Commission Reviews Expertox
Texas Commission Reviews Expertox
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
E. Professional Negligence Finding:Against Dr. Lykissa for Charging Extra for a………..
“Forensic” Version of a Report Issued for Clinical Purposes…………………….…..24
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EXHIBIT INDEX
G. Letter dated March 22, 2021 from Smith to Lykissa Requesting Responses
iii
I. COMMISSION BACKGROUND
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
B. Commission Jurisdiction
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
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
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
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
Commission that a license holder or applicant for a license has committed professional
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
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
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
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
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
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
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.
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.
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
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.)
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
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
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
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
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”
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
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
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
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
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
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
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.
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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.
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
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.
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,
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.
Page 13
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
less than 50 pg/mg of hair. The analysis was conducted October 6-14, 2019. Dr. Rohrig’s review
• 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
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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.
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
• The calibration curve did not include the origin, contrary to the SOP.
• 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
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
• 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.
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
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
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.
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
“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,
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
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
examination or test performed on physical evidence, including DNA evidence, for the purpose of
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
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
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
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
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
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
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,
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
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
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.
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,
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
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
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
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.
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
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
Page 27
EXHIBIT A
EXHIBIT B
1430 Center Street
Deer Park, Texas 77536
Ph. 281-476-4600
Fx. 281-930-8856
www.expertox.com
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).
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
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.
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:
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.
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,
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
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.
www.pharmacology-toxicologyconsultant.com
EDUCATION
Rockhurst College
Kansas City, Missouri
B.S. degree awarded 1978
Major: Chemistry
ACADEMIC APPOINTMENTS
EMPLOYMENT
EMPLOYMENT CONT.
Position: Director
EMPLOYMENT CONT.
Position: Toxicologist
Rockhurst College
Department of Chemistry
5225 Troost Avenue
Kansas City, Missouri 64110
Position: Lecturer
PROFESSIONAL ORGANIZATIONS
Laboratory Inspector
Member
Member
Instructor
Member
Board Member
January 2016
Member
Member
Feb 2019
Board Member
Vice Chair
HONORS
Rho Chi National Honorary Pharmaceutical Society Alpha Omega Chapter Univ of MO-KC 1982
PRESENTATIONS
Invited presentation at Best Practices in Child Welfare Law Training sponsored by Office of
Judicial Administration-Kansas Judicial Center.
Presented at a workshop entitled “Driving Under the Influence: NPS Benzodiazepines” at the
Society of Forensic Toxicologists Annual Meeting
T.P. Rohrig, “Drug Facilitated Sexual Assault-Miscellaneous Therapeutics: OTC Antihistamines, Tricyclic
Antidepressants, and Carisoprodol”
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
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
PRESENTATIONS con’t
T.P. Rohrig, “Social Drink and the Common Cold: Alcohol and Antihistamines in Drug Facilitated Sexual
Assault”
Presented at the Graduate Seminar Series in Forensic Science at Emporia State University
Invited Presentation at OSU Center for Health Sciences Friday Seminar Series
T.P. Rohrig* and C.M. Moore, “Road-Side Drug Testing: An Evaluation of the Alere DDS®2 -A Pilot Study”
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
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
Presented at the Kansas Alliance for Drug Endangered Children- Sedgwick County seminar on
Drugs-Effects, Testing, Trends and Professional Safety
Presented at the Kansas Alliance for Drug Endangered Children- Sedgwick County seminar on
Drugs-Effects, Testing, Trends and Professional Safety
Presented at the Graduate Seminar Series in Forensic Science at Emporia State University
Presented at Prosecuting Attorneys’ Seminar: 21 st Century Prosecution; The New and the Novel
T.P. Rohrig, “Oral Fluid as a Test Specimen: Guidelines for Implementing a Data Collection Program”
PRESENTATIONS con’t
A.J. Whitaker*, L. Harryman and T.P. Rohrig, “Single Dose Urinary Kinetics of Carisoprodol”
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)”
T.P. Rohrig, “But Judge It’s Therapeutic – Driving Under the Influence of Prescription Medications”
PRESENTATIONS con’t
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
PRESENTATIONS con’t
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
T.P. Rohrig, “Alcohol Biomarkers: Ethyl Glucuronide – Diagnostic and Forensic Utility”
T.P. Rohrig, “Driving Under the Influence of Drugs: Forensic Implications – Pharmacology,
Pharmacokinetics and Interpretation”
PRESENTATIONS con’t
Presented at the workshop entitled “Interpretation of Toxicological Analysis in the Elderly” at the
American Academy of Forensic Sciences Annual Meeting
Invited presentation at the Midwest Association for Toxicology and Therapeutic Drug Monitoring
Annual Meeting
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”
PRESENTATIONS con’t
T. Thompson* and T.P. Rohrig, “The Identification of Capsaicinoids in Pepper Spray Residues”
C.L. Huber*, L.J. Goodson and T.P. Rohrig, “Oxycodone – An ELISA Method Validation”
PRESENTATIONS con’t
Invited presentation and panel member at the New York State Toxicology Seminar
J.C. Epley, J.L. Henry and T.P. Rohrig, “The Distribution of Zolpidem in Postmortem Cases”
Presented at DHHS Drug Testing Advisory Board - Scientific Meeting on Drug Testing of Alternative
Specimens and Technologies
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
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
Invited presentation at the Ethyl Alcohol Symposium. Sponsored by the Southwestern Association
of Toxicologists
L.E. Balding, F.B. Jordan, C.S. Choi and T.P. Rohrig*, "Gas Flames, Closed Spaces and Hypoxia"
PRESENTATIONS con’t
T.P. Rohrig and N.G. Ray, "Tissue Distribution of Bupropion in a Fatal Overdose"
G.W. Kunsman, and T.P. Rohrig, "Tissue Distribution of Ibuprofen in a Fatal Overdose"
A.W. Mitchell, B.D. Curtis, and T.P. Rohrig, "Headspace Analysis of Toluene"
PRESENTATIONS con’t
T.P. Rohrig*, L.E. Balding and R. W. Prouty, "Triazolam: Analysis and Case Studies"
R.W. Prouty* and T.P. Rohrig, "Forensic Considerations in the Evaluation and Interpretation of Postmortem
Blood Alcohol Results"
E.F. Hatch, P.J. Cooper and T.P. Rohrig, "Amphetamine Screening in Medical Examiner Cases”
P.S. Mork and T.P. Rohrig, "Detection of Fentanyl in Postmortem Blood by Radioimmunoassay"
PRESENTATIONS con’t
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
T.P. Rohrig* and D.M. Yourtee, "In Vitro Metabolic Turnover of Aflatoxin Q1 by Rat Liver"
CONFERENCES/SYMPOSIUMS
Invited Participant at the "International Symposium on Driving Under the Influence of Alcohol and/or Drugs"
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
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.
CONFERENCES/SYMPOSIUMS con’t
Invited Instructor for the Ames Lab/Midwest Forensic Resource Center sponsored workshop [4.5 days] on
“General Principles of Drug Pharmacokinetics [ADME]”
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”
Invited Instructor for the Ames Lab/Midwest Forensic Resource Center sponsored workshop [4.5 days] on
“Postmortem Toxicology: Interpretive Challenges and Considerations”
Invited participant and co-chairman for Ames Lab/Midwest Forensic Resource Center sponsored
conference entitled “Symposium in Toxicology [DUID]”
Invited Instructor for the Midwestern Association of Forensic Scientists sponsored Spring Toxicology
workshop [2.5 days] on “Postmortem Toxicology: Interpretive Challenges and Considerations”
Invited Speaker at the Kansas Alliance for Drug Endangered Children-Sedgwick County Seminar.
Presentation entitled, “Interpretation of Hair and Urine Drug Test Results”
Invited Instructor for the Southwestern Association of Toxicologists sponsored Spring Workshop [2.5
hours] on “ADME: General Principles of Drug Pharmacokinetics”
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”
2. Tiscione N.B. and Rohrig T.P. “1,1-Difluoroethane Forensic Aspects for the Toxicologist and
Pathologist”
3. Rohrig T.P., Nash E., Osawa K.A., Shan X., Scarneo C., Youso K.B., et al. “Fentanyl and Driving
Impairment”
4. Rohrig T.P., Osawa K.A., Baird T.R. and Youso K.B. “Driving Impairment Cases involving Etizolam
and Flubromazolam”
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”
6. Rohrig TP, Miller SA and Baird TR. “U-47700: A Not So New Opioid”
7. Rohrig TP, Moore CM, Stephens K, et al. “Roadside drug testing: An evaluation of the Alere
DDS®2 mobile test system”
8. Rohrig, T.P. and Hicks, C.A., “Brain Tissue: “A Viable Postmortem Toxicological Specimen”
9. Stockham, T. and Rohrig, T.P., “The Use of “Z-Drugs” to Facilitate Sexual Assault”
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”
11. Rohrig, T.P. and Moore, C.M., “Zolpidem: Forensic Aspects for the Toxicologist and Pathologist”
13. Rohrig, T.P. and Moore, C., “The Determination of Morphine in Urine and Oral Fluid following
Ingestion of Poppy Seeds”
14. Henry, J., Epley, J., and Rohrig, T.P., “The Analysis and Distribution of Mescaline in Postmortem
Tissues”
15. Epley, J.C., Henry, J.L., and Rohrig, T.P., “The Distribution of Zolpidem in Postmortem Cases”
16. Rohrig, T.P., “Comparison of Fentanyl Concentrations in Unembalmed and Embalmed Liver
Samples”
18. Balding, L., F.B. Jordan, C.S. Choi and T.P. Rohrig, "Gas Flames, Closed Spaces and Hypoxia"
19. Rohrig, T.P. and L.E. Harty, "Postmortem Distribution of Mexiletine in a Fatal Overdose"
20. Kunsman, G.W. and T.P. Rohrig, "Tissue Distribution of Ibuprofen in a Fatal Overdose"
21. Rohrig, T.P. and N.G. Ray, "Tissue Distribution of Bupropion in a Fatal Overdose"
PUBLICATIONS CON’T
24. Rohrig, T.P. and R.W. Prouty, "A Nortriptyline Death With Unusually High Tissue Concentrations"
25. Rohrig, T.P. and R.W. Prouty, "Fluoxetine Overdose: A Case Report"
27. Rohrig, T.P., D.A. Rundle and W.N. Leifer, "Fatality Resulting From Metoprolol Overdose"
28. Rohrig, T.P. and R.C. Backer, "Amoxapine Overdose: Report of Two Cases"
29. Yourtee, D.M. and T.P. Rohrig, "The In Vitro Metabolism of Aflatoxin Q1 by Mouse and Rabbit
Liver Preparations"
30. Rohrig, T.P. and D.M. Yourtee, "In Vitro Metabolism of Aflatoxin Q1 by Rat Liver
Postmitochondrial Homogenates"
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"
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
At your request and supplied by your office, I have reviewed the following material in the
above captioned case.
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
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 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]:
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]
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:
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.
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.
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 SOP states “Review of the data is documented by the Director or Certifying
Scientist’s initials on the chromatograms.”
Page | 9
THC Validation Study
The Accuracy and Precision Studies for THC and Carboxy-THC, with approval
sign-off [see below], were dated 21 May 2018.
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:
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].
NO
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
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:
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
5.3: 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.
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,
Page | 17
EXHIBIT L
1430 Center Street
Deer Park, Texas 77536
Ph. 281-476-4600
Fx. 281-930-8532
www.expertox.com
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.
10 VIA ZOOM
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12 of ExperTox.
24 lidocaine.
9 appropriate.
11 line.
13 unmute?
22 said that their work was for clinical purposes only and
8 They said, well, can you see it? If you -- if you see
11 there.
15 quantitatively.
5 perpetrator.
11 absolute.
13 finish my statement.
24 analyst license.
4 the extent that the work you do does interface with the
15 reply?
24 that in Texas.
19 for you, but also you can get some intensity of signal
3 defined under Texas law. What the law does not say is
7 forensic purposes --
12 door and we went ahead and test it, okay, but they were
20 okay, and then I get the test and I'm not given any
5 with the DA's office, and it's also quite clear that you
10 not.
18 then the best option is just to take you off the list of
3 what the law says. So you can't have it both ways. And
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1 REPORTER'S CERTIFICATE
3 STATE OF TEXAS )
4 COUNTY OF TRAVIS )
10 above-entitled matter.
17 June, 2021.
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EXHIBIT N
ETHICS
Guiding Principles of Professional Responsibility
>> Download SOFT's Ethics Procedures <<
>> Download SOFT's Ethics Complaint Form<<
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.
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.
6. Refrain from exercising professional or personal conduct adverse to the best interests and objectives of the
Society.
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.
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] 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