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Investigation of NY State Dept of Corrections and Community Supervision Incarcerated Individual Drug Testing Program - Jan 2022

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State of New York
Offices of the Inspector General

Investigation of New York State Department of
Corrections and Community Supervision
Incarcerated Individual Drug Testing Program

January 2022

Lucy Lang
Inspector General

EXECUTIVE SUMMARY
On September 19, 2019, the New York State Department of Corrections and Community
Supervision (DOCCS) informed the Offices of the New York State Inspector General that its
newly acquired incarcerated individuals 1 drug testing system might be falsely indicating positive
results when testing for the opioid buprenorphine. This drug testing system was procured by
DOCCS from the Microgenics Corporation (Microgenics) and installed in DOCCS’ facilities
beginning in January 2019. 2
From January through August 2019, incarcerated individuals found to have positive drug
test results at a disciplinary hearing received significant—and in some cases ultimately
undeserved—punishments that jeopardized their rehabilitation and release, including:
•

Solitary confinement in a Special Housing Unit (SHU) 3

•

Confinement to one’s cell (keeplock)

•

Delays in parole eligibility

•

Loss of privileges including receipt of packages, commissary, and telephone
use

•

Loss of access to prison rehabilitation programs

•

Loss of “good time” and family visitation rights

•

Missed scheduled parole interviews

Further, disciplinary matters concerning drug use can adversely affect Board of Parole
decisions and the granting of parole.
Upon receiving the complaint from DOCCS, the Inspector General immediately
commenced an investigation into the matter. This investigation included more than 40
interviews of witnesses including DOCCS staff and incarcerated individuals, toxicologists, and
Microgenics representatives, and the review of tens of thousands of documents including drug
test results, disciplinary records, DOCCS emails, contracts, policies, and manufacturer
specifications for drug tests and equipment. Additionally, dozens of hours of recorded
Per Chapter 322 of the Laws of 2021, the terms “inmate” and “inmates” have been replaced in this report with the
words “incarcerated individual” and “incarcerated individuals.” See,
https://www.nysenate.gov/legislation/bills/2021/s3332.
2
Microgenics Corporation is a wholly-owned subsidiary of Thermo Fisher Scientific Inc. See,
https://www.sec.gov/Archives/edgar/data/97745/000009774519000007/tmo201810kex21 htm. Microgenics
Corporation and Thermo Fisher Scientific Inc. are referred to as one entity in this report.
3
New York Code of Rules and Regulations, Title 7, Part 1, § 1.5(v) defines such confinement as “segregated
confinement.”
1

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disciplinary hearings were reviewed. The Inspector General also retained the services of
Elizabeth Spratt M.S., F-ABFT 4, an expert in toxicology, to review and verify the findings in this
investigation.
Given the possible implications for incarcerated individuals, the Inspector General
advised DOCCS in late 2019 to immediately cease all adverse action against incarcerated
individuals for any positive drug test results until confirmatory testing from an independent
outside laboratory could be obtained. 5
DOCCS’ Urinalysis Testing Policy 6 mandates that if a screening test produces a positive
result, a second test must be performed on the same sample. If both produce positive results, a
misbehavior report may be issued against the incarcerated individual, with the test results used as
evidence in a subsequent disciplinary hearing.
In practice, however, DOCCS would initially test an incarcerated individual’s urine
sample using the Microgenics test. When a test produced a positive result, DOCCS then merely
retested that same urine sample using the same Microgenics test, instrument, and method. This
process was contrary to the clear and prominent instructions provided with Microgenics test kits
that require confirmatory testing to be done using a “more specific alternative” method.
The Inspector General found several examples of impacted incarcerated individuals
raising concerns about their drug test results with DOCCS and Microgenics personnel:
•

A woman at Albion Correctional Facility, who had never tested positive for
drug use during her then more than two-year incarceration with DOCCS,
asserted that a January 2019 drug test wrongly indicated that synthetic
cannabinoids had been detected in her urine sample. Because of this and a
subsequent Microgenics test, she was confined to her cell for 40 days and
solitary confinement for 45 days. She lost her prison job and coveted housing
assignment, and lost privileges including recreation time, receipt of packages,
and telephone use for a total of 105 days. Additionally, she lost the privilege
to participate in DOCCS’ Family Reunion Program and therefore was denied
the continuation of visits with her three children.

•

Two Attica Correctional Facility incarcerated individuals tested positive for
drug use in February 2019. Both had served lengthy terms with DOCCS and

See Spratt’s resume and curriculum vitae attached to this report as Addendum 1.
See attached November 5, 2019 and December 31, 2019 letters from the Inspector General to DOCCS acting
Commissioner Annucci.
6
DOCCS Directive 4937, Urinalysis Testing (December 27, 2018).
4
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2

never previously tested positive for drugs while incarcerated. The first man,
then incarcerated with DOCCS for almost a decade and a participant in
DOCCS’ Alcohol and Substance Abuse Treatment Program, tested positive
for buprenorphine. The second man, who was incarcerated since 1984 and
participated in DOCCS’ Family Reunion Program, tested positive for
synthetic cannabinoids. Both men were confined to their cells pending a
disciplinary hearing. Ultimately, their misbehavior reports were dismissed
and expunged from their records due to technical errors.
•

An incarcerated individual who tested positive for buprenorphine in February
2019 questioned a Microgenics representative about possible cross-reactions
with over-the-counter medications. The representative wrongly advised the
individual that over-the-counter drugs would not cause a false positive and
“anything that would cause a positive would be some sort of variation of
buprenorphine or . . . something chemically related.” Nevertheless, this
individual was found guilty and sentenced to 180 days in SHU with loss of
recreation, package privileges, telephone and commissary privileges and
recommended loss of 30 days of good time.

•

A woman who upon her admission to DOCCS’ Shock Incarceration Program
at Lakeview Shock Incarceration Facility in August 2019 asserted that a drug
test wrongly indicated that synthetic cannabinoids had been detected in her
urine sample. Because of this and a subsequent Microgenics test, she lost
privileges including visitation, recreation time, receipt of packages, and
telephone use for a total of 30 days. Most notably, she was removed from the
Shock program, which if she completed without incident would have made
her likely eligible to be released within six months. Instead, she was not
released until September 2020.

•

In March 2019, an incarcerated individual questioned a Microgenics
representative about the reliability of the preliminary drug screening tests.
This individual, who denied using buprenorphine, had never failed a urine
screening test while incarcerated with DOCCS. The Microgenics
representative advised the individual that the test was 99.9 percent accurate,
and he could not recall ever seeing a false positive result. The individual was
found guilty and ultimately sentenced to 40 days of cell confinement, 75-days
loss of recreation and package, telephone, and commissary privileges, and
recommended loss of two months of good time.

The Inspector General’s investigation found multiple shortcomings in the drug testing
program that potentially impacted incarcerated individuals’ rights and due process including:
•

DOCCS disciplined incarcerated individuals based solely on the results of
preliminary drug screening tests. These preliminary screening tests were not
confirmed by more specific alternative tests as is required by Microgenics’
drug test instructions.

•

DOCCS failed to take prompt corrective action upon learning that some
incarcerated individuals had been charged with drug violations and punished
due to false positive drug screening test results
3

•

DOCCS improperly procured its drug testing systems and services

•

DOCCS failed to adequately oversee and train staff utilizing Microgenics’
drug testing systems

•

DOCCS experienced various administrative failures, which prevented the
proper operation of the Incarcerated Individual Drug Testing Program

•

Microgenics withheld information from DOCCS concerning false positive test
results and research involving its drug testing systems and provided
misleading and inconsistent statements during disciplinary hearings.

Specifically, the Inspector General’s investigation found that in January 2019, DOCCS
began using drug tests and instruments purchased from Microgenics to test urine samples of
incarcerated individuals for the presence of prohibited substances including buprenorphine and
synthetic cannabinoids, among others. Soon after implementation of these new tests, complaints
from incarcerated individuals of false positive drug test results increased, including complaints
from long-incarcerated individuals who had never before tested positive for illegal drugs while
imprisoned. In a limited review of six positive samples using Microgenics’ tests, two outside
laboratories later determined four of the six positive test results were incorrect.
Microgenics’ drug tests contain written instructions, which require that following a
preliminary drug screening test, a “more specific alternative chemical method must be used to
obtain a confirmed analytical result.” These more specific alternative tests are typically
performed by outside laboratories and can precisely identify and quantify drugs in urine samples
thereby eliminating any false positive preliminary drug screening test results, which may be
caused by cross-reacting substances or other factors.
During the period that DOCCS used Microgenics’ drug testing systems in its facilities,
2,199 incarcerated individuals tested positive for buprenorphine. Based on the results of these
preliminary drug screening tests, DOCCS charged and punished 1,632 incarcerated individuals. 7
Punishment included solitary confinement in SHU, confinement in one’s cell (keeplock), delays
in parole eligibility and/or release, and/or the loss of privileges such as the receipt of packages,
commissary, telephone use, and participation in the Family Reunion Program and other
programs.

According to DOCCS, of the incarcerated individuals who tested positive for buprenorphine, 1,280 were punished
with confinement and the remaining 352 received some other form of punishment. DOCCS was unable to verify
whether punishment was meted out, in part or entirely, due to the positive drug test and/or other misbehavior.

7

4

The investigation also found DOCCS unreasonably relied on three-decade old case law—
with distinct holdings based on another manufacturer’s drug test and methodology—to justify
forgoing confirmatory testing of Microgenics’ drug test results. The court in that case did not
consider the possibility that urine samples might contain cross-reacting substances that would
trigger false-positive results. Nonetheless, the court concluded that this different manufacturer’s
drug screening test results were reliable enough to satisfy due process concerns without the need
for confirmatory testing. Given the inapplicable case law, and in light of the confirmed cases of
drug testing errors with Microgenics’ systems, DOCCS should obtain confirmatory testing of all
positive preliminary drug screening test results.
This decision to forgo confirmatory testing of Microgenics’ drug screening tests was
largely promoted by just two individuals—the then administrator of the Incarcerated Individual
Drug Testing Program and a Microgenics salesperson. Although neither the program
administrator nor the salesperson had the education or training to conduct the necessary legal and
scientific reviews required for a decision of this magnitude, they also revised DOCCS’ drug
testing policy to support the use of Microgenics systems. Moreover, DOCCS provided no
evidence of any scientific evaluation or substantive legal review of this matter. The investigation
was unable to determine if DOCCS’ executive staff and commissioner were specifically apprised
of this issue.
The Inspector General further found that a former DOCCS associate commissioner failed
to take prompt corrective action after discovering that at least five incarcerated individuals had
been wrongfully charged and punished for drug violations. In August 2019, the associate
commissioner, while reviewing complaints of false drug test results, provided an outside
laboratory with urine samples from six incarcerated individuals who had tested positive for
buprenorphine using Microgenics’ drug screening tests. The outside laboratory found no
detectable buprenorphine in five of the six samples. However, the associate commissioner took
no action to remedy the matter and claimed that he did not recall if he had reported the testing
errors to the acting commissioner or other executives.
The investigation also found that DOCCS procured its drug testing systems and services
likely in violation of State Finance Law. Although State Finance Law provides a series of steps
that must be taken when agencies seek to purchase commodities and services, DOCCS has
historically failed to take these steps when purchasing drug testing systems. DOCCS also

5

entered into lease agreements for drug testing instruments in apparent violation of State Finance
Law. In addition, the investigation found that DOCCS did not perform due diligence when
contracting with Microgenics for its drug testing systems, failing to understand that such tests
were merely preliminary screening tests that would require additional confirmatory testing.
DOCCS also committed various administrative failures in the Incarcerated Individual
Drug Testing Program, which hindered the proper operation of the program. These included the
failure by testing officers to enter all required information into a central disciplinary tracking
database and to consistently consult medical staff on possible cross-reacting drugs—actions
required by policy. Also, the investigation found DOCCS did not adequately train drug testing
staff and hearing officers on the drug tests and instruments.
The investigation found that Microgenics failed to disclose to DOCCS issues it had
discovered with its urinalysis tests, and Microgenics representatives provided incorrect and
misleading information during DOCCS’ disciplinary hearings. Indeed, when Microgenics
learned that its buprenorphine test had produced four false positive results when testing six urine
samples from DOCCS incarcerated individuals, it did not advise DOCCS of these results. And
when Microgenics internal research revealed that one of its drug tests was susceptible to crossreactivity with a common medication and another substance and might thereby produce false
positive results, Microgenics again did not advise DOCCS of this fact. 8 Moreover, when
Microgenics representatives provided responses to questions asked by incarcerated individuals
during disciplinary hearings, the information provided was sometimes misleading and incorrect.
In fact, the Inspector General found while reviewing approximately 30 disciplinary hearing
recordings that Microgenics representatives never advised incarcerated individuals that its drug
screening tests required confirmation testing by more specific alternate methods.
Additionally, the investigation found that DOCCS was one of only seven known state
correctional systems in the country that disciplines incarcerated individuals based solely on the
results of preliminary drug screening tests and without confirming results by a more specific
alternative testing method. 9 Most state correctional agencies in the United States either contract

These include an over-the-counter antacid and a natural sweetener used as a sugar substitute.
This review found that 35 states have policies addressing confirmation testing, seven states did not require
confirmation testing prior to disciplinary action, and the drug testing policies for the remaining eight states was not
determined.
8
9

6

for confirmatory testing services with private laboratories or conduct confirmatory testing using
state-run laboratories.
Notably, prior to referring this complaint to the Inspector General, DOCCS, on August
19, 2019, ceased testing the urine of incarcerated individuals for buprenorphine. DOCCS later
reversed the punishments of those individuals found guilty, which included releasing 140
incarcerated individuals from internal confinement and reversing and expunging their records. 10
On November 5, 2019, after the Inspector General’s then ongoing investigation found
additional deficiencies in DOCCS’ Incarcerated Individual Drug Testing Program for other
prohibited substances, the Inspector General formally advised DOCCS that it immediately cease
taking adverse action against incarcerated individuals based on positive drug test results using
Microgenics systems for all illegal drugs without first confirming those results by a more specific
alternative method. DOCCS immediately accepted this recommendation and in December 2019,
began using an outside laboratory to confirm all positive results of drug screening tests prior to
taking administrative action.
On December 31, 2019, after the Inspector General found similar flaws in DOCCS’
testing for synthetic cannabinoids, the Inspector General formally advised DOCCS to reverse the
disciplinary dispositions and expunge the records of those individuals who tested positive for
synthetic cannabinoids. DOCCS also complied with these recommendations.
On January 15, 2020, DOCCS terminated its contract with Microgenics.
On February 22, 2021, DOCCS resumed its Incarcerated Individual Drug Testing
Program after acquiring another drug testing vendor. DOCCS also revised its Urinalysis Testing
Policy to require that “all initial positive test results will be sent to the outside laboratory for
confirmation testing.” DOCCS now uses a preliminary drug screening test known as the Premier
Biotech Bio-Cup to analyze urine samples from incarcerated individuals. Positive results from
these preliminary screening tests are then tested using a more specific alternative method: gas
chromatography – mass spectrometry (GC-MS) and/or liquid chromatography – tandem mass
spectrometry (LC-MS/MS), by Cordant Health Solutions.
In light of the termination of the Microgenics contract and the restructuring of the
Incarcerated Individual Drug Testing Program, the Inspector General recommends that DOCCS
10

These incarcerated individuals were released between September 11 and October 22, 2019.

7

review its policies to ensure that DOCCS medical and legal staff review and approve any future
modifications to the program. DOCCS must also ensure that when incarcerated individuals test
positive for illegal drug use, its medical staff reviews any drugs prescribed by the New York
State Office of Mental Health to those incarcerated individuals for treatment.
Additionally, the Inspector General recommends that DOCCS undertake a review of its
Contract Procurement Unit processes to ensure compliance with State Finance Law in all
procurements. DOCCS’ Counsel’s Office should review and approve all contracts and purchase
orders over a designated monetary threshold set by the agency after an internal review is
conducted.
The Inspector General also recommends that DOCCS provide comprehensive training to
its drug testing and hearing officers on the drug testing policy, tests, and instruments used in the
program. In addition, testing and hearing officers should be reminded of the requirement to enter
all required drug testing information into DOCCS’ disciplinary tracking database and to
consistently consult medical staff on possible cross-reacting drugs.
INTRODUCTION AND COMPLAINT
In 2017, the United States Department of Health and Human Services declared a public
health emergency in response to the nationwide opioid crisis. 11 New York State found itself in
the throes of this epidemic and continues to battle increased use of opioids and other drugs
statewide. 12
In support of its mission, DOCCS prohibits illegal drug use by individuals incarcerated in
State prisons. 13 DOCCS attempts to combat substance abuse in its correctional facilities through
its alcohol and substance abuse treatment programs and the Incarcerated Individual Drug Testing
Program. 14
https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-addressnational-opioid-crisis html.
12
https://www.health.ny.gov/community/opioid epidemic/.
13
https://www.ny.gov/agencies/department-corrections-and-community-supervision.
14
DOCCS operates the Alcohol and Substance Abuse (ASAT) and Comprehensive Alcohol and Substance Abuse
(CASAT) programs. The former is available to all incarcerated individuals while the latter is available to certain
incarcerated individuals approved for Presumptive Work Release. According to DOCCS’ website, CASAT is
“legislatively mandated substance abuse treatment developed to ensure that substance use disordered
individuals receive the maximum benefit from a substance abuse treatment experience during their preparation for
transition back to the community.” Under CASAT, certain incarcerated individuals are provided a six-month
intensive substance abuse treatment program followed by community reintegration (outpatient treatment) and
aftercare (through Community Supervision).
11

8

On September 19, 2019, DOCCS informed the Inspector General that its newly acquired
drug testing system, which tests incarcerated individuals’ urine for the presence of various
prohibited substances, may be producing inaccurate results. Specifically, DOCCS advised that
drug tests at its facilities might falsely indicate a positive result when testing for the opioid
buprenorphine. This drug testing system was procured by DOCCS from Microgenics and
installed in DOCCS’ facilities statewide beginning in January 2019.
Given the possible implications of faulty drug testing for incarcerated individuals,
including unjustly prolonged prison sentences, extended confinement in cells, and loss of access
to rehabilitation programs and privileges, the Inspector General immediately commenced a
comprehensive investigation and ensured DOCCS suspended all buprenorphine drug testing and
reversed all punishment resulting from positive buprenorphine tests. Additionally, during the
investigation, when evidence indicated potential issues with other Microgenics’ drug tests, the
Inspector General likewise advised DOCCS to suspend these tests and reverse related adverse
action against incarcerated individuals. 15
DOCCS’ Incarcerated Individual Drug Testing Program
Pursuant to DOCCS’ Urinalysis Testing policy (Directive 4937), incarcerated individuals
are given drug tests if suspected of illegal drug use, when involved in certain programs, and
when randomly selected by an electronic program. Incarcerated individuals who participate in
DOCCS’ Family Reunion Program must submit up to three urine samples each visit of a family
member (pre-visit, day of visit, and post-visit). Incarcerated individuals’ samples are collected
by DOCCS correction officers and tested by officers trained to conduct such tests.
Per policy, an incarcerated individual who fails two consecutive urine tests—an initial
test and a “second test . . . performed on the same sample,” is issued a misbehavior report and
immediately isolated. 16 Subsequently, the incarcerated individual attends an administrative
hearing at which they may respond to the allegations of drug use. Microgenics representatives
may be contacted by telephone during these disciplinary hearings to respond to questions from
incarcerated individuals about the drug testing process, tests, and instruments.

See attached November 5, 2019 and December 31, 2019 letters from the Inspector General to DOCCS acting
Commissioner Annucci.
16
Directive 4937(IV)(G)(1)(d).
15

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If found guilty at a disciplinary hearing, punishment includes isolation in SHU and cells
(keeplock), and/or loss of “good-time,” family visitation rights, access to rehabilitation and work
programs, the receipt of packages, and access to telephones and the commissary. Disciplined
individuals may also miss scheduled parole interviews, thereby prolonging their incarceration.
Further, disciplinary matters concerning drug use may adversely affect Board of Parole decisions
and the granting of parole.
DOCCS Acquires a New Incarcerated Individual Drug Testing Vendor and Revises Its
Drug Testing Policy
From at least 1999 to October 2018, DOCCS procured its urine drug tests and testing
instruments for incarcerated individuals from Siemens Healthcare Diagnostics Inc. (Siemens). 17
Under this contract, Siemens’ salesperson Brenda Collum was the company’s liaison with
DOCCS from 1999 until 2015. In 2015, Collum left Siemens for employment at its competitor,
Microgenics.
In 2011, then DOCCS Corrections Lieutenant Corey Bedard was assigned oversight of
DOCCS’ Incarcerated Individual Drug Testing Program. In this role, Bedard worked closely
with Collum on drug testing matters.
Also in 2011, Bedard discovered that DOCCS was paying Siemens more for its drug tests
than the price Siemens offered to other agencies for these tests under a New York State
centralized contract. When DOCCS’ contract with Siemens expired in 2013, Siemens agreed to
provide to DOCCS drug tests at the lower prices found in the State centralized contract.
However, Siemens then required that DOCCS lease its drug testing instruments, which had been
previously provided to DOCCS without additional cost under the original contract.
In response, DOCCS required each of its then 52 correctional facilities to enter into
separate, monthly lease agreements with Siemens for the drug testing instruments. This
arrangement dramatically increased DOCCS’ statewide costs for the administration of its
Incarcerated Individual Drug Testing Program. 18 Consequently, in 2016, Bedard began a search
for similar, lower-priced urine drug tests and instruments in order to cut costs.

Siemens Medical Solutions USA, Inc. d.b.a. Siemens Healthcare Diagnostics Inc.
In 2013, DOCCS and Siemens entered into a seven-year lease agreement for drug testing instruments at a cost of
$705 per testing instrument/ per month. At that time, with DOCCS operating 52 correctional facilities, the total cost
for drug testing instruments under this lease was approximately $440,000 per year. In addition, DOCCS purchased
drug test kits from Siemens at an annual cost of approximately $150,000.
17
18

10

In May 2016, Bedard recommended to his supervisors that DOCCS end its current
instrument leases with Siemens and procure drug tests and instruments from another vendor. In
July 2016, Bedard identified Microgenics as one potential new vendor and forwarded contact
information for Collum, who was then a Microgenics salesperson, to his supervisors.
By November 2016, at Bedard’s request, his supervisors approved a trial side-by-side
comparison of Microgenics’ and Siemens’ drug tests and instruments at a correctional facility.
In tests conducted in December 2016 and January 2017, both Microgenics’ and Siemens’ drug
tests and instruments performed comparably, with one exception: in one instance, an incarcerated
individual’s urine sample, which was tested using both systems, produced both a positive
(Microgenics) and negative (Siemens) result for the presence of the illegal drug buprenorphine. 19
In January 2017, Microgenics advised DOCCS that the contradictory result found in the
side-by-side comparison was due to its test. Specifically, Microgenics’ CEDIA Buprenorphine
Assay (Buprenorphine I test) had produced a false positive result for buprenorphine. According
to Microgenics, this result was due to the fact that the incarcerated individual had likely
consumed Tylenol with codeine, a medication he was prescribed, before providing a urine
sample.
To overcome this failure with its test, Microgenics proposed to DOCCS that should
DOCCS contract with Microgenics, Microgenics would provide DOCCS a new urine drug test
that produced both fewer false positive and false negative test results than its Buprenorphine I
test. This test, the CEDIA Buprenorphine II Assay (Buprenorphine II test), had not yet been
approved for use by the United States Food and Drug Administration (FDA), which is the federal
regulatory agency responsible for reviewing and approving such tests by government agencies
and in the private sector.
In February 2017, DOCCS began its public search for a new provider of drug tests and
instruments for its Incarcerated Individual Drug Testing Program by requesting information from
interested companies. Bedard emailed Collum directly to inform her of the public notice and
consequently, Microgenics began to prepare its bid.

Buprenorphine, sold under the trade names Buprenex, Suboxone, and Subutex, is a narcotic used in clinical
settings to assist with the treatment of opiate addiction. It is also a controlled substance under New York Public
Health Law, Schedules of Controlled Substances, §3306.

19

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In 2017 and into mid-2018, DOCCS commenced a competit ive procurement and solicited
bids from companies for drng testing systems . Four companies submi tted bids, including
Siemens and Microgenic s. In October 20 18, DOCCS awarded Microgenics a five-year contrnct
to provide drng tests and instruments for its Incarcerated Individual Drng Testing Program. As
paii of this conh'act, Microgenics made available its technical service repre sentatives to provide
stateme nts at DOCCS ' disciplinaiy hearings . The estimated value of this conti·act was $1.6
million over the five-yeai· period, an average annual cost of approximate ly $320,000.
Microgenic s prov ided DOCCS several different drng tests under this conti·act, inclu ding the
Buprenorphine II test and a test for synthetic cannab inoids known as the CEDIA AB-PINACA
test (AB PINACA test), among others.

Microgenics' CEDIA Bupreno1phine II test kit (The1m0Fisher)

Prior to DOCCS ' implementation ofMicrogenics ' drng testing system , Bedai·d was
tasked by DOCCS with revising its Urinaly sis Testing policy. 20 This revision was neces sa1y as

20

Bedar d's supervisors at this time w ere Donal d Venettozzi , the director of Special Housing and Incarcerated
Individual Disciplinruy Program s, and Anthony Rodriguez , the assistant director. In Janua1y 20 19, Bedard was
promoted to another position and Jennifer Booth became the head of the progrrun.

12

the policy at that time appended a description of the “principles and validity” of the drug testing
program, which was based on a then 32-year-old court case that affirmed DOCCS’ testing
procedures using Siemens’ drug testing systems. This 1985 federal class action lawsuit,
Peranzo et al. v. Coughlin, et al. (Peranzo), did not refer to Microgenics’ drug testing systems. 21
Notably, Siemens’ and Microgenics’ analyses operate using different substances and
methodologies.
In order to revise DOCCS’ drug testing policy, Bedard turned to Microgenics salesperson
Collum. In November 2018, Collum provided Bedard excerpts from scientific journals which
she indicated equated Siemens’ and Microgenics’ technologies and could be included in the new
policy. Bedard revised DOCCS’ drug testing policy accordingly.
Between January and April 2019, Microgenics installed its drug testing systems at each
of DOCCS’ then 52 correctional facilities. Also at this time, Microgenics provided DOCCS staff
at each facility training on its urine drug tests and testing instruments, and confirmed the
instruments were properly cleaned and calibrated and that DOCCS staff could do the same.
Upon completion of the installation and training at each facility, drug testing of incarcerated
individuals was resumed using Microgenics’ testing systems.
Incarcerated Individuals Allege Microgenics’ Drug Tests Produce False Positive Results
Upon DOCCS’ implementation of Microgenics’ drug testing systems in its facilities,
complaints lodged by incarcerated individuals of false positive drug tests noticeably increased. 22
Among the complaints received by DOCCS were those from individuals who had never before
tested positive for drug use while incarcerated with DOCCS.
One such compelling claim came from a female incarcerated at Albion Correctional
Facility. In several letters to DOCCS acting Commissioner Anthony Annucci, this individual,
who had never before tested positive for drug use during her then more than two-year
incarceration with DOCCS, asserted that a January 2019 drug test wrongly indicated that
synthetic cannabinoids—“K2/Spice”—had been detected in her urine sample. As a consequence
of this and a subsequent Microgenics drug test 23, the incarcerated individual was confined in
Peranzo v. Coughlin, 608 F. Supp. 1504 (S.D.N.Y. 1985).
Multiple DOCCS employees testified to the Inspector General that they had noticed an increase in complaints at
their respective facilities since the implementation of Microgenics’ drug testing systems.
23
The incarcerated individual again tested positive for synthetic cannabinoids in early March 2019, despite being
confined to SHU as a punishment for the original drug use violation. Notably, incarcerated individuals confined in
21
22

13

keeplock (40 days) and SHU (45 days), lost her prison job and coveted housing assignment, and
lost privileges including recreation time, receipt of packages, and telephone use for a total of 105
days. Most importantly to the individual, she lost the privilege to participate in DOCCS’ Family
Reunion Program and therefore was denied the continuation of visits with her three children.
In her February and March 2019 letters to the commissioner, this individual noted that
while incarcerated at DOCCS she had sought rehabilitation by earning a high school diploma,
completing Incarcerated Individual Program Associate training (where she assisted prison staff
in new incarcerated individual orientation and GED preparation programs), and participating in
the Medaille College program. In addition, she participated in DOCCS’ Alcohol and Substance
Abuse Treatment Program, where she served as a facilitator and “happily celebrated my second
year of sobriety.”
Although the individual noted that she was taking four prescribed drugs at the time she
provided her urine samples, none appeared as cross-reacting substances in Microgenics’
scientific literature—literature that she found “complicated and confusing.” Despite forcefully
asserting she had taken no illegal drugs, she wrote that “after testimony from pharmacy and the
testing officer . . . it became clear that I was out of my element; and I believed the two witnesses
that my test was performed properly.”
In another example, a woman who upon her admission to DOCCS’ Shock Incarceration
Program at Lakeview Shock Incarceration Facility in August 2019 asserted that a drug test
wrongly indicated that synthetic cannabinoids had been detected in her urine sample. Because of
this and a subsequent Microgenics test, she lost privileges including visitation, recreation time,
receipt of packages, and telephone use for a total of 30 days. Most notably, she was removed
from the Shock program, which if she completed without incident would have made her likely
eligible to be released within six months. Instead, she was not released until September 2020.
In yet another example, two incarcerated individuals at Attica Correctional Facility
tested positive for drug use in February 2019. Both had served lengthy terms with DOCCS and
never previously tested positive for drugs while incarcerated. The first individual, then
incarcerated with DOCCS for almost a decade and a participant in DOCCS’ Alcohol and
Substance Abuse Treatment Program, tested positive for buprenorphine. The second individual,
SHU are individually confined in a secure cell 23 hours each day, and individually recreate one hour each day in
enclosed and secure areas.

14

who was incarcerated since 1984 and participated in DOCCS’ Family Reunion Program, tested
positive for synthetic cannabinoids. Each incarcerated individual was issued a misbehavior
report and confined to their respective cells pending a disciplinary hearing. Each contested their
purported positive test results to DOCCS. 24
Attica Correctional Facility Responds to Incarcerated Individuals’ Claims of False Positive
Drug Test Results
In March 2019, in response to the many claims of false test results at Attica, a correction
officer at the facility who suspected possible testing errors contacted Microgenics and requested
a review of test results for 18 individuals who had recently tested positive for drug use at the
facility. Attica executive staff notified incarcerated individuals that DOCCS was consulting with
Microgenics to determine whether there were any issues with the drug tests or instruments. On
March 4, 2019, a Microgenics field technician examined the positive test reports and found no
errors.
As complaints of false positive drug test results continued to grow at Attica, in April
2019, the facility’s Incarcerated Individual Liaison Committee (a representative group of
incarcerated individuals selected by other incarcerated individuals to raise concerns with facility
staff) requested that Attica discontinue its use of Microgenics’ drug tests and instruments. In
response, Attica staff advised the committee that although Microgenics had reviewed a number
of recent positive drug test results at the facility and found no issues, Attica would request that a
Microgenics field technician visit the facility and inspect its drug tests and instruments to ensure
DOCCS was using proper procedures.
In May 2019, a Microgenics field technician visited Attica and advised the new head of
DOCCS’ Incarcerated Individual Drug Testing Program, Jennifer Booth, that he had found no
errors with the drug tests, instruments, or procedures performed by the testing officers.
Microgenics salesperson Collum opined to Booth that the increase in positive drug test results
could be because the Buprenorphine II and synthetic cannabinoids tests were more sensitive than
earlier tests. Booth informed her supervisors of Microgenics’ responses. 25

Subsequently, these misbehavior reports were dismissed and expunged from the incarcerated individuals’ records
due to technical errors; the individuals had not been offered an opportunity to consult with staff prior to their
hearings, as is provided by DOCCS directive.
25
Booth was supervised at this time by Venettozzi and Rodriguez. Subsequently, in July 2019, Charles Kelly, an
associate commissioner and the executive assistant to acting Commissioner Annucci, began to assert some oversight
over the Incarcerated Individual Drug Testing Program and Booth.
24

15

Prisoners’ Legal Services of New York Files Complaints with DOCCS
In June 2019, DOCCS received a complaint from Prisoners’ Legal Services of New York
(PLSNY), a not-for-profit organization that provides legal representation and assistance to
indigent incarcerated individuals. 26 The complaint contained allegations of false positive test
results for buprenorphine and synthetic cannabinoids made by four individuals who were
incarcerated at Albion, including the woman cited earlier in this report.
PLSNY’s complaint noted that the four individuals had no prior history of drug use in
prison or any prior disciplinary history and had “wholeheartedly applied their energies to
rehabilitation.” Additionally, the complaint emphasized that many of the tests were not random
but were taken at times when the individuals were aware they would be screened and taken as a
requirement of programs they were participating in, including the Family Reunion, Alcohol and
Substance Abuse Treatment (ASAT), and college credit programs. One individual even
submitted to a urine test in support of her application for participation in a DOCCS’ work release
program. According to PLSNY, these facts made it beyond improbable that these individuals
“would each suddenly elect to take drugs . . . while participating in programs where they knew
drug testing was a regular and known occurrence.” PLSNY advised that these collective drug
results indicated the urinalysis testing equipment at Albion was materially or operationally
defective.
PLSNY followed up with a second letter to DOCCS a month later in July 2019, which
stated that PLSNY and several other incarcerated individuals’ rights organizations had received
numerous additional complaints of false positive drug test results from individuals incarcerated
at Albion, Attica, Bare Hill, Eastern, Fishkill, Great Meadow, and Green Haven correctional
facilities. 27 PLSNY noted that given these widespread claims of false drug test results from
individuals, many of whom had little or no prior history of substance abuse or drug-related
misconduct, “it is highly likely the [Microgenics] drug testing apparatus, recently installed at
many DOCCS facilities, has an operational or technical fault of some type.”
PLSNY also advised DOCCS of the detrimental consequences of such false drug test
results. According to PLSNY, many individuals reported they believed that medications
prescribed to them to treat medical and mental health issues might be the cause of the false
https://www.plsny.org/about-pls.html.
The other incarcerated individuals’ rights organizations included The Legal Aid Society Prisoners’ Rights Project
and the CUNY School of Law Defenders Clinic.

26
27

16

positive drug test results, and they had been forced to choose between continuing their
medications or forgoing them in order to avoid disciplinary sanctions. PLSNY asked DOCCS to
take immediate investigatory action to determine whether prescribed drug cross reactivity could
be a factor in the surge in reports of false positive drug test results and concluded that if DOCCS
took no action to address this matter, it would be “unnecessarily exposing incarcerated persons to
undeserved punitive sanctions, which arbitrarily inflates their disciplinary record and impacts
their ability to parole.” 28
Subsequently, in November 2019, PLSNY and a private law firm filed a federal class
action lawsuit in the Eastern District of New York against Microgenics for those incarcerated
individuals “unjustly punished for false positive drug test results.” 29 In September 2020, an
incarcerated individual filed a lawsuit against Microgenics and DOCCS in the Eastern District of
New York alleging the same. 30 With similar claims, in July 2021, an incarcerated individual
filed a lawsuit in the Southern District of New York. 31 These lawsuits are currently pending.
DOCCS Reviews Claims of False Positive Drug Test Results
In July 2019, as complaints of false positive test results continued to mount, Booth, the
head of DOCCS’ Incarcerated Individual Drug Testing Program, arranged a meeting to discuss
the matter with Microgenics salesperson Collum and Collum’s supervisor, Larry Wilkie. At this
meeting, Collum and Wilkie requested DOCCS provide urine samples from incarcerated
individuals who had tested positive for buprenorphine and a list of medications taken by these
specific individuals so that any potential cross reactivity with the medications could be
examined.
Later that same month, after Booth had gathered urine samples from six individuals who
tested positive for buprenorphine at Eastern Correctional Facility and a list of all medications
used by these specific individuals, a Microgenics field technician visited the facility and retested
the urine samples using Microgenics’ drug tests and instruments. All again returned positive test

In September 2019, after not receiving a response from DOCCS, PLSNY again wrote DOCCS of the numerous
additional complaints of false positive drug test results it had received from incarcerated individuals incarcerated at
Eastern, Fishkill, Attica, Albion, Collins, Sing, and Woodbourne correctional facilities. In this letter, PLSNY
advised DOCCS it “must deal with the issue of unreliable drug testing immediately” or PLSNY would be forced to
take appropriate action.
29
See, Steele-Warrick v. Microgenics Corporation, U.S.D.C. (E.D.N.Y.), Case No. 1:19-cv-06558.
30
See, Wills v. Microgenics Corporation and DOCCS, U.S.D.C. (E.D.N.Y.), Case No. 1:20-cv-04432.
31
See, Taylor v. Microgenics Corporation and DOCCS, U.S.D.C. (S.D.N.Y.), Case No. 7:21-cv-06452.
28

17

results. As for the promised review of possible cross reactivity with medications, no results were
ever reported by Microgenics to DOCCS.
In late July 2019, Charles Kelly, then an associate commissioner and Annucci’s executive
assistant, began a broader review of incarcerated individuals’ claims of false positive drug test
results. At his direction, in August 2019, DOCCS provided Microgenics with urine samples
from another group of six incarcerated individuals who had tested positive for buprenorphine.
Microgenics agreed to have these urine samples tested using analyses performed on more
specific testing instruments.
Microgenics provided half of each urine sample to two different laboratories for
confirmatory testing. The first laboratory found that four of the urine samples had no
buprenorphine, and the second laboratory found that two of those urine samples had no
detectable buprenorphine and the other two had trace amounts of buprenorphine at levels below
positive test results. In sum, the outside laboratories had found that four of the six urine samples
had returned false positives to DOCCS. Despite this disturbing outcome, Microgenics did not
inform DOCCS of these results at this time or subsequently. Nor did Kelly follow up with
Microgenics about the results of the retesting of the six urine samples.
Separately, in August 2019, Kelly provided an outside company urine samples from yet
another group of six individuals who had tested positive for buprenorphine at Eastern
Correctional Facility. The outside company, which used more specific instruments and
processes to provide confirmatory testing services to DOCCS for parolees under an established
contract, found that five of the six urine samples contained no detectable buprenorphine. Once
again, using Microgenics’ tests and instruments, DOCCS had received false positive results
when testing urine samples from incarcerated individuals.
DOCCS Suspends Buprenorphine Testing, Reverses Sanctions, and Alerts the Inspector
General
On August 19, 2019, DOCCS issued a memorandum to all State correctional facility
superintendents instructing them to continue to obtain urine samples from those suspected of
drug violations or randomly chosen but to cease taking any disciplinary action for positive
buprenorphine tests. At this time, DOCCS did not address those incarcerated individuals then
being punished for positive buprenorphine test results.

18

On September 4, 2019, DOCCS and Microgenics participated in a conference call to
discuss the allegations of false positive drug tests due to cross reactivity with medications taken
by incarcerated individuals. On that same day, Microgenics received results from one of the two
outside laboratories, which confirmed that four urine samples from incarcerated individuals did
not contain buprenorphine. Rather than share this information with DOCCS, Microgenics
instead recommended that DOCCS transition from using the Buprenorphine II test to the less
sensitive Buprenorphine I test.
More than three weeks after issuing the memorandum, on September 10, 2019, DOCCS
directed its correctional facility superintendents to end the punishment of individuals then
serving internal confinement and/or other restrictions as a result of receiving a positive
buprenorphine test result. During the next five weeks, DOCCS reviewed the disciplinary records
of incarcerated individuals, including those transferred to other facilities during the relevant
period, ultimately releasing 140 individuals from internal confinement. DOCCS also began to
reverse and expunge incarcerated individuals’ records of associated misbehavior reports.
The New York State Attorney General Files a Civil Lawsuit on Behalf of DOCCS Against
Microgenics
In February 2020, the New York State Attorney General filed a civil lawsuit on behalf of
DOCCS against Microgenics in Albany County Supreme Court with eight causes of action
including breach of contract and negligent misrepresentation. The lawsuit is currently pending.
DOCCS DISCIPLINED INCARCERATED INDIVIDUALS BASED ON THE RESULTS OF
PRELIMINARY AND UNCONFIRMED DRUG SCREENING TESTS
The Inspector General’s investigation found that DOCCS disciplined individuals based
on the results of Microgenics’ preliminary drug screening tests and ignored test instructions that
results be confirmed using a more specific alternative method. DOCCS also unreasonably relied
on three-decade old case law—in which the court’s holdings were based on a different
manufacturer’s drug test—to justify forgoing the confirmation of Microgenics’ preliminary drug
screening test results. Specifically, the court in Peranzo did not consider cross-reacting
substances possibly found in incarcerated individuals’ urine samples, further calling into
question DOCCS’ reliance on this case to abstain from confirmatory testing. These deficiencies
worked to the detriment of incarcerated individuals who were disciplined, confined, and lost
privileges based on drug test results that were or may have been in error.

19

DOCCS Failed to Confirm Preliminary Drug Screening Test Results Using a “More
Specific Alternative” Method
Pursuant to DOCCS’ Urinalysis Testing policy, incarcerated individuals’ urine samples
are analyzed by trained correctional officers using drug testing instruments. If a test produces a
positive result, the policy requires that “a second test shall be performed on the same sample.” If
this second test also produces a positive result, the incarcerated individual is issued a
Misbehavior Report and the positive test result “may be used as evidence of the illicit use” of a
prohibited drug by the incarcerated individual in a subsequent disciplinary hearing.
In practice however, during the period at issue, DOCCS initially tested an individual’s
urine sample using Microgenics’ tests and instruments located in each facility. 32 When a test
produced a positive result, DOCCS then merely retested that urine sample using the same
Microgenics test, instrument, and method. 33 This second retest was contrary to instructions
provided with Microgenics test kits, which require confirmatory testing using a “more specific
alternative” method. (Emphasis added).
Confirmatory Testing of Preliminary Drug Screening Results
Microgenics manufactures drug tests used by DOCCS, including the Buprenorphine II
and AB-PINACA (synthetic cannabinoids) tests, among others. The tests are sold with package
inserts containing written instructions describing the tests’ intended use, test procedures and
guidelines, reagent and sample handling, and test limitations, and include lists of substances that
Microgenics has tested for cross-reactivity.
For example, the first four paragraphs of the package insert for the Buprenorphine test
include the following language:
The assay is intended to be used in laboratories and provides a simple and rapid
analytical screening procedure to detect buprenorphine and its metabolites in
human urine.
The assay provides only a preliminary analytical test result. A more specific
alternative chemical method must be used to obtain a confirmed analytical
result. Gas chromatography/mass spectrometry (GC/MS) or Liquid
chromatography/tandem mass spectrometry (LC-MS/MS) is the preferred
confirmatory method.
Clinical and professional judgment should be applied to any drugs of abuse test
result, particularly when preliminary results are used.
These instruments were known as Microgenics Indiko Plus Benchtop Analyzers.
In interviews with the Inspector General, DOCCS personnel consistently and incorrectly referred to this second
test as a “confirmatory test.”

32
33

20

Buprenorphine

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Importantly, the test instructions note that the test is a “screening procedure” that
provides “only a preliminary analytical test result.” Further, the instructions state that a “more
specific alternative chemical method must be used to obtain a confirmed analytical result.”
(Emphasis added.) The instructions for Microgenics’ synthetic cannabinoid test read similarly.
The “preferred” confirmatory methods per the Microgenics’ test instructions include gas
chromatography – mass spectrometry (GC/MS) and liquid chromatography – tandem mass
spectrometry (LC-MS/MS). These confirmatory tests, which are usually performed by outside
laboratories, precisely identify and quantify the presence of drugs in urine samples. The
confirmatory tests act to eliminate any false positive preliminary drug screening test results,
which may be caused by a faulty test, procedure, or cross-reacting substance, among other
factors.

21

However, despite Microgenics’ instructions, the Inspector General’s investigation found
that DOCCS failed to conduct confirmatory testing for incarcerated individuals’ urine samples
that tested positive when screened. During the period Microgenics’ drug testing kits were used
by DOCCS, 3,018 incarcerated individuals tested positive for a prohibited substance. 34
Of significant note, the Inspector General learned that DOCCS’ Community Supervision
division, which oversees its parolee drug screening program, has for more than two decades used
an outside laboratory for GC/MS confirmatory testing for parolee drug screening tests. 35
Community Supervision only takes action against a parolee when a screening test is confirmed
positive using this more specific alternate method. 36 However, the Corrections division of
DOCCS did not adequately coordinate with the Community Supervision division to leverage the
use of existing resources, which would have allowed for using the same vendor to cut costs and
streamline processes. Additionally, Community Supervision could have provided guidance to
Corrections about the importance of confirmatory testing from a lessons-learned perspective.
This lack of collaboration within the agency not only presented missed opportunities, but
contributed to the administration of inconsistent testing and undeserved punishments.
DOCCS Unreasonably Relied on Case Law as the Basis to Forgo Confirmatory Testing
According to the testimony of DOCCS witnesses, and as reflected in DOCCS’ policy, the
decision to forgo confirmatory testing of positive drug screening tests was made by DOCCS
more than three decades ago pursuant to specific case law. The Inspector General’s investigation
found this court decision and DOCCS’ drug testing policy were not appropriately reconsidered
before or after DOCCS implemented Microgenics’ drug testing systems in January 2019.
DOCCS’ Urinalysis Testing policy includes an attachment entitled Enzyme
Immunoassay Case Law, which describes “the scientific principles and validity of the testing
apparatus.” It cites federal case law in support of DOCCS’ decision to forgo confirming positive
preliminary drug test results using a more specific alternative method. The attachment reads:
In its decision dated October 26, 1987, in the federal class action suit of Peranzo
et al. v. Coughlin, et al., 37 the Southern District of New York found that ‘with a
DOCCS conducted drug tests of 24,228 incarcerated individuals during this period.
DOCCS’ Community Supervision unit uses a different manufacturer’s drug screening test. Like Microgenics’
tests, these screening tests also require confirmatory testing.
36
Parolees who admit to drug use after a positive screening test may be charged with drug violations without the
need for confirmatory testing.
37
Peranzo v Coughlin, 675 F. Supp. 102 (S.D.N.Y. 1987).
34
35

22

98+% rate of accuracy, the double EMIT 38 testing as performed by DOCCS is
sufficiently reliable so that the use of the results as evidence, even as the only
evidence, in a disciplinary hearing does not offend due process.’ The Court relied
upon DOCCS’ record of 98.7% accuracy rate in proficiency testing with the
American Association of Bioanalysts over the past four years.
In Peranzo, State incarcerated individuals brought a class action lawsuit in 1985 against
DOCCS and the Board of Parole 39 (Parole) claiming that the individuals’ 14th Amendment due
process rights were violated when DOCCS and Parole punished them based on positive results
from unreliable urine drug screening tests. Specifically, the individuals argued that DOCCS and
Parole took disciplinary action against and denied parole for those accused of prohibited drug use
after two positive screening tests. At this time, DOCCS used Siemens’ EMIT tests and
instruments in its Incarcerated Individual Drug Testing Program to screen for marijuana and
other prohibited drugs. Notably, no tests were available at this time for either buprenorphine or
synthetic cannabinoids. The court in Peranzo found that DOCCS’ practice of twice using
Siemens’ screening tests to test urine samples was reliable enough to satisfy due process
concerns and ultimately granted DOCCS’ motion for summary judgment, dismissing the
incarcerated individuals’ lawsuit.
The Inspector General’s investigation, however, found that DOCCS failed to perform an
appropriate legal review to determine if the holding in Peranzo, which involved the use of
Siemens’ drug testing systems in the 1980’s, remained a basis upon which to forgo confirmatory
testing using Microgenics’ drug testing systems. Instead, with guidance provided only by
Microgenics salesperson Collum, Bedard revised DOCCS’ drug testing policy, thereby giving
equal deference to Siemens’ and Microgenics’ drug tests for composition, procedure, and
reliability. Notably, Siemens’ and Microgenics’ analyses operate using different substances and
methodologies.
Specifically, the investigation found that in October 2018, Bedard, then the administrator
of DOCCS’ Incarcerated Individual Drug Testing Program, sought assistance from Microgenics
salesperson Collum to revise DOCCS’ drug testing policy. Collum provided Bedard excerpts
from scientific journals, which she indicated equated Siemens’ and Microgenics’ technologies
and the reliability of the two testing systems. By considering the two technologies equal, the
Siemens’ Enzyme Multiplied Immunoassay Technique (EMIT) tests.
At this time, the Board of Parole was part of the Division of Parole. In 2011, the Division of Parole merged with
the Department of Corrections to become the Department of Corrections and Community Supervision. Community
supervision is generally referred to as parole.

38
39

23

holding in Peranzo would appear to support DOCCS’ testing procedures using Microgenics’
drug tests and instruments. This legal application of Peranzo allowed DOCCS to rely on
Microgenics’ preliminary drug screening tests as the sole basis for the discipline of incarcerated
individuals, much as it had historically with Siemens’ tests.
Notably, the investigation found that neither Bedard nor Collum had the requisite
experience and education to evaluate the two technologies and ensure that the court’s holding in
Peranzo still legally applied. Additionally, Bedard did not seek an independent scientific review
of his policy changes or provide the proposed policy to the DOCCS’ chief medical officer for his
evaluation. The Inspector General also found no evidence that DOCCS’ Counsel’s Office
conducted a substantive review to ensure there was a sound basis for its continued reliance on
Peranzo. Given the at least 44 false positive test results found by outside laboratories, the
continued reliance on Peranzo was undoubtedly misplaced.
The Court in Peranzo Did Not Consider Cross-Reacting Substances Possibly Found in
Actual Urine Samples
The court in Peranzo did not consider the possible presence of cross-reacting substances
in urine samples provided by incarcerated individuals for drug tests. This fact makes DOCCS’
reliance on Peranzo to forgo confirmatory testing questionable.
The Peranzo decision emphasized DOCCS’ “record of 98.7% accuracy rate in
proficiency testing” when holding that DOCCS’ practice of twice using Siemens’ screening test
to test urine samples was reliable enough to satisfy due process concerns. However, the
Inspector General’s investigation found that DOCCS’ proficiency testing was not conducted with
actual urine samples but instead with samples of a solution that either contained or did not
contain a target drug. Notably, these samples were free of any possible cross-reacting
substances. Moreover, Siemen’s instruments, procedures, and tests were used rather than
Microgenics’ instruments, procedures, and tests. DOCCS provided no evidence to the Inspector
General of having obtained proficiency testing results using actual urines samples and
Microgenics’ instruments, procedures, and tests.
Microgenics evaluates its drug tests by determining if certain substances cross react to
produce false positives. 40 Its drug tests are provided with documentation reflecting substances
tested, cross reactions observed, and the quantities of the substances present in the samples at
40

See Addendum 3, which illustrates the manner in which the tests produce results.

24

which cross reactions were either observed or not observed. Instructions provided with drug test
kits note that substances other than those investigated by Microgenics “may interfere with the
test and cause false results.” Significantly, the investigation found that Microgenics did not
publish test results for certain substances found in over-the-counter drugs and medications
commonly prescribed to and used by incarcerated individuals.
As a consequence of early reports of false positive results by outside laboratories
conducting confirmatory testing, DOCCS began using an outside laboratory for confirmatory
testing of all positive preliminary drug screening test results in November 2019. In the five
months that followed, more than 27 percent of all positive Microgenics preliminary screening
tests submitted by DOCCS to this outside laboratory were found to be in error—false positives. 41
It remains unknown if the cause of any of these false positive test results is due to cross-reacting
substances.
These results call into question the reliability of Microgenics’ drug testing systems for the
incarcerated individual population, make imperative the confirmation of positive preliminary
drug screening test results, and make DOCCS’ reliance on Peranzo inapposite.
DOCCS FAILED TO TAKE PROMPT CORRECTIVE ACTION AFTER DISCOVERING
FALSE POSITIVE DRUG TEST RESULTS
The Inspector General found that Charles Kelly, then DOCCS associate commissioner
and executive assistant to the acting commissioner, failed to take prompt corrective action after
discovering in August 2019 that five incarcerated individuals who tested positive for
buprenorphine using Microgenics’ drug testing systems had no detectable buprenorphine in their
urine.
In June 2019, Kelly commenced a review of incarcerated individuals’ allegations of false
positive drug urine tests after facilities began “receiving a lot of positive results with
[incarcerated individuals] that had no drug history and some superintendents were concerned.”
The Inspector General’s review of confirmation testing by outside laboratories of urine samples was greatly
hindered by DOCCS’ failure to maintain complete records of confirmation test results and sufficiently identify
samples sent for testing. Between November 2019 and March 2020, DOCCS submitted at least 158 positive
preliminary/screening tests to an outside laboratory for review. Of this number, 18 samples were rejected for
various reasons. Of the 140 remaining tests, 39 returned false positive results. These included 25 synthetic
cannabinoid tests, 12 THC tests, and two opiate tests. The Inspector General also identified another 175 tests of
urine samples that were conducted by this outside laboratory but not included in DOCCS’ database. Additionally,
the Inspector General found that DOCCS may have neglected to record thousands of other testing results in its drug
testing database.
41

25

According to Kelly, he “reported it up . . . [and] it became my problem.” Kelly, whose job duties
included assisting the commissioner with special projects and drafting agency policies, had no
direct oversight of DOCCS’ Incarcerated Individual Drug Testing Program, or education,
training, or experience in drug testing. Kelly enlisted Bedard, the former administrator of the
program, and Booth, the current administrator, in his review of the matter.
As part of his review, in August 2019, Kelly and Bedard consulted with Timothy
O’Brien, the DOCCS director of internal operations for community supervision, to learn about
the State’s parolee drug testing program. O’Brien advised that the parolee drug testing program
did not use the Microgenics’ tests used by DOCCS for State incarcerated individuals but instead
another manufacturer’s preliminary drug screening tests for parolees. 42 O’Brien further advised
that in the event a parolee’s urine sample produces a positive test result and the parolee does not
admit to consuming drugs, the sample is sent to an outside laboratory for confirmatory testing
using GC/MS. 43 Significantly, O’Brien advised Kelly and Bedard that only if a preliminary drug
screening test is confirmed positive using this more specific alternative method does Community
Supervision take action against a parolee. Despite learning that Community Supervision, a
DOCCS division, obtained confirmatory testing for all positive preliminary drug screening test
results (absent a parolee’s admission of guilt), Kelly took no action at this time to review and
revise the Incarcerated Individual Drug Testing Program’s procedures.
In mid-August 2019, at Kelly’s direction, DOCCS provided Microgenics with urine
samples from six incarcerated individuals who had tested positive for buprenorphine.
Microgenics provided one half of each urine sample to a Massachusetts-based laboratory and the
second half to a Germany laboratory. Each laboratory, using more specific instruments and
processes, tested the identical samples for buprenorphine. The Massachusetts laboratory found
that four of the urine samples had no buprenorphine. The German laboratory found that two of
those urine samples had no detectable buprenorphine and the other two had trace amounts of
buprenorphine at levels below positive test results. In sum, the outside laboratories had found
that four of the six urine samples had returned false positives to DOCCS. Despite this alarming
finding, Microgenics never informed DOCCS of these results.

Community Supervision (commonly known as Parole) uses iCup urinalysis tests manufactured by Abbott
Laboratories.
43
Parolees who admit to drug use after a positive screening test may be charged with drug violations.
42

26

On August 9, 2019, Kelly directed that another six urine samples that had tested positive
for buprenorphine at Eastern Correctional Facility using Microgenics’ preliminary drug
screening tests be sent to an outside laboratory for confirmatory testing. 44 On August 12, 2019,
the outside laboratory, using more specific alternative methods, advised Kelly that it had found
that five of the six samples did not contain buprenorphine. 45
Kelly, who testified that he was aware at this time that the five individuals who provided
the urine samples at Eastern Correctional Facility were still in confinement pending sentencing
on their disciplinary charges, took no immediate remedial action to address the matter. When
asked by the Inspector General whether the results from the outside laboratory provided evidence
that the individuals may not be guilty, Kelly responded, “Possibly.” According to Kelly, based
on articles he had read, he believed the findings of the outside laboratory were unreliable because
the samples had “degraded.” Kelly provided no scientific evidence to the Inspector General to
support his contention. Kelly also testified that he may have verbally advised his superiors of the
outside laboratory’s findings, but he did not provide them with the actual test results.
Kelly should have immediately sought to reverse the disciplinary decisions and expunge
the records of the five Eastern Correctional Facility incarcerated individuals who had tested
positive for buprenorphine using Microgenics’ preliminary drug screening tests but who were
determined by an outside laboratory to have no detectable buprenorphine in their urine samples.
Additionally, this discovery should have caused Kelly to immediately notify acting
Commissioner Annucci and other DOCCS executives about these irregularities with Corrections’
drug testing program.
DOCCS LIKELY IMPROPERLY PROCURED ITS DRUG TESTING SYSTEMS AND
SERVICES
The Inspector General’s investigation found that DOCCS appeared to violate New York
State Finance Law when contracting for commodities and services for its Incarcerated Individual
Drug Testing Program.
State Finance Law section 163 requires that State agencies give first priority to preferred
sources when the commodities or services sought are available from a preferred source in the

Kelly testified that he may have informed acting Commissioner Annucci and Deputy Commissioner James
O’Gorman that the samples were undergoing confirmatory testing.
45
The samples analyzed by the outside laboratory were found to have no buprenorphine at or above the 1ng/ml cutoff value established for the test.
44

27

“form, function and utility” required by a State agency. 46 The New York State Office of General
Services maintains a list of New York State Procurement Council-approved preferred source
commodities and services. 47 If a preferred source does not meet the “form, function, and utility”
requirement or cannot otherwise fulfill an agency’s request, an agency must next determine
whether the commodities or services sought can be acquired through an OGS centralized
contract, agency or multi-agency centralized contract, respectively. If not, an agency may
procure commodities or services through competitive bidding.
However, the Inspector General’s investigation found that prior to 2014, DOCCS
neglected to determine if drug testing kits for its Incarcerated Individual Drug Testing Program
were available through a preferred source, OGS centralized contract, or agency or multi-agency
centralized contract. Instead, DOCCS procured urine drug testing kits from Siemens at a higher
price than prices listed in a New York State centralized contract. In 2014, also in apparent
violation of State Finance Law, DOCCS entered into separate lease agreements for Siemens’
urine analyzers at each of its correctional facilities at a cost to DOCCS of approximately
$440,000 annually.
By way of background, in 2013, Bedard was assigned to oversee the Incarcerated
Individual Drug Testing Program. At this time, DOCCS was utilizing urinalysis tests and
instruments procured from Siemens. As part of its contract with DOCCS, Siemens provided its
instruments at no cost but charged DOCCS for its urinalysis test kits, which included reagents,
controls, and calibrators.
Bedard soon discovered that DOCCS was paying more for Siemens’ test kits than the
price Siemens had agreed to provide State agencies in a New York State centralized contract.
According to Bedard, when he informed DOCCS’ Budget Office, the office advised such an
arrangement violated State Finance Law and the Siemens contract would be reviewed.
Subsequent to this review, DOCCS demanded that Siemens provide it drug test kits at the lower
price found in the centralized contract. 48 In response, Siemens advised it would instead charge
for the use of its drug testing instruments.
New York State Office of General Services, “NYS Procurement Bulletin: Preferred Source Guidelines,”
https://ogs ny.gov/procurement/nys-procurement-bulletin-preferred-source-guidelines (last accessed 10/22/2021).
47
New York State Office of General Services, List of Preferred Source Offerings, Revised May 2020,
https://ogs ny.gov/system/files/documents/2020/05/the-list-of-preferred-source-offerings 0.pdf (last accessed
10/22/2021).
48
The Inspector General was unable to confirm if DOCCS’ Budget Office conducted any such review.
46

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In 2014, DOCCS and Siemens reached a fiscal agreement on the matter. As part and
parcel of this agreement, Siemens would provide its drug test kits to DOCCS at the lower
centralized contract price, and each DOCCS correctional facility would lease drug testing
instruments from Siemens. As a result, DOCCS’ costs to administer the Incarcerated Individual
Drug Testing Program dramatically increased. 49
However, the investigation revealed that this agreement was entered into without
following the mandates of State Finance Law. DOCCS failed to determine if urinalysis testing
kits and instruments were available from a preferred source, State centralized contract, or agency
or multi-agency centralized contract before entering into this new agreement with Siemens. In
fact, representatives from DOCCS’ Contract Procurement Unit advised the Inspector General
that they had never performed such a procurement review when purchasing instruments and tests
for DOCCS’ Incarcerated Individual Drug Testing Program. Notably, DOCCS has procured
drug tests for its Community Supervision parolee program using a State centralized contract for
many years and did not explore using this existing vendor as a proposed approach.
In 2018, when DOCCS sought to acquire new drug testing systems, it again likely failed
to follow the requirements of State Finance Law. Again, DOCCS did not determine if urinalysis
testing kits and instruments were available from a preferred source, State centralized contract, or
agency or multi-agency centralized contract. Instead, DOCCS initiated a competitive
procurement without performing a diligent review.
DOCCS Failed to Perform Due Diligence in Procuring Microgenics’ Drug Testing Systems
The Inspector General’s investigation found that DOCCS failed to perform due diligence
prior to contracting with Microgenics as DOCCS failed to understand that the company’s
preliminary drug screening tests alone do not produce reliable results and all positive results
must be confirmed by a more specific alternative method when used in a correctional facility
setting. 50
Specifically, the investigation found that Bedard, the administrator of DOCCS’
Incarcerated Individual Drug Testing Program from 2011 to January 2019, coordinated

According to Bedard, the costs almost doubled. From testimony and a review of records, DOCCS’ total annual
cost for drug testing systems under Siemens at this time was approximately $590,000 while Microgenics drug
testing systems cost DOCCS approximately $320,000 annually.
50
The use of such preliminary screening drug tests may be appropriate in a clinical setting and should be
distinguished from use in a correctional/penal setting.
49

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procurement of Microgenics’ drug testing systems and perpetuated DOCCS’ misinformed
practice of relying solely upon positive results of preliminary drug screening tests to discipline
incarcerated individuals. Bedard, who was responsible for ensuring drug tests were administered
properly, tracking test results, and training hearing officers, requested that DOCCS reevaluate its
urine testing vendor in 2016, created the required specifications for selecting a new drug testing
vendor, and revised DOCCS’ Urinalysis Testing directive. Notably, the investigation found that
Bedard, who lacked any scientific or legal education or training, was not qualified to evaluate the
drug testing systems of the vendors that participated in the procurement. 51
In December 2016, after discovering issues with DOCCS’ earlier procurement of drug
testing systems from Siemens, Bedard began to seek other vendors for the program. In
furtherance of this effort, in 2017, Bedard requested that Microgenics salesperson Collum
coordinate a side-by-side comparison of Siemens’ and Microgenics’ instruments and tests.
According to Bedard, he chose to compare the instruments and tests manufactured by only two
vendors—Siemens and Microgenics, “even though there were other vendors that were out there
claiming that they could provide us the services” sought. 52
Bedard testified that the results of the comparison showed the two manufacturers’ testing
systems were essentially the same but for “one discrepancy.” Microgenics’ testing systems
found one urine sample was positive—and therefore was found to contain buprenorphine, while
the same sample tested negative using Siemen’s drug testing systems. Microgenics concluded
that its test result had been incorrect, claiming the urine sample likely contained Tylenol with
codeine, a medication prescribed to the incarcerated individual, which had cross reacted with its
test. Microgenics representatives advised Bedard that the matter would be remedied if DOCCS
were to procure its new test, the Buprenorphine II test. However, this test had yet to receive
FDA approval or been prepared for marketing.
In anticipation of DOCCS’ switch to Microgenics’ drug testing systems, Bedard then
took steps to revise DOCCS’ Urinalysis Testing policy, which at the time referenced only
Siemen’s drug testing systems. In October 2018, with the assistance of Microgenics salesperson
Collum, Bedard revised the policy to, in essence, equate Siemen’s and Microgenics’ testing
systems so that the court’s holding in Peranzo would be applicable. Collum provided quotes
Bedard testified to the Inspector General that “the science behind all this is not my forte.”
Two other vendors, Alere, Inc. (now known as Abbott Laboratories) and Alliance Laboratories also submitted
bids to DOCCS under this procurement.

51
52

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from scientific journals that spoke to the reliability of Microgenics’ tests and analogized the
results of the two tests. However, the Inspector General found no evidence that Bedard sought
review of his policy changes by scientific experts or DOCCS’ medical personnel. 53
Subsequently, DOCCS awarded the drug testing system contract to Microgenics.
The investigation found that at the time of the award, Microgenics’ Buprenorphine II
testing system was not being used by any other correctional system in the country. 54
Additionally, the investigation found that DOCCS was one of only seven states that disciplines
incarcerated individuals based on the results of preliminary drug screening tests without
confirming those results with a more specific alternate method. 55 DOCCS presented no evidence
to the Inspector General that it was aware of these facts or had contacted other states to obtain
information about confirmatory testing.
Bedard’s errors, which were due to his inexperience and the lack of oversight by his
supervisors, were heightened by DOCCS’ failure to provide adequate procurement guidance and
review by all necessary parties. Bedard testified that he merely intended to acquire instruments,
tests, and services similar to those historically provided to DOCCS by Siemens, and Microgenics
offered the analyzers and tests at lower costs. Unfortunately, Bedard and DOCCS failed to fully
examine their internal practices to the detriment of the incarcerated individuals.
ADMINISTRATIVE FAILURES AFFECTED THE OPERATIONS OF THE
INCARCERATED INDIVIDUAL DRUG TESTING PROGRAM
Testing Officers Neglected to Consistently Record Testing Results in Internal Database
The investigation found that although DOCCS’ Urinalysis Testing policy requires testing
officers to enter certain information on drug test results in an internal disciplinary tracking
database, such officers often neglected to enter all required information. 56 Specifically, testing
officers did not consistently record the specific rule an individual was found to have violated. As
a result, when DOCCS attempted to identify all individuals who were disciplined based on

This policy, found in Directive 4937, was approved by then Deputy Commissioner James O’Gorman.
According to Microgenics, its products at this time were being used by the Arkansas and Hawaii Departments of
Corrections, Georgia Department of Community Supervision, Federal Probation and Parole, and various state crime
labs and drug courts throughout the country.
55
The Inspector General reviewed publicly available drug testing policies for incarcerated individuals nationwide.
This review found that 35 states have policies requiring confirmation, or permitting confirmation in specific
circumstances, of preliminary screening urine tests prior to disciplinary action, and seven states did not require
confirmation testing prior to disciplinary action. The Inspector General was unable to determine the drug testing
policies for the remaining eight states.
56
Directive 4937(VI).
53
54

31

positive results of Microgenics’ drug tests, they were initially unable to do so using the
information contained in the database. Consequently, DOCCS resorted to manually searching
through hearing records to identify all individuals disciplined due to positive results of
Microgenics’ drug tests. This physical search took DOCCS almost three months to complete.
Testing Officers Neglected to Consistently Consult Medical Staff on Possible CrossReacting Drugs
Although DOCCS policy requires testing staff to consult with DOCCS medical staff
concerning whether an incarcerated individual was prescribed any medication that could cause a
false positive drug test result, this procedure was not consistently followed. 57 The investigation
found that compliance with this policy varied among DOCCS’ correctional facilities. Moreover,
DOCCS had no procedure or uniform practice for its medical staff to review drugs prescribed by
the New York State Office of Mental Health (OMH) to incarcerated individuals receiving mental
health care. The Inspector General found the failure to have medical staff consistently review all
medications prescribed to individuals to eliminate possible concerns of cross reactivity is
alarming. 58
DOCCS Failed to Adequately Train Incarcerated Individual Drug Testing Staff and
Hearing Officers
The investigation found that DOCCS failed to adequately train its drug testing and
hearing officers, who generally did not understand the scientific operation of the drug tests and
instruments utilized by DOCCS. In testimony to the Inspector General by testing and hearing
officers and from a review of recordings of disciplinary hearings, this deficiency was evident.
DOCCS’ drug testing officers responsible for administering DOCCS’ Incarcerated
Individual Drug Testing Program received only two days of training on the operation of
Microgenics’ drug testing instruments when the machines were first installed in DOCCS’
facilities. No training was provided to the officers on the science behind the drug testing system.
After a measurable increase in positive test results was observed following the
installation of Microgenics’ drug testing systems in DOCCS’ facilities in early 2019, few testing
officers recognized this issue and elevated concerns to supervisors and executive staff. Indeed,
several witnesses testified that they assumed the increase was due to the fact that Microgenics’
Directive 4937(IV)(D)(2).
DOCCS could not provide the total number of incarcerated individuals who received services from the New York
State Office of Mental Health (OMH) and were disciplined for positive drug test results.
57
58

32

systems were better and more sensitive. No action was taken at any level within DOCCS to
consider if the increase in positive test results could be linked to cross-reactivity or other factors.
Further, DOCCS’ hearing officers, who are responsible for making determinations of fact
on whether incarcerated individuals have used illegal drugs, received no training on testing
technology. The investigation found that hearing officers often failed to understand arguments
made by incarcerated individuals and explanations provided by Microgenics technical service
representatives concerning testing technology. In fact, the Inspector General reviewed 30
recorded disciplinary hearings in which it appeared hearing officers did not understand the
reliability of preliminary drug screening tests, the need for confirmatory testing, and crossreactivity. These failures placed incarcerated individuals at a disadvantage when advocating for
their innocence.
MICROGENICS FAILED TO DISCLOSE ISSUES WITH ITS URINALYSIS TESTS AND
ITS REPRESENTATIVES PROVIDED MISLEADING INFORMATION DURING DOCCS’
DISCIPLINARY HEARINGS
The Inspector General’s investigation found that in 2019, Microgenics failed to disclose
to DOCCS that its Buprenorphine II test had produced four false positive results when testing six
DOCCS urine samples, and that internal research had shown the test was susceptible to crossreactivity with some common medications and might thereby produce false positive results.
Microgenics Failed to Disclose to DOCCS Information on False Positive Test Results
In July 2019, as incarcerated individuals’ complaints of false positive drug test results
increased, Booth, who assumed oversight of DOCCS’ Incarcerated Individual Drug Testing
Program in January 2019, contacted Microgenics to request its assistance with evaluating these
claims. Booth provided Microgenics with urine samples from six individuals who had tested
positive for buprenorphine using Microgenics’ Buprenorphine II test.
Microgenics retested the six urine samples using its Buprenorphine II test and all returned
positive results. Microgenics then tested the six samples using what it purports to be a less
sensitive test, its Buprenorphine I test. These tests produced different results—two positive, two
“borderline” positive, and two negative test results.
Microgenics then sent the six urine samples to two outside laboratories for confirmation
testing using Gas Chromatography – Mass Spectrometry. The first laboratory found that two
urine samples contained buprenorphine, confirming the results found for those two urine samples
33

using both the Buprenorphine I and II tests. However, strikingly dissimilar to the positive results
of the earlier Buprenorphine II tests, the first lab found that the four remaining urine samples
were negative for buprenorphine at the specified cut-off value. 59 The second laboratory had the
same findings as the first laboratory, but further found that two of the negative samples had no
detectable buprenorphine or its metabolites.
In all, the confirmatory testing mandated by Microgenics—which DOCCS had neglected
to obtain since Microgenics drug tests and instruments were installed at DOCCS’ correctional
facilities beginning in January 2019—had found that four of six urine samples had returned false
positives. Despite this unacceptable finding and contrary to the very purpose of Microgenics’
review, which was to assist DOCCS in discovering what might be causing false positive test
results, Microgenics failed to disclose these findings to DOCCS.
Notably, the first outside laboratory’s results were received by Microgenics on September
4, 2019, the same day that DOCCS and Microgenics held a conference call specifically to
discuss incarcerated individuals’ claims of false positives results by the Buprenorphine II test.
Rather than reveal the apparent unreliability of its Buprenorphine II test, Microgenics instead
recommended to DOCCS that it begin to use its older, less sensitive test, the Buprenorphine I
test. 60
Microgenics’ Internal Research Finds but Does Not Disclose to DOCCS that its
Buprenorphine II Test is Susceptible to Cross-Reactivity with Some Common Medications
Microgenics also failed to disclose to DOCCS that internal research had found that some
common medications prescribed to incarcerated individuals and other common substances
ingested by them might cross-react with its test reagents and cause false positive results when
using the Buprenorphine II test. In addition, Microgenics did not advise DOCCS that its
research had found that high doses of commonly prescribed medications might cause false

Diagnostic drug tests set “cut-off values” to distinguish positive from negative samples. Samples testing at or
above a cut-off value are considered positive, while samples testing below are considered negative. Of note, the first
laboratory also tested the four samples for norbuprenorphine, a metabolite of buprenorphine, and likewise found it
was not present at the Buprenorphine II test cut-off value.
60
As DOCCS’ Incarcerated Individual Drug Testing Program had been suspended by this date, DOCCS did not use
Microgenics’ Buprenorphine I test.
59

34

positive results. For example, the medications Codeine, Dextromethorphan (a cough
suppressant), and Oxycodone might cause false positive results if taken in higher doses. 61
In July 2019, DOCCS provided Microgenics with a list of medications commonly
prescribed to individuals at one of its correctional facilities and requested that Microgenics
determine if the medications could factor into potential false positive drug test results. As noted
earlier in this report, Microgenics’ tests include a package insert which lists, among other
information, substances that have been found to cross-react with the test and thereby potentially
cause false positive test results. Some of the medications on the list provided by DOCCS were
not listed on Microgenics’ package insert as identified cross-reactive substances. However,
Microgenics advised that some of the prescribed medications, while not tested by Microgenics,
have a “high probability of interference” and therefore could cause a false positive test result.
These medications included Omeprazole (an antacid), Naproxen (a commonly prescribed pain
reliever), and a “multivitamin tab,” among others.
According to Microgenics, it tests substances for cross-reactivity after the product is
brought to market, and it may receive requests from customers, field technicians, or technical
support to test particular substances. Microgenics reviewed the list and identified three
substances that cross-react with the Buprenorphine II test but were not listed on package inserts.
These substances, which included metabolites of a commonly prescribed antacid and a natural
sweetener, could return a false positive result. 62 However, Microgenics never notified DOCCS
of this finding. Microgenics advised the Inspector General that it had not disclosed these new
findings because they were “preliminary screening results” that had not been verified by the
FDA. Microgenics claimed that it relies on FDA review and approval as part of its decision
making about whether to disclose test results and findings to customers.
Microgenics Representatives Provided Misleading and Inconsistent Information to DOCCS
and Incarcerated Individuals at Disciplinary Hearings
The investigation found that Microgenics representatives provided misleading and
inconsistent statements during disciplinary hearings for individuals incarcerated with DOCCS.

The substances listed on Microgenics’ package inserts only disclose the highest amount of a substance known to
produce a negative result. Microgenics does not disclose the amount of a substance that would produce a positive
result.
62
The substances were two metabolites of Omeprazole, a commonly prescribed antacid, and one metabolite of a
compound found in Stevia, a natural sweetener. This antacid was found to cross-react at 25,000 ng/mL compared to
most substances listed on the package insert that were found not to cross-react at levels up to 100,000 ng/mL.
61

35

Specifically, while participating at these hearings, Microgenics representatives failed to verify
that positive preliminary drug screening test results must be confirmed by a more specific
alternative method. This contention was true even in instances where incarcerated individuals
pointed out that such confirmation testing was mandated in instructions provided with all
Microgenics tests. Moreover, the investigation found that Microgenics Sales Representative
Collum instructed company representatives not to discuss confirmatory testing during DOCCS’
hearings.
Pursuant to its contract with DOCCS, Microgenics representatives staffed a telephone
hotline and provided answers to questions posed during disciplinary hearings about Microgenics’
instruments and tests.
The Inspector General reviewed recordings of approximately 30 disciplinary hearings
made during the relevant period and identified several in which incarcerated individuals asked
the representatives if positive results found using Microgenics tests required confirmation. In
response, Microgenics representatives failed to verify the need for confirmatory testing and often
replied that DOCCS was responsible for determining whether such tests must be confirmed.
In a July 2019 disciplinary hearing the following exchange took place:
Incarc. Indiv: My following question, sir, has to do with your documentation
specific for the CEDIA buprenorphine assay. It says, my question
is, isn’t it true that official documentation of your company Thermo
Fisher Scientific clearly states that this machine utilizes, the study of
buprenorphine assay is for screening purposes only?
Hearing Off: Here, let me see that. His question is, the documentation that he has
in front of him shows that the machine that we are using is a
preliminary analytical test. Is that true?
Micro. Rep:

For normal use, yes. For government use, though, that is dependent
on the site. The information we see is what we [inaudible] available
on our website. That is normally used by like a pain clinic other . . .

Incarc. Indiv: Sir, that is not my question.
Micro. Rep:

Other hospitals and pain clinics, those are governed by, by a different
set of rules. For government facilities, it is up to them as to . . .
operating procedures . . . It’s really up to the facility . . . government
entities like the New York Department of Corrections . . . they don’t
always have to comply with what we’d, what’s normally released
for our non-government entities.
36

Incarc. Indiv: Yeah, I’m sorry, but that’s not what it says in the document, sir. The
document says that the assay will provide you with preliminary
analytical test results. It doesn’t say anything about hospitals or
prisons or law enforcement or non-law enforcement use, it says that
it provides only preliminary analytical test and more specific
alternative careful methods must be used, not should be, must be
used, to confirm any analytical results and then they recommend gas
chromatographic mass spectrometry is the preferred confirmatory
method. Is that true?
Micro. Rep:

For pain clinics and [inaudible], yes.

Incarc. Indiv: That’s not what it says in the document, sir.
Micro. Rep:

I know what is says on the document. I have it in front of me.

Incarc. Indiv: So do I, sir.
Hearing Off: So, do you have any other questions for him?
Incarc. Indiv: Yes. Why must it be confirmed by a second GCMS test?
Hearing Off: The question is that with this testing procedure, and it says here,
more specific alternative method must be used to obtain a confirmed
analytical result. Is that true?
Micro. Rep:

Only if there’s a need to know the specific level of buprenorphine
that’s in the system. . . It’s used by pain clinics to determine if a
customer or the patient is compliant with their current regimen of,
say, in this case, buprenorphine. If they’re being prescribed
suboxone, which is to help them get off of opioids, there needs to be
a critical level of buprenorphine in their system. And LCMS is one
way that you could determine the exact amount, that way the pain
clinic knows that they’re not saving their pills and that they’re taking
enough to get a positive and not giving enough of the buprenorphine
in their system to show that they’ve really taken the pills in.

The incarcerated individual quoted above justifiably asked about the type of drug testing
during the disciplinary hearing. However, the hearing officer misconstrued the question and the
Microgenics representative failed to verify the need for confirmatory testing. In this matter, the
hearing officer ultimately “found discrepancies” and found this incarcerated individual not
guilty.
In testimony to the Inspector General, this Microgenics representative stated that
confirmation testing only applied to medical clinics, where the quantity of a drug present in a

37

urine sample must be determined. According to the representative, as DOCCS only needed to
know whether an incarcerated individual’s sample was positive or negative, no such
confirmation testing was required. This testimony by the vendor’s representative contradicts the
instructions Microgenics provides with all drug tests.
Additionally, the Inspector General found no evidence that the requirement of
confirmatory testing was conditioned on the type of facility using the tests. Notably, other
Microgenics personnel interviewed by the Inspector General advised that the tests used by
DOCCS were preliminary drug screening tests that must be confirmed.
The Microgenics representative further testified that when DOCCS awarded its drug
testing contract to Microgenics, Collum instructed the technical service representatives that
DOCCS does not perform confirmatory testing and therefore it should not be discussed by the
representatives during incarcerated individual hearings. Collum denied this statement in
testimony to the Inspector General. Such instruction, if given, would have almost certainly
hindered the responses of these representatives to questions raised by incarcerated individuals
during their disciplinary hearings.
The Inspector General also found that Microgenics representatives—on multiple
occasions—provided other misleading or inconsistent information in disciplinary hearings.
In one example, in March 2019, an incarcerated individual questioned a Microgenics
representative about the reliability of the preliminary drug screening tests. This individual, who
denied using buprenorphine, had never before failed a urine screening test while incarcerated
with DOCCS. The Microgenics representative advised the individual that the test was 99.9
percent accurate, and he could not recall ever seeing a false positive result. No mention was
made of confirmatory testing. This individual was found guilty and ultimately sentenced to 40
days keeplock; 75 days loss of recreation and package, telephone, and commissary privileges;
and a two-month loss of good time was recommended.
In another example, an incarcerated individual who tested positive for buprenorphine in
February 2019 questioned a Microgenics representative about possible cross-reactions with overthe-counter medications. The representative advised the individual that over-the-counter drugs
would not cause a false positive and “anything that would cause a positive would be some sort of
variation of buprenorphine or . . . something chemically related.” This is incorrect.
Nevertheless, this individual was found guilty and sentenced to 180 days in SHU; 180 days loss
38

of recreation and package, telephone, and commissary privileges; and a 30-day loss of good time
was recommended. He was also referred to DOCCS’ Alcohol and Substance Abuse Treatment
Program.
FINDINGS AND RECOMMENDATIONS
DOCCS Disciplined Incarcerated Individuals Based Solely on Preliminary Drug
Screening Test Results
The Inspector General’s investigation found the DOCCS disciplined incarcerated
individuals based on the results of preliminary and unconfirmed drug screening tests. Despite
instruction included with all Microgenics drug tests that require a “more specific alternative
chemical method must be used to obtain a confirmed analytical result,” this did not occur.
During the eight-month period in which Microgenics’ drug testing systems were used at
DOCCS, 3,018 incarcerated individuals tested positive for drug use, with 2,199 incarcerated
individuals testing positive for buprenorphine, 1,632 of which were charged and punished. 63
Punishment for these individuals included solitary confinement in SHU and keeplock,
delays in parole eligibility and/or release, and/or the loss of privileges such as the receipt of
packages, commissary, telephone use, and participation in the Family Reunion Program and
other programs.
Bedard unreasonably relied on three-decade old case law—with holdings based on
another manufacturer’s drug test—to forgo confirmatory testing of preliminary drug screening
test results obtained using the new Microgenics drug testing systems. This reliance was
misplaced and not appropriately reviewed by DOCCS’ Counsel’s Office or medical examiner.
Additionally, the court in the Peranzo case did not consider cross-reacting substances possibly
found in incarcerated individual urine samples.
During the investigation, the Inspector General recommended to DOCCS that it confirm
the results of all urine tests prior to taking disciplinary action. DOCCS advised the Inspector
General that on January 15, 2020, it terminated its contract with Microgenics.
On February 22, 2021, DOCCS resumed its Incarcerated Individual Drug Testing
Program following a revised Urinalysis Testing Policy requiring that “all initial positive test
results will be sent to the outside laboratory for confirmation testing.” DOCCS now uses a
DOCCS’ internal disciplinary database does not track whether an incarcerated individual’s punishment is based
upon a positive drug test alone or includes some other charge.

63

39

preliminary drug screening test known as the Premier Biotech Bio-Cup to test urine samples.
Positive results from these preliminary drug screening tests are then tested using a more specific
alternative method, Gas Chromatography – Mass Spectrometry, by Cordant Health Solutions.
During the investigation, the Inspector General advised DOCCS to release from internal
confinement any individuals then-currently confined solely based upon positive drug screening
results. Between September 11, 2019 and October 22, 2019, DOCCS released 140 incarcerated
individuals from confinement that met these conditions.
The Inspector General also advised DOCCS to reverse and expunge all records of
incarcerated individuals who were found guilty of drug consumption based upon a Microgenics
preliminary screening test. DOCCS advised that it subsequently reversed and expunged
approximately 2,500 disciplinary records.
In light of the termination of the Microgenics contract and the restructuring of the
Incarcerated Individual Drug Testing Program, the Inspector General recommends that DOCCS
review its policies to ensure that DOCCS medical and legal staff review and approve any future
modifications to the program.
DOCCS Failed to Take Prompt Corrective Action Upon Learning Some
Incarcerated Individuals Had Been Charged with Drug Violations and Punished
Due to False Positive Drug Screening Test Results
Former DOCCS Associate Commissioner Kelly failed to take prompt corrective action
after discovering that at least five incarcerated individuals had been wrongfully charged and
punished for drug violations. Kelly retired from State service in August 2020, while this
investigation was pending.
DOCCS Likely Improperly Procured its Drug Testing Systems and Services
DOCCS procured its drug testing systems and services and entered into lease agreements
for drug testing instruments in apparent violation of State Finance Law. Moreover, DOCCS did
not perform due diligence when contracting with Microgenics for its drug testing systems, failing
to understand that such tests were merely preliminary screening tests that would require
confirmatory testing. The Corrections division of DOCCS also failed to coordinate with the
Community Supervision division to leverage the use of existing resources, which would have
allowed Corrections to use the same vendor to cut costs and streamline processes.

40

The Inspector General recommends that DOCCS undertake a review of its Contract
Procurement Unit’s processes to ensure compliance with State Finance Law in all procurements.
Additionally, DOCCS’ Counsel’s Office should review and approve all contracts and purchase
orders over a designated monetary threshold set by the agency after an internal review is
conducted.
Administrative Failures Affected the Operations of the Incarcerated Individual Drug
Testing Program
DOCCS engaged in various administrative failures in the Incarcerated Individual Drug
Testing Program that affected the operations of the program. These included the failure by
testing officers to enter all required information into a central disciplinary tracking database, and
to consistently consult medical staff on possible cross-reacting drugs—as is required by policy.
Also, the investigation found DOCCS did not adequately train drug testing staff and hearing
officers on the drug tests and instruments. Additionally, DOCCS had no procedure or uniform
practice for its medical staff to review drugs prescribed by OMH to incarcerated individuals
receiving mental health care.
The Inspector General recommends that DOCCS provide comprehensive training to its
drug testing and hearing officers on the drug testing policy, tests, and instruments used in the
program. In addition, testing and hearing officers should be reminded of the requirement to enter
all required drug testing information into DOCCS’ disciplinary tracking database and to
consistently consult medical staff on possible cross-reacting drugs. DOCCS must also ensure
that when incarcerated individuals test positive for illegal drug use, its medical staff reviews
drugs prescribed by OMH for those individuals receiving treatment. DOCCS should also
evaluate its disciplinary hearings database to determine if other information should be captured
including the type of violation and other agencies involved.
Microgenics Withheld Information from DOCCS Concerning False Positive Test Results
and Research Involving its Drug Testing Systems and Provided Misleading and
Inconsistent Statements during DOCCS’ Incarcerated Individual Disciplinary Hearings
Microgenics failed to disclose to DOCCS issues it discovered with its urinalysis tests, and
Microgenics representatives provided incorrect and misleading information during DOCCS’
disciplinary hearings. Namely, when Microgenics discovered that its Buprenorphine II test had
produced four false positive results when testing six individuals’ urine samples, it did not advise
DOCCS of these results. And when Microgenics’ internal research revealed that one of its drug
41

tests was susceptible to cross-reactivity with some common medications and might thereby
produce false positive results, it again did not advise DOCCS of this fact. Additionally, when
Microgenics representatives provided responses to incarcerated individuals’ questions during
disciplinary hearings, the information provided was sometimes misleading and incorrect and the
representatives never advised incarcerated individuals that Microgenics’ preliminary drug
screening tests required confirmation testing by more specific alternate methods.
DOCCS’ RESPONSE TO THE INSPECTOR GENERAL’S INVESTIGATION AND REPORT
DOCCS advised the Inspector General that it has adopted and is implementing all of the
Inspector General’s recommendations.
Additionally, DOCCS advised that it undertook a comprehensive review of all possible
adverse impacts on the incarcerated population to determine what remedial actions were
necessary to make whole each incarcerated individual that was potentially affected by an
expunged disciplinary ticket for Drug Use regardless of the substance. That review resulted in
approximately 2,500 disciplinary records expunged followed by the proactive removal or
redaction of over 2,100 impacted records related to transfer orders and substance abuse
treatment.
According to DOCCS, in addition to the remedial steps outlined below, DOCCS
eliminated segregated confinement as a potential sanction for Drug Use disciplinary violations
starting December 1, 2020. DOCCS further advised that many of the remedial actions taken
required intensive collaboration across DOCCS, including but not limited to: immediate release
from segregated confinement; de novo interview with the Board of Parole; reassessed open date
for release; return of lost good time credit or merit consideration; reinstatement to temporary
work release; return to the CASAT program; return to college or other academic/vocational
programs; reassessed status in substance abuse treatment programing; reinstatement to sex
offender treatment; removed visitation sanctions and restrictions; reassessed Family Reunion
Program applications; payment of lost incarcerated individual wages; and return to an area of
preference facility. Lastly, DOCCS advised that each category of remedial action was actively
monitored by the Commissioner’s Task Force.

42

Addendum 1
ELIZABETH SPRATT, MS, F-ABFT
Telephone: (914) 274-8858
Cell: (914) 275-8351
Fax: (914) 271-8717

Forensic Toxicology Services
420 South Riverside Avenue, #282
Croton-on-Hudson, NY 10520

Experience
Forensic Toxicology Services
January 2000 to Present

Providing wide range of Forensic Toxicology consulting services in both criminal and civil areas including
DWI/DWAI and DFSA, insurance claims, Dram shop casework and court testimony. Serve as inspector
for Workplace Drug Testing, Department of Defense, and American Board of Forensic Toxicology
Laboratories. Lecturer for professional and community groups regarding toxicological issues.
Director of Toxicology
January 2006 to January 2019
Chief of Toxicological Services
August 1990 to December 2005
Senior Toxicologist
October 1986 to August 1990

Westchester County Department of Labs and Research
Valhalla, NY

Responsible for Forensic Toxicology Analyses. Duties include supervising activities of full service forensic
toxicology laboratory which serves Westchester County’s medicolegal needs. Work comprises legal drug
screening and blood alcohol determinations for local, county, and New York State Police as well as
methods development. Involved in Medical Examiner’s, DWI/DWAI, and DFSA cases and providing
expert testimony in judicial hearings. Responsible for ABFT (American Board of Forensic Toxicologists),
and ASCLD (American Society of Crime Lab Directors) accreditation in the laboratory. Instrumentation
includes GC/MS, GC/FID, HPLC, LC/MS, LC/MS/MS, LC/MS-TOF, UV and TLC.
Research Scientist; Pharmaceutical Development
November 1981 to October 1986

Ortho Pharmaceutical Corporation
Raritan, NJ

Supervised Process Validation Group, Pharmaceutical Analysis. Responsibilities include interfacing with
Process Development for analytical testing; methods development for cleaning; and analytical
troubleshooting for production using HPLC, GC, UV and TLC.
Pilot Manager; White Collar Productivity Improvement Program
January 1985 to October 1986

This project evaluated all services provided by the entire Pharmaceutical Development Division and
resulted in the proposal and initiation of action plans to improve the delivery of these services.
Technical Supervisor; Toxicology, Special Chemistry
April 1978 to October 1981

Hospital of the University of Pennsylvania
Philadelphia, PA

Managed department activities: methods development, routine toxicology, special chemistry and
research. Techniques included GC, UV, HPLC, EMIT, fluorometry, and AA. Other duties: QC,
proficiency testing, regulatory compliance, methods and instrumentation troubleshooting. Coordinated
contracted projects from outside agencies. Supervised daily activities of seven technologists.

Toxicologist; Laboratory Procedures East
September 1974 to April 1978

The Upjohn Company
King of Prussia, PA

Supervised day and night shifts of technical staff of eight. Responsible for all legal analyses, QC, and
proficiency testing. Used standard laboratory analytical methods and instrumentation including ASV and
RIA.
Toxicologist
May 1972 to September 1974

Allegheny County (PA) Coroner’s Office
Pittsburgh, PA

Qualitative and quantitative analyses of drugs and toxic substances in blood, urine, and unidentified
samples were performed on coroners’ cases, overdoses and emergency night calls.
Education
M.S., Pharmacology/Toxicology
Duquesne University
September 1972 to May 1974
Pittsburgh, PA
Thesis: “Interfering Compounds in Urine Screening for Drugs”
B.S., Chemistry
September 1968 to May 1972

Certifications

Duquesne University
Pittsburgh, PA

Forensic Toxicology, Fellow (1/15)
Forensic Toxicology, Diplomate (1/02)
Forensic Toxicology Specialist
Toxicological Chemist
Blood and Urine Alcohol Analysis
Breath Analysis Operator: Breathalyzer, Intoxilyzer, Datamaster, Datamaster DMT, Draeger Alcotest 7110 MKIII,
and Alcotest 9510

American Board of Forensic Toxicology (F-ABFT)
American Board of Forensic Toxicology (DABFT)
American Board of Forensic Toxicology (FTS-ABFT)
National Registry of Certified Chemists (1989)
NY State Department of Health
NY State Department of Health

Federal Inspector

National Laboratory Certification Program (formerly
NIDA)
American Board of Forensic Toxicology
U.S. Department of Defense Urine Testing Program

Laboratory Inspector
Laboratory Inspector (former)

American Society of Crime Lab Directors (ASCLD)

Professional Society and Committee Memberships
American Board of Forensic Toxicology (member, Board of Directors, June 8, 2008 to
June 30, 2017)New York State Crime Laboratory Advisory Committee (NYCLAC)
Society of Forensic
Toxicologists
American Academy of
Forensic Sciences
American Association of Certified Chemists
The International Association of Forensic Toxicologists
Technical Working Group, Toxicology (TWGTOX,
New York State) SWGTOX (Scientific Working
Group Toxicology, Federal Committee)Impaired
Driving Advisory Council (NYS)

Publications
A Fatality Due to Accidental Pinesol® Ingestion; JAT 24:7, p664 (October 2000)

A Fatality Related to the Veterinary Anesthetic Telazol®; JAT 23:6, p552 (October 1999)

LC/MS with a Particle Beam Interface; Forensic Toxicology, Clinics in Laboratory Medicine 18:4,651
(December 1998)

Elizabeth Spratt M.S., F-ABFT
Curriculum Vitae

Certifications:
American Board of Forensic Toxicology - Fellow 1/2015
American Board of Forensic Toxicology- Diplomate 1/2002
American Board of Forensic Toxicology- Forensic Toxicology Specialist
US Depart. of Human & Health Services/Inspector HHS National Laboratory Certification
Program
National Registry in Certified Chemistry-Toxicological Chemist
Breath Instrument Certifications/expertise: Datamaster, Intox-4011ASA, Breathalyzer 900/900A
and Draeger Alcotest 7110 MK III, Datamaster DMT, Alcotest 9510
Certified by New York Department of Health: Blood and Urine Permit Testing for DWI/DWAI
Samples- 1986-2019
Certified Trainer for Saliva Alcohol Testing (12/95)
PUBLICATIONS
“An Unusually High Level of Barium in a Prison Fatality”
Case Note – ToxTalk: Volume 28 No. 3 (September 2004)

"A Fatality Due to Accidental PineSol Ingestion"
JAT 24:7, 664-666 (October 2000)

"A Fatality Related to the Veterinary Anesthetic Telazol"
JAT 21(6): 552-555 (10/99)
“LC/MS with a Particle Beam Interface in Forensic Toxicology”
Clinics in Laboratory Medicine 18(4): 651-663 (1998) 12/98
Presentations/Lectures
Diane Schuler Parkway Tragedy
New Rochelle High School Forensic Class
New Rochelle, NY (Zoom Presentation)
June 5, 2020
Alcohol and Drugs, Facts and Fiction
18B and Legal Aid Attorneys
Suffolk County Bar Association
Hauppauge, NY
May 16, 2019
New Drugs Detected in Westchester County and Aspects of the
Diane Schuler Parkway Tragedy
New Rochelle High School Forensic Class

New Rochelle, NY
April 9. 2019
New Drugs Detected in Westchester County and Aspects of the
Diane Schuler Parkway Tragedy
New Rochelle High School Forensic Class
New Rochelle, NY
December 14, 2017
New Drugs in Westchester County and Aspects of the
Diane Schuler Parkway Tragedy
New Rochelle High School Forensic Class
New Rochelle, NY
April 27, 2017
Forensic Toxicology in New York State, 2016 Report
Traffic Safety Committee
White Plains, NY
December 6, 2017
Heroin Overdose Response Initiative in Westchester County
Westchester County Response Team
Valhalla, NY
October 23, 2017
Toxicology Update in Westchester County
Student Assistant Services Corporation
White Plains, NY
August 15, 2017
Forensic Toxicology Cases in Westchester County and Aspects of the
Diane Schuler Parkway Tragedy
New Rochelle High School Forensic Class
New Rochelle, NY
April 27, 2017
Forensic Toxicology Cases in Westchester County and Aspects of the
Diane Schuler Parkway Tragedy
New Rochelle High School Forensic Class
New Rochelle, NY
February 12, 2016
Forensic Toxicology in Westchester County
District Attorney Continuing Education Seminar
White Plains, NY
June 14, 2013
Diane Schuler Taconic Parkway Crash
NEAFS Annual Meeting
Saratoga Springs, NY
November 16, 2012
Forensic Toxicology in Westchester County and Aspects of the
Diane Schuler Parkway Tragedy
Kendal Way Association

Sleepy Hollow, NY
March 29, 2010
Speaker at Westchester County Breath Instrument Training/Certification
Testimony for Breath Instruments and Toxicology Submissions
Westchester County Police Academy Training Center
Valhalla, NY
January 7, 2010
Speaker at Dutchess County Annual Law Enforcement Ceremony/Luncheon
Toxicology and the Diane Schuler Case
Dutchess County Stop DWI
Wappingers Falls, NY
November 13, 2009
Preparation for the ABFT Examination
Analytical Techniques
Society of Forensic Toxicologists Meeting
Oklahoma City, OK
October 19, 2009
Trends in Toxicology- Blood/Urine in Westchester County
Region One: GTSC-Drug Recognition Expert
Recertification/Training
Valhalla, NY
June 9, 2009
Everything You Wanted to Know About Forensic Toxicology
WMC Dept. of Pathology Resident Training Conference
Westchester Medical Center
Valhalla, NY
May 15, 2009
Understanding the Toxicology of DWI/DWAI Cases
Westchester County District Attorney’s Office
White Plains, NY
January 9, 2009
Toxicological Aspects of Crime Scene Evidence
Advanced Crime Scene Investigation Seminar
October 22, 2007
Toxicological Aspects of Crime Scene Evidence
Advanced Crime Scene Investigation Seminar
June 7, 2007
Cocaine and Driving Impairment
Interpretive DUID Workshop
SOFT Continuing Education Cmte. & SOFT/AAFS Drugs &
Driving Committee Seminar
Albany, NY
May 22, 2007
Stimulants and Driving Impairment (MA/AMP – MDMA/MDA)
Interpretive DUID Workshop

SOFT Continuing Education Cmte. & SOFT/AAFS Drugs &
Driving Committee Seminar
Albany, NY
May 22, 2007
Toxicology in Westchester County
District Attorney’s Office
White Plains, NY
January 10, 2007
Toxicology in Westchester County
Governor Traffic Safety Committee and
Nassau County District Attorney’s Office
Horizontal Gaze Nystagmus (HGN) and Toxicology
Speaker and attendee
Mineola, NY
July 31, 2006
Toxicological Aspects of Crime Scene Evidence
Advanced Crime Scene Investigation Seminar
June 26, 2006
Toxicology in Drug Facilitated Sexual Assault Cases
The Forensic Education Project: Future Solutions…Now
NYSCASA
Criminal Justice Collaboration Project
Poughkeepsie, NY
February 28, 2006
Toxicological Aspects of Crime Scene Evidence
Advanced Crime Scene Investigation Seminar
November 14, 2005
Marijuana
Forensic Toxicology Review, sponsored by SOFT
Albany, NY
September 13, 2005
Antihistamines & NSAIDs
Forensic Toxicology Review, sponsored by SOFT
Albany, NY
September 13, 2005
Toxicological Aspects of Crime Scene Evidence
Advanced Crime Scene Investigation Seminar
June 7, 2005
DWI: Everything You Wanted To Know About Breath Instruments in Westchester County
Westchester County Bar Association
White Plains, NY
April 6, 2005
Becoming an Accredited Forensic Toxicology Laboratory
FBI Laboratory Symposium/SOFT

Washington, DC
August 30, 2004
Use of Breath Instruments in Driving While Intoxicated Cases
Mount Vernon Bar Association
Tuckahoe, NY
May 25, 2004
Toxicology in DWI Cases
New York Prosecutors Training Institute
Suffern, NY
February 23, 2004
Drug Facilitated Sexual Assault – Helping the victim while strengthening your case
New York State Coalition Against Sexual Assault
9/10/03 – New York Medical College, Valhalla, NY
9/23/03 – Bellevue Hospital Manhattan, NY
2/3/04 – Elmhurst Hospital, NY
Marijuana Abuse: Assessing Marijuana Abuse through Hair, Blood and Urine Testing
Student Assistant Services Corp. and Caron Foundation
Tarrytown, NY
12/03/02
Forensic Toxicology - What is it?
St. Joseph's College, Rennselear, IN 3/11/02
Toxicology - preparation for ABC exam for Forensic Scientists
9/6/01
Issues in Toxicology
1999 NY State Conference on Impaired Driving Issues 11/17/99
Breath Alcohol Testing
Stop DWI Conference

9/18/99

Toxicology-Drugs Found in Rape Cases
Victims Assistance Services
7/14/99
“Drug Testing: The Myths vs. The Realities”
Student Assistant Services Liberty Management Inc.
Tarrytown, NY
12/98
“Suicide Solution: A Case Report to Highlight Versatility in Forensic Toxicology”
Northeastern Association of Forensic Scientists, Newport, RI
11/4/98
What is Toxicology?
Rye Neck Middle School, Women in Business Day

3/98, 3/00, 3/01, 3/02, 3/04

"Olanzepine: A Little or A lot, It All Depends on the Problems You've Got."
NEAFS, White Plains, NY
10/97
"LC/MS in Forensic Toxicology Drug Screening"
AAFS Annual Meeting 2/97

Acute Mixed Drug Overdose-Some Are and Some Are Not
AAFS Annual Meeting 2/95
Sertraline and Paroxetine Quantitation in Medical Examiner’s Cases
SOFT Annual Meeting 11/94
Toxicology and Medical Examiner Testing
AlChemE (Alliance of Chemistry Educators) 10/1/94
Laboratory Testing and Procedures, Samples and Trends in Present Samples
Stop DWI Enforcement Conference 1992
Changing Patterns in Poly Drug Abuse: A Two Year Study
A Survey of Coabuse of Alcohol and Cocaine

1992

1992

Fluoxetine in Medical Examiner's Cases by GC/ITD 1992
The Effects of Solvents on the Intoxilyzer 4011AS-A
NEAFS Annual Meeting 1987
AAFS Annual Meeting
1989
Training Courses , Workshops and Seminars
Applied Pharmacodynamics
Center for Forensic Science Research &Education
Virtual 15 hours

10/19-21/21

NLCP Inspectors' Training - Virtual
SOFT Annual Meeting
Nashville, TN

9/26/21

Therapeutic use of Psychedelic Drugs
& Minimum Requirements for Drug Identification (6 hours)
The International Association of Forensic Toxicologists
Virtual

7/13/21

Cannabis Impaired Driving
SOFT Annual Meeting
Virtual

9/22/20

Oral Fluid Toxicology: Workplace Testing, Pain Management & DUID
SOFT Annual Meeting
San Antonio, TX

10/15/19

Driving Under the Influence: The NPS Edition
SOFT Annual Meeting
San Antonio, TX

10/14/19

Best Practices for Investigation of Overdose Deaths
SOFT Annual Meeting
San Antonio, TX

10/14/19

NLCP Inspectors' Training

10/13/19

SOFT Annual Meeting
San Antonio, TX
The American Academy of Forensic Sciences (AAFS) Responds to
The Opioid Crisis
AAFS Annual Meeting
Baltimore, MD

2/20/19

The National Transportation Safety Board (NTSB): Understanding and
Preventing Impairment in Transportation
AAFS Annual Meeting
Baltimore, MD

2/19/19

Novel Psychoactive Substance (NPS) Surveillance, Detection, And
Intelligence for Use by Forensic Laboratories, Public Health and Public
Safety
AAFS Annual Meeting
Baltimore, MD

2/18/19

NLCP Inspectors' Training
SOFT Annual Meeting
Minneapolis, MN

10/7/18

“Can We Say That” – Drug Impaired
Driving Testimony
SOFT Annual Meeting
Minneapolis, MN

10/8/18

Incorporating the Updated NSC ADID Lab Guidelines into Casework:
Pharmacology, Methodologies and Case Reports for Buprenorphine, Fentanyl
And Tramadol
SOFT Annual Meeting
Minneapolis, MN

10/9/18

Keeping Pace in the NPS Race: US Resources and Trends
SOFT Annual Meeting (Delayed from September)
Boca Raton, FL
Toxicological Investigation of Deaths in Alberta Due to Fentanyl, Its Analogues
and other Opioids
SOFT Annual Meeting (Delayed from September – Lunch Seminar)
Boca Raton, FL

1/8/18

1/8/18

High Resolution Mass Spectrometry Techniques to Detect Fentanyl Analogues
SOFT Annual Meeting (Delayed from September – Lunch Seminar)
Boca Raton, FL

1/7/18

Cannabis in DUID Investigations
SOFT Annual Meeting (Delayed from September)
Boca Raton, FL

1/7/18

NLCP Inspectors' Training
2017 Virtual Inspector/Lab Director Virtual Workshop

9/15/17

Interpreting Blood Cannabinoids: Markers of Recent Use
Webinar, Sponsored by National Medical Services

8/22/17

Latent Cause Analysis
DCJS Sponsored Seminar
Albany, NY

3/13/17

Conflict Resolution Seminar
Westchester County EAP
Valhalla, NY

12/7/2016

Opioids in DUID investigations
SOFT Annual Meeting
Dallas, TX

10/17/16

NLCP Inspectors' Training
SOFT Annual Meeting
Dallas, TX

10/16/16

Pharmacology and Toxicology of Synthetic Cathinones and Phenethylamines
SOFT Annual Meeting
Atlanta, GA

10/19/15

Management Practices in Forensic Toxicology: A Panel Discussion
SOFT Annual Meeting
Atlanta, GA

10/19/15

NLCP Inspectors' Training
SOFT Annual Meeting
Atlanta, GA

10/18/15

Implementing DUID Drug Recommendations
SOFT Annual Meeting
Grand Rapids, MI

10/20/14

NLCP Inspectors' Training
SOFT Annual Meeting
Grand Rapids, MI

10/19/14

NLCP Inspectors' Training
SOFT Annual Meeting
Orlando, FL

10/27/2013

Analytical Methods in Workplace Drug Testing – Mass Spectrometry
RTI International Workshop

3/10/13

Analytical Methods in Workplace Drug Testing – Sample Preparation
RTI International Workshop

10/14/12

Analytical Methods in Workplace Drug Testing - Immunoassay
RTI International Workshop

10/14/12

Opioid Drugs: 21st Century Killers
SOFT Annual Meeting

7/2/12

Boston, MA
NLCP Inspectors' Training
SOFT Annual Meeting
Boston, MA

7/1/12

Publishing in Journals for Forensic Toxicologists
SOFT Annual Meeting
San Francisco, CA

9/26/11

NLCP Inspectors' Training
SOFT Annual Meeting
San Francisco, CA

9/25/11

Marijuana, Pharmacology – Practical Applications for the
Forensic Toxicologist
SOFT Annual Meeting
Richmond, VA
NLCP Inspectors' Training
SOFT Annual Meeting
Richmond, VA
Packaging and Shipping of Infectious Diseases
Department of Labs and Research
Valhalla, NY
Applications of LC/MS Technologies in Forensic Toxicology
New York State DCJS and SOFT
Albany, NY

10/18/10

10/17/10

10/7/10

9/27-28/10

K2 and Synthetic Cannabinoids, Effects and Chemical Analysis
National Medical Services
Web Seminar

9/16/10

Assessment and Interpretation of Toxicology in Neonatal,
Pediatric and Geriatric Deaths
AAFS Annual Meeting
Seattle, WA

2/22/10

Applications of LC Mass Spectrometry Technologies in
Forensic Toxicology
Sponsors: NYS – DCJS and SOFT
Albany, NY
Training and Operation of AU400 Autoanalyzer
Labs & Research
By ABS Scientific
LC/MSMS and GC/MS/MS Seminar
Thermo Scientific
Valhalla, NY
Ethics Training
Sponsored by the Office of the Inspector General

9/27-28/10

8/5/10

11/2/09

10/28/09

Valhalla, NY
NLCP Inspectors' Training
SOFT Annual Meeting
Oklahoma City, OK

10/18/09

Expert Witness Training
NYS DCJS
Office of Forensic Services
Albany, NY

09/14/09

Strategies in Defending the DWI and DUI Cases
Lorman Seminar
Albany, NY

12/04/08

Stimulating Realm of Sympathomimetic Amines and Tryptamines
Workshop SOFT Annual Meeting
Phoenix, AZ

10/27/08

NLCP Inspectors' Training
SOFT Annual Meeting
Phoenix, AZ

10/26/08

NLCP Inspectors' Training
SOFT Annual Meeting
Durham, NC

10/14/07

Toxicology Jeopardy – DUID Testing
Workshop SOFT Annual Meeting
Durham, NC

10/16/07

Tox. Analysis of Drug Facilitated Crimes
Workshop SOFT Annual Meeting
Durham, NC

10/15/07

Beyond Herbals: The Toxicology of Plants
Workshop SOFT Annual Meeting
Durham, NC

10/15/07

Interpretive DUID Workshop
SOFT Continuing Education Cmte. & SOFT/AAFS Drugs &
Driving Committee Seminar
Albany, NY
Driving While Intoxicated: Field Sobriety Testing
And Breath Analysis Instrument Update
Westchester County District Attorneys
Officer Stewart Smith
White Plains, NY
New Antidepressants & Antiepileptics: Clinical Pharmacology,
Pharmacogenomics, Gene Expression and Neurobiology of Depression
& Suicide & Forensic Toxicology
Workshop SOFT Annual Meeting
Austin, TX

5/22-24/07

1/10/07

10/04/06

Addiction and Pain Management for Forensic Toxicologists
Update on Drug Therapy, Clinical and Forensic
Workshop SOFT Annual Meeting
Austin, TX
Doping, Testing for Doping Substances and the Organization
Of Doping Control Efforts
Workshop SOFT Annual Meeting
Austin, TX
Postmortem Pharmacokinetics – The Good, The Bad & The Ugly
Workshop SOFT Annual Meeting
Austin, TX
Training on Horizontal Gaze Nystagmus (HGN) and Toxicology
Governor’s Traffic Safety Committee
Nassau County District Attorney’s Office
Mineola, NY

10/04/06

10/03/06

10/03/06

7/31/06

Post Mortem Interpretation
Workshop SOFT Annual Meeting

10/18/05

Oral Fluids-Research and Application
Workshop SOFT Annual Meeting

10/18/05

Receptor Site Theory & Drug Interactions
Workshop SOFT Annual Meeting

10/17/05

Interpretive Pharmacogenomics and Proteomics
In Forensic Toxicology
Workshop SOFT Annual Meeting

10/17/05

NLCP Inspectors' Training
SOFT Annual Meeting

10/16/05

Forensic Toxicology Review
Sponsored by SOFT
Albany, NY

9/13-14/05

NYS Department of Health Recertification for
Breath Analysis Operator
Pomona, NY

12/08/04

Forensic Aspects of Alcohol Seminar
A.W. Jones, Ph.D., DSc
NYU Medical Center
New York, NY

12/06/04

Advanced Mass Spectrometry Theory and Interpretation
FBI Laboratory Symposium
Washington, DC

8/30/04

New and Unique Technologies for Forensic Toxicology Laboratories
FBI Laboratory Symposium

8/29/04

Washington, DC
Statistics and Method Validation
FBI Laboratory Symposium
Washington, DC

8/29/04

NLCP Inspectors' Training
SOFT Annual Meeting

8/28/04

Feeling Blue? Antidepressant Workshop
Workshop, SOFT Annual Meeting

10/21/03

Practical Applications for LCMS in Routine Toxicology
Workshop, SOFT Annual Meeting

10/20/03

Forensic Toxicology of Metals
Workshop, SOFT Annual Meeting

10/20/03

NLCP Inspectors' Training
SOFT Annual Meeting

10/19/03

Pharmacology and Toxicology of Brain Drugs
Workshop, SOFT Annual Meeting

10/14/02

DUID, Research to Court
Workshop, SOFT Annual Meeting

10/13/02

NLCP Inspectors' Training
SOFT Annual Meeting

10/12/02

NLCP Inspectors' Training
SOFT Annual Meeting

10/05/01

Ethanol
Seminar, SOFT Annual Meeting

10/01/01

Urine Testing and Human Performance
Seminar, SOFT Annual Meeting

9/30/01

Herbal Medicine
Seminar, SOFT Annual Meeting

9/30/01

The Effects of Alcohol and Drugs on Human Performance and Behavior:
1999 Forensic Toxicology Seminar, NYS-Police Academy, Albany, NY

7/20-23/99

Pharmacology Reviews: Selected New Drugs: SOFT Annual Meeting

10/10/99

Drugs, Driving and Traffic Safety: Update: SOFT Annual Meeting

10/11/99

Practical Aspects of CI/MS for Drugs of Abuse Workshop: SOFT Annual Meeting

10/5/98

Rohypnol Detection Workshop: SOFT Annual Meeting

10/5/98

Operator Training for the Datamaster Model K Breath Alcohol Testing Instrument:
National Patent Analytical Systems, Inc., Valhalla, NY
2/18-19/1998
Operator Training for the Draeger Alcotest 7110 MK III Breath Alcohol Testing Instrument,
Draeger Instruments Corp., Valhalla, NY
1/22/98
"Forensic Toxicology Teleconference, James Garriott speaker: Sponsored by AACC

2/3/98

Operator Training for the Draeger Alcotest 7110 MK III Breath Alcohol Testing Instrument:
New York State Police, Washington Hollow, NY
5/97
Training for the Draeger Alcotest 7110 MK III Breath Alcohol Testing Instrument: WC District
Attorney's Office, White Plains, NY
1997
Illicit Production of Cocaine: AAFS Annual Meeting

2/18/97

Looking Forward & Backward: Three Decades of Toxicological Analyses:
AAFS Annual Meeting
New York, NY

2/18/97

Uppers and Downers: AAFS Annual Meeting

2/18/97

ASCLD/LAB Inspector Training Course: Albany, NY

11/23-25/97

Fundamentals of Medical Examiner Toxicology: SOFT Annual Meeting

10/96

Use of LIMS in a Forensic Laboratory: SOFT Annual Meeting

10/96

Drugs and Driving: Current Pharmacologic Issues (NHTSA): SOFT Annual Meeting

10/95

Advanced Forensic Toxicology: Pharmacologic Interpretative Issues (NHTSA):
SOFT Annual Meeting

10/95

Conference on Drug Testing in Hair: SOFT Annual Meeting

10/94

Human Performance Testing Drugs and Driving Impairment: SOFT Annual Meeting

10/94

Legal Aspects of Urine, Blood, and Hair Testing: SOFT Annual Meeting

10/94

Statistical Approaches to Accuracy in Toxicology: AAFS Annual Meeting
San Antonio, TX

2/94

Fundamentals in Forensic Toxicology: Pharmacologic Concepts

2/94

Inspector Training for SAMSHA Laboratories:
HHS National Laboratory Certification Program VA

4/93

Human Performance- Drugs and Driving: SOFT/CAT Annual Meeting

10/93

GC/MS Workshop: SOFT/CAT Annual Meeting

10/93

Toxicology and Highway Safety Meeting, NYSP Crime Lab
Surviving the 90’s: How to Manage Your Laboratory to Meet the New
Federal Regulations
Ciba Corning
Saddle Brook, NJ

1/93
5/21/91

COMMITTEE
AAFS Awards and Scholarship Committee
American Academy of Forensic Sciences
2019-2021
Impaired Driving Advisory Council
New York State 12/2014
SWGTOX Group (Scientific Working Group – Toxicology)
Sponsored by Senator Lehey
February 2010 to 2014
ABFT Board of Directors
July 1, 2008 – June 30, 2017
ABFT Nomination Committee
2006-2007

MEETINGS
SOFT Annual Meeting (2020)
Virtual/Several Days
SOFT Annual Meeting (2019)
San Antonio, TX
AAFS Annual Meeting (2019)
Baltimore, MD
SOFT Annual Meeting (2018)
Minneapolis, MN
SOFT/TIAFT Annual Meeting (2017 – postponed until 1/7/2018)
Boca Raton, FL
SOFT Annual Meeting (2016)
Dallas, TX
SOFT Annual Meeting (2015)
Atlanta, GA
SOFT Annual Meeting (2014)
Grand Rapids, MI
SOFT Annual Meeting (2013)
Orlando, FL
NEAFS Annual Meeting (2012)
Saratoga Springs, NY
SOFT Annual Meeting (2012)
Boston, MA
SOFT Annual Meeting (2011)

San Francisco, CA
SOFT Annual Meeting (2010)
Richmond, VA
AAFS Annual Meeting (2010)
Seattle, WA
SOFT Annual Meeting (2009)
Oklahoma City, OK
SOFT Annual Meeting (2008)
Phoenix, AZ
SOFT Annual Meeting (2007)
Durham, NC
SOFT Annual Meeting (2006)
Austin, TX
SOFT Annual Meeting (2005)
Nashville, TN
FBI/SOFT/TIAFT Annual Meeting (2004)
Washington, DC
SOFT Annual Meeting (2003)
Portland, Oregon
SOFT Annual Meeting (2002)
Detroit, Michigan
SOFT Annual Meeting (2001)
New Orleans, LA
SOFT Annual Meeting (1999)
Puerto Rico
SOFT Annual Meeting (1998)
Albuquerque, NM
AAFS Annual Meeting
New York, NY
(1997)
SOFT Annual Meeting (1996)
Denver, CO
SOFT Annual Meeting (1995)
Baltimore, MD
SOFT/TIAFT Annual Meeting (1994)
Tampa, FL
AAFS Annual Meeting (1994)
San Antonio, TX

Eighth International LIMS Conference (6/94)
Pittsburgh, Pa.
STOP DWI Law Enforcement Conference (4/94)
SOFT/CAT Annual Meeting (1993)
Phoenix, AZ
AACC Annual Meeting (1993)
SOFT Annual Meeting (1992)
Cromwell, CT
AACC Annual Meeting (1991)
Washington, DC
SOFT Annual Meeting (1991)
Montreal, Canada
SOFT Annual Meeting (1990)
Melville, NY
AACC Annual Meeting (1990)
San Francisco, CA
Meetings prior to 1990, not listed

Addendum 2

STAT! OF Nl!W YO RK

OFFICE OF TH I! INSPl!CTOR Gl!Nl!RAL
OFFI CE OF THE WELFARE INSPECTOR GENERAL
OFFICE OF THE WORKERS' COMPENSATION FRAUD INSPECTOR GENERAL
EMPIRESTATEPLAZA
AGENCY BLOG. 2, 16TNFLOOR

ALBIINY,NEWYORK 12223
61 BROADWAY, SUITE 2100
NEW YORK, NEW YORK 10006
(212) 6J5-a150

{S 18) 474-1010

es COURT

STREET, s•• FLOOR
BUFFIILO, NEW YORK 1'202
(71 6) M7•7118

LETIZIA TAGLIAFIE RRO
INSPECTORGENERAL

November 5, 2019

Anthony J. Annucci , Esq.
Commissioner
New York State Department of Corrections
and Community Supervision
The HarrimanState Office Campus
1220Washington Ave
Albany, New York 12226

Dear Commissioner Annucci:
As you know, the Inspector General's Office is conducting a review of DOCCS's
current utilization of assay kits for inmate drug testing. While this review is ongoing, and
to ensure the integrity of the drug testing process, DOCCS must verify any positive test
results from irnmunoassays of any kind through a laboratory independent from Thermo
Fisher/Microgenics before any disciplinary or other adverse action is taken.

STATE OF NEW YORK

OFFICE OF THE INSPECTOR GENERAL
OFFICE OF THE WELFARE INSPECTOR GENERAL
OFFICE OF THE WORKERS ' COMPENSATION FRAUD INSPECTOR GENERAL

61 BROADW AY, SUITE 2100
NEW YO RK, NEW YORK 10006

EMPIRE STATE PLAZA
AGENCY BLOG . 2 , 161" FLOOR
ALBANY , NEW YORK 12223
(518) 474-1010

65 COURT STREET , S™ FLOOR
BUFFALO , NEW YORK 14202
(716 ) 847-7118

(212) 1135-3150

LET IZIA TAG LIAFIERRO
INSPECTOR GENERAL

December 31, 2019

VIA BAND DELIVERY

Anthony J . Annucci , Esq.
Acting Commissioner
New York State Department of Corrections
and Comm unity Supervision
The Harriman State Office Campus
1220 Washington A venue
Albany, ew York 12226
Case:

YS IG 2764-316-2019

Dear Acting Commissio ner Annucci:
As you know , the Office of the ew York State Inspector General is investigating
the ew York State Department of Corrections and Community Sup ervision ' s (DOCCS)
inmate drug testing program , including its current contrac t with Thenno
Fisher/Microgenics. Recently pursuant to my ovember 5, 2019 correspondence ,
DOCCS began subm itting positive test results that were obtained using Thermo
Fisber /Microgenics testing equipment and procedures to an independe nt laboratory for
verification purposes.
On December 19, 2019 , base d on preliminary information gathered by my office ,
I advised DOCCS to consider releasing any inmate who was serving a Spec ial Housing
nit (SHU) or keeplock sanction as a consequence of a posit ive test for synthet ic
cannabinoids prior to November 5, 20 19. According to DOCCS , this recommendation
resulted in one inmate being relea ·ed from SHU.

On December 30,2019, my office learned that DOCCS submitted to Alere
Toxicology /Abbo tt samp les from 15 inmates who had initially tested po.~itivefor
synthetic cannabinoids using the Thenno Fisher benchtop analyzer and procedures.
According to the Alere results, all I 5 samples were in fact negative for synthetic
cannabinoids .
Based on these results , it is imperative that DOCCS undertake an immediate
review of the records of any inmate who tested positive for synthetic cannabinoids since
the installation of the Thermo Fisher benchtop analyzers at each New York State
correctional facility. As part of this review, in an abundance of caution , I strongly advise
DOCCS to consider reversing the disciplinary dispositions, expunging the records, and
restoring the privileges of those inmates who tested positive for synthetic cannabinoids
without an independent positive confinnatory test result.

Sincere ly,

Letizia Tagliafierro
Inspector General

Enc.: Letter of November 5, 2019

Addendum 3
CEDIA-like Positive Result Due to Presence of Target Drug Molecules

f

.

f"t',e _ (m.lg: M;o.'I_Ctll _:Ii

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1

D

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Ri-:i¢11l10j'j,
ai; . by Analyz .r

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l'!loW Boo
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o.ni-

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Em:ym r[AI.. ot Bournl to An-'l'lb.od5J'
ek ,g,f ArnlibodyAllows. - art Ial
Enzymesto .!loin ,[A+'B);.
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:subirtft't_ SOIi.it._. to C.1.i
1

As illustrated above, the immunoassay does not measure the free drug in the sample, but
rather measures the color change caused by the known amount of drug molecules that did not
bind with antibodies to complete the reaction. The strength of this reaction—the color
change— is then measured.

Conversely, when the target drug being tested for is not found in the urine sample, the
following illustration shows what occurs:
CEDIA-like Negative Result Due to Absence of Target Drug Molecules
IDrq :Meil cYJt,M~lili flil!rtlJ1
Enzyme 1
(Aj1.Atta-i;hed
R mtl'nd ,of
(fl;.:_di,_1no1;1n-tJ
IP I Enrym itB~

U.n~1u 1wn1Molecu1e:s
.In
!JII s:i,mp

+
I/lb~

,comlfl111lion,~ i'lt,COfoiflt

wJdl1n,sc lu,1iloo

Su'b.stta't · Solud<m Cl 1e'_m'lt; I flieac 1n1
1

Dt . e . byAr11 ¥t -,

+.

Antlbod'j' BtJHl!SI
wltih
[)il\!!I
Mot . ut Affl! -to P...art
l.il Bnzym · (A'

c9

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\;!,I

un

+

Sil!- -fl~ ~ ·-·· N'O't
'
!i'1 l1i'l
a1!Ei\l'yn'I
IRtB'
ailat
Wlt!1
011t
,r .- y· n'li. .d lt7yAntlooaw
CO.m
p _te 6nf!l,Me;
•from ro.lWrn,:wr:th
o Colllir Chana: o«u ,
P iitl I ntym - A

Immunoassay Cross-reactivity
Cross-reactivity occurs when molecules from a substance other than the drug being tested
for bind with antibodies in a sample. Although antibodies are drug and/or drug-class specific
and will generally bind with the target drug molecules, other factors may cause antibodies to
bind with other substances. One such factor is that the chemical structure of a different
substance so closely resembles the target drug molecule’s chemical structure that the antibodies
instead bind to the other substance’s molecules.
The following illustration shows a cross-reactive immunoassay result.
CEDIA-like Positive Result Due to Cross-Reactivity
Di'U,i

lill

I

Spetlfil~lillif ood't

f

1

FH!. OJ"!J,g
Mo le 11
les
n Ud ne Sam pl'e
1,11
nkn0wn amowrt]

Pil"illal

n:t;m••(Al Attldm!

Rem:ai
lnder of
Ptrti _- !Enz-yin_ (IB)

(Ui!Cdia-rno1mt)

( 1

.
.

+

+

combl natlnn

swbdtr. ft,
wilh li'll•JO:lu _Qilll

c.olode.s;11

SUbJtil1l'elSOI_tlon •
·Ctl m.kal !Rneitlon
D11- «N In Ai!ilfHII

+
DliVi;Mo Cl!!- $ ,m:u - to 1'111:i
-~
En.a;ymelA)N:otIBoondto .An'llloodles;
11.acfi:
o.1.A111ilbody
Allows P.artl~ll
En.nm, _ to,Jot-niA·Bl,
Erifym Formacfo:ri
R•.-cu,w itlil
.Sub~r,1te Solu'lll0n to
s:e
Me.a:swr;111:J4
e Co'lor Chn[!le •

In this instance, the immunoassay will still cause a color change although the antibodies
have attached to a substance other than the target drug. Such cross-reactivity may cause a false
positive test result even though the target drug is not present. Given the potential for crossreactivity, the DRI and CEDIA immunoassays only provide an indication that a sample may
contain target drug molecules.
Cross-reactivity in immunoassays that test for drugs of abuse may both increase the
sensitivity of the test and result in false positives. For example, buprenorphine, the primary
component in the commonly used drugs Subutex and Suboxone, quickly breaks down in the
body into three metabolites before being excreted in urine. An immunoassay that can test for
buprenorphine and cross-react with each of the three metabolites will provide a greater indication
that the urine contains buprenorphine. However, if a urine sample contains a substance, like an
over-the-counter medication, with a structurally similar chemical composition to
buprenorphine or its three component metabolites, cross-reactivity could occur and cause a false
positive test result.

 

 

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