Drug Testing Company Averhealth Scrutinized After Claims of Inaccurate Results — ProPublica

In 2020, a foster care supervisor in Montcalm County, Michigan, messaged her boss with considerations about drug testing. A father who was working to reunite together with his kids had examined optimistic for methamphetamine with the lab the state had a contract with, Averhealth, and the outcomes contradicted assessments ordered by different legislation enforcement businesses, she wrote.

“Choose indicated on the document that the difficulty of Averhealth’s testing outcomes was a state-wide subject and that probate court docket judges everywhere in the state had been having related issues.”

Months later, one other official with Michigan’s Division of Well being and Human Companies wrote to colleagues about related worries. “We’re struggling to do casework with Averhealth and don’t belief them,” supervisor Sara Winter wrote. “We’re making BIG choices, together with having dad and mom go away residence or elimination, and that’s scary to do if you don’t belief who you’re getting companies from.”

The reason for the discrepancies was unknown. However that 12 months, 2021, Averhealth’s accreditor faulted its practices and positioned the lab on a six-month probation, citing, amongst different points, knowledge manipulation and failed proficiency assessments, that are carried out to make sure check accuracy.

When state officers caught wind of the investigation and repeatedly inquired about it, they hit a wall. The School of American Pathologists’ Forensic Drug Testing Accreditation Program informed them that “findings of the investigation are stored confidential.” They asked Averhealth’s then-CEO Jason Herzog for all out there studies on the lab. He was out of the workplace, he stated, and promised to “observe down when I’ve web connection.”

Averhealth didn’t disclose that it had been positioned on probation — its contract didn’t require such notification. And greater than a 12 months would go earlier than Michigan officers bought a full image of what accreditors noticed at one of many nation’s largest drug-testing operations for baby welfare, custody and probation circumstances. 

Michigan’s Division of Well being and Human Companies declined to touch upon the messages its employees despatched concerning Averhealth.

A ProPublica investigation discovered that Averhealth’s lab practices haven’t solely been faulted by its personal accreditor but in addition focused in lawsuits, and prompted Michigan’s baby welfare company to order its employees to not use Averhealth’s assessments as proof in court docket and to withdraw any petitions primarily based solely on the lab’s outcomes.

Six former workers informed ProPublica that the corporate’s central lab facility in St. Louis was mismanaged. The previous workers, who embrace two chemists and two lab managers, complained variously of understaffing, damaged and poorly maintained devices, and stress from administration to hurry up the supply of check outcomes, even when some feared they had been compromising accuracy.

In statements and interviews, the corporate defended its practices and denied that management mismanaged its laboratory. “Averhealth offers correct and forensically defensible check outcomes,” firm CEO Dominique Delagnes stated in a statement. “The integrity of the information and data that we offer is of the best significance to us.” Averhealth’s aim, she stated, is to “reclaim lives, unite households, and strengthen communities” and “not separate kids from their dad and mom.”

Delagnes has known as the selection to not inform Michigan officers of the corporate’s probation “a enterprise determination” that was made by Herzog, whom she succeeded as CEO. Averhealth’s accreditor stated the issues it noticed on the lab weren’t regarding sufficient to halt testing.

The corporate attributed the conflicting check outcomes flagged by officers in Montcalm County, Michigan, to totally different technical requirements utilized by different labs, including that it “on no account calls into query the accuracy or reliability of Averhealth’s testing.” It additionally stated that no single check consequence has a big impression on a case. “It normally takes a lot of optimistic assessments in addition to different indications of danger earlier than vital penalties are imposed,” an organization spokesperson stated in an interview. The corporate cited an impartial evaluation by outdoors scientists as proof that its protocols are sound, together with the truth that Averhealth by no means misplaced accreditation.

In 2023, a bunch of fogeys filed a lawsuit alleging that check outcomes had been inaccurate, which prevented them from seeing their kids and in some circumstances induced them to lose custody completely. “Averhealth’s false optimistic outcomes have had a devastating impression,” in response to the criticism, which cited “substantial emotional misery, together with anxiousness, despair, stress and sleeplessness.” Averhealth denied the allegations within the lawsuit, which it attributed to “opportunistic plaintiffs’ attorneys hoping for a windfall settlement and plaintiffs looking for to flee the implications of their optimistic assessments,” in response to a press release. Averhealth settled the lawsuit in September.

ProPublica interviewed greater than 50 folks concerned in household court docket or prison proceedings who stated they had been examined by Averhealth and had obtained what they believed had been inaccurate outcomes. Some stated that they had tried to dispute the findings by presenting in court docket damaging check outcomes from different labs — one of many solely methods to formally dispute a court-ordered drug check, and a technique usually really useful by attorneys. However assessments from totally different labs are tough to check, and judges don’t all the time give credence to contradictory outcomes.

“After a number of investigations and a probationary interval, no entity or particular person has discovered any materials inaccuracy in Averhealth’s reported check consequence,” the corporate stated in a press release.

After the lab’s probation was made public, Michigan’s and Georgia’s businesses overseeing baby welfare minimize ties with Averhealth. Michigan’s Division of Well being and Human Companies stated in a press release that its “contract with Averhealth has expired and we have now not used Averhealth since March 2022.” The Georgia Division of Household & Youngsters Companies informed ProPublica in a statement that it didn’t renew the contract when it led to 2023 “as a consequence of a wide range of dangers recognized” throughout an evaluation.

The lab’s issues went past what the accreditor discovered, a number of the former workers informed ProPublica. And people issues continued after the probation interval ended, they stated. 

Different authorities purchasers are sticking with the corporate. “They’ve been a valued accomplice of the Judicial Department,” stated a spokesperson for the Judicial Department of Arizona in Maricopa County, whose Grownup Probation and Household Courtroom order 7,000-10,000 assessments a month from the corporate.

The corporate that turned Averhealth was based in 1995 by former California police officer Rick McIntire, who spent his profession in undercover narcotics and considered medication as a societal menace. Drug testing was booming, with courts getting federal grants to implement packages. Scientific labs had been billing $600 a check, McIntire recalled. He noticed a chance to cost much less and earn a living on quantity.

There’s next to no regulation of court-ordered drug testing by the federal authorities, states or the courts. At one level, McIntire stated, a hospital lobbyist sought laws in California to ban labs like McIntire’s. McIntire stated he satisfied lawmakers that testing doesn’t require scientific experience. “It was decided that that is non-diagnostic in nature,” he stated, which means it isn’t used to find out medical situations. “Due to this fact, it doesn’t require any particular licensing — you could be a businessman.”

In 2011, McIntire offered his firm to funding bankers Herzog, Jeff Herr and David Keys, who later renamed it Averhealth. The trio, who didn’t reply to requests for remark, had no lab expertise however specialised in mergers and acquisitions. Their aim, McIntire recollects from conversations with them, was to develop and promote. In 2019, 5 Arrows Capital Companions, a personal fairness fund and arm of Rothschild & Co., acquired a majority stake. It valued Averhealth at $150 million, in response to a deposition of Herzog for the dad and mom’ lawsuit towards the corporate.

With new funding, Averhealth “centered on progress by acquisition” of regional labs, “simply making an attempt to principally get new contracts,” one former finance workforce member stated in an interview. The previous worker requested to not be named to guard their job prospects. (5 Arrows and Rothschild & Co. didn’t reply to requests for remark.)

Averhealth markets its science because the gold commonplace. Its St. Louis lab is overseen by Ph.D. toxicologists and “is run by very devoted and competent workers beneath nicely thought out tips,” present lab director Tonya Mitchell stated in an e mail. Firm advertising and marketing supplies say it has the aptitude to detect when samples are diluted by dishonest test-takers and to check for rising and obscure medication.

Christopher Totten, a former enterprise growth supervisor who pitched the corporate’s companies within the Southeast, known as Averhealth the Apple of judicial drug testing. Its strategies are an unlimited enchancment on — and considerably costlier than — the in-house labs nonetheless utilized by some rural courts, the place nonscientists use immediate assessments and don’t all the time affirm the accuracy of the outcomes, he stated.

Averhealth doesn’t publicly disclose its whole consumer record or complete revenues from the numerous state businesses it serves. However in 2019, for instance, the Michigan Division of Well being and Human Companies agreed to a five-year contract valued at an estimated $27 million to do testing for its baby welfare system. And Massachusetts budgeted greater than $5 million final fiscal 12 months for the corporate to check probationers, in response to public information.

The corporate boasts that its innovation extends past lab work. Its Aversys software program, which randomizes testing schedules and collects knowledge on test-takers, options “predictive analytics” that “ID sufferers in danger for relapse — earlier than they relapse,” the corporate web site stated in 2023. Averhealth said it did this by monitoring when folks known as in to see if they might be required to check that day or in any other case interacted with its test-scheduling system.

Habit specialists say they’re doubtful of such claims. “To my data, there may be completely no scientific knowledge to assist the notion that irregularity in logging in to an app predicts relapse,” stated Katie Witkiewitz, a professor of psychology and the director of the College of New Mexico Heart on Alcoholism, Substance Use, and Addictions. Based on a former worker with data of Averhealth software program, the corporate didn’t gather knowledge to assist this advertising and marketing declare. “I noticed no proof of them monitoring end result knowledge on relapse,” stated the previous worker, who requested to not be named to guard their job prospects within the trade.

After being contacted by a reporter, the corporate faraway from its web site the declare that it may well “ID sufferers in danger for relapse.”

The corporate stated in a press release that “the web site is regularly up to date, and regardless, Averhealth has by no means claimed to foretell {that a} relapse will occur. It has solely ever claimed that its software program can determine these in danger.”

One among Averhealth’s largest promoting factors is velocity: The corporate guarantees to report outcomes by the following enterprise day. This requires its assortment facilities across the nation to ship hair, saliva and urine samples in a single day to Missouri, the place the lab runs 24 hours a day.

Three former lab workers — a lab tech, a chemist and a lab supervisor — informed ProPublica that they often labored 12- and even 14-hour shifts and nonetheless couldn’t meet the deadlines.

Stress to hurry up supply of outcomes got here from the highest, stated one other lab supervisor, who labored at Averhealth in 2022. The supervisor, who requested to stay nameless to guard their job prospects, stated lab devices had been often in disrepair and out of service, which made assembly deadlines tough. The supervisor met often with Delagnes, who was COO on the time, and different higher administration. The supervisor recollects them saying, “The purchasers are calling and screaming, ‘What are you going to do to get these outcomes by means of?’ And sometimes my reply was, ‘The devices are damaged once more. I don’t have sufficient folks.’” The supervisor was not sure whether or not instrument upkeep affected the accuracy of check outcomes.

A former worker named Stephen Penn, a chemist who additionally labored on the firm in 2022, stated he skilled related deadline pressures. “They emphasised velocity over accuracy,” he stated. When getting ready samples for testing, “I used to be taken with getting it carried out nicely. However the push was to get it carried out quick.” Penn, who has over 20 years of expertise in labs, left Averhealth “due to the velocity subject.”

One other chemist, Jennifer Picker, who labored at Averhealth from January of 2021 to July of 2022, stated that when loading samples onto an instrument that confirms outcomes, known as a excessive efficiency liquid chromatograph, she was pressured to hurry as much as the purpose that she fearful samples can be linked to the fallacious particular person. “I used to be all the time terribly sluggish and meticulous in regards to the placement of my pattern on the HPLC. And there have been lots of complaints about that I wasn’t quick sufficient. And I’m like, ‘No manner. That is that affected person’s life.’”

Averhealth acknowledged that it emphasizes speed however added that it’s not on the expense of accuracy. “Averhealth requires its workers to work effectively to fulfill its clients’ manufacturing requirements and required turnaround occasions,” the corporate stated in a press release. “Importantly, delaying check outcomes might result in a miscarriage of justice, as litigants’ circumstances are delayed and doubtlessly endanger kids and the group who depend on the court docket system, in cooperation with Averhealth, to maintain them secure.” Delagnes stated in a sworn statement offered to ProPublica that she has “by no means positioned velocity over accuracy in our lab testing, nor have I ever directed anybody else to take action.”

Picker, the chemist, shared documentation to assist her allegation that commonplace lab practices weren’t adopted at Averhealth, together with a photograph of a pipette upkeep log. Chemists had been to finish the logs each day to confirm instrument efficiency. However in response to Picker, this didn’t occur. She famous that the picture exhibits every day’s required checks had been signed in the identical ink and handwriting. “I watched folks fill this out retroactively,” she stated.

Picker additionally shared a photograph of urine samples outdoors the biohazard lab space, sitting on a desk subsequent to non-public objects and snacks. This was a violation of coverage, she stated, citing notices posted within the lab stating that specimens had been to not be eliminated.

Averhealth denied that lab devices had been damaged or poorly maintained and that workers stuffed out upkeep logs retroactively. Relating to the picture of a pipette upkeep log, the corporate stated: “The identical worker can be chargeable for filling out the log, so it makes excellent sense that they might have the identical handwriting and use the identical pen at their workstation.”

Averhealth initially informed ProPublica that eradicating samples from the lab’s biohazard space and leaving them on a desk subsequent to non-public objects and snacks was not a coverage violation. Picker had a “elementary misunderstanding of the lab safety and pattern integrity process,” it stated. “There was no mishandling.” When introduced with photographs of an indication on a lab door saying to not take away samples from the realm, an organization consultant stated: “At any firm there are going to be cases the place doubtlessly insurance policies aren’t adhered to sometimes. I’m not conscious that it is a vital subject for Averhealth.”

The corporate described Picker as “a disgruntled former worker pushing a false narrative” whose time on the firm “was marked by repeated disciplinary points, together with bullying different workers and failing to report back to work.” The corporate stated in a press release, “Picker struggled to fulfill her workload, not due to firm calls for, however as a result of the medicine she was taking left her sleepy, torpid, and incessantly absent.”

Picker denied that she had disciplinary points or struggled to fulfill her workload. Whereas she did take an allergy drugs at work, she stated it didn’t have an effect on her efficiency. Picker stated she resigned when her criticism in regards to the misplaced urine samples was not taken severely. Averhealth didn’t touch upon Picker’s causes for resigning.

The corporate additionally questioned Penn’s declare that the corporate “emphasised velocity over accuracy.” In a press release, Averhealth stated that Penn “didn’t elevate any considerations about Averhealth earlier than or after his resignation.” The corporate additionally famous that Penn is “carefully linked to Ms. Picker.” (Penn rents residing house in Picker’s residence.) 

“I had made up my very own thoughts in regards to the firm and separating from them,” stated Penn. “What I noticed, that they positioned velocity over accuracy, didn’t have something to do with my relationship with Jennifer.”

Penn stated he didn’t deliver his considerations to the corporate as a result of “I didn’t assume it could make a distinction.”

Probably the most consequential and public criticism of Averhealth has come from Sarah Riley, a professor of pathology at Saint Louis College, who was employed because the lab’s director in September 2020. After seven weeks in that function, she abruptly resigned and filed a federal whistleblower lawsuit.

The Division of Justice investigated Riley’s claims and pursued a case, however selected to intervene on solely a number of the allegations.

Based on the DOJ, the corporate had billed Michigan’s Division of Well being and Human Companies for assessments it didn’t carry out: Averhealth’s contract required it to verify all optimistic drug assessments utilizing a second methodology; the federal government alleged it had examined samples solely as soon as.

Averhealth agreed to pay the DOJ $1.3 million to settle the case in June 2024. The corporate didn’t admit wrongdoing.

“We consider Averhealth absolutely carried out beneath the MDHHS contract,” Delagnes stated in a statement to ProPublica. “Averhealth settled the matter to keep away from the price and distraction of litigation.” The corporate stated in a press release that as a result of the DOJ investigated however didn’t intervene on Riley’s declare that its assessments had been inaccurate, Averhealth outcomes are correct.

Mark Johnson, who was Averhealth’s CEO from 2022 to 2024, stated in an interview that Averhealth conducting only one check on the Michigan samples “didn’t impression reliability as a result of we went to a extra superior check,” a check usually used to verify an preliminary optimistic consequence. Through the DOJ investigation, the corporate’s enterprise “carried out nicely” and the amount of assessments it carried out continued to develop, Johnson added. 

Riley obtained a $228,586 whistleblower award from the DOJ settlement. She declined to remark for this text about her expertise at Averhealth.

In February 2021, Riley was called to testify in a Michigan courtroom by a lawyer representing a mother making an attempt to reunite together with her children within the foster system. The mother had examined optimistic for marijuana with Averhealth, however outdoors lab assessments had discovered no proof of drug use.

In court docket, Riley stated that she had resigned from Averhealth after discovering what she thought of to be issues with the lab’s accuracy. She testified that the lab routinely failed to make use of correct quality control on its affirmation assessments. Such assessments, supposed to definitively show optimistic outcomes, are carried out on subtle lab devices known as mass spectrometers. Based on Riley’s testimony, Averhealth technicians weren’t utilizing the gear correctly as a result of they “had been beneath large stress” to report outcomes shortly.

“Did you deliver these considerations to the eye of the administration of Averhealth?” the Michigan mother’s lawyer requested.

She had, Riley stated. “Their response was, ‘Thanks for bringing us your considerations. Please don’t change something right now. We have now contractual time agreements to get the information out, and we simply need to get the information out.’”

The choose within the case, Lisa McCormick, declined to toss the contested Averhealth check outcomes. “Dr. Riley’s testimony was speculative and didn’t present the Courtroom with any particular examples,” she wrote in her opinion. The choose later terminated the mother’s parental rights, in response to court docket paperwork, citing missed drug assessments and failure to learn from companies, amongst different points. Termination of parental rights, which is usually irreversible, means kids might be adopted by different households.

In 2024, Riley was deposed in Foulger vs. Avertest, the lawsuit introduced by the dad and mom who alleged their check outcomes had been incorrect. She once more testified that the lab’s emphasis on velocity was problematic. “Dominique and I had weekly calls, no less than weekly, typically it was greater than that,” Riley stated of the CEO, “and the emphasis was all the time on getting the outcomes out earlier than anything.” Her concern about velocity was echoed by the previous workers interviewed by ProPublica.

Averhealth denied Riley’s allegations about its lab practices and stated that her testimony exhibits she misunderstood its science. Riley has estimated that Averhealth’s price of inaccurate assessments may very well be as excessive as 30%. Within the 2024 deposition, she stated the best way the lab used calibrators was flawed and contributed to those errors. Calibrators make sure the measurements produced by mass spectrometers are right.

However Averhealth stated that she didn’t grasp how the lab distinguishes between optimistic and damaging assessments, and that its course of had been endorsed by lab regulators.

The choose within the dad and mom’ case expressed doubts that Riley’s allegations about accuracy would maintain up in court docket. Earlier than the case was settled, the choose wrote in an order, “At trial the Courtroom might find yourself sustaining an objection to her opinion that thirty % of Averhealth’s assessments are unreliable until Plaintiffs lay enough basis to elucidate why her thirty % estimate (which presumably arises solely out of testing hair samples for THC) is dependable as to different types of assessments for different medication.”

Riley’s allegations triggered investigations by a number of outdoors scientists.

In January of 2021, Michigan’s Division of Well being and Human Companies employed an impartial agency, Wagner Toxicology Associates, to audit Averhealth’s lab and handle judges’ considerations about Riley’s allegations. Two toxicologists, who had been unaware of Riley or her complaints, spent two days within the lab “to verify that the laboratory personnel had been performing their laboratory work in accordance with their laboratory guide,” they wrote. “A comparatively small variety of studies was audited through the go to, and the reporting course of was noticed.” Wagner Toxicology issued a nine-page report stating that Averhealth’s scientists had been competent and adopted process, and that the lab’s outcomes may very well be “scientifically supported and forensically defended in court docket.”

Michigan’s company didn’t know the separate, confidential investigation by Averhealth’s accreditor was additionally underway. That investigation, launched after Riley despatched a letter to the accreditor, would attain totally different conclusions in regards to the lab’s operations.

Averhealth’s accreditor is the forensic drug testing program on the School of American Pathologists, a personal skilled group that gives knowledgeable oversight to forensic labs. In early 2021, the group’s toxicologists reviewed 1000’s of pages of information from Averhealth’s lab and located “quite a few” issues with hair, urine and oral fluid testing. “This laboratory has many high quality assurance points within the areas of high quality management and proficiency testing,” Arthur Zebelman, commissioner of the forensic drug testing program, wrote in a 2021 email to colleagues that was later made public in a lawsuit.

CAP substantiated Riley’s allegations. In a letter, it said that these allegations had been: “concern concerning unacceptable high quality assurance of mass spectrometry confirmatory testing”; “failure to comply with procedures as written”; “concern concerning the manipulation of instrument calibrations”; and “concern concerning the evaluation of high quality management outcomes.”

CAP knowledgeable Averhealth it was on probation “primarily based on the laboratory’s lack of steady compliance” with “high quality administration” requirements.

The aim of the investigation was to verify whether or not the lab adopted correct protocols, to not confirm the accuracy of all of the assessments Averhealth had reported. However the query of false positives and false negatives did come up.

Inside emails present CAP scientists discussed how issues within the lab may impression check outcomes however didn’t attain a particular conclusion about whether or not the problems they discovered would affect accuracy. “The laboratory doesn’t appear to have an issue with false optimistic outcomes,” one toxicologist wrote, including that its course of for figuring out the amount or focus of medicine “is at occasions unacceptable and they don’t appear to take the well timed decision of such issues severely sufficient.” One other toxicologist concerned within the audit appeared to disagree. “Qualitative reporting errors might exist,” that toxicologist wrote, citing “imprecision and lack of quantitative accuracy.” A qualitative reporting error is a damaging check that’s reported as a optimistic, or vice versa.

The probation lasted six months, throughout which the lab continued testing. “CAP didn’t discover any check outcomes that had been incorrectly reported and didn’t require Averhealth to rereport outcomes with a special consequence,” the corporate stated in a press release.

In an interview, Zebelman defended permitting Averhealth to proceed testing whereas on probation.  The lab was forthcoming with information and cooperated with inspectors to repair errors, he stated, emphasizing that CAP membership is a “voluntary, instructional program for laboratory enchancment. We’re not making an attempt to create gotcha moments.”

Michigan’s Division of Well being and Human Companies repeatedly asked Averhealth in regards to the investigation, in response to public information reviewed by ProPublica. CAP informed the state company that the findings can be stored confidential.

Herzog, then Averhealth’s CEO, made the choice to not disclose that it was on probation, in response to Delagnes, the present CEO, who stated as a lot in a deposition within the dad and mom’ lawsuit towards the corporate. “I’m not making an attempt to go the buck. It was a enterprise determination that began with him,” she stated.

(CAP informed ProPublica that authorities businesses might require labs to be extra clear about accreditation points. A baby welfare company might, as an example, contractually require a lab to robotically notify it of accreditors’ revocations and probations. However most businesses haven’t carried out that, stated Denise Driscoll, CAP’s senior director for accreditation and regulatory affairs.)

In July of 2021, after a nonroutine inspection, CAP lifted the probation, writing that “the allegations are being appropriately addressed.” 

Seven months after Averhealth’s probation ended, in 2022, Michigan’s Division of Well being and Human Companies learned from the DOJ that Averhealth was beneath investigation and had issues with accreditation. The Michigan company instantly halted testing with Averhealth and informed its employees to ignore the corporate’s ends in any circumstances the place they had been the one proof, in response to court docket paperwork. (CAP agreed to provide Michigan’s Division of Well being and Human Companies information associated to the probation after Michigan had already halted testing.)

Averhealth didn’t touch upon the company directing its employees to ignore its drug assessments as proof.