Drug Testing Firm Averhealth Scrutinized After Claims of Inaccurate Outcomes — ProPublica

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

“Decide indicated on the report that the problem of Averhealth’s testing outcomes was a state-wide concern and that probate courtroom judges all around the state had been having comparable issues.”

Months later, one other official with Michigan’s Division of Well being and Human Providers wrote to colleagues about comparable 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 depart dwelling or elimination, and that’s scary to do once you don’t belief who you’re getting providers 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 completed 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 instructed them that “findings of the investigation are saved confidential.” They requested 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 a superb 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 obtained a full image of what accreditors noticed at one of many nation’s largest drug-testing operations for youngster welfare, custody and probation instances. 

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

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

Six former staff instructed ProPublica that the corporate’s central lab facility in St. Louis was mismanaged. The previous staff, who embrace two chemists and two lab managers, complained variously of understaffing, damaged and poorly maintained devices, and strain 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 supplies correct and forensically defensible check outcomes,” firm CEO Dominique Delagnes stated in a press release. “The integrity of the info and data that we offer is of the very best significance to us.” Averhealth’s purpose, 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 resolution” 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 completely 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 end result has a big impression on a case. “It often takes quite a lot of constructive assessments in addition to different indications of threat earlier than vital penalties are imposed,” an organization spokesperson stated in an interview. The corporate cited an unbiased overview by exterior scientists as proof that its protocols are sound, together with the truth that Averhealth by no means misplaced accreditation.

In 2023, a gaggle of oldsters filed a lawsuit alleging that check outcomes had been misguided, which prevented them from seeing their kids and in some instances induced them to lose custody completely. “Averhealth’s false constructive outcomes have had a devastating impression,” in accordance with the grievance, which cited “substantial emotional misery, together with nervousness, melancholy, 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 results of their constructive assessments,” in accordance with a press release. Averhealth settled the lawsuit in September.

ProPublica interviewed greater than 50 folks concerned in household courtroom or felony 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 courtroom damaging check outcomes from different labs — one of many solely methods to formally dispute a court-ordered drug check, and a technique typically beneficial by attorneys. However assessments from completely different labs are troublesome 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 end result,” the corporate stated in a press release.

After the lab’s probation was made public, Michigan’s and Georgia’s companies overseeing youngster welfare minimize ties with Averhealth. Michigan’s Division of Well being and Human Providers stated in a press release that its “contract with Averhealth has expired and we’ve got not used Averhealth since March 2022.” The Georgia Division of Household & Kids Providers instructed ProPublica in a press release that it didn’t renew the contract when it resulted in 2023 “as a result 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 staff instructed ProPublica. And people issues continued after the probation interval ended, they stated. 

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

The corporate that grew to become Averhealth was based in 1995 by former California police officer Rick McIntire, who spent his profession in undercover narcotics and considered medicine 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 possibility to cost much less and earn a living on quantity.

There may be subsequent 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 medical experience. “It was decided that that is non-diagnostic in nature,” he stated, which means it isn’t used to find out medical circumstances. “Subsequently, it doesn’t require any particular licensing — you is usually a businessman.”

In 2011, McIntire bought 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 purpose, McIntire recollects from conversations with them, was to develop and promote. In 2019, 5 Arrows Capital Companions, a non-public fairness fund and arm of Rothschild & Co., acquired a majority stake. It valued Averhealth at $150 million, in accordance with 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 mainly get new contracts,” one former finance group 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 staff below properly thought out pointers,” present lab director Tonya Mitchell stated in an electronic mail. Firm advertising and marketing supplies say it has the potential to detect when samples are diluted by dishonest test-takers and to check for rising and obscure medicine.

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

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

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 said in 2023. Averhealth stated 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 consultants say they’re doubtful of such claims. “To my information, there’s 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 information 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 business.

After being contacted by a reporter, the corporate faraway from its web site the declare that it may “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 greatest promoting factors is pace: The corporate guarantees to report outcomes by the subsequent 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 staff — a lab tech, a chemist and a lab supervisor — instructed ProPublica that they often labored 12- and even 14-hour shifts and nonetheless couldn’t meet the deadlines.

Strain 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 troublesome. The supervisor met often with Delagnes, who was COO on the time, and different higher administration. The supervisor recollects them saying, “The shoppers are calling and screaming, ‘What are you going to do to get these outcomes by?’ And sometimes my reply was, ‘The devices are damaged once more. I don’t have sufficient folks.’” The supervisor was uncertain 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 comparable deadline pressures. “They emphasised pace over accuracy,” he stated. When getting ready samples for testing, “I used to be considering getting it completed properly. However the push was to get it completed quick.” Penn, who has over 20 years of expertise in labs, left Averhealth “due to the pace concern.”

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 nervous samples could be linked to the flawed individual. “I used to be all the time terribly gradual and meticulous concerning the placement of my pattern on the HPLC. And there have been plenty 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 pace however added that it’s not on the expense of accuracy. “Averhealth requires its staff to work effectively to fulfill its prospects’ manufacturing requirements and required turnaround instances,” the corporate stated in a press release. “Importantly, delaying check outcomes may result in a miscarriage of justice, as litigants’ instances are delayed and doubtlessly endanger kids and the group who depend on the courtroom system, in cooperation with Averhealth, to maintain them protected.” Delagnes stated in a sworn assertion supplied to ProPublica that she has “by no means positioned pace 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 accordance with Picker, this didn’t occur. She famous that the picture reveals 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 exterior the biohazard lab space, sitting on a desk subsequent to private 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 staff stuffed out upkeep logs retroactively. Concerning the picture of a pipette upkeep log, the corporate stated: “The identical worker could 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 instructed ProPublica that eradicating samples from the lab’s biohazard space and leaving them on a desk subsequent to private objects and snacks was not a coverage violation. Picker had a “basic misunderstanding of the lab safety and pattern integrity process,” it stated. “There was no mishandling.” When introduced with images of an indication on a lab door saying to not take away samples from the world, an organization consultant stated: “At any firm there are going to be cases the place doubtlessly insurance policies aren’t adhered to once in a while. I’m not conscious that it is a vital concern 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 staff 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 remedy she was taking left her sleepy, torpid, and ceaselessly 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 grievance concerning 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 pace over accuracy.” In a press release, Averhealth stated that Penn “didn’t increase any issues about Averhealth earlier than or after his resignation.” The corporate additionally famous that Penn is “carefully linked to Ms. Picker.” (Penn rents residing area in Picker’s dwelling.) 

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

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

Essentially 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 Providers for assessments it didn’t carry out: Averhealth’s contract required it to verify all constructive drug assessments utilizing a second technique; 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 below the MDHHS contract,” Delagnes stated in a press release 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 constructive end result. Through the DOJ investigation, the corporate’s enterprise “carried out properly” and the quantity of assessments it performed 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 known as to testify in a Michigan courtroom by a lawyer representing a mother making an attempt to reunite together with her youngsters within the foster system. The mother had examined constructive for marijuana with Averhealth, however exterior lab assessments had discovered no proof of drug use.

In courtroom, 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, meant to definitively show constructive outcomes, are carried out on refined lab devices known as mass spectrometers. Based on Riley’s testimony, Averhealth technicians weren’t utilizing the tools correctly as a result of they “had been below large strain” to report outcomes rapidly.

“Did you deliver these issues 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 issues. Please don’t change something at the moment. We have now contractual time agreements to get the info out, and we simply wish to get the info out.’”

The decide within the case, Lisa McCormick, declined to toss the contested Averhealth check outcomes. “Dr. Riley’s testimony was speculative and didn’t present the Court docket with any particular examples,” she wrote in her opinion. The decide later terminated the mother’s parental rights, in accordance with courtroom paperwork, citing missed drug assessments and failure to learn from providers, amongst different points. Termination of parental rights, which is often irreversible, means kids may 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 pace was problematic. “Dominique and I had weekly calls, not 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 the rest.” Her concern about pace was echoed by the previous staff interviewed by ProPublica.

Averhealth denied Riley’s allegations about its lab practices and stated that her testimony reveals she misunderstood its science. Riley has estimated that Averhealth’s charge 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 appropriate.

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

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

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

In January of 2021, Michigan’s Division of Well being and Human Providers employed an unbiased agency, Wagner Toxicology Associates, to audit Averhealth’s lab and tackle judges’ issues 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 handbook,” 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 courtroom.”

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 completely different conclusions concerning the lab’s operations.

Averhealth’s accreditor is the forensic drug testing program on the School of American Pathologists, a non-public skilled group that gives knowledgeable oversight to forensic labs. In early 2021, the group’s toxicologists reviewed hundreds of pages of knowledge 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 electronic mail 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 relating to unacceptable high quality assurance of mass spectrometry confirmatory testing”; “failure to observe procedures as written”; “concern relating to the manipulation of instrument calibrations”; and “concern relating to the overview of high quality management outcomes.”

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

The aim of the investigation was to examine 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.

Inner emails present CAP scientists mentioned how issues within the lab would possibly 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 constructive outcomes,” one toxicologist wrote, including that its course of for figuring out the amount or focus of medicine “is at instances 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 may exist,” that toxicologist wrote, citing “imprecision and lack of quantitative accuracy.” A qualitative reporting error is a damaging check that’s reported as a constructive, 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 unique end result,” 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 data 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 Providers repeatedly requested Averhealth concerning the investigation, in accordance with public data reviewed by ProPublica. CAP instructed the state company that the findings could be saved confidential.

Herzog, then Averhealth’s CEO, made the choice to not disclose that it was on probation, in accordance with 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 resolution that began with him,” she stated.

(CAP instructed ProPublica that authorities companies may require labs to be extra clear about accreditation points. A toddler welfare company may, as an illustration, contractually require a lab to routinely notify it of accreditors’ revocations and probations. However most companies haven’t completed 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 Providers realized from the DOJ that Averhealth was below investigation and had issues with accreditation. The Michigan company instantly halted testing with Averhealth and instructed its employees to ignore the corporate’s ends in any instances the place they had been the one proof, in accordance with courtroom paperwork. (CAP agreed to present Michigan’s Division of Well being and Human Providers data 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.