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Coronavirus

Whistleblower alleges Maryland health officials failed to alert hundreds of patients of potentially spoiled vaccines

The Maryland Department of Health for months did not notify hundreds of people who may have received spoiled vaccines from a contractor, and an employee who reported the mishandled doses alleges in a complaint that the agency retaliated against her for pressing to fix the issues.

The U.S. Centers for Disease Control and Prevention has advised the state health department to revaccinate the patients who may have gotten ineffective doses, according to emails obtained by The Baltimore Sun. A Maryland Department of Health spokesman said the agency planned to notify vaccine recipients by this week of their need for another shot.

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The whistleblower filed her complaint this month with the Office of the Inspector General for the U.S. Department of Health and Human Services after the state health department’s inspector general declined to investigate and referred her to the federal agency.

The complaint centers on vaccines administered by TrueCare24. The state hired the company in June to run mobile vaccination clinics under an emergency contract worth $1.4 million, although it has paid out only about $166,000.

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Jessicah Ray, a licensed clinician and formerly deputy director of a Maryland Department of Health coronavirus recovery program, alleges in her complaint that the department ignored the input of employees involved with clinical operations, who recommended terminating the contract.

Emails between health department employees and TrueCare representatives show TrueCare stored vaccines in refrigerators that were medical-grade, but were kept overnight in hotel rooms and cars instead of at a storage facility TrueCare was required by the contract to use.

TrueCare didn’t provide the state with complete records, so health officials can’t say for certain how many doses were compromised, emails between health department personnel show. The department estimates there are at least 876 people affected, according to an email from a health department official to colleagues. In her complaint, Ray estimates more than 1,000 doses are in question.

Health department spokesman Andy Owen said in a statement the agency is aware of the allegations against TrueCare, but had no further comment. San Francisco-based TrueCare did not respond to phone calls and emails requesting an interview.

The federal inspector general’s office did not immediately respond to a request from The Sun for comment and has not yet answered Ray’s complaint.

Ray said in her complaint she was removed from her deputy director position for insisting the state address noncompliance issues at vaccination sites. She was moved to an advisory role for congregate care services, doing what she described as “entry-level admin tasks,” and told she shouldn’t communicate with her former colleagues.

“My concerns about safety and quality were in the way of operations,” Ray said in an interview.

It’s not clear when the department notified the CDC, but the shots were administered between July and September and Ray submitted her complaint to the state health IG Sept. 23 — months before the CDC told the health department in early December to reach out to the vaccine recipients. They may need another one or two vaccinations, depending on the timing of their shots.

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The three vaccines available to U.S. consumers — made by Pfizer/BioNtech, Moderna, and Johnson & Johnson — have strict storage requirements. Most vaccines are to be kept at temperatures between 36 and 46 degrees in refrigerators. According to TrueCare’s logs, temperatures in its refrigerators rose to 95 degrees on at least one occasion.

The vaccines are fragile, and may not work if they are stored at different temperatures, according to medical professionals and immunologists.

“It’s the equivalent of not getting a full dose of the vaccine,” said Democratic state Sen. Clarence Lam, a physician who represents parts of Baltimore and Howard counties. “Is it going to hurt you? Probably not, except for the fact that you’re acting like you’re [fully] vaccinated.”

The health department did not terminate TrueCare’s contract, but it stopped giving the company new assignments by the end of September and isn’t renewing the contract, according to Owen and the information obtained by The Sun in a public records request.

TrueCare was founded in 2016 and provides patients with at-home health care services. During the pandemic, it has administered coronavirus tests and vaccinations.

The state Board of Public Works approved the vaccination contract in June, with three six-month renewal options at the same price. Without a renewal, the contract expires at the end of 2021.

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TrueCare’s operations were questioned by employees tasked with reviewing contractor compliance from the outset, the documents show.

It wasn’t able to hold its first clinic July 17 because health department employees found TrueCare didn’t have required on-site medical equipment and was missing certifications for staff members, such as CPR and coronavirus training, Ray wrote in her complaint to the state health inspector general. It was clear TrueCare was “grossly unfamiliar” with CDC and state reporting policies, Ray wrote in a July report.

Ray said in an interview that as a lead clinical adviser — meaning that she oversaw teams covering testing and vaccine operations and advised officials on best practices — she recommended then that TrueCare’s contract be paused or terminated. However, the state put TrueCare on a remediation plan, requiring it to outline how it intended to resolve its noncompliance, and allowed it to administer vaccines July 30.

On Sept. 3, a state health department manager ordered TrueCare to halt vaccinations after another health department employee reported the vendor was storing vaccine in hotels and cars, emails show.

“We have no reliability on the vaccines that they have stored in those units and if they were even viable vaccines that they administered,” wrote Kurt Seetoo, the state health department’s Immunization Program Manager. He was greatly concerned, he said, and questioned “the credibility of the operation.”

On Sept. 15, Ray wrote a report addressed to Health Secretary Dennis Schrader, telling him TrueCare wasn’t complying with the contract, but it’s not clear if he reviewed it. The report recommended the department warn recipients of “possible less effective vaccine” and offer another shot. A Sept. 9 email to health department employees from a consultant includes the subject line “Re: Webster, Sec Schrader and Corey are all discussing TrueCare now.”

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The investigation proved difficult because TrueCare’s records were in disarray, emails show. The vendor failed to produce complete temperature logs, data and chain-of-custody reports for more than 1,000 doses, Ray said. She estimates that’s an estimated 70% of vaccinations the company administered across more than 100 sites.

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TrueCare held clinics at sites that included grocery stores, the Baltimore Circuit Court, prisons in Baltimore City and in Anne Arundel and Howard counties, and the Maryland Renaissance Festival in Crownsville.

TrueCare provided required logs for a fraction of its mobile clinics, and most were missing dates and signatures, Ray said. When there were “excursion events,” meaning the temperature went out of the proper range, Ray said required reports explaining what happened weren’t completed.

Logs maintained by TrueCare staff list a range of problems with the equipment, including unspecified “malfunctions,” at least one instance of a refrigerator’s humidity plug disconnecting and several drops in temperature due to “condensation.”

Email messages indicate state officials looked into the allegations, but did not alert vaccine recipients of a potential issue.

“This is not a quick process,” Seetoo wrote in a Sept. 15 email to health department staff members. “We need to gather a lot of information to piece together the big picture.”

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In an Oct. 8 email, Seetoo told staff that vaccine manufacturers had reviewed temperature and digital data provided by TrueCare earlier that month that supported the viability of vaccines at two dozen of TrueCare’s sites. He said that was the “vast majority” of clinics for which TrueCare provided information.

After the health department contacted the CDC for guidance, Seetoo wrote Dec. 1 to colleagues that the federal agency recommended revaccinating people with one dose immediately, regardless of the total number of doses they’ve received.


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