A mobile vendor accused of mishandling hundreds of COVID-19 vaccine doses delivered a majority of the suspect shots at public clinics at a state park, courthouses, grocery stores and other community settings, according to a Baltimore Sun data analysis.
TrueCare24, the San Francisco-based company, is the subject of a complaint filed last month by a Maryland Department of Health employee accusing the company of improperly storing and handling vaccines and not providing required records, potentially affecting the vaccines’ effectiveness.
TrueCare reported giving at least 1,455 doses of vaccine during a period spanning from late July to mid-September, according to documents obtained by The Baltimore Sun. Of those, the state health department said it “validated,” or cleared for use, about 500 of the doses given with the help of the vaccines’ clinical and medical support staff at manufacturers Pfizer, Moderna and Janssen, the Johnson & Johnson pharmaceutical arm.
But of the nearly 1,000 shots that the department did not validate, about a quarter were given out at Sandy Point State Park in Annapolis, according to the records. TrueCare made at least eight trips to Sandy Point from Aug. 15 to Sept. 6 and administered some 230 doses in all. The next most common sites were courthouses followed by Compare Foods stores.
The largest portion of the vaccines TrueCare administered went to people at state detention centers, but most of those were among the doses cleared by the state health department. Health department officials said 135 doses TrueCare gave at detention centers were not validated by the department. The Maryland Department of Public Safety and Correctional Services declined to comment.
Representatives from TrueCare, Moderna and Janssen have not responded to requests for comment. Representatives from Pfizer declined to comment, calling the situation a “local matter.”
The health department began notifying those who may have received problematic doses of vaccine late last month, spokesman Andy Owen said, and the matter remains under internal review.
On Thursday, state Health Secretary Dennis R. Schrader said during a virtual hearing with Maryland lawmakers that the department had notified 873 individuals of the situation and had offered each a supplemental dose of vaccine “out of an abundance of caution.” He said the individuals were contacted by email, phone, text message and letters, with Spanish language translation available.
In her complaint, Jessicah Ray, a licensed clinician and former deputy director of a Maryland Department of Health coronavirus recovery program, said TrueCare improperly stored and handled vaccines and kept incomplete and problematic records.
The three vaccines available to U.S. consumers have strict storage requirements. Most vaccines are to be kept at temperatures between 36 and 46 degrees in refrigerators. The vaccines are fragile, and may not work if they are stored at different temperatures, according to medical professionals and immunologists.
It’s possible, Ray said, that those who received mishandled doses could be less protected against COVID-19 than they think. As the new, more contagious omicron variant circulates, she said it’s important that those who received a questionable dose get revaccinated.
Ray said she was comfortable that the validated doses met “validity criteria,” based on her assessments of the digital temperature logs and after cross-checking the storage requirements of the vaccines.
She said there were several procedural errors and other quality control blunders that made her question the integrity of TrueCare’s work. Company representatives failed, she said, to submit chain-of-custody forms that detail how the vaccine temperatures fared during transit to the department. They are necessary to ensure the full reliability of vaccines.
Dr. Jinlene Chan, the state’s deputy secretary for public health services, told lawmakers Thursday that the agency’s and federal regulators’ chief concern centered on the documentation problems. This, however, does not mean the vaccines themselves were “spoiled,” she said.
“The issue is not so much that we know that they were spoiled, just the documentation,” Chan said. “So, we are uncertain that the vaccines were held at the appropriate temperature. It does not mean that they were not, it just means that the documentation was not there.”
She said the department does not believe the vaccines had the potential to cause harm or other adverse effects to those who received them.
“We do not believe that would be the case, given the circumstances,” Chan said. “That’s why we are emphasizing, out of abundance of caution, we’re recommending based on CDC guidance, an additional dose.”
Ray also said TrueCare’s handwritten logs documenting the vaccine temperatures during site operations didn’t always match the digital logs. When MDH pressed for more missing documents, TrueCare representatives did provide many, she said, though they did not always correspond with the original digital logs.
When there were “excursion events,” meaning when the temperatures were too high or too low, she alleges the company failed to complete required reports explaining what happened. Those reports help validate that the vaccines are safe and effective to use.
Ray wasn’t the only one asking questions.
In emails obtained by The Sun, Kurt Seetoo, immunization program manager at the health department, said there were at least eight hours of temperature excursion events Sept. 2 that the company didn’t provide an explanation for.
“There are alarms on the current logs for a total of more than 8 hours (7 hours too high 1 hour too low) on the 9/2 log,” Seetoo wrote in a Sept. 9 email. “What did the team do in response to these alarms? What is their protocol?”
According to Ray, the health department identified at least 75 excursion events during a preliminary review, and there was difficulty identifying the cause.
Asked for advice, the U.S. Centers for Disease Control and Prevention recommended health officials notify and revaccinate hundreds of people, the health department said. The CDC has not replied to a request for comment.
Several Maryland lawmakers have called for more transparency into the mobile vaccination program run by the state health department, which has overseen the vaccination of millions of people statewide since the shots first became authorized for use by the U.S. Food and Drug Administration in December 2020.
State Del. Heather Bagnall, an Anne Arundel County Democrat whose district includes Sandy Point State Park, said she has heard from a handful of constituents worried about the clinics they attended in her district. Some of them already have been contacted by the health department to advise them to get another shot, but it’s not clear what process health officials are following to reach patients, she said.
”We don’t know what that process of notification is, which makes it hard to know … if we are adequately notifying the people that might have been affected,” she said. “That’s my greatest concern.”
In addition to thinking the health department didn’t act quickly enough to notify vaccine recipients about the potential problems with their shots, Bagnall said she also worries about Ray’s protection at work.
Ray said she was removed from her position as a deputy director overseeing vaccine and testing compliance and put into a different program, where she was instructed not to communicate with her colleagues involved in assessing the compliance of clinical operations.
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“We might need greater protections for whistleblowers so that if people see something, they can say something,” Bagnall said.
Meanwhile, State Sen. Shelly Hettleman, a Democrat who represents Baltimore County, called the decision of the department’s inspector general not to investigate “really concerning.”
She said it illustrates why she proposed a bill that passed the legislature last year to establish an independent inspector general office for the agency. The law doesn’t take effect until July. Currently, the inspector general’s office is a division within the department that is empowered to investigate potential fraud, waste and abuse of state funds.
Schrader said Thursday that the department takes the effectiveness of vaccines and patient safety seriously. That’s why the department stopped assigning TrueCare new clinics once the complaints surfaced, he said.
He said he agrees that the notification process took too long. After the CDC advised the department Nov. 22 to reach out to the affected individuals, that didn’t start happening until Dec. 30, Schrader said.
“I am not happy about how long it took MDH to determine clinical next steps and reach out to individuals,” he said. “What we were slow at was getting the advice from manufacturers and the CDC. And that should’ve been much faster.”
Schrader said the department is holding four “supplemental vaccine clinics” this week for the individuals vaccinated at detention centers — all inmates.