OBERLIN — Records obtained by the Ohio Department of Health indicate that Kidz First Pediatrics of Oberlin kept vaccines at improper temperatures for at least two days in October 2011.
And, during that time, at least 1,123 doses of vaccines were affected by the bad temperatures, the Ohio Department of Health reported.
The temperature logs from Kidz First Pediatrics showed several discrepancies in recordings.
Dr. John Sanderson, pediatrician at the clinic, said the vaccines, which were administered from October to December 2011, were kept in a refrigerator unit that was adjusted by an employee after the temperature began to “fluctuate.”
He said, due to the temperature adjustment, the temperature became too cold overnight, causing the vaccines to be ineffective.
The temperature log, which is required to be checked twice a day, was checked only once on Oct. 18 and 19. However, on Oct. 19, two sets of initials were signed. On Oct. 20, there were four different markings on the log.
It wasn’t until Oct. 21 and 22 that the temperature dipped into the “too cold” range and recorded at 30 and 34 degrees, consecutively.
Melanie Amato, spokeswoman for the Ohio Department of Health, said the issue was never reported to the department, despite a note on the temperature log that reads, “Report and correct any temperature issue below 35 degrees immediately!” followed by a phone number to the vaccine warehouse.
Storage temperatures between 38 and 43 degrees are the “target area ideal range.”
The vaccines were provided to the clinic by the Ohio Department of Health through the Vaccines for Children program, a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay.
At least one parent whose child was vaccinated by Kidz First Pediatrics from October to December 2011 said they were not notified that the vaccines were ineffective until they were contacted by the Lorain County General Health District.
Another parent learned of the ineffective vaccine after The Chronicle-Telegram reported the discrepancy March 27.
Amato said the temperature problems weren’t reported to the Ohio Department of Health, as required, by Kidz First Pediatrics. Instead, the issue was discovered when leftover vaccines and the temperature logs were transferred to the Lorain County General Health District. Amato said the Lorain County General Health District was going to use the extra vaccines before they expired.
Dave Covell, commissioner for the Lorain County General Health District, said the defective vaccines were discovered before the Lorain County General Health District could administer them.
The problem was reported Jan. 9, 2012 — about three months after the temperature rendered the vaccines ineffective on Oct. 21, 2011. Amato said Sanderson reported an inventory of 1,123 doses of vaccines in stock when the temperatures became too cold.
Sanderson said the issue was never brought to his attention. He said he learned about it during an audit by the Ohio Department of Health.
When asked about the employee who initialed the log on Oct. 21 and 22, he declined to name the employee by stating, “I can’t talk about individuals.”
He did confirm that the employee is no longer working at Kidz First Pediatrics. He said that employee was not aware that the cold temperatures would render the vaccines ineffective.
After the defective vaccines were discovered, Kidz First Pediatrics was ordered to quarantine all vaccines, as well as revaccinate patients at the clinic’s cost, Amato said.
“As soon as the temperature excursion was discovered on Jan. 9, 2012, his office was ordered to quarantine all vaccine and not use it. He was responsible to revaccinate all the patients that were vaccinated from Oct. 21, 2011 through Jan. 9, 2012, with his own stock (not VFC) at no cost to the patient,” Amato said.
That wasn’t done, however.
Sanderson, who has appealed the Ohio Department of Health’s corrective action plan, said revaccinating patients wasn’t an option. He said it would cost about $60,000 to do so, and the clinic doesn’t have the money.
Instead, he said he was verbally directing patients to other facilities that provided VFC vaccines.
In a corrective action notice issued to Kidz First Pediatrics on Jan. 13, 2012, the Ohio Department of Health also ordered the clinic to submit a list of patients to the Ohio Department of Health who may have been affected, as well as a corrective action plan to make sure that the incident would not happen again.
Yet, some patients, like Leslie Barber’s 7-year-old daughter, were not notified.
Barber said she was informed that her daughter’s vaccines were ineffective on Monday. Now she must revaccinate her child with an adult dose.
Lacey Bates, who now lives in Holmes County, only learned of the defective vaccines after her mother sent her The Chronicle-Telegram’s online news article Thursday.
Bates’ 2-year-old son was vaccinated as a newborn at the clinic between October and December 2011 by Sanderson.
“Basically, it’s like giving them water. I didn’t get a phone call. Nothing. It’s devastating,” she said.
Bates said that even though she has since relocated out of the county, the emergency contact numbers on her son’s medical chart were valid, as was her contact information.
“It’s his job as a doctor to run his office the proper way. There is no excuse for this. When they found out, they should have rectified it right away. This breaks my heart. There was no reason he couldn’t have gotten ahold of me,” Bates said through tears.
Because Kidz First hasn’t been in compliance with the Ohio Department of Health — to revaccinate patients at the clinic’s cost — Kidz First Pediatrics is not permitted to administer VFC vaccines. The clinic is providing vaccines to patients with private insurance, however.
“He did appeal the action in July 2012. He has only met three of the nine notifications that we cited him for, and we never heard from him again. He is still inactive (to administer VFC vaccines) because he still has six notifications that he still has not filed,” Amato said Friday.