Update: NJ Health Hotline has been set up for parents, guardians and other family members who have questions about whether their children should be evaluated for re-vaccination, at 866-448-2432.
STAFFORD – A Manahawkin pediatric doctor is at risk of losing his license after a state complaint alleging gross misconduct was filed January 9.
The complaint, through the state Department of Consumer Affairs – Attorney General’s Office, alleges Dr. Michael Bleiman’s Southern Ocean Pediatrics and Family Medicine office was part of a free or low-cost vaccine program that failed to keep the vaccines refrigerated within the range of acceptable temperatures.
According to a statement by the state Department of Health, approximately 900 children should be revaccinated. The vaccines were not harmful, but could have lost efficacy, due to the alleged improper refrigeration, officials said.
Bleiman’s pediatric office, which is inside Southern Ocean Medical Center in Manahawkin, had no comment when reached by phone January 10.
SOMC spokesperson Donna Sellmann issued a statement January 10: “We recognize that news concerning improperly stored vaccines is alarming to parents and we are partnering with the Department of Health to assist the families who may want to have their children evaluated and re vaccinated if appropriate.”
The Department of Health said SOMC would be creating a hotline to assist families with inquiries. Letters to patients were being mailed following the complaint, to patients as far back as 2014.
“The Department of Health is mailing letters this week to impacted families whose children were vaccinated at Southern Ocean Pediatrics and Family Medicine in Manahawkin, which is the medical office of Dr. Michael Bleiman. The Department suspended shipment of VFC vaccine to Dr. Bleiman on July 28, 2016, when, during a routine compliance visit, problems with refrigeration temperatures were discovered,” wrote the DOH in its press release.
The AG complaint, filed January 9 through the State Board of Medical Examiners, alleges gross negligence, professional misconduct and other violations by Dr. Bleiman, in regard to the offices temperature logs, use of quarantined vaccines and other record-keeping issues through the Vaccines for Children (VFC) program.
VFC is a federally funded, state operated program that provides 1.6 million free or low-cost vaccines to eligible low-income children at more than 1,000 medical offices around the state each year.
According to the complaint, Bleiman’s office received the training and approvals to take part in the program and administer vaccines such as measles, mumps, rubella, chickenpox, hepatitis A & B, rotavirus, DTaP/Tdap, Hib, pneumococcal, polio, meningococcal and HPV.
But by storing the vaccines outside the range of acceptable temperatures, the vaccines may have lost some of their potency. The complaint alleges those vaccines were administered through July 28 but were refrigerated improperly.
According to the complaint, a state compliance officer discovered the improper refrigeration in the July visit.
The officer ordered the existing 280 vaccines be quarantined so that the manufacturer could test their efficacy, and required Bleiman’s office to use an electronic data logger that tests the refrigerator’s temperature every 30 minutes.
New vaccines – 335 total – were received by the pediatric office to be administered through the VFC program.
The complaint alleges Bleiman’s office distributed the quarantined vaccines, did not verify with the manufacturer the vaccines’ viability, and continued to register improper refrigerator temperatures, which meant the newly received vaccines were possibly compromised, the complaint states.
The office also allegedly failed to keep records in compliance with VFC temperature-log standards, with “little to no variation in recorded temperatures for extended periods of time; handwritten out-of-range temperatures recorded that were not electronically reported to the VFC and no corrective action was undertaken,” according to the complaint documents.
In an October 24 visit, VFC program staff removed all remaining doses from the pediatric office, and retrieved the installed electronic data logger and handwritten copies of the temperature logs dating prior to January 1, 2016, the complaint states.
The VFC conducted its examination of Bleiman’s VFC vaccine inventory, and according to the complaint, found that the quarantined vaccines were unusable. Of the 280 vaccines that were quarantined, 11 were administered to children, and several others were missing. Several of the non-quarantined vaccines were also missing.
Since then, the pediatric’s office was suspended from participating in the VFC program and has not been re-certified to participate.
The complaint order requires a response from Dr. Bleiman within 35 days of the order, responded to counts of gross negligence and professional misconduct.
Signed by state Attorney General Christopher S. Porrino, the complainant is seeking a plenary hearing suspending or revoking Bleiman’s license to practice medicine in New Jersey, and seeks civil penalties and restitution, through the state board of medical examiners.
“As part of an ongoing investigation, the Department made referrals to and is working with the New Jersey Board of Medical Examiners, the Medicaid Fraud Division in the Office of the State Comptroller; and the Medicaid program in the New Jersey Department of Human Services,” according to state officials.
What Patients Should Do
According to a statement from the state Department of Health, approximately 900 children who participated in the VFC program may need to be re-vaccinated. The children who should be evaluated for revaccination were vaccinated between November 2014 and July 28, 2016.
The state DOH said those vaccinated were not harmed by the vaccines, but are likely not protected from the disease they were vaccinated against.
“Vaccine that has not been properly refrigerated under the recommendation of the manufacturer may be less effective. Children who receive these vaccines might not be fully protected against vaccine-preventable diseases, according to the guidelines of the federal Centers for Disease Control and Prevention (CDC). Receiving improperly-stored vaccines is not a danger to the health of the recipient, however, according to the CDC guidelines, exposure to temperatures outside the manufacturer’s recommended range can make vaccines less effective at preventing disease,” said the DOH.
The DOH’s recommendations:
Parents may want to discuss revaccination with a health care provider. The vaccines the children received include measles, mumps, rubella, chickenpox, hepatitis A & B, rotavirus, DTaP/Tdap, Hib, pneumococcal, polio, meningococcal and HPV.
Families enrolled in Medicaid Managed Care Organizations should contact their health plan for assistance in providing an in-network provider.
Parents or guardians of uninsured children can contact Federally Qualified Health Centers in the area, including the Center for Health Education, Medicine & Dentistry (CHEMED) in Lakewood and Ocean Health Initiatives in Lakewood.
In addition, Southern Ocean Medical Center in Manahawkin, which is part of Hackensack Meridian Health, will also be setting up a hotline to help families evaluate the need for revaccination.”
What tips does the DOH offer parents in seeking out a physician who properly stores vaccine?
“Parents and guardians should ask their health care provider if they follow the CDC guidelines for handling and storage of vaccine,” said Donna Leusner, DOH Director of Communications.
She said the CDC storage and handling toolkit is the best resource for questions about proper refrigeration temperatures of vaccine: cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf.