As many as 2,345 Dean Clinic patients may have been exposed to the bloodborne illnesses hepatitis B and C and HIV because a diabetes nurse educator reused the handles of insulin demonstration pens and finger stick devices over a five-year period, from 2006 to 2011, clinic officials said Monday.
Both Craig Samitt, Dean's chief executive officer, and Mark Kaufman, chief medical officer, described the risk as "small" because the educator, who worked out of the Dean clinics on Stoughton Road and in Sun Prairie, did not re-use actual needles.
Even so, said Kaufman, it is possible that blood from patients contaminated the bases of the re-used demonstration pens, which are supposed to be used to show how to inject insulin and aren't intended for use on people, or the plastic handles of the finger stick devices.
"We're confident the person always changed needles between uses of the devices," said Kaufman. "But even if you're changing the needle, there is the possibility that the first person's blood could come in contact with the next person's blood."
Abigail Tumpey, a spokesperson for the federal Centers for Disease Control and Protection, said Dean has consulted with that agency about the incident. Craig said the clinic has also been in touch with the state Division of Public Health. Officials with both agencies were unsure Monday whether further investigations will be conducted.
"We would agree that the risk is small," said Tumpey. Regardless, she added, most people in such education programs expect no risk. Tumpey said the CDC works with clinics in such situations to make sure patients are notified and that their needs and concerns are met.
"The goal is more health care transparency," said Tumpey. "It is a very scary time for many of these patients."
Samitt said this was an "isolated" incident involving the single educator, who has since been fired. He declined to identify the individual. Samitt said clinic officials learned of the potential exposure on August 10 from another employee and conducted an investigation. Monday, the clinic mailed letters to all 2,345 patients to inform them that they may be at increased risk.
Also, Samitt said, a team of 25 nurses is taking telephone calls from affected individuals to determine whether they should be tested for HIV, which is the virus that causes AIDS, or for either form of hepatitis, a disease that attacks the liver. He said calls were already being received Monday after stories about the possible exposure began appearing in the media.
"This is a very difficult situation for us at Dean," said Samitt. "I'd like to apologize for the concern this has caused patients and their families. We'll do whatever it takes to care for affected patients."
Kaufman said risk to individual patients depends on whether the nurse actually used one of the insulin devices on them. "Did the nurse use any sharp instrument on you? If the answer is 'No,' then there is no risk. If you don't remember, then we could assume there was a risk, no matter how small."
But Samitt said anybody who is concerned about exposure will be offered testing. He said while most of the involved patients are from Dane County, a handful from outside the county and even outside the state may have been referred to the educator. "We're casting a very broad net to include each and every patient the nurse could have seen," said Samitt.
As for how the misuse of the devices could have gone for so long without being detected, Samitt said the clinic is still trying to figure that out.
"We'd like to know the answer to that question as well," said Samitt. "This is an active investigation."
Samitt said the nurse was certified through state and federal programs, including the Association of Diabetic Educators, to work as a diabetes educator. Also, he said, the nurse went through Dean's own training program. An important part of that training, he said, is learning not to re-use the testing devices. The insulin demonstration pen, for example, is not supposed to be used on people but rather is used on oranges or pillows to show patients how to inject insulin.
"This is upsetting to us as well," Samitt said. "There is a basic standard of care principle here."
Samitt added that it was unclear whether the nurse went through the clinic's refresher course on standard practices. He said there was apparently little oversight or evaluation of the nurse's work.
"There weren't regular, routine observations," said Samitt.
Samitt said that in the wake of the incident the clinic is requiring staff to be retrained in the use of the devices, improving monitoring the use of the devices and also making sure that practices by clinic staff are routinely observed.
The state Department of Safety and Professional Services is also reviewing information about the case, according to John Murray, executive assistant at the agency.