Sharon Regional Health System

Federal officials don’t know who delivered unprescribed and nearly doses of insulin to four patients nearly two years ago at the hospital of Sharon Regional Health System.

Federal authorities quickly developed several “persons of interest” suspected of delivering unprescribed and potentially fatal doses of insulin to four non-diabetic patients at the hospital of Sharon Regional Health System in July 2004.

Investigators questioned employees who had access to the patient rooms and intravenous bags on the fifth floor of the hospital’s west wing where all of the affected patients were staying, according to a redacted 82-page copy of the Food and Drug Administration’s investigation of the incidents.

The FDA’s Office of Criminal Investigation closed its portion of the case last year based on a “lack of additional investigative leads” without determining how the patients received enough insulin to require treatment in the hospital’s intensive care unit.

Hospital staff discovered the patients’ sudden drop in blood sugar levels between July 15 and July 18. Within the next four days investigators had decided to zero in on employees who either had not been showing up for work or were known to have an “adversarial” relationship with the hospital, according to the report released to The Herald through a Freedom of Information Act request.

The employees “of interest” authorities interviewed included: one who was unhappy with his work schedule and missed several days of work the next week; a fired employee who may have had access to the fifth floor before the incidents; an employee who “made statements that he knew how to harm people if needed” and a worker who disagreed with hospital management on the future of a program and was “heard to say that the hospital should be wary of workforce reductions because that is when accidents happen.”

Three of those employees passed polygraph exams. The fourth, who authorities deemed to be of lesser interest after an interview, offered to take a polygraph.

An employee on duty who had direct contact with three of the affected patients also passed a polygraph.

The FDA blacked out most of the job titles and all of the names of hospital employees and investigators on the copy of the investigation the agency released.

The suspected contaminated intravenous bags were forwarded to Sharon police as evidence along with “a used syringe and an empty vial of insulin” found in a soiled linens room next to the intensive care unit, the report states.

A custodial worker found those items July 19, 2004, and told police in an interview she discovered them after dumping trash into a bin. “The vial and syringe should not (have) been in the room,” one investigator wrote. That is the only reference to the items in the report.

The hospital’s intensive care unit is on the fourth floor, one floor below where the patients were staying.

A nurse who worked on the west wing of the fifth floor and provided care to the patients during the shift before the illnesses were discovered was interviewed at the Sharon police station for about 4è hours, starting at about 9:30 p.m. Sept. 16, 2004, and ending at about 2:05 a.m. the next day.

The nurse admitted it was possible someone could have tainted the saline flush vials with insulin and that she could have flushed the intravenous lines with insulin.

She said she “could have flushed the lines with insulin accidentally, but not four times.”

She explained that a “flush,” usually with saline solution, is done before and after medication is given. The nurse said she had given morphine to one of the affected patients during her shift.

Mercer County District Attorney James P. Epstein said there was not enough evidence to “pin” the illnesses on any one person.

While the FDA has closed its portion of the investigation, Epstein has pledged to keep the case alive and said the FDA has told him it will reexamine the incidents if new leads open up. He urges anyone with information on the incidents to contact Sharon police.

“I think I’ve made it about as clear as I can that from our perspective a case like this is never closed,” Epstein said.

In an attempt to develop additional leads and examine hospital security measures, 153 hospital employees completed an eight-page questionnaire about the illnesses on Aug. 11, 2004, according to the report.

The workers were selected to fill out the survey based on their access to the west wing of the hospital’s fifth floor.

The questionnaire asked the employees point blank if they knew who injected the insulin into the intravenous drip bags or access ports. It also sought suggestions on how to conduct the investigation and offered questions to illicit information on how to improve the hospital’s control over its medication.

The survey included such questions as: “Is there anything about you and the handling of IV drip bags and/or access ports that we should know about?” and “While filling out this form what were your emotions?”

During the review, investigators uncovered several deficiencies in the hospital’s internal control over the delivery of medication, including a lack of security over the access code for each medication cart, the report states.

Investigators recommended ways of remedying the deficiencies and the hospital adopted many of them, the report shows.

Sharon Regional had no comment on the FDA report.

A lawsuit on behalf of each of the four patients that alleges medical malpractice has been filed against the hospital. Families for three of the patients claim the administration of insulin was a substantial factor in the deaths of their loved ones.

The causes of death for Joseph Noga Jr., 87, who died Aug. 7, 2004, and Walter W. Huey, 81, who died Oct. 3, 2004, are listed as cardiac arrest in their lawsuits. John C. Williams, 75, died Sept. 3, 2004, of congestive heart failure, his suit says. All three men were from Hermitage.

The status report an investigator filed with the FDA on Dec. 3, 2004, says that two of the affected patients have since passed away. “The deaths were not directly attributed to the insulin incident,” the investigator wrote.

The fourth plaintiff, Jodi Lynn Evans, of Greenville, lived.