State says failures throughout hospital led to baby's death

greenspun.com : LUSENET : Y2K discussion group : One Thread

Almost four months after a newborn baby died of a lethal dose of medication at Stony Brook University Hospital, a scathing state Health Department report has criticized operations at almost every level of the institution, from the chief executive to the technician who filled the prescription.

Far from being a single mistake stemming from a missing decimal point on a prescription, the report indicates, the overdose that killed 6-day-old Gianni Vargas on Feb. 5 was the cumulative result of numerous errors and policy violations at different points in the hospital, indicating chronic, systemwide failures.

Not only did the nurse practitioner prescribe an excessive dose, the report found, but an unlicensed, poorly supervised technician was allowed to fill the order, an apparent violation of state law, and a nurse then administered it without notifying the attending physician, as required by Stony Brook's policies.

Gianni Vargas, who was born to Ana Celina and Giovanni Vargas of Brentwood on Jan. 30, died after being given 10 times more potassium chloride than he should have received to treat a potassium deficiency. The overdose was reminiscent of a previous 1995 incident, when another baby, Petra Morgan Fiel, was given 10 times the proper dose of morphine at Stony Brook, the main tertiary care facility serving Suffolk County.

"At three points this error could have been noticed by the staff and this tragic situation would have been avoided, but it was not," said Rob Kenny, a spokesman for the state Health Department. "Given the severity of the outcome and the fact it was a recurrent violation, similar to a case in 1995, we're taking it very seriously and moving to take enforcement action." Fines have not yet been determined, he said.

David Raimondo, the Lake Grove attorney representing the Vargas family, characterized the report as "a bombshell" that described the complete "collapse of the system or systems in place to protect human life."

Referring to the hospital's earlier plan of correction, put in place after the 1995 infant overdose, Raimondo said, "It is evident that the hospital cannot police itself. Perhaps outside intervention is necessary."

Hospital officials responded to the report by releasing a statement saying they have been and continue to take steps to reinforce patient safety, including establishing a patient safety committee and a medication ordering improvement group. They mentioned many improvements in the pharmacy, including the purchase of computerized software with built-in dosing guidelines and the recruitment of new pharmacy management.

"Hospitals are very complicated places," said hospital spokesman Dan Rosett. "We started looking at processes and systems even before the death of the baby. It takes time to purchase and implement and train people. ... The steps are comprehensive."

No department was spared - with criticism aimed at the administration, medical staff and nursing services. Chief executive Bruce Schroffel was faulted for not implementing appropriate personnel practices and, specifically, for not providing orientation to new registered pharmacists about providing care to neonatal patients.

But the state's harshest criticisms focused on the mismanagement of the understaffed pharmacy and the failures of its computer program. The pharmacy, the state said, relies excessively on poorly supervised pharmacist technicians, while its computer program still lacks the capability to assess the safety of drug dosages for infants younger than 30 days.

During a tour of the pharmacy by state health officials, the report said, a pharmacist was asked to program an erroneous order that was 10 times greater than the prescribed dose for a newborn baby. "The computer program did not identify the calculation error," the report said. "This was brought to the attention of the director of pharmacy who indicated ... the program is not able to identify dosing errors for children under 30 days old."

Because the pharmacy had been understaffed, supervision of pharmacist technicians was lax; the report said they routinely mixed intravenous solutions without adequate supervision. The pharmacist interviewed told state officials that he often initials the mixtures prepared by technicians in his absence without ever verifying the contents.

Moreover, the report said, the pharmacy staff had been down one pharmacist for quite a while and "the lack of another pharmacist may have contributed to the overdosing and the demise of the 6-day-old infant, by using unlicensed personnel to function beyond his scope of practice."

A state review of hospital pharmacy activity found 81 medication "incidents" over a six-month period in 2001, and the report specifically referred to at least three medication overdoses involving infants.

With regard to potassium chloride, which is frequently the object of medication errors, the hospital had clear written policy and procedures in place that were disregarded by both the nursing and pharmacy staff, the report said.

Potassium chloride, a naturally occurring element found in certain foods, is used to treat a number of conditions of potassium deficiency, but overdoses can produce severe side effects, because the heart is very sensitive to rapid changes in the concentration of potassium in the bloodstream.

One of the ironies in the state report is that the Vargas baby may not have needed an intravenous solution at all. Had the hospital's own policy been followed, the baby's case would have been classified only as a "mild" deficit, which could have been treated with an oral solution.

The Vargas parents declined to comment yesterday, but their lawyer, Raimondo, said that after the report came out the mother asked him one question. "She just wanted to know if her child had suffered," he said.

newsday

-- Anonymous, May 25, 2002


Moderation questions? read the FAQ