A state investigation has found numerous safety deficiencies at the Johns Hopkins Home Care Group, which supplied an improperly mixed IV solution to a 2 1/2 -year-old cancer patient who died as a result of the mistake.
In a report made public yesterday, the Maryland Office of Health Care Quality termed the lapses "serious in nature" and said they went beyond the case of 34-month-old Brianna Cohen. The state ordered the group to submit a corrective action plan by this weekend.
State officials found that the home care group, used by about 5,000 area outpatients, employed an unqualified pharmacist and kept a "fragmented and disorganized" record of Brianna's care. Multiple safety lapses were also noted in the care of other patients.
The state began investigating the home care group and Hopkins Hospital after Hopkins reported Brianna's Dec. 4 death as a so-called "sentinel event." Recovering at home from a bone marrow transplant at the Hopkins Children's Center, Brianna received an IV solution that contained five times the prescribed amount of potassium. Though an autopsy was not performed, Hopkins officials believe the error triggered an irregular heartbeat and caused Brianna's heart to stop.
According to the state's report, the pharmacist who oversaw the mixture's preparation failed to "clarify orders, coordinate care and ensure that [IV] infusions were provided in a timely manner." The state also said that the pharmacist, who was provided on a temporary basis by an outside agency, had less than half the required two years of experience when he was hired. It would have been his job to double-check the work of the technician who prepared the solution.
Hopkins, which accepted "full responsibility" for the death, declined yesterday to answer specific questions about the state's findings. Hopkins has said previously that all the proper procedures were followed -- at least on paper. State officials also declined to discuss their report.
Communication problems apparently contributed to confusion over the delivery of Brianna's original mixture of total parenteral nutrition, or TPN, as well as a new mixture that was to contain much less potassium than initially ordered. TPN mixtures, which contain a range of nutrients, are used for patients who can't consume a normal diet.
The first batch was delivered to Brianna's parents, Mark and Mindell Cohen of Owings Mills, several hours after it was promised and only after a nurse called the pharmacy looking for it. Two days later, a physician at the Children's Center outpatient oncology clinic ordered a new batch of TPN in response to Brianna's rising potassium level, but the solution was never delivered.
The Cohens had been told to begin using the new batch Dec. 3, the day before Brianna died. But the family said the home-care pharmacy called to say that it couldn't be delivered and that the clinic had said it would be all right to use the remaining mixture once more.
The state found no documentation to show that a home-care pharmacist had contacted the Hopkins clinic to determine whether the delay would be acceptable. "It is unclear who made the decision to delay use of the new TPN mixture, or if the doctor was even consulted about the delay," the report said.
The release of the state's findings yesterday coincided with a joint announcement from the Cohens and Hopkins that the parties have agreed to an out-of-court settlement. The terms of the settlement, reached last week, were not disclosed.
Hopkins has agreed to dedicate a Children's Center playroom in the child's name and pledged to "take all the necessary steps to investigate the causes and to put into place measures to improve safety processes."
The home care pharmacy has stopped preparing outpatient TPN solutions; the inpatient pharmacies at the Children's Center and Hopkins Hospital have taken over that role.
The state's investigation of the home care group found numerous safety lapses unrelated to Brianna's death. In one case, a high-protein formula was delivered to a 7-month-old who was protein intolerant; the child was later brought to the emergency room in a comatose state. The report noted other potentially serious errors in medication delivery and recordkeeping, among other things.
Hopkins said in a separate statement that detailed plans for corrective action will be submitted to the state and that safety improvements are in the works. It stressed that all of its facilities remain fully accredited.
The Cohens filed a claim last month with the state Health Claims Arbitration Office, a signal of their intention to sue Hopkins in court. They said at the time that they had been seeking an out-of-court settlement for the $1.59 million maximum allowed under Maryland's malpractice law. But Mark Cohen said that Hopkins was disputing whether Brianna suffered and "minimizing the value of her life."
Commenting yesterday on the settlement, Cohen said: "Am I satisfied? No, I'm not satisfied from a personal standpoint. But from a legal standpoint, I'm satisfied. There's nothing like having your little girl around."
The Cohens have created the Brianna Rose Cohen Foundation to help other children with cancer; they plan to make a sizable donation from the proceeds of the settlement.
The Cohens' lawyer, Gary Wais, said yesterday that the family was considering legal action against the agency that supplied the temporary pharmacist.