The University of Vermont Medical Center waited seven weeks to implement changes in the way nurses prepare and administer drugs after a patient was killed by a Ketamine overdose accidentally injected by a nurse, documents show.
An inspection report by Vermont’s Division of Licensing and Protection found eight violations of federal standards at the hospital, four of which were so severe they could have threatened its federal funding if they weren’t fixed. The hospital has now addressed all of the violations, a spokesman says.
Fifty-five-year-old Gregory Davis went to the emergency room on January 27, 2015. He was obese, had heart disease and was a “chronic” alcohol user, according to his death certificate. Documents from state inspectors show Davis “sought treatment in the Emergency Department (ED) on 1/27/15 after experiencing three days of shortness of breath.”
A chest X-ray taken early that afternoon showed Davis had pulmonary edema (fluid in the lungs) and maybe pneumonia as well, the report says. Doctors decided he should be admitted, and at 4:20 they started transferring him to the Medical Intensive Care Unit (MICU), but things went wrong. Five minutes later, doctors decided they needed to immediately intubate Davis and put him on “mechanical ventilation as a result of respiratory distress/compromise,” according to the documents.
A doctor directed a nurse to give Davis two drugs: a muscle relaxant and Ketamine, an anesthetic and painkiller. But instead of injecting Davis with one dose of Ketamine, the nurse used a whole vial – five times the amount the doctor called for.
“Although the physician had ordered Ketamine 100 mg, amounting to 1 cc [cubic centimeter] of medication, Nurse #1 drew up the total amount of the multi-dose vial of 5cc/500mg of Ketamine and subsequently at 4:46 p.m. administered the entire contents of the syringe totaling 500 mg into [Davis,]” the report from state inspectors says.
Eight minutes later, Davis’ heart stopped. He was pronounced dead at 5:16 p.m. on January 27, 2015. His death certificate lists the manner of death as "Accident."
‘A Potential For Error’
The nurse who injected the Ketamine overdose into Davis didn’t deviate from common hospital practice until the very last moment, when he or she injected the final 400 milligrams of Ketamine instead of stopping after the ordered dose of 100. The report says it was common practice in the hospital to draw up an extra amount of a drug as sort of a just-in-case measure to make it easier if more of the medication was needed later.
That practice was in apparent conflict with hospital policies, but was common throughout the Critical Care unit, the report says.
The nurse told state investigators that at the time, “s/he thought [Davis] may require increasing doses of Ketamine to achieve the desired effect and therefore drew up more of the drug in the syringe in anticipation that the physician would order more to be administered during the procedure,” according to the report.
When it came time to inject the drugs, though, the nurse had apparently forgotten about that.
“At the moment, I thought I only had 100 mg in the syringe,” the nurse told the investigators.
The potential for such mistakes was widespread in the intensive care unit, inspectors found.
“The nursing practice of drawing up more medication than what was ordered was further confirmed by the Nurse Manager of MICU on 3/17/15 at 9:45 a.m. noting a lot of nursing staff probably draw up more medication than what the physician has ordered, especially during an emergent patient situation,” the report says.
Another nurse at the hospital told the investigators that “at times, s/he would draw up extra medication than what was ordered.”
Vice President of Nursing Julie Morse told the state’s inspectors that her understanding was different.
“The VP of Nursing also stated the practice related to medications is ‘… you draw up what the order is and that is what is expected …’ of nurses,” the report says.
Inspectors also interviewed the medical director of Adult Critical Care Services, Gilman Baker Allen. He told them that the practice of loading a syringe with more of a drug than a doctor ordered creates “a potential for error.”
Davis’ estate, under the direction of his daughter, hired the father-son personal injury law firm Maley and Maley to pursue a wrongful death case. Christopher Maley said the firm has offered to go into mediation with the hospital to negotiate a settlement, but hasn’t yet received a response.
UVM Medical Center spokesman Mike Noble said the hospital, as a matter of policy, does not comment on legal matters.
Two days after Gregory Davis died, hospital officials put together a “root cause analysis” of the incident and came up with three “action plans” to “improve patient safety and nursing practice,” the report says. But by March 17, inspectors say in the report, “none of the plans had been initiated.”
Noble said he isn’t sure why the report says that.
“All I can say is that within 48 hours after this occurred we did do a root cause analysis, and that process is geared at understanding what happened and what sort of improvements can be made within the system to minimize the possibility of whatever happened happening again,” he said. “And in this case, corrective plans of action were initiated almost immediately after the root cause analysis was complete, which took I think about a day. So there were action plans initiated right away.”
The fixes hadn’t yet been completed when inspectors arrived in March, Noble said, but the process started within days of Davis’ death.
The hospital had corrected all of the problems named in the Division of Licensing and Protection report within 30 days of the investigators’ site visit after having known about at least some of the problems just two days after Davis died, according to the DLP report. It says that for seven weeks, problems that were known to have contributed to a patient’s death went unaddressed in the largest hospital in the state.
One of the problems the hospital’s root cause analysis found was “the size and concentration of the multidose vial of Ketamine used by Nurse #1,” the state’s report says. The 500 mg size is intended to be multiple doses, and the hospital’s action plan included looking into other vial sizes, perhaps a single or double dose vial.
“This would provide a safety barrier in preventing a larger dose of Ketamine being drawn and administered,” the report says. If the nurse hadn’t had a vial with five times the ordered dose, the overdose wouldn’t have been as likely, but those larger vials were still in use in March, the report says.
“The director [of patient safety and advocacy] confirmed although it had been 49 days since the death of [Davis], changes had not been made to remove the 500 mg multidose vials for Ketamine from the RGI medication boxes, in exchange for a reduced concentration,” the report says.
The director reportedly told the inspectors that part of the reason the change wasn’t made was a Ketamine drug shortage, but when the inspectors asked the pharmacy manager for clinical practice, they got a different answer.
The pharmacy manager “confirmed there was a drug shortage of Ketamine in December of 2009 and was resolved in 2010. The manager further confirmed that if asked in January 2015 to make a change in Ketamine vial concentrations, various drug concentrations were and still are available,” according to the report. The vial changes were made by March 19, the third day of the investigators’ visit.
Hospital spokesman Noble said in an interview that he can’t speak to why the change wasn’t made sooner without consulting the pharmacy manager. But he said that “immediately after the root cause analysis, staff was educated as to what medication would be available and how then to draw from it.”
Among other changes in response to the March inspection, the hospital corrected its drug management practices so that if a shortage results in a substitution of “form, concentration, or size,” that substitution must be reviewed weekly so that the original product can re-enter the hospital’s supply stream when it becomes available. That change was completed on April 1.
Another change was a mandatory “education module” telling nurses to only draw the ordered amount of a drug into a syringe and to repeat drug orders back to doctors. That was rolled out the afternoon of March 18, the second day inspectors were at the hospital, and all nurses were required to “attest that they have completed the educational module prior to the delivery of patient care.”
Noble said the education module was rolled out that day after a development period that began well before inspectors arrived.
“The education process was initiated and started,” he said. “It was not completed before they arrived, because there are a number of people that need to go through that module, and it does take some time. That was initiated right after the Root Cause Analysis. The need for that was identified during the Root Cause Analysis, and that action plan was initiated right after the Root Cause Analysis.”
Noble said he wasn’t sure why the education happened the day after inspectors arrived.
“I really can’t speak to the fact that we did not tell nurses sooner than seven weeks because I don’t know when they actually started to roll out the education plan itself. First of all they had to develop it, and then we roll it out, and that rollout occurred from my understanding prior to the time the inspectors arrived. They had set a completion date for that of a certain date, and it was done shortly after that.”
Other various changes to hospital policy to prevent future mistakes came within a month of the state inspection, the findings of which could have caused the hospital to lose its federal funding if problems weren’t corrected.
Noble said “the solutions were in the works from shortly after the Root Cause Analysis was completed, and then those action plans were completed during or after the time inspectors arrived here in March. Then they approved the plan of correction and what we had done [to fix the problems] in April.”
Noble said patient safety is the hospital’s top priority.
“We regard matters like this very, very seriously,” he said.