Fatal
errors: hospitals learn lessons the hard way
March 23, 1997
Santa
Rosa Press-Democrat
Santa Rosa, California
By CAROL BENFELL Press Democrat staff writer
SANTA ROSA
Irene Fox, an 80-year-old Santa Rosa grandmother,
was in declining health when she was admitted to Community Hospital in
October to undergo tests for possible pancreatic cancer.
When a nurse went to clean the intravenous line leading to Fox's heart
by using a saline solution, a common procedure, she grabbed a vial of undiluted
potassium chloride instead, according to the coroner's report.
Fox's daughter, Colleen, who was in the room, saw the nurse attach the
syringe and then heard her mother cry out, "This hurts."
"My mother sat up in bed, seizured and died within a few seconds,"
Colleen Fox said. "It was pretty awful."
Three months almost to the day after Irene Fox died, another 80-year-old
woman, Beverly Coffman of Windsor, died at Santa Rosa Memorial Hospital--also
after being accidentally injected with undiluted potassium chloride, a
chemical used to execute criminals on Death Row.
Both hospitals permitted the deadly drug to be kept on patient floors despite
a nationwide alert issued a year earlier recommending that full-strength
potassium chloride be restricted to hospital pharmacies as a safety precaution.
Community and Memorial officials said the deaths were caused by human error
and, as a result, both hospitals have removed the potassium concentrate
from all patient areas except intensive care and the emergency room.
"It's just (that) sometimes things happen and it's tragic," said
nursing director Robin Hagenstad at Memorial Hospital.
But the president of a national pharmaceutical education organization said
it should not have been necessary for someone to die before the hospitals
acted.
"These are preventable accidents," said Michael Cohen, president
of the Institute for Safe Medication Practices in Warminster, Penn.
"There is no reason for this drug not to be diluted in the pharmacy.
It's just an outrage that hospitals would continue to keep it in a patient-care
area and risk people's lives," Cohen said.
In March 1995, the Institute sent a warning letter to every hospital pharmacy
and nursing director in the country recommending potassium chloride be
removed from all patient care areas. The Institute, a nonprofit organization,
can only recommend and cannot order changes.
Community Hospital was the only hospital in Sonoma County that, at the
time of Fox's death, still allowed vials of concentrated potassium chloride
in general medical and surgical wards. The hospital was cited by the state
in connection with Fox's death. Memorial, which still isunder investigation,
allowed it in the cardiac unit, where Coffman was housed, as well as the
emergency room and the intensive care unit.
Kaiser Hospital does not use the concentrate at all, but relies on premixed,
prediluted solutions from the manufacturer.
Memorial and Community officials said they were fully aware of the hazards
of concentrated potassium chloride, but allowed it in the patient areas
involved because their hospitals had had no problems as far back as anybody
could remember.
"It had not been a problem, and there was no indication there was
ever a problem," said Carol Hasselbrack, director of nursing at Community
Hospital.
Potassium chloride is frequently prescribed in trace amounts as a beneficial
electrolyte, but accidental deaths are exceedingly rare. Fox's death was
the first at Community in 15 years and Coffman's, the second potassium
chloride death at Memorial in 20 years, hospital officials said.
Of 7.4 million hospital admissions statewide in 1994 and 1995, the latest
figures available, there were no reports of deaths among 108 accidental
poisonings involving potassium chloride and other electrolyte compounds,
according to the Office of Statewide Health Planning and Development.
The medical community is very aware of the hazards of potassium chloride
concentrate, officials at hospitals around the county agreed.
Articles about the hazards of potassium chloride and possible safeguards
have appeared since the early 1980s in numerous medical periodicals, including
the Journal of the American Medical Association. Even the TV show "60
Minutes" reported on it.
"That's why we don't keep bottles of potassium chloride in the medical
and surgical units," said Marty Peart, pharmacist at Columbia Healdsburg
General Hospital.
In 1991, after 40 or 50 deaths had been attributed to concentrated potassium
chloride, the federal Food and Drug Administration required distinctive
black tops and inner closures on all potassium chloride vials. Both the
top and the inner closure carry a "must be diluted" warning label
in white letters.
But patients continued to die.
In October, USP Quality Review, a publication for pharmacists, listed 23
potassium chloride accidents or near-accidents in hospitals since the new
labeling went into effect. Seven of the patients died.
The warning letter from the Institute for Safe Medication Practices recommended
that the drug be stored only in hospital pharmacies, where the focus is
on measuring and allocating drugs, not patient care. Many hospitals also
require that a second person check the drug and dosage before it leaves
the pharmacy and goes to the patient, said Jeff Cox, a pharmacist at Community
Hospital.
Nurses' responsibilities are diverse. They attend to patients and patients'
families as well as occasionally supervising other nurses. But there is
no one to double-check the drugs they administer.
To make matters worse, the shape and label color of drug bottles are constantly
changing, as hospitals shift from manufacturer to manufacturer to get the
best price, said Rita Colthurst, nursing supervisor at Columbia Palm Drive
Hospital.
"No matter what you pick up, you have to read the label. There's no
forgiveness," Colthurst said.
The Institute for Safe Medication Practice believes the deaths will continue
until hospitals ban potassium chloride from patient areas, Cohen said.
"I don't care if it's the best nurse in the country, accidents are
going to happen given concerns over cost, the ready availability of potassium
and the stress everyone is under, particularly in the wake of managed care,"
Cohen said. "Nurses are trying to do their best, but the system sets
them up to fail."
Despite the medical literature and the Institute's warning letter, Community
Hospital allowed the potassium chloride concentrate in all patient areas
until Fox's death on Oct. 15, Hasselbrack said.
"If any kind of medication was ordered for a patient, including potassium
chloride, it was kept on the patient's medication cart," she said.
Memorial Hospital, mindful of potassium chloride hazards, removed the concentrate
from its surgical and medical units in the early 1990s, Hagenstad said.
But officials still allowed it in the cardiac unit where Coffman, suffering
from congestive heart failure, died on Jan. 14.
Cardiac patients often need specially-mixed solutions of potassium chloride
because they cannot tolerate the high volume of liquid usually used, Hagenstad
explained, so the concentrate was kept in a supply room in the cardiac
area.
Coffman's doctor at Memorial prescribed furosemide, the generic form of
the diuretic Lasix, because her weakened circulatory system was not moving
waste liquids out of the bloodstream. Potassium levels drop when diuretics
are used, so electrolytic potassium also was prescribed.
In a statement to the county Coroner's Office, the attending nurse said
she grabbed the wrong vial and injected undiluted potassium chloride instead
of Lasix.
Coffman complained of a burning sensation and collapsed. Almost simultaneously
the nurse realized her error and withdrew the injection, the coroner's
report said. But Coffman could not be resuscitated.
The bottle for the diuretic was completely different in size and color
than the bottle for potassium chloride. The diuretic was stored on the
patient's medical tray, the potassium chloride was stored in a supply cabinet.
Hospital officials declined to discuss the cause of the confusion to protect
the nurse's privacy.
In Fox's case, doctors at Community had prescribed potassium chloride in
its diluted form for several days after her admission and then switched
to a total nutrient intravenous solution which included electrolytes.
But the pharmacy was not notified and continued to send vials of concentrated
potassium chloride to Fox's medicine drawer, according to the Department
of Health Services citation.
"I never expected it to be admitted by anyone," said Colleen
Fox, a Los Angeles school teacher. "I was almost proud that the system
worked."
Loriann DeMartini, the investigator for the state Department of Health
Services in the Fox and Coffman deaths, said the burning sensation that
Coffman reported before she died is a giveaway to potassium chloride poisoning.
"Putting undiluted potassium chloride in the veins has exactly the
same effect as putting hydrochloric acid in the vein," she said. "It
literally burns the veins."
The Coroner's Office reported both the saline and the potassium chloride
bottles had pink labels and both were in the medical drawer. The hospital
now is using a different manufacturer and the saline solution comes in
a light- green label, Cox, the Community pharmacist, said.
"If you can mix up those two vials so easily then maybe they should
be marked better," said Colleen Fox. "Apparently it is an easy
mistake to make and a fatal one."
Some 60 percent of 156 hospitals surveyed in 1995 by the safe medication
institute have removed potassium chloride from all patient areas, Cohen
said, but many times the change isn't made until someone dies or nearly
dies.
"In any other industry, they learn from a single accident. Every airline
learns from every other airline's accident," Cohen said.""But
hospitals don't talk to other hospitals. In every single potassium death
we've seen, the hospital didn't take action until someone died."
The coroner's reports on Fox and Coffman said the overdoses were accidental,
so criminal charges are not being brought. The hospitals have some remaining
questions, but do not dispute the coroner's findings, even though they
are aware lawsuits may be in the offing.
Michael Casey, the Fox family attorney, said a "negligence professional
malpractice suit is being considered."
"This obviously was a senseless tragedy that could have easily been
avoided," he said. "It appears that the nurse grabbed the wrong
vial."
Both nurses face an investigation and possible disciplinary action by the
state Board of Registered Nursing, said Susan Brank, a board spokeswoman.
The Department of Health Services cited Community Hospital for three violations
in Fox's death, but the department can levy no penalties except requiring
corrective action. Memorial Hospital is still under investigation.
Community's violations included giving the patient the wrong drug, poor
communication between the pharmacy and the physician and failing to notify
the state about Fox's death. The Department of Health Services learned
of it only through an anonymous tip.
In documents provided the state, Hasselbrack said the hospital did not
think the death fell under the state's reporting criteria of an "unusual
occurrence which threatens the welfare, safety or health of patients."
Fox's death was an isolated incident and the nurse was immediately suspended,
so there was no threat to the welfare, safety or health of patients to
report, Hasselbrack said.
"We had absolutely no intention of hiding anything," she said.
"We believed we were following up on this in an appropriate manner."
Memorial Hospital notified the state immediately after Coffman's death.
Both hospitals say staffing levels did not contribute to the deaths. At
Community, the nurse had more than 10 years' experience and was supervising
five patients, a typical case load, said Hasselbrack. DeMartini, who investigated
the death, confirmed staffing was adequate. The incident happened at the
beginning of the nurse's shift, so fatigue was not a factor, DeMartini
said.
"The nurse was an extremely conscientious person who accepted full
responsibility for what happened. She's devastated," DeMartini said.
"We're talking about two lives that have been irrevocably harmed."
At Memorial, the nurse also was experienced and was attending to four patients.
DeMartini could not comment on that case, since it is still under investigation.
The hospitals would not say whether the nurses had been returned to duty.
Copyright 1997, The Press Democrat. Reprinted with permission.
See also: Potassium chloride: routine but deadly drug
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