A deadly error: Routine dialysis leads to Heights woman's death
It is too much for James E. Allen to talk about the day his wife died -- the day she left for her regular dialysis treatment and never came home.
By the numbers:
69: Muskegon County residents newly diagnosed with end stage renal (kidney) disease in 2007.
197: County residents undergoing dialysis for chronic renal failure as of Dec.31, 2007.
17,000: Estimate of county residents with diabetes.
— Sources: Renal Network of the Upper Midwest and Michigan Department of Community Health
It is difficult even for him to speak Ethel "Betty" Mae Allen's name. After 26 years of marriage, the two had become inseparable and her death has left him empty and alone.
"She was all I had," Allen says. "She was everything to me."
Aug. 15, 2007, started as many days did for Betty Allen. She showed up at the DaVita Inc. dialysis center in Muskegon just as she had three days a week for the preceding three years.
But routine quickly turned to tragedy as a fatal error on the part of a technician sent a corrosive and acidic cleaning solution -- rather than the life-giving hemodialysis solution -- directly into Betty Allen's artery.Her eyes rolled back in her head as she went into cardiac arrest. She was rushed two blocks to the emergency room at Mercy Health Partners' Mercy Campus where medical workers decided to send her on to Spectrum Health in Grand Rapids.
There, she clung to life for five days, suffering another two heart attacks and a severe brain injury. Finally, her family said she'd had enough. The next heart attack was her last -- she was not resuscitated and was pronounced dead at 3:49 a.m. on Aug. 21.
Ethel "Betty" Mae Allen, died in a dialysis accident Aug. 21, 2007. It was supposed to be a routine dialysis treatment, but a technician's error sent a cleaning solution directly into her artery.
There is no doubt about what happened to Betty Allen and DaVita's role in it. Her death certificate says she died after "exposure to Renalin during hemodialysis," giving DaVita's Muskegon address. Medical notes from DaVita and Spectrum repeatedly refer to her accidental infusion with Renalin during dialysis, as does the autopsy report.
Betty Allen's death, clearly an accident that could have been avoided, was never reported to any authorities. DaVita wasn't required to. The technician who failed to rinse the dialyzing filter of its corrosive "Renalin" cleaner was required only to have a high school equivalency diploma.
And, despite the error and the potential dangers of reusing filters -- a practice that many dialysis centers have given up -- DaVita's Web site and a National Kidney Foundation executive indicate that it continues to reuse filters at its centers, including ones in Muskegon, Grand Haven and Fremont. It has received required state approval to reuse filters, according to a state offical.
DaVita officials are not talking about the accident.
"This is just a botched job," said Randall Fielstra, a Muskegon attorney representing James Allen in a lawsuit against DaVita.
A horrible death
Hypertension and diabetes -- which plague a higher-than-average number of people in Muskegon County -- are main causes of kidney disease. Nearly 200 Muskegon County residents receive dialysis on a regular basis to rid their bodies of wastes that their ailing kidneys no longer can filter out.
Betty Allen, 71, had suffered from hypertension as well as vascular disease. Her kidneys had failed and so her life depended on the hemodialysis she received at DaVita, 1277 Mercy Drive, provided by technicians whose training consisted only of instruction provided by the huge for-profit company.
During dialysis, patients are hooked up to a machine that pumps their blood from their body and through a dialyzer that cleans the blood with a dialysate solution before it is returned to the patient.
Dialyzers -- a sort of filter -- come in two types: single-use, which is thrown out after each treatment, and reusable.
DaVita uses reusable dialyzers -- assigning each patient their own -- which are cleaned after each treatment by soaking in Renalin, a solution of hydrogen peroxide, peracetic acid, acetic acid and water. After the soak, it is flushed with saline solution and tested to be sure none of the corrosive Renalin remains.
According to DaVita procedures, two employees are required to verify that dialyzers are appropriately cleaned.
But that apparently didn't happen when Betty Allen arrived at DaVita on Aug. 15, 2007. According to Fielstra and Spectrum hospital notes, when she arrived, she was taken to a dialysis machine, but it had a different patient's dialyzer in it. Technicians quickly sought out Allen's dialyzer, found it still soaking in the Renalin bath, removed it and inserted into the machine without the required rinse or testing, Fielstra said.
Allen was hooked to the machine for less than two minutes, the acidic solution coursing into her artery, before it was apparent something was horribly wrong. Betty Allen complained about burning pain at the needle site, according to a DaVita employee's progress notes, and then she became "glassy-eyed."
"Boom, her eyes roll back," Fielstra says. "It must be assumed she was exquisitely horrified and uncomfortable."
Oxygen bubbles had been introduced into Allen's arteries, essentially blocking blood flow. She went into cardiac arrest and her brain suffered severe injury -- perhaps a stroke, hospital notes indicate -- due to a lack of oxygen. It took 12 minutes of cardiopulmonary resuscitation before rescue workers could find a pulse.
From Mercy, she was sent to Spectrum for treatment of the gas embolism with a hyperbaric chamber in an attempt to dissolve the bubbles and resume normal blood flow. But the brain damage was severe, and she wasn't breathing on her own.
James Allen remembers being called to Spectrum after the accident.
"I didn't want to see her like that," he says tearfully, describing her as "gripping my hand" with eyes that were open but didn't seem to see him.
The death certificate leaves no doubt the cause of Betty Allen's death, explaining that she had been "exposed to Renalin during hemodialysis."
"This woman's death was horrible," Fielstra says. "No one deserves to die this way."
An inherent risk:
The Michigan Department of Community Health -- contracted by the federal government to oversee dialysis centers in the state -- was not aware there had been a death as the result of actions taken at the Muskegon dialysis center.
There is no requirement that dialysis centers report a death or severe injury, says Richard Benson, chief of the licensing and certification division of the department's bureau of health systems.
If there is a complaint, the state would investigate, but none was lodged in Allen's case, Benson says. Currently, the federal government expects inspections be conducted about every four years, he says. The last state visit to DaVita was in March because the center added new services, Benson says.
Dialysis centers are not licensed by the state, nor are employees required by the state to have certifications. Centers that want to receive federal Medicare reimbursement, the main form of payment for dialysis patients, get certified by Medicare and are required to have at least one licensed health professional -- physician, registered nurse or licensed practical nurse -- on the premises.
But a new federal law requires that technicians who hook patients up to dialysis machines -- known as patient care technicians -- receive training through state or national certifying organizations and pass a state or national exam by December 2009.
"It will add a certain level of professionalism to the role," says Dolph Chianchiano, vice president for health policy at the National Kidney Foundation.
However, Chicanchiano says that does not include the "reuse technicians" who are responsible for cleaning and rinsing dialyzers. According to DaVita's Web site, reuse technicians' qualifications are a high school or equivalent diploma and completion of DaVita's reuse technician training.
Fielstra says he was told the reuse technician on the job at the time of Betty Allen's accident was fired.
DaVita officials, citing patient privacy laws and the pending lawsuit, declined to comment or answer questions about Allen's death and the company's procedures. The company issued a statement saying its "sympathies are with the family as they attempt to deal with this situation."
Chianchiano says there are no national statistics on how many patients die as the result of accidents at dialysis centers. However, he says Allen's death is the only one he has heard of.
Maurie Ferriter, director of programs and services for the National Kidney Foundation of Michigan, says some dialysis patients watch technicians "like a hawk" while others, especially older patients, are trusting "of anybody who wears a white coat."
"Every single time you get hooked up to a dialysis machine, there is an inherent risk in the process," says Ferriter, who receives regular dialysis.
Dialysis was first successfully used in 1945 and its use became more common in the 1960s. In 1973, Medicare started paying for it, and most dialysis operations were in nonprofit hospitals staffed by licensed medical personnel.
By 1985, 44 percent of dialysis units were in hospitals and 56 percent were in freestanding clinics; 46 percent were operated by for-profit groups, according to the Centers for Disease Control and Prevention.
By 2002, 85 percent of dialysis units were in freestanding clinics, and 81 percent were for-profit.
"Over the years, as the for-profit industry started to get involved in dialysis, there were big changes ... unlicensed technicians or uncertified technicians instead of nurses," Ferriter says. "It has become more impersonal. When you think about it, it's the same principle as an assembly line."
For DaVita, dialysis is big business that is growing. It serves about 107,000 patients at 1,300 clinics. Dialysis treatments, which numbered 15.3 million in 2007, were up 5.7 percent over 2006, according to DaVita's 2007 annual report. Its net income for 2007 was $340 million.
The largest dialysis provider is Fresenius Medical Care, serving 173,863 patients worldwide at more than 2,200 clinics. Its net income for 2007 was $717 million.
One big difference between DaVita and Fresenius is the type of dialyzers they use. DaVita reuses them; Fresenius uses them once and tosses them out, says Chianchiano of the National Kidney Foundation.
"The reason why people reuse is because the dialyzers they use are so expensive," Chianchiano says.
A much smaller dialysis provider is Renal Advantage Inc., which operates a clinic at 1080 W. Norton in Roosevelt Park. It has 85 centers across the nation.
Sharon Burbage, vice president of clinical services for Renal Advantage, says the Roosevelt Park facility uses single-use dialyzers -- a decision made by local staff. Burbage says it is generally considered cheaper to reuse dialyzers, but the corporation leaves it up to each clinic to decide which ones to use.
"The bottom line is that if you reuse, you have to make sure appropriate safety measures are taken at all times," she says.
With DaVita not disputing that the actions of one or more of its employees caused Betty Allen's death, Fielstra had tried negotiating a settlement with the multimillion-dollar corporation.
But he says he was disappointed in the company's response, and so filed the lawsuit in May. The state caps noneconomic damages at $717,000 for medical errors causing brain injury; $400,000 for other types of injuries.
For James Allen, no amount of money could make up for the loss of the woman he dated since the 1960s and married in 1981. But he wants money to put a marker on his wife's grave at Mona View Cemetery.
"I don't hate them; I can forgive them," he says of DaVita. "Somebody's got to pay for it and do the right thing."
His constant companion these days is Duke, his dog. They sit together on the front porch of his Muskegon Heights home and sometimes "take a ride around the block."
He can't bear to go fishing anymore -- something he and Betty did every day, staking out their favorite spot on Muskegon Lake.
"I'll be thinking about her when I go fishing," he says. "I probably won't go anymore."