by Robin Fields
ProPublica, Nov. 10, 2010, 7:53 a.m.
Barbara Scott relied on dialysis to do what her damaged kidneys could not. Three times a week, a machine pumped her blood out of her body, pushed it through a specialized filter, then returned it cleansed of waste. The bright crimson circuit kept the 73-year-old retired bookkeeper alive.
Until it nearly killed her.
Partway through Scott's treatment on Dec. 28, 2005, the tube feeding blood back into her became dislodged. A temporary employee at her storefront clinic in Poughkeepsie, N.Y., hadn't taped the tube in place properly, and the facility didn't follow safety rules requiring the connection to remain visible, regulators later determined [1].
As Scott rested under a blanket, more than a quarter of her blood pooled beneath her and spilled onto the floor instead of flowing back into her system. She barely managed to call for help before losing consciousness.
Dialysis patients die or are hospitalized every year as a result of catastrophic hemorrhages during treatment, a ProPublica review of regulatory and court records has found. In dozens of cases in which patients suffered such harm, government inspection records show, regulators later cited clinics for failing to adhere to minimum standards of care.
These incidents are among the most gruesome -- and most preventable -- lapses in a dialysis system that has some of the highest mortality and hospitalization rates in the industrialized world. Each year, about 1 in 5 patients die, almost twice the mortality rate of countries with the best outcomes.
No one knows for sure how often line separations or dislodgements occur during dialysis. They are relatively rare, but 5 percent [2] of patients who responded to a 2007 safety survey [3] by the Renal Physicians Association said they had a needle dislodge mid-treatment within the previous three months. Another review, based on incidents in a Pittsburgh hospital system, suggested that each year hundreds of patients may fall victim to more serious bleeding episodes.
The absence of more precise data points to a broader problem, patient safety advocates say. Though the government pays for most dialysis through Medicare, federal regulations do not compel clinics to report treatment-related errors, injuries or deaths, whether from bleeds or other mishaps. That's despite an overhaul of dialysis regulations in 2008, which, among other things, mandated that clinics have programs to improve patient safety.
"People don't want it out there -- it's liability, it's exposure -- but we have to have transparency to learn from one another's mistakes," said Tricia West, a nurse and former dialysis clinic owner who also served as president of the California Association for Healthcare Quality. "Things can and do happen, but it shouldn't be the same things over and over."
Officials at the Centers for Medicare and Medicaid Services said the agency's new administrator, Dr. Donald Berwick, a longtime patient-safety advocate, may bring a more aggressive approach to this issue.
"We are being challenged to do everything we can ... to address patient safety and to reduce errors in [all] settings of care," said Dr. Barry Straube, CMS' chief medical officer. "The dialysis world is an area in which we'd like to see that happen more."
Barbara Scott never really recovered. She was rushed to the hospital in shock and stayed for more than three weeks. Just 5 feet tall and always petite, she dropped below 100 pounds. Her face grew gaunt, her skin papery. When she finally went home, she was so frail she couldn't walk her dog or work in her garden.
"She'd sit and cry for no reason," said her daughter, Cathleen Sharkey.
Scott died soon after of heart failure. On the final day of her life, she hired an attorney to sue her clinic, Dutchess Dialysis Center, for negligence.
A spokeswoman for Fresenius Medical Care North America, which owns Dutchess Dialysis through an affiliate, said the company could not comment on the matter because of patient privacy rules. The company agreed to a $300,000 settlement in 2008, Sharkey said.
"This didn't have to happen," Sharkey said. "My mother was a woman to be reckoned with. She was dealing with dialysis the way she dealt with everything. She was organized, she kept track of her test results, she ate and drank exactly what they told her. She would still be here today."
Discovered Too Late, a Deadly Drip
Close to 400,000 Americans receive chronic dialysis, a number that has almost tripled in the last 20 years as obesity and diabetes have reached epidemic proportions. More than 90 percent of them receive what's called in-center hemodialysis [4], thrice-weekly treatments at outpatient facilities.
In a typical treatment, a technician attaches the patient to the machine by inserting two needles into the patient's access point. Each needle is attached to tubing. One tube carries the patient's blood into a filter called a dialyzer. Dialysate solution flows in the opposite direction, removing toxins and restoring the blood's chemical balance. The other tube returns the clean blood. Sessions average three to four hours in length.
Advances in technology have made dialysis simpler and safer, but it's hardly foolproof.
A patient in Petaluma, Calif., died soon after an incident in which a contract nurse -- given just one day of orientation -- reversed her bloodlines without using a clip to hold the tubes in place, and one became disconnected, inspection records show. At a clinic in San Diego, a staffer mistakenly connected a bloodline to a machine drain and not the needle returning blood to her body, regulators found. The patient, a 61-year-old woman, lost about a pint of blood and had to be hospitalized for a transfusion.
In their current generation, dialysis machines cycle patients' blood at a rate of 300 milliliters to 500 milliliters per minute, making dislodgements more dangerous than in earlier eras when treatments were done more slowly.
"It
