Robin Fields, writing for ProPublica, spent more than a year investigating dialysis in the United States. Her report is also excerpted and co-published as “God Help You. You’re on Dialysis” in the December 2010 issue of the Atlantic. Fields’s reporting—she’s one of the best in the business—should be a wake-up call for everyone, but old news to dialysis patients.
“The findings were bleak: At clinics from coast to coast, patients commonly receive treatment in settings that are unsanitary and prone to perilous lapses in care,” reports Fields. “Regulators have few tools and little will to enforce quality standards. Industry consolidation has left patients with fewer choices of provider. The government has withheld critical data about clinics’ performance from patients, the very people who need it most. Meanwhile, the two corporate chains that dominate the dialysis-care system are consistently profitable, together making about $2 billion in operating profits a year.”
Fields’s reporting is surprisingly, absolutely accurate in every detail. Two years ago, ProPublica asked the Centers for Medicare and Medicaid Services (CMS) clinic-specific outcome data for dialysis patients under the Freedom of Information Act (FOIA). For two years, CMS stonewalled and last week provided ProPublica with the data for 2002-10. ProPublica says it’s “reviewing the data and plans to make it available for patients, researchers, and the general public.” That data, when made publicly available, just might encourage dialysis providers to take better care of their patients. Or failing that, public accessibility to the data may force regulators to force providers to take better care of their patients.
In the US, taxpayers support most of the country’s 400,000 dialysis patients’ treatments to the tune of about US$77,000 per patient per year. And more than 100,000 new patients begin dialysis each year. In 1972, the US Congress changed the Social Security Act to specifically cover the costs of dialysis treatments under Medicare. The vast majority of dialysis patients are on Medicare. Having maintained private insurance since my end-stage renal disease diagnosis and start of dialysis in 2000, I’m an exception. Nonetheless treatment of end-stage renal disease became America’s first venture into socialized medicine, a reaction to rationing. Currently, end-stage renal disease treatment—including dialysis and transplantation—accounts for about six percent of all Medicare spending.
While the US spends more on dialysis than any other industrialized nation, its mortality rate is among the highest. Dialysis is a profitable enterprise in the US, split between two major players: DaVita and Fresenius. No other dialysis provider comes close (not within 20 percent) to the two behemoths’ size or profits. As Fields reports, “In 2009, the dialysis giants booked combined North American operating profits of US$2.2 billion, their most ever.”
Fields points to Italy as a model for improving dialysis, as that country spends less money on the treatment—about one-third less per patient than the US—and has a better mortality rate—one in nine dialysis patients die each year in Italy, compared to one in five in the US. In Italy, at least one doctor and multiple nurses are present at each facility; in the US, only a registered nurse is mandated, and most of the work is performed by technicians in total disregard of the fact that dialysis is the single most invasive medical procedure to take place outside of a hospital operating room. The US has no mandates with regard to staffing levels. Fields reports that “Italian dialysis patients have more than five times as much contact with their physicians as US patients.”
What makes Italian dialysis so different? Professional medical staffing, as already noted has a tremendous impact. As does earlier intervention, use of fistulas, earlier and easier referrals to specialists, and longer treatment times. Dialysis services in Italy are mostly provided by public (non-profit) hospitals. What’s surprising is that the Italians pay about 50 percent more per dialysis treatment than Medicare in the US, but Italian per-patient costs for dialysis are significantly lower than those in the US because, as Fields writes, “indirect expenses, particularly for hospitalization, are smaller and because coverage includes drugs as well as dialysis.”
Fields’s research uncovered a pattern of the same issues repeatedly cropping up: “Unsafe and unsanitary conditions, prescription and medical errors, issues of infection control and breaches in infection control, issues that dealt with the amount of staffing, the training of staff, and the supervision of staff,” as she told Terry Gross on Fresh Air the same day her ProPublica report was published.
Fields points out that the pattern of problems don’t exist at all provider clinics. She notes in the Gross interview that “some clinics do a great job under very difficult circumstances.” My own experience reinforces that finding. I feel that I receive adequate care at my current provider, DaVita Highland Park Dialysis, although I remain very concerned about staff training and appropriate staffing levels. And because of dominant treatment modalities, and the necessity of continuing to work full-time, I remain perpetually under-dialyzed. You can bet the farm I’ll be poring over ProPublica’s data when it’s published. And I’ve received what I consider to be adequate care at DaVita’s Dialysis Center of Middle Georgia-Macon.
I’ve received what I consider to be inadequate care at a Fresenius Dialysis Roseville as well as DaVita’s Saint Paul Dialysis.
In the case of Fresenius Dialysis Roseville, it was my first out-patient dialysis treatment and the first question the charge nurse, who formerly worked in the state prison system, asked me was, “What do you want us to do if your heart stops?” It got worse; the second time I went for dialysis treatment, the clinic had no record of my appointment and I left, not knowing just how long it would take to die without treatment. I didn’t return.
In the case of DaVita’s Saint Paul Dialysis, my initial treatments were the best I’ve ever had. While there was never a doctor on premises—except for those doing rounds—there were always at least three—sometimes four—nurses on duty. And these were nurses with more than a century of combined experience. The patient to staff ratio in those days was never worse than three-to-one. Currently, DaVita facilities run at ratios of four-to-one, sometimes as high as six-to-one, with a single nurse. Gradually, the quality of care at DaVita’s Saint Paul Dialysis degraded. There were more deaths and instances of catastrophic mistakes. Few, if any, of the catastrophic instances were reported. There were regular instances of less-than-catastrophic mistakes as well—like the time a licensed practical nurse ran a full two-liter bag of saline into my body over the course of a few minutes.
In most cases, problems in dialysis provider clinics—everything from poor quality supplies (and eliminating expensive, but necessary supplies like SureSeal pressure bandages) to staffing levels and lack of staff training—can be traced directly to attempts to increase the parent corporation’s profits.
As Tom F. Parker III, a Dallas nephrologist, says to Fields, “We’re offering our patients a therapy we wouldn’t accept for ourselves.”
Fields followed up with “When Needles Dislodge, Dialysis Can Turn Deadly,” a second article in the series. She cites a 2007 Renal Physicians Association safety survey finding that five percent of patient respondents “said they had a needled dislodge mid-treatment within the previous three months.” No one knows for sure how many catastrophic events occur during dialysis because, as Fields reports, “federal regulations do not compel clinics to report treatment-related errors, injuries or deaths, whether from bleeds or other mishaps.”
Only Colorado, Georgia, New York, and Tennessee require dialysis facilities to “report incidents resulting in unexpected patient deaths or injuries,” according to Fields’s report.
Medicare requires only internal documentation of adverse events.
Facilities run by the US Department of Veterans Affairs (VA), “including its 66 dialysis units, are required to report not only events in which patients suffer harm, but also near misses,” Fields writes. The VA manages a database where each incident is coded by severity. Fields cites an October 2008 VA National Center for Patient Safety report on bleeding incidents, finding 40 incidents considered “serious” between March 2002 and April 2008. As a result of the VA’s findings, VA dialysis facilities are now required to purchase bloodline clips that prevent the bloodlines from loosening. Alarms that sense blood loss must be used outside of dialysis facilities, patients outside of staff sight lines, and patients identified as at high risk for dislodged needles.
Mandatory incident reporting leads to resolution which leads to better outcomes, as shown by the VA’s process.
The US dialysis industry, predictably, disputes Fields’s reporting. Allen Nissenson, DaVita’s chief medical officer, told Steve Raabe, writing for the Denver Post, Fields’s article was “profoundly disappointing. It took some information and did not clearly explain or (present) it in a way that people could understand the issues.”
Nissenson goes on to attribute higher death rates in US dialysis patients than other industrialized nations to a sicker patient population and higher proportions of blacks and Latinos.
As Bill Peckham, writing for Fix Dialysis, reports, “The first half of this statement is the sort of issue that is controlled for when these international mortality comparisons are made. The second half of this statement is a non sequitur. A higher incidence of kidney disease does not imply or lead to, a higher mortality rate.” Peckham cites a 2007 report in Seminars in Nephrology finding that “the risk of death is nearly 45% lower in African-Americans than Caucasians undergoing chronic hemodialysis.”
Barry Staube, chief medical officer for CMS, was also a guest on Terry Gross’s Fresh Air the day Fields’s ProPublica article was published. Staube attributes the lack of required dialysis clinic inspections to lack of congressional funding and congressional pressure to “pay more attention to nursing homes than other types of facilities, including dialysis units.”
Staube goes on to tell Gross that Fields’s article “overstates significantly the degree of the problem out in the real world.” The truth will reveal itself in the data CMS withheld for two years after Fields’s FOIA request. If the data reveals that Fields’s findings were “overstated,” why was it withheld?
Staube then drops the turd in the punchbowl with regard to dialysis clinic staffing. “Well, I think that over time there has been a tendency to using fewer number of nurses and also using more technicians,” Staube says. “This is not necessarily a compromise in the quality of care, because the technicians are extremely well-trained and the services that need to be performed for most aspects of the dialysis treatment are quite routine and certainly within the competence and skill set of a well-trained technician.” That technicians are well trained is demonstrably false. But it gets worse: “I think the absence of an MD does not necessarily compromise the quality of care in the acute setting also,” says Straube. A dialysis clinic is a chronic setting, not an acute setting. A hospital is an acute setting. Zero doctors are mandated to be on-site in a dialysis clinic. How many doctors do you suppose are on-site in any given hospital?
In response to questions about better outcomes and lower costs in other developed countries, Straube pulls the red herring out of his pants. “There’s still a tremendous amount of waste in the system where services that are not necessary are being provided,” Straube tells Gross, presumably fully aware that other developed countries provide more dialysis services to each patient at a greater cost with better outcomes and lower overall costs. “Services that are more costly than others of equal benefit are being provided, and any number of other reasons.”
ProPublica also published a leaked public relations damage control plan document authored by Kidney Care Partners, a lobbyist for the US dialysis industry. (Kidney Care Partners’ response to Fields’s work is breathtaking in its absolute and complete lack of patient concern, instead focusing solely on industry cheerleading hyperbole.)
The lobbyist’s talking points for a public relations blitz led by Patton Boggs and Schmidt Public Affairs:
- Quality of dialysis in the US is getting better
- We’ve educated patients about the disease and disease management
- Deflect dialysis questions to transplant issues; the US is second-best in transplantation rates
- We’ve worked with the US Congress to address payment issues
The marching orders? “We do not want to call unnecessary attention to the story or give it ‘legs’ in any way.” Good luck with that.
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