Few dialysis sites inspected each year

Few dialysis sites inspected each year

8:38 PM, Apr. 24, 2011 |

Written by
CLARK KAUFFMAN
CKAUFFMAN@DMREG.COM

11.3% Licensed

Iowa doesn't license dialysis centers, and inspections have been spotty. Only seven of Iowa's 62 dialysis facilities undergo a full inspection in any given year. As of last fall, there were 22 centers in Iowa that hadn't been inspected for four to six years.

Dialysis centers provide some of the most intensive, high-risk - and costly - medical care available.

Patients with kidney failure - often a result of diabetes or high blood pressure - face extraordinarily high risks, and the cost of their treatment is staggering. Almost all of the expense is borne by taxpayers since dialysis treatment is largely funded by Medicare - even for patients under 65 - at a rate of $20 billion annually.

The drugs alone cost about $26,000 per year, per patient. Despite all of the spending, the United States still has one of the industrialized world's highest mortality rate among dialysis patients.

Iowa doesn't license dialysis centers, and inspections have been spotty. In fact, only seven of Iowa's 62 dialysis facilities undergo a full inspection in any given year. As of last fall, there were 22 centers in Iowa that hadn't been inspected for four to six years, and state officials were projecting that some wouldn't be visited any time "in the foreseeable future."

Patient advocates and taxpayer advocacy groups say more oversight is needed. They say the process of dialysis - in which a kidney patient's blood is removed, cleaned of toxins, and returned to the body - calls for government-mandated standards and regular inspections that can uncover life-threatening problems involving unsanitary conditions and poor equipment maintenance.

'I'm bleeding!' patient yells during inspectors' visit

Last July, state inspectors visited the dialysis unit at Davenport's Genesis Medical Center. It was the unit's first state inspection since 2004.

Although it was ranked by state officials as among the 20 percent of dialysis facilities least likely to have poor patient outcomes, inspectors cataloged 64 violations, including unsanitary conditions and poor infection control.

As inspectors watched, one patient ran through the front lobby of the unit, shouting, "I'm bleeding!" Inspectors said blood was spurting from the patient's arm, covering her hands, clothes and purse. The blood "sprayed on the counter and cabinet doors," ran 50 feet from the lobby floor, down a hallway, past a restroom and into the dialysis unit, inspectors said.

The unit's medical staff immediately tended to the patient, who is unidentified in state reports. But 38 minutes later, the blood on the floor had yet to be cleaned up.

The inspectors produced a 223-page report detailing a wide range of problems in the unit, including inadequate staff training and 179 lab supplies that were past their expiration date. Inspectors returned in August and cited the unit for an additional 18 violations. Because the state doesn't license dialysis centers, there was no mechanism to impose even a modest fine.

Genesis spokesman Craig Cooper said the hospital welcomes inspections, which provide an "outside, independent view of what we are doing. If we are not meeting all requirements, we want deficiencies to be pointed out to us."

In each of the past three years, the Iowa Department of Inspections and Appeals has proposed that the state begin licensing dialysis centers as a way to impose minimum state standards, increase oversight, enhance accountability and provide for fines against repeat violators. Each year, the proposal has died before it could even be considered by the full House and Senate.

Department director Rod Roberts said the proposal may be resurrected at some point, although his agency did nothing to advance the idea during the current legislative session.

"We've had conversations about it," he said. "It's worth spending time looking at that."

For-profit dialysis centers have higher fatality rates

In 2003, the Government Accountability Office reported that, nationally, hundreds of dialysis clinics were years past due for an inspection. The GAO recommended frequent inspections and changes in federal law that would allow for fines.

In the eight years since that report was published, inspection rates haven't improved, and in most states, Iowa included, there's still no mechanism to penalize repeat offenders.

In the meantime, new concerns have been raised about the quality of care delivered in some of the nation's most profitable dialysis centers:

- A 2007 study published in the Journal of the American Medical Association found that patients in for-profit dialysis centers were consistently given the highest doses of Epogen and similar drugs, regardless of the extent of their anemia.

- A study published last year in the journal Health Services Research found that the fatality rate at for-profit dialysis centers was 13 percent higher than at nonprofits. At centers run by the for-profit chains Fresenius Medical Care and DaVita Inc., the risk of death was 19 and 24 percent higher than at the largest nonprofit chain.

Fresenius and DaVita Inc. dominate dialysis treatment in America. Combined, the companies control two-thirds of the American market.

DaVita has been accused of trying to increase its profitability by overprescribing Epogen. In 2005, a former sales manager for Epogen's maker, Amgen, filed a federal whistle-blower lawsuit, alleging that Amgen sales managers had "regularly instructed sales personnel to increase Epogen sales through review of confidential patient charts or patient-specific data without the patients' knowledge or consent." Amgen and DaVita then defrauded taxpayers by overadministering Epogen at doses that were "potentially harmful" to patients, the lawsuit alleged.

Today, the lawsuit is still working its way through the courts. DaVita's lawyers say the allegations are without merit, noting that the federal government investigated the matter for four years and ultimately decided against joining the lawsuit.

http://www.desmoinesregister.com/article/20110425/NEWS/104250316