Led by California, Inspection Backlogs Weaken Dialysis Oversight
An investigation by ProPublica found that some states are failing to meet inspection targets for the nation’s more than 5,000 dialysis clinics. Patient advocates say the backlog increases risks for patients in a system that has one of the industrialized world’s highest mortality rates.
Valerie Prenkert is haunted each time she thinks of the small Northern California clinic where her mother got dialysis.
At the start of a treatment on Oct. 6, 2008, a clinic employee inserted a needle into her mother's arm improperly, puncturing the back wall of her blood vessel, court and medical records show. Less than two hours later, 67-year-old Jessie Kay Christiansen was dead from massive internal bleeding.
The loss was shocking. So was a fact that Prenkert and her attorney discovered only later: Regulators responsible for ensuring that dialysis facilities meet health and safety standards had not conducted a full inspection of Christiansen's clinic in more than 10 years.
Such checks, called recertification surveys, are supposed to be done every three years on average, but rates vary widely from state to state. Of those that lag behind, California has by far the biggest backlog relative to its number of facilities, according to a ProPublica investigation drawing on federal and state records and dozens of interviews.
At least half of California's more than 500 dialysis centers have not had a recertification survey for five years or more. One in 10 hasn't had one since Bill Clinton was in the White House, federal records show.
The U.S. has among the highest mortality and hospitalization rates for dialysis care in the industrialized world. The effect of regulatory scrutiny on these outcomes is hard to measure. But physicians and patient advocates say gaps in oversight contribute to the system's risks, allowing practices to erode and problems to go undetected.
"There's more and more of a tendency to be sloppy," said Dr. John Capelli, a New Jersey kidney specialist and former president of the Renal Physicians Association. "You're more reliant on facilities to run themselves. If you had regular inspections, units wouldn't allow that kind of deterioration to happen."
Officials with the Centers for Medicare & Medicaid Services, the federal agency that regulates dialysis facilities, said they were pressing states like California to do better, threatening to withhold funds if they fail to inspect a minimum of clinics flagged each year for poor patient outcomes.
Their ability to do much more is limited: Despite reports early in the decade blasting the inspection system's inadequacies, Congress has not expanded the agency's resources or enforcement authority in this area.
"We would like to see dialysis facilities surveyed with greater frequency," said Thomas Hamilton, director of CMS' survey and certification group. "The concern is for the life and well-being of the beneficiaries -- the individuals who about three times a week are going to undergo dialysis for their very ability to live."
California health officials conducted a complaint investigation and a recertification survey at Christiansen's clinic, Benicia Dialysis, in the months after she died.
They did not cite the facility for violations directly related to her care, but found more than three dozen deficiencies overall. Two were for failing to keep patients' needle sites visible at all times. Others were for not having adequate staff on duty to meet patients' needs and for failing to ensure patient care technicians were properly certified.
Separately, Prenkert found records showing that the facility's administrator had his nursing license revoked in the 1990s for abusing drugs and that a nurse who treated her mother had been refused a license by Arizona for errors and misrepresentations he allegedly made working as a dialysis technician.
Prenkert and other family members filed a wrongful-death lawsuit against Benicia Dialysis' owner, DaVita Inc., in October 2009. The suit is ongoing. DaVita officials declined to comment on the matter, citing patient privacy laws. They said the nurse and facility administrator are no longer with the company.
Officials with the California Department of Public Health said the deficiencies cited in the survey did not contribute to the incident involving Christiansen.
But Rebecca Freeman, the attorney representing Christiansen's relatives, said she thought it could have made a difference had inspectors shown up sooner.
"It's human nature that if clinics think they're going to be inspected more, they're more careful," she said. "By the time they did it [an inspection], it was too late for her."
Low on States' Priority Lists
The United States spends more than $20 billion a year to care for the almost 400,000 Americans who rely on chronic dialysis to live. Most dialysis is paid for through a special Medicare entitlement created in 1972. There are more than 5,000 dialysis facilities, the majority of which are run by for-profit corporate chains.
Inspection rates are inconsistent, varying from higher than 40 percent per year in some states to lower than 10 percent in others, partly because of the hybrid nature of the oversight system.
The federal government sets standards for dialysis clinics, as well as other types of health care facilities, but pays state health agencies to enforce them. States conduct recertification inspections at specified intervals and more limited checks following complaints. A recertification typically involves inspectors observing operations for several days, poring through medical records and other logs and interviewing staff and patients.
The money states receive has not kept pace with the expanding number of facilities in some areas of the country. Also, some facilities -- such as nursing homes, home health agencies and certain hospitals -- are considered higher priorities than dialysis centers.
"You just can't cover that much ground," said Chris Cahill, an inspector for the state of California from 1995 to 2006. "We all had a high level of frustration. It was impossible for us to maintain the level of oversight on all of the facilities."
California is not the only state that has lagged. As of last month, about 45 percent of dialysis clinics in Oklahoma and about one-third of those in Louisiana and Colorado hadn't had inspections in at least five years, federal records show.
But California's backlog has become markedly larger in recent years as the state budget crunch slowed efforts to replace inspectors like Cahill when they retired or left.
The number of clinics that have gone six years or more without a check has tripled since 2005, CMS records show. Dozens of clinics haven't been inspected since an initial certification survey first cleared them to accept Medicare patients. Manteca Dialysis, in California's central valley, had its most recent -- and only -- survey in 1992.
"It's absolutely appalling," said Roberta Mikles, a retired nurse and patient safety advocate in San Diego who posts surveys of California dialysis facilities on her website, www.qualitysafepatientcare.com. "Patients are placed in situations of potential or actual harm when there aren't timely surveys."
An official with the California Dialysis Council, which represents providers, said surveys help keep clinics "on their toes," but he disputed the notion that patient care had suffered in their absence.
"The history of success of dialysis clinics in California is very good," said Michael Arnold, the group's legislative consultant. "There have been very, very few problems."
California's patient outcomes are average for the nation or slightly better, government data shows. But overall numbers may not capture problems with day-to-day practices at individual clinics, federal regulators and patient advocates say, making regular on-site checks a crucial part of the safety net.
California health officials said they saw no sign that care had eroded as the inspection rate fell.
If it had, "[w]e would expect this to be reflected in our data," Kathleen Billingsley, the former deputy director of the California Department of Public Health's center for health care quality, said in an October e-mail. "We would expect, for example, an increase in the number of complaints associated with [dialysis clinics]. This has not been the case."
Billingsley, who left the department last month, said that California inspectors have responded promptly to all complaints about dialysis clinics. When facilities are the subject of complaints, she said, these investigations "would likely trigger" inspections that could flag more systemic issues.
Complaints Not a Backstop
Yet records show this has not always been the case.
A clinic in Contra Costa County has had three substantiated complaints since 2003, including one in which an employee told an inspector the facility's condition was so poor he "would not let his mother dialyze here." Its last full inspection was in 2001.
An Orange County center has compiled four substantiated complaints, including one in which it was cited for prescription errors that employees blamed on staffing cuts made soon after its last recertification survey, in 2002.
Complaints are just one way that problems with care bubble to the surface.
Dialysis providers must submit data on patient outcomes to the government, and CMS uses this information to rank clinics in each state based on a trio of measures, including survival rates.
Since 2006, the agency has targeted poor performers for inspection, directing state health officials to inspect half of the facilities in the bottom 20 percent each year.
But Hamilton said California did not meet this goal in 2007 and 2008, when it left dozens of centers with the poorest rankings unchecked.
Renal CarePartners of Los Angeles (formerly known as Intensive Renal Care Inc.) was among the California facilities flagged by CMS each year from 2006 to 2008. Yet it hasn't had a recertification survey since it opened in 2001, state officials acknowledged.
For much of that time, government data show, the clinic's mortality rates have been unusually high -- 30 percent to 50 percent worse than expected, factoring in patients' characteristics. Its patients have been hospitalized for blood infections at a rate double, and at times almost triple, the state average.
Jim Spafford, vice president of operations and compliance at Renal CarePartners, which acquired Intensive Renal in 2007, said in an e-mail that the clinic has worked with a regional CMS contractor to review its mortality rates and participated in a special quality improvement project last year.
"Based on our experience, we know that the clinic's patients are generally of greater acuity than what we would typically see in an average dialysis facility," Spafford said. "We relocated the patients to a new, state-of-the-art facility in 2009, and are very proud of all of our facilities and the patient care we provide."
After CMS warned that it would withhold funds if California did not complete its share of targeted dialysis inspections in 2009, state health officials put more than 20 newly trained inspectors into the field and cut deals to hire back retirees as contractors.
It met the CMS minimum for surveys in fiscal 2009 and 2010, but its overall backlog continues to grow.
The department "recognizes that dialysis patients are an extremely vulnerable and medically fragile population," Pam Dickfoss, acting deputy director of the California public health department's center for health care quality, said in answer to questions from ProPublica. But "due to limited resources and competing priorities," she wrote, the agency can do no more.
Providers Police Themselves
Recognizing that there may always be gaps in the inspection system, the federal government has pushed dialysis providers to do more to police themselves.
When CMS overhauled regulations for clinics in 2008, it strengthened requirements for internal quality and safety programs with the idea that they will reduce the need for external inspections, said Hamilton, the agency's inspection chief.
Some providers say they have had such mechanisms in place for years.
The largest chains, DaVita and Fresenius Medical Care North America, have elaborate internal auditing systems that track clinics' performance data on a continual basis. They also do their own on-site critiques.
"We view the regulatory requirements as threshold standards, and where medically and operationally feasible, we set policy that exceeds them," Fresenius spokeswoman Jane Kramer said in a written statement.
DaVita said it conducts monthly safety, infection control and biomedical audits, as well as annual comprehensive reviews.
Still, it takes outside intervention to address problems at some facilities.
A series of critical internal audits at BMA-South Annapolis, a Maryland clinic owned by Fresenius, preceded the death of patient Lillie Alexander in 2006.
An inspector was sent to assess BMA-South Annapolis after the Maryland Department of Health and Mental Hygiene received a complaint about Alexander's care.
According to her report, Alexander, 72, went into cardiac arrest midway through a dialysis treatment on July 18. She became unresponsive and stopped breathing.
Then, the report said, she went without oxygen "for at least six minutes" as employees struggled to locate and use commonplace breathing equipment. Though the clinic had a defibrillator, workers did not use it, waiting for paramedics to do so instead.
By the time Alexander reached the hospital, she had suffered irreversible brain damage. She died eight days later without regaining consciousness.
In examining the clinic's records, the inspector found that company audit data provided to the facility administrator several months before Alexander's death had identified safety problems that included flaws with emergency response and supplies.
Subsequent monthly audits by the company's regional office showed corrective action had not been taken -- even after the incident involving Alexander, the inspector's report said. Fresenius declined to comment on Alexander's case or the material in the complaint investigation.
Paul Alexander, Lillie's husband, said he hadn't known that regulators cited the clinic for mishandling his wife's care until he was contacted by ProPublica.
He remembered going to the hospital that day. His wife always took her wedding ring off before dialysis. He recalled bringing it to her bedside and slipping it back onto her finger so she could be buried in it.
Congress Fails to Enact Reforms
Concern with oversight of dialysis care has surfaced before on a national level.
In 2000 and again in 2003, the U.S. Government Accountability Office issued reports saying hundreds of dialysis clinics were long overdue for inspection, that rates were inconsistent from state to state, and that regulators lacked effective tools to keep troubled facilities in line.
The GAO proposed requiring more frequent inspections for problem clinics and giving CMS authority to fine those with repeated serious violations.
Lawmakers have not acted to provide CMS with additional enforcement options, however. Also, in the years after the GAO reports, the proportion of Medicare money allotted for inspections declined as the number of health-care facilities continued to rise. The overall inspection rate for dialysis centers has remained virtually unchanged.
A handful of states have stepped in with tougher oversight provisions where the federal government has not.
Under Texas law, for example, regulators can fine clinics found to be out of compliance with state standards. They also may require them to hire state-selected monitors to assist in making specific kinds of improvements.
The monitors -- physicians, nurses or technical experts, depending on the clinic's deficiencies -- typically stay in place for at least six months, submitting regular progress reports until regulators are satisfied.
"We don't want a quick fix," said Derek Jakovich, manager of the Texas Department of State Health Services patient quality care unit. "We really want to bring about lasting change."
Colorado passed legislation requiring dialysis clinics to report incidents resulting in patient deaths and injuries and recently increased licensing fees to pay for additional inspections. Regulators expect to check one-third of the clinics statewide by July 1, 2011.
"Dialysis is a lifeline," said Judy Hughes, chief of acute, primary and community-based services for the Colorado Department of Public Health and Environment. "We weren't getting in and being able to know what was going on in these facilities."
So far, there's been little push to expand oversight in California.
A 2008 bill that would have required annual inspections and given regulators power to fine facilities for catastrophic lapses in care died without a single hearing amid cost concerns and opposition from the dialysis industry.
Patricia McGinnis, executive director of the California Advocates for Nursing Home Reform, said she was told there was no money to add safeguards for a relatively small and not particularly vocal patient community.
"They pick their priorities by who raises the most hell," she said, referring to state legislators. "Dialysis clinics often aren't on the radar."
Nearly 40 years after Congress created a unique entitlement for patients with kidney failure, U.S. death rates and per-patient costs are among the world's highest while the biggest for-profit providers flourish.
The Story So Far
Dialysis holds a special place in U.S. medicine. In the 1960’s, it was the nation’s signature example of rationing, an expensive miracle therapy available only to a lucky few. A decade later, when Congress created a special entitlement to pay for it, dialysis became the country’s most ambitious experiment in universal care.
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