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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.

Paul Alexander, widower of Lillie Alexander, who died after going into cardiac arrest during a dialysis treatment at an Annapolis clinic, sits in his home in Annapolis, Md. An inspection report of the clinic 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. (Ricky Carioti/The Washington Post)

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.

A portrait of Lillie Alexander, who went into cardiac arrest while on dialysis at a clinic in Annapolis, Maryland. The 72-year-old went without oxygen for about six minutes as staffers struggled to locate and use commonplace breathing equipment. Alexander died eight days later. (Ricky Carioti/The Washington Post)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."

Roberta Mikles

Dec. 28, 2010, 11:28 a.m.

The Benicia facility survey can be reviewed at http://www.qualitysafepatientcare.com - at the 2010 surveys. In fact, to recall, this survey identifies a tag that access sites were not visible. This cited deficiency is after the death of this individual, thereby, in my opinion, indicating that staff did not implement their plan of correction.Question - Where was the unit-level supervision to ensure the plan of correction was carried forth for patient safety, esp, after the death of a patient? Were staff adequately retrained and re-educated in proper procedures after this preventable death?
It is a simple process to check a Registered Nurses’ license in the state of California. In fact, RNs in California are fingerprinted. Even if the facility manager does not do patient care, but is an RN, there should be a license verification done. There are instances, whereby in emergency situations that managers are out on the floor tending to patient needs. Therefore, all licenses should be verified.

It is my opinion that CMS should take full responsibility. It is the duty of CMS to protect Medicare beneficiaries and this means to ensure there is enough funding to conduct timely surveys. In fact, providers pushed for their ‘new’ facilities to be inspected timely - bu,t has anyone ever heard a provider, or lobbyist, push for timely surveys to ensure compliance?  Over the last six years, I have contacted CMS, even with submitting public comments with my concerns regarding the lack of oversight and basically NO enforcement, thereby placing patients in situations of potential or actual negative outcome situations. It is my opinion, that CMS could have moved faster and addressed congressional members to solve the survey problems. It is well known that there is basically NO enforcement of regulations. Even with the new regulations (Conditions), it is my opinion, that there is no difference in care and in fact, even with mandatory certification of dialysis technicians, the deficiencies cited are the same as prior to the new Conditions. In fact, the most frequent cited deficiency is that of lack of correct infection control practices. Numerous CA surveys had Conditions NOT met for this area, even, knowing that infection is the number two killer of this vulnerable population, we continue to see major infractions.  Of GREAT concern with the survey process, itself, is that a sample of patients is used e.g. review of medical records or patient interviews. Therefore,  if a Surveyor finds a serious issue in a patient’s medical record (in the sample) my question is “What about those patients out of the survey sample? Are there other patients experiencing the same as those in the sample? This is something to think about and I do, each time I read a survey report. One example that comes to mind with one of the 2010 California surveys is a patient who left over her dry weight for numerous treatments. This was not noted either by the technician, or the RN and the patient ended up in the hospital for fluid overload. Now, question, again, ‘what about patients out of the survey sample? How many experienced the same?
Roberta Mikles
Dialysis Patient Advocate

Roberta Mikles

Dec. 28, 2010, 11:30 a.m.

cont-
Providers continue to state that outcomes are good, but the survey process is able to find those deficient practices e.g. staff not following their own, unit, policies and procedures. If they were, they would not be cited. Many cited deficiencies are found during ‘record review’ therefore, indicating that these problems existed out of the survey time onsite. I mention this because I have had providers tell me that staff are nervous when surveyors are in the unit.  Having communicated with some corporate level providers, I do believe there are some that have sincere concern for patients. However, I also believe that often that which happens at the unit-level is not adequately corrected. Another example is one where a patient contacted me. She was aware of some infection control deficiencies cited at his facility. The staff, after the survey were implementing correct practices e.g. disinfecting dialysis chairs, etc., then soon after, days later, staff were back to their old habits. Where was the unit-level supervision, esp when dried debri, perhaps was found on chairs? When she asked about why one staff was disinfecting correctly, the staff’s response was ‘oh, she likes to do it that way’.
Having communicated with hundreds of patients and their families, often these individuals do not report their concerns to unit staff, let alone, the state. Often patients are met with the following that tells the patient ‘do not ask again’. (a rolling of the eyes, a shoulder shrugging, a facial expression, body language, or a mere comment) Therefore, patients might fear reprisal. Further,  many patients state that they stop bringing forth concerns because ‘they (staff) wont do anything about it’.  One reason we posted the California surveys to our website http://www.qualitysafepatientcare.com was because of the communications we had with patients/families. The most frequent statement was that they were afraid to request such because the facility might find out and get mad, or they would say ‘what good is it as I have complained about that and nothing was done’. Many patients were unaware they could even request a copy of their facility’s survey from the state.  Dialysis facilities do not have to post their surveys in a conspicuous place as do nursing homes. Even though this was suggested during the public comment period for the new Conditions, it was not included in the final regulations. If providers continue to profess good care then I, personally, do not see why they would object to such posting.
Roberta Mikles

Roberta Mikles

Dec. 28, 2010, 11:32 a.m.

con’t
I am now reminded of one survey where a patient was involuntarily discharged (a 2010 survey in CA) for apparent no reason. The physician’s statement, to recall, was that there was a ‘personality conflict’... I had to wonder what the underlying reasons were because there are many personality conflicts that arise when patients bring forth concerns to staff e.g. incorrect practices being implemented.

The concerns with staff not continuing to implement the plan of correction needs to be addressed. I am reminded of the facility, or several, that did not have access sites visible even with the plan of correction.  One California facility had a complaint filed for reuse e.g. using the wrong patient’s dialyzer for another patient. The facility, a few months later, was again cited for the same. Where was the unit level supervision?

I have read surveys (CALIF) dating back to 2003, and it is my opinion, that delivery of care has not changed and patients continue, in many facilities, to be placed in situations where preventable errors can result in negative outcomes.
It is my opinion that providers can not adequately police themselves as evidence by the survey findings. For instance, if facilities were adequately policing themselves, then, when the survey was being conducted, the types of deficiencies found would not be present, e.g. lack of internal auditing, infection control, not following MD orders, etc.  As far as CMS revising the regulations, from my review of CA surveys, I have not seen any change in delivery of care. In fact, numerous facilities were cited for not implementing their own policies related to internal auditing. This was also cited, many times, prior to the revised Conditions.

The bi,l in 2008, SB 1474 Dialysis Facilities, was the result of my working with Senator Alquist’s office. There were, in fact, some patients who wanted to testify, then at the last minute were fearful to do so. The bill would have increased state-level oversight and would have held facilities more accountable to ensure safe care was being delivered. Further, monies received from providers, e..g fines for certain deficient practices, etc., would have supported timely surveys.  There are no consequences for deficient practices and this is a problem, as I see it. Patients expect to have quality safe care delivered—it is an expectation and I would ask providers to take a look at the CA surveys and ask yourself, “Is this the care you would want to have, or you would want a loved one to have e.g. preventable infection, wrong dialyzer, not having physician orders carried out accurately, etc.

In all due respect to providers, their lobbyist and provider organizations, please recognize that there are problems in many facilities and that the survey process can be used as a tool to correct such. We must work together and resolve the problems which start with ensuring staff are adequately trained and educated with an understanding of rationale behind practices and consequences for not implementing correct practices, e.g. patient harm.. and, to ensure that there is adequate unit-level supervision to ensure safe practices and unit policies and procedures are being carried out.
Roberta Mikles RN
Patient Safety Advocate
.(JavaScript must be enabled to view this email address)

Patients are afraid of being identified as difficult and getting kicked out of their unit so they do not file complaints. Many patients go to the center closest to their homes and do not have any other options. If they stir things up it can go badly, as has been seen over and over. Dialysis centers have the right to refuse service.

Been putting up Colorado state inspection reports on our website along with a lawsuits section, adding links to articles etc… when appropriate, and highlighting problems in bold.  People need to know what goes on at these clinics!

The problems in Colorado’s El Paso County have really stood out: swapped dialyzers (blood cleaning filters) between patients, TWO incidents in just ONE county.  The clinics’ filter cleaning doesn’t get rid of things like hepatitis C and AIDS!  One Colorado incident involved hep C!  Reuse needs to go!

But thanks to the press and Colorado’s state inspection teams for getting on top of these problems!

Chris Schwab
DialysisEthics.org

As an octogenarian who’s seen a lot in his time, I am not easily impressed.  Over a year ago I began PD (Peritoneal Dialysis).  Shortly after that, I had a catheter blockage, and spent two weeks on Hemodialysis while the incisions of the repair operation healed.  Over the past 18 months I’ve had ample opportunity to see the workings of the DaVita Clinic that has kept me in good health over this period.  What strikes me about this investigation ProPublica describes is the lack of detail about the nature of the patient pool with which the clinics work. 

From the many times I have been at my clinic, I see the ambulances that brought the patients lined up along the curb.  Most patients I see appear to be frail, some semi comatose, others suffering from dementia, and any number of other serious medical problems in addition to failed kidneys.  Indeed, the majority of the patients are old, appear to be from low income homes, and probably are not well educated.  Some of them don’t speak a word of English. 

If this is typical of what the clinics have for a patient pool, then the infection, morbidity, and mortality rates are understandable when one considers that it is not only the clinic where the patient can easily receive an infection, and it is not only errors in the dialysis treatment that can cause these problematically ill patents to expire.  The one clinic with which I have substantial experience is, in my opinion, a first class, very well run operation.  The antiseptic regimen I see being followed is strict, and extensive.

Stan,

I would be surprised to find out DCI, here in the U.S., works with a different patient pool than DaVita: http://www.dialysisethics2.org/forum/index.php?topic=592.0 or that they are fudging their stats.

You might also ask DaVita about their average pump speeds: http://www.dialysisethics2.org/index.php/More-Featured-Items/pump-speeds-and-mortality.html

Chris Schwab
DialysisEthics.org

Rich Berkowitz

Dec. 28, 2010, 6:35 p.m.

First, I’d like to make a quick correction.  For the nearly 400,000 dialysis patients in the U.S., there are over 9000 clinics.  How do I figure that?  There are over 5000 in-center and over 4000 at home.  Let’s not ignore the growing number of people on home hemodialysis.  If you compare statistics between the two, you’ll find far fewer safety issues and much better results regarding mortality with those dialyzing at home.  Regarding infiltrations as occurred to Jessie Kay Christensen, you’d find fewer occurring at home for two reasons: 1) buttonhole needles are primarily used and 2) the same person is cannulating each time, whether it be the dialyzor self-cannulating or the partner doing it.  In a center the practice is to use sharp needles and have a different person doing the cannulation each time as a practice.  There’s no way of knowing what the cause was, but the California Department of Public Health said the deficiencies cited in the survey did not contribute to the incident involving Christiansen.
I’m not foreign to what goes on in-centers.  I spent three years in two centers to probably be able to write a book about what I and others experienced.  Much of it is avoidable and some the fault of the center.  Infections are a tough one.  Is it because techs don’t change gloves, or is it because many first time patients start dialysis with a catheter rather than a fistula?
The recently released Frequent Hemodialysis Network Study proved that those doing frequent hemodialysis, averaging 5.2 days per week, as compared with conventional hemodialysis, was associated with favorable results with respect to the composite outcomes of death or change in left ventricular mass and death or change in a physical-health composite score.  It should be noted the FHN study was done in-center and not at home, yet showed much better outcomes that conventional 3x4 sessions.  One might wonder if the FHN study was done at a center that experienced deficiencies per a survey.
Irrespective of what surveys show, there still is a better method of dialysis than the conventional treatments talked about here.  The crux of the problem with U.S. dialysis is that the for-profits co-opted the model that was first presented to Congress in the early 70’s when a proportion of 50% home to 50% in-center was suggested.  But based upon faulty testimony, the standard of care became the conventional 3x4, the model in which for-profits would gain the greatest profit.
The real question we should be talking about is how we can go backwards to the mid-70’s and correct what happened so we can then have better dialysis in the future.  The last 30+ years are lost, with tens, if not hundreds, of thousands perishing unnecessarily.  Patients have to demand better treatment; providers must, per the Conditions for Coverage, tell patients of all modalities, whether available at the particular center or not; and nephrologists must begin to get a true informed consent based upon informing their patients of different modalities and outcomes.  Nephrologists must start practicing medicine by putting their patients and medical ethics before profits.
As dialysis patients remain in-center and get more and more debilitated as time goes on, it’s no wonder the mortality rates remain high.  We need to change the way dialysis is done in this country, including how centers operate as the ProPublica series has shown so well, but go beyond that to give patients a chance at a more optimal life, which means a more optimal dialysis is necessary.

Rich Berkowitz
NxStageUsers

Funding for most clinics come from the State * or Federal Government. Those funds are in the first tier when the budget cuts are enacted. Considering most pay rates, the lack of inspections of both clinic & personnel due to shortage of qualified inspectors, it’s no wonder the health system in lacking. Even at that, the agencies don’t do their jobs for what ever excuse they have. I’ve had experience with the State licensing board in California, where they are more concerned with applicants who get parking tickets and don’t pay, than whether or not they are qualified to do the job they have applied for. I haven’t the answer, nor the solution, but the problem just keeps multiplying each year.

We don’t dare complain.  My specia needs adult daughter has been refused for treatment by 2 different nephrologists who own the dialysis centers.  The center that finally accepted her is DaVita, which means the nephrologists who do treat my daughter don’t have much say so when things are wrong at the dialysis center.  I have tried to see the list of ratings for dialysis centers in California, but all I get is “404-no URL.”  How do I find out where this center is listed?  It is also difficult to find any kind of supervisor who is employed by DaVita but not on our local level.  Since the new director took over, 80% of the techs have resigned.

Roberta Mikles

Dec. 29, 2010, 8:56 a.m.

\Ivy Berr, here is the Propublica ‘tracking’ data page where you can get all the information on facilities by entering a zip code. http://projects.propublica.org/dialysis/

There are alot of reasons why techs leave a unit. I remember, at our unit, a few of the techs asked me to support them when they were working with less staff than they should have. I supported such by writing a letter as I felt it was a patient safety issue. Then, when things changed, for a whlie, there were three ‘new-to-dialysis’, I was told, staff and two techs that were experienced. I even questioned having three new staff on the unit - alot of problems with that also, esp if there is an emergency

I have already had patients/families contact me who have communicated over the last year with facility complaints that are thinking of changing to a better unit, after reviewing the tracking data. Patients/families, in order to make informed decisions and choices must have data publicly reported. thanks to Robin Fields patients have more choices now.

If you are in California, and your facility has been inspected in 2009 or 2010, it will probably by at our site http://www.qualitysafepatientcare.com ..

the data at Dialysis Facility Compare really does not show true care that happens in facilities. One facility can have great numbers in lab work, etc, but that does not show real care in many units.

As far as Davita and supervisory person, you can ask the unit manager for their regional managers name and she/he should give it to you.
You can also call the Corporate office for Davita if you can’t get results from the unit.

Also, the nephrologists, at the units, although are basically responsible for ensuring safe care, per the ESRD Conditions (regulations, federal) they are not employees of the company but they are contracted, to my understanding. I might be wrong, ..In the California surveys, on our site, I recall several facilities being cited for the Medical Director not overseeing care.

Davita has corporate offices in California, unless they have moved, I am not sure, they are in El Segundo.

Also, when providers state their outcomes are good, this does not address the ‘human aspect’ of care, as I call it, in the facilities - the direct patient care.
Roberta Mikles
Dialysis Patient Safety Advocate

Rick, you are so right.  Nephrologist must get back to being doctors and putting their patients first.  My husband was never told of the different modalities available to him other than in-center hemo and transplantation.  He was receiving less than quality care and afraid to speak up since he heard how other patients were “put out” as to say, had to find other means of getting treatment when they were less than happy with the current care.  This was how the treatment center dealt with patient dissatisfaction. 
Through my own research I was able to learn about at home hemo. This is what we are currently doing and he has never been healthier. He no longer has to wait for hours to have his treatment. We dialyze every day for 21/2 hours, his blood levels are great and his diet is easier to manage.  And the bonus is NO Fluid Restrictions.  The staff who trained us are very pro-active and believe as we do, the patient does best when they are independent.

However, BEWARE there are nephrologist who find patients doing at-home- hemo to be threatening. They are not comfortable with the patient knowing more about themselves than the doc thinks he knows. We have encountered this when my husband was hospitalized for emergency gallbladder surgery.
I would encourage anyone with CKD to do their own research. There are multiple modalities which enable us to find the best fit.  In-center dialysis is a must for some patients who ae not able or do not have caregivers available to assist them with some of the other methods.  If you do get your treatment for an in-center. Keep your eyes open. Watch the nurses and techs, learn who is good at cannulating and who is not, ask if you can cannulate yourself so you can decrease the risk of infections and infiltrations.  Talk to other patients at the center.  Keep an eye on the caregivers at the center who smoke outside and return to care for you in their sweatshirts and not using lab coats. 

Roberta there is not enough space for us to address the “human aspect” of neglect with in-center care.  You did nean neglect of care, right?
Patients are numbers, have no life to discuss and should just listen to the staff discuss their weekends, vacations and love life. Patients are not asked about themselves or their families since you have kidney failure and are unable to live. This is the way they respond to the patients; not what the patients say.

lambchop

Roberta Mikles

Dec. 29, 2010, 4:32 p.m.

Lampchop, you are right in all that you state.
We, too, lived it.

I encourage ALL patients, if they can, to do home dialysis in order to havde improved quality of life, less medications to take, more independence and freedom and, in my opinion, it is must safer than receiving treatment in many facilities. I still shutter when I read the survey reports of which CMS shold POST to the dialysis facility compare site.
Roberta Mikles
http://www.qualitysafepatientcare.com

Roberta I commend you on what you are doing to get the information out to the public about dialysis care and treatment. 
I’ve been considering starting a group for patients and caregivers in my area who do not feel they can speak for themselves for fear of repercussions.  As the caregiver. no one can refuse me treatment or black ball me from care.
My only concern is as to how this might affect my husband. However he is encouraging me to start the group.

Roberta Mikles

Dec. 29, 2010, 8:01 p.m.

Lampchop, good for you about starting a group.I understand as those I speak for have such fear that it is emotionally distressing.  Staff have even contacted me wtih concerns about their speaking out.  It is truly sad that providers continue to profess that their outcomes are good, hence, care is good.. because, as the article states,, the day to day care in units, evidenced by survey findings, are what makes a ‘good’ unit, versus a ‘not so good’ unit.
Over the last six years, my communications with so many is rewarding as many of these patients/families are now contacting me telling me they are looking at another facility after reading their tracking data (dialysis facility reports) provided by Propublica. This transparency is needed in order to allow patients and their families to make informed decisions and choices. This dialysis facility reports will increase one’s interest in becoming more educated e.g. if the unit has a high percentage of infections, then patients can ask staff to explain their procedures that will prevent infections and if staff forget, etc., patients can remind them and be part of the patient-centered team. This is just one example. I am reminded of the APIC (Assoc Professionals in Infection Control) Guidelines for Infection Control in Dialysis Facilities.. this clearly states that patients should be thoroughly educated in specific procedures that staff will implement in order to prevent infections. Hence, e.g. when gloves need to be changed, when hand hygiene is applicable, disinfecting access site, (catheter or fistula), etc.. this is all important

Please feel free to contact me as this problem with reprisal needs to stop.

Roberta Mikles
Dialysis Patient Advocate
http://www.qualitysafepatientcare.com

David L. Rosenbloom, Kidney Patient Advocate

Dec. 30, 2010, 11:42 a.m.

Patients and their care partners clearly need better education and greater emotional support than they are now getting through their dialysis centers. In-center dialysis can and often does foster “learned helplessness.” Patients become or remain passive, not active participants in their health care regimen. Many internists and nephrologists unfortunately leave the daily practice of dialysis to overworked and often undertrained, in-center nurses and technicians. These doctors have only limited personal contact with patients. They primarily review patient labs monthly and issue treatment orders to dialysis center staffers, ignoring important emotional issues, which if dealt with, could greatly improve patient health and attitudes. Patients are scared, sick and often depressed; most receive only adequate, not optimal dialysis. Many of these same doctors also have a financial stake in keeping the system as it is.

Yes, government oversight and regular inspections of dialysis clinics is necessary, but so is optimal dialysis, which is largely absent from our treatment of ESRD in America today. Only those who break away, as I did, from the standard 3-day/wk. treatments and seek daily dialysis, fully realize how debilitating and dangerous is the current treatment system.

Roberta Mikles

Dec. 30, 2010, 3:12 p.m.

David, as we have discussed, you are ABSOLUTELY right in what you stated. Optimal dialysis should be more of a focus.

The culture within the facilities, most, in my opinion, need a change… it must be a true patient-centered model of which it is NOT.

Roberta Mikles RN
Dialysis patient Advocate
http://www.qualitysafepatientcare.com

1.  I hope this will lead to improvements and higher standards. Dialysis patients are trying so hard to survive or they wouldn’t endure the treatment. My mother also died due to do a bad stick at a Fresenius dialysis clinic. Cause and effect led to internal bleeding and a painful death. She was on hemo for years at the same clinic. For those many years, we sought help and filed complaints trying to improve the quality of care. Even after a government inspection, nothing changed. It is true that they do not want to deal with the issues. The quality of workers at these clinics is a main issue. It’s a trying job; but, pay and training should be there to entice quality staff. And, the companies providing the service should be held accountable and penalized in ways that will make these lives matter.  We cannot change the past; but, we can fight for a better future.

I have recently lost my mom while taking a treatment for Dialysis. They called my mom’s roomate and stated the shunt was not working properly then 1 hour later she went into catiac arrest and passed away. I have not received an explination or a call from them. Who can I contact to ensure she was properly taken care of and did not die due to others mistakes.
Thank you Joe

Roberta Mikles

Dec. 30, 2010, 10:36 p.m.

Joe, please accept my condolences for your loss. How sad that the company did not call you where your mother had dialysis. The fear of law suits is ever-present. You can file a complaint with the state agency that inspects the facilities. Usually it is the Department of Health. Then ask to speak to whoever inspects facilities and tell them you want them to investigate your mother’s death. They will do such. Of course, I hate to say it, but from my working in healthcare, I can say that often medical records are altered. I am not saying that this will happen in your case, but it does happen. Even when I reviewed my father’s medical record, parts of it, there was important data left out that would have given the physician information regarding his treatment.. then, there were statements e.g. ‘ppr’ per patient request.. of which he did not request what was documented. But, we documented thoroughly for the time he was on dialysls. I also learned of the defensive documentation of staff

Roberta Mikles RN
Dialysis Patient Advocate
http://www.qualitysafepatientcare.com

I am a former dialysis patient coming up on my fifth anniversary for a transplant.  I firmly believe that we kidney patients need to be much more involved with our care.  I opted not to do hemodialysis although that was what had been offered.With a little research I found peritoneal dialysis and it was a life saver.  No one will take better care of you than you!  You have no dietary or fluid restrictions and it works in a much more natural, less traumatic fashion.  You are responsible for making certain that you observe all sterile conditions, logging your fluid out put and dry weight and BP daily.  Other than that and a wee bit of time there is nothing to it.  There are some issues that you must be vigilant about but every modality has that.  The problem is that the US Dialysis Industry is geared toward hemodialysis. It is big money, and a huge employer.  Few places want to give that up.
Believe me when I say that I never regretted using PD and for many countriesin the world it is the preferred method.

My husband will be go initiating dialysis for the 1st time in Jan. He will be hospitalized for 3 days, then go to a center 3 days/wk. I didn’t know much, & I’ve learned alot by reading this blog. Now, I’m actually more nervous…new terminology: should one start with a catheter or fistula? Dialysize at home or in center to avoid chances of infection which is the #2 cause of death…The Dr only recommended this option coupled w/going on the transplant list…what other options are there?

An access can take up to 6 weeks to “cure”.  If your husband needs dialysis immediately then I assume that they will use a temporary catheter until the fistula or other acces is ready.  From what I have been reading more frequent home hemodialysis may be preferable since it is donedaily and more toxins are cleared out.  If he goes to a center 3 times it means he has to rely on the tech and commit about 4 to 5 hours to the center.  It’s pretty life disrupting.  Of course you have to assess how much you think you can take on as well.
Home Dialysis can also be Peritoneal Dialysis which I wrote about previously.  There is still the chance for an infection but if he observes all the rituals i.e.masking, clean hands access site care, etc. he should do fine.  A center still has to train him in how to do it and the do a couple of tests to determine how often he needs to do it.  Medicare will pay for the training.  You also need a little bit of space to store the supplies—I live in a studio apt. and was able to handle that- and the supply companies are very good about delivering on time.  The drivers take it very seriously.  If you can do a bit of planning, they will ship to wherever you want to go on vacation. I spent many vacations in Puerto Rico and my supplies were always there.  Nothing really held me back.  Why not go on the Kidney Foundation websites and see what they say about the different forms of dialysis and see what appeals to you both.  Also start the transplant process immediately.  I waited 3 years but whereever you are the list may be shorter.  He will never regret it.

It is so inspiring to see this public discussion of dialysis. Often patients go blindly into care and are overwhelmed with all there is to learn.
Laela: We have an online forum for discussion and support. IHateDialysis is a site for patients, by patients. Do not let the site’s name fool you. We are not negative, we hate dialysis - but we love life. IHD is the largest and most active dialysis message board on the Internet. We are a community that is very supportive of each other and we help both new and veteran patients cope with the daily struggles of living with kidney disease. If you are affected by kidney disease, then please join us, whether you are pre-dialysis, or on hemo, pd, home-hemo, or a transplant patient. If you are a spouse, relative, friend, or a loved one, then you are invited to join IHD too, as are those who work in the medical community.
E-mail:    .(JavaScript must be enabled to view this email address)
Website:  http://www.ihatedialysis.com

Roberta Mikles

Dec. 31, 2010, 9:08 a.m.

For home dialysis you can go to http://www.nxstageusers.com/ and ask questions, etc. Also, there is a dialysis technician manual at http://www.kidneyschool.org (or, dot com) that I have referred patients/families to.

It is very important to be as educated as you can be in orer to ask questions, and make informed choices and decisions. One problelm, that we hear, over and over, is that patients incenter are not fully educated. Just the other day, a patient contacted me and, even after four years on dialysis, still did not know what the ‘bath’ was, or how his potassium level was connected to the ‘bath’. This is important because staff are human, and in the surveys I have read, staff do, accidently, use the wrong bath.. It would be great if all units would allow patients to have a significant other with them. It would be great if all worked as a team to prevent errors because it takes all (patient/family/staff, etc) working together to prevent errors.
Roberta Mikles
http://www.qualitysafepatientcare.com

Rich Berkowitz

Dec. 31, 2010, 12:33 p.m.

According to the Conditions for Coverage, which all dialysis centers are to follow to remain recognized by CMS, all new patients are to be educated about all of the modalities available, even if that particular modality is not offered.  Nephrologists, by law, are supposed to get informed consent from their patients.  That means they are suppose to talk about all modalities and what one can expect from each, including survivability.  However, the fact is neither practice is being done very much.

A 2009 stude was release by a distinguished group of Toronto nephrologists which showed that frequent nocturnal hemodialysis was equivalent to a cadaver transplant and is the gold standard for dialysis.  Also over 90% of dialysis professionals would do longer and more frequent dialysis instead of the standard 3x4 sessions.  Yet, only 8% of their patients are receiving the therapy they would choose for themselves.  Why is there such a disconnect?  Why os there so much hypocrisy?  We need to break through this situation so patients can make informed decisions about the therapy they would choose.

The problems surrounding U.S. dialysis is plentiful.  To correct them we must break the stranglehold of the for-profits and make dialysis primarily be for the benefit of people rather to corporations whose main purpose is to make money for shareholders.

Joe, I am very sorry for your loss.  The answer you received from the facility is unsatisfactory.  Contact the Centers for Medicare and Medicaid Serivces regional office closest to your home (Boston, NY, Phila., K.C., Denver, S.F., Chicago, Seattle, Atlanta, or Dallas) and ask for the survey and certification division, specifically the staff responsible for ESRD health and safety enforcement.  You have a potential health and safety complaint againist the facility in current regulations (the citation is 494.60(3) Condition: Emergency preparedness - requirement for the facility to have an automated external defibrillator (AED) in the unit with staff trained to use it.  That requirement was added specifically to address your relative’s situation when CMS learned that cardiac arrest was the leading cause of death in dialysis facilities.  Use the regional office staff or the state survey agency in your state, not the ESRD Network, to follow up on this investigation.  The applicable regulations were published on 4/15/08 in the Federal Register, (Vol 73, N0 73) - the full text available on the Internet.  Good luck.

David L. Rosenbloom, Kidney Patient Advocate

Dec. 31, 2010, 3:49 p.m.

Here we go again. NBC’s overly simplistic reports on the failures of in-center hemodialysis and the “miracle of modern kidney transplantation” is sensationalistic and not very helpful to those facing a life with chronic kidney disease. It makes for good copy, but ignores the real issue of rehabilitation of people with kidney failure through optimal dialysis, particularly the majority who are not or never will be eligible for transplant.

If we continue to focus on the failures and problems of outmoded, 3x wkly. dialysis treatment, then we miss the golden opportunity to improve thousands of lives today through available daily hemodialysis and PD modalities.

Rich Berkowitz’s vital point on the lack of informed consent, i.e. doctors not explaining all treatment options to patients beginning dialysis, is critical to any serious discussion of improving kidney loss treatment in America. Without full patient education, we will continue to rehash the same horror stories over and over and nothing will change the status quo. It takes just as much energy to change the system as it does to complain about it. The more kidney patients complain about the lack of treatment options available to them, the faster the dialysis industry will be forced to accommodate their health needs versus the industry’s financial considerations.

Roberta Mikles

Dec. 31, 2010, 5:31 p.m.

As a Dialysis Patient Safety Advocate, I agree completely with the other two Advocates, Rich and David, and what they have stated. There are many Conditions that are not implemented, even though they are suppose to be. Medicare reimbursement is based upon facility compliance with the Conditions, however, have we ever seen a facility with many regulations not met, yet they continue to receive reimbursement?

As I read the post of Max, I was reminded that the facility we went to was cited, to recall, ( I might be wrong, but if I remember correctly) twice for not having either staff fully trained in emergency procedures related to emergency equipment and/or emergency equipment not working properly. No wonder I was concerned about my father and if an emergency presented and he needed that type of intervention.
As I have said many times, and the more I read survey findings, and my continued communication with patients/families, even staff, ....“If you can you should do home dialysis” Our legislators, CMS and others, including providers, should take a long serious look at the research and documents that focus on the benefits of longer dialysis. And, is it not a shame that providers, as someone mentioned, provide that which they would not want.

I know that at our unit, once the bundling rule went through, or a little before, there were large posters in the lobby all over the wall that were focused on doing home dialysis. Interesting that this was NOT done prior to bundling. Says alot….. an awful lot.

Roberta Mikles, RN
http://www.qualitysafepatientcare.com

Roberta Mikles

Dec. 31, 2010, 5:33 p.m.

As a Dialysis Patient Safety Advocate, I agree completely with the other two Advocates, Rich and David, and what they have stated. There are many Conditions that are not implemented, even though they are suppose to be. Medicare reimbursement is based upon facility compliance with the Conditions, however, have we ever seen a facility with many regulations not met, yet they continue to receive reimbursement?

As far as informed consent, how many patients really understand all the forms that they HAVE TO sign before their first treatment. They sign them, listen to staff briefly tell them what each form means, etc. Does anyone ever return to explain the forms in detail. Patients, on their first treatment, certainly have other things on their mind that might be distracting them from fully understanding, or reading each and every lengthy form..e.g. fear of first treatment and not knowing what to expect, not feeling well, etc etc.
As I read the post of Max, I was reminded that the facility we went to was cited, to recall, ( I might be wrong, but if I remember correctly) twice for not having either staff fully trained in emergency procedures related to emergency equipment and/or emergency equipment not working properly. No wonder I was concerned about my father and if an emergency presented and he needed that type of intervention.
As I have said many times, and the more I read survey findings, and my continued communication with patients/families, even staff, ....“If you can you should do home dialysis” Our legislators, CMS and others, including providers, should take a long serious look at the research and documents that focus on the benefits of longer dialysis. And, is it not a shame that providers, as someone mentioned, provide that which they would not want.

I know that at our unit, once the bundling rule went through, or a little before, there were large posters in the lobby all over the wall that were focused on doing home dialysis. Interesting that this was NOT done prior to bundling. Says alot….. an awful lot.

Roberta Mikles, RN
http://www.qualitysafepatientcare.com

jessica swanson

Dec. 31, 2010, 6:57 p.m.

i live in north jacksonville flroida and have experienced first hand the staff and management bully patients if they have complaints. the person becomes listed as a trouble maker. if you know somoeones family member that complained you can see the difference in the attitude of the care that is given to them. (wheteher the complaint was right or wrong) alot of clinics hire technicians right from the street with no formal education or medical background. alot are there for a paycheck and will leave if the dollar is higher across or down the street. the patients are afraid to discuss concerns because they know they may not get the help they need if they say something.the staff reflects the people in charge. very bad! the doctors have no say in the big companies running dialysis. you can complain at their offices but they say they will try to do something only to find later they say the manager says no.

Roberta Mikles

Jan. 2, 2011, 11:21 a.m.

Jessica, many, as myself and my recently deceased father, experienced such as you speak of…in fact, we even had a patient, who told us she would not speak up because she saw how things happens when either my father, or I, spoke out. Another patient told me the continued fear to speak out because of what might happen. It is truly sad that those working facilities, many, not all, do not understand. I remember when I worked in a similiar situation, in my nursing career, for most of it… it was a chronic population, with many return hospitalizations, etc. I taught my staff to realize first and foremost how difficut it was for patients and their loved ones. Staff donot realize so many aspects of what the patient or their loved ones experience when kidney failure takes over ones life with life changes, for many, not all (this is why home is BETTER for many.
the culture within the facilities (not all) is such that patients feel they are at the mercy of the staff. I watched staff, some, react different with some patients because they received better gifts e.g. at xmas, etc. And, often, as you say, patients are treated with a different ‘‘attitude’’ and that IS the perfect word. As far as the medical directors, my understanding is that they are contract employees, howevever, if you look at the facility surveys on our site http://www.qualitysafepatientcare.com you will see several facilities that were cited for the medical director NOT carrying forth their responsibilities. They are responsible to ensure safe care. We jus posted a new page to our site to show our concerns and the serious level of such in some facilities.  http://www.qualitysafepatientcare.com/looking-deep-into-the-survey.php 
My patient advocacy has put me in touch with so many who have had your experiences and as I said to someone one day ‘you can lead a horse to water, but you can’t make it drink’.. youc an not make people be compassionate and care about what they do, if they don’t want to. and, my father used to say that. He had a few staff who he knew truly cared and showed their kindness, but on the other hand, we also were aware of how some staff talked about patients behind their back. Patients see things, right.
Hopefully, this New Year will bring forth providers finally working towards the best interests of patients, as well as their pocketbooks. My opinions, as above are, as all my comments, a result of speaking with hundreds of patients throughout the US. And, perhaps, providers, etc, should sit in the chair and walk in the shoes of their patients for a few days.. to hear, over and over, that outcomes are good, patients receive good care, etc… is somewhat contraditory when you read a facility’s survey who has had good outcomes. It does not account for the day to day care and that is a real indicator—how patients are treated

Roberta Mikles
http://www.qualtiysafepatientcare.com

This article is part of an ongoing investigation:
Dialysis

Dialysis: High Costs and Hidden Perils of a Treatment Guaranteed to All

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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