Led by California, Inspection Backlogs Weaken Dialysis Oversightby Robin Fields
ProPublica, Dec. 28, 2010, 9:36 a.m.
* 4 Comments
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 [1] 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 [2] 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 [3]. "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 [4].
DaVita said [5] 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)
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 [6], 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."
1.
http://www.propublica.org/article/in-dialysis-life-saving-care-at-great-risk-and-cost 2.
http://www.propublica.org/documents/item/federal-inspection-report-benicia-dialysis 3.
http://www.qualitysafepatientcare.com 4.
http://www.propublica.org/documents/item/statement-from-fresenius-medical-care-north-america-on-oversight 5.
http://www.propublica.org/documents/item/statement-from-davita-on-oversight 6.
http://www.propublica.org/documents/item/federal-inspection-report-bma-south-annapolis * Tweet 6
* Share12
* E-mail
Your e-mail Your name Friends’ e-mail(s) max 10, separated by commas Personal message
* Print
3 comments
Roberta Mikles
Today, 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
Today, 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
Today, 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
RMiklesRN@aol.com
Karol Franks
0 minutes ago
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.
http://www.propublica.org/article/led-by-california-inspection-backlogs-weaken-dialysis-oversight
I Hate Dialysis Message Board
Author
