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Sen. Grassley Demands Information on Dialysis Clinic Conditions

Sen. Charles Grassley, R-Iowa, sent a letter Tuesday to Dr. Donald Berwick, administrator of the Centers for Medicare and Medicaid Services, expressing concern about clinic conditions and oversight described in a report published by ProPublica and the Atlantic Monthly in November.

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Sen. Charles Grassley (Alex Wong/Getty Images)

3:21 p.m.: This post has been updated.

In response to an investigation by ProPublica, a key senator is demanding answers from federal regulators about the care patients are receiving at U.S. dialysis facilities.

Sen. Charles Grassley, R-Iowa, sent a letter Tuesday to Dr. Donald Berwick, administrator of the Centers for Medicare and Medicaid Services, expressing concern about clinic conditions and oversight described in a report published by ProPublica and the Atlantic Monthly in November.

Grassley -- among the senate's most vigilant and vocal watchdogs over health care -- is the ranking member of the Senate Finance Committee, which has jurisdiction over Medicare and Medicaid. Most dialysis is paid for by Medicare under a special entitlement created in 1972.

"I have a responsibility to the more than 100 million Americans who receive health care coverage under these programs to oversee their proper administration and ensure that taxpayer dollars are appropriately spent on safe and effective medical treatments," Grassley wrote.

ProPublica's investigation found that patients often received treatment in environments that were unsafe or unsanitary. A review of inspections conducted between 2002 and 2009 at more than 1,500 clinics turned up hundreds of instances in which facilities were cited for breaches in infection control, as well as egregious cases in which lapses in care may have led to patient injuries or deaths.

Grassley has asked for CMS to provide documents to determine the extent of such problems and to explain what steps the agency is taking to improve oversight of dialysis clinics.

He also has asked agency officials to explain why critical data about clinics' performance has not been made public. ProPublica reported that CMS has long had a trove of data about individual dialysis center performance but has not released measures such as rates of mortality, hospitalization for infection and transplantation.

ProPublica requested this information from CMS in 2008 under the Freedom of Information Act. The week before our investigation was published, the agency provided reports for all clinics from 2002 to 2010. ProPublica is preparing the data for public release.

Grassley is expected to become the ranking member of the Judiciary Committee next year but has said he will keep a seat on the finance panel, where he previously has pushed for improvements in dialysis care. He held hearings in 2000 after a critical report by the U.S. Government Accountability Office and pressed Medicare officials after the GAO reported little progress in 2003.

He has asked for CMS to respond to his current inquiry no later than Jan. 4.

CMS officials said they have received Grassley's requests and will be responding to them.

WALTER C LUNDY JR

Dec. 22, 2010, 11:10 p.m.

I’M GLAD FOR SENTOR GRASSLEY REQUEST. A URINARY TRACT INFECTION COULD BE FATAL. THANK GOD FOR GRASSLEY!

We at RenalCarPartners of Fairfax are commited to deliver safe treatment and a clean,pleasant environment.
I have been in Dialysis field since 12/1980. I understand this treatment is very costly. In my 30 years of experience, There have been alot of improvement, From infection control ,needle sticks to no transfusion needed.  Hemodialysis does save lives ,but prolong life as well. in many case there are no quality of life after certain age. As a nures in my openion there should be a cut off age and also the patient should be held responsible to cooperate in their treament.  The patients know they can reject thier prescription or a drug.  if they do notcomply with doctors order and miss treatment . refuse medical guidelines . The clinical team are held responsible. Thank you for the oportunity to voice my concers.  Merry Christmas and Have avery Happy New Year.  Hafiza Riaz,R.N.

Roberta Mikles

Dec. 23, 2010, 1:35 p.m.

We all agree to disagree, however, n my opinion, there are indeed patients that do not comply, but the reason is “why?” Have the staff fully investigated as to why a patient is noncompliant? What about deficiencies cited during surveys,,, staff are noncompliant and patients expect to have those providing care compliant with oversight regulations. As far as infections, as you know, infection remains the number two killer of this vulnerable population. In fact, if you look at the ‘tracker’ Propublica has provided it is shocking. At our unit, we complained about lack of infection control and were constantly told that the unit had few, if any, infections. Come to find out the unit was double the percentage compared to the national rate for infection - access site.  I guess, again, my opinion is that something is greatly amiss, especially when you read through the tracking provided…..
It would be nice is there was more transparency with providers in admitting they do not, in many facilities adhere to their own policies/procedures as evidenced by surveys.. let’s all work together to improve care’
Roberta Mikles
Dialysis Patient Advocate
http://www.qualitysafepatientcare.com

Roberta Mikles

Dec. 23, 2010, 1:58 p.m.

I would like to add, if I read your post correctly, you are saying there has been improvement in infection. I beg to differ, considering for years infection remains #2 killer and that infection control, according to CMS is the most frequent cited deficiency. Also, I believe that, if I checked correctly that the unit you are speaking of was above the national average for infection - access site and septicemia
Roberta Mikles
http://www.qualitysafepatient.com

RaVanda Vallette

Dec. 23, 2010, 5:03 p.m.

I agree with Sen. Grassley, for the first time someone wants to take notice to what the patients have to look at, and the conditions they have to endure. Short staff, non working articles,staff with bad attitudes because they are short,and the staff member you have is burnt out. Did you ever know what it’s like to try and be a staff member with four patients. Yes four is the golden number, one gets sick, one wants to come off early. One want’s to know why he or she is coming off early,so take me off early as well.You try and explain this is not good for your UFR,if you get off early you will lessen your life by x many days or months. Have we given them any thing to care about, have we made their life meaningful to them? Many people I know and knew had joy in eating the things they learned to love. With this disease the little joy they had was taken away as well. You can’t eat this or this and never this, I was around only one dietitian that taught the patients how to eat and cheat. I think she had better results with them being honest, if you have pizza on Monday you have to eat according to the renal-diet the rest of the week. It gave them something to look forward to, and I think we all need something to look forward to. We had another dietitian that was good, he would cook thing for them to show them it’s not all bad tasting. Only two I saw that cared enough about the whole person, these are whole people with a disease, and if we don’t start treating the whole person we will lose the flock.

Melville Hodge

Dec. 23, 2010, 6:18 p.m.

With the FHN randomized clinical trial of 6x vs 3x dialysis report now in (more than 10 years in planning and execution), confirming hundreds of observation and limited randomized trials over several decades, it is clear that nephrologists and Medicare should prescribe and support a shift of every qualified dialysis patient to daily dialysis.

Since this is economically unfeasible in dialysis centers, dialysis must also be shifted to the home, whenever possible.  Patients would not only live much longer and feel much better, they would also escape the reported hazards of in-center dialysis, while reducing costs as well as the rate of future cost inflation for Medicare.

(For detail see my papers “The Path to a a Paradigm Shift in Hemodialysis” - Hemodialysis International 2010, 14:5-10 and “Practicable Frequent Hemodialysis: A Proposal to Meet the Needs of Patients and the Requirements of Medicare” - American Journal of Kidney Diseases, Vol. 52, No 3 (September), 2008: pp 387-390)

I am working in chronic dialysis since 2002. I started with DaVita in an inner city clinic and then decided to work for FMC and ARA.
Chronic dialysis is devastating to all patients. Most already have diabetis and hypertension and renal disease only adds to the list of “wrong things” and “restrictions”. I truly love my patients and wish to help them find for themselves a reason to go on, do well, and enjoy the life they have. I know that sometimes we cannot add years to their life but we can always add life to their years by helping them enjoy the things they previously could enjoy, and by letting them know that even after kidney failure, they are still valuable members of our communities, of their churches and, especially, of their families.
If anyone, patient or medical staff, has any ideas how to help my patients with their diet, medication, dialysis, and fluid management, please let me know at .(JavaScript must be enabled to view this email address)

Peter Laird, MD

Dec. 24, 2010, 2:41 a.m.

Dear Simona, RN, I would simply state that the best way to help dialysis patients would be to move to Canada, Europe, Japan, New Zealand or Australia. In all seriousness, if you have been working in the dialysis industry since 2002 here in the US, it is unlikely that you have seen the true benefits of optimal dialysis. I am a patient myself and dialyze at home. 5.5 times a week on average.  Dialysis is NOT devastating to all patients.  There are some of us who have escaped the American style short, rapid and violent dialysis as usually practiced in America alone. If you want to truly help your patients with your list above, give them longer, slower and more gentle dialysis and you will see an entirely different set of patients in front of you.  It is time for America to step away from the dark ages of dialysis care and enter the modern era, which really is modern at all, it is the way that they started with dialysis in America in the 1960’s, thrice weekly overnight hemodialysis for 9 hours for a total of 27 hours each week. 

Just going back to where we started would give you and your colleagues an entirely new experience in dialysis and seeing how wonderful a gift of life it truly is.  I hope you get the chance to actually witness that firsthand.

Roberta Mikles

Dec. 24, 2010, 4:10 p.m.

As I read through Propublica’s ‘tracking’ I am shocked to see the number of facilities who had infection percentages higher than the national average for either septicemia or access-site infections. It is discouraging to know that CMS has had this data and has NEVER included it in Dialysis Facility Compare, for example.  As I look at these numbers I am reminded AGAIN that there must be, in my opinion, a lack of eduation/training/oversight when it comes to implementation of effective infection control practices. I was also shocked at one home unit that had a high number which indicated, to me, in my opinion, that the home patients were not being trained appropriately. Now that this data is out in the open, perhaps providers WILL admit that something is wrong with their training/education as well as their unit level supervision Of course, not all units, but there are ALOT. Perhaps, we can have some transparency/honesty and good faith with providers and they will revisit their training programs to ensure staff understand the rationale and consequences for infection control practices.
Roberta Mikles RN
Dialysis Patient Advocate
http://www.qualitysafepatientcare.com
.(JavaScript must be enabled to view this email address)

I’m running the organization - DialysisEthics - that started the hearings in 2000 mentioned in the article.  I hope this isn’t going to be the usual indignant dancing by Senator Grassley then a disappearing act as soon as the microphone is off.  I’m really hoping Propublica will keep the pressure on him and actually get some action.  What would I like to see?  DaVita and Fresenius converted to NonProfits for starters, minimum 4 hour treatment times like they have in Germany and Japan, and proper patient-staff ratios.

I’ve seen these companies fined before, they take it out of their lunch money then continue on as they please.

Roberta Mikles

Dec. 25, 2010, 10:29 a.m.

CMS NEEDS to provide states enough funding to inspect facilities. This data now supports concerns of us advocates e.g. protecting patients.
Chris, thanks to Dialysis Ethics Org patients who have been involuntarily discharged, for no reason, have been able to have treatments in another facility. THANK YOU. My hopes are that Senator Grassely in addressing Dr> Berwick results in Dr Berwicks understanding of the problems considering he is a patient advocate and coauthor of To Err Is Human.. The preventable errors in facilities should NOT happen.  I agree with more dialysis for more quality of life, as well as independence. We can no longer allow these providers to not address these severe and serious problems that are continuing. As I stated, as I reviewed California’s data, I was shocked, but just what I suspected, esp for the unit my father went to…. considering we constantly were bringing forth concerns related to infection control.
Roberta Mikles
http://www.qualitysafepatientcare.com
.(JavaScript must be enabled to view this email address)

The letter to Dr. Berwick was vintage Grassley.  It was always obvious to HCFA/CMS staff that Senator Grassley was making a career out of these faux witch hunts.  His questions regarding what additional authorities CMS might request to take action against facilities and how much funding CMS devotes to ESRD facility inspection feign ignorance of existing federal law.  He knows from dozens of exchanges with nursing home enforcement staff in CMS that there are 17,600 nursing homes that must be inspected, under federal law, every 15 months.  He also knows the nursing home inspection area of CMS has requested Congressional authority to take action against nursing home chains repeatedly and Congress has done nothing.  Because two large for-profit chains have approximately 60% of Medicare’s ESRD patients one would think he has already received similar requests from CMS (if those requests made it past the political appointees).  As someone already noted, if you cannot go after the entire chain, fines will not be effective.  Grassley also knows that almost all of the CMS survey and certification funds are devoted to annual surveys of 17,600 nursing homes.  ESRD enforcement staff would prefer to inspect ESRD facilities every two years (they settled for saying every three years), but without sufficient survey funding from Congress of course ESRD facilities will not be inspected every three years.  Remember, this is the same Senator who was talking about those nonexistent “death panels” in the ACA during his recent re-election campaign.  ESRD needs the same kind of legal auhthority stipulated in the nursing home enforcement statute, with additional authority to go after chains like DaVita.  Charles Grassley isn’t trying to solve ESRD’s health care problems, he and his colleagues are the problem.

Roberta Mikles

Dec. 27, 2010, 8:44 p.m.

Max, agree… ESRD facilities should have the same type of inspection guidelines as SNFs. and, as far as I am concerned the same grid to determine fines.. After reviewing the California dialysis facility reports, I continue to be shocked at what I am reading. For instance, for six years my father and I brought forth concerns about the lack of infection control… Now, I know, and realize that we were not too far off base as I read the percentages for infection etc. Additionally, I had to, on various occasions address the Epogen and this also is substantiated in the DFR. So, I was, in fact, advocating for my father and he was advocating for himself and other patients.
Something needs to be done because I am not starting to believe, forgive my naive thinking, that those at the corporate level really are only concerned about the almighty dollar… otherwise, in my opinion, we would see different percentages and data on these DFR.. and, all one has to do is look at the surveys and correlate the deficiencies with the number of infections.. Clearly, CMS could have included infection rates in the QIP and shame shame on CMS for not doing so knowing they had this information. Of course, there are facilities here in CALIF that have not been surveyed since 2000.
When will providers take real responsibility and get staff that are adequately trained, educated and also have supervisory positions that are effective… just my opinions
Roberta Mikles
http://www.qualitysafepatientcare.com

Roberta, I am sorry to hear about your father’s experience.  Amgen, the manufacturers of the anemia drug Epogen, is one of Senator Grassley’s main controbutors.  Amgen makes approximately half of its profits from this one product, and also enjoys an uncomfortably cozy relationship with the National Kidney Foundation.  It should be noted that the industry that contributes the most to Grassley’s ongoing committee activities and campaigns is the health care industry.  I am not an expert on ESRD data, however, I do know there has been a long tug of war between CMS and the ESRD Networks over control of the data, and all of this is information that Senator Grassley knows. The expert on ESRD data, and the industry’s efforts to conceal it, is Robert Wolfe, Ph.D., a researcher at the University of Michigan.  ProPublica has opened a can of worms by launching this investigation but they seem unusually persistent and detail oriented and perhaps they can [to paraphrase one of Grassley’s mantras] get to the bottom of it.  I hope so.  The focus of propublica’s investigation should be on the high mortality rate in the U.S., the past and present role of the ESRD Networks (which are part of the ESRD industry), the heavy presence of for-profit companies in ESRD, the way in which dialysis is delivered here in comparison with countries with much better results, and the payment disinsentives to provide better care.  I had to agree with the person who posted earlier that much longer daily sessions and home dialysis is a much better option then going into one of these corporate facilities three times a week for maintenance dialysis that will gradually wear you down until you are unemployable and eventually too sick to function at all.  I would also move to Canada if I had this disease.  Whatever happens regarding Grassley’s request I can almost guarantee you nothing will change.  He will deliberately ask the wrong questions to embarass CMS and the administration in order to resolve nothing.  The same thing happened in 2000.

Roberta Mikles

Dec. 29, 2010, 9:03 p.m.

We can only hope that change will happen. Improved care incenter where patients ARE part of the patient-centered team and more patients being referred to home diallysis

Roberta Mikles
http://www.qualitysafepatientcare.com

I see from previous comments that some issues are universal. Thank goodness we do not have a sepsis issue at the clinic where I work, but we definitely have staffing issues (1 nurse and 2 techs to 15 patients x 2 shifts/30 patients max/day for 13 hour days 3x week and only 1 half-hour lunch break) and I pray nothing happens due to being short-handed and/or exhausted and too tired to think. We also have a supplies issue: our disposable gowns are locked up, as is the paper tape we need to use on patients. The reason for the lockup? Cost efficiency! Our clinic has gotten awards for this, and rumor has it that management gets some sort of monetary bonus based on the numbers. That the running of our clinic is about the all-mighty dollar and not the patients needs is sad and has had us talking on more than one occasion about looking for a job elsewhere, where patient care matters. We always end up staying because we love our patients, but still it would be nice if things were run a little differently. Thanks for letting me rant…

Roberta Mikles

Dec. 31, 2010, 8:15 a.m.

To Chris RN, Thank you for sharing, as a Dialysis RN. This information supports alot of what us advocates have been stating. I, also thank you for your dedication to your patients.  I have also heard that Facility Administrators get a bonus if they are ‘under’ budget. I am wondering if you have ever approached management with concerns about staffing and patient safety. I would suggest that you write to management, have all staff sign and then discuss the specific safety issues related to delivery of patient care. As I said, I had been approached by two techs to support them, of which I did by writing a letter.. however, I was a family member of a patient. You also, for your protection as an RN, document that you have notified management of patient safety issues. You have a license. It would not surprise me if there were a preventable error that resulted in injury or death that management would not come back and say to you, ‘why did you not tell us you had concerns, we did not know’ . Don’t fool yourself, as I have had many in dialysis tell me this. You can also contact the state and report your safety concerns. Also, if there have been incidents that you believe were a result of being short=staffed, you can include that in your letter to management or the state. Patient’s lives come first.
Roberta Mikles
Dialysis Patient Safety Advocate
http://www.qualitysafepatientcare.com

Robert F. Hickey, Ph.D.

Jan. 2, 2011, 6:17 p.m.

Having been a dialysis patient from March, 1999 through October, 2004, I had the opportunity to observe the protocol at my base dialysis center (DaVita) in Denver as well as several others over the years as I took vacations during that period. In all venues I found the frontline staff members, particularly the RNs, to be very dedicated, well trained, and efficient. The techs left me cold and worried. What was of great concern to me was the desensitization of staff to the worries, concerns, and ignorance of the patients. Even though I had spent most of my 35 year professional career teaching at medical schools and associated hospitals, I was terrified as I entered the arena of dialysis as a patient.
Certainly, I had to deal with the side effects of each treatment session. The nausea, vomiting, weakness, and pain of 14 gauge needles being injected in my arm for each session were regular companions. However, the most frightening was witnessing patients die in nearby chairs. The disheartening information during each visit of finding out that other regular fellow patients had died. In some cases other patients would scream in pain as the needles were injected. Frequently blood would fly as the dialysis needles became dislodged from patient arms.
After getting an altruistic, non-related, livingdonor kidney transplant in October, 2004 I began to research the transplant system in the US including dialysis operators. What I have learned is stunning and maddening. The system is fueled by greed, money, and power with almost no oversight by federal or state authorities.
Dialysis executives and managers making tens of millions of dollars annually in salary and bonuses. Nephrologists contracted by the dialysis center operators receiving bonuses for keeping dialysis chairs fully occupied in addition to huge contract payments. These funding patterns encourage physicians at the centers not to refer patients for more than a year to transplant centers.
The private contractor, the United Network for Organ Sharing (UNOS) is corrupt and mismanaged. Organ Procurement Organization (OPO) revenues from selling donated organs running into the billions of dollars every year. These so-called non-profits enrich their executives and managers. Why should an OPO pay non-medical executives hundreds of thousands of dollars a year. As an example, Tom Mone, CEO of the California Transplant Donor Network is paid more than $600,000.00 annually as is the dictatorial CEO of UNOS, Walter Graham. The OPO in Colorado, the Colorado Donor Alliance even pays its ‘Chief Surgeon’, Stephen Kelley more than $250,000.00 annually. Kelley is not a surgeon, not even a physician! I could go on with chapter and verse as I do when I lecture on the lack of transplant ethics across the country. The most shocking in what I have learned is that patients on dialysis and those seeking transplants are not the priority. The money they generate is!!!

I must admit I don’t know much about what has been going on with transplants, I’ve been watching dialysis for more for ten years and after seeing that maybe I’ve been afraid to look!  However, I wouldn’t mind learning more.  You can always contact me through the DialysisEthics.org website.

I just stopped by to see if there was anything new with grassley, hope he hasn’t disappeared already.

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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