Standards of Care in Colorado

[plugger]

We at DialysisEthics.org have decided to push for Standards of Care here in Colorado.  The following is what has resulted after a meeting back in June with Davita representatives to discuss conditions in dialysis that left many unanswered questions (in attendance were: two representatives from Davita, Colorado State Representative John Kefalas, Della from DialysisEthics.org, and myself).  Also we have contacted Northwest Kidney Centers and received information on patient/staff ratios, Dr. John Agar from Home Dialysis Central has provided information, and we have been in contact with DCI.

The following has resulted after the above inquiries and years of watching the goings-on in dialysis.  This list is a wish-list that can be added to, subtracted from, revised, and definitely commented on.  It could result in a Colorado state bill, but State Representative John Kefalas hasn't committed to anything - however, he is very aware and interested in this.  (link is provided at end of post to flyer in pdf form)

Possible Standards of Care in Colorado

A group of us have been working on possible Standards of Care here in Colorado for several months.  The following are 5 items we have come up with for better care in dialysis.  To add items, comment on the following items (either in favor or not), or to seek more information email can be sent to the following people:

Main contacts:
Chris Schwab, DialysisEthics.org:  chriss.deo.ceo@gmail.com
Front Range Kidney Patient Association:   gp134b@yahoo.com
Alternate contact: (John has asked that the "Main Contacts" filter most emails and contacts, however if something is better directed to him he can be contacted)           
Colorado State Representative John Kefalas:  john.kefalas.house@state.co.us                                            ph. 303-866-4569 (office),  970-221-1135 (home)

1) Increased time on dialysis
 How:                                                                                                                                                                           
Run pump speeds between 300 and 325 ml/min - as they do in Australia.  Increase time on dialysis and keep standardized Kt/V the same.  And possibly use HDP to figure dialysis adequacy:
HDP:  http://www.therenalnetwork.org/qi/resources/HDP.pdf
Dr. John Agar and discussion on pump speeds and time on dialysis: http://forums.homedialysis.org/showthread.php/2961-Hdp
Why:                                                                                                                                                       
"Disappearance of postdialysis fatigue, better dialysis adequacy, a higher removal of middle and large molecules, a reduction of phosphate binders, improvement of status nutritional, and an important reduction of cardiovascular risk factors " http://www.ncbi.nlm.nih.gov/pubmed/12787423
"Just as speed on the road kills, so it does in hemodialysis." Dr. Carl Kjellstrand, http://www.dialysisethics2.org/index.php/Our-Concerns/dr-carl-kjellstrand.html
"Japan, Europe, Australia and New Zealand have long recognized the survival benefits of longer, slower and gentler dialysis compared to our American style violent sessions." Peter Laird, MD:  http://www.billpeckham.com/from_the_sharp_end_of_the/2010/10/do-we-need-to-abandon-high-ultrafiltration-rates-in-america.html%20
 
2) Standardized Patient/Staff ratios: 
Standard community dialysis units in Colorado would have a 40/60 percent ratio of nurses to techs.  Units with Special Care patients and those with 12 or less patients would have a 50/50 percent ratio of nurses to techs. The ratio of staff to patients would be 1/3.                     (Numbers obtained from Northwest Kidney Centers and Arlene Mullin, former dialysis tech and a founder of DialysisEthics)

3) Reuse would be abolished
Why:                                                                                                                                                                &nb sp;
1. "Dialysis in freestanding facilities reprocessing dialyzers with peracetic/acetic acid may be associated with worse survival than dialysis in free-standing facilities not reprocessing dialyzers" Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Medical Center, Philadelphia 19104-6021, USA.  http://www.dialysisethics2.org/forum/index.php?topic=58.0
2. Human error  with reuse hasn't been eliminated after years of trying to get it right:                                                                                        "In April, however, Price’s routine at Pikes Peak Dialysis Center went awry when he was mistakenly hooked up to a reusable filter, a dialyzer, that belonged to another patient — a person who had a virulent bacterial infection commonly known as MRSA. Price’s health was probably not in danger, his doctors say, and giving one person’s dialyzer to another patient is a mistake that doesn’t happen often at Colorado dialysis centers.

But it happened to Price, and it happened in February at a sister clinic when a patient was given a dialyzer belonging to someone infected with Hepatitis C. (Hepatitis C  and AIDS are not killed by current sterilization techniques) "               Colorado Springs Gazette, http://www.gazette.com/articles/dialysis-102290-three-mix.html

4) Blood Transfusions are to be done in a Hospital, NOT in a dialysis clinic
From Roberta Mikles RN, QualitySafePatientCare:
1) The reality is such that the RNs barely have time to conduct their usual work load, and with the added necessary observation, etc required during a transfusion, the result might be a dialysis technician, unqualified to do such, will be monitoring a patient, or even, perhaps, administering such, even though this is prohibited. Also, most units do not have a sufficient number of RNs.                           2) The Nurse Practice Act, in various states, clearly identifies responsibilities, of Registered Nurses.                                                                                                                                                                     
3) The storage of blood, e.g. temperature of refrigerators --- >this is  a concern considering, when reviewing refrigerator temperatures in surveys, this is a cited deficiency.                                                                   
4) Administering transfusions in a dialysis unit is a very potentially dangerous situation. If a patient has an adverse reaction, which can mean the difference between life and death, that requires immediate intervention, this might not happen, and if it does, it might not be successful e.g. saving a patient's life.
 
5) Non-compete agreements would be abolished.
Monopolies are normally bad.  Doctors and nurses are a limited resource and should be free to move to other companies, as is just about everybody else in our society.
"The mud began to fly last year when the second-largest group of Denver kidney doctors, called nephrologists, ended their exclusive affiliation with DaVita and partnered with a Massachusetts dialysis company entering the Denver market."    http://www.denverpost.com/firstinthepost/ci_12830453
"That might explain why a company (DaVita) that treats about 114,000 patients nationally is pursuing unspecified damages from six physicians in Colorado Springs who treat roughly 400." http://www.gazette.com/articles/davita-57449-dialysis-doctors.html#ixzz1YsZOgkWx

click_for_pdf_flyer

[jeannea]

This is all really interesting and some great research. But if we are to be honest, do we think this will happen? I just feel cynical after all I read here. However, if I lived in CO I'd be writing my congressman.

[plugger]

A lot of people didn't think we would get the bill for tech certification through back in 2007 - we did!  I believe if we can reach critical mass - enough people participating and adding their voices - it just could happen again.  We have until January when all the state bills get started.

[Joe]

So just for grins plugger, do you know the outcome of the suit DaVita filed against PPN? As a patient there, I'm curious just where that stands. And I've never had anything but stellar care from the folks at Liberty, would unhesitatingly recommend them to anyone needing kidney care.

[thegrammalady]

So just for grins plugger, do you know the outcome of the suit DaVita filed against PPN? As a patient there, I'm curious just where that stands. And I've never had anything but stellar care from the folks at Liberty, would unhesitatingly recommend them to anyone needing kidney care.

if the liberty center in castle rock did nocturnal, i'd be there in a heart beat! there is hope the do nocturnal in colorado springs.

[dialysisadvocate]

Fantastic... Plugger (Chris) a great job, indeed. I remember how interested Rep Kefalas was when I spoke with him after analyzing the CO surveys (for certification). The blood transfusion issue is one of great concern. With providers, possibly administering less Epogen, due to the  reimbursement structure, does this mean that more and more patients will require a transfusion. This is going to potentially place a heavy burden (on blood supply) on non dialysis patients hwo might need a transfusion during an emergency, surgery , etc. I still have concerns, even though many believe that blood transfusions in the unit are a safe practice'.. Having reviewed surveys and knowing that there are those that have been cited for non compliance in so many areas that reflect major problems... well, this is a great concern......roberta

[plugger]

So just for grins plugger, do you know the outcome of the suit DaVita filed against PPN?

I'm afraid not.  But thanks for reminding me!  I'm going to have to look into that more at some point.

And I've never had anything but stellar care from the folks at Liberty, would unhesitatingly recommend them to anyone needing kidney care.

Guess I've been on the fence about Liberty ever since a lawyer/journalist I know says he met them and they were former Davita folks running the show who wanted a bigger piece of the pie - doesn't mean they want more pie by not giving good care though.

I was wondering, do they encourage more time on the machine?  Do they do reuse?  Thanks!

[plugger]

if the liberty center in castle rock did nocturnal, i'd be there in a heart beat! there is hope the do nocturnal in colorado springs.

I seem to recall Home Dialysis Central keeps a list of who does slow nocturnal in Colorado and elsewhere.  Hey, maybe HDC could give some tips for getting slow noc. at your clinic!  Don't know, just off the top of my head.  I do know they put out out some nice postcards, was putting them on windshields at clinics around here, there for awhile.

[plugger]

many believe that blood transfusions in the unit are a safe practice'..

Scares the beejeebees out of me too!

[thegrammalady]

if the liberty center in castle rock did nocturnal, i'd be there in a heart beat! there is hope the do nocturnal in colorado springs.

I seem to recall Home Dialysis Central keeps a list of who does slow nocturnal in Colorado and elsewhere.  Hey, maybe HDC could give some tips for getting slow noc. at your clinic!  Don't know, just off the top of my head.  I do know they put out out some nice postcards, was putting them on windshields at clinics around here, there for awhile.

there are 4 centers in the denver metro area that do nocturnal. 2 da vita and 2 frenenius. i love my nocturnal shift, the liberty clinic in castle rock is just 10 miles closer tio home.

[plugger]

Great to hear you are on nocturnal!  Always considered slow nocturnal the cadillac of treatments, especially after the conversations I had with Dr. Bays, a founder of DialysisEthics and US Senate witness: http://www.dialysisethics2.org/index.php/Information/dr-kenneth-bays-us-senate-testimony.html

[Joe]

I was wondering, do they encourage more time on the machine?  Do they do reuse?  Thanks!

I'm a home PD patient, so can't answer your questions on machine time and reuse, sorry.

[plugger]

Good to hear you are on PD!  I like to think the clinics have improved over the years, but as you can see from the top post I'm still a little concerned (ok, a lot concerned).

[plugger]

Quote of the day:

Dori Schatell
Executive Director
The Medical Education Institute, Inc. and Home Dialysis Central

When asked:
"So are other countries doing more frequent dialysis - Italy, Australia maybe?"

Dori:
"I'm not aware that ANY other country has upped the frequency of dialysis. But what they HAVE done--and it has saved countless lives--is they do longer HD runs. In the US, per the DOPPS study (Saran R et al, Kidney Int. 2006, 69:1222-28), the average treatment time was just 211 minutes (3.5 hours), vs. 232 minutes in Europe (3.86 hours) and 244 minutes in Japan (4 hours). In that study, getting a minimum of 4 hours of treatment improved survival by 30%--and each extra 30 minutes beyond that further improved survival by another 7%. I've seen that survival on dialysis in Japan is triple that of the US, and in Europe it is double. Time matters, too! So, in the U.S., we have two marks against us: too-short treatments AND the 2-day gap. In other countries, they only have the gap.

For logistic/transportation reasons, I think it will be very difficult for in-center programs to do a 2-week rotation of Mon-Weds-Fri-Sun-Tues-Thurs-Sat to get rid of the 2-day killer gap. (Some transportation companies only operate on weekdays.) They'd have to be 100% in or 100% out--imagine trying to run a clinic where some folks come every other day and some 3x/week. The scheduling would be a nightmare! So, more frequent treatments are best done at home, or perhaps in areas with multiple clinics, some could offer 3x/week and some every-other-day..."
http://forums.homedialysis.org/showthread.php/3161-The-Long-Dialysis-Weekend-Might-Kill-You-But-We-Won-t-Change?p=21681&mode=linear#post21681

[plugger]

A retired dialysis nurse I know looked over the proposed Standards of Care and mentioned it looked like they are coming along nicely.  She did mention however that Fresenius hadn't done transfusions for quite a while (15 years or so).  May have to find out if they are starting up again.  I've contacted Roberta Mikles from QualitySafePatientCare about it.

[jeannea]

Is the longer treatment time the only variable that increases survival in other countries? I understood that in many countries they have much stricter criteria for even starting dialysis. So the sickest people who would die sooner don't get dialysis. Whereas here in the US, if granny is 85 with heart problems and the family wants dialysis she gets it. But then granny dies in 3 months because she was dying before dialysis started. And that helps skew mortality rates.

Not that I'm disputing that more dialysis is better. Just that statistics don't always tell the whole story.

[cariad]

Is the longer treatment time the only variable that increases survival in other countries? I understood that in many countries they have much stricter criteria for even starting dialysis. So the sickest people who would die sooner don't get dialysis. Whereas here in the US, if granny is 85 with heart problems and the family wants dialysis she gets it. But then granny dies in 3 months because she was dying before dialysis started. And that helps skew mortality rates.

Not that I'm disputing that more dialysis is better. Just that statistics don't always tell the whole story.

I don't think it's true that people in other westernized countries are refused dialysis based on age. Transplant maybe. South Africa rations dialysis, but the South Africans I spoke to describe themselves as a third world country, and young people are refused dialysis there. Australia/NZ, Canada, the UK, Ireland - I think those countries do not hesitate to treat older citizens, so I don't think the stats are obscuring any significant data. I would really love to hear if anyone else knows any differently and could point me to articles verifying same. I am going to be giving an in-class talk on the state of American dialysis in a month or so. If there is some sort of sampling bias, I would want to know.

[jeannea]

I'll have to do a little research. I was sure I read that in Italy they only let the healthiest ones have dialysis, not those with lots of other problems. I'll have to think where I read it. Darn brain like a sieve.

[cariad]

I'll have to do a little research. I was sure I read that in Italy they only let the healthiest ones have dialysis, not those with lots of other problems. I'll have to think where I read it. Darn brain like a sieve.

That's what is so great about the internet - can always refresh your memory.

Italy was specifically cited in the ProPublica article as having superior outcomes to the US, apparently due in large part to the fact that they are able to intervene earlier, before the individual begins to deteriorate. Intervention comes earlier because people don't have to worry about the cost of preventative care under a socialized system, and so they do not put off going to the doctor the way many are forced to do here. The article referenced 3 Italian "senior citizens" who had been dialysing together for years. I think it's difficult for some to admit that capitalism+healthcare=failure, so perhaps you read an article with someone trying to find fault with other systems, but I would be surprised if it were true.

I do think that it makes sense, if someone is beyond any real help, to not put them through the ordeal of dialysis, but from everything I've read, the recommendation to forego dialysis in these instances would be made in the US as much as anywhere else.

[Bill Peckham]

The study cited by Dori is from the DOPPS:

The DOPPS is a prospective cohort study of hemodialysis practices based on the collection of observational longitudinal data for a random sample of patients from a representative and random sample of units in 12 countries (Australia, Belgium, Canada, France, Germany, Japan, Italy, New Zealand, Spain, Sweden, the United Kingdom, and the United States).

Since 1996, data collection has yielded detailed information on more than 38,000 patients in over 900 dialysis facilities.The study seeks to determine which dialysis practices are associated with the best patient outcomes; its primary goals are improving patient longevity and quality of life. With over 100 peer-reviewed publications, the DOPPS continues to provide findings that are relevant for patients and practicing clinicians. The DOPPS is supported by research grants from Amgen (since 1996), Kyowa Hakko Kirin (since 1999, in Japan), Genzyme (since 2009), Abbott (since 2009), and Baxter (since 2011) without restrictions on publications.

So the idea is to compare apples to apples.

But I'd note that when it comes to duration of treatment there doesn't have to be case mix - the average treatment length is an average of all reported, grouped by country. One thing I've suspected is that if you looked at treatment length per kilogram the US would look even worse and Japan would look even better because I would guess that the average 65 year old American dialyzor is significantly larger than a 65 year old dialyzor in Japan.

I volunteer with the DOPPS. I'm presenting at a DOPPS Symposium at the ASN meeting in Philadelphia next month. My talk uses DOPPS data to say that Quality Of Life correlates to important outcomes among dialyzors - namely mortality and hospitalization. The problem is that the tools we have to measure QOL are too difficult to use frequently (though it is interesting that in most DOPPS countries patients aren't asked at all). I'll use DOPPS data to show that things like appetite, recovery time and exercise correlate to QOL. Thus while you can't give patients sf36 surveys every month you can keep track of their QOL by asking about their appetite, recovery time and activity level.

[Bill Peckham]

I'll have to do a little research. I was sure I read that in Italy they only let the healthiest ones have dialysis, not those with lots of other problems. I'll have to think where I read it. Darn brain like a sieve.

That's what is so great about the internet - can always refresh your memory.

Italy was specifically cited in the ProPublica article as having superior outcomes to the US, apparently due in large part to the fact that they are able to intervene earlier, before the individual begins to deteriorate. Intervention comes earlier because people don't have to worry about the cost of preventative care under a socialized system, and so they do not put off going to the doctor the way many are forced to do here. The article referenced 3 Italian "senior citizens" who had been dialysing together for years. I think it's difficult for some to admit that capitalism+healthcare=failure, so perhaps you read an article with someone trying to find fault with other systems, but I would be surprised if it were true.

I do think that it makes sense, if someone is beyond any real help, to not put them through the ordeal of dialysis, but from everything I've read, the recommendation to forego dialysis in these instances would be made in the US as much as anywhere else.

The data I've seen, again from the DOPPS, suggests a lot of the mortality advantage flows from more use of a fistula at first treatment which as you say cariad that is much more likely to happen in a system that treats healthcare like a public utility. In the US, compared to the other DOPPS countries, dialyzors are much more likely to start treatment a step down and sometimes that can't be made up.

One other thing to look for on these mortality number is which dialyzors are included in the equation when the mortality rate is calculated. I'd have to look at the specific data Dori is citing but DOPPS often uses prevalent patients - meaning they have been on treatment since a specific date or for six months, you try to exclude people using dialysis for palliative care. The Dialysis Facility Reports Pro Publica published, I believe, exclude people who die in the first three months.

[plugger]

I do recall Drs. Blagg and Kjellstrand had this to say about patient selection: "The mortality in U.S. patients has increased from 10 to 25% over the last three decades, but has remained stable at around 10% in Japan. There is no obvious difference in patient selection. The Japanese accept almost as high a proportion of diabetic patients as does the United States, and the mean age of incident patients is higher in Japan."
http://www.ncbi.nlm.nih.gov/pubmed/19379344?dopt=Abstract

And I did want to mention I got some info from Roberta Mikles about blood transfusions and FMC - it does sound like they might be thinking about starting again.

[plugger]

So just for grins plugger, do you know the outcome of the suit DaVita filed against PPN? As a patient there, I'm curious just where that stands. And I've never had anything but stellar care from the folks at Liberty, would unhesitatingly recommend them to anyone needing kidney care.

Joe,

Did ask about the suit at PPN, however my friends seem quite occupied at the moment and might be a little slow getting back with an answer.

I must say though, I am warming up to Liberty after getting back the following response from renal network 15 about who was doing slow nocturnal (believe these are the percentage of clinics doing slow nocturnal in Colorado):

nocturnal dialysis numbers. The correct information is -

DaVita-19%

FMC- 18%

ARA- 17%

Liberty-40%


P.S.
Denver_meeting_Oct._30th

[Joe]

Plugger, thanks for the follow up. I'll keep an eye out for the answer.
Would be interested in attending the meeting on the 30th, but I'm working Sunday. Maybe next time.