Anyone have PureFlow Dyalisate fail lab tests?

[Black]

... the sample passed all their tests and we can go back to using the PureFlow again. ...Tom

Glad to hear the good news. 

[silverhead]

Bill, Sorry about the "CENTER" error, posted late at night and as usual my head all was fouled up.....
Tom

[Hawkeye]

CMS has issued new guidance to State surveyors regarding the PureFlow here: http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCletter07-34.pdf I have read through once - it looks like there will be monthly testing and testing each time the PAK is changed - Hawkeye I'd be interested in your take - along with everyone else. My provider has had me using bags since April - I think this guidance supports their concerns while leaving a couple concerns undressed.
My take away is that water/dialysate purity is the hardest nut to crack when it comes to providing optimal dialysis in the home.

Well what was described in the CMS article was exactly what we have to go through for in center and home hemo every month.  The only real difference is that instead of doing an AAMI water analysis every year we do one every 3 months, and Fresenius has more restrictive bacteria and endotoxin restrictions than AAMI has.  From the sounds of it their filtering system just isn't cutting the mustard and is violating safety standards to cover it up.  We will have to wait to see where this one goes I guess, I would expect to see more changes on the way with their system.

[Black]

If I understood the description of the minimum standards correctly, then I do not forsee NxStage having any difficulty with this, though it is a little bit like expecting today's train to have a "cow catcher" on the front.

Initial and annual testing of water source, and having AAMI determine that the PAK is efficient in removing contaminates should be easily doable.

If a person is trained in sterile procedure in connecting to a dialysis machine they should be easily trainable to collect annual water samples and monthly dialysate samples.

Chloramine testing is already done on every batch.

As far as I know, there has never been any problem with "maintenance" of NxStage equipment.

It will be additional inconvenience to take the samples, and additional expense for the center, but if it makes CMS happy then I guess we'll have to do it.

[Black]

We received the NxStage testing instructions from our center.  We are waiting for testing supplies, and clarification of some of the instructions which are not clear.  Looks like it will be only a minor inconvenience for us, and a little more expense for the lab.

[Black]

Our PureFlow and well water passed all of the first tests on the first try.      They are a minor inconvenience but easy to do. 

I feel bad for the non-profit center having to do and pay for tests we know are probably redundant.  We do not have insurance but they do not bill us for the 20% medicare doesn't pay, so they are already losing money on us.  Oh well, keeps CMS happy and shows the skeptics that the PureFlow is working just as NxStage Medical says it does. 

[jbeany]

My center just started monthly water and dialysate checks as well.  No problems with the first one - but yet another giant box of supplies to store in an already overcrowded space!

[Black]

My center just started monthly water and dialysate checks as well.  No problems with the first one - but yet another giant box of supplies to store in an already overcrowded space!

What did they send?  I think all we got was a small plastic grocery bag with the sterile catch containers and a small box of face masks.

[jbeany]

I got supplies for 6 months of water and dialysate testing.  Tubes, containers, shipping boxes, gloves, masks, sterile drapes, ice packs to go in the boxes, and enough paper work to hold my own confetti covered parade down the street.  It's divided into 6 monthly batches, and each one comes in it's own box, so the huge shipping box is big enough to hide a computer and monitor in it.

[Black]

I got supplies for 6 months of water and dialysate testing.  Tubes, containers, shipping boxes, gloves, masks, sterile drapes, ice packs to go in the boxes, and enough paper work to hold my own confetti covered parade down the street.  It's divided into 6 monthly batches, and each one comes in it's own box, so the huge shipping box is big enough to hide a computer and monitor in it.

Oh my!  That would be inconvenient to store.

We already had most of what we needed, but I do wish we had some sterile gowns, sterile gloves, and sterile drapes.  I think it's ridiculous to be so careful getting the samples when they expect you to wear a non-sterile gown, non-sterile exam gloves and use the non-sterile blue-backed pads that come in an open, non-sterile  box.  Our samples were fine, but if they ever fail I'm going to blame it on the non-sterile stuff we use and ask that they get us sterile supplies for the collection.  I'll make room!

BTW, I don't use the non-sterile exam gloves at all, even during dialysis.  I wash my hands under forced spray, with antibacterial soap, dry with paper towels, and then slather on the hand sanitizer.  That has to be better than the exam gloves.

[jbeany]

We don't use the gloves much here either - I figure I'm just as well off with well-scrubbed hands dried with fresh paper towel as I would be with the gloves, and Hubby and I are the only ones who ever touch the machine anyhow.  I only use a glove for holding gauze afterwards because I hate getting blood under my nails if the site is really oozy.