Has there been any updates on the rules regarding the water requirements for home dialysis facilities? Approximatlye a year and a half ago, there were attempts to open a stand alone home program in South Texas, which did not pass the space & design survey due to not having a “water system”. After disputing the fact that the equipment to be used did not require water what so ever, the surveyor replied that the department would be working on changing the regs to catch up with the technological advances. This particular home program never got off the ground due to the delay from the dept. Any updates on this issue would be greatly appreciated.
It’s my understanding from a contact at CMS that the Texas rules currently require “all” dialysis units to have a water treatment system with a circulating loop. This probably wasn’t “intended” to include PD only or even places that do only home HD training (esp with NxStage), but that is what the rules say, and what the survey agency is holding every facility to. The TX rules are scheduled to be revised this year, and the Network in Texas has recommended this requirement for the water system be clarified as not applicable for PD only units. It’s my understanding that there will need to be discussion about programs like NxStage. This is an area where clinics using NxStage HHD equipment only may want to educate and advocate. I’d contact the TX Network to see what is in the works now.
I also have heard that AAMI is currently developing specific water treatment guidelines for home patients as an Annex for the Dialysate Recommended Practice. You might want to check on the AAMI website periodically for updates. I suspect it would be posted here:
http://www.aami.org/publications/standards/dialysis.html
I just found on the ESRD Network 14 website the revised ruling on the PD only facility clarifying the water treatment and other very important issues with a PD only facility. Anyone interested may want to take a look. There is still no word on the home hemo program. This modality is so desperatley needed in many areas still. While everyone is pushing the benefits and cost effectiveness of this modality, we are unable to fully reach the goals being presented because of the wording of the requirements.