I asked these once before to get a feel for the industry practices and received a few responses. Figured I'd try again. Theres 2 parts. Part 1: Does anyone check the electrolyte level of the dialysate of specific machines? If so, why and how frequently? We test every machine quarterly, and am wondering if theres some written recognizable national or medical standard that requires this. Part 2: Bacteria testing: On dialysis machines, how often are you testing and why? Once again, we test every machine quarterly and am wondering if theres some written recognizable national or medical standard that requires this. It seems many processes are done not only in this industry, but others as well, because "things have always been done this way", and in actuality no valid reason or requirement exists.

You might want to order these: http://www.aami.org/publications/standards/dialysis.html
Also, the manufacturer of your machines will have specified the frequency of PM's and conductivity checks on your machines. Read the owner's manual, at least.

Biomedical Tech: I have the most current AAMI standards on hand,and have read them and the manufacturers technical literature. If you re-read the question and pay closer attention, thats not what I was asking,or, perhaps I wasnt clear enough. While its true the conductivity of a given solution will give a relative indication that the chemistry of the dialysate is correctly proportioned, the electrolyte testing I am referring to consists of drawing a sample and sending to a laboratory for an exact analysis. I'm guessing you dont do this or else you would have answered the questions I asked. Anyone else have any input thats relative to the questions being asked?

Newestguy,

We do electrolyte testing on at least one random machine every month and we do acid concentrate for alalysis on our standard baths every month. We do it for several reasons. To make sure that what we mix is whats being delivered from the machine, to make sure that our acid and bicarb loop pressures are not to high or low and to spot check the staff to make sure that they are mixing the special baths correctly. Our doctor orders alot of specials and we have found in the past that some of our previous staff liked to "cut" corners when mixing the acids.

As for your #2 question we do 1/3 of all of our machines every month and we have them on a rotation. I have found it easy to just draw my electrolytes when drawing my monthly cultures on my machines.

As for the AAMI guidelines and all our company makes us go above and beyond the AAMI guidelines so we usually do not have to worry when it comes to this.

Hope this helps if you would like more info email me.

NewestGuy,
No we do not sample electrolytes from dialysate. We check conductivity, pH, and temperature of dialysate prior to each treatment.
Yes we culture 20% of the hemodialysis machines on a monthly basis.
Hope this help.

We used to do monthly Na, K, Ca and HCO3 samples on all machines and additional sampling after PPM or service action on the condo system. We found that the lab results tended to be variable (same sample different result). We looked at trends and compared these with the readings from our conductivity test equipment and found that our meters were very reliable and accurate.

Subsequently we now only random sample from machines, quarterly from test meters which are cross compared for uniformity checks.

As far as microbiological testing goes, we test the water system monthly (RO out, random outlets, final return) and machines at random.

refer to your states health and safety regulations whch are usually based on the AAMI recomendations. AAAMI is planning to adopt new recomendations about dialysate, which some states(such as mine, Texas)have already passed as regulations.
gotta go...i'll be back

ok...now that i have put out that fire...my regs state "The facility owner and medical director shall each demonstrate responsibility for the water treatment and dialysate supply systems.....to ensure that the dialysate is correctly formulated..." This includes documentation of elctrolyte levels(lab analysis)as well as pm documentation that the machines displayed conductivity correlates with your external meter(s)documented conductivity. And you need to have documentation that your meters have been calibrated to validated standards.Also, by regs, we are allowed only one concentrate family and when a new concentrate is brought in or a manufacturer is changed we must sample. we currenly have no facility policy regarding more frequent lab analysis of the dialysate. If your budgets allow for quarterly testing of each machine, more power to you. Bacteria testing...we are now required(and have been) culturing each machine on a rotational basis quarterly. for me this is three or four machines per month, unless we hit action levels and then it's repeats. we are now also required to do LAL tests on each machine at least quarterly( new AAMI recomendations).
If you don't have them, download your states regs. read and highlight pertinent passages, but don't read anything into them, don't read between the lines. My inspectors were very specific on that last point. These are laws and are to be taken as written. And i now have to have ro product water analysis done four times a year instead of two. I'm not complaining. Patient safety is first and foremost, period. no discussion. But my CFO wants a better reason than the regs says i have to as to why my labs costs are going up almost $2500.00 a year.

Guano and others: Thanks for your contributions thus far. Point for Guano: As far as I know, the new AAMI standards on dialysis were released already this year. I dont recall seeing any more new releases forecast. Anyways, you stated "my regs...". What do you mean by that? The regs of the dialysis center, the state, or some other governing body? Thanks for sharing.

by my regs...i mean the regulations of the state or federal health agency governing my work. clinics ,facilities,hospitals adopt policies based on the state and federal regulations and recomedations that govern them.I work under the policies that my employer has chosen to implement based on my recomendations. those policies will meet and usually exceed the minimum required by the governing agency.

Guano �
I have 2 questions for you that I would like a specific answer to so that I may reference for my own knowledge and never ending quest to be compliant.
1) Where in the AAMI Standards does it state that LAL testing is required on each machine on a quarterly basis?
2) What regulation are you referring to with regard to RO product water analysis must be done quarterly? Is this a federal regulation or a state specific regulation?

A general question for all:
Does anybody have a link to the CMS guidelines required for a dialysis facility? There website is not the easiest to navigate. My copy of the guidelines is dated 1998 and I want to make sure I have the latest version on hand. Is anybody aware if CMS has adopted RD62 yet as the standard yet?

Thanks!

in answer to #1 it doesn't, but i have not seen the latest AAMI RD5/2003.

as to #2, i mis-worded that sentence. my state regs say every six months, but they specify "at the end of the water treatment components AND at the most distal point in each water distribution loop."

When i questioned a surveyor about the wording, she affirmed it meant two analysis. so i will split up the sampling rotation to four times a year, 2 for R.O product immediately exiting the R.O. and 2 at the end of my loop.

hope that helps

guano,

I have a couple of questions also...

1) Did you question the rationale behind having to do 2 AAMI analysis on the same water? Unless your loop and distribution system is coppper (gasp) or some other non-compatible material this is needlessly redundent.

2) Are you sure they were talking about AAMI's and not about cultures?

Chuck

I agree with Chuck. Seems ridiculous to take AAMI analysis on the same water twice unless it's flowing through a loop made of materials that are known to leach. Hopefully, as Chuck so comedically put it, that's not the case. Do explain what you find, though. I'm interested to learn more. I can see how redundant some current policies are and it honestly wouldn't suprise me to see this true as well. Lol.

i know it seems and is redundant to do two analysis on the same water. i specifically questioned the use of the word "AND" in the regulations regarding ro product analysis. they want two. pre and post so to speak. the rational being the possible potential maybe if coulda some type of leaching of material from the water loop. What if scenarios...don't you just love 'em.

the only thing metal on my loop are the stainless screws holding the pipe hangers or the unistrut. pvc all the way. no hard 90's. no branches off the run. square cuts and all edges beveled.

in my experience with surveyors/inspectors, you should know the answer to your question before you ask it because they tend to turn it back to you to see what you know or how you draw your conclusion.

not that there is anything wrong with that