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Post by Chuck Weddle on Aug 18, 2021 11:33:32 GMT
So.....We've been sending weekly samples from new machines to the lab for it seems like forever. Twice now we get to the 4th and final week of their validation and there is a FedEx delay in delivering the samples and naturally the results are elevated. Normally there is a note on the results saying that the samples were delayed and to interpret the results with caution. This time, there was no note so I questioned the lab. Their response was that the samples fell within their 48 hour window of stability. I rebutted with an excerpt from AAMI RD62 5.2.1 that says samples must be assayed (plated) within 24 hours. Their response was an excerpt from AAMI 13959 that says if samples can't be assayed within 4 hours to follow the labs instructions for storage and shipping. This thinking/response is flawed in a number of ways: - 13959 (what was quoted) does not address time to assay the sample, it is a lab "policy".
- IF 13959 did say 48 hours is good it still wouldn't matter. 13959 has not been adopted by CMS, RD62 is what is enforced.
- While we are free to use policies that are more restrictive than regulations, we can't use ones that are less restrictive. RD62's 24 hour window is more restrictive so IT must be what is followed.
- There is no way to convince me that samples left in a truck or the cargo hold of a plane sitting out in the sun for 2 days are going to stay between 4-6 degrees C.
- The allowable levels for bacteria are based off of specific methods and conditions. If the conditions (time, temperature) are not met, results are not reliable. A sample too cold, frozen, or not incubated long enough can result in a falsely low viable colony count. Conversely. A sample that is too warm or incubated too long (including time to plating) can result in a falsely high colony count. Time and temperature are two of the largest factors that affect the rate of binary fission.
Regardless, we still need to start the 4 week validation all over again. I just want the note from the lab explaining why the results are elevated.
This might get messy!
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Post by Admin on Aug 18, 2021 14:19:24 GMT
Oh boy! I'm sorry you're going through that, Chuck. It can be a bit of a disaster sometimes.
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Post by gfreely on Aug 18, 2021 17:26:16 GMT
We must use the same lab...:/
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Post by Chuck Weddle on Aug 18, 2021 17:53:32 GMT
Ascend?
They have sent my comments to their QA department for review/comment "and will get back to me". Translated means "we won't respond and he'll go away". They don't know me very well!
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Post by Admin on Aug 18, 2021 18:03:26 GMT
Sounds like you need a Hotline to their team  |
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Post by gnurk on Aug 18, 2021 21:53:29 GMT
how about you switch to spectra
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Post by Chuck Weddle on Aug 19, 2021 9:33:48 GMT
how about you switch to spectra A number of reasons: - I don't trust anything owned by Fresenius.
- They don't do all of the testing we want.
- Reporting sucks.
- In normal Fresenius fashion, they rape you on pricing.
- Long turnaround times. It's rumored that FMC clinics get preference if the lab is busy.
- It's Fresenius.
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joey
Full Member
Posts: 186
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Post by joey on Aug 19, 2021 15:09:20 GMT
A number of reasons: - I don't trust anything owned by Fresenius.
- They don't do all of the testing we want.
- Reporting sucks.
- In normal Fresenius fashion, they rape you on pricing.
- Long turnaround times. It's rumored that FMC clinics get preference if the lab is busy.
- It's Fresenius.
I hear you on all things Fresenius !! That being said, we used satellite forever with no real issues then it was ascend and we started having issues not long after so we went with Spectra. Spectra has two entities...one for the Fresenius owned clinics and one for the non. We are a non and we have never had issues in any manner. I will not say the reporting is great in terms of the website interface but it works. they come Mon-Fri and pick up the samples and we have the results in a timely manner. We have to send the quarterlies to California via UPS or Fed ex and haven't had issues with that either. We have been using them for at least 5 years I believe. Our pricing was better than Ascend as well. |
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Post by belvedere on Aug 19, 2021 17:15:11 GMT
how about you switch to spectra A number of reasons: - I don't trust anything owned by Fresenius.
- They don't do all of the testing we want.
- Reporting sucks.
- In normal Fresenius fashion, they rape you on pricing.
- Long turnaround times. It's rumored that FMC clinics get preference if the lab is busy.
- It's Fresenius.
Chuck, one other factor that you may not have considered is their relationship to Fresenius... |
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Post by dialysis20yrsplus on Sept 15, 2021 11:11:17 GMT
Hey Chuck, are you using the 4 week validation on Dialysis Machines? If so, is this a policy your company has that you have to start the validation process all over again because of a late arrival to the lab? Are you not using the machines due to the fact you are unable to validate for 4 consecutive weeks? In V253 it states "Culture …dialysate fluid weekly for new systems until a pattern has been established.." With the validation of a water treatment system the 4 week validation is to ensure the disinfection protection is viable between monthly disinfections. The same is true for bicarb mixing/distribution systems that weekly cultures must be obtained for 4 weeks even though bicarb mixing/distribution systems require weekly disinfections. This is due to bicarb being such a rich environment for microbial growth. In my experience the validation of dialysis machines is to ensure the machine disinfection is sufficient to provide protection for microbial growth from daily disinfections after use and intermittent disinfections when a machine is not being used. It would stand to reason that if you have drawn 3 weeks of dialysate cultures with acceptable results, then had a late arrival that was processed and found to be acceptable, drawing one additional week would round out the validation process. This would show a "pattern" being established. Our process is the draw initial cultures on install and 10% of the machines are tested for electrolytes. The machines are placed in service and the additional cultures are drawn weekly on all machines for 3 additional weeks. If there is a machine that cultures or endotoxins are elevated the process starts over for that machine. If there is a late arrival to the lab then an additional sample is drawn. I would not see where, if a surveyor would look at this and ask questions, the explanation of the issue wouldn't be accepted. If the surveyor would cite, then I would not see how it would make it past the surveyor's supervisor who, at least in my state, has the decision on whether to cite or not. Just my two cents.
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Post by Chuck Weddle on Sept 15, 2021 11:37:56 GMT
Hey Chuck, are you using the 4 week validation on Dialysis Machines? If so, is this a policy your company has that you have to start the validation process all over again because of a late arrival to the lab? Are you not using the machines due to the fact you are unable to validate for 4 consecutive weeks? In V253 it states "Culture …dialysate fluid weekly for new systems until a pattern has been established.." With the validation of a water treatment system the 4 week validation is to ensure the disinfection protection is viable between monthly disinfections. The same is true for bicarb mixing/distribution systems that weekly cultures must be obtained for 4 weeks even though bicarb mixing/distribution systems require weekly disinfections. This is due to bicarb being such a rich environment for microbial growth. In my experience the validation of dialysis machines is to ensure the machine disinfection is sufficient to provide protection for microbial growth from daily disinfections after use and intermittent disinfections when a machine is not being used. It would stand to reason that if you have drawn 3 weeks of dialysate cultures with acceptable results, then had a late arrival that was processed and found to be acceptable, drawing one additional week would round out the validation process. This would show a "pattern" being established. Our process is the draw initial cultures on install and 10% of the machines are tested for electrolytes. The machines are placed in service and the additional cultures are drawn weekly on all machines for 3 additional weeks. If there is a machine that cultures or endotoxins are elevated the process starts over for that machine. If there is a late arrival to the lab then an additional sample is drawn. I would not see where, if a surveyor would look at this and ask questions, the explanation of the issue wouldn't be accepted. If the surveyor would cite, then I would not see how it would make it past the surveyor's supervisor who, at least in my state, has the decision on whether to cite or not. Just my two cents. We used to do just an initial culture/endotoxin and put the machines into service providing the results were good. About 10 years ago, a surveyor cited us for not doing the 4 week validation on new machines. I argued that it was for water systems and they countered with a single sentence in AAMI that mentions machines. I will try to dig it up and post it. We don't automatically restart the validation because of a late arrival, we wait to see the results. Many times they are acceptable and it doesn't matter. |
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Post by Chuck Weddle on Sept 15, 2021 11:53:58 GMT
V-253 actually was what they cited. It says:
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40 (a)
7.2 Microbial monitoring methods:
7.2.1 General: Dialysate: monthly dialysate sample/collection/freq
Culture …dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution.
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Post by dialysis20yrsplus on Sept 15, 2021 22:14:29 GMT
V-253 actually was what they cited. It says: ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40 (a) 7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/freq Culture …dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. So it appears the adhoc'd the Vtag and by adoption 7.2.1. That is a shame and from my perspective (for what that is worth, lol) not right. |
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Post by Chuck Weddle on Sept 15, 2021 23:20:24 GMT
I agree with you 100%.
Dialysis machines are disinfected daily. What kind of pattern are they expecting to establish?
For what it's worth, I think this is something that was misworded and slipped by AAMI.
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Post by stephenccarr on Sept 16, 2021 22:48:13 GMT
Still Culturing Bacteria?
40 some years ago dialysis standards mandated culturing water and dialysate fluids for bacteria by a qualified lab. The maximum limits allowable were in the thousands of cfu/ml. At the time it was known that high bacteria levels were associated with problem outcomes and it was the only feasible biological test available.
At least in America, the trade organization AAMI published the standards used at the time, and did for many years thereafter. More recently the CMS has set the rules and enforcement.
Subsequently it was realized that bacteria were too large to pass through a dialyzer and that the threat to the patient was due to small endotoxins, which easily pass. The rabbit fever test for endotoxin was being substituted by the LAL floc test but few labs had this capability, and it was expensive and based upon serial dilution. This was something affordable for those making WFI (water for injection) or solutions so based, but not for the dialysis clinic.
The technical breakthrough was the development of equipment that could measure the rate of formation of the LAL floc. It was more precise than serial dilution and much less expensive. Over time this equipment became more portable so that a clinic itself could make the measurement. Results in hours of something clinically important were available versus days of delay for culturing bacteria on site and even longer when done by an outside lab.
Well, the commercial labs did not want to lose a lucrative market, so the requirement for culturing by these labs continued with little justification. The Europeans went one step further with the use of a different culturing medium requiring an 8 day incubation. Corporate power over trade organizations is not really any different the other side of the pond.
In the 1990’s I tried to participate in AAMI’s dialysis group. They made it as difficult as possible. They did not want outside input to their club of companies milking the taxpayer funding of dialysis treatments.
So I can sympathize with all those who must take the samples, ship them by Next Day Air, and await answers days later that are of dubious value at best.
Stephen Carr
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