Are millipore paddles acceptable for CMS inspectors? We are considering doing the Endosafe Reader from Charles River for endotoxins, anyone else out there doing this and having any problems with inspectors and doing all of you labs in house except the AAMI water panels?

Yes Millipores are acceptable for CMS inspections. We do both bacteria and LALs in house. Millipores for bacteria and we use endotoxin test kits from Associates of Cape Cod. Definitely keeps the costs down. It is a good idea to also have samples sent to a second source to verify that your test are good. We have our water provider do this once a month. If you do your own sani's you may have to set up with an outside lab but you wouldn't have to send as many cultures to them. We just have 3 bacteria from these outlets RO, post UF and return and LAL is also from the return, tested by them.

We use the Millipore and Endosafe for cultures and LAL. The inspectors had no problem with us doing it in-house. Since we have a number of portable RO for our acutes, we do a lot of pre and post disinfection cultures. It is easy and the results are quicker.

What do you say when they ask if you are a biologist? Where is your training on how to read them?

I use Millipore also. It's hard to read them when you have large masses on the plate or multiple strains. And the lab co's have no incentive to tell you little or no growth. So I don't know which is better.

I've spoke with Millipore about the large blobs you can get on the paddles. Question was is it one big cfu or many cfus? They said it could possibly be both and the only way to know for sure is to use a dilution method. If you call them they can send you some info on it and it may be on their website. Retesting is also an option. The thing I don't like about that is sometimes it seems like you aren't really able to do much. i.e. you take a dialysate sample incubate it for the 48 hours and you get readings above the limits or even the action level. You still do what your policy is for this like pull the machine and retest but by then the machine has been cleaned either by heat or chemical probably twice since you took your initial sample. Different jugs have been used if that is what you do. Then on your retest you read good numbers, so it feels like a lot of work and you really didn't seem like you accomplished much except question your procedure on when you got the sample and wonder if it got cross contaminated. So it just leaves you wondering. That 48 hours period for incubation really bugs me. It is a period of unknown potential problems. You read them and have a high count, especially on portables and for that 48 hour period patients have been running and getting exposed to that bacteria and hopefully all your filters to help prevent that are doing their job during that period.

As far as being asked if I'm a biologist and where I got trained. The instructions come in both the millipore boxes and the endotoxin kits. It doesn't say I need a degree to run those test. I would be more than glad to have someone else be responsible for this who might have a degree in Micro and just tell me the results and I would take the appropriate action. So if I was asked or told that I need a degree to do that job I would probably celebrate.

quote:

Originally posted by Goe:
What do you say when they ask if you are a biologist? Where is your training on how to read them?

AAMI RD52 7.2.3 states.....
Dip samplers may be used for bacterial surveillance. However, they should be used only in conjunction with a quality assurance program designed to ensure their appropriate use. Elements of the quality assurance program should include staff training in areas such as the correct methods of inoculation, incubation, and interpretation, and verification involving duplicate samples sent to a certified laboratory on at least an annual basis. Plates shall be incubated at 35 °C for 48 hours. (This method is an indicator of water quality only and is not to be confused with total heterotrophic plate counts, which require much longer incubation times at 28 °C).

Chuck

joebiomed,

Along with big blobs and small colonies, you can have very tiny colonies. I have also seen total coverage of paddle with transparent colonies. You can see the gridlines but unless you look carefully under good light you can miss this growth. When training, I suggest using a Q-tip to swab the surface of the paddle and look for visible growth on the swab or a path on the paddle.