Humidity Monitoring

We have multiple sites using the Siemens Clinitek Status Plus in various geographical areas that frequently have low relative humidities. COLA, as our deemed authority for our sites, made the recommendation to perform QC for the Clinitek and document within our temperature monitoring system the outcome of the QC testing as being within recoverable limits. (The documentation in the temperature/humidity documentation system was done to pair the humidity reading with the statement of QC performance. This could just as easily be documented in whatever means of recording QC that is in use.) This would demonstrate that although the target humidity value (18%) was not achieved, the results obtained are within anticipated limits and are comparable to results obtained when the measured relative humidity is within stated limits.

We believe that this approach is more likely to deliver a meaningful, accurate, and reproduceable value than to utilize a manually timed and human-read value.

Our ICP indicate that humidifiers can be used, but there are many items of documentation and housekeeping that must be performed and documented. The level of intervention necessary if a humidifier is used may outweigh any advantages of locally increasing the humidity by artificial means.

Thank you, Andries, for your reply. Do you perform QC every day that the humidity is out?

We are located in Cincinnati Ohio and are having the same problem you are having. Humidity as low as 14%, cannot use a humidifier and we have Cliniteks. Currently as long as daily QC passes, we are continuing to use the Clinitek. I am interested to hear what other POC programs are doing.

Although not specifically required, we perform Clinitek QC daily as a standard practice, partially to accommodate this issue and to help assure that nothing has happened to any opened bottle of strips.

what is the margin of error for your humidity monitoring device? Maybe you can use the margin of error to justify that it is still within by having the lab director state +/- whatever the margin of error is. Just an idea.

As the Cliniteks are being used in Waived settings, wouldn't performing QC outside of the 18-80% humidity range as stated in the Operator's manual to prove it is OK for patient testing make it not Waived any longer? 

Shanna, you bring up a good point. I will need to investigate that.

Here in the southwest (New Mexico) we have a constant problem with low humidity, in the lab as well as POCT. Infection control does not like humidifiers, and it's hard to get POCT operators to keep them properly operating. We have been around and around with this discussion with the entire organization, especially since CAP seems to be concentrating on this issue. There's really not much we can do. The low humidity for the Clinitek only impacts the screen, with statis electricity. We've been through it with Siemens multiple times, but since they don't manufacture all the parts of the device, they really can't change anything. We've done extensive studies of both QC and patient results for months at a time, and that' just going to have to be enough. We do have one site that, once they take the reading, if it's out they will send urines to the lab. We have also gone back to the dark ages with monitoring. In spite of electronic temp/humidity monitoring, we've gone back to daily manual monitoring, including moving the probe to the highest humidity area. It's a crazy problem, and one that just can't be solved unless we put a dome over NM!

Siemens sent out a Customer Notification about humidity. I will attach it.

Status low humidity bulletin.pdf

Thanks so much, Karin. This is my biggest complaint about Siemens. They are rubbish at communication, at least in our state. I am so glad we have this listserv. This is reminding me of the DCA debacle, where the listserv was the way many of us found out there was even a problem. I'm quite over it!