Low Humidity

Wow! That is really low humidity. We do have a device that does not consistently meet the humidity range for testing. The device is on a movable cart. The cart is temperature & humidity monitored, giving readings every 5 minutes. If the cart can be relocated to an acceptable humidity, qc will be rerun and patient testing can resume. If a location cannot be identified that will meet the IFU, testing cannot occur and backup to main laboratory must be utilized. 

We never had the very low humidity you got but whenever we encounter humidity issues, we perform QC's to validate patient results are not impacted.

Just curious, why did you cease testing? The manufacturer supplies optimal operating specifications in their IFUs. Just because the humidity is below this optimal range, does not mean that the instrument needs to be taken out of service unless the manufacturer states so. I would call the manufacturer's Tech Support and get the facts- could be that simply running external QC and it being acceptable is enough to proceed with patient testing. We also employ humidifiers at some locations. 

In our case of moderate testing POC, the IFU does not state the temperature and humidity as "optimal range", they are listed as Specifications for use. We use temperature/ humidity monitoring with the ranges set to flag if not reading within. Accreditation requires intervention and documented follow up.  Any deviation of performance would make the test high complexity. 

In the case of waived testing, the IFU might say something more relaxed and suggestive. 

@Karin Gehringer, What humidifiers are you using?   This has always been a struggle for me to try to find something that is approved by infection control.  Not sure if this was an issue in your organization.

This is a constant struggle here in the Southwest, where our humidity is often low. There is really no good fix for it except maybe a dome over New Mexico! What we do now is site the instrument near the humidifier and take the humidity reading once a day. It seems counter-productive when we have an automatic temperature/humidity logger. But there you are--sometime the regulations, in an attempt to make this more accurate or safe, actually put roadblocks in our way. We are struggling with this as an organization, as there is a new CAP GEN checklist question about this. If we ignore the manufacturer's specifications, it will make the device high complexity, and who needs that with a
waived urine device! SMH.  

Yes, I was referring to a waived (not moderate) POCT where I verified with the manufacturer's Tech Support the Operating Specifications were the optimal conditions for the device. With the guidance from the manufacturer, we verified performance by running external and internal controls and we were able to proceed with patient testing. I cannot recall which test it was, but there was no need to cease testing that day. I would never condone ignoring manufacturer's instructions for use! Some of our clinics bought humidifiers and they were approved for use by our Biomed dept. regarding safety but are not under the scientific oversight of the laboratory. They are just simple humidifiers bought at the store. I will ask about our Infection Control involvement for outpatient locations and humidifiers. Thank you!

We had a Clinitek at one hospital ED years ago. We would run QC if humidity was low, and if ok, we'd continue testing. CLIA came in and said that made the device high complexity, so we had to get a humidifier for it. We could use the device only if the manufacturer changed their requirements. And Siemens could/would not change anything--we tried!

I seem to have the most issues at my Anti-Coag Clinic with my Coaguchek , which has an operating humidity of >10%.  We called the manufacturer, and they said it absolutely had to be.  We worked with our Biomed/Facilities Services to get an approved humidifier from them.  However, humidifiers also need to be approved by Infection Control.  Due to the possibility of water borne pathogens from a humidifier, the humidifier would need a high level disinfection process, which literally destroys most humidifiers.  When the humidity is 9%, we move down the hallway to another room that has a slightly higher humidity, however 5% is never going to work.  At that point, we were drawing the patients and sending the samples to the lab.  Looks like that's the way until warms up.  Thanks.

This is insane! I know that most of the issues with low humidity are probably electronic. For the Clinitek, it's the screen and they worry about static electricity if humidity is low. That's understandable, but it doesn't impact the testing. There has to be some wiggle room in these regulations. Once the devices started being used, they became part of patient care and can't easily be just discarded. The asks just seem to get sillier, without really impacting patient safety or test accuracy.

Agree! Kathleen mentioned a new CAP GEN checklist item regarding this. Our CUS GEN checklist only has GEN.60250 and GEN.61300 so it may not apply to our facility. There's no mention of high-level disinfection requirements there. Where is this found? Thanks in advance for any information.

The cleaning with a high-level disinfection comes not from a CAP requirement, but from my hospital Infection Control and their policies.  I did not dig in to see if it was a requirement with their accreditation as the hospital is DNV certified, but I still don't think I'm going to win against Infection Control.  Luckily the weather is warmer and humidity is 20%.

Same here with the high-level disinfection.  It's more of a Joint Commission thing than a CAP one.