POC use of refractometer
I was approached by my Hem/Oncology POC educators regarding the possible use of the refractometer for their chemo patients. It looks like several hospitals are moving away from using strips because of the unreliability of the specific gravity in this patient population. I reached out to the manufacturer of a well known strip to see if they had any input. I was provided a bulletin put out last November which stated that their product "should not be used to make a medical decision regarding chemotherapy treatment". This now presents a significant problem for us. Do any of you utilize the refractometer as a point of care instrument (or even in the lab for that matter)? From what I can tell, it will be a moderately complex test. Any input/information you can provide will be appreciated.
Debbie
Debra Howard BSMT(ASCP)
POCT Coordinator/CLS
Children's Hospital of the Kings Daughters
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I use the Atago digital refractometer at POC. Its very easy to use and really dependable. Run distilled water and 5% NaCl as two levels of controls daily.
Hi Debra,
We use a digital refractometer in three units in our hospital to screen urines for hCG testing. The brand is Sper Scientific and has been very reliable.
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How often do you eliminate urine samples for hCG testing based on the SG?
Donna MCCalla, MT ASCP
POCC Main Line Health
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Not very often do we get low specific gravities but we do attach a comment to that effect when we get one and let the physician determine how they want to proceed.
Regarding low S.G. rule-out on urine hCGs, one study I did showed that it affected roughly 10% of samples received.
And yes, unfortunately, it is moderately complex, simple as it is. I was caught on this once by TJC, never dreaming it was moderate. We dropped using it to screen urines as it did not seem to be worth the trouble, and we wanted the physician office lab using it to be reduced to waived/PPMP only.
Didn't know about the unreliability with regard to chemo patients, thanks for sharing. Wonder what the nature of that is. I have never much trusted teststrip-based S.G., but with it being the primary means of testing for 30+ years, I always sort of assumed it was good enough for most purposes, in most physician's eyes.
James,
The digital refractometer is still considered moderate complex? Do you know where I would be able to find that regulatory standard?
We are currently using refractometers in POCT but hoping to move away from them to a waived test because of having enough staff to manage it as Mod-complex. Unfortunately dipsticks do not correlate well enough for our chemo patients.
This is a case where CMS needs to catch up with the current technology. I agree that the refractometer from the "dark ages" should be classified as moderately complex. The digital format however is simpler than the urinalysis instrument which is classified as waived.
It was a Joint Commission survey where we were cited, but they were likely just pointing to the fact that it is not on the CLIA list of waived devices/methods. As Debra said, it is definitely an area where CMS needs to get out of the dark ages. My guess is most test methods get pushed into waived status at the behest of their manufacturers, so they can sell more, of course. Without a strong manufacturer push, that is likely why the ol' refractometer remains moderately complex.
Brystal, for the current list of waived test see
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/analyteswaived.cfm
Hope this helps!
Thank you.