ROM + Unknowns
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Does anyone out there have suggestions for Patient Unknown specimens for ROM+ competency?
Users need to run QC and an unknown patient. QC is easy, but what is everyone using for Patient unknowns?
Thanks!
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Gloria,
Is this a waived test? If it is, then competency assessment does not require all 6 elements. The lab can decide how to assess. Running QC and taking a quiz should be sufficient. Your SOP needs to be revised accordingly.
If it is a non-waived test, then you can use previously tested proficiency samples in place of patient samples.
This is a non-waived test, and therefore needs all 6 elements. The huge problem with these tests done at POC is that there are so many operators. The tests are expensive, and using previous proficiency samples doesn't always work because there are multiple people who need to prove competency.
So, if there are any vendors on--it would be soooooo wonderful if someone would start a company to make training samples and devices (i-STAT cartridges, etc.) to be used for training and competency assessment. We would pay for them, but hopefully a lower cost. That would be such a great help to POCCs everywhere!
What we have found is that trying to use their QC material for the positive unknown doesn't work so well. I think this is because the QC is not run the same way as a patient- you crack the vial, shake for 45 seconds and dispense directly into the sample well.
We found that we would *still* get a positive result if processed like a patient (Dip swab in QC sample for 15 sec, put in buffer 15 sec, dispense), but the result is very weak and takes longer than the prescribed 20 minute test time to come up.
The proficiency samples don't have a long shelf life, and there isn't enough material there to evaluate everyone.
The vendor offers a validation set of 20 unknown amniotic samples which can be thawed and refrozen 3X if we follow instructions. I think we will be opting for this choice; we can make them last quite a while if properly stored.