My clinics have the HemoCue Hb 201+ and they use the below:

By HemoCue

| MFR#: HCLNH3 | TIGER#: TM73687

We use the HemoCue 801. We do not require/run external QC, when we brought it in there were no controls in the US that had been approved, although I believe there are now. 

Full Disclosure: I am the Product Specialist for Eurotrol.

We have HemoTrol Duo which is an approved QC for the HemoCue 801.  3 levels- low,normal and high.

I have a clinic that wants to use HemoCue Hb801. We do not use HemoCue at all in our main hospital, and thus I'm not familiar with this device. Looking through the manual there does not appear to be a "QC Lockout" feature. There is no barcode scanner or manual way to identify a specimen being tested as quality control. If QC where to fail, the HemoCue Hb801 would still allow patient testing which is unfortunate.

 This clinic is not accredited by CAP, TJC or COLA. I am familiar with CAP guidelines, but since they are only inspected by CMS, I'm looking through the State Operation Manual Appendix C for their guidelines and I'm finding it difficult to navigate. Per §493.15(e)(1) manufacturer's instructions must be followed. The operator's manual says, "If an external quality control is required by local or other regulations, see section 9 for procedure instructions." These two statements seem to be going in a loop. 

Being that Hb801 is a CLIA Waived test, I'm trying to find supporting documentation for running only two levels of control with every lot of cuvettes and every 30 days. CMS Interpretive Guideline §493.1256(c) states, "Traditionally, laboratories have tested two levels of external control materials daily to monitor the accuracy and precision of the analytic test system components."

Is there a way to justify running external controls Monthly instead of Daily under CMS guidelines on a CLIA Waived test such as the Hb801?
Or, how do you get away with not running any external quality controls?

External QC is not required on the HemoCue Hb801 hemoglobin analyzer. I work for HemoCue and can provide you with the documentation for that. Also, you are correct in that the Hb801 does not have a barcode scanner or manual way to enter QC data. However, the Hb201 DM (Data Management) analyzer has both of those features as well as QC Lockout; it is also capable of connecting to your EHR via middleware.
     If you have any questions or need more information, please feel free to contact me. I can also put you in touch with your local rep for further discussion.