Octifuge at home CLIA regulation?


I was wondering if anyone has had issues with Home Hemo pt’s spinning their labs at home? Does CLIA have any type of certification or is a waiver needed to operate the Octifuge? The pt. receives training and skill is on the check list during their initial training. The equipment is supplied by lab.


Susan Ronning, RN, BSN

It’s my understanding that CLIA applies to labs, not patients who do testing in their homes. That said, most patients have blood drawn at dialysis clinics or by their local doctors with the results sent to the dialysis clinic. If you’re concerned about home patient’s’ hemoglobin levels and are fearful of having a cut in reimbursement if they continue to self-administer EPO and their Hgb goes too high, you may want to read the Claims Processing Manual which says:

“Effective for services provided on or after April 1, 2006, Medicare has implemented a national claims monitoring policy for EPO administered in Medicare renal dialysis facilities. This policy does not apply to claims for EPO for patients who receive their dialysis at home and self-administer their EPO.”

http://www.cms.hhs.gov/manuals/downloads/clm104c08.pdf (see page 53)