Medicare program; protocol for the reuse of dialysis bloodlines--HCFA. Proposed rule.
This proposed rule would establish standards for reuse of bloodlines during hemodialysis as a Medicare condition of coverage for suppliers of end-stage renal disease (ESRD) services. The rule would require that if a facility reuses bloodlines it must reuse only a bloodline for which the Food and Drug Administration (FDA) has accepted the manufacturer's protocol for reuse for that particular bloodline, and that the facility reuse the bloodlines only in accordance with that protocol. Effective July 1, 1988, bloodlines labeled "for single use only or its equivalent" may not be reused but items labeled, for example, "sterility guaranteed for first use only" could be reused if the facility follows a manufacturer's protocol for reprocessing accepted by the FDA. Section 1881(f)(7)(C) of the Social Security Act, added by section 9335(k) of the Omnibus Budget Reconciliation Act of 1986, provides that failure of a facility to comply with these standards would be cause for us to terminate the facility from participation in the Medicare program and to deny payment for the dialysis treatment affected.
D002985:Clinical Protocols; D004209:Disposable Equipment / Q000592:standards*; D006801:Humans; D006278:Medicare / Q000331:legislation & jurisprudence*; D011356:Product Labeling / Q000592:standards; D006435:Renal Dialysis / Q000592:standards*; D014481:United States