October 1996 

   The Food and Drug Administration (FDA) and Health Care Financing Administration (HCFA) have just set out new regulations to cover what must happen when it is learned that a blood donor has apparently given blood during the window of time between infection with the HIV virus and detectable antibodies first appearing in the blood.

   The FDA’s new regulations announced September 9, 1996 apply to establishments which accept, process and consign blood and blood products to hospitals. When a donor, whose blood sample tested negative for HIV during a previous donation, later gives a sample which upon repeated retesting appears HIV-reactive, any hospital which previously received blood which came from this donor must be notified.

   HCFA’s new regulations were announced September 9, 1996 concurrently with the FDA’s new regulations. HCFA’s regulations apply to every hospital which participates in the Medicare or the Medicaid program, irrespective of whether the particular patient involved is a Medicare or Medicaid patient.

   HCFA will require, effective November 8, 1996, that hospitals have written procedures in effect to quarantine any blood or blood products remaining in stock from a donor who the hospital has been notified has given a subsequent blood sample which is HIV-reactive.

   Hospitals must also create procedures to attempt to contact the treating physician of a recipient of blood or blood products from such a donor, or the recipient, if the donor is conclusively established to be HIV-positive, and must document the results of such attempts at notification.

   Recipients must be made aware of the need for HIV testing and counseling. HCFA has not offered guidance whether physicians or patients should or should not be advised of the specific details behind notification being necessary, such as the identities of the companies or agencies which collected, processed and/or administered the blood. The donor’s identity, however, even if known, must remain confidential.

   HCFA has stated unequivocally that it is not up to the hospital to weigh the issue of whether or not it is appropriate to notify any particular individual that he or she may have been given HIV-infectious blood or blood products. A documented, good faith effort to notify the patient is mandatory.

   The means for notifying patients are only suggestions from HCFA at this time. HCFA has suggested a hospital should start by making three attempts to reach the patient’s treating physician by phone within one week of first learning of a potential problem, the physician being the most appropriate person to bring up the subject with the patient, according to HCFA.