[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.47]

[Page 82]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 610_GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
     Subpart E_Testing Requirements for Communicable Disease Agents
 
Sec.  610.47  ``Lookback'' notification requirements for transfusion services.

    (a) Transfusion services that are not subject to the Health Care 
Financing Administration's regulations on conditions of Medicare 
participation for hospitals (42 CFR part 482) are required to take 
appropriate action in accordance with paragraphs (b) and (c) of this 
section when a recipient has received Whole Blood or blood components 
from a donor determined to be unsuitable when tested for human 
immunodeficiency virus (HIV) infection in accordance with Sec.  610.45 
and the results of the additional tests as provided for in Sec.  
610.46(b) are positive.
    (b) Notification of recipients of prior transfusion. If the 
transfusion service has administered Whole Blood or blood components as 
described in paragraph (a) of this section, the transfusion service 
shall notify the recipient's attending physician (physician of record) 
and ask him or her to inform the recipient of the need for HIV testing 
and counseling. If the physician is unavailable or declines to notify 
the recipient, the transfusion service shall notify the recipient and 
inform the recipient of the need for HIV testing and counseling. The 
notification process shall include a minimum of three attempts to notify 
the recipient and be completed within a maximum 8 weeks of receipt of 
the result of the licensed, more specific test for HIV. The transfusion 
service is responsible for notification, including basic explanations to 
the recipient and referral for counseling, and shall document the 
notification or attempts to notify the attending physician or the 
recipient, pursuant to Sec.  606.160 of this chapter.
    (c) Notification to legal representative or relative. If the 
transfusion recipient has been adjudged incompetent by a State court, 
the transfusion service or physician must notify a legal representative 
designated in accordance with State law. If the transfusion recipient is 
competent, but State law permits a legal representative or relative to 
receive the information on the recipient's behalf, the transfusion 
service or physician must notify the recipient or his or her legal 
representative or relative. If the transfusion recipient is deceased, 
the transfusion service or physician must continue the notification 
process and inform the deceased recipient's legal representative or 
relative. Reasons for notifying the recipient's relative or legal 
representative on his or her behalf shall be documented pursuant to 
Sec.  606.160 of this chapter.

[61 FR 47423, Sept. 9, 1996]