Section 58-2.26 - Exceptions

58-2.26 Exceptions.

(a) When, for indications generally accepted by the medical community, an allogeneic donor who would not otherwise qualify to donate blood or blood components is found to be uniquely suited to meet a given patient's needs, exceptions may be made to the requirements in sections 58-2.2(b) and (c), 58-2.3(a), 58-2.4(c), and 58-2.15(c), (d) and (e) of this Subpart. Such exceptions shall be approved in writing by both the medical director of the blood bank collecting the blood or his/her physician designee, and the director of the transfusion service transfusing the blood or his/her physician designee. If donation under such circumstances presents an increased risk to the donor's health or safety, the donor shall be informed of the risk and must consent in writing to such donation. If the donation presents an increased risk to the recipient's health or safety, the written authorizations of the recipient's health care provider and the recipient or person legally authorized to consent on behalf of the recipient are also required. All such exceptions granted shall be reported to the department annually in a format designated by the department.

(b) Exceptions to the requirements of this Subpart, other than the exception specified in subdivision (a) of this section, may be granted by the department on a case-by-case basis and for a limited time only, if necessitated by a medical emergency or special medical conditions. Persons seeking an exception shall apply to the department as soon as possible and shall describe the nature of the emergency or special medical conditions and the exception requested. All such emergencies or special medical conditions must be documented in the medical record, and any action taken in response which is contrary to the requirements of this Subpart must be approved by the director of transfusion services. If it is not possible to request an exception in advance or if the department has not responded before an action contrary to the requirements of this Subpart had to be taken, the director of transfusion services must report the action taken to the department as soon as possible thereafter but not later than the end of the next business day after the action was taken.
 

Effective Date: 
Tuesday, October 23, 2007
Doc Status: 
Complete