§ 30.21. Responsibilities of directors and supervisor.
(a) The medical director shall be responsible for determining and establishing policies and procedures governing all phases of blood banking. The licensee is obliged to demonstrate that the medical director spends sufficient time on the premises to fulfill the requirements of this section.
(b) The blood bank director shall be responsible, under the direction of the medical director, for implementing policies and procedures governing all phases of blood banking.
(c) The supervisor shall be responsible, under the direction of the medical director and blood bank director, for application of policies and procedures governing all phases of blood banking. Depending upon the size and complexity of the establishment, there may be more than one level of technical and nursing supervisors.
(d) Any procedures involving the service of transfusing or injecting of blood products into humans must be under the supervision of the medical director.
(e) The supervisor must be present during the normal working hours of the blood bank, including mobile units.
(f) The medical director or properly qualified designee must be available for consultation at all times outside of regular working hours.
(g) Any time blood is being obtained from a human donor, a physician who is licensed to practice medicine in this Commonwealth shall be available within ten to 15 minutes so as to be able to handle emergencies which may arise.
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