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Role of the Physician in the Blood Center
Physicians play a central role in blood centers with direct and indirect responsibilities. The physician’s role actively participates in the blood center activities, including collection, manufacturing, storage, and distribution of biologics (cellular therapies and blood components), and, in some cases, infectious disease testing, reference laboratories, therapeutics (apheresis, cell salvage), and research ( Fig. 4.1 ). Blood centers serve a humanitarian need, and mission statements of blood centers often include performing at the highest level regarding donor and patient care. However, blood centers are corporate entities and have financial responsibilities. As physicians, the ultimate responsibility is to advocate for the best donor and patient outcomes and not blood center revenues ( Box 4.2 ).
Blood center physician oversight.
Blood Center Table of Organization
Physicians in blood centers are often given the title of Chief Medical Officer (CMO) or Medical Director with a reporting line to the Chief Executive Officer (CEO). They may have business units or areas where they are directly responsible; however, their responsibility often extends beyond documented lines of authority as they are responsible for medical aspects of the organization. Furthermore, the CMO may also be CEO, Clinical Laboratory Improvement Amendments (CLIA) director, and/or FDA responsible head.
Specific Roles
Blood collection is performed under the direction of the medical director. The physician must be qualified by education, training, and/or experience and licensed. The physician is responsible for donor selection and safety, including donor eligibility For example, New York state has specific requirements for medical director in that they are responsible for direction and operation of the blood bank, compliance with all applicable regulations and requirements, establishment and implementation of written standard operating procedures, ensuring competency of and delegating responsibilities to blood bank staff, investigation of cases of possible transfusion-transmitted diseases, and reporting adverse events as required by regulatory agencies and accrediting organization. The medical director per American Association of Blood Banks has responsibility and authority for all medical and technical policies, processes, and procedures, and for the consultative and support services that relate to the care and safety of donors and/or transfusion recipients. As such, physician’s roles may include determining appropriate equipment, adjusting donation intervals, methods to decrease donor or patient adverse events, and implementing new donor tests or testing algorithms.
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