Title: Section 58-2.21 - Limited transfusion services

58-2.21 Limited transfusion services.

(a) No person shall own or operate a limited transfusion service in New York State unless approved by the department. An inspection may be conducted prior to departmental approval. Limited transfusion services shall comply with the provisions in this Part governing transfusions in general.

(b) Limited transfusion services shall have a written agreement with an issuing facility holding a permit in blood services-transfusion. The agreement shall specify the division of responsibilities for ensuring compliance with the provisions of this Part. The agreement shall be subject to the prior approval of the department. The agreement must include:

(1) the written approval of the issuing facility's director of transfusion services and the director of the limited transfusion service;

(2) the procedures for transport and storage of blood and means to ensure compliance with such procedures;

(3) a description of the transfusion committee of the issuing facility, its responsibilities and composition;

(4) procedures for training of personnel at the limited transfusion service;

(5) requirements for handling adverse reactions, including training of personnel, availability of a physician, 24-hour coverage, and reporting and investigation of such reactions;

(6) procedures for administration of transfusions, including staffing requirements; and

(7) recordkeeping procedures as required in sections 58-2.18 and 58-2.19 of this Subpart, clearly describing responsibilities for maintenance of records and their location.

(c) Transfusions may be performed outside of hospitals only if the patient is cooperative, is able to respond to verbal commands and give informed consent and does not have a history of hemolytic or anaphylactic reactions. The initial transfusion for a given patient shall not be performed in the home setting, and subsequent transfusions may be performed in a patient's home only if physican limitations or hardships exist which would impede transportation to or transfusion in a hospital or ambulatory care setting.

(d) A qualified licensed physician must supervise personnel administering transfusions by limited transfusion services and must be responsible for ensuring that such personnel have adequate training and experience.

(e) A licensed physician, physician assistant, or nurse practitioner must be immediately available for personal or telephone consultation during the transfusion and for 30 minutes afterward.

(f) Any site at which a transfusion is performed by a limited transfusion service must have available an accessible working telephone to allow communication in case of an adverse reaction. All medications, equipment and supplies necessary for the management of adverse reactions must be immediately available on the premises. Infectious waste disposal must be undertaken using containers and procedures found acceptable by the department pursuant to Part 70 of this Title.

(g) Referral of a patient for out-of-hospital transfusion therapy must be approved by the director of the limited transfusion service or his/her designee. Each such transfusion must be ordered by a licensed physician, physician assistant, or nurse practitioner, and a copy of the order must be provided to both the limited transfusion service and the facility issuing the blood.