N.Y. Comp. Codes R. & Regs. Tit. 10 § 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 shall 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
(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 physical
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.
Notes
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