Title: Section 58-2.16 - Required standards for transfusion
58-2.16 Required standards for transfusions.
(a) Transfusion services. Every institution which performs transfusions or supplies blood to a limited transfusion service or ambulance transfusion service shall designate a physician who is a member of the staff as director of transfusion services. Such physician must be licensed and currently registered in New York State. The premises, equipment, procedure manuals, records, and all blood, blood components and derivatives shall be available for inspection by the department.
(1) It shall be the responsibility of the chief executive officer or other person in charge of each institution and of the director of transfusion services to determine that:
(i) the rules and regulations of the Council on Human Blood and Transfusion Services and the Administrative Rules and Regulations of the department and related requirements are complied with;
(ii) attending and other staff members and nurses are properly instructed regarding all required procedures;
(iii) records required by the aforesaid rules and regulations are maintained;
(iv) serious unexpected reactions and incidents involving blood components that have been issued by the transfusion service are reported to the department's Wadsworth Center, with sufficient detail to facilitate evaluation and investigation, within seven (7) calendar days of the reaction or incident, or its discovery and, if required, to federal authorities; and
(v) a written policy exists regarding use of blood components negative for cytomegalovirus antibody, irradiated components, leukocyte-reduced components and other specialty components. Such a policy shall include recommended indications for component use and a protocol for component processing and issuance. There shall also be a written policy on recommended indications for transfusion of whole blood, fresh frozen plasma and platelets.
(2) The institution shall report annually to the department the name(s) of the physician(s) in charge of the transfusion service.
(3) If blood componets are issued to a limited transfusion service or an ambulance transfusion service, the director of transfusion services of the issuing facility and the director of the limited transfusion service or an ambulance transfusion service performing the transfusion shall ensure compliance with all requirements of this Part.
(b) Each institution that performs transfusions or supplies blood to a limited transfusion service and/or an ambulance transfusion service shall have a transfusion committee that meets at least quarterly. The committee shall:
(1) be composed of at least five members;
(2) include members with expertise in clinical medicine and/or transfusion medicine and who are qualified to review the appropriateness and technical aspects of a transfusion; and
(3) review all or a representative sample of transfusions of all categories of blood and blood products issued by the facility for administration at any location, including all intraoperative and postoperative recovery procedures.
(c) Each institution, through its transfusion committee, shall establish guidelines for reservation (compatibility or crossmatching) of blood for each elective surgical procedure which has been performed there more than five times in the preceding calendar year and shall set the maximum number of hours that crossmatched blood will be held on reserve.
(d) Whole blood, red blood cells, plasma, or other components and derivatives shall be prepared and administered by methods generally accepted by the F.D.A. or American Association of Blood Banks and/or by other methods approved by the department as in conformance with generally accepted laboratory principles. No medications except physiologic saline for intravenous use shall be added to, mixed with, or administered in the same line with a blood component unless approved for this use by F.D.A. and there is documentation available to show that the addition is safe and does not adversely affect the blood component. A filter meeting F.D.A. requirements shall be incorporated into the intravenous administration set to be used for blood or blood component transfusions.
(e) In a health care setting, the person initiating transfusion of blood or blood components shall be a: (1) physician; (2) registered nurse; (3) physician assistant; (4) nurse practitioner; (5) board-certified cardiovascular perfusionist (intraoperatively); or (6) licensed practical nurse who has completed a transfusion training program meeting criteria specified by the department and by the New York State Education Department, when supervised by a registered nurse, physician assistant, or a physician who is immediately available on site.
(f) In a health care setting, following comparison of the unit's label with all accompanying information, the person initiating transfusion of a blood component shall, at the patient’s side, immediately prior to initiating the transfusion, positively identify the recipient and the blood component to be transfused, using the patient’s name and a unique numerical or alphanumerical identifier. One additional person, authorized to initiate transfusion, and who is not a licensed practical nurse if the person initiating the transfusion is a licensed practical nurse, shall also so identify the recipient and the blood component, unless another procedure to ensure accurate identification is used, in which case a single identification shall be sufficient. Each identification procedure shall be documented in writing by each participant. Two persons authorized to initiate blood transfusions shall be immediately available during a blood component transfusion and for 30 minutes afterward, except for transfusion of a patient enrolled in a chronic transfusion program who has no history of adverse reactions. A blood component recipient’s vital signs shall be serially recorded, in accordance with written policies and procedures. If the person recording the vital signs is a licensed practical nurse, all measurements outside of established parameters shall be reported to a registered nurse, physician, physician assistant, or nurse practitioner for assessment and action. Such notification shall be documented. (g) For transfusions outside a health care setting, including those in a patient's home, but not including those in an ambulance, the person initiating the transfusion and monitoring the patient shall be a physician, registered nurse, physician assistant, or nurse practitioner. Following comparison of the blood product label with all accompanying information, this person shall, at the patient’s side, immediately prior to initiating the transfusion, positively identify the recipient and the blood product to be transfused or infused, using the patient’s name and a unique numerical or alphanumerical identifier. Each such identification procedure shall be documented in writing. A person authorized to monitor transfusions and another competent adult, other than the recipient, shall be immediately available at all times during a transfusion. Both persons shall be available for 30 minutes afterwards, except for transfusions of patients enrolled in a chronic transfusion program who have no history of adverse reactions. The recipient’s vital signs shall be monitored serially and documented, in accordance with written policies and procedures. (h) Transfusions during transport between hospitals may be administered only by a registered nurse, nurse practitioner, physician assistant, physician, or emergency medical technician certified at the critical care or paramedic level, provided such emergency medical technician has received training in blood administration in accordance with requirements established by the department and is performing these services as part of an ambulance transfusion service approved by the department. Blood components to be issued to an ambulance transfusion service must be ordered by a health care provider caring for the patient using a standard order form approved by the department. The transfusion service issuing the blood components shall be made aware that the blood is intended for possible administration during transport between hospitals and shall be informed of the destination hospital. Blood components intended for possible administration during transport shall be packed in a suitable container validated to maintain the appropriate temperature for the anticipated duration of transport. Prior to departure, the identification of the patient and of any blood components to be transported for possible administration during transport shall be verified in accordance with subdivision (f) of this section. In addition, a registered nurse, physician assistant, nurse practitioner, or physician shall verify, at the patient’s side, the identification of the patient and all blood units, with the qualified person who will be caring for the patient during transport. (i) Every facility or limited transfusion service performing transfusions shall provide 24-hour-a-day post-transfusion patient coverage by telephone as necessary.
(j) Each institution, through its transfusion committee, shall develop and implement procedures to encourage the use of autogeneic blood whenever medically indicated. These procedures shall include a mechanism for informing staff physicians of the risks and benefits of autogeneic blood and the options for autogeneic blood transfusion available at the institution, including, but not limited to, intraoperative blood recovery, isovolemic hemodilution and presurgical deposit, as applicable. These procedures shall also include a mechanism to encourage physicians to inform their patients of such options whenever medically indicated. (k) If blood is warmed prior to transfusion, the warming system shall be equipped with a visible thermometer and an alarm to ensure that the blood is not warmed above the temperature specified by the director of the blood bank, in conformance with the system manufacturer’s instructions. Blood warmer temperature shall be monitored and recorded on each day of use, and such records shall be available for inspection for at least five years. Maintenance and operation of blood warmers must conform to the manufacturer’s instructions.
VOLUME A-1 (Title 10)