Title: Section 58-2.6 - Collection and handling of blood for subsequent allogeneic or autogeneic transfusion
58-2.6 Collection and handling of blood for subsequent allogeneic or autogeneic transfusion.
(a) Phlebotomy apparatus and blood containers shall be clean, pyrogen-free and sterile. Anticoagulants shall be placed in containers prior to sterilization.
(b) Phlebotomy sites shall be prepared by a procedure found by the department to meet medical standards generally accepted in New York State.
(c) Blood collection systems shall meet the following minimum requirements:
(1) Blood shall be collected under aseptic conditions using an approved closed system or a vented system if adequately protected against contamination.
(2) Anticoagulant solutions shall be sterile and pyrogen-free. F.D.A.-approved formulae such as anticoagulant citrate dextrose (ACD) (21-day storage), citrate phosphate dextrose (CPD) (21-day storage), trisodium citrate (48-hour storage), heparin (48-hour storage), citrate phosphate dextrose adenine-1 (CPDA-1) (35-day storage), and other safe and effective formulae and storage periods, of such length as to assure the blood's continued effectiveness for transfusion and retention of its safety, purity and potency, as approved by the department, may be employed.
(d) Blood in transit shall be refrigerated at one to 10 degrees Celsius, preferably at four to six degrees Celsius, with the exception of units from which platelets will be separated, which may be stored at room temperature. (e) Labeling requirements. (1) For allogeneic collection, the container and the attached pilot blood specimens shall be legibly labeled at the time of collection with the associated unit’s identification code. The container label shall indicate the date of expiration. As soon as available, the results of ABO and Rh grouping tests shall be affixed to component containers. (2) With the exception of units collected in an operating room which never leave the immediate proximity of the patient, for autogeneic collection, the following information shall appear on a label or tag attached to the blood container: ( i) the identification of the collecting facility; ( ii)the patient's name and if available, the name of the hospital or limited transfusion service where the patient is to be transfused and the patient's birth date or identifier. This tag shall be removed if the unit is subsequently used for allogeneic transfusion; ( iii) ABO and Rh group; ( iv)date of expiration; ( v) if the unit does not qualify for allogeneic transfusion, a prominent label to read “For autologous use only" or similar wording; ( vi) an autogeneic unit from a donor who has tested positive or reactive on any of the tests required in section 58-2.3(a) of this Subpart, with the exception of anti-HBc, within the previous 30 days shall be labeled as a biohazard unless confirmatory testing has been negative. The exterior of the shipping container shall not contain any information identifying the donor; and ( vii) a label bearing the donor classification statement "Autologous donor" shall be permanently affixed to the unit.
(f) The blood shall be collected in the manner appropriate for the container employed. Following collection, the container shall be sealed securely. If a container is opened or entered in any way, the blood component must be transfused within 24 hours or discarded, unless a sterile connecting device which maintains a functionally closed system has been utilized for entry.
(g) Until issued, whole blood and red cell components shall be stored continuously in a refrigerator either with a fan for circulating air, or of a capacity and design to ensure that the proper temperature is maintained throughout, and equipped with automatic temperature recording and an audible alarm. Periodic verification of alarm function, in accordance with the manufacturer’s recommendations, shall be documented. Storage shall be at one to six degrees Celsius. No items other than specimens, tissue, or reagents shall be stored in a refrigerator in which whole blood and red blood cell components are stored. Temperature records shall be available for inspection for at least five years. Autogeneic units shall be stored in a separate, specifically designated portion of the refrigerator.
(h) Until issued, cryoprecipitate, fresh frozen plasma, FP24, and cryoprecipitate-poor plasma shall be stored continuously at a temperature not higher than minus 18 degrees Celsius for up to one year or, with F.D.A. approval, at a temperature not higher than minus 65 degrees Celsius for up to seven years, in a freezer equipped with automatic temperature recording and an audible alarm. Periodic verification of alarm function, in accordance with the manufacturer’s recommendations, shall be documented. Such frozen components shall not be relabeled as different components and released for transfusion, but may be used for fractionation into derivatives. After thawing, plasma shall be transfused immediately or stored at one to six degrees Celsius. Cryoprecipitate intended for factor VIII replacement shall be transfused within six hours after thawing. Freezer temperature records shall be available for inspection for at least five years.
(i) Until issued, platelets shall be stored at 20 to 24 degrees Celsius and shall be continuously rotated on a rotator designed for such use. Temperature records shall be available for inspection for at least five years.
(j) Until issued, frozen red blood cells shall be stored at a temperature not higher than minus 65 degrees Celsius in a freezer equipped with automatic temperature recording and audible alarm, or in liquid nitrogen. Liquid nitrogen levels must be mechanically or visually monitored daily. Periodic verification of alarm function, in accordance with the manufacturer’s recommendations, shall be documented. Storage time shall not exceed ten years. Freezer temperature or liquid nitrogen level records shall be available for inspection for at least five years. After thawing, red blood cells shall be transfused or refrozen within 24 hours or discarded, unless deglycerolized using a closed system that allows a 14-day expiration date, as approved by the F.D.A. If a refrozen unit is subsequently rethawed and deglycerolized, a notation indicating such previous thawing and deglycerolizing shall be made on a label or tag attached to the blood unit, or on accompanying paperwork.
(k) Whenever blood is irradiated, a protocol for such irradiation, , approved by the director of transfusion services or the director of the blood bank, must be followed. Maintenance and operation of blood irradiators must conform to the manufacturer's instructions. Whenever irradiation of blood is medically indicated because of a blood relationship between donor and recipient, such irradiation shall be performed by the blood bank collecting the blood unless the hospital notifies in writing the facility collecting the blood that the hospital will be responsible for irradiation, in which case such blood shall be identified as requiring irradiation on a tag or paperwork accompanying the units. Blood that has been irradiated shall be identified as "Irradiated" on label or tag attached to the unit.
(l) Fresh frozen plasma, cryoprecipitate, FP24 and frozen red blood cells shall be thawed only in a water bath at a temperature not exceeding 38 degrees Celsius, with entry ports protected from water contamination by positioning or a protective overwrap, or in another device specially designed for such thawing. If a water bath is used for thawing, its temperature shall be recorded each day of such use. Temperature records shall be available for inspection for at least five years. Maintenance and operation of all equipment for processing or preparation of blood components shall conform to the manufacturer's instructions and shall follow a protocol approved by the director of transfusion services.
(m) Except for blood recovered intraoperatively or postoperatively, or collected for use in a reinfusion procedure, all blood intended for transfusion shall, upon collection, become the responsibility of the blood collection service. Disposition of blood collected by phlebotomy shall be at the discretion of the director of the collection service until the blood is transferred to a transfusion service, at which time its disposition shall be at the discretion of the director of transfusion services. The director of the blood bank shall ensure that during any transport blood is packed and handled appropriately, and only by authorized individuals. No directed or autogeneic blood unit or component shall be transported to a transfusion service unless the director of the receiving transfusion service or his/her designee has authorized such transport. A transfusion service which has granted standing authorization for receipt of blood shall be given specific notice prior to each shipment. Disposition of blood recovered intraoperatively or postoperatively shall be at the discretion of the intraoperative or postoperative blood collection service, unless the blood is transferred to the hospital blood bank for storage, at which time its disposition shall be at the discretion of the director of transfusion services. Blood banks shall not release blood or blood components intended for transfusion to any site or entity in New York State not holding a department permit as a collection service or transfusion service, or approved by the department as a limited transfusion service or an ambulance transfusion service.
(n) The premises, equipment, procedure manuals, records, circulars of information, and all blood, blood components and derivatives shall be available for inspection, review and approval by the department during normal business hours.
VOLUME A-1 (Title 10)