Title: Section 58-2.9 - Issuance of blood, blood components and derivatives
58-2.9 Issuance of blood, blood components and derivatives.
(a) Unless they are needed to meet a medical emergency, blood and blood components shall be transported in a leak-resistant, crush-resistant and puncture-resistant container featuring a prominent label which:
(1) identifies the contents as "human blood" or "biomedical product";
(2) describes the contents, the packing agent, if any, and any special precautions necessary in handling such blood; and
(3) contains the name, address and twenty-four hour telephone number of the person or entity to be contacted in the event that the container is found to be leaking or damaged, or to have been misdirected.
(b) Except in an emergency or except as indicated in section 58-2.3(c) or (d) of this Subpart, blood and blood components shall not be made available for allogeneic transfusion, unless a donor blood sample reacts negatively to tests required in section 58-2.3(a) of this Subpart, and testing specified in section 58-2.3(f) of this Subpart has been completed. Untested or incompletely tested blood, including blood from directed donations and cytapheresis collections, shall not be issued if a fully tested blood component is available, except in the case of autogeneic donations, as specified in section 58-2.3(a) of this Subpart. Cytapheresis units for which testing has not been completed may be distributed to a hospital by the facility collecting the units, but such components may not be issued by a transfusion service until testing is complete, except in the case of a life-threatening emergency or when the clinically useful shelf life of the component precludes completion of testing prior to issuance. The release of cytapheresis components from a donor found to have a positive result for anti-HBc may be permitted upon the authorization of the health care provider ordering the transfusion and the written authorization of the medical director or designee who is a physician, provided that such authorization documents the indication and justification for such release. Such components shall be labeled with all positive test results. Blood from a donor whose blood specimen reacts positively in testing for syphilis and is nonreactive in confirmatory testing shall be appropriately labeled and may be used for plasma fractionation. Blood from a donor whose blood specimen reacts positively in testing for anti-HBc shall be appropriately labeled and may be used for plasma fractionation. Blood from a donor whose blood specimen reacts positively in testing for HBsAg, HIV nucleic acid, HCV nucleic acid, or antibodies to HCV, HIV-1, HIV-2, or HTLV-I/II shall be appropriately labeled and may not be used for allogeneic transfusion or for fractionation. Blood from a donor whose blood specimen reacts positively in testing for HBsAg, HIV nucleic acid, HCV nucleic acid, or antibodies to HCV, HIV-1 and/or HIV-2 may not be used for autogeneic transfusion without the written authorization of the patient’s physician and, if drawn by another facility, the director of the transfusion service receiving the unit.
(c) Blood, blood components and derivatives shall be issued only if ordered by a licensed physician or other person authorized by law. Recipients shall receive whole blood of the same ABO group or compatible red blood cells. Rh(o) (D)-negative recipients shall receive Rho (D)-negative blood, except for reasonable exempting circumstances as determined by the director of transfusion services. Rho (D)-positive recipients may receive Rho (D)-positive or Rho (D)-negative whole blood or red blood cells. In an emergency, appropriately documented in the records, blood may be released for transfusion prior to the completion of compatibility tests. Any transfusion service which issues blood components for transfusion by a limited transfusion service or ambulance transfusion service shall perform the required tests on its own premises.
(d) Whole blood, red blood cells, plasma and other blood components shall be inspected visually immediately prior to issuance. If the color or physical appearance is abnormal or there is indication or suspicion of microbial contamination, the unit of whole blood or blood components shall not be issued for transfusion.
(e) Blood, blood components or derivatives may not be made available for transfusion beyond the designated expiration date, except that whole blood may be used to prepare plasma within nine days after the designated expiration date, provided that it meets the inspection standards required in subdivision (d) of this section.
(f) An established protocol for processing or pooling of blood components prior to issuance must be in place.
(g) The director of transfusion services shall establish a written policy that specifies the circumstances under which more than one unit of red blood cells for a particular patient may be issued simultaneously for transfusion within a hospital without documented approval of the director of transfusion services or designee who is a physician.
(h) If an unused, unopened unit is returned to the blood bank, the time, date and condition of the unit must be recorded.
(i) A sample of red cells or whole blood from each red cell product issued for transfusion shall be retained for a minimum of seven days after the transfusion for further testing in the event of an adverse reaction.
(j) After issuance, red blood cells may be stored at room temperature for up to one hour or by refrigerating at one to six degrees Celsius. Red blood cells kept at room temperature for more than one hour may not be returned to the blood bank and later reissued for transfusion unless the temperature of the component is documented not to have risen above ten degrees Celsius. If refrigerated, red blood cells shall be stored in a refrigerator designed for the purpose of storing blood, except that a cooler with suitable coolant may be used for refrigeration, provided that the temperature of the blood is maintained at one to ten degrees Celsius.
(k) Blood or blood components shall not be identified or labeled or preferentially distributed according to the donor's membership in a category based on age, race, color, creed, national origin, sex, marital status or social organization, except for purposes of phenotyping of blood units. The sequence of issuance by a transfusion service of blood donated for designated recipients shall not be based on factors other than medical considerations.
(l) Blood or blood components from a donor who had been determined in the past to be unsuitable for subsequent donation shall not be released for transfusion unless the donor has been approved for reentry into the donor pool by the director of the blood bank. (m) Blood components issued to a limited transfusion service shall be transported in a leak-resistant, crush-resistant and puncture-resistant container that has been validated to maintain the appropriate temperature for the anticipated duration of storage and that has a label indicating the issuing transfusion service. (n) Blood components issued to an ambulance transfusion service shall be transported in a leak-resistant, crush-resistant and puncture-resistant container that has been validated to maintain the appropriate temperature for the anticipated duration of transport and that has a label indicating the intended receiving hospital’s blood bank.
VOLUME A-1 (Title 10)