PART 630—REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371; 42 U.S.C. 216, 262, 264. Source: 66 FR 31176, June 11, 2001, unless otherwise noted. Subpart A—General Provisions Source: 80 FR 29898, May 22, 2015, unless otherwise noted. § 630.1 Purpose and scope. (a) What is the purpose of subparts A, B, and C of this part (1) Determining the eligibility of a donor of blood and blood components; (2) Determining the suitability of the donation of blood and blood components; and (3) Notifying a donor who is deferred from donation. (b) Who must comply with subparts A, B, and C of this part § 630.3 Definitions. As used in this part and in part 610, subpart E, and part 640 of this chapter: (a) Blood (b) Blood component (c) Donor (2) Presents as a potential candidate for such donation. (d) Eligibility of a donor (e) Infrequent plasma donor (1) Not donated plasma by plasmapheresis or a co-collection of plasma with another blood component in the preceding 4 weeks; and (2) Not donated more than 12.0 liters of plasma (14.4 liters of plasma for donors weighing more than 175 pounds) in the past year. (f) Intimate contact with risk for a relevant transfusion-transmitted infection (g) Physician substitute (1) A graduate of an education program for health care workers that includes clinical training; (2) Currently licensed or certified as a health care worker in the jurisdiction where the collection establishment is located; (3) Currently certified in cardiopulmonary resuscitation; and (4) Trained and authorized under State law, and/or local law when applicable, to perform the specified functions under the direction of the responsible physician. (h) Relevant transfusion-transmitted infection (1) Any of the following transfusion-transmitted infections: (i) Human immunodeficiency virus, types 1 and 2 (referred to, collectively, as HIV); (ii) Hepatitis B virus (referred to as HBV); (iii) Hepatitis C virus (referred to as HCV); (iv) Human T-lymphotropic virus, types I and II (referred to, collectively, as HTLV); (v) Treponema pallidum (vi) West Nile virus; (vii) Trypanosoma cruzi (viii) Creutzfeldt-Jakob disease (referred to as CJD); (ix) Variant Creutzfeldt-Jakob disease (referred to as vCJD); and (x) Plasmodium (2) A transfusion-transmitted infection not listed in paragraph (h)(1) of this section when the following conditions are met: (i) Appropriate screening measures for the transfusion-transmitted infection have been developed and/or an appropriate screening test has been licensed, approved, or cleared for such use by FDA and is available; and (ii) The disease or disease agent: (A) May have sufficient incidence and/or prevalence to affect the potential donor population; or (B) May have been released accidentally or intentionally in a manner that could place potential donors at risk of infection. (i) Responsible physician (1) Licensed to practice medicine in the jurisdiction where the collection establishment is located; (2) Adequately trained and qualified to direct and control personnel and relevant procedures concerning the determination of donor eligibility; collection of blood and blood components; the immunization of a donor; and the return of red blood cells or other blood components to the donor during collection of blood component(s) by apheresis; and (3) Designated by the collection establishment to perform the activities described in paragraph (i)(2) of this section. (j) Suitability of the donation (k) Trained person ( l Transfusion-transmitted infection (1) That could be fatal or life-threatening, could result in permanent impairment of a body function or permanent damage to a body structure, or could necessitate medical or surgical intervention to preclude permanent impairment of body function or permanent damage to a body structure; and (2) For which there may be a risk of transmission by blood or blood components, or by a blood derivative product manufactured from blood or blood components, because the disease or disease agent is potentially transmissible by that blood, blood component, or blood derivative product. Subpart B—Donor Eligibility Requirements Source: 80 FR 29898, May 22, 2015, unless otherwise noted. § 630.5 Medical supervision. (a) Who must determine the eligibility of a donor (b) Which activities related to the collection of blood and blood components, other than Source Plasma and plasma collected by plasmapheresis, may the responsible physician delegate (1) The responsible physician may delegate the following activities to a physician substitute or other trained person: (i) Determining the eligibility of a donor and documenting assessments related to that determination, except the responsible physician must not delegate: (A) The examination and determination of the donor's health required in § 630.10(f)(2) for donors with blood pressure measurements outside specified limits, or for certain more frequent donations under § 630.15(a)(1)(ii); (B) The determination of the health of the donor required in §§ 630.10(f)(4), 630.20(a), and 640.21(e)(4) of this chapter. The responsible physician may make this determination by telephonic or other offsite consultation; or (C) The determination of the health of the donor and the determination that the blood or blood component collected would present no undue medical risk to the transfusion recipient, as required in § 630.20(c). The responsible physician may make these determinations by telephonic or other offsite consultation. (ii) Collecting blood or blood components; (iii) Returning red blood cells to the donor during apheresis; (iv) Obtaining the informed consent of a plateletpheresis donor as described in § 640.21(g) of this chapter; or (v) Other activities provided that the Director, Center for Biologics Evaluation and Research, determines that delegating the activities would present no undue medical risk to the donor or to the transfusion recipient, and authorizes the delegation of such activities. (2) The responsible physician need not be present at the collection site when activities delegated under paragraph (b)(1) of this section are performed, provided that the responsible physician has delegated oversight of these activities to a trained person who is adequately trained and experienced in the performance of these activities and is also adequately trained and experienced in the recognition of and response to the known adverse responses associated with blood collection procedures. (c) Which activities related to the collection of Source Plasma and plasma collected by plasmapheresis may the responsible physician delegate (1) Donor eligibility and blood component collection activities. (A) The activities listed in paragraphs (b)(1)(i) through (iii) and (b)(1)(v) of this section, with respect to Source Plasma and plasma collected by plasmapheresis. However, the responsible physician must not delegate: ( 1 ( 2 ( 3 ( 4 ( 5 (B) The collection of Source Plasma in an approved collection program from a donor who is otherwise determined to be ineligible. (C) The collection of a blood sample in accordance with § 640.65(b)(1)(i) of this chapter. (ii) The responsible physician, who may or may not be present when these activities are performed, may delegate to a physician substitute the following activities: (A) Approval and signature for a plasmapheresis procedure as provided in § 640.65(b)(1)(ii) of this chapter; and (B) Review and signature for accumulated laboratory data, the calculated values of each component, and the collection records in accordance with § 640.65(b)(2)(i) of this chapter. However, the responsible physician must not delegate the decision to reinstate the deferred donor in accordance with that provision. (2) Donor immunization. (i) The responsible physician may delegate to a physician substitute or other trained person the administration of an immunization other than red blood cells to a donor in an approved collection program, provided that the responsible physician or a physician substitute is on the premises at the collection site when the immunization is administered. (ii) The responsible physician may delegate to a physician substitute the administration of red blood cells to a donor in an approved collection program, provided that the responsible physician has approved the procedure and is on the premises at the collection site when the red blood cells are administered. (3) Medical history, physical examination, informed consent, and examination before immunization. (4) Infrequent plasma donors. (A) The examination and determination of the donor's health required in § 630.10(f)(2) for donors with blood pressure measurements outside specified limits, or in § 630.15(b)(7) for certain donors who have experienced red blood cell loss; or (B) The determination of the health of the donor required in § 630.10(f)(4). (ii) For infrequent plasma donors who are otherwise ineligible or are participating in an approved immunization program, the responsible physician may delegate only in accordance with paragraphs (c)(1) through (3) of this section. (d) Must rapid emergency medical services be available § 630.10 General donor eligibility requirements. (a) What factors determine the eligibility of a donor (1) The health of the donor; or (2) The safety, purity, or potency of the blood or blood component. (b) What educational material must you provide to the donor before determining eligibility (c) When must you determine the eligibility of a donor (1) When a donor is donating blood components that cannot be stored for more than 24 hours, you may determine the donor's eligibility and collect a sample for testing required under § 610.40 of this chapter, no earlier than 2 calendar days before the day of donation, provided that your standard operating procedures address these activities. (2) In the event that, upon review, you find that a donor's responses to the donor questions before collection were incomplete, within 24 hours of the time of collection, you may clarify a donor's response or obtain omitted information required under paragraph (e) of this section, provided that your standard operating procedures address these activities. (d) How must you determine the eligibility of a donor (1) You must consult the records of deferred donors maintained under § 606.160(e)(1) and (2) of this chapter. Exception: If pre-collection review of the record described in § 606.160(e)(2) of this chapter is not feasible because you cannot consult the cumulative record at the collection site, you must consult the cumulative record prior to release of any blood or blood component prepared from the collection. (2) Assure that the interval since the donor's last donation is appropriate; (3) Assess the donor's medical history; and (4) Perform a physical assessment of the donor. (e) How do you assess the donor's medical history (1) Factors that make the donor ineligible to donate because of an increased risk for, or evidence of, a relevant transfusion-transmitted infection. A donor is ineligible to donate when information provided by the donor or other reliable evidence indicates possible exposure to a relevant transfusion-transmitted infection if that risk of exposure is still applicable at the time of donation. Information and evidence indicating possible exposure to a relevant transfusion-transmitted infection include: (i) Behaviors associated with a relevant transfusion-transmitted infection; (ii) Receipt of blood or blood components or other medical treatments and procedures associated with possible exposure to a relevant transfusion-transmitted infection; (iii) Signs and/or symptoms of a relevant transfusion-transmitted infection; (iv) Institutionalization for 72 hours or more consecutively in the past 12 months in a correctional institution; (v) Intimate contact with risk for a relevant transfusion-transmitted infection; and (vi) Nonsterile percutaneous inoculation. (2) Other factors that make the donor ineligible to donate. A donor is ineligible to donate when donating could adversely affect the health of the donor, or when the safety, purity, or potency of the blood or blood component could be affected adversely. Your assessment of the donor must include each of the following factors: (i) Symptoms of a recent or current illness; (ii) Certain medical treatments or medications; (iii) Travel to, or residence in, an area endemic for a transfusion-transmitted infection, when such screening is necessary to assure the safety, purity, and potency of blood and blood components due to the risks presented by donor travel and the risk of transmission of that transfusion-transmitted infection by such donors; (iv) Exposure or possible exposure to an accidentally or intentionally released disease or disease agent relating to a transfusion-transmitted infection, if you know or suspect that such a release has occurred; (v) Pregnancy at the time of, or within 6 weeks prior to, donation; (vi) Whether, in the opinion of the interviewer, the donor appears to be under the influence of any drug, alcohol or for any reason does not appear to be providing reliable answers to medical history questions, or if the donor says that the purpose of donating is to obtain test results for a relevant transfusion-transmitted infection; and (vii) The donor is a xenotransplantation product recipient. (f) How do you perform a physical assessment of the donor (1) Temperature. (2) Blood pressure. (3) Hemoglobin or hematocrit determination. (i) Allogeneic donors must have a hemoglobin level or hematocrit value that is adequate to assure donor safety and product potency. The following minimum standards apply. (A) Female allogeneic donors must have a hemoglobin level that is equal to or greater than 12.5 grams of hemoglobin per deciliter of blood, or a hematocrit value that is equal to or greater than 38 percent. Recognizing that lower levels are also within normal limits for female donors, you may collect blood from female allogeneic donors who have a hemoglobin level between 12.0 and 12.5 grams per deciliter of blood, or a hematocrit value between 36 and 38 percent, provided that you have taken additional steps to assure that this alternative standard is adequate to ensure that the health of the donor will not be adversely affected due to the donation, in accordance with a procedure that has been found acceptable for this purpose by FDA. (B) Male allogeneic donors must have a hemoglobin level that is equal to or greater than 13.0 grams of hemoglobin per deciliter of blood, or a hematocrit value that is equal to or greater than 39 percent. (ii) An autologous donor must have a hemoglobin level no less than 11.0 grams of hemoglobin per deciliter of blood, or a hematocrit value no less than 33 percent. (4) Pulse. (5) Weight. (6) Skin examination. (ii) The donor's arms and forearms must be free of punctures and scars indicative of injected drugs of abuse. (g) Are there additional requirements for determining the eligibility of the donor (1) Proof of identity and postal address. (2) Donor's acknowledgement. (ii) The donor acknowledgement must not include any exculpatory language through which the donor is made to waive or appear to waive any of the donor's legal rights. It must, at a minimum clearly address the following: (A) The donor has reviewed the educational material provided under paragraph (b) of this section regarding relevant transfusion-transmitted infections; (B) The donor agrees not to donate if the donation could result in a potential risk to recipients as described in the educational material; (C) A sample of the donor's blood will be tested for specified relevant transfusion-transmitted infections; (D) If the donation is determined to be not suitable under § 630.30(a) or if the donor is deferred from donation under § 610.41 of this chapter, the donor's record will identify the donor as ineligible to donate and the donor will be notified under § 630.40 of the basis for the deferral and the period of deferral; (E) The donor has been provided and reviewed information regarding the risks and hazards of the specific donation procedure; and (F) The donor has the opportunity to ask questions and withdraw from the donation procedure. (h) What must you do when a donor is not eligible § 630.15 Donor eligibility requirements specific to Whole Blood, Red Blood Cells and Plasma collected by apheresis. (a) What additional donor eligibility requirements apply when you, an establishment that collects blood or blood components, collect Whole Blood or Red Blood Cells by apheresis (1) Donation frequency must be consistent with protecting the health of the donor. (i) For a collection resulting in a single unit of Whole Blood or Red Blood Cells collected by apheresis, donation frequency must be no more than once in 8 weeks, and for apheresis collections resulting in two units of Red Blood Cells, the donor must not donate more than once in 16 weeks. (ii) The limitations in paragraph (a)(1)(i) of this section apply unless the responsible physician examines the donor at the time of donation and one of the following conditions exists: (A) The donation is for autologous use as prescribed by the donor's physician and the responsible physician determines and documents that the donation may proceed; or (B) The donation is a dedicated donation based on the intended recipient's documented exceptional medical need and the responsible physician determines and documents that the health of the donor would not be adversely affected by donating. (2) Therapeutic phlebotomy. (i) The donor meets all eligibility criteria; (ii) The donor undergoes a therapeutic phlebotomy as prescribed by a licensed health care provider treating the donor for: (A) Hereditary hemochromatosis; or (B) Another disease or condition, when the health of a donor with that disease or condition will not be adversely affected by donating, and the donor's disease or condition will not adversely affect the safety, purity, and potency of the blood and blood components, or any products manufactured from them, and the collection is in accordance with a procedure that has been found acceptable for this purpose by FDA; and (iii) You perform without charge therapeutic phlebotomies for all individuals with that disease or condition. (b) What additional donor eligibility requirements apply when you, an establishment that collects blood or blood components, collect Source Plasma or plasma by plasmapheresis (1) Medical history and physical examination. (i) The responsible physician must conduct an appropriate medical history and physical examination of the donor on the day of the first donation or no more than 1 week before the first donation and at subsequent intervals of no longer than 1 year. (ii) The responsible physician must examine the donor for medical conditions that would place the donor at risk from plasmapheresis. If the donor is determined to be at risk, you must defer the donor from donating. (iii) The responsible physician must conduct a new medical history and physical examination of a donor who does not return for 6 months. (2) What requirements apply to obtaining informed consent (i) The responsible physician must obtain the informed consent of a plasma donor on the first day of donation or no more than 1 week before the first donation, and at subsequent intervals of no longer than 1 year. (ii) The responsible physician must obtain the informed consent of a plasma donor who does not return within 6 months of the last donation. (iii) The responsible physician must explain the risks and hazards of the procedure to the donor. The explanation must include the risks of a hemolytic transfusion reaction if the donor is given the cells of another donor and the risks involved if the donor is immunized. The explanation must be made in such a manner that the donor may give their consent and has a clear opportunity to refuse the procedure. (iv) If a donor is enrolled in a new program, such as an immunization or special collection program, the responsible physician must again obtain an informed consent specific for that program. (3) Weight. (4) Total protein level. (5) Examination before immunization. (ii) You are not required to repeat the medical history and physical examination required under paragraph (b)(1) of this section for a donor currently participating in a plasmapheresis collection program and determined to be eligible under § 630.10 unless the medical history and physical examination are due under paragraph (b)(1)(i) or (b)(1)(iii) of this section. (6) Deferral of donors due to red blood cell loss. (ii) You must defer a donor from donating plasma by plasmapheresis for a period of 16 weeks if the donor donates two units of Red Blood Cells during a single apheresis procedure; (iii) You must defer a donor for 8 weeks or more if the cumulative red blood cell loss in any 8 week period could adversely affect donor health. (7) Exceptions to deferral due to red blood cell loss. (i) The responsible physician examines the donor at the time of the current donation and determines and documents that the donor is in good health and the donor's health permits the plasmapheresis; (ii) The donor's plasma possesses a property, such as an antibody, antigen, or protein deficiency that is transitory, of a highly unusual or infrequent specificity, or of an unusually high titer; (iii) The special characteristics of the donor's plasma and the need for plasmapheresis of the donor under § 630.20(b) are documented at your establishment; and (iv) The extracorporeal volume of the apheresis device is less than 100 milliliters. (8) Malaria. (9) You must comply with other requirements for collection of plasma in part 640 of this chapter and this part including restrictions on frequency of collection as specified in §§ 640.32 and 640.65 of this chapter. § 630.20 Exceptions for certain ineligible donors. After assessing donor eligibility under §§ 630.10 and 630.15, an establishment may collect blood and blood components from a donor who is determined to be not eligible to donate under any provision of § 630.10(e) and (f) or § 630.15(a) if one of the following sets of conditions are met: (a) The donation is for autologous use only as prescribed by the donor's physician, the donor has a hemoglobin level no less than 11.0 grams of hemoglobin per deciliter of blood or a hematocrit value no less than 33 percent, and the responsible physician determines and documents that the donor's health permits the collection procedure; or (b) The donation is collected under a Source Plasma collection program which has received prior written approval from the Director, Center for Biologics Evaluation and Research, to collect plasma for further manufacturing use into in vitro products for which there are no alternative sources, the donor meets the criteria in § 630.10(f)(1) through (6), and the responsible physician determines and documents for each donation that the donor's health permits the collection procedure, and the collection takes place under the medical oversight specified in the approved plasmapheresis program. (c) The donation is restricted for use solely by a specific transfusion recipient based on documented exceptional medical need, and the responsible physician determines and documents that the donor's health permits the collection procedure, and that the donation presents no undue medical risk to the transfusion recipient. § 630.25 Exceptions from certain donor eligibility requirements for infrequent plasma donors. For an infrequent plasma donor who is not participating in an immunization program, establishments are not required to: (a) Perform a medical history and physical examination of the donor under § 630.15(b)(1); (b) Perform a test for total protein under § 630.15(b)(4); (c) Determine the total plasma or serum protein and immunoglobulin composition under § 640.65(b)(1)(i) of this chapter; or (d) Review the data and records as required in § 640.65(b)(2)(i) of this chapter. § 630.30 Donation suitability requirements. (a) When is a donation suitable (1) The donor is not currently deferred from donation as determined by review of the records of deferred donors required under § 606.160(e) of this chapter; (2) The results in accordance with §§ 630.10 through 630.25 indicate that the donor is in good health and procedures were followed to ensure that the donation would not adversely affect the health of the donor; (3) The results in accordance with § 630.10(e) indicate that the donor is free from risk factors for, or evidence of, relevant transfusion-transmitted infections and other factors that make the donor ineligible to donate; (4) The donor's blood is tested in accordance with § 610.40 of this chapter, and is negative or nonreactive, unless an exception applies under § 610.40(h) of this chapter; and (5) The donation meets other requirements in this subchapter. (b) What must you do when the donation is not suitable (2) You must defer the donor when a donation is determined to be unsuitable based on the criteria in paragraphs (a)(1) through (4) of this section. (3) You must defer the donor of bacterially contaminated platelets when the contaminating organism is identified in accordance with § 606.145(d) of this chapter as likely to be associated with a bacterial infection that is endogenous to the bloodstream of the donor. (4) You must notify the deferred donor in accordance with the notification requirements in § 630.40. § 630.35 Requalification of previously deferred donors. Establishments may determine a deferred donor to be eligible as a donor of blood and blood components if, at the time of the current collection, the donor meets the eligibility criteria in this part, except for the record of the previous deferral, and you determine that the criteria that were the basis for the previous deferral are no longer applicable. Criteria for the previous deferral are no longer applicable if the following conditions are met: (a) The previous deferral was for a defined period of time and that time period has passed, or the deferral was otherwise temporary, such as a deferral based on eligibility criteria described in §§ 630.10(f)(1) through (5) or 630.15(b)(4); or (b) For a donor deferred for reasons other than under § 610.41(a) of this chapter, you determine that the donor has met criteria for requalification by a method or process found acceptable for such purpose by FDA. Subpart C—Donor Notification Source: 80 FR 29898, May 22, 2015, unless otherwise noted. § 630.40 Requirements for notifying deferred donors. (a) Notification of donors. (b) Content of notification. (1) That the donor is deferred or determined not to be eligible for donation and the reason for that decision; (2) Where appropriate, the types of donation of blood or blood components that the donor should not donate in the future; (3) Where applicable, the results of tests for evidence of infection due to relevant transfusion-transmitted infection(s) that were a basis for deferral under § 610.41 of this chapter, including results of further testing as required in § 610.40(e) of this chapter; and, (4) Where appropriate, information concerning medical followup and counseling. (c) Time period for notification. (d) Autologous donors. (i) Information that the autologous donor is deferred based on the results of tests for evidence of infection due to relevant transfusion-transmitted infection(s), as required under § 610.41 of this chapter, and the reason for that decision; (ii) Where appropriate, the types of donation of blood or blood components that the autologous donor should not donate in the future; and (iii) The results of tests for evidence of infection due to relevant transfusion-transmitted infection(s), that were a basis for deferral under § 610.41 of this chapter, including results of further testing as required in § 610.40(e) of this chapter. (2) You must make reasonable attempts to notify the autologous donor's referring physician within 8 weeks after determining that the autologous donor is deferred as described in paragraph (a) of this section. You must document that you have successfully notified the autologous donor's referring physician or when you are unsuccessful that you have made reasonable attempts to notify the physician. [66 FR 31176, June 11, 2001. Redesignated and amended at 80 FR 29898, May 22, 2015]