Effective November 7, 2007

Subpart 58-2
Blood Banks

Statutory Authority: Public Health Law, sections 3121(5) and 3124

[Subpart 58-2: PDF file]

(a) Blood bank means a facility for the collection, processing, storage or distribution of human blood, human blood components or blood derivatives, or the performance of reinfusion procedures. A blood bank shall employ a qualified director for administrative purposes and, if blood collection is performed, a qualified medical director.

(b) Blood donation center means a facility, fixed or mobile, that is operated by a blood bank and used for the collection of blood, plasma or cytapheresis products, or separation of whole blood into components.

(c) Donor or blood donor means a person who provides his/her blood or plasma for transfusion of whole blood, blood components or derivatives.

(d) Blood components means those preparations separated from a single donation of whole blood, or collected by apheresis, intended for direct use in transfusion, including but not limited to plasma, fresh frozen plasma, red blood cells, washed red blood cells, leukocyte-reduced red blood cells, platelets, granulocytes, and cryoprecipitate.

(e) Derivatives means those preparations separated from plasma derived from multiple donors, including but not limited to albumin, immune globulin, plasma protein fraction and clotting factor concentrates.

(f) Blood products means whole blood, blood components or derivatives.

(g) Plasmapheresis means the withdrawal of blood to obtain plasma with subsequent or simultaneous reinfusion into the donor of his/her own red blood cells.

(h) Serial plasmapheresis program means a program of individual donor donations on a regular basis by plasmapheresis yielding three liters or more of plasma per consecutive four-week period.

(i) Cytapheresis means the separation and collection of blood cells or other formed elements by hemapheresis for the purpose of obtaining a transfusable blood component.

(j) Intraoperative blood recovery means recovery of blood from a surgical field and processing of recovered blood for direct reinfusion, storage or infusion into a cardiopulmonary bypass pump. Intraoperative blood recovery does not include performance of perioperative normovolemic hemodilution procedures. Postoperative blood recovery means recovery of blood from a wound following surgery, and processing of recovered blood for direct reinfusion or storage. Intraoperative blood recovery was formerly termed intraoperative blood salvage.

(k) F.D.A. means the Food and Drug Administration of the United States Department of Health and Human Services.

(l) Limited transfusion service means a facility, home care services agency, physician's office, or other entity which administers blood or blood components, and may temporarily store blood or blood components, and distribute them within its own organization, but relies on a blood bank holding a permit in blood services-transfusion to perform laboratory tests required under section 58-2.17 of this Subpart.

(m) Holding facility means a facility at which blood is temporarily stored but which does not offer any other blood banking services.

(n) Transfusion service means a service which issues blood, blood components or blood derivatives for administration into a person, but does not include a limited transfusion service.

(o) Institution means a hospital or other facility operating a transfusion service under a permit issued by the department.

(p) Allogeneic collection means the removal and storage of blood or blood components from a donor for transfusion into another person, and includes blood donated for directed donation to another person, or donated for autogeneic use and subsequently crossed-over in whole or in part for use by others. Allogeneic collection was formerly termed homologous collection.

(q) Autogeneic collection means the removal and storage of blood or blood components from a donor for subsequent reinfusion into that same person, and includes preoperative hemodilution procedures if at any time the blood leaves the operating room in which surgery is performed. Autogeneic collection was formerly termed autologous collection.

(r) Directed donation means an allogeneic collection in which blood from a particular donor is designated for use by a specified recipient.

(s) Medical director means a qualified physician who is employed by a blood bank and is responsible for donor selection and safety.

(t) Department means the New York State Department of Health.

(u) Reinfusion procedure means the withdrawal of a small amount of blood or a component thereof from a patient, its processing by addition of substances or by culturing, and administration of the product so obtained,in whole or in part, into the same patient for diagnostic or therapeutic purposes. Reinfusion procedures shall include, but not be limited to, radioisotopic tagging, and genetic and immunologic manipulation, but shall not include processing of whole blood units into components for autogeneic reinfusion, such as platelet concentrates, packed red blood cells and plasma.

(v) Normovolemic hemodilution means the collection of blood prior to surgery, and includes fluid replacement and reinfusion during or after surgery for purposes of reducing red cell loss during surgery.

(w) Limited reinfusion service means a facility, home care services agency, physician's office or other non-hospital entity that performs reinfusion procedures.

(x) Clinical laboratory technician means a clinical laboratory practitioner who performs clinical laboratory procedures and examinations, pursuant to established and approved protocols of the department, which require limited exercise of independent judgment, and are performed under the supervision of a clinical laboratory technologist, laboratory supervisor, or director of a clinical laboratory.

(y) Clinical laboratory technologist means a clinical laboratory practitioner who, pursuant to established and approved protocols of the department, performs clinical laboratory procedures and examiniations and any other test or procedures conducted by a clinical laboratory, including maintaining equipment and records, and performing quality assurance activities related to examination performance, which require the exercise of independent judgment and responsibility.

(z) Health care provider, for the purposes of this Subpart, means a physician, physician assistant or nurse practitioner.

(aa) Nurse practitioner means a registered professional nurse licensed and currently registered under the Laws of the State of New York, to diagnose illness and physical conditions, and perform therapeutic and corrective measures, in accordance with a collaborative agreement with a physician qualified to collaborate in the specialty involved.

(bb) Physician means an allopathic or osteopathic physician licensed and currently registered, under the Laws of the State of New York or in the state of practice, to practice medicine.

(cc) Physician assistant means a person licensed and currently registered, under the Laws of the State of New York, to practice medicine under the supervision of a physician.

(dd) Physician designee means a physician designated by the medical director to be responsible for one or more routine or special tasks.

(a) The medical director shall be responsible for the determination that blood may be collected safely from a donor and that the donor's blood is acceptable for collection. This determination shall be made by the medical director or trained staff members under the medical director's supervision on the day of collection of the blood. In addition, autogeneic collections prior to anticipated surgery or other medical procedure shall require the written authorization of the donor's health care provider and written consent of the donor. If autogeneic blood is to be subsequently used for allogeneic transfusion, all requirements in subdivision (f) of this section must be met.

(b) Only those persons may be accepted as donors of blood for allogeneic use who are in good health as indicated by:

(1) freedom from acute respiratory diseases;

(2) freedom from infectious skin lesions at the phlebotomy site and from any infectious skin disease generalized to an extent that creates a risk of contamination of the blood;

(3) freedom from any disease transmissible by blood transfusion, insofar as can be determined by history and examinations required in this Subpart;

(4) freedom from active tuberculosis. A person with a history of tuberculosis may be accepted as a blood donor following completion of drug therapy;

(5) freedom from syphilis. However, blood for plasma fractionation into heat-treated or pathogen-inactivated derivatives may be accepted;

(6) freedom from a history of viral hepatitis for a duration specified by the United States Public Health Service;

(7) freedom from a history of malaria or travel to or residence in malarially endemic areas for periods of time considered to increase risks for malaria exposure, as determined by the United States Public Health Service. However, plasma for transfusion or fractionation may be accepted from donors with a history of malaria or travel to a malarially endemic area;

(8) freedom from signs and symptoms of human immunodeficiency virus (HIV) infection; and

(9) freedom from other medical contraindications.

(c) For allogeneic collections, a person may not be accepted as a blood donor:

(1) whose health may be affected adversely by the bleeding;

(2) who has received a transfusion of blood or blood components within the past year, with the exception of autogeneic transfusion;

(3) who is under 17 years of age, except that donors who are 16 years of age may be accepted, if they have presented written permission specific to the occasion from a parent or guardian.

(4) who is more than 75 years of age, except that donors over 75 may be accepted after satisfactory case-by-case review by the medical director or physician designee;

(5) who is known to use or presents indications of having used illegal injectable drugs;

(6) whose oral temperature exceeds 37.5 degrees Celsius (99.5 degrees Fahrenheit);

(7) whose pulse after resting is faster than 110 or slower than 45 beats per minute, except if the donor is an athlete with high exercise tolerance; or whose pulse exhibits pathologic irregularities;

(8) whose systolic blood pressure exceeds 180 millimeters of mercury, or whose diastolic pressure exceeds 100 millimeters;

(9) whose weight is less than 50 kilograms (110 pounds), except that a donor whose weight is between 40 kilograms (88 pounds) and 50 kilograms (110 pounds) may donate a volume proportionate to the donor's weight, provided that the anticoagulant is proportionately reduced and the container is appropriately labeled;

(10) whose hemoglobin content is less than 12.5 grams per deciliter or whose hematocrit is less than 38 percent, as determined by techniques found by the department to meet medical standards generally accepted in New York State;

(11) who is known ever to have received pituitary-derived human growth hormone; or

(12) who falls into a category of individuals determined by the United States Public Health Service to be unsuitable for blood donation.

(d) For allogeneic collection:

(1) All donors shall be given educational materials on risk activities for HIV infection and shall be advised that persons at risk for HIV infection should refrain from donating blood.

(2) Each donor shall be provided the opportunity to indicate confidentially that blood collected is unsuitable for transfusion.

(e) For autogeneic collection only:

(1) There are no age limits.

(2) The hemoglobin concentration of the donor-patient should be no less than 11 grams per deciliter, or the hematocrit, if substituted, should be no less than 33 percent, unless otherwise approved in writing by the medical director of the blood bank or other physician designated by such medical director.

(3) The frequency of phlebotomy for autogeneic transfusion shall be determined by the medical director of the blood bank and the donor-patient's physician. Phlebotomy of the donor-patient within 72 hours of the time of the anticipated surgery or transfusion must be authorized in writing by the medical director or other physician designated by the medical director.

(4) Donation for autogeneic transfusion should not be undertaken if medically contraindicated.

(f) Blood withdrawn for autogeneic transfusion may not be used for allogeneic transfusion unless the donor meets all the criteria set forth in subdivision (b), and paragraphs (c)(2), (5) and (6) of this section, and the unit meets the requirements set forth in section 58-2.3(a) of this Subpart. The minimum hemoglobin concentration for such a unit shall be 12.5 grams per 100 milliliters or a hematocrit of 38 percent, and the minimum volume for such a unit shall be 405 milliliters.

(g) Blood withdrawn in order to promote the health of a donor otherwise qualified under the provisions of this section shall not be used for transfusion unless the container label indicates the donor's disease that necessitated withdrawal of blood, except that, in the case of a donor with hemochromatosis, blood without such labeling may be used for transfusion, provided that the blood bank has demonstrated that therapeutic phlebotomy is available free of charge to hemochromatosis patients and that all other requirements of this Subpart have been met.

(a) For allogeneic collections under New York State permit, approved tests for syphilis; hepatitis B surface antigen (HBsAg); HIV-1 and hepatitis C virus (HCV) nucleic acid; and antibodies to hepatitis B core antigen (anti-HBc), hepatitis C virus (HCV), HIV-1, HIV-2 and human T-lymphotropic virus types I and II (HTLV-I/II) shall be performed in a New York State-permitted laboratory. For autogeneic collections, such testing shall be performed unless the blood is intended for transfusion at the same facility where it is collected and a system is in place to ensure correct disposition of each blood unit, but the testing need not be performed again if already performed within the previous 30 days or if performed on a specimen collected subsequently. Results of a given test run shall not be accepted and reported if results of test kit controls are outside of the predetermined acceptable range. A written report shall be received thereon prior to the release of blood or blood components for transfusion and, if serologic tests are positive, shall preclude release for allogeneic transfusion except as described in section 58-2.9(b) of this Subpart. Until such testing is completed, all blood and blood components shall be stored in a separate refrigerator or prominently labeled separate area of the refrigerator reserved for quarantined units. However, in an emergency requiring release for transfusion prior to receipt of such report, the results shall be recorded subsequently on the recipient's chart. Any unacceptable blood unit identified, as well as all of its components, shall be removed immediately from the quarantine area and disposed of or moved to a separate area reserved for such units. Units unacceptable for transfusion, which are retained for other purposes, shall be labeled with pertinent test results.

(b) All test runs for required tests for infectious disease markers that generate numeric readings shall include a weakly reactive control. If the results of this weakly reactive control or any other control do not fall within the predetermined acceptable range, results from that run shall not be reported until the run is repeated. Results of all tests shall be verified by a second staff member to preclude errors in transcription or interpretation. In a manual system, examination of the original instrument tape shall be conducted by the second staff member. Except for results of tests performed on samples from autogeneic donors, as specified in section 58-2.23 of this Subpart, incomplete test results shall not be reported to donors, including any initially reactive test results not yet repeated in duplicate. Release of blood units from quarantine shall be based on examination of a signed and verified hard copy, or electronic equivalent, of all test results. The director of the laboratory conducting the testing shall be responsible for ensuring that testing is performed in accordance with this Subpart. The blood bank director shall be responsible for development of algorithms for test result interpretation and shall approve, in writing, the laboratory procedures to be used.

(c) Plasma collected for fractionation purposes only need not be tested for HTLV-I.

(d) If platelets are donated by the infant's mother to an infant with alloimmune neonatal thrombocytopenia, the donor's blood need not be tested as required in subdivision (a) of this section. In such case, the donor requirements specified in section 58-2.2 of this Subpart may also be waived with the written authorization of the medical director of the blood bank or physician designee.

(e) If multiple patient-dedicated blood components are donated by a single donor to support a particular patient, that donor's blood may be screened for all analytes specified in subdivision (a) of this section every 30 days, rather than at each donation.

(f) For both allogeneic and autogeneic collection, the ABO and Rh groups of every donor shall be determined in accordance with procedures approved by the department.
The determination shall be made by:

(1) testing the blood cells with anti-A and anti-B grouping sera; testing the serum or plasma from the blood with known group A and group B red blood cells; and

(2) testing the blood with anti-Rho (anti-D) grouping serum, including, in the case of initially negative testing with anti-Rho (anti-D), a method designed to detect weak D.

(g) For allogeneic collection, required tests for detecting unexpected alloantibodies:

(1) All donor blood shall be tested for unexpected alloantibodies using reagent red blood cells that meet F.D.A. standards and are intended for this purpose.

(2) Methods of testing for alloantibodies shall be those that demonstrate sensitizing and hemolytic antibodies.

(h) Errors or accidents in collecting, testing or processing of donor blood that may affect the safety or purity of any product or health of the donor or recipient shall be reported to the department's Wadsworth Center within seven calendar days of such an error or its discovery.

(a) Prior to collection of blood for testing, a signed form must be obtained from the donor or person legally authorized to consent on behalf of such donor, in which the donor or the person legally authorized to consent acknowledges that he/she has been provided with written materials stating that HIV testing for donor screening purposes shall be performed in conjunction with all donations.

(b) Quantity limitations. Allogeneic and autogeneic donors may give a maximum of 550 milliliters of whole blood in addition to pilot samples of up to 30 milliliters.

(c) Frequency limitations. No allogeneic blood donor may donate more than 550 milliliters of whole blood within an eight-week period, unless approved to do so by a physician who examines the potential donor at the time of the proposed second donation. In no event may an allogeneic blood donor donate more than twice within a sixteen-week period. The foregoing prohibition on donations does not apply to allogeneic blood donors diagnosed with hemochromatosis. For autogeneic collections, the frequency of donation shall be as specified in section 58-2.2(e)(3) of this Subpart.

(a) Every blood donation shall be obtained under the direction of the medical director. Medical services for emergency care of the donor shall be available. Collection of blood for transfusion may be conducted only at blood banks with a permit in blood services-collection and at blood donation centers approved by the department.

(b) Phlebotomy apparatus and blood containers shall be clean, pyrogen-free and sterile. Anticoagulants shall be placed in containers prior to sterilization.

(c) Phlebotomy sites shall be prepared by a procedure found by the department to meet medical standards generally accepted in New York State.

(d) 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.

(3) Labeling requirements.

(i) 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.

(ii) 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:

(a) the identification of the collecting facility;

(b) the patient's name and if available, the name of the hospital where the patient is to be transfused and the patient's hospital registration number or, if unavailable, social security number, birth date or similar identifying information. This tag shall be removed if the unit is subsequently used for allogeneic transfusion;

(c) ABO and Rh group;

(d) date of expiration;

(e) if the unit does not qualify for allogeneic transfusion, a prominent label to read "For autologous use only" or similar wording;

(f) 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 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

(g) a label bearing the donor classification statement "Autologous donor" shall be permanently affixed to the unit.

(e) For allogeneic and autogeneic collections, adequate specimens of blood sufficient for all testing to be performed shall be taken.

(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. After deglycerolizing, frozen red blood cells shall be transfused or refrozen within 24 hours, or shall be discarded. 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. After thawing of fresh frozen plasma, its blood component shall be transfused immediately or stored at between one and six degrees Celsius. Plasma stored in the liquid state for more than 24 hours shall be released only for medical indications other than replacement of labile coagulation factors. Cryoprecipitate intended for factor VIII replacement must be transfused within six hours after thawing.

(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. Storage shall be at a temperature of not less than one degree Celsius nor more than 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. Blood in transit shall be refrigerated at a temperature between one degree Celsius and 10 degrees Celsius, preferably between four degrees Celsius and six degrees Celsius, with the exception of units from which platelets will be separated. Units which will be used as a source of platelets shall be stored at room temperature, preferably at 20 to 24 degrees Celsius, until platelets are separated, but for no more than eight hours. Autogeneic units shall be stored in a separate, specifically designated portion of the refrigerator.

(h) Until issued, cryoprecipitate, fresh frozen plasma and cryoprecipitate-poor plasma shall be stored continuously at a temperature not higher than minus 18 degrees Celsius in a freezer equipped with automatic temperature recording and an audible alarm. Storage time shall not exceed one year. Such components shall not be relabeled as different components and released for transfusion, but may be used for fractionation into derivatives. 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 no 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. 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, blood shall be transfused within 24 hours or discarded.

(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 a label or tag attached to the unit.

(l) Fresh frozen plasma, cryoprecipitate and frozen red blood cells shall be thawed only in a water bath at a temperature not exceeding 38 degrees Celsius 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 components or blood intended for transfusion to any site in New York State not permitted as a collection service or transfusion service, or approved as a limited 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.

(a) Labeling of specimens intended for pre-transfusion testing shall include the patient's name, patient's identification number, and date of collection. Identification of the person collecting the specimen shall be recorded.

(b) All tests, including, but not limited to, ABO and Rho(D) grouping, antibody detection and identification, and compatibility testing, shall employ methods, techniques or procedures which have been approved or recommended for the particular reagent in use by the F.D.A. or the American Association of Blood Banks, and which have been demonstrated to be effective in a manner acceptable to the department, in conformance with generally accepted laboratory principles. All grouping antisera, reagents, devices, methods, and procedures for blood unit processing or transfusion-related testing shall be approved by the F.D.A. or conform to the recommended minimum requirements of the F.D.A.

(c) All reagents shall be stored in labeled containers under conditions appropriate for each reagent as directed by the manufacturer and shall be removed from use after their expiration date. The reactivity and specificity of each reagent shall be determined whenever a new lot is employed. All methods shall conform to manufacturers' instructions unless otherwise approved by the department.

(d) Negative controls run on each day of use are not required for anti-human globulin and antibody screening cells, provided manufacturers' instructions are followed. New lots of reagents shall be thoroughly evaluated, but antibody identification cell panels need not be tested with a known antibody. All test procedures to be used shall be determined by the blood bank director and shall be documented in the standard operating procedure manual. If no negative reactions are observed on a given test run, an investigation shall be performed and controls run. Such quality control records shall be accessible to laboratory personnel engaged in immunohematology testing and to the department.

(e) Centrifuges used for testing of red blood cell agglutination shall undergo revolutions per minute (RPM) and timer checks quarterly. Functional calibration that determines optimal centrifugation conditions shall be performed prior to initial use, after adjustments or repairs, and at least annually thereafter, and shall be documented. The procedure shall specify the speed and duration of centrifugation to be used. A microscope shall be located in the work area designated for immunohematology testing, if use of a microscope is specified by the facility's standard operating procedure manual or by a test kit manufacturer's package insert. Microscopic examination shall be performed for red blood cell agglutination tests whenever indicated for the procedure in use.

(a) Current standard operating procedure manuals or other procedural guides specific to the facility shall be available at all times in the immediate work area of personnel engaged in the collection, processing, testing, storage, distribution and administration of blood, blood components or derivatives for autogeneic or allogeneic use, and for therapeutic, prophylactic or diagnostic purposes. There shall be a written protocol for all procedures performed at the facility. Manuals shall contain a protocol for writing, maintaining and periodic review of standard operating procedures by user personnel and management staff. Procedure manuals shall have the following features:

(1) a standardized format;

(2) a system of numbering and/or entitling individual procedures;

(3) a clearly written description of purpose for each procedure;

(4) a reference section listing appropriate scientific literature;

(5) clearly defined areas of personnel responsibility by title;

(6) documented approval of procedures and procedural modifications by the director, and annual review by the director or authorized supervisor;

(7) instructions for the completion of reports and forms, including examples;

(8) effective date and date of review for each procedure; and

(9) a system of archiving earlier versions of procedures and forms. Discontinued procedure documents and forms shall be retained and be available for inspection for at least seven years. Dates of initial use and discontinuance shall be recorded.

(b) The procedure manual shall include a written procedure for documenting errors or accidents in collection, testing, processing, storage or distribution that may affect the safety or purity of any product, or health of the donor or recipient. If the error or accident is not detected prior to issuance of the blood, blood components or derivatives, the error or accident shall be reported immediately to the receiving facility. All such errors and accidents shall also be reported to the department's Wadsworth Center within seven calendar days of discovery.

(c) The procedure manual shall include written policies and protocols regarding the following, for activities performed at the site:

(1) use and maintenance of blood warming devices;

(2) type of infusion sets and filters for all components;

(3) inspection of components prior to issuance;

(4) type of personnel who may remove components;

(5) for collecting facilities, obtaining blood or components from other institutions during emergency situations;

(6) prenatal and neonatal testing;

(7) evaluation of reported transfusion reactions; and

(8) emergency release of uncrossmatched blood;

(9) method validation requirements;

(10) professional qualifications of personnel who may collect blood specimens for pretransfusion testing; and

(11) specimen and labeling requirements for pretransfusion samples.

(d) The policies and procedures specified in the procedure manual shall be followed at all times. If deviations are identified, appropriate corrective action shall be taken and documented.

(e) The blood bank director or the director of transfusion services shall establish and maintain a planned and periodic internal review program for monitoring and evaluating the quality and appropriateness of standard operating procedures in the performance of blood bank and transfusion service activities. Included in the program shall be a system for designing and implementing corrective action for any problems identified. Quality assurance deficiencies shall be documented, and evidence shall be available that problems are reported to the appropriate individuals in a timely manner and that corrective action is implemented and subsequently followed-up.

(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 24-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. 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 physician designee, 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 a test 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 tests for anti-HBc shall be appropriately labeled and may be used for plasma fractionation. Blood from a donor whose blood specimen reacts positively in tests for HBsAg, HIV or 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 sample reacts positively in tests for HBsAg or antibodies to 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 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. Rho (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 for transfusion at a limited transfusion service shall perform the required tests on its own premises unless the limited transfusion service holds the required permit issued by the department to perform such tests.

(d) Whole blood, red blood cells, plasma or other blood components and derivatives 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 or units of whole blood, blood components or derivatives 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) Except in emergency situations, or in cases in which the patient has multiple vascular access lines and more than one unit will be transfused simultaneously, or in case of release to an operating room with a monitored refrigerator, only one unit of red cells at a time may be issued within a hospital for a particular patient, unless otherwise authorized in writing by the director of transfusion services.

(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 between one and 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 between one and 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.

(a) Complete and accurate records of blood, blood components and derivatives released for allogeneic or autogeneic transfusion shall be kept for seven years or six months after the expiration date of the individual product, whichever is later, by the blood bank preparing the product and by the institution using the product. Such records shall be open to inspection by the department and shall include the information specified in sections 58-2.11 and 58-2.12 of this Subpart. For all collected or distributed blood, blood components and derivatives, the donor's name, address, telephone number, social security number and any other information which would directly or indirectly identify the blood donor of any specific unit shall not be disclosed by the blood bank to any person or entity except upon the written consent of the donor or except to the department and other agencies which issue clinical laboratory and/or blood bank permits to the facility whose records are requested.

(b) Blood banks and transfusion services shall file a Blood Services Activity Report annually with the department.

(c) Records shall be maintained of all tests, controls, reagents and current procedures, in a manner acceptable to the department in conformance with generally accepted laboratory principles.

(a) Every blood bank shall maintain a record of each container of blood or blood components collected or prepared therein. The record shall contain the following information:

(1) donor's full name, address, age, sex and identifying code;

(2) date and amount of blood collected;

(3) any adverse reaction of the donor;

(4) signature of the phlebotomist;

(5) results of all tests performed on a sample from the donor or a unit;

(6) disposition of the blood or blood components;

(7) for autogeneic donation, documentation of written or verbal consent of the donor-patient's health care provider if donation takes place prior to anticipated surgery or medical procedure, of the physician responsible for collection or his/her designee, and of the donor-patient. If the blood is to be considered for allogeneic use, the donor shall sign a consent form giving consent for such use, specifying procedures for release of the unit by the health care provider, and stating that to the best of the donor's knowledge, the blood is safe for use by others; and

(8) if a donor is determined to be unsuitable for donation based on donor history, laboratory test results or implication in a case of transfusion-transmitted disease according to the protocol of the blood collection service, a record of the donor's name and identifying information. Blood from such a donor shall not be released, even if results of testing on subsequent donations are negative, unless the donor has been approved for reentry into the donor pool by the director of the blood bank.

(b) Blood banks and transfusion services shall file a Blood Services Activity Report annually with the department.

(a) For blood and blood components, logbook records of the following information, where relevant, shall be kept in the blood bank and made available to the department for inspection:

(1) source;

(2) donor identification code;

(3) ABO and Rh groups;

(4) expiration date;

(5) results of compatibility tests;

(6) disposition of the unit, including recipient's name if administered;

(7) signature or initials of the person removing the unit;

(8) date and time of issue; and

(9) results of all tests associated with the investigation of all transfusion reactions, with the conclusions reached and the report signed, or approved by electronic equivalent, by the director of the blood bank or a qualified physician designated by the director of the blood bank.

(b) For coagulation factor concentrates, logbook records of the following information shall be kept and made available to the department for inspection:

(1) manufacturer;

(2) lot number;

(3) expiration date;

(4) disposition, including recipient's name if administered; and

(5) date of issue.

(c) For all derivatives, records associated with the investigation of all reactions, with the conclusions reached and the report signed, or approved by electronic equivalent, by the director of the blood bank or a qualified physician designated by the director of the blood bank, shall be kept and made available to the department for inspection.

(d) These recordkeeping requirements shall also apply to blood issued to limited transfusion services.

(a) A blood bank may maintain blood donation centers at fixed sites provided written approval is obtained from the department for the establishment of each such center.

(b) Each blood donation center shall be under the supervision of the director of the blood bank, and shall be adequately lighted and ventilated, and equipped and operated in a manner satisfactory to the department.

(c) Other activities, including preparation of components, storage, distribution and donor qualification laboratory testing shall not be performed at blood donation centers without prior written approval of the department.

(d) The blood bank shall inform the department, upon request, of the number and type of mobile units active under its direction, and the provisions made for the handling of medical emergencies.

(a) The standards that apply to whole blood collection and processing shall apply to serial plasmapheresis except as otherwise specified. Whenever the plasma is not intended for transfusion, or for the preparation of fractions for transfusion, the criteria for donor selection may be limited to those designed for the safety of the donor. In such instances, the plasma unit shall be prominently labeled "NOT FOR TRANSFUSION" or similar language.

(b) Direction. The director of a serial plasmapheresis program shall be a physician who must demonstrate satisfactory training in all aspects of hemapheresis, including a minimum of two years' experience.

(c) Informed consent. The consent of a prospective serial plasmapheresis donor shall be obtained in writing after a licensed physician explains the hazards of the procedure to the donor in such a manner that he/she is offered an opportunity to refuse consent. The donor shall be told of the risks of serial plasmapheresis, including the possibility of a hemolytic transfusion reaction if he/she is given someone else's red cells, risks of any medications or sedimenting agents to be used, and, if he/she is to be immunized or hyperimmunized, of the hazards involved. For example, in the case of immunization with human blood components, the donor shall be told specifically about the risk of viral hepatitis, as well as about the increased risk of receiving incompatible blood if he/she ever needs a transfusion. A prospective donor who is to be deliberately exposed to an antigen shall also be given a general description of the immunization program, including the nature of the material to be injected. All of this information shall also be given to each prospective donor in written form, and the donor's consent shall be signed and witnessed on a form approved by the department.

(d) Donor qualification. A donor may not be accepted for serial plasmapheresis unless the criteria in section 58-2.2(b) and (c) of this Subpart, with the exception of sections 58-2.2(b)(5) and (7), and 58-2.2(c)(10) and (11) are met.

(e) Care of serial plasmapheresis donors. A qualified, licensed physician shall be available within fifteen minutes' travel time of the premises at which serial plasmapheresis is performed, immediately available for personal or telephone consultation in the treatment of a donor who manifests an adverse reaction, and responsible for all phases of plasmapheresis conducted. A physician or a registered nurse designated by the medical director shall be available on the premises at all times. The floor supervisor shall be a registered nurse, physician assistant, or person with at least two years' experience performing plasmapheresis procedures, and shall have completed a plasmapheresis training program that includes documented satisfactory performance of donor plasmapheresis procedures. Persons performing manual plasmapheresis procedures shall be licensed practical nurses, registered nurses, clinical laboratory technologists, physician assistants, or persons with at least two years' experience performing manual plasmapheresis procedures. Persons performing automated plasmapheresis procedures shall be licensed practical nurses, registered nurses, clinical laboratory technologists, clinical laboratory technicians or physician assistants, or persons with at least six months' experience in collecting whole blood for transfusion. All persons performing plasmapheresis procedures shall have one year's experience performing plasmapheresis procedures or shall have completed a training program in plasmapheresis procedure technique. The training program must include training in donor screening, venipuncture techniques, instrument operation, prevention of and initially addressing donor reactions, and proper documentation of all completed procedures. At the end of the training program, each plasmapheresis operator must be able to:

(1) safely and effectively operate the cell separator systems in use at the facility;

(2) harvest plasma which meets quality standards;

(3) manage fluid volumes safely;

(4) prevent, and when necessary, initially address adverse reactions;

(5) develop the ability to work independently, utilizing the floor supervisor as a resource when necessary; and

(6) provide support to the donor while maintaining control of the operation of the instrument. The director shall establish an agreement with an accredited hospital in the vicinity of the plasmapheresis center for the admission of donors who sustain adverse reactions and require hospital care.

(f) Laboratory testing. A serologic test for syphilis shall be performed within 24 hours on a specimen collected at the time of the first donation and, at four-month intervals thereafter. A donor with a reactive serologic test for syphilis shall not be plasmapheresed again until the donor's serum is nonreactive in confirmatory testing, except that donors with reactive tests for syphilis may be plasmapheresed to obtain plasma to be used for manufacturing control serum for serologic tests for syphilis. Approved tests for HBsAg, antibodies to HCV, HIV-1 and HIV-2 shall be performed on the retained plasma or on a specimen obtained from the donor at the time of donation. If the plasma is intended for transfusion, all tests required in section 58-2.3(a) of this Subpart shall be performed.

(g) Return of red blood cells to donor. If it is not possible to return red blood cells to a plasmapheresis donor, or if whole blood is donated, the donor shall not be plasmapheresed again for eight weeks, unless the donor's extracorporeal red blood cell volume during the procedure is not expected to exceed 100 milliliters.

(h) Manual plasmapheresis procedures. Containers and anticoagulants shall meet the standards for whole blood. Before the blood container is separated from the donor for processing, it shall bear two separate and independent means of identification to enable both the donor and the phlebotomist to determine without doubt that the contents originate from the donor. Plasmapheresis shall be performed aseptically under conditions that avoid air embolism. During their separation, the red blood cells shall be maintained at a temperature not exceeding 37 degrees Celsius and under conditions known to assure the sterility and viability of these cells upon their return to the donor. The identity of the donor and the container shall be confirmed by at least two technical staff members prior to reinfusion of the red blood cells. Red blood cells shall be returned to the donor within two hours of the phlebotomy. If plasmapheresis is to be performed using equipment dissimilar to blood bags used for the collection of blood so that the standards for containers and anticoagulants for whole blood do not apply, specific approval from the department is required.

(i) Automated plasmapheresis procedures. Plasmapheresis shall be performed aseptically under conditions that avoid air embolism and maintain sterile technique. If plasmapheresis is to be performed using equipment dissimilar to blood bags used for the collection of blood so that the standards for containers and anticoagulants for whole blood do not apply, specific approval from the department is required.

(j) Records. All institutions performing plasmaphereses shall maintain records of all plasmaphereses performed, and the clinical and laboratory information pertinent thereto. These records shall include complete information on each donor, signed consent of the donor, his/her identification code, and the amount of plasma removed. When immunizations are performed, the antigen and the procedures employed shall be identified and recorded, and the donor shall give specific consent for the immunization. These records shall be available for inspection for at least seven years after each plasmapheresis.

(a) Selection of donors. The standards that apply to whole blood donation shall apply in the selection and care of the donor for apheresis, unless otherwise specified.

(b) Informed consent. The consent of a prospective donor shall be obtained in writing after a qualified and specially trained individual explains the hazards of the procedure in such a manner that the donor is offered an opportunity to refuse consent. The donor shall be informed of the risks of apheresis and the risks of any sedimenting agents or medications to be used.

(c) Qualifications and care of the donor.

(1) Only those persons may be accepted as blood donors for apheresis who are in good health as indicated by the qualifications of a whole blood donor as specified in section 58-2.2 of this Subpart, with the following exceptions:

(i) Ingestion of aspirin-containing medications within three days of donation shall preclude donation of platelets.

(ii) Cytapheresis of donors who do not meet the requirements of this subsection shall be performed only if the harvested cells are expected to be of particular value to an intended recipient, and only if the supervising physician has confirmed in writing the particular value of these cells and has certified that the donor's health permits cytapheresis.

(iii) Medications or sedimenting agents to facilitate cytapheresis shall not be used in donors whose medical history suggests that these may exacerbate previous or intercurrent disease. Guidelines for use of such agents shall be established by the medical director.

(2) The medical director, who must demonstrate satisfactory training in all aspects of apheresis, including one year of experience, shall be responsible for all phases of apheresis conducted. Persons performing apheresis procedures shall be registered nurses, licensed practical nurses, clinical laboratory technologists, clinical laboratory technicians or physician assistants, or persons with at least six months' experience collecting blood for transfusion. All persons performing apheresis procedures shall have at least one year's experience performing apheresis procedures or shall have completed a training program in apheresis procedure technique. The training program must include training in donor screening, venipuncture techniques, instrument operation, prevention of and initially addressing donor reactions, and proper documentation of all completed procedures. At the end of the training program, each apheresis operator must be able to:

(i) safely and effectively operate the cell separator systems in use at the facility;

(ii) harvest blood components which meet quality standards;

(iii) manage fluid volumes safely;

(iv) prevent, and when necessary, initially address adverse reactions;

(v) develop the ability to work independently, utilizing the floor supervisor as a resource when necessary; and

(vi) provide support to the donor while maintaining control of the operation of the instrument.