Proposed Rule Making:
Amendment of Subpart 58-2 of Title 10
(Blood Banks)
| Publication Date: 07/03/2007 | Comment Period Expiration: 08/17/2007 |
Proposed Text and Statements:
Summary of Express Terms
This amendment to Subpart 58-2 reflects currently accepted nomenclature and technology, updates practice standards, and provides needed clarification of provisions for regulation of blood banks and transfusion services. Definitions have been revised for the terms intraoperative blood recovery, allogeneic collection, and medical director, while new definitions are added for the terms clinical laboratory technician, clinical laboratory technologist, health care provider, nurse practitioner, physician, physician assistant, and physician designee. References to solvent/detergent-treated plasma have been deleted from definitions for the terms blood components and derivatives.
The minimum age for allogeneic blood donors is lowered from 17 to 16 years, with written parental permission.
The amendment requires that blood donor samples undergo nucleic acid testing for detection of human immunodeficiency virus and hepatitis C virus. Current regulatory language is modified to reflect the industry standard of utilizing a combination test for human T-lymphotropic virus types I and II. To recognize advances in technology, the requirement for weakly reactive controls is made generic so as to apply to any test methodology that might be employed.
Testing of a specimen collected subsequent to the date of donation is permitted for autogeneic donors.
Repeated listings of individual blood grouping and infectious disease tests are replaced by references to the section that specifies the required tests.
Requirements for labeling pre-transfusion specimens are expanded to include identification of the individual drawing the specimen.
Centrifuge maintenance and frequency of functional calibration requisites are specified. The amendment also clarifies initiation of the time limit for storage of blood recovered during or after surgery, and for blood collected for normovolemic hemodilution.
Requirements for collection, by serial plasmapheresis, of plasma for fractionation are separated from those for collection, by infrequent apheresis, of plasma for transfusion. A new provision requires that all floor supervisors complete a training program that includes documented satisfactory performance of donor apheresis procedures. The amendment specifies that a person specifically trained in recognizing and addressing reactions that may occur in association with the procedures being performed to be immediately available on the premises during an apheresis procedure, rather than relying solely on educational credentials for qualification of staff.
The amended regulation specifies that a supervisor must possess one year of experience in overseeing allogeneic blood collections, and specific training in the recognition and treatment of any reactions that may occur.
The roles and responsibilities of transfusion staff within and outside a health care setting are delineated. Identification procedures for the unit of blood to be transfused, the accompanying paperwork, and the recipient are clarified.
The maximum temperature of blood warmers is changed from 42 degrees Celsius to “the temperature specified in a written protocol, in conformance with the system manufacturer’s instructions.” The amendment specifies that blood warmer temperatures be recorded on each day of use.
Minimums for apheresis donor hemoglobin, hematocrit, and weight are clarified, and maximum permissible red blood cell loss is increased.
Required elements are enumerated for full documentation of the product name, lot number, and expiration date of infused plasma derivatives.
Pursuant to the authority vested in the Council on Human Blood and Transfusion Services by Section 3121(5) of the Public Health Law, subject to approval by the Commissioner of Health, Subpart 58-2 of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York is amended, to be effective upon publication of a Notice of Adoption in the New York State Register, as follows:
The table of contents for Subpart 58-2 is amended as follows:SUBPART 58-2
BLOOD BANKS
(Statutory authority: Public Health Law, Sec. 3121(5))
Sec.
58-2.1 Definitions
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58-2.14 [Plasmapheresis] Serial plasmapheresis
58-2.15 [Cytapheresis] Collection of blood components by apheresis
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Subdivisions (d) and (e) of Section 58-2.1 are amended as follows:
(d) Blood components means those preparations separated from a single donation of whole blood, or [a cytapheresis or plasmapheresis product] collected by apheresis, intended for direct use [as final products for] 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. [For purposes of this Part, solvent/detergent-treated plasma intended for direct transfusion shall be considered to be a blood component.]
(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. [For purposes of this Subpart, derivatives does not include solvent/detergent-treated plasma intended for direct transfusion.]
Subdivision (j) of Section 58-2.1 is amended as follows:
(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 [cardiac] 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.
Subdivision (p) of Section 58-2.1 is amended as follows:
(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.
Subdivision (s) of Section 58-2.1 is amended as follows:
(s) Medical director means a qualified physician [licensed to practice medicine and currently registered under the laws of the State of New York or in the state of practice and] who is employed by a blood bank, and is responsible for donor selection and safety.
New subdivisions (x), (y), (z), (aa), (bb), (cc) and (dd) of Section 58-2.1 are added as follows:
(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 examinations and any other tests 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.
Subdivision (a) of Section 58-2.2 is amended as follows:
(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 [physician] 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.
Paragraph (5) of subdivision (b) of Section 58-2.2 is amended as follows:
(5) freedom from syphilis. However, blood for plasma fractionation into heat-treated or [inactivated] pathogen-inactivated derivatives may be accepted;
Paragraphs (3) and (4) of subdivision (c) of Section 58-2.2 are amended as follows:
(3) who is under 17 years of age, except [with specific permission of the donor’s own physician;] 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 [over] more than 75 years of age, except that donors over 75 may be accepted [at the discretion of] after satisfactory case-by-case review by the medical director or physician designee;
Subdivisions (a), (b), (d) and (e) of Section 58-2.3 are amended as follows:
(a) For allogeneic collections under New York State permit, [a specimen of blood shall be collected from the donor at the time of each donation on which] approved tests for syphilis; [and] hepatitis B surface antigen (HBsAg)[,] ; HIV-1 and hepatitis C virus (HCV) nucleic acid; and [tests for] antibodies to hepatitis B core antigen (anti-HBc), [hepatitis C virus (HCV),] HCV, HIV-1, HIV-2, and human T-lymphotropic virus [type I (HTLV-I)] 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 [of optical density or fluorescence] 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 [specimens] 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.
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(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 [cytapheresis products] 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.
Subdivisions (b) and (c) of Section 58-2.4, “Collection of blood,” are amended as follows:
(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 [can] may an allogeneic blood donor donate more than twice [in] within a 16-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.
Subparagraph (i) of paragraph (3) of subdivision (d) of Section 58-2.6 is amended as follows:
(i) For allogeneic collection, the container and the attached pilot blood specimens shall be legibly labeled at the time of collection with the [donor's] 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 [the container] component containers. [The test results for syphilis, HBsAg and anti-HBc, and test results for antibodies to HCV, HIV-1, HIV-2, and HTLV-I shall be affixed to the container or included in the product circular for blood and blood products intended for transfusion.]
Subdivision (e) of Section 58-2.6 is amended as follows:
(e) For allogeneic and autogeneic collections, adequate specimens of blood sufficient [to perform the tests required by section 58-2.3(a) of this Subpart] for all testing to be performed shall be taken. [These specimens shall be used for blood grouping tests and tests for syphilis, HBsAg and anti-HBc, and tests for antibodies to HCV, HIV-1, HIV-2 and HTLV-I. When CPDA-1 is used as an anticoagulant, pilot samples for compatibility testing shall contain blood mixed with CPDA-1.]
Section 58-2.7 is amended as follows:
58-2.7 Immunohematology testing.
(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.
[(a)] (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 [minimal] minimum requirements of the F.D.A.
[(b)] (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 [and potency] 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.
[(c)] (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.
[(d)] (e) Centrifuges used for testing of red blood cell agglutination shall [be calibrated quarterly, and optimal centrifugation conditions shall be employed.] 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.
Subdivision (b) of Section 58-2.9 is amended as follows:
(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 [from the donor] reacts negatively to [approved] tests [for syphilis, HBsAg and anti-HBc, and tests for antibodies to HCV, HIV-1, HIV-2 and HTLV-I] 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 [products] 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 [products] components from a donor found to have a positive result for anti-HBc may be permitted upon the authorization of the [physician] health care provider ordering the transfusion and the written authorization of the medical director or [other] physician [designated by the medical director] designee, provided that such authorization documents the indication and justification for such release. Such [products] components shall be labeled with all positive test results. Blood from a donor whose blood [sample] 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 [sample] 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 [sample] specimen reacts positively in tests for HBsAg, HIV or HCV nucleic acid, or antibodies to HCV, HIV-1, [and/or] HIV-2, or [HTLV-I] 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.
Paragraphs (5) and (7) of subdivision (a) of Section 58-2.11 are amended as follows:
(5) results of [the tests for ABO and Rh groups, screening tests for unexpected alloantibodies, and, if performed, results of the hemoglobin or hematocrit determination and the tests for syphilis, HBsAg and anti-HBc, and tests for antibodies to HCV, HIV-1, HIV-2 and HTLV-I.] all tests performed on a sample from the donor or a unit;
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(7) for autogeneic donation, documentation of written or verbal consent of the donor-patient’s [physician] 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 [which gives] giving consent for such use, [specifies] specifying procedures for release of the unit by the [physician] health care provider, and [states] stating that to the best of the donor’s knowledge, the blood is safe for use by others; and
The title of Section 58-2.14 is amended as follows:
58-2.14 [Plasmapheresis.] Serial plasmapheresis.
Subdivisions (a) and (c) through (f) of Section 58-2.14 are amended as follows:
(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.
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(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. [The assistants under the physician's supervision shall be fully trained in the recognition and prevention of all hazards associated with the procedure, shall monitor and observe each donor for reactions during the procedure, and shall be prepared to institute emergency care while awaiting the physician's specific directions. The] A physician or a registered nurse designated by the [physician] medical director shall be available on the premises at all times. The floor supervisor shall be a registered nurse, [physician's] physician assistant, or person with at least [six] two years' experience performing plasmapheresis procedures, and shall have completed a plasmapheresis training program that includes documented satisfactory performance of donor plasmapheresis procedures. [For] Persons performing manual plasmapheresis procedures [, the assistants] shall be licensed practical nurses, registered nurses, [medical] clinical laboratory technologists, [physician's] physician assistants, or persons with at least two years' experience performing manual plasmapheresis procedures. [For] Persons performing automated plasmapheresis procedures [, the assistants] shall be licensed practical nurses, registered nurses, [medical] clinical laboratory technologists, [medical] clinical laboratory technicians or [physician's] physician assistants, or persons with at least six months' experience in collecting whole blood for transfusion. All [assistants] 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, [recognition and treatment of] 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, [provide initial management of] initially address adverse reactions;
(5) develop the ability to work independently, utilizing the [supervising assistant] floor supervisor as a resource when necessary; and
(6) provide support to the donor while maintaining control of the operation of the instrument. The [physician] 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 [sample] specimen collected at the time of the first donation and [, in the case of serial plasmapheresis,] 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[,] and antibodies to HCV, HIV-1 and HIV-2 shall be performed on the retained plasma or on a [sample] specimen obtained from the donor at the time of donation. If the plasma is intended for transfusion, [approved tests for anti-HBc and antibodies to HTLV-I] all tests required in section 58-2.3(a) of this Subpart shall [also] be performed.
Section 58-2.15 is amended as follows:
Section 58-2.15 [Cytapheresis] Collection of blood components by apheresis.
(a) Selection of donors. The standards that apply to whole blood donation shall apply in the selection and care of the donor for [cytapheresis] 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 [cytapheresis] 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 [cytapheresis] apheresis who are in good health as indicated [in] by the qualifications of a whole blood donor [as] specified in section 58-2.2 of this Subpart, with the following exceptions:
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(2) The medical director, who must demonstrate satisfactory training in all aspects of [cytapheresis] apheresis, including one year of experience, shall be responsible for all phases of [cytapheresis] apheresis conducted. [The medical director shall designate a licensed physician to supervise the procedure, as well as assistants fully trained in the recognition and prevention of any adverse reactions. The assistants shall be prepared to institute emergency care during such reactions, while awaiting specific instructions from the supervising physician. These assistants] Persons performing apheresis procedures shall be registered nurses, licensed practical nurses, [medical] clinical laboratory technologists, [medical] clinical laboratory technicians or [physician's] physician assistants, or persons with at least six months' experience collecting blood for transfusion. All [assistants] persons performing apheresis procedures shall have at least one year's experience performing [cytapheresis] apheresis procedures or shall have completed a training program in [cytapheresis] apheresis procedure technique. The training program must include training in donor screening, venipuncture techniques, instrument operation, [recognition and treatment of] prevention of and initially addressing donor reactions, and proper documentation of all completed procedures. At the end of the training program, each [cytapheresis] 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, [provide initial management of] initially address adverse reactions;
(v) develop the ability to work independently, utilizing the [supervising assistant] floor supervisor as a resource when necessary; and
(vi) provide support to the donor while maintaining control of the operation of the instrument. [The floor supervisor shall be a registered nurse, physician’s assistant, or person with at least six years’ experience performing pheresis procedures. The physician or a registered nurse designated by the physician shall be immediately available on the premises at all times during a cytapheresis procedure. A qualified licensed physician shall be immediately available, at least for telephone consultation, during all procedures.]
(3) The floor supervisor shall be a:
(i) registered nurse;
(ii) physician assistant;
(iii) person with at least two years’ experience performing apheresis procedures; or
(iv) person with at least one year of experience supervising allogeneic blood collection.
(4) The floor supervisor shall have completed an apheresis training program that includes documented satisfactory performance of donor apheresis procedures.
(5) A person specifically trained in recognizing and addressing reactions that may occur in association with the procedures being performed shall be immediately available on the premises at all times during an apheresis procedure. A qualified licensed physician shall be immediately available, at least for telephone consultation, during all procedures.
(d) Volume and frequency of [cytapheresis] apheresis. Extracorporeal blood volume shall not exceed 15 percent of the donor’s estimated blood volume. No more than [1,000 milliliters] 12.0 liters of plasma shall be removed per [seven days] year from a donor weighing 175 pounds or less, and no more than [1,200 milliliters] 14.4 liters shall be removed per [seven days] year from a donor weighing more than 175 pounds. The interval between procedures shall be at least 48 hours. The above volume and frequency requirements may be waived upon written authorization of the supervising physician, provided the donor meets all other eligibility requirements. Red blood cell loss shall not exceed [275] 300 milliliters per eight weeks, unless the following requirements are met:
(1) for male donors, the donor’s weight [exceeds] is at least 130 pounds;
(2) for female allogeneic donors, the donor’s weight [exceeds] is at least 150 pounds;
(3) for female autogeneic donors, the donor’s weight [exceeds] is at least 130 pounds;
(4) the allogeneic donor’s hemoglobin content [exceeds] is 13.3 grams per deciliter or greater or hematocrit [exceeds] is 40 percent or greater;
(5) the autogeneic donor’s hemoglobin content [exceeds] is 12.0 grams per deciliter or greater or hematocrit [exceeds] is 36 percent or greater;
(6) the volume of packed red blood cells removed does not exceed 550 milliliters; and
(7) the volume removed is replaced with at least 225 milliliters of normal saline.
Following a red cell apheresis procedure in which red blood cell loss exceeds [275] 300 milliliters, the allogeneic donor shall not donate whole blood or undergo another apheresis procedure for a minimum of 16 weeks. For autogeneic donors, frequency and volume to be removed shall be determined by the medical director of the blood bank in conformance with recommendations of the manufacturer of the apheresis device.
(e) Return of red blood cells to donor. If it is not possible to return red blood cells to a donor, or if whole blood is donated, the donor shall not [be cytapheresed] undergo apheresis again for eight weeks, unless the donor’s extracorporeal red blood cell volume during the procedure will not exceed 100 milliliters.
(f) Procedures for collection of blood components by apheresis and their processing [of cytapheresis products]. Such procedures shall follow a written protocol approved by the medical director. Containers and anticoagulants shall meet the standards for whole blood. [Cytapheresis] Apheresis shall be performed aseptically under conditions that prevent air embolism, and assure sterility and viability of cells returned to the donor.
(g) Required records. All facilities performing [cytapheresis] apheresis shall maintain records of all [cytapheresis] such procedures performed, and the clinical and laboratory information pertinent thereto. These records shall include complete information on the donor, volume of blood removed, anticoagulants used, duration of the procedure, volume of [products] components obtained, medications and sedimenting agents used, including manufacturer, lot number, expiration date and amount administered, and any adverse reactions and their management. These records shall be available to the department for inspection for at least seven years after each procedure.
Subdivisions (d), (f), (g) and (j) of Section 58-2.16 are amended as follows:
(d) Whole blood, red blood cells, plasma, or other components and derivatives shall be prepared and administered by methods generally accepted by the F.D.A. or American Association of Blood Banks and/or by other methods approved by the department as in conformance with generally accepted laboratory principles. For blood and blood components, the person [performing] initiating the transfusion shall be a physician, registered nurse, [physician’s] physician assistant, nurse practitioner, licensed practical nurse or board-certified cardiovascular perfusionist (intraoperatively). [, or licensed practical nurse.] A licensed practical nurse shall [perform] initiate transfusions only following satisfactory completion of a transfusion training program meeting criteria specified by the department and by the [Department of] New York State Education Department and only when a registered nurse, physician assistant, or a physician [or other person authorized by law to manage transfusion reactions,] is immediately available on site. A filter meeting F.D.A. requirements shall be incorporated into the intravenous administration set to be used for blood or blood component transfusions.
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(f) [Immediately prior to the administration of a blood product,] In a health care setting, following comparison of the blood product label with all accompanying information, the person [administering the blood product] initiating the transfusion shall, at the [patient site] patient’s side, immediately prior to initiating the transfusion, positively identify the recipient and the blood product to be transfused or infused, using the [patient] patient’s name and a unique numerical or alphanumerical identifier[, the recipient and the blood product to be transfused or infused]. For administration of a blood component, one additional person [other than the recipient], who must be a physician, registered nurse, physician assistant, nurse practitioner, licensed practical nurse, or board-certified cardiovascular perfusionist (intraoperatively), shall also so identify the recipient and the blood component, unless another procedure to ensure accurate identification is used, in which case a single identification is sufficient. At least one person identifying the patient and blood component at the patient’s side shall be a physician, registered nurse, physician assistant, nurse practitioner, or board-certified cardiovascular perfusionist (interoperatively). Each identification procedure shall be documented in writing by each participant. Two persons authorized to initiate blood transfusions shall be immediately available during a blood component transfusion and for 30 minutes afterward, except for transfusion of a patient enrolled in a chronic transfusion program who has no history of adverse reactions. A blood component recipient’s vital signs shall be serially recorded, in accordance with written policies and procedures. If the person recording the vital signs is a licensed practical nurse, all measurements outside of established parameters shall be reported to a registered nurse, physician, physician assistant, or nurse practitioner for assessment and action. Such notification shall be documented.
(g) For transfusions outside a health care setting, including in patient homes, the person initiating the transfusion and monitoring the patient shall be a physician, registered nurse, physician assistant, or nurse practitioner. Following comparison of the blood product label with all accompanying information, this person shall, at the patient’s side, immediately prior to initiating the transfusion, positively identify the recipient and the blood product to be transfused or infused, using the patient’s name and a unique numerical or alphanumerical identifier. Such identification procedure shall be documented in writing. The person administering the transfusion and another competent adult, other than the recipient, shall be immediately available at all times during a transfusion. [Transfusion staff] Both persons shall be available for 30 minutes afterwards, except for transfusions of patients enrolled in a chronic transfusion program who have no history of adverse reactions. The recipient’s vital signs shall be monitored and documented, in accordance with written policies and procedures.
* * *
(j) If blood is warmed prior to transfusion, the warming system shall be equipped with a visible thermometer and an alarm to ensure that the blood is not warmed above the temperature specified by the director of the blood bank, in conformance with the system manufacturer’s instructions. [Temperature] Blood warmer temperature shall be monitored and recorded on each day of use, and such records shall be available for inspection for at least five years. Maintenance and operation of blood warmers must conform to the manufacturer’s instructions.
Section 58-2.19 is amended as follows:
Section 58-2.19 Records to be kept when plasma derivatives are infused. The following information shall be included on the recipient’s chart or in records maintained in the blood bank or pharmacy:
(a) product name, lot number, and expiration date;
(b) date of infusion and quantity of material infused; and
[(b)] (c) description of any adverse reaction and the results of investigations related to this reaction.
Subdivisions (e) through (g) of Section 58-2.21 are amended as follows:
(e) A licensed physician, physician assistant, or nurse practitioner must be immediately available for personal or telephone consultation during the transfusion and for 30 minutes afterward.
(f) Any site at which a transfusion is performed by a limited transfusion service must have available an accessible working telephone to allow communication [with the physician] in case of an adverse reaction. All medications, equipment and supplies necessary for the management of adverse reactions must be immediately available on the premises. Infectious waste disposal must be undertaken using containers and procedures found acceptable by the department pursuant to Part 70 of this Title.
(g) Referral of a patient for out-of-hospital transfusion therapy must be approved by the director of the limited transfusion service or his/her designee. Each such transfusion must be ordered by a licensed physician, physician assistant, or nurse practitioner, and a copy of the order must be provided to both the limited transfusion service and the facility issuing the blood.
Section 58-2.23 is amended as follows:
Section 58-2.23 HIV-1 and HIV-2 antibody testing results. No blood bank shall inform any blood or plasma donor or his/her [physician] health care provider of the results of HIV-1, HIV-2 or HIV-1/HIV-2 combination antibody screening tests unless such results are negative, with the exception of autogeneic donors, whose [physician] health care provider may be informed of screening test results if there is insufficient time prior to surgery for completion of supplemental testing, provided that such [physician] health care provider is instructed that the donor may not be informed that he or she is positive for HIV-1 or HIV-2 antibodies based on the incomplete results. Initial reactive screening tests shall be repeated in duplicate. If two of three screening tests are reactive, the sample shall be considered repeatedly reactive, and supplemental testing shall be performed. Notification that a donor is positive shall be made only if the results have been reactive for more than one screening test, and the supplemental HIV antibody test result has been unequivocally positive. Appropriate counseling of donors regarding the significance of all test results must be available. HIV results [which] must be reported to donors if the results are substantiated as positive, or upon supplemental testing show an increased likelihood of representing seroconversion to positive, as determined by the director of the laboratory performing the supplemental testing[, must be reported to donors]. This report must be made in person unless repeated efforts to encourage a donor to come in have failed, in which case notification may be made by certified restricted delivery mail. HIV results [which] that are substantiated as negative, or upon supplemental testing are indeterminate but do not show an increased likelihood of representing seroconversion to positive, as determined by the director of the laboratory performing the supplemental testing, may be reported to donors by mail, provided that such donors are not informed that they are seropositive. Any notification of HIV results [given] to donors who were repeatedly reactive on initial screening tests, regardless of the results of supplemental testing, must include an offer of appropriate counseling [and encouragement to return for follow-up testing].
Subdivisions (b), (e) and (f) of Section 58-2.25 are amended as follows:
(b) Methods for intraoperative or postoperative recovery of blood and for normovolemic hemodilution shall be safe and aseptic, and shall ensure accurate identification of all blood collected. The equipment used shall be operated according to the manufacturer’s instructions, shall be pyrogen-free, shall include a filter capable of retaining particles potentially harmful to the recipient, and shall prevent air embolism. If the blood is warmed prior to reinfusion, the warming system shall be equipped with a visible thermometer and an alarm to ensure that the blood is not warmed above [42 degrees Celsius] the temperature specified in a written protocol, in conformance with the system manufacturer’s instructions.
* * *
(e) If not immediately transfused, recovered blood shall be stored under one of the following conditions:
(1) at one to 24 degrees Celsius for up to six hours after initiating the collection; or
(2) at one to six degrees Celsius under monitored conditions for up to 24 hours, provided that storage at one to six degrees Celsius is begun within six hours of initiating the collection and the blood is washed under sterile conditions.
(f) Blood collected for normovolemic hemodilution shall be stored under one of the following conditions prior to initiation of transfusion:
(1) at one to 24 degrees Celsius for up to eight hours after initiating the collection; or
(2) at one to six degrees Celsius under monitored conditions for up to 24 hours, provided [that] storage at one to six degrees Celsius is begun within eight hours of initiating the collection.
Subdivision (a) of Section 58-2.26 is amended as follows:
(a) When, for [immunologic reasons] indications generally accepted by the medical community, an allogeneic donor who would not otherwise qualify to donate blood or blood components is found to be uniquely suited to meet a given patient’s needs, exceptions may be made to the requirements [specified] in sections 58-2.2(b) and (c), 58-2.3(a), 58-2.4(c), and 58-2.15(c), (d) and (e) of this Subpart. Such exceptions shall be approved in writing by both the medical director of the blood bank collecting the blood or his/her physician designee, and the director of the transfusion service transfusing the blood or his/her physician designee. If donation under such circumstances presents an increased risk to the donor’s health or safety, the donor shall be informed of the risk and must consent in writing to such donation. If the donation presents an increased risk to the recipient’s health or safety, the written authorizations of the recipient’s [physician] health care provider and the recipient or person legally authorized to consent on behalf of the recipient are also required. All such exceptions granted shall be reported to the department annually [on a form] in a format designated by the department.
REGULATORY IMPACT STATEMENT
Statutory Authority:
Article 31 of the Public Health Law (PHL) establishes the Department’s authority to protect the public health, safety and welfare through oversight of the collection, processing, fractionation, storage, distribution and supply of human blood, and blood products for transfusion. The New York State Council on Human Blood and Transfusion Services is authorized by PHL Section 3121(5) to enact, amend and repeal rules and regulations setting forth minimum standards for these processes as applied to blood and blood products, subject to the approval of the Commissioner of Health.
Legislative Objectives:
The Council on Human Blood and Transfusion Services has proposed revision of Subpart 58-2 to update practice standards and promote safe blood bank operation, ensure that donor safeguards are not compromised, and prevent release of unsuitable blood units. Such amendment, which is necessary to keep pace with technology and codify practice standards, is consistent with the legislative mandate that the Department regulate the blood supply.
Needs and Benefits:
This regulatory amendment is necessitated by advances in medical technology, chronic blood shortages, and the need to maintain consistency with the State Education Department’s standards of practice for licensed health professionals, and to clarify regulatory intent. The amendment facilitates expansion of the blood supply and enhances apheresis, plasmapheresis and blood transfusion safety without compromising blood donor safeguards.
References to solvent/detergent-treated plasma have been deleted because this product is no longer available. Minor changes for clarification purposes are also proposed for the definitions of blood components, derivatives, intraoperative blood recovery, allogeneic collection, and medical director. The amendment would set forth new definitions for the terms clinical laboratory technician, clinical laboratory technologist, health care provider, nurse practitioner, physician, physician assistant, and physician designee. References to health care providers caring for patients have been broadened to recognize the growing role of physician extenders, such as physician assistants and nurse practitioners, in health care delivery, consistent with their scope of practice as specified by the State Education Department. Clinical laboratory technician and clinical laboratory technologist have been defined consistent with the recently enacted Clinical Laboratory Technology Practice Act (Article 165 of the Education Law).
The minimum age of allogeneic blood donors has been lowered from 17 to 16 years, provided that the 16 year-old has presented written permission specific to the occasion from a parent or guardian. This provision is expected to expand the domestic donor pool and reduce the need to import blood from out-of-State sources. The added opportunities for blood donation during potential donors’ high-school years may make these donors more aware of their civic responsibility earlier and more likely to become repeat blood donors as adults. In terms of donor safety, the rate of adverse incidents for donors 16 years of age is not significantly higher than that for donors 17 years of age, and adverse reactions (e.g., fainting) are similar in scope and severity. These factors are demonstrated by a retrospective review of blood center collection data for the years 2001 through 2003 made available to the Department by several major blood centers.
The Department has long recognized advances in testing technologies applicable to donated blood processing and blood donors, and proposes to codify several upgrading modifications to existing procedures. A requirement is added for blood donor testing with nucleic acid testing (NAT) technology. Such testing has been shown to detect human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) infection significantly earlier than antibody testing, thus reducing the risk that an infectious blood donation may go undetected. Terminology related to testing blood donors for human T-lymphotropic viruses (HTLV) is proposed to reflect the current industry standard of using a combination test for HTLV types I and II, referred to as HTLV-I/II. New provisions would permit testing of an autogeneic donor specimen collected subsequent to the date of donation. To simplify regulatory language and thereby facilitate compliance, actual lists of tests for blood grouping and detection of infectious diseases have been replaced by a reference to the regulation’s section specifying the required tests. To recognize advances in technology, the requirement for weakly reactive controls is made generic so as to apply to any test methodology that might be employed.
Several other technical requisites have been clarified, including those for frequency of centrifuge maintenance, as well as the time limit restriction for storage of blood recovered during or after surgery and blood collected for normovolemic hemodilution, consistent with industry standards.
Specimen labeling for pre-transfusion testing is further detailed to include identification of the person collecting the specimen. Errors in labeling of such specimens have been found to contribute to administration of incompatible blood, which may cause a fatal reaction. Requirements for collection by serial plasmapheresis of plasma intended for fractionation into blood derivatives have been separated from those for collection, by infrequent apheresis, of plasma for transfusion. Serial plasmapheresis is a more intensive and risky procedure that calls for additional donor safeguards. The revisions clarify requisites, increase donor safety, improve component quality, and take into account currently available equipment, which allows collection of plasma for transfusion in combination with other components, such as platelets or red blood cells.
The proposed regulation would permit persons with one year’s experience in supervising allogeneic blood collections to qualify as apheresis site floor supervisors, rather than the previous limitation of such supervision to registered nurses, physician assistants or individuals with six years’ experience. This change would maximize the availability of qualified candidates without compromising blood donor or recipient safety. The requirement for a physician or registered nurse to be immediately available on the premises at all times during a cytapheresis procedure has been replaced by a provision that a person be present specifically trained in recognizing and addressing reactions that may occur in association with apheresis procedures. Given the ongoing shortage of registered nurses in New York State, blood collection facilities have found it difficult to retain fulltime registered nurses to work in apheresis collection sites, necessitating the hiring of per diem nurses from temporary services agencies solely to meet current regulatory requirements. This proposed change, which appropriately places emphasis on training and experience rather than on educational credentials, would increase donor safety by ensuring that an appropriately trained person is present to handle any donor reactions and would eliminate the need to retain per diem nurses, without such specific training, solely to meet regulatory requirements.
Minimum apheresis donor hemoglobin, hematocrit and weight restrictions are clarified, and maximum-allowable red blood cell (RBC) loss is increased, consistent with apheresis equipment manufacturers’ requirements. These revisions would serve to increase the number of eligible donors without compromising donor safety. Also, Section 58-2.15, currently entitled, “Cytapheresis,” has been renamed, “Collection of blood components by apheresis,” to reflect the variety of apheresis procedures available with current technology.
Identification procedures for blood units and attendant paperwork, as well as for the recipient and blood to be transfused, have been expanded to clarify the individual steps necessary. Errors in such identification procedures are the primary cause of acute hemolytic transfusion reactions, a leading cause of deaths due to transfusion complications.
To enhance patient safety, the types of personnel who may administer transfusions within and outside a health care setting have been clarified, consistent with State Education Department practice guidelines and this Department’s requirements for healthcare facilities and home care services.
The present maximum temperature for blood warmers (42 degrees Celsius) has been replaced by “the temperature specified in a written protocol, in conformance with the system manufacturer’s instructions.” This change would allow regulated parties to purchase U.S. Food and Drug Administration (FDA)-approved blood warmers programmed to alarm prior to red blood cell hemolysis, but not necessarily at 42 degrees Celsius. This change is consistent with existing Section 58-2.16(j) specifications for blood warming systems.
The regulation has been amended to list product name, lot number, and expiration date as specific elements for full documentation of infused plasma derivatives. Such documentation would facilitate identification of patient risk in case of adverse events and recall of unsuitable blood products.
Costs for the Implementation of, and Continuing Compliance with, the Regulation to the Regulated Entity:
Regulated parties implementing the proposed amendments would incur minimal costs to modify written procedures in their standard operating procedure manuals. Labeling of specimens intended for pre-transfusion testing reflects good laboratory practice, and minimal costs to regulated facilities are anticipated.
Facilities already voluntarily employ approved tests for HIV-1 and HCV nucleic acid based on FDA recommendations, and have already hired technologists or contracted out the services to New York State-permitted laboratories.
Although some facilities could expend resources, and therefore incur costs, in obtaining parental permission for donations by 16-year-olds, considerable cost savings would be realized by an expanded donor base, lessening the need to import blood from out-of-State.
Facilities that now employ per diem RNs may realize cost savings since they will no longer need to do so solely to meet regulatory requirements.
Apheresis training programs are an industry standard. Minimal cost is anticipated for supervisory training, as on-site training programs for operators are already in existence. The supervisory training program may be less extensive than the operators’ training program.
Costs to State and Local Government:
State and local government agencies that operate blood banks would incur the same costs and benefits as private regulated parties. School districts may incur minimal costs for staff at high schools to participate in coordination, distribution and collection of parental permission forms for 16-year-old donors.
Costs to the Department:
Monitoring compliance with these revisions would entail minimal Department staff time. Costs incurred by the Department would include the costs of revising inspection-related documents and training staff members who conduct compliance inspections of regulated facilities. These one-time costs are estimated to be less than $1,000, and will be recovered by the Department through Clinical Laboratory Reference System fees.
Local Government Mandates:
This proposed amendment imposes no new mandates on any county, city, town or village government, fire or other special district.
Paperwork:
Regulated parties would need to modify written procedures in their standard operating procedure manuals to implement the amendment.
Duplication:
This proposed amendment does not duplicate any other State regulations, as Subpart 58-2 is the only State regulation governing blood banking. This proposed amendment does not duplicate federal rules pertaining to blood banks found in Parts 600 through 640, Title 21 of the Code of Federal Regulations.
Alternative Approaches:
The Council on Human Blood and Transfusion Services is charged with ensuring the safety and adequacy of the blood supply in the State of New York through promulgation and amendment of regulations. There are no alternatives that would adequately clarify and render enforceable requirements essential for protecting the public health, recognize technological advances, and ensure the least restrictive practices, consistent with national standards.
Federal Standards:
FDA has established requirements governing blood products shipped in interstate commerce. Existing Subpart 58-2 applies to New York State-permitted blood banks operating intra-state and interstate, and is consistent with federal requirements and recommendations where in place. The proposed rule does not exceed minimum federal standards in the same or related subject areas, with the exception of HIV-1 and HCV nucleic acid testing (NAT), which is recommended, but not mandated, by FDA.
Compliance Schedule:
The Department has notified affected regulated parties to solicit preliminary comments regarding the proposed amendments. Regulated parties should be able to comply with these amended regulations as of their effective date, upon publication of a Notice of Adoption in the New York State Register.
Contact Person: Mr. William R. Johnson
New York State Department of Health
Bureau of House Counsel, Regulatory Affairs Unit
Corning Tower Building, Rm. 2415
Empire State Plaza
Albany, New York 12237
(518) 473-7488
(518) 486-4834 (FAX)
REGSQNA@health.state.ny.us
REGULATORY FLEXIBILITY ANALYSIS FOR SMALL BUSINESSES
AND LOCAL GOVERNMENTS
Effect of Rule:
The Department of Health has determined that the proposed amendment, when adopted, would not result in adverse economic impact, nor impose burdensome record keeping, reporting or other compliance requirements on small businesses or local governments.
Compliance Requirements:
The proposed revisions to Subpart 58-2 would not extend regulatory oversight to any parties not regulated presently. Most facilities approved to collect and/or transfuse blood that are small businesses or operated by local governments would be affected by at least one proposed change, but not in an adverse manner. However, full compliance would not significantly increase overall costs, or reporting or record keeping requirements for any regulated parties, including those that are small businesses and operated by local governments. Savings could be realized by focusing on adequately trained personnel, rather than employing individuals with specific educational credentials in order to satisfy regulatory requirements.
Three hundred fifty-four (354) facilities hold a New York State permit or approval to conduct blood services activities. Two hundred forty-nine (249) of those facilities have a New York State permit for collection and/or transfusion activities. Of those 249 facilities, five are self-declared as meeting the criteria for small businesses, while eight have not indicated their status. The remaining 105 facilities are providers of limited transfusion services, and include 56 dialysis centers, 15 physician offices, four home care agencies, nine skilled nursing facilities, 13 ambulatory surgery centers, two outpatient transfusion services, five cancer treatment centers, and one diagnostic and treatment center. Their small business status is unknown, but the impact of the amendment on such sites would be minimal nonetheless.
All facilities would benefit from the amendments' objectives to: clarify terminology; standardize requirements for labeling of patient specimens intended for pre-transfusion testing; specify centrifuge maintenance and associated documentation; increase flexibility in maximum temperatures for blood warmers and associated documentation; require human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) nucleic acid testing (NAT) to decrease the incidence of transfusion-associated infectious disease during the window period of infection; lower the minimum age for blood donation to 16 years of age with parental permission; increase staffing flexibility by modifying supervisory qualifications; increase apheresis donor safety by amending training requirements for staff present to handle any reactions; and clarify storage limits for recovered blood and blood collected for normovolemic hemodilution. The small businesses that collect blood would benefit from the proposed expanded donor pool. Portions of the amendments may also apply to limited transfusion services, but their impact would be minimal.
Professional Services:
Regulated parties will not need additional professional services to comply with these regulations.
Compliance Costs:
Small businesses and local governments that operate blood banks implementing the proposed requirements would need to modify their standard operating procedure manuals, thus incurring minimal costs. Facilities already voluntarily employ approved tests for HIV-1 and HCV nucleic acid based on U.S. Food and Drug Administration recommendations. Clarification of requirements for labeling of specimens for pre-transfusion testing had been requested by transfusion services and blood banks; no additional costs to regulated facilities are anticipated as a result of this change.
Economic and Technical Feasibility:
The proposed changes present no economic or technical difficulties to small businesses and local governments. Although some revisions to blood collection procedures and record keeping practices are necessary, these requirements are straightforward and easily instituted by existing blood bank staff.
Minimizing Adverse Impact:
The proposed amendments would have no significant adverse impact on small businesses presently in compliance with established industry standards. These amendments were developed with the goal of minimizing any burdens on regulated parties.
Small Business and Local Government Participation:
The Department has notified all regulated parties directly regarding the proposed regulation in order to solicit comments. Recommended changes have been incorporated, as appropriate, based on comments and suggestions received as a result.
RURAL AREA FLEXIBILITY ANALYSIS
Types and Estimated Numbers of Rural Areas:
Three hundred fifty-four (354) facilities hold a New York State permit or approval to conduct blood service activities. One hundred nineteen (51 percent) of the 232 in-State facilities with a New York State permit for collection and/or transfusion, and 57 (54 percent) of the 105 facilities approved to provide limited transfusion services (LTS) are located in rural counties.
Reporting, Record Keeping and Other Compliance Requirements, and Professional Services:
This proposed amendment would not extend regulatory oversight to any parties not presently regulated. Most facilities approved to collect and transfuse blood would be affected by some of the provisions of the proposal, but not in an adverse manner. The amendments would have no adverse effect on blood banks located in rural areas, as full compliance would not significantly increase overall costs, or reporting or record keeping requirements for any regulated parties, including blood banks located in rural areas.
This amendment would not impose an adverse economic impact on public or private entities in rural areas. Many of the proposed revisions are less restrictive than those in the existing regulation. Regulated parties may, but would not be required to, relax present practices to comply with the proposed amendments.
All facilities would benefit from the amendments' objectives to: clarify terminology; standardize requirements for labeling of patient specimens intended for pre-transfusion testing; specify centrifuge maintenance and associated documentation; streamline language pertaining to maximum temperatures for blood warmers and associated documentation; require human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) nucleic acid testing (NAT) to decrease the incidence of transfusion-associated infectious disease during the window period of infection; lower the minimum age for blood donation to 16 years of age with parental permission; increase staffing flexibility by modifying supervisory qualifications; enhance apheresis donor safety by modifying training requirements for staff present to handle any reactions; and clarify storage limits for recovered blood and blood collected for normovolemic hemodilution. Facilities located in rural areas that collect blood would benefit from the proposed expanded donor pool. Portions of the amendments may also apply to LTS facilities.
Regulated parties will not need additional professional services to comply with these regulations.
Costs:
Regulated parties in rural areas implementing the revised requirements would need to modify their standard operating procedure manuals, thus incurring minimal costs. Facilities already employ approved tests for HIV-1 and HCV NAT based on U.S. Food and Drug Administration recommendations. The proposal’s detailing labeling requirements for specimens intended for pre-transfusion testing had been requested by transfusion services; no additional costs to regulated facilities are anticipated. Although some facilities may incur some minimum costs in documenting parental permission for 16-year-old donors, long-term cost savings would be realized by an expanded donor pool, reducing the need to import blood from out-of-State sources. Additional savings would in fact be realized, as per diem RNs will no longer need to be hired from temporary services agencies solely to meet regulatory requirements.
Minimizing Adverse Impact:
The proposed amendments would have no significant adverse impact on blood banks in rural communities presently in compliance with established industry standards. These amendments were developed with the intent to minimize any burdens on regulated parties.
Rural Area Participation:
The Department has notified all regulated parties directly regarding the proposed regulation in order to solicit comments. Recommended changes have been incorporated, as appropriate, based on comments and suggestions received as a result.
JOB IMPACT STATEMENT
A Job Impact Statement is not included because it is apparent, from the nature and purpose of the proposed rule, that it will not have a substantial adverse impact on jobs and employment opportunities. Since the amendment simply clarifies or relaxes current requirements, there are no implications for job opportunities. Laboratories that have voluntarily adopted human immunodeficiency virus type 1 and hepatitis C virus nucleic acid testing technology have already hired technologists or contracted out these services to clinical laboratories under permit to operate in New York State.