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.

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.

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 recordkeeping, 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 recordkeeping 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 Technological 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.

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, RecordKeeping 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 recordkeeping 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.

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.