Section 58-2.1 definitions for the terms blood bank, blood donation center, transfusion service and reinfusion procedure are amended. The definition of blood components is revised to include plasma frozen within 24 hours after phlebotomy and specifically exclude lymphocytes collected from a hematopoietic progenitor cell donor. The definition for holding facility is replaced by a definition for distribution facility. Ambulance transfusion service and hospital are defined in new subdivisions (ae) and (af), respectively.

Section 58-2.2 as modified, alters the qualifications for allogeneic blood donors by removing an obsolete provision pertaining to acute respiratory diseases, expanding options for review and acceptance of donors who are 76 years of age or older, and clarifying the timing of opportunities provided for donor self-exclusion.

Section 58-2.3(e) is amended to permit infectious disease testing to be performed on a donor blood specimen collected prior to the donation of such a component.

Section 58-2.4(a) clarifies the locations at which blood collection activities may be conducted, to include a blood donation center, a self-contained blood collection vehicle, and a temporary collection operation conducted by a blood bank. A new subdivision (d) stipulates that persons collecting blood for transfusion must be trained in recognition of donor reactions, and that a nurse or other qualified person specially trained to address donor reactions be present.

Section 58-2.6(a), which details locations for collection of blood, is repealed, as this requirement is now addressed in Section 58-2.4(a). Subdivisions (b), (c) and (d) of Section 58-2.6 are renumbered as subdivisions (a), (b) and (c), respectively. Requirements for storage of collected whole blood during transport are moved from Section 58-2.6(g) to the new subdivision (d) and limitations on duration of storage for whole blood units from which platelets will be separated are deleted. Labeling requirements now in paragraph (3) of renumbered subdivision (c) replace the existing provisions in subdivision (e), which are duplicative of Section 58-2.4(b) as amended. The labeling provisions of renumbered Section 58-2.6 (e)(2)(vi) are amended to eliminate the requirement for biohazard labeling of autogeneic blood and blood components from patient-donors testing positive for antibodies to hepatitis B core antigen. Provisions regarding storage temperature for thawed plasma, and duration of storage for thawed cryoprecipitate intended for factor VIII replacement, are moved from Section 58-2.6(f) to (h). Section 58-2.6(h) extends the allowable shelf life of non-cellular components stored at a temperature not higher than minus 65 degrees Celsius to seven years. Provisions regarding duration of storage for thawed red blood cells are moved from Section 58-2.6(f) to subdivision (j), and the allowable shelf life for red blood cells deglycerolized using a closed system is extended to 14 days. Subdivisions (g), (h) and (j) are also amended to clarify that periodic verification of refrigerator, freezer and liquid nitrogen alarm function must be documented. Section 58-2.6(l) adds a requirement that entry ports be protected from water contamination by positioning or a protective overwrap when blood components are thawed in a waterbath. The amendment also adds ambulance transfusion services to the listing in Section 58-2.6(m) of entities to which blood and blood components may be released.

Section 58-2.7(a) adds a requirement that blood specimens intended for pretransfusion testing be labeled at the patient’s side at the time of collection. Subdivision (d) is amended to specify that all quality control records associated with testing be retained for five years.

Section 58-2.8(b) is amended to clarify the department’s expectation that regulated parties comply with federal rules for reporting errors and accidents to federal authorities. Section 58-2.8(c) expands requirements for procedure manuals to include written procedures for: transfusion-related testing; release of blood and blood components to limited transfusion services and ambulance transfusion services; and the administration of blood components, including prevention of transfusion reactions. Section 58-2.8(c) also stipulates that written procedures for emergency release of uncrossmatched blood must expressly require completion of compatibility testing following such release and that evaluation of reported transfusion reactions be prompt.

Section 58-2.9(b) is amended to expand the circumstances under which blood components may be issued prior to completion of infectious disease testing. Section 58-2.9(c) allows release of autogeneic blood from a patient-donor whose blood tests positive for human immunodeficiency virus (HIV) or hepatitis C virus (HCV) nucleic acid, or antibodies to HCV, if authorized in writing by the patient-donor’s physician. Section 58-2.9(c) requires that transfusion services issuing blood components to ambulance transfusion services perform required testing on their own premises, and deletes an inaccurate reference to limited transfusion services. Subdivision (g), specifying circumstances under which more than one unit of blood may be released at one time for a particular patient, is repealed and replaced with a more flexible requirement that the director of transfusion services specify in a written policy the permissible circumstances for simultaneous issuance of multiple units. Two new subdivisions, numbered (m) and (n), are added to Section 58-2.9 to detail the requirements for transport containers for blood components issued to a limited transfusion service or an ambulance transfusion service, respectively.

Section 58-2.11(a)(4) allows the identity of the phlebotomist collecting the blood for transfusion to be recorded by methods other than his or her signature.

Section 58-2.12(a) modifies the requisites for records to be kept when blood and blood components are issued for transfusion, clarifying that the unit identification code and blood group must be recorded and that a visual inspection and location of any remote storage must be documented. Section 58-2.12(d) is also amended to specify that these recordkeeping requirements apply to blood components issued to ambulance transfusion services.

Section 58-2.13 is repealed and replaced by a new Section 58-2.13.

Section 58-2.15(d) decreases hemoglobin/hematocrit requirements for some double red blood cell donors, provided conformance is maintained with United States Food and Drug Administration (F.D.A.) requirements for the apheresis device.

Section 58-2.16(a) has been modified to include an ambulance transfusion service as an entity to which blood can be issued. Section 58-2.16(a)(1)(iv) clarifies the department’s expectation that regulated parties comply with federal requirements for reporting serious unexpected transfusion reactions. Section 58-2.16(b), concerning transfusion committees, is modified to remove the requirement for majority attendance at meetings, add expertise in clinical medicine as possible qualification for membership, and specify an option for review of a representative sample of transfusions. Section 58-2.16(d) is modified to combine similar existing requirements pertaining to the administration of blood components. Section 58-2.16(e), as modified, simplifies the language detailing the individuals authorized to initiate transfusions and perform patient and unit identification at the patient’s side. Section 58-2.16(f) clarifies the requirements for identification of a transfusion recipient. Section 58-2.16(g) clarifies that transfusions outside a health care setting do not include those in an ambulance. Renumbered subdivision (j) of Section 58-2.16 supplies examples of options for autogenic blood transfusion that, if available at a given institution, must be made known to staff physicians through the transfusion committee.

A new Section 58-2.16(h) adds provisions to permit advanced life support emergency medical technicians with specialized training to monitor transfusions and initiate additional units during interfacility transport to facilitate expeditious transport of patients requiring transfusion during transport.

A misplaced reference to the use of a validated computer system has been moved from subdivision (a) to subdivision (c) of Section 58-2.17. Section 58-2.17(a) clarifies that the requirement for ABO reverse grouping of an intended transfusion recipient is not applicable to infants under four months of age. Section 58-2.17(b) adds a provision allowing the use of maternal serum or plasma in testing for unexpected antibodies. Provisions regarding compatibility testing in the case of infants under four months of age are moved from Section 58-2.20 to Section 58-2.17(c). Section 58-2.17(e) is repealed in light of substantial redundancy with subdivision (c) as modified.

Section 58-2.18 is repealed and replaced by a new Section 58-2.18, which clarifies the records required when blood components are transfused and eliminates a requirement that the quantity of material transfused be recorded.

Section 58-2.19 adds requirements that records regarding infusion of derivatives include the manufacturer’s name, the name of the person administering the product, and documentation of identification of the recipient and visual inspection of the product.

Section 58-2.20 is repealed and replaced by a new Section 58-2.20, which adds requirements for approval of ambulance transfusion services.

Section 58-2.21(a) clarifies that a limited transfusion service may not operate in New York State without approval of the department.

The provisions of Section 58-2.22 are repealed, and the section is reserved for later use.

A new Section 58-2.27(a) clarifies that entities performing reinfusion procedures must either hold a department laboratory permit or be approved by the department as a limited reinfusion service.

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, transfusion, and supply of human blood and blood products. The New York State (NYS) Council on Human Blood and Transfusion Services (Blood Council) is authorized by Section 3121(5) to enact, amend and repeal rules and regulations setting forth minimum standards for these processes as applicable to blood and blood products, subject to the approval of the Commissioner of Health.

Legislative Objectives:

The Blood Council has proposed this revision of 10 NYCRR Subpart 58-2 to update practice standards in order to promote safe blood bank operation. The amendment is consistent with the legislative mandate that the department oversee the blood supply and ensure that the safety of blood donors and transfusion recipients is not compromised.

Needs and Benefits:

This regulatory amendment is necessitated by advances in medical technology and the need to codify practice standards and eliminate obsolete requirements, afford regulated parties with greater flexibility in complying with department regulations, clarify regulatory intent, and provide for safe transfusion of blood components during interfacility transport of patients. Several changes are intended to align the department’s rules with federal requirements.

To reflect technological advances and increase availability of blood components, the proposed amendment extends the expiration date of red cells deglycerolized in a closed system to 14 days, as approved by the U.S. Food and Drug Administration (F.D.A.). Provisions for plasma frozen within 24 hours after phlebotomy are added and the shelf life of non-cellular components is extended to seven years for frozen storage at or below -65°C.

This amendment would provide for department oversight of any ambulance service offering transfusion during interfacility transport. The proposed amendment does not require that ambulance services seek approval as an ambulance transfusion service. In fact, it is estimated that only 50 of the 619 advanced life support (ALS) providers would apply. The proposed regulation allows certain emergency medical technicians (EMTs), with specific additional training, to administer transfusions during interhospital transport, obviating the need for a registered nurse (RN) to accompany the patient. Requirements for training and structured paperwork are intended to ensure that trained EMTs perform transfusion-related procedures in a safe manner. Patients requiring transfusion during interhospital transport could receive optimal medical care without delay. The amendment would not permit blood transfusion in the field or during initial transport to a hospital. However, it is not intended that an approved ambulance transfusion service would be prohibited from transporting a patient from an approved limited transfusion service to a hospital if a medical emergency arises requiring blood transfusion during transport.

Transfusion recipient safety is enhanced by the addition of requirements that:

• frozen components be thawed in a water bath in a manner that protects the entry ports from contamination;

• the inspection of components prior to issuance be documented;

• patient specimens be labeled at the bedside;

• routine compatibility testing be completed after emergency release of uncrossmatched blood, to facilitate needed actions; and

• records for infusion of derivatives include the manufacturer’s name.

To help prevent inadvertent transfusion of contaminated blood components, the list of infectious disease markers requiring written authorization of the patient-donor’s physician is expanded.

Several changes are proposed to provide regulated parties with compliance flexibility, including:

• permitting “identification” of phlebotomists collecting blood rather than requiring their signature; and removal of the requirement for records to be retained in logbook format, thereby affording facilities options for electronic records;

• allowing the release of components when their clinically useful shelf-life precludes completion of testing prior to issuance;

• allowing infectious disease testing to be performed on a donor specimen collected prior to the donation when the clinically useful shelf-life precludes completion of testing prior to unit expiration;

• making blood count requirements for apheresis donors less restrictive;

• eliminating the time limit for platelet production;

• allowing inspection of derivatives at any time prior to infusion; and

• expanding options for acceptance of allogeneic blood donors who are 76 years of age or older.

To clarify regulatory intent, the proposed amendment:

• combines requirements pertaining to administration of blood components;

• simplifies the language detailing the persons authorized to initiate transfusions;

• specifies types of locations at which blood for transfusion be may collected;

• clarifies that hospital reporting of incidents to the department applies to only blood components that have been issued by the transfusion service;

• specifies that the transfusion committee is to review “all or a representative sample” of transfusions;

• codifies expectations that Subpart 58-2 pertains to laboratories performing immunohematology testing;

• specifies that the timing of opportunities for blood donors to indicate confidentially that their blood may be unsuitable for transfusion may be at the time of or after donation; and

• details requirements for reinfusion procedures.

Several changes are proposed, as advised by the U.S. Centers for Medicare and Medicaid Services, in order for NYS to retain its state-exempt status for laboratory oversight. These include:

• clarifying the expectation that facilities report errors, accidents and serious adverse reactions to federal authorities;

• expanding standard operating procedure manual requirements to include “the prevention of transfusion reactions”;

• requiring that the evaluation of reported transfusion reactions must be “prompt”; and

• adding a requirement that verification of alarm function for refrigerators and freezers be documented.

The amendment eliminates obsolete provisions, including requirements that:

• an autogeneic unit from a donor with antibodies to hepatitis B core antigen (anti-HBc) be labeled as biohazardous;

• donors be free of acute respiratory diseases; and

• hospitals issuing components to limited transfusion services perform all testing onsite.

Costs:

Regulated parties would incur minimal costs to modify some written procedures. Approximately one hour of staff time would be required to complete ambulance transfusion service application forms. Ambulance services would incur some costs to provide required training (approximately four hours in duration) for some existing personnel. Training of new personnel could be incorporated into existing training programs. Duplication of training materials is estimated to cost less than $50.

Because interfacility transfusion should not change the total number of transfusions, costs incurred by hospitals for associated supplies should not increase. It may be necessary to purchase insulated coolers, at approximately $30 each, to maintain blood components at the proper transport temperature. Normal saline is the only solution that can be run in the same line during a transfusion. Some ambulance services may need to purchase saline solution ($170/case of 24 500 mL bags). The cost of the saline, medications for treating transfusion reactions and any other supplies could be recouped through ambulance service fees. Hospitals transferring patients would realize some cost savings, as RNs would no longer be needed to accompany patients.

The department would incur costs in approving ambulance transfusion services and monitoring compliance. Development of training materials and application packets would require approximately 20 hours of staff time. Processing the 50 anticipated applications would require approximately 100 hours to review applications, issue approval documents, and update databases. Costs for monitoring compliance include one-time costs of revising inspection-related documents and training blood bank inspectors, estimated at under $1,000, and recoverable through Clinical Laboratory Inspection and Reference fees.

Local Government Mandates:

The proposed regulations impose no new program, service, duty, or responsibility on any county, city, town or village government. The four counties and one city that operate hospital-based blood banks would be affected to the same extent as other regulated parties. The vast majority of interhospital transport is currently performed by commercial ambulance services; it is not anticipated that municipal ambulance services would seek approval to offer transfusion services.

Paperwork:

Blood banks may need to modify some written procedures to implement the amendment. Ambulance services that choose to offer transfusion services would need to revise written protocols, and comply with some additional recordkeeping requirements.

Duplication:

This proposed amendment does not duplicate any other State regulations, as 10 NYCRR Subpart 58-2 is the only State regulation governing the collection, processing, distribution, and transfusion of blood.

Alternatives:

The Blood Council is charged with ensuring a safe and adequate blood supply through promulgation and amendment of regulations. No alternatives would adequately protect the public health, recognize technological advances, and allow the least burdensome practices, consistent with national standards.

Failure to adopt changes in technical standards could adversely affect the blood supply. Failure to extend the expiration date of deglycerolized red cells to 14 days, and the shelf life of frozen non-cellular components to seven years at or below -65°C, would likely result in reduced availability for NYS patients. Failure to protect the entry ports of frozen components while thawing in a water bath could result in transfusion of bacterially contaminated components. Not requiring bedside labeling of patient specimens could increase the chance of specimen mislabeling and consequent issuance of incompatible blood, increasing the chance of fatal transfusion reactions. Failure to include the manufacturer’s name in medical records of patients receiving derivatives would hinder identification of patients who received a recalled product. Components with a very short shelf-life (e.g., 24 hours) may outdate before the completion of infectious disease testing. Failure to allow issuance of a component when the clinically useful shelf-life precludes completion of testing could forestall needed patient therapy. Leaving blood count requirements for apheresis donors unchanged would result in deferral of suitable donors. Retaining the eight-hour time limit for platelet production would adversely affect platelet inventories when blood is collected in outlying areas.

Failure to allow some EMTs to administer blood during interfacility transport would adversely affect emergency medical care. Hospital nurses may not be immediately available to accompany patients, so some patients would encounter delays in transfer. Authorization to initiate and monitor blood transfusions cannot be extended to all EMTs because those at the basic level do not have the prerequisite knowledge base and skill set. In contrast, EMTs certified at the critical care or paramedic level have received training in IV therapy, and would need to build on this knowledge through additional training in transfusion basics and transfusion reaction recognition/management. An alternative would be to restrict this practice to EMTs certified at the paramedic level, as suggested by some commenters. However, this would severely hinder patient care, as many rural communities lack sufficient personnel so trained. Based upon its experience with certifying EMTs and approving training curricula, the department believes that EMTs certified at the critical care level, with additional training, would have sufficient knowledge and skills to transfuse patients safely. Additionally, the department intends to develop a training curriculum to ensure adequate training.

Elements of the proposed amendment were carefully considered and all viable options were identified and evaluated. The best options were selected based on their merits, with the ultimate goal of ensuring the availability of blood components and preserving or increasing patient safety.

Federal Standards:

The F.D.A. has established blood donor standards and requirements governing blood products shipped in interstate commerce. New York, however, exercises regulatory oversight of facilities and services. Specifically, Subpart 58-2 applies to NYS-permitted blood banks operating in the state. State regulations provide greater detail regarding the collection, processing and use of blood products, while maintaining consistency with F.D.A. regulations.

Compliance Schedule:

The department has notified, via mail, affected parties with a permit for blood collection and/or transfusion, in order to solicit preliminary comments regarding the proposed amendments. Ambulance services have been notified via State and regional advisory councils and regional program agencies. Revisions have been made based on comments received. Current regulated parties (blood banks) and ambulance services that may wish to seek approval as an ambulance transfusion service have been afforded notice sufficient for compliance with the amended regulations within 60 days of publication of a Notice of Adoption in the State Register.

Effect of Rule:

Of the 235 blood banks located in New York State (NYS) holding a permit for blood collection and/or transfusion, only three are small businesses. The vast majority of blood banks are operated by hospitals or are blood centers with more than 100 employees. Four counties and one city operate hospital-based blood banks.

The proposed revisions would extend regulatory oversight by the department’s Blood and Tissue Resources Program (BTRP) to any ambulance service seeking to offer, as a service, transfusion of patients during interhospital transport. The proposed amendment does not require that ambulance services seek approval as an ambulance transfusion service; in fact, only a fraction of ambulance services providing advanced life support services (ALS) also perform interhospital transport.

Of the 1,096 ambulance services that operate in NYS, 619 provide ALS services and are eligible to apply for approval as an ambulance transfusion service. Of these, 68 are owned/operated by municipalities. The vast majority of interhospital transport is performed by commercial ambulance services, and it is not anticipated that municipal ambulance services would seek approval to offer transfusion services.

Compliance Requirements:

The department believes that the small businesses approved to collect blood components would likely not be affected by this amendment. Most facilities operated by local governments would be affected by at least one proposed change, but not in an adverse manner. The department has determined that the proposed amendment, once adopted, would not impose burdensome reporting, recordkeeping, training or other compliance requirements on small businesses (e.g., ambulance services seeking approval as ambulance transfusion services) or local governments (including government-operated hospitals and ambulance services). The proposed amendment does not require that ambulance services seek approval as an ambulance transfusion service. Should an ambulance service be approved as an ambulance transfusion service, its ALS personnel would require training in the administration of blood components, as well as the recognition of and response to transfusion reactions. This provision is intended to promote safety for transfusion recipients and would minimize liability risk for ambulance services and individual personnel. A standardized training curriculum developed by BTRP, in conjunction with the department’s Bureau of Emergency Medical Services, would include standard didactic training and additional training at the regional level.

Professional Services:

No professional services would be needed.

Compliance Costs:

The department has determined that the proposed amendment, once adopted, would have no adverse economic impact on small businesses or local governments. Small businesses and local governments that operate blood banks implementing the proposed requirements would incur the same minimal compliance costs and receive the same benefits as private entities.

Ambulance services, including small businesses and those operated by local governments, that choose to seek approval as an ambulance transfusion service would not encounter significant cost increases in complying with the amendment. It is estimated that approximately one hour of staff time would be required to complete the ambulance transfusion service application forms. While training of new personnel could be incorporated into existing training programs, ambulance services would incur some costs to provide required training for some existing personnel. It is estimated that this training can be accomplished in four hours. The cost of duplicating training materials is estimated to be less than $50.

Hospitals transferring patients to another hospital would provide a blood administration set with each unit of blood issued, so that ambulance services would not need to purchase such supplies. Allowing in-ambulance transfusion should not change the total number of units transfused, so that costs incurred by hospitals for associated supplies are not expected to increase. Some blood banks and ambulance transfusion services, however, may need to purchase insulated coolers for the storage of blood components at the proper temperature during interhospital transport. A 16-quart (15-liter) hard-sided cooler may be purchased for approximately $30. Since normal saline is the only solution that can be run in the same line during a transfusion, ambulance transfusion services not currently stocking normal saline may need to purchase it. The solution can be purchased in 500-mL bags for $170 per 24-bag case. Ambulance transfusion services may need to stock some additional medications to be administered in case of a transfusion reaction. However, the cost of additional supplies could be recouped in fees charged by the ambulance transfusion services. Local government-operated hospitals arranging for transport would realize some cost savings, as an RN would no longer be needed to accompany a patient being transferred, solely to meet regulatory requirements.

Economic and Technological Feasibility:

The proposed changes present no economic or technical difficulties to small businesses or local governments. Although some revisions to procedures and recordkeeping practices may be necessary, the modifications would be straightforward and easily implemented by existing staff.

Transporting patients requiring transfusions from one hospital to another may prove to be a source of income for ambulance services approved as an ambulance transfusion service.

Minimizing Adverse Impact:

The proposed amendment would impose no adverse economic impact on small businesses or local government facilities presently in compliance with established industry standards. This amendment was developed with the goal of minimizing any burdens on regulated parties. The requirements for transfusions during interhospital transport, including required training of EMTs certified at the critical care or paramedic level, would minimize liability risk for ambulance services and individual personnel. Training of new personnel could be incorporated into existing training programs.

Small Business and Local Government Participation:

The department has notified regulated parties, including the small businesses and those operated by a local government, regarding the proposed regulation, in order to solicit comments. Recommended revisions have been incorporated, as appropriate, based on comments received.

Types and Estimated Numbers of Rural Areas:

One-hundred fourteen (49 percent) of the 235 blood banks in New York State (NYS) with a department permit for collection and/or transfusion are located in rural counties, as are 287 (48 percent) of the 619 ambulance services providing advanced life support (ALS) services in NYS.

Reporting, Recordkeeping and Other Compliance Requirements; and Professional Services:

Most blood banks approved to collect and/or transfuse blood components would be affected by some of the provisions of the proposal, but not in an adverse manner. The amendments would impose no adverse effects on blood banks located in rural areas, as full compliance would not significantly increase overall costs or reporting or recordkeeping requirements. The costs for regulated parties in rural areas would be the same as for regulated parties in urban areas.

This amendment would not impose a burden on public or private entities in rural areas. Many of the proposed revisions are less restrictive than those in existing regulations. Regulated parties may, but would not be required to, modify present practices to comply with the proposed provisions that are less restrictive than current requirements.

This proposed amendment would extend regulatory oversight to any ambulance service seeking approval as an ambulance transfusion service. The service’s ALS personnel would require additional training in blood administration procedures. The standardized training curriculum developed by the department’s Blood and Tissue Resources Program, in conjunction with the department’s Bureau of Emergency Medical Services, would be made available to the ambulance transfusion service medical director or his/her designee regardless of location. No additional professional services would be needed. No significant adverse impact is anticipated for ambulance transfusion services located in rural areas. Ambulance services choosing to offer transfusion during transport, including those located in rural counties, would need to comply with some additional recordkeeping and reporting requirements.

Costs:

Full compliance with the amendment would not increase significantly overall costs for regulated parties, including those located in rural counties. Regulated parties in rural areas implementing the revised requirements may need to modify their standard operating procedure manuals, incurring minimal costs. However, savings would be realized, as an RN would no longer be needed to accompany a patient being transferred, solely to meet regulatory requirements. This provision would result in more efficient utilization of nursing staff within the rural hospital setting, and could decrease hospital expenses and help alleviate nursing shortages. It is estimated that approximately one hour of staff time would be expended by ambulance services to complete the ambulance transfusion service application forms. While training of new personnel could be incorporated into existing training programs, ambulance services would incur some costs to provide required training for some existing personnel. It is estimated that this training can be accomplished in four hours. The cost of duplicating training materials is estimated to be less than $50. Providing transfusion as an additional service during interhospital transport may prove to be a source of income for ambulance services approved as an ambulance transfusion service.

Hospitals arranging for transport would provide a blood administration set with each unit of blood issued, so ambulance services would not need to purchase these supplies. Allowing for in-ambulance transfusion should not change the total number of units transfused, so that costs incurred by hospitals for associated supplies are not expected to increase. Some hospital blood banks and ambulance transfusion services, however, may need to purchase insulated coolers for storage of blood components at the proper temperature during interhospital transport. A 16-quart (15-liter) hard-sided cooler may be purchased for approximately $30. Since normal saline is the only solution that can be run in the same line during a transfusion, ambulance transfusion services not currently stocking normal saline might need to purchase the solution. Normal saline can be purchased in 500-mL bags for $170 per 24-bag case. Ambulance transfusion services may need to stock some additional medications to be administered in case of a transfusion reaction. However, the cost of additional supplies could be recouped in fees charged by ambulance transfusion services. Hospitals arranging for transport would realize some cost savings, as an RN would no longer be needed to accompany a patient being transferred, solely to meet regulatory requirements.

Minimizing Adverse Impact:

The proposed amendment would confer no significant adverse impact on blood banks in rural areas that are presently in compliance with established industry standards. These amendments were developed with the intent of minimizing any burdens on regulated parties and increasing compliance flexibility by offering various alternatives.

Rural Area Participation:

The department has notified regulated parties, including those in rural areas, regarding the proposed regulation in order to solicit comments. Changes have been made based on comments received.

A Job Impact Statement is not included in this proposal because it is apparent, from the nature and purpose of the proposed rule, that it would not have a substantial adverse impact on jobs and employment opportunities.