S4347

An Act concerning pre-hospital blood transfusions by advanced life support providers, designated as the “Gary Letizia Pre-Hospital Blood Transfusion Act,” and supplementing various parts of the statutory law.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. The Legislature finds and declares that:

a. Uncontrolled hemorrhage is a leading cause of preventable death in trauma patients, and timely administration of blood products significantly improves survival rates.

b. In the United States, postpartum hemorrhage affects approximately three to five percent of obstetric patients and is a leading cause of maternal mortality.

c. The expansion of blood administration by advanced life support providers, under appropriate medical oversight, is necessary to improve the pre-hospital care of acute blood loss and to save lives in New Jersey.

2. As used in this act:

“Advanced life support agency” means an entity licensed to provide pre-hospital emergency advanced life support services in the State of New Jersey.

“Advanced life support provider” means a person who is certified by the Commissioner of Health to provide advanced life support services in the State, including, but not limited to, paramedics, mobile intensive care nurses, or other appropriately credentialed clinicians as authorized by the Department of Health.

“Blood product” means any therapeutic substance prepared from human blood, including whole blood, blood components, and plasma derivatives.

“Carrier” means an insurance company, health service corporation, hospital service corporation, medical service corporation or health maintenance organization authorized to issue health benefits plans in this State.

“Covered person” means a person on whose behalf a carrier offering the plan is obligated to pay benefits or provide services pursuant to the health benefits plan.

“Department of Health” means the New Jersey Department of Health.”

“Health benefits plan” means a benefits plan which pays or provides hospital and medical expense benefits for covered services, and is delivered or issued for delivery in this State by or through a carrier.

“Low-titer O whole blood” means blood that is universally transferrable and recommended for emergency use in pre-hospital settings.

“Medical oversight” means the supervision of advanced life support providers by a licensed physician trained in trauma or emergency care.

3. a. An advanced life support agency seeking to administer blood products shall:

(1) notify the Department of Health at least 60 days in advance of intent to begin a blood transfusion program;

(2) designate a blood bank medical director to serve as the medical director of the blood transfusion program. If the blood products are sourced from a hospital-based blood bank, the hospital’s blood bank medical director shall retain ultimate authority over the storage, handling, and medical appropriateness of blood product use. The blood bank medical director may delegate responsibilities related to pre-hospital operations, such as protocol development and oversight of training, to the emergency medical services director; however, the blood bank medical director shall retain ultimate authority over the program;

(3) only utilize advanced life support providers who have completed a blood administration course that has been approved by the Department of Health;

(4) ensure the presence of at least two trained advanced life support providers during the administration of blood products; and

(5) maintain proper blood storage and warming equipment, including transport coolers. All blood product storage, warming, and other equipment shall be those approved by the federal Food and Drug Administration (FDA), if applicable.

b. Blood products shall be stored using any anticoagulant preservative solutions approved by the FDA, or Department of Health, when applicable. Such solutions may include CPDA-1 (citrate phosphate dextrose adenine-1), CPD (citrate phosphate dextrose), or other anticoagulants that provide varying shelf lives and preparation compatibility, including spinning down into packed red blood cells (PRBCs). The Department of Health shall consider factors such as shelf life, ability to prepare PRBCs, and waste minimization in its approvals. Blood products shall be transported and administered in accordance with:

(1) regulations on blood, and storage and handling promulgated by the FDA;

(2) American Association of Blood Banks standards; and

(3) any applicable guidelines issued by the Department of Health.

c. Participating advanced life support providers shall:

(1) conduct quarterly audits of pre-hospital blood transfusions;

(2) submit reports to the Department of Health in accordance with the reporting cadences already required under applicable standards, including daily clinical documentation to the Office of Emergency Medical Services; and

(3) implement protocols for recognizing and managing transfusion reactions.

4. a. Advanced life support providers, under medical oversight, shall be authorized to administer a blood product to a patient in a pre-hospital setting if:

(1) the patient exhibits signs and symptoms consistent with current clinical practice requiring administration of blood products;

(2) the advanced life support provider has completed a blood administration training program that has been approved by the Department of Health; and

(3) the administration follows established protocols approved by the Department of Health.

b. An advanced life support provider shall not be required to obtain on-scene physician approval prior to administration but shall notify the receiving trauma or emergency center upon initiating a transfusion.

c. Advanced life support providers shall obtain informed consent, when feasible, from the patient or the patient’s legal representative prior to administering a blood product. In emergency situations where the patient is unconscious or otherwise incapable of providing consent, administration may proceed under the doctrine of implied consent, consistent with State and federal emergency care guidelines.

5. The Department of Health shall establish a grant program in order to assist participating advanced life support agencies with the initial costs of implementation, including, but not limited to: blood storage and transportation equipment; blood warming and infusion devices; and training and certification costs.

6. a. The NJ FamilyCare and Medicaid programs shall provide coverage for pre-hospital blood transfusion services delivered to a covered person on the same basis as when blood transfusion services are delivered within the facilities of a hospital, in accordance with the Centers for Medicare and Medicaid Services Advanced Life Support Level 2 billing code.

b. Any reimbursement rate for the blood transfusion program under this section shall be established pursuant to the guidelines for Medicaid and Medicare reimbursement, particularly for the cost of blood products, storage, and administration.

7. A carrier that offers a health benefits plan in this State shall provide coverage for pre-hospital blood transfusion services delivered to a covered person on the same basis as when blood transfusion services are delivered within the facilities of a hospital, in accordance with private insurance billing policies that are aligned with federal reimbursement standards.

8. The Department of Health shall work with blood banks and hospitals to ensure adequate availability of low-titer O whole blood and other blood products for advanced life support provider use.

9. a. All participating air medical services and mobile intensive care programs shall implement a defined stewardship program to prevent waste through the responsible handling and storage of whole blood and blood components. This system shall ensure that:

(1) blood products stored by advanced life support agencies are tracked in real time;

(2) blood products stored by advanced life support agencies are regularly rotated with hospital blood banks;

(3) advanced life support agencies transfer any blood products that are approaching expiration to a designated partner hospital. Blood return timelines may be determined by the EMS agency in collaboration with the partner hospital, as permitted under applicable law, provided the blood is returned with sufficient lead time for clinical use or reprocessing; and

(4) partner hospitals incorporate the received units into the active transfusion inventory of the hospital.

b. The Department of Health shall develop standardized protocols and digital inventory coordination systems to support efficient, compliant, and transparent blood product exchange between advanced life support agencies and hospitals, including the return and restocking of coolers and supplies, as needed. Blood rotation logistics shall prioritize minimizing waste and maximizing clinical utility while maintaining chain of custody and temperature control throughout the process.

10. The Commissioner of Human Services shall apply for any State plan amendments or waivers as may be necessary to implement the provisions of this act and to secure federal financial participation for State Medicaid expenditures under the federal Medicaid program.

11. The Commissioner of Health, in consultation with the State Office of Emergency Medical Services, and within 180 days following the date of enactment of this act, shall develop and adopt rules and regulations, pursuant to the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), as may be necessary to implement the provisions of this act.

12. This act shall take effect on the first day of the seventh month following enactment, except that the Commissioners of Health and Human Services may take any anticipatory administrative action in advance as may be necessary for the implementation of this act.

STATEMENT

This bill, to be known as the “Gary Letizia Pre-Hospital Blood Transfusion Act,” would allow advanced life support providers to establish a blood transfusion program. An advanced life provider would have to notify the Department of Health (department) at least 60 days in advance of its intent to begin such a program. The advanced life support provider, in establishing the program, would need to:

· designate a blood bank medical director as the medical director of the blood transfusion program, who may delegate responsibilities related to emergency medical services (EMS) to an EMS director;

· utilize only advanced life support providers who have completed a blood administration course approved by the department;

· ensure the presence of at least two trained advanced life support providers during the administration of blood products; and

· maintain proper blood storage and warming equipment, including transport coolers. All blood product storage, warming and other equipment must be those approved by the federal Food and Drug Administration, if applicable.

Additionally, the advanced life support provider would need to:

· conduct quarterly audits of pre-hospital blood transfusions;

· submit reports to the department in accordance with the existing daily, monthly, quarterly, and annual cadence of clinical, equipment, and quality reporting standards already in practice; and

· implement protocols for recognizing and managing transfusion reactions.

Once the program is established, a licensed advanced life support provider would be authorized, with medical oversight, to administer blood products to a patient in a pre-hospital setting under certain conditions. Reimbursement rates for pre-hospital blood transfusions would be at rates equivalent to hospital-based transfusions.

Additionally, the department would establish a grant program to assist advanced life support providers with the initial cost of implementation of the blood transfusion program. The department would work with blood banks and hospitals to ensure an adequate supply of low-titer O whole blood is available for advanced life support provider use. Additionally, the department would develop a Statewide blood rotation system to prevent the expiration and waste of blood products.

The “Gary Letizia Pre-Hospital Blood Transfusion Act” is named in honor of Gary Letizia, whose life was extended by timely blood transfusions. His family’s enduring commitment to raising awareness about the life-saving power of transfusion in partnership with first responders continues to inspire this vital initiative.