ASSEMBLY, No. 5673
STATE OF NEW JERSEY
221st LEGISLATURE
INTRODUCED MAY 15, 2025
Sponsored by:
Assemblyman JOHN V. AZZARITI JR., M.D.
District 39 (Bergen)
Assemblywoman MARGIE DONLON, M.D.
District 11 (Monmouth)
Co-Sponsored by:
Assemblyman Auth
SYNOPSIS
"Gary Letizia Pre-Hospital Blood Transfusion Act"; authorizes paramedics, under medical oversight, to administer blood products to patients in pre-hospital settings, and establishes certain reimbursement for emergency medical services providers.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning pre-hospital blood transfusions by emergency medical services personnel, 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 (PPH) affects approximately three to five percent of obstetric patients and is a leading cause of maternal mortality.
c. While New Jersey permits aeromedical units to administer blood products, no statutory or regulatory authority currently exists to allow ground-based paramedics to do so.
d. Other states, including New York and West Virginia, have successfully implemented pre-hospital blood transfusion programs for paramedics.
e. The expansion of blood administrations by emergency medical services personnel, under appropriate medical oversight, is necessary to improve trauma care and save lives in New Jersey.
2. As used in this act:
"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.
"Emergency medical services provider" means an entity licensed to provide pre-hospital emergency medical care in the State of New Jersey.
"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 emergency medical services personnel by a licensed physician trained in trauma or emergency care.
"Paramedic" means a person certified by the New Jersey Department of Health as a mobile intensive care paramedic pursuant to P.L.2022, c.118 (C.26:2K-8.1 et al.).
3. a. An emergency medical services (EMS) provider 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 licensed physician specializing in trauma or emergency medicine, or Emergency Medical Services as the medical director of the blood transfusion program;
(3) only utilize paramedics 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 emergency medical services personnel during the administration of the blood products;
(5) 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 (FDA), if applicable.
b. Blood products shall be stored using CPDA-1, citrate phosphate dextrose adenine, unless an alternate anticoagulant-preservative solution is approved by the Department of Health as providing equal or superior shelf life, safety, and efficacy for pre-hospital transfusion. 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 EMS providers shall:
(1) conduct audits of pre-hospital blood transfusions quarterly;
(2) submit an annual report to the Department of Health with detailed outcomes and protocol compliance; and
(3) implement protocols for recognizing and managing transfusion reactions.
4. a. A licensed paramedic, under medical oversight, shall be authorized to administer a blood product to a patient in a pre-hospital setting if:
(1) the patient exhibits significant hemorrhage or hemorrhagic shock;
(2) the paramedic 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. A paramedic shall not be required to obtain on-scene physician approval prior to administration but must notify the receiving trauma or emergency center upon initiating a transfusion.
c. Emergency medical services personnel 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 New Jersey Department of Health shall establish a grant program in order to assist participating emergency medical services agencies with the initial costs of implementation, including, but not limited to:
a. blood storage and transportation equipment;
b. blood warming and infusion devices; and
c. 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 for emergency medical services use.
9. a. The Department of Health shall develop and implement a Statewide blood rotation system to prevent expiration and wastage of blood products. This system shall ensure that:
(1) low-titer O whole blood stored by emergency medical services (EMS) agencies is tracked in real time;
(2) low-titer O whole blood stored by EMS agencies is regularly rotated with hospital blood banks;
(3) EMS agencies transfer any units of low-titer O whole blood that are within 10 days of expiration to designated partner hospital, allowing sufficient time for clinical use within the hospital setting; and
(4) partner hospitals incorporate the received units into the active transfusion inventory of the hospital.
b. The department shall develop standardized protocols and digital inventory coordination systems to support efficient, compliant, and transparent blood product exchange between EMS 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 Trauma System Advisory Committee, 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 next following enactment, except that the Commissioner of Health 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 emergency medical services (EMS) providers to establish a blood transfusion program. An EMS 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 EMS provider, in establishing the program, would need to:
designate a licensed physician specializing in trauma or emergency medicine, or Emergency Medical Services as the medical director of the program;
utilize only paramedics who have completed a blood administration course approved by the department;
ensure the presence of at least two trained emergency medical services personnel 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 EMS provider would need to:
conduct quarterly audits of pre-hospital blood transfusions;
submit an annual report to the department with detailed outcomes and protocol compliance; and
implement protocols for recognizing and managing transfusion reactions.
Once the program is established, a licensed paramedic 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 EMS 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 EMS use and 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.