A4678

An Act concerning sepsis protocols in hospitals and supplementing chapter 2H of Title 26 of the Revised Statutes.

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

1. a. Each general or special hospital licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.) shall adopt, implement, periodically update, and submit to the Department of Health evidence-based protocols for the early recognition and treatment of patients with sepsis, severe sepsis, and septic shock, which shall:

(1) be based on generally accepted standards of care;

(2) include components specific to the identification, care, and treatment of both adult and pediatric patients; and

(3) clearly identify where and when the components differ with regard to adult and pediatric patients.

b. The sepsis protocols established pursuant to subsection a. of this section shall include:

(1) a process for the screening and early recognition of patients with sepsis, severe sepsis, and septic shock;

(2) a process that shall be used to identify and document individuals appropriate for treatment in accordance with sepsis, severe sepsis, and septic shock protocols, and which shall include explicit criteria to determine those patients who should be excluded from the protocols, such as patients who have certain clinical conditions or have elected to undergo palliative care;

(3) specific guidelines for treatment appropriate to the patient’s condition, including treatment goals, treatment methodologies, criteria for invasive and non-invasive treatment, and timeframe goals;

(4) a procedure for identifying the source of infection and delivering early antibiotics, with timeframe goals; and

(5) such other requirements as the Commissioner of Health may establish by regulation.

c. Each hospital shall ensure that all professional staff with direct patient care responsibilities, and appropriate professional staff with indirect patient care responsibilities including, but not limited to, laboratory and pharmacy staff, are periodically trained to implement the sepsis protocols established pursuant to this section. The hospital shall ensure updated staff training upon adoption of substantive changes to the protocols.

d. Each hospital shall submit proposed sepsis protocols to the department for review no later than 120 days after the effective date of this act, and shall implement the protocols upon receipt of approval of the protocols from the department. A hospital may revise and update its protocols as necessary and consistent with evidence-based standards. Protocols shall be resubmitted to the department for review no more than once every two years, unless the department identifies hospital-specific performance concerns.

e. Each hospital shall be responsible for the collection and use of quality measures related to the recognition and treatment of sepsis, severe sepsis, and septic shock for the purpose of internal quality improvement. The quality measures shall include, but not be limited to, data sufficient to evaluate the hospital’s adherence rate to its own sepsis protocols, including adherence to timeframes and implementation of all protocol components for adult and pediatric patients.

f. Each hospital shall annually report to the department such data as the department may require for the purposes of developing risk-adjusted sepsis, severe sepsis, and septic shock mortality rates, as well as any other data as may be required by the department. Each hospital shall be subject to audit at the department’s discretion.

2. The Commissioner of Health shall, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), promulgate such rules and regulations as may be necessary to effectuate the purposes of this act.

3. This act shall take effect the first day of the fourth month next following the date of 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 requires general and special hospitals licensed in the State to establish protocols for the early recognition and treatment of patients with sepsis.

Sepsis is a serious and potentially life-threatening condition caused by the body’s overwhelming immune response to infection. Sometimes known as “blood poisoning,” sepsis results when the immune chemicals released into the bloodstream cause widespread inflammation, leading to blood clots, impaired blood flow, and oxygen and nutrient deprivation in the organs. Sepsis can result in permanent organ damage, cognitive impairment, physical disability, or death. It is estimated that over one million Americans suffer from sepsis every year, and that the condition is fatal in 28 to 50 percent of those cases. Sepsis is the eighth-leading cause of death in New Jersey, and one of the leading causes of death in infants under one year of age in the State after congenital defect, birth injury, and unintentional injury.

The protocols required under the bill would incorporate distinct components for adult and pediatric patients, and would include processes for screening, early recognition, and treatment of sepsis, severe sepsis, and septic shock, including specific treatment guidelines for various circumstances and procedures for screening out patients for whom treatment would be inappropriate. Hospitals will be required to ensure that appropriate staff members are periodically trained to implement the sepsis protocols.

Hospitals will be required to submit proposed sepsis protocols to the Department of Health for review no later than 120 days after the effective date of the bill and implement the protocols upon receipt of department approval. Hospitals will be permitted to revise and update the protocols based on newly emerging evidence-based standards, and resubmit the protocols to the department for review no more than once every two years, unless the department identifies hospital-specific performance concerns.

Hospitals will be responsible for collecting and using quality measures related to the recognition and treatment of sepsis, severe sepsis, and septic shock for the purpose of internal quality improvement and evaluating the implementation and adherence to the protocols.

Hospitals will be required to submit to the department such data as may be necessary for the department to develop risk-adjusted sepsis, severe sepsis, and septic shock mortality rates, along with any other data the department may require. Hospitals will be subject to audit at the department’s discretion.