A1950 1R

An Act concerning sepsis protocols in hospitals ¹, amending P.L.2007, c.196,¹ 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:

¹1. (New section) This act shall be known and may be cited as the “Stop Sepsis Act.”¹

¹[1.] 2.¹ a. Each general or special hospital licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.) shall adopt, implement, ¹and¹ periodically update ¹[, and submit to the Department of Health]¹ evidence-based protocols ¹based on best practices¹ for the early recognition and treatment of patients with sepsis, severe sepsis, and septic shock, which shall ¹include, but not be limited to¹:

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

(2) include]¹ components specific to the identification, care, and treatment of ¹[both]¹ adult ¹, geriatric, obstetric,¹ and pediatric patients; and

¹[(3)] (2)¹ clearly ¹[identify] identifying¹ where and when the components differ with regard to adult ¹, geriatric, obstetric,¹ 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 ¹[palliative] hospice¹ care;

(3) specific guidelines for treatment appropriate to the patient’s condition, including treatment goals, treatment methodologies, criteria for ¹[invasive and non-invasive] evidence-based¹ treatment and management¹ , 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 ¹[professional] clinical¹ staff ¹[with direct patient care responsibilities, and appropriate professional staff with indirect patient care responsibilities including, but not limited to, laboratory and pharmacy staff,] involved in the recognition, treatment, or prevention of sepsis¹ 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. ¹Subject to the availability of funds, the department shall offer continuing education credits and other educational opportunities related to sepsis, such as health care provider briefings on the early recognition and treatment of patients with sepsis.¹

d. ¹[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.]¹ 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.

¹[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.] e. (1) The Commissioner of Health shall compile information necessary to develop and expand the reporting of appropriately risk-adjusted sepsis-related quality measures in a report card, which shall be updated annually and made available on the Internet website of the Department of Health. The report card shall be designed to provide information about hospital quality measures related to the recognition and treatment of sepsis, severe sepsis, and septic shock.

(2) In developing and expanding the risk-adjusted sepsis-related measures included in the report card, the commissioner shall consult with hospitals, clinical experts, and the Quality Improvement Advisory Committee. The department shall utilize data submitted pursuant to P.L.1971, c.136 (C.26:2H-1 et al.).

(3) For each hospital, the report card shall include:

(a) the number of, average length of stay for, and risk-adjusted mortality rate for surgical inpatient cases of sepsis, severe sepsis, and septic shock;

(b) the number of, average length of stay for, and risk-adjusted mortality rate for non-surgical inpatient cases of sepsis, severe sepsis, and septic shock;

(d) the number of patients with sepsis, severe sepsis, and septic shock discharged to hospice.

f. For the purposes of the early identification and treatment of sepsis, a third-party payor, managed care organization, or health benefits plan with which the Division of Medical Assistance and Health Services in the Department of Human Services contracts for the delivery of Medicaid services, and any health benefits plan, as defined pursuant to section 2 of P.L.2003, c.193 (C.17B:27D-2), shall not substitute its own clinical judgment for that of the treating licensed health care provider with respect to the diagnosis and treatment of suspected sepsis, sepsis, severe sepsis, or septic shock. Diagnosis and treatment shall include, but not be limited to, denial, downcoding, retrospective review, or payment reduction based on the application of alternative clinical definitions, proprietary algorithms, payer-developed medical necessity policies, or retrospective clinical validation reviews when the diagnosis has been documented and coded in accordance with ICD-10-CM official guidelines or any successor guidelines.

g. As used in this section, “hospital” means a general or special hospital licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.).¹

¹3. Section 3 of P.L.2007, c.196 (C.26:2H-12.41) is amended to read as follows:

3. A general hospital licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et al.) shall be required to report quarterly to the Department of Health, in a form and manner prescribed by the Commissioner of Health:

a. process quality indicators of hospital infection control that have been identified by the federal Centers for Medicare & Medicaid Services, as selected by the commissioner in consultation with the Quality Improvement Advisory Committee within the department; and

b. beginning 30 days after the adoption of regulations pursuant to this act, data on infection rates for the major site categories that define health care facility-associated infection locations, multiple infections, and device-related and non-device related infections, identified by the federal Centers for Disease Control and Prevention, as selected by the commissioner in consultation with the Quality Improvement Advisory Committee within the department which is appropriately risk adjusted provided that any infection rate data required under this subsection shall be reported and publicly displayed only in a transparent, clinically valid format that accounts for relevant patient, facility, and case-mix factors. Submission of the reports required pursuant to this section shall be made through the National Healthcare Safety Network as the internet-based surveillance system to which each general hospital shall report federal Centers for Disease Control healthcare associated infection data, or any successor system selected by the federal government.¹

(cf: P.L.2012, c.17, s.202)

¹[2.] 4.¹ 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.

¹[3.] 5.¹ This act shall take effect the first day of the ¹[fourth] twelfth¹ month next following the date of ¹[enactment] the adoption of rules and regulations pursuant to section 4 of P.L. , c. (C. ) (pending before the Legislature as this bill)¹ , except that the Commissioner of Health may take any anticipatory administrative action in advance as may be necessary for the implementation of this act.