2019 -- S 0773

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LC002138

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2019

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A N   A C T

RELATING TO HEALTH AND SAFETY - SEPSIS PROTOCOLS

     Introduced By: Senators Pearson, Lynch Prata, and McCaffrey

     Date Introduced: April 04, 2019

     Referred To: Senate Health & Human Services

     It is enacted by the General Assembly as follows:

     SECTION 1. Chapter 23-17 of the General Laws entitled "Licensing of Health-Care

Facilities" is hereby amended by adding thereto the following sections:

     23-17-65. Protocols for the early recognition and treatment of patients with severe

sepsis/septic shock.

     (a) The licensing agency, with the advice of the health services council, shall require that

the following patient care practices are implemented, shall monitor the hospital's compliance with

these patient care practices, and shall take corrective action as necessary to attain compliance.

     (b) Hospitals shall have in place evidence-based protocols for the early recognition and

treatment of patients with severe sepsis/septic shock that are based on generally accepted

standards of care.

     23-17-65.1. Hospital medical staff accountability - sepsis protocols.

     (a) The medical staff shall be organized and accountable to the licensing agency for the

quality of medical care provided to all patients. The medical staff shall adopt, implement,

periodically update and submit to the director evidence-based protocols for the early recognition

and treatment of patients with sepsis, severe sepsis, and septic shock ("sepsis protocols") that are

based on generally accepted standards of care. Sepsis protocols must include components specific

to the identification, care and treatment of adults and of children, and must clearly identify where

and when components will differ for adults and for children. These protocols must include the

following components:

     (1) A process for the screening and early recognition of patients with sepsis, severe sepsis

and septic shock;

     (2) A process to identify and document individuals appropriate for treatment through

severe sepsis protocols, including explicit criteria defining those patients who should be excluded

from the protocols, such as patients with certain clinical conditions or who have elected palliative

care;

     (3) Guidelines for hemodynamic support with explicit physiologic and biomarker

treatment goals, methodology for invasive or non-invasive hemodynamic monitoring, and

timeframe goals;

     (4) For infants and children, guidelines for fluid resuscitation with explicit timeframes for

vascular access and fluid delivery, consistent with current evidence-based guidelines for severe

sepsis and septic shock with defined therapeutic goals for children;

     (5) A procedure for identification of infectious source and delivery of early antibiotics

with timeframe goals; and

     (6) Criteria for use, where appropriate, of an invasive protocol, and for use of vasoactive

agents.

     (b) The medical staff shall ensure that professional staff with direct patient care

responsibilities and, as appropriate, staff with indirect patient care responsibilities, including, but

not limited to, laboratory and pharmacy staff, are periodically trained to implement sepsis

protocols required pursuant to this section. Medical staff shall ensure updated training when the

hospital initiates substantive changes to the protocols.

     (c) Hospitals shall submit sepsis protocols required pursuant to this section to the director

for review on or before July 1, 2019. Hospitals must implement these protocols no later than

forty-five (45) days after receipt of a letter from the director indicating that the proposed

protocols have been reviewed and determined to be consistent with the criteria established herein.

Hospitals must update protocols based on newly emerging evidence-based standards. Protocols

are to be resubmitted at the request of the director, not more frequently than once every two (2)

years unless the director identifies a hospital specific performance concern.

     (d) The medical staff shall be responsible for the collection, use, and reporting of quality

measures related to the recognition and treatment of severe sepsis for purposes of internal quality

improvement and hospital reporting to the director. The measures shall include, but not be limited

to, data sufficient to evaluate each hospital's adherence rate to its own sepsis protocols, including

adherence to timeframes and implementation of all protocol components for adults and children.

     (e) Hospitals shall submit data specified by the director to permit the director to develop

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risk-adjusted sepsis mortality rates in consultation with appropriate national, hospital and expert

stakeholders.

     (f) Data shall be reported annually, or more frequently at the request of the director, and

shall be subject to audit at the discretion of the director.

     (g) Definitions. For the purposes of this section, the following terms shall have the

following meanings:

     (1) "Sepsis" means a proven or suspected infection accompanied by a systemic

inflammatory response;

     (2) "Septic shock" means severe sepsis with persistent hypotension or cardiovascular

organ dysfunction despite adequate IV fluid resuscitation; and

     (3) "Severe sepsis" means sepsis plus at least one sign of hypoperfusion or organ

dysfunction.

     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO HEALTH AND SAFETY - SEPSIS PROTOCOLS

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     This act would require hospital medical staff to adopt, implement, periodically update

and submit to the director of health, evidence-based protocols for the early recognition and

treatment of patients with sepsis, severe sepsis and septic shock ("sepsis protocols", that are based

on generally accepted standards of care).

     This act would take effect upon passage.

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