SB2403 99TH GENERAL ASSEMBLY

LRB099 18409 MJP 42785 b

99TH GENERAL ASSEMBLY
State of Illinois
2015 and 2016
SB2403

Introduced 2/3/2016, by Sen. Chapin Rose

SYNOPSIS AS INTRODUCED:

20 ILCS 2310/2310-314 new
210 ILCS 85/6.23a new

Amends the Hospital Licensing Act. Requires hospitals to adopt, implement, periodically update, and submit to the Department of Public Health evidence-based protocols for the early recognition and treatment of patients with sepsis, severe sepsis, or septic shock that are based on generally accepted standards of care. Requires the protocols to contain certain components, including components specific to the identification, care, and treatment of adults and of children. Requires hospitals to submit the protocols to the Department no later than 6 months after the effective date of the amendatory Act. Provides that protocols shall be resubmitted at the request of the Department, but not more frequently than once every 2 years unless the Department identifies hospital-specific performance concerns. Requires hospitals to report certain sepsis-related data to the Department. Amends the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois. Requires the Department to publish guidelines to assist hospitals in developing the sepsis protocols. Contains provisions concerning rulemaking.

FISCAL NOTE ACT MAY APPLY

A BILL FOR

AN ACT concerning regulation.

Be it enacted by the People of the State of Illinois, represented in the General Assembly:

Section 5. The Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois is amended by adding Section 2310-314 as follows:

(20 ILCS 2310/2310-314 new)

Sec. 2310-314. Sepsis screening protocols.

(a) The Department shall publish guidelines to assist hospitals in developing the sepsis protocols required in Section 6.23a of the Hospital Licensing Act. The guidelines published by the Department shall include, but not be limited to, an appropriate process for screening all patients to ensure early recognition of patients with possible sepsis and, once possible sepsis has been documented, establishing clear timeframes for the administration of antibiotics and full protocol implementation.

(b) The Department shall adopt rules to implement Section 6.23a of the Hospital Licensing Act.

Section 10. The Hospital Licensing Act is amended by adding Section 6.23a as follows:

(210 ILCS 85/6.23a new)

Sec. 6.23a. Sepsis screening protocols.

(a) As used in this Section:

"Sepsis" means a proven or suspected infection accompanied by a systemic inflammatory response.

"Septic shock" means severe sepsis with persistent hypotension or cardiovascular organ dysfunction despite adequate intravenous fluid resuscitation.

"Severe sepsis" means sepsis plus at least one sign of hypoperfusion or organ dysfunction.

(b) Each hospital shall adopt, implement, periodically update, and submit to the Department evidence-based protocols for the early recognition and treatment of patients with sepsis, severe sepsis, or 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 also include the following components:

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

(2) a process to identify and document individuals appropriate for treatment through 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 the 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.

(c) Each hospital 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 the sepsis protocols required under subsection (b). The hospital shall ensure updated training of staff if the hospital initiates substantive changes to the sepsis protocols.

(d) Each hospital shall submit the sepsis protocols required under subsection (b) to the Department for review no later than 6 months after the effective date of this amendatory Act of the 99th General Assembly. A hospital must implement these protocols no later than 45 days after receipt of a letter from the Department indicating that the proposed protocols have been reviewed and determined to be consistent with the criteria established in this Section. A hospital must update protocols based on newly emerging evidence-based standards. Protocols shall be resubmitted at the request of the Department, but not more frequently than once every 2 years unless the Department identifies hospital-specific performance concerns.

(e) Each hospital 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 reporting to the Department. These 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 sepsis protocol components for adults and children.

Each hospital shall submit data specified by the Department to permit the Department to develop risk-adjusted sepsis mortality rates in consultation with appropriate national, hospital, and expert stakeholders. This data shall be reported annually, or more frequently at the request of the Department, and shall be subject to audit at the discretion of the Department.