Sepsis Regulations: Guidance Document 405.4 (a)(4)

Background & Purpose of this Document

Sepsis is a range of clinical conditions caused by the body's systemic response to an infection and impacts approximately 50,000 patients in New York State (NYS) each year. The mortality rate is influenced by the prompt identification and treatment of patients with sepsis. Hospitals in NYS have implemented evidence-based protocols to facilitate early identification and management of patients with sepsis as part of a statewide initiative to decrease sepsis mortality in NYS.

On November 14, 2018, the Department finalized amendments to subdivision (a) of Section 405.4 of Title 10 (Health) of the Official Compilation of Codes, Rules, and Regulations of the State of New York. The purpose of this document is to highlight the changes of this regulatory amendment.

To Whom It Applies

Section 405.4 of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York requires all hospitals licensed to operate in NYS to have in place evidence-based protocols for the early identification and treatment of patients with severe sepsis and septic shock.

Changes to Regulation


  • Protocol components no longer must include guidelines for hemodynamic support with explicit physiologic and biomarker treatment goals, methodology for invasive or non-invasive hemodynamic monitoring as well as criteria of an invasive protocol and for use of vasoactive agents;
  • Protocols must include monitoring, therapeutic endpoints;
  • Hospitals no longer must submit protocols to the Department each time there is an update. The Department may request and review hospital protocols at any time.


For the purposes of hospital data collection, the following terms have the following meanings:

  • Sepsis: a confirmed or suspected infection accompanied by two system inflammatory response syndrome (SIRS) criteria;
  • Severe Sepsis: sepsis complicated by organ dysfunction;
  • Septic Shock (Adults): sepsis-induced hypotension persisting despite adequate IV fluid resuscitation and/or evidence of tissue hypoperfusion;
  • Septic Shock (Pediatrics): sepsis and cardiovascular organ dysfunction.

The Sepsis Protocol

Hospitals shall establish, monitor, review and update when appropriate a sepsis protocol based on current evidence.

  1. Objectives: Protocol/s established by hospitals shall, (a) assist in rapid identification of patients with severe sepsis and septic shock; (b) specify an approach to stratifying patients into sepsis, severe sepsis and septic shock based on appropriate clinical and laboratory findings; (c) specify treatment approaches.
  2. Inclusion and Exclusion criteria: Protocols shall contain processes to rapidly identify individuals appropriate for treatment. Protocols can be tailored specific to populations like newborns and infants in NICU, pregnant women, etc. Protocols shall include explicit criteria defining those patients who should be excluded from protocols, such as patients with certain clinical conditions or those who have elected palliative care.
  3. Basic frame: A basic framework for both adult and pediatric protocols must address the following: (1) the physiologic measurements that will be used to guide resuscitation interventions; (2) the time frame goals for interventions such as fluid administration; (3) need to obtain blood cultures and cultures from identified infection sources prior to antibiotic administration; (4) the goal for timely administration of broad spectrum antibiotics; 5) criteria for on-going treatment or transfer to more intensive level of care.
  4. Adult protocol - minimum requirements: Protocols for adult patients must include consideration of the following elements, based on evidence-based guidelines, and target timeframes for critical interventions: (1) measurement of a blood lactate level; (2) collection of blood cultures; (3) administration of broad-spectrum antibiotics; (4) fluid administration; (5) fluid status assessment; (6) vasopressors and remeasurement of lactate for eligible patients.
  5. Pediatric protocol - minimum requirements: Protocols for pediatric patients must include consideration of the following elements, based on evidence-based guidelines: (1) blood culture collection; (2) antibiotic administration; (3) fluid administration and therapeutic endpoints.

Staff Training

Hospital staff shall ensure updated training when the hospital initiates substantive changes to the protocols. Such training shall include, but not be limited to, appropriate medical, nursing, pharmacy and laboratory staff. Hospitals shall also make available information technology resources to assist in the implementation of protocols.