VVM1 Task 1: Quality Improvement Projects Report New York State Legal Requirements
New York State Legal Requirements
New York State Department of Health
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.
The Sepsis Protocol
Hospitals shall establish, monitor, review and update when appropriate a sepsis protocol based on current evidence.
1
, VVM1 Task 1: Quality Improvement Projects Report New York State Legal Requirements
i. 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.
ii. 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.
iii. 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.
iv. 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.
v. 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.
Information pulled from: Department of Health. (2019, June). Sepsis regulations: Guidance
document 405.4 (a)(4). New York State.
https://www.health.ny.gov/regulations/public_health_law/section/405/
2
New York State Legal Requirements
New York State Department of Health
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.
The Sepsis Protocol
Hospitals shall establish, monitor, review and update when appropriate a sepsis protocol based on current evidence.
1
, VVM1 Task 1: Quality Improvement Projects Report New York State Legal Requirements
i. 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.
ii. 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.
iii. 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.
iv. 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.
v. 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.
Information pulled from: Department of Health. (2019, June). Sepsis regulations: Guidance
document 405.4 (a)(4). New York State.
https://www.health.ny.gov/regulations/public_health_law/section/405/
2
