The regulations announced today will make New York the first state in the nation to require all hospitals to adopt evidence-based protocols for the early diagnosis and treatment of sepsis. Specifically, hospitals will be required to adopt protocols that provide for:
- The screening and early recognition of patients with sepsis, severe sepsis and septic shock;
- A process to identify and document individuals appropriate for treatment through severe sepsis protocols; and
-Guidelines for treatment including for early delivery of antibiotics.
Protocols must be evidence-based and based on generally accepted standards of care and include components specific to the identification, care and treatment of adults and of children and make clear when different approaches are required for adults and children.
Guidance to be issued by the Department of Health following adoption of these regulations will outline the specific timeframe goals that current research shows to be a best practice: for example, pursuing administration of antibiotics within one hour of a diagnosis of sepsis, and implementation of other protocol components within 3 or 6 hours (for severe sepsis and septic shock) as appropriate. Including this information in guidance materials will allow it to be updated based on research findings and scientific advancement.
Protocols must be approved by the Department of Health and periodically updated, and hospitals will be required to ensure that appropriate hospital staff members are trained in the protocols. The regulations will also require hospitals to collect data and quality measures to make internal quality improvements, and to report data to the Department of Health for use in monitoring compliance and updating best practices.
The second set of regulations announced today will make key reforms to improve quality and oversight of care provided to pediatric patients, including provisions to strengthen the ability of parents to play a meaningful and informed role in a child's healthcare decisions. Specifically, the regulations announced will newly require hospitals to implement procedures to ensure that parents and primary care providers receive key information about children's care, particularly by facilitating the communication of key tests and lab results. The regulations proposed today require hospitals to develop and implement policies and procedures to:
-Ensure that all test results are reviewed upon completion by a physician, physician assistant or nurse practitioner;
-Ask the identity of a patient's primary care provider, if any, on admission, and forward all test results to that primary care provider;
-Prohibit the discharge of a patient until test results that may reasonably be expected to yield "critical values" – indicating a life-threatening or other condition requiring immediate medical attention – are completed and communicated; and
-Communicate prior to discharge all categories of tests ordered, all critical value test results, and what, if any, (non-critical) tests are still pending; and
-Carry out such communication in plain, understandable terms to the patient or the patient's parent or medical decision-maker, as appropriate.
-The pediatric regulations also will make other key reforms to the delivery of pediatric care, such as requiring hospitals to:
-Enable parents or guardians to stay with pediatric patients while they are receiving care, including to permit at least one parent or guardian to remain with the pediatric patient at all times;
-Ensure that hospitals admitting children have appropriate staff, resources and age-appropriate equipment and establish policies and procedures for transferring children when needed and appropriate.
To ensure that parents and patients are aware of the protections afforded in these regulations, the regulations also require hospitals to post these protections in a "Parent's Bill of Rights" so that patients and parents are aware of what they are entitled to and can more fully participate in their care.
Ken Raske, President, Greater New York Hospital Association, said "By focusing on this highly challenging medical condition, Governor Cuomo is once again showing true leadership. New York's hospitals are deeply committed to saving lives through improved sepsis identification and treatment, and pledge to continue to work closely with the New York State Department of Health in aggressively fighting sepsis. From January 2011 to September 2012, the 55 hospitals in the GNYHA/United Hospital Fund STOP Sepsis Collaborative – whose singular goal has been to reduce mortality from severe sepsis and septic shock – achieved a 22% reduction in severe sepsis inpatient mortality rates."