Governor Andrew M. Cuomo today announced that New York State will lead the nation by becoming the first state to require all hospitals to adopt best practices for the early identification and treatment of sepsis, a medical condition which is the number one killer in hospitals and the eleventh leading cause of death in the United States. These measures, which will be implemented through regulations issued by the Department of Health, will save an estimated 5,000 to 8,000 lives per year.
At the same time, the Governor also announced that the Department of Health will issue proposed regulations to ensure that the unique needs of pediatric patients are respected by requiring, among other things, that hospitals communicate critical test results in plain language to parents before a child is discharged from the hospital. The regulations also require hospitals to post a "Parents' Bill of Rights" letting parents and patients know of the important protections provided by these regulations. These sepsis and pediatric care reforms deliver on the commitment in the Governor's 2013 State of the State address that New York set a "gold standard" for patient care.
These initiatives, together called "Rory's Regulations," were announced today with the participation of Ciaran and Orlaith Staunton, whose 12-year old son, Rory, died of sepsis in April 2012, and who have advocated tirelessly since then to increase awareness about sepsis and to improve the delivery of pediatric care in hospitals.
"By adopting the regulations proposed today, New York will lead the nation and establish a gold standard for patient care that other states should follow," Governor Cuomo said. "I commend those in the healthcare community who worked closely with our Department of Health to develop these new regulations, which are expected to save thousands of lives in New York. I extend my most sincere appreciation to the Staunton family for their strength and unwavering commitment to this vital effort."
Ciaran and Orlaith Staunton said, "We wish to thank Governor Cuomo, the Health Commissioner Dr. Shah and all those who have worked so hard to make it possible to combat sepsis in a far more aggressive and urgent manner. We are also grateful for their focus on pediatric care especially in emergency rooms. Our son Rory was a battler for the underdog, who understood that helping those most in need was one of the most important lessons in life. We know his wish would be that no one suffer as he did and no family be left bereft when lives can be saved. We think these actions by the governor and the Health Commissioner are a huge step in the right direction."
State Health Commissioner Nirav R. Shah, M.D., M.P.H., said "Early detection of sepsis is a vital tool to treat this potentially life-threatening condition and save lives. Using evidence-based standards, we have identified key protocols to improve patient outcomes for sepsis. Further, we are taking additional steps to ensure that children's vital health information, including lab and test results, is communicated effectively to both parents and primary care providers. Thanks to Governor Cuomo, New York is a leader in implementing these critical measures."
Sepsis is a progressive shutdown of the body's organs and systems caused by systemic inflammation following infection that enters the blood or soft tissue. More than 750,000 Americans get sepsis each year, and over 200,000 die from it, making it the leading cause of death in hospitals and the eleventh leading cause of death overall in the United States, killing more people annually than AIDS, prostate cancer, and breast cancer combined. Those who don't die often experience life-altering consequences like missing limbs or organ dysfunction. Given its prevalence and consequences, sepsis is a huge driver of medical costs, accounting for an estimated $17 billion annually in national healthcare expenses.
Experts agree that the key to fighting sepsis is ensuring quick diagnosis and treatment within the "golden hour" when it can be most effective. Pilot initiatives in some hospital systems have shown great strides in decreasing sepsis mortality through effective implementation of what is basically a "checklist": a standardized protocol to facilitate quick and accurate diagnosis and fast and effective treatment as soon as any sign of sepsis arises. But no state has required these simple protocols be implemented at all hospitals.
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."
Healthcare Association of New York State President Daniel Sisto said, "Governor Cuomo's sepsis initiative will provide a tremendous boost to our collective efforts to combat this debilitating illness. HANYS is committed to working with our members to continually improve sepsis care, and to ensure that the needs of pediatric patients and their caregivers are met. We will continue to work closely with national experts such as the Surviving Sepsis Campaign to provide educational and best practice resources to our members, and with the Governor and the Department of Health to develop regulations designed to improve patient outcomes."
Michael Dowling, president and CEO, North Shore-LIJ Health System, said, "North Shore-LIJ has been privileged to work with the Stauntons on a proposed parents' bill of rights and to explain the steps we have taken to reduce sepsis mortality by 35 percent since 2008. And although I know I can't begin to fathom the pain they still feel nine months after Rory's death, the Stauntons are carrying on Rory's memory by educating the public and raising awareness of sepsis. We need to talk about sepsis openly, educate our clinicians and the public, and devote as many resources as we can muster to fix it."
Partnership for Quality Care Chair George Halvorson said, "The Partnership for Quality Care is thrilled by the leadership that Governor Cuomo has shown in fighting the deadly effects of sepsis. Sepsis is the number one cause of death in American hospitals today killing more patients than cancer or stroke. The steps that New York State is taking to better identify and treat this serious condition will save money, improve the quality of care at hospitals, and most important save countless lives. As a national coalition of health care workers and providers with partners throughout the state of New York we're proud to see the Empire State help light the path to higher quality health care across the nation."
Terence Brady, MD, FACP, President and Brad Sherman, MD, FACP, Quality Chair, both of the New York Chapter of the American College of Physicians said, “Sepsis is a disease that when unrecognized can lead to patient death, but when recognized early and treated aggressively can result in very successful treatment outcomes. We pledge our Chapter’s support for distribution and implementation of the guidelines and increased communication and education as a necessary step to improve patient care#157;
In October, 2012, Commissioner Shah convened a panel of experts to discuss strategies and initiatives to improve detection and treatment of sepsis, with a goal of improving survival rates in New York and across the nation. The panel reviewed initiatives undertaken by a collaboration of the Greater New York Hospital Association (GNYHA) and United Hospital Fund (UHF) at 57 hospitals across New York, and also key projects implemented by hospital systems in other states. New York's draft regulations reflect some of the effective strategies in these programs.
Both sets of regulations will be submitted to the New York State Public Health and Health Planning Council (PHHPC) for consideration on February 7, 2013, and will be published in the State Register for a 45-day public comment period. Following that review and approval by PHHPC, it is anticipated the regulations will take effect in May, 2013. Under the sepsis regulations, hospitals must submit protocols to the State Health Department for review before July 1, 2013 and will be required to implement the protocols no later than 45 days following Department approval. The full text of the regulations will be available today on the Department of Health's website.