This month, Ciaran Staunton traveled to Boston to participate in the inaugural meeting of the Massachusetts Sepsis Consortium. In Massachusetts, sepsis and disseminated infections are the third leading cause of hospitalization after labor and newborn delivery. The Consortium brings together relevant organizations and institutions to develop and execute statewide initiatives to improve the prevention, diagnosis, and treatment of sepsis.
In addition to the Rory Staunton Foundation and the National Family Council on Sepsis, the Consortium includes state agencies and legislators such as the Executive Office of Health and Human Services, MassHealth, and the department of Public Health, and health care associations and insurers, including the Society of Critical Care Medicine and the Massachusetts Health and Hospital Association.
We are pleased that Massachusetts has launched this response to the sepsis crisis and look forward to collaborating with our peers in the sepsis space. Our special thanks to the members of the MA National Family Council on Sepsis who attended the kickoff meeting, particularly the family of Emily Edwards, pictured here, which has been fighting so hard for the adoption of sepsis protocols in their home state. We continue to believe that any response to sepsis must include mandatory sepsis protocols and we will continue to work towards this goal in Massachusetts and across the country.
We are delighted to report that the Pennsylvania Department of Health has committed to including regulatory sepsis protocols in their updated hospital regulations. This was confirmed recently in a letter from the Department of Health to Chris Aiello, Secretary of the National Family Council on Sepsis pictured with his young daughter Emily who died tragically from sepsis, at 14 years of age in May 2015.
“As was discussed with the Rory Staunton Foundation, the inclusion of sepsis protocols will be in the overall update. Regulatory language… such as New York’s regulations, were reviewed and adapted for the department’s hospital regulations.”
In a statement, Chris Aiello said, “I’m incredibly proud of my home state of Pennsylvania and their commitment to adopt sepsis protocols. These regulations will save thousands of lives. Although this will not bring our lovely Emily back, Pennsylvania is putting families and people first and I am grateful.”
Pennsylvania will follow New Jersey who announced they had introduced mandatory sepsis protocols in January 2018 when New Jersey State Health Commissioner, Cathleen D. Bennett credited the Rory Staunton Foundation for help in making the decision. “After meeting with the Rory Staunton Foundation, Roy’s tragic and preventable death underscored how critical mandatory sepsis protocols are to save lives in New Jersey and the Department is proud to implement them.”
To read about Emily’s story visit our Sepsis Stories and read also about Conall Harvey a young survivor whose family has been passionately fighting for sepsis protocols.
This month, the Rory Staunton Foundation led a delegation of families impacted by sepsis on a two-day tour of the California state capital to raise awareness of the sepsis death toll and advocate for the adoption of evidence-based sepsis protocols in all California hospitals.
The group held meetings with legislators and policymakers, sharing their stories of how sepsis had devastated their lives and how commonsense protocols could have prevented their tragedies. The #SepsisSafeCA campaign ended with a meeting with CA Governor Jerry Brown.
We are enormously proud of the individuals who bravely and eloquently shared their stories so that others would not experience the same heartbreak. We will continue to press the California Department of Health and and State legislators until California joins New York, New Jersey, and Illinois to become a #SepsisSafe state!
New Jersey, We Did It!
“After meeting with The Rory Staunton Foundation, Rory’s tragic and preventable death underscored how critical mandatory sepsis protocols are to save lives in New Jersey, and the Department is proud to implement them,” – New Jersey Health Commissioner, Cathleen D. Bennett
We could not be more delighted to announce that New Jersey has become the third state to adopt mandatory sepsis protocols, known as Rory’s Regulations! The Rory Staunton Foundation has been advocating for sepsis protocols in New Jersey since 2014. It took numerous meetings with members of the New Jersey legislature, the New Jersey Hospital Association, the Governor’s Office and, above all, the NJ Department of Health but the protocols are worth the wait! In New York, Rory’s Regulations have saved more than 5,000 thousand lives and we are happy and relieved that our neighbors in the Garden State now have the same protections.
We must highlight a few heroes of this victory. First, National Family Council on Sepsis member, New Jersey resident and sepsis survivor Nicole Taylor who showed her determination and fighting spirit every step of the way and wouldn’t take ‘no’ for an answer–thank you for your advocacy, Nicole! And second, New Jersey Health Commissioner Cathleen D. Bennett who came to our first meeting with an open mind and a willingness to learn the facts and do what was necessary to keep New Jerseyans safe from sepsis. From all of us impacted by sepsis, our heartfelt thanks.
New England Journal Of Medicine Confirms Viability of Rory’s Regulations
and Deems Sepsis is “A Public Health Crisis Worthy of a Policy Response”
-The Rory Staunton Foundation Calls on Health & Human Services,
Tom Price to Adopt Rory’s Regulations Nationally-
The Rory Staunton Foundation for the Prevention of Sepsis (http://www.rorystauntonfoundation.org) today reported on a new study released on May 21, 2017 in the New England Journal of Medicine (NEJM) confirming that sepsis protocols in New York State hospitals are leading to expedited intervention and sepsis deaths steadily declining. Ciaran and Orlaith Staunton, who lost their son Rory, at twelve years old, from undiagnosed and untreated sepsis are the driving force in the adoption of New York State’s Rory’s Regulation protocols. Their unrelenting presence in the medical, institutional and governmental agencies, resulting in the NEJM abstract, are calling state and federal officials to action in the adoption of Rory’s Regulation protocols nationally.
Sepsis will kill upwards of 300,000 Americans in 2017 and will result in more that $20 billion in healthcare costs. Ciaran and Orlaith Staunton commented: “In light of this new evidence, we call on governors, health commissioners, and Health and Human Services Secretary, Tom Price, to adopt these protocols nationally. Families across America, to date still do not know the meaning of the word sepsis and because of that and lack of policy, are losing their family members in droves. It’s time to enact these lifesaving, low-cost, simple regulations in every medical institution in the country. Constituents should hold their elected officials accountable and ask them why they are allowing this crisis to continue when it is within their power to prevent it.”
The NEJM study, co-authored by Dr. Chris Seymour, assistant professor at the University of Pittsburgh, and Dr. Mitchell Levy, a physician and professor at Brown University’s medical school, examines data from New York and confirms that the sepsis regulations adopted in 2013 led to faster care and increased chances of survival for sepsis patients. Rory’s Regulations, require hospitals to follow a checklist of steps within the critical three hour window; including blood tests, checking blood lactate levels (a marker for sepsis) and beginning antibiotics. The faster hospitals completed the checklist, the lower the risk of death.
Sepsis is the body’s overwhelming reaction to infection. It causes inflammation, damages tissue, and leads to organ failure and death. The Stauntons established the Rory Staunton Foundation for Sepsis Prevention following their son’s death and actively campaign for the adoption of sepsis protocols in every state by 2020. Illinois adopted regulations in 2016 and Pennsylvania is moving to do so this year with more states to follow. The new study should bolster support for the regulations–and the Stauntons and their supporters will continue to fight at the state and national level until every hospital in the country operates with a sepsis protocol in place. None other than Atul Gawande, the physician, bestselling author of The Checklist Manifesto, and author of the World Health Organization’s Surgical Safety Checklist hailed the progress made by New York State as “impressive and important.” He added, “It’s real evidence that time matters.”
April 1st represented the fifth year since Rory’s Staunton’s death. “We are not going away. We demand a systemic change within our nation’s healthcare system. The most respected and recognized medical journal concurs with the benefits of Rory’s Regulations. The suggested “policy response” is long overdue,” Orlaith Staunton concluded.
After a three-year campaign by residents, including sepsis survivor Nicole Taylor and her family, and the Rory Staunton Foundation, New Jersey has agreed to Mandatory Sepsis Protocols in ALL New Jersey hospitals!
But we’re not there yet…
Public comment on the proposed rule change will be accepted through August 18th. Your voice matters! Go to NJ Department of Health Web Site now to comment.
The rule citation must be referenced when you comment, as follows:
“I want mandatory, life-saving sepsis protocols in New Jersey hospitals!” “Proposed New Rule: N.J.A.C. 8:43G-14.9/Hospital Licensing Standards – Infection Control: Sepsis Protocols
So, copy and paste the above and click HERE now to comment.
Yes, there are hospitals in NJ that have sepsis protocols in place, but not every hospital. …what if you or your loved ones go to a hospital that doesn’t follow sepsis protocols?
We can NOT allow “choosing the right hospital” to determine life or death with regards to sepsis!
Let Commissioner Bennett know that you encourage her to implement these protocols immediately to start saving lives. ALL New Jersey residents deserve life-saving, sepsis protocols in ALL hospitals – NOW!
Join us in making New Jersey SAFE FROM SEPSIS!
By Konrad Reinhart, M.D., Ron Daniels, M.D., Niranjan Kissoon, M.D., Flavia R. Machado, M.D., Ph.D., Raymond D. Schachter, L.L.B., and Simon Finfer, M.D.
Published by New England Journal of Medicine, August 03, 2017 |
“Some very important clinical issues, some of them affecting life and death, stay largely in a backwater which is inhabited by academics and professionals and enthusiasts, dealt with very well at the clinical and scientific level but not visible to the public, political leaders, leaders of healthcare systems. . . . The public and political space is the space in which [sepsis] needs to be in order for things to change.”
So said Sir Liam Donaldson, the former chief medical officer for England and the current World Health Organization (WHO) envoy for patient safety, on May 24, 2017.1 Two days later, the World Health Assembly (WHA), the WHO’s decision-making body, adopted a resolution on improving the prevention, diagnosis, and management of sepsis.2
The term “sepsis” dates back to at least the time of Hippocrates, who considered it the process by which flesh rots and wounds fester. More recently, it has been defined as life-threatening organ dysfunction resulting from infection. Despite this long history, sepsis has existed in the backwater described by Donaldson, and as a result innumerable patients around the world have died prematurely or faced long-term disability. This toll of unnecessary suffering drove Germany, with the unanimous support of the WHO executive board and at the urging of the Global Sepsis Alliance (GSA), to propose the resolution adopted by the WHA. The resolution urges member states and the WHO director general to take specific actions to reduce the burden of sepsis through improved prevention, diagnosis, and management (see table.
The true burden of disease arising from sepsis remains unknown. The current estimates of 30 million episodes and 6 million deaths per year come from a systematic review that extrapolated from published national or local population estimates to the global population.3 The likelihood that the result was a significant underestimate was recognized by the authors, who could find no data from the low- and middle-income countries (LMICs) where 87% of the world’s population lives. Thus, their estimate is based on data on hospital-treated sepsis in high-income countries. This lack of data is compounded by the fact that sepsis is treated as a “garbage code” in the Global Burden of Disease statistics, where most deaths due to sepsis are classified as being caused by the underlying infection. Improving the coding of sepsis and establishing a proper accounting in those statistics are essential steps envisaged by the WHA.
The resolution also calls for health care workers to increase awareness of sepsis by using the term “sepsis” in communication with patients, relatives, and other parties.4 National surveys consistently report low community awareness of sepsis, its signs and symptoms, its causes, and its toll of death and disability. In Australia, only 40% of surveyed people had heard of sepsis and only 14% could name one of its signs. In Brazil, the figures are even lower, with 7% of surveyed people aware in 2014 and 14% in 2017. In the United States, the United Kingdom, and Germany, high-profile campaigns have proven effective and increased awareness to 55%, 62%, and 69%, respectively.
Ensuring greater awareness on the part of both the public and health care workers is a crucial step in reducing the global burden of sepsis. Approximately 70% of sepsis cases are community-acquired, and since treatment with appropriate antibiotics must begin early to be effective, educating people about seeking treatment without delay is key to preventing unnecessary deaths and disability. The progression from infection to sepsis can be insidious and is unpredictable. Although populations such as the very young, the very old, and the immunosuppressed are known to be at high risk and should be targeted for education, sepsis can affect anyone at any time, which means that national public awareness programs are needed.
Awareness programs should also teach health care workers both to recognize sepsis and to understand it as a true time-critical medical emergency. Government reports and individual patient stories consistently identify delayed treatment as a major cause of preventable death and disability.5 Encouraging patients, relatives, and health care workers to ask “Could this be sepsis?” saves lives.
Clear treatment guidelines and performance targets tailored to local environments and available resources are also essential. Effective examples of this approach that have reduced mortality can serve as templates to be adapted for local conditions and use; these include “Rory’s Regulations” in New York State, the “Sepsis Kills” program in New South Wales, Australia, the National Health Services’ commissioning levers in England, and a multifaceted education program in Brazil.
Promulgation of comprehensive treatment guidelines such as those developed by the Surviving Sepsis Campaign has been associated with reduced mortality in high-income countries, but guidelines written for and by clinicians in these countries may not be applicable in the LMICs that bear most of the sepsis burden. Context-specific guidelines or modification of current guidelines for individual LMICs will be most effective if the guideline process is led by local clinicians and policymakers; the resolution envisages the WHO, in collaboration with others, playing a role in the development and promulgation of such guidelines. In addition, attention to bolstering public health initiatives to prevent sepsis, surveillance systems for detecting outbreaks early, and provision of simple early treatment can help to counterbalance the effects of a lack of critical care facilities in many LMICs.
The WHO resolution recognizes the perceived conflict between rapid administration of antibiotics to treat sepsis and efforts to combat antimicrobial resistance. Global efforts to reduce the burden of sepsis must go hand in hand with measures to minimize antimicrobial resistance and be consistent with the WHO-approved Global Action Plan on Antimicrobial Resistance. However, sepsis is the condition that is most appropriate to treat empirically with broad-spectrum antibiotics, with rapid deescalation based on identification of the causative organisms.
Progress toward the GSA’s vision of “a world free of sepsis” also requires recognition of the key role of prevention. Prevention of infection and resultant sepsis through vaccination; access to clean water, sanitation, and hygiene (WASH) in homes, schools, and health care facilities; clean childbirth and surgical practices; and hand hygiene in health care facilities is already the focus of WHO programs. The new resolution on sepsis supports and reinforces these programs.
Increased awareness, early presentation to a health care facility or early recognition of health care–associated sepsis, rapid administration of appropriate antibiotics, and urgent treatment according to locally developed guidelines can significantly reduce deaths from sepsis. Since such measures have reduced case fatality rates in high-income countries, however, the substantial burden carried by survivors of sepsis has become clearer. The sequelae of sepsis can include clinically significant physical, cognitive, and psychological disability that often goes unrecognized and untreated. In LMICs, postdischarge mortality after sepsis is about the same as sepsis-related mortality in the hospital, and perinatal sepsis poses great and ongoing risks for both mother and infant. Yet around the world, coordinated services for sepsis survivors are virtually nonexistent.
The WHA resolution, with its implicit recognition of sepsis as a major threat to patient safety and global health, has the potential to save millions of lives. To realize this potential, the actions proposed in the resolution need to be taken. These actions require coordinated efforts by politicians, policymakers, health care administrators, researchers, and clinicians working with people of all ages in all health care settings and in the community. Actions will vary by region and country and must acknowledge the unique challenges faced by LMICs.
To read the original article on NEJM.org, please click here.
Disclosure forms provided by the authors are available at NEJM.org.
This article was published on June 28, 2017, at NEJM.org.
From Jena University Hospital, Jena, Germany (K.R.); the Heart of England NHS Foundation Trust, Birmingham, United Kingdom (R.D.); the Department of Pediatrics, Emergency Medicine and Critical Care, University of British Columbia (N.K.), and Synergy Business Lawyers (R.D.S.) — both in Vancouver, Canada; the Department of Anesthesiology, Pain and Intensive Care Medicine, Federal University of São Paulo, São Paulo (F.R.M.); and the George Institute for Global Health, University of New South Wales, Sydney (S.F.). The authors constitute the Executive Board of the Global Sepsis Alliance.
Misdiagnosed ‘Sepsis’ Now a Global Health Priority for World Health Organization
GENEVA – Sepsis, one of the most prevalent but misdiagnosed, deadly diseases, was established as a global priority today by the World Health Assembly (WHA), the decision-making body of the World Health Organization (WHO).
On the unanimous recommendation of the Executive Board of the WHO, the WHA adopted the resolution to improve, prevent, diagnose, and manage sepsis through a series of actions directed at developed and developing countries around the world. The resolution was adopted at the seventieth WHA, which is meeting between May 22-31 in Geneva.
Sepsis, commonly referred to as ‘blood poisoning’, is the life-threatening condition that arises when the body’s response to infection results in organ dysfunction or failure. Sepsis is often confused with other conditions in its early stages, with delayed recognition of the signs and symptoms quickly leading to multi-system organ failure and ultimately death.
The resolution urges the 194 United Nation Member States to implement appropriate measures to reduce the human and health economic burden of sepsis. In the USA alone, sepsis causes or contributes to half of all deaths in hospitals and has become the leading cause of annual hospitals costs, at over 24 billion USD per year.
The resolution also requests the Director-General of the WHO, Dr. Margaret Chan, to draw attention to the public health impact of sepsis and to 1) publish a report on sepsis and its global consequences by the end of 2018, 2) support the Member States adequately, 3) collaborate with other UN organizations, and 4) report to the 2020 WHA on the implementation of this resolution.
“Community-acquired and health care-acquired sepsis represent a huge global burden that has been estimated to be 31 million cases every year, six million of which result in death,” said Dr. Chan. “One in ten patients world-wide acquires one health care associated infection which often manifests itself with sepsis conditions. I commend the member states for the content of the resolution on sepsis which point to key actions that need to be taken to reverse these shocking statistics.”
The WHO has allocated $4.6 million USD to help implement their sepsis resolution.
The adoption of sepsis as a global priority was initiated by the Global Sepsis Alliance who gathered the consensus and authority of clinicians and families from over 70 countries.
“Worldwide, sepsis is one of the most common deadly diseases, and it is one of the few conditions to strike with equal ferocity in resource-poor areas and in the developed world,” said Dr. Konrad Reinhart, Chairman of the Global Sepsis Alliance. “In the developed world, sepsis is dramatically increasing by an annual rate of 5-13 per cent over the last decade, and now claims more lives than bowel and breast cancer combined. When sepsis is quickly recognized and treated, lives are saved but health care providers need better training because they are the critical link to preventing, recognizing, and treating sepsis.”
The adopted Resolution on Sepsis states:
1. Each year, sepsis causes approximately six million deaths worldwide, most of which are preventable.
2. Sepsis is a syndromic response to infection and the final common pathway to death from most infectious diseases.
3. Sepsis represents the most vital indication for the responsible use of effective antimicrobials for human health.
4. The UN Member States urgently need to implement and promote measures for prevention; such as clean childbirth practices, infection prevention practices in surgery, improvements in sanitation, nutrition and delivery of clean water.
5. Many vaccine-preventable diseases are a major contributor to sepsis in children and adults; national immunization programs are needed urgently.
6. Sepsis is an emergency that requires time-critical actions, improved training of health care professionals and laypeople.
7. UN Member States are required to promote research aimed at innovative means of diagnosing and treating sepsis across all ages, including research for new antimicrobial and other novel medicines/interventions, rapid diagnostic tests, and vaccines.
8. Public awareness needs to be raised and encouraged, for example by using the term ‘sepsis’ when communicating with patients, relatives, and other parties, or by supporting World Sepsis Day, every year on September 13.
9. Integrated approaches to the prevention and clinical management of sepsis are urgently needed, including access to appropriate health care for survivors.
10. The International Classification of Diseases (ICD) system needs to be applied and improved to establish the prevalence and profile of sepsis and the development of specific epidemiologic surveillance systems.
“With the exception of maternal and neonatal sepsis, ‘sepsis’ as a diagnosis is not cited in the Global Burden of Disease statistics and is therefore not a priority by policy makers or health care authorities,” said Dr. Reinhart added. “In addition, it is mostly unknown and poorly understood by the public. Further preventable deaths occur as many healthcare professionals lack training and expertise in the prevention, early recognition, and evidence-based management of sepsis as a critical medical emergency.”
In most low and middle income countries, an integrated approach to managing sepsis through clinical and laboratory services and timely access to appropriate sepsis care is limited or absent. In high income countries, effective best practice approaches to the early recognition and management of sepsis are often poorly implemented.
Representatives of WHO are set to strike a Task Force with the GSA to develop the strategy to implement the resolution and to secure international political and financial support.
For its part, the GSA identifies its key priorities as: 1) achieving adequate documentation of sepsis in the global and national disease statistics and reports, 2) encouraging the development of national action plans for all countries, 3) fostering quality improvement initiatives on all levels of care and for all health care settings, and 4) collaborating with governmental and non-governmental bodies focused on strengthening health systems and improving patient safety.