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Roberta WagnerDeputy Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition
FY 14-15: Agency Priority Goal
Reduce foodborne illness in the population.
Priority Goal
Goal Overview
Salmonella is the leading known cause of bacterial foodborne illness and death in the United States. Each year in the United States, Salmonella causes an estimated 1.2 million illnesses, including fever and diarrhea, and between 400 and 500 deaths. Salmonella serotype Enteritidis (SE), a subtype of Salmonella, is now the most common type of Salmonella in the United States and accounts for approximately 20% of all Salmonella cases in humans. The most significant sources of foodborne SE infections are shell eggs (FDA-regulated) and broiler chickens (USDA-regulated). Therefore, reducing SE illness from shell eggs is the most appropriate FDA strategy for reducing illness from SE. Preventing Salmonella infections depends on actions taken by regulatory agencies, the food industry and consumers to reduce contamination of food, as well as actions taken for detecting and responding to outbreaks. As part of the shared vision to reduce foodborne illness, HHS's Food and Drug Administration (FDA) has developed a Priority Goal to reduce Salmonella contamination in shell eggs, and the Centers for Disease Control and Prevention (CDC) is working with FDA to gather more data to better estimate sources of illness. Additionally, USDA, FDA and CDC are involved in many interagency efforts, including the Interagency Food Safety Analytics Collaboration (IFSAC). This interagency collaboration is working to improve methods used to estimate the proportion of foodborne illnesses associated with specific sources.
Strategies
- Ensuring compliance with the Egg Rule
- Large producers (82% of eggs consumed) requirement to comply with the rule started in 2010
- Outreach and education
- Inspections of all firms and timely compliance follow-up
- Small producers requirement to comply with the rule started in 2012
- Outreach and education
- Inspections of some firms and compliance follow-up
- Large producers (82% of eggs consumed) requirement to comply with the rule started in 2010
- Estimating attribution of SE illnesses to eggs
- Evaluate use of new data sources in attribution models
- Develop methods to estimate change in attribution since baseline period
Progress Update
On July 9, 2009, FDA's final egg rule, "Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation" was published. This rule required shell egg producers to implement controls to prevent SE from contaminating eggs on the farm and from further growth during storage and transportation. The regulation also requires egg producers to maintain records concerning their compliance with the egg rule to register with FDA. The final rule is expected to reduce SE-associated illnesses and deaths by reducing the likelihood that shell eggs are contaminated with SE. The compliance date was July 9, 2010 for egg producers with 50,000 or more laying hens, and July 9, 2012 for producers with fewer than 50,000 but at least 3,000 laying hens. For firms that must comply with the refrigeration requirements, the compliance date was July 9, 2010.
FDA drafted and published on the FDA website a guidance for industry to aid them in complying with the rule. FDA trained FDA and state investigators on inspecting for compliance with the rule in 2010. Inspections began in 2010 and will continue to provide assurance that the industry remains in compliance.
Since FY 2010, FDA has conducted over 1100 inspections of large and small egg producers. In November, FDA issued the new assignment to continue inspections of small and large egg producers for FY 2015. As of September 30, 2015, FDA has conducted a total of 136 inspections or investigations. The emergence of Highly Pathogenic Avian Influenza (HPAI) at commercial egg producing operations impacts FDA’s ability to monitor compliance with the Egg Rule. On May 5, 2015, FDA temporarily suspended physical inspections of egg laying facilities to safeguard against possible spread of HPAI. The FDA is working closely with USDA and other federal, state and local agencies to track and manage the effects of recent outbreaks of HPAI. Prior to resuming inspection, the Agency will be providing enhanced biosecurity training to all food safety staff in FDA and States performing inspections on egg farms.
For CDC, the work to attribute the SE illnesses to shell eggs is an important part of the strategy. Historically, SE illnesses in humans have been linked to shell eggs, poultry meat, raw milk, pork, beef, sprouts, raw almonds, contact with reptiles, and other sources. It is necessary to know the major sources of SE illness so that the regulatory agencies know what foods to target in their contamination reduction efforts, and can assess the effect of their efforts. The particular food responsible for a person’s illness is typically only known in outbreaks, and fewer than five percent of illnesses are part of recognized outbreaks. Source attribution analyses use statistical modeling approaches that use the limited data that is available to estimate the sources of SE infections across the whole population. CDC, in partnership with the Interagency Food Safety Analytics Collaboration (IFSAC), estimated the proportion of SE foodborne illnesses attributable to shell eggs by using a mathematical “exposure” model that incorporated data from foodborne disease outbreak investigations and from a case-control study of sporadic (non-outbreak) illnesses. This model was used to estimate the proportion of foodborne and total SE illnesses attributable to shell eggs during 2007-2009.
To estimate source attribution for more recent years, the model needs to be updated with more recent data.
All 10 FoodNet sites are transmitting exposure information to CDC. Information about the exposures of 979 people with domestically-acquired, sporadic SE illness in 2013 and 2014 has been mapped to exposures included in the attribution model and has been evaluated for quality. Information on an additional 373 SE sporadic illnesses collected as of June 2015 is being reviewed and will be added to future analyses. A project proposal of the Interagency Food Safety Analytics Collaboration (IFSAC) includes work to explore how to use both the new exposure information and whole genome sequence data (collected through FDA Genome Trakr network) in the model. The IFSAC Steering Committee approved the project plan in September 2015
CDC is working with FDA to obtain data suitable for a “food product” model used in other countries to link contamination rates in foods to illness incidence.
In January 2015, the FDA CDC workgroup met in Washington DC to review data that FDA collected during the FY 2013 and FY 2014 inspection assignments and to discuss strategies to enhance data collection. The focus of the discussion was 1) data FDA might collect on SE contamination of shell eggs by doing a survey that includes microbiologic testing of shell eggs, 2) data FDA might collect during egg farm inspections in FY 2016 that could be used in attribution analyses, and 3) determining approaches to analyze whole genome sequence data from SE isolates obtained from contaminated food products and ill persons and using this information to identify genomic profiles to determine the likely sources of SE isolates obtained from ill people. Based on these discussions, the IFSAC project plan approved in September 2015 includes analysis of whole genome sequence data.
CDC reported that the illness rate during the 12-month period ending June 30, 2015 was 2.9 illnesses per 100,000. This is a decrease from the 2010 rate (3.5 cases per 100,000) but is higher than the 2007-2009 baseline rate of 2.6 cases per 100,000 population.
Next Steps:
- Continue inspections of small and large egg producers.
- FDA and CDC will continue to evaluate whether representative data can be obtained securely from egg-producing farms to use in the “food product” model.
- The FDA CDC workgroup will plan to schedule a meeting to occur no later than January 2016 to revisit and discuss sampling strategies for data collection, to assure progress on data sharing, and to identify and remove any obstacles to achieving goals.
- CDC plans to update the current SE exposure model with new data as it becomes available.
Next Steps
No Data Available
Contributing Programs & Other Factors
FDA programs
Foods Program
The mission of the Foods Program is to protect and promote the health of humans and animals by ensuring the safety of the American food supply, animal feed and cosmetics, as well as the safety and effectiveness of animal drugs and devices. Outbreaks of foodborne illness and contamination events have a substantial impact on public health – an estimated 48 million foodborne illnesses occur every year resulting in an estimated 128,000 hospitalizations and 3,000 deaths.
Congress recognized the unique challenges faced by FDA in the area of food safety in the 21st century, and gave the Agency a modern legislative mandate to meet these challenges by enacting the FDA Food Safety Modernization Act of 2011 (FSMA). FSMA directs FDA to build a food safety system based on the public health principle of comprehensive prevention, an enhanced focus on risk‐based resource allocation, and partnership across the public and private sectors to minimize hazards from farm to table.
The Foods Program focuses on securing high rates of compliance with science-based food safety and labeling standards by implementing integrated, prevention-oriented, and risk-based programs to protect the safety and security of foods and cosmetics and to ensure that food labels contain useful and reliable information.
FDA Headquarters and Program Support
FDA Headquarters (HQ) provides Agency-wide program direction and administrative services to ensure that FDA's consumer and patient safety programs are effectively and efficiently managed. Below are the seven primary HQ components responsible for providing Agency-level oversight and advice to FDA leadership and programs: Office of the Commissioner, Office of Chief Counsel, Office of the Chief Scientist, Office of Operations, Office of Foods and Veterinary Medicine, Office of Medical Products and Tobacco, and Office of Global Regulatory Operations and Policy.
CDC programs
Emerging and Zoonotic Infectious Diseases
The Emerging and Zoonotic Infectious Diseases program aims to prevent disease, disability, and death caused by a wide range of infectious diseases. The program focuses on diseases that have been around for many years, emerging diseases (those that are new or just recently identified), and zoonotic diseases (those spread from animals to people). The program’s work is guided in part by a holistic "One Health" strategy, which recognizes the vital interconnectedness of microbes and the environment.
To carry out this mission, the program uses many different tactics: providing leadership in public health, conducting exemplary science, strengthening preparedness efforts, establishing public health policy, sharing vital health information with the public, and building partnerships.
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Strategic Goals
Strategic Goal:
Advance the Health, Safety, and Well-Being of the American People
Statement:
Advance the Health, Safety, and Well-Being of the American People
Strategic Objectives
Statement:
Promote the safety, well-being, resilience and healthy development of children and youth
Description:
HHS partners with service providers to sustain an essential safety net of services that protect children and youth, promote their emotional health and resilience in the face of adversity, and ensure their healthy development from birth through the transition to adulthood. HHS also works to achieve this objective by identifying and implementing evidence-based interventions; promoting greater coordination across programs; and strengthening the human services workforce.
Statement:
Promote economic and social well-being for individuals, families and communities
Description:
HHS agencies work together and collaborate across Federal departments to maximize the potential benefits of various programs, services, and policies designed to improve the well-being of individuals, families, and communities. Many HHS agencies fund essential human services to those who are least able to help themselves, often through the Department’s state, local, and tribal partners.
Statement:
Improve the accessibility and quality of supportive services for people with disabilities and older adults
Description:
HHS programs and initiatives have special significance for older adults and people of all ages who have disabilities. Older adults and individuals with disabilities may need services and supports to assist them in performing routine activities of daily living such as eating and dressing. Improving access to, and the quality of, supports and services for older adults and people with disabilities is an HHS policy priority and is seen throughout HHS programs.
Statement:
Description:
HHS works to promote prevention and wellness across its programs and agencies. As the Nation's principal prevention agency, CDC has primary responsibility for addressing chronic diseases through population and community health activities; working to support State, local, and tribal public health agencies; promoting health through education; and conducting outreach to vulnerable populations. Over the next several years, HHS's focus will be on creating environments that promote healthy behaviors to address the chronic diseases and health conditions that result in the most deaths, disability, and costs.
Statement:
Reduce the occurrence of infectious diseases
Description:
Addressing infectious diseases - including vaccine-preventable diseases, foodborne illnesses, HIV/AIDS and associated sexually transmitted infections, hepatitis, tuberculosis, health care-associated infections, novel influenza viruses, and infections transmitted by animals and insects - is an HHS priority. HHS is working with its governmental and nongovernmental partners to strengthen basic and applied research, surveillance, diagnosis, and treatment efforts to reduce the burden of infectious diseases in the U.S. and throughout the world.
Statement:
Protect Americans’ health and safety during emergencies, and foster resilience to withstand and respond to emergencies
Description:
Over the past decade, our Nation has renewed its efforts to address large-scale incidents that have threatened human health, such as natural disasters, disease outbreaks, and terrorism. Working with its Federal, State, local, tribal, and international partners, HHS continues to support capacity-building efforts and strengthened linkages between government, nongovernmental organizations, and the private sector. HHS is now guided by the first National Health Security Strategy, a comprehensive framework for how the entire Nation must work together to protect people's health in the case of an emergency.
Agency Priority Goals
Statement:
To reduce the national rate of healthcare-associated infections (HAIs) by September 30, 2015 by demonstrating a 10% reduction in national hospital-acquired catheter-associated urinary tract infections (CAUTI) from the current SIR of 1.03 to a target SIR of 0.92.
Description:
At any given time, about one in every 25 hospitalized patients has a healthcare-associated infection while over 1 million HAIs occur across the U.S. healthcare system every year. These infections can lead to significant morbidity and mortality, with tens of thousands of lives lost each year.
Of these hospital-acquired events, catheter-associated urinary tract infections (CAUTI) are among the most common. Research has shown that a significant portion of these infections can be prevented, avoiding patient morbidity and mortality from this HAI while reducing costs accrued to the healthcare system.
The HAI Agency Priority Goal is to reduce the national rate of HAI by demonstrating significant, quantitative and measurable reductions in hospital-acquired CAUTI. As such; the FY2014-15 HAI Agency Priority Goal (APG) is to reduce the national CAUTI standardized infection ratio by 10% by September 2015 over the current 2012 baseline of 1.03. Of note, this SIR baseline was changed from 1.02 to 1.03 in this goal. This reflects the fact that the CDC released preliminary final numbers for 2012 in September 2013, the time at which this goal was written. However, hospitals still had through the end of the year to report final data to NHSN. Accounting for the last three months of data submitted by some hospitals caused a slight adjustment in the final (and thus baseline) 2012 SIR from 1.02 to 1.03. We make this adjustment in the HAI.APG to reflect the finalized SIR and to maintain consistency with other HAI reports moving forward.
As we carry this portion of the goal from the FY2011-13 goal, a concerted effort between the Centers for Medicare and Medicaid Services (CMS), Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), and Office of the Assistant Secretary of Health (OASH) will continue to be a crucial to meeting goal targets. The main US Department of Health and Human Services (HHS) operating divisions that constitute this workgroup will focus on applying their HAI programmatic efforts in a way that aligns strategy and metrics, provides consistent messaging to its audience, uses data to target those facilities in most need of improvement, and creates synergy to achieve CAUTI reduction outcomes.
We will continue to use combined HHS programmatic levers to contribute to the achievement of CAUTI targets. These initiatives include:
- Quality Improvement Organization (QIOs) Program
- Hospital Inpatient Quality Reporting (HIQR) Program
- Disseminating Data for Action using the National Healthcare Safety Network (NHSN)
- State HAI programs
- Partnership for Patients (PfP)
- Comprehensive Unit-based Safety Program (CUSP) for CAUTI Ongoing coordination through HAI strategic planning, HAI Regional and National Meetings
- Regular review and updates to the National Action Plan to prevent HAIs: "Roadmap to Elimination."
Attention to several factors are necessary to assess progress toward goals in this new period. As in the previous HAI goal and consistent with a measurement strategy used by a majority of hospitals that participate in national HAI reporting initiatives, this goal will use the standardized infection ratio (SIR) as the measure, NHSN, the CDC-run infection surveillance system as the primary data source and report data points on a biannual basis. A six month lag in data will remain in order to ensure the most complete and accurate data being reported out and minimize statistically insignificant variations in the data.
Lessons learned from the previous goal allow us to predict potential changes in the CAUTI SIR trend in the months following January 2015 now that CMS' Hospital Inpatient Quality Reporting (HIQR) program requires participating hospitals to report CAUTI in non-intensive care units to receive their full annual payment update. The influx of new CAUTI reporters in the middle of the previous 2011-13 HAI.APG was identified as one but not the sole, etiology behind an increase in the CAUTI SIR over the life of this goal. The differences in CAUTI SIRs in ICU and non-ICU settings along with the influx of new reporters among non-ICU locations in 2015 may impact this goal. The degree to which this could again be a factor again is unknown especially since through programmatic outreach, many hospitals already report non-ICU CAUTI data to NHSN voluntarily.
We also anticipate application of the new CAUTI definition, which went into effect January 1, 2015, to the APG data we will report in subsequent quarters. Because our baseline CAUTI SIR was calculated using the old CAUTI definition, a strategy to ensure continuity and validity of new SIR data across this goal has been established. The CDC will construct a new SIR by applying the new CAUTI definition to our current baseline SIR and data points proceeding January 1, 2015. In other words, we will translate SIR data including our baseline data prior to January 1st to SIR data that is reflective of the changes in the CAUTI definition. We will also be able to illustrate the CAUTI SIR baseline and trending data by applying the new vs the old definition in order to demonstrate the degree of difference or lack thereof resulting from this definitional change. CDC has changed the CAUTI definition in response to input from stakeholders and scientific data.The HAI Workgroup will present full details on the definition change in relation to this goal and our targeted CAUTI SIR reductions to HHS leadership in November of 2015.
Lastly, analysis of the CAUTI data continues to reveal marked difference in reductions between intensive care and non-intensive care units. Intensive care units have significantly higher SIRs, higher number of catheter-days, and show less reductions in these indicators of progress than in the non ICU setting. The difference in CAUTI reductions between ICUs and non-ICU settings have been highlighted in analysis of both NHSN and CUSP for CAUTI data. Given the fact that sicker patients are admitted in ICUs, retaining a urinary catheter for longer may be a rooted in practice necessity or provider belief that it is a necessity and so concentrating on behavioral and systems process change may need to be further emphasized as we work in this setting to reduce CAUTI. The 10% goal for CAUTI reduction in this APG effort represents a composite goal that reflects greater reductions in non-ICU settings and lesser reductions in ICUs. Improvements in CAUTI however, have been demonstrated in large scale improvement programs when actively engaged in embedding evidence-based infection control protocol and a culture of safety unit and facility-wide. It’s also important to note that preliminary projections through the first three quarters of 2015 continue to show a fall in the CAUTI SIR and an on-track trajectory for achieving the CAUTI goal target.
Statement:
By September 30, 2015, improve the quality of early childhood programs for low-income children through implementation of the Quality Rating and Improvement Systems in the Child Care and Development Fund, and through implementation of the Classroom Assessment Scoring System in Head Start.
Description:
This Priority Goal calls for actions in FY 2014 and FY 2015 to improve the quality of early childhood education programs for low-income children. For the ACF Child Care program, the goal is to increase the number of states with Quality Rating and Improvement Systems (QRIS) that meet the seven high quality benchmarks for child care and other early childhood programs, developed by HHS. QRIS is a mechanism by which to improve the quality of child care available in communities and increase parents’ knowledge and understanding of the child care options available to them. In order for a QRIS to be considered as meeting high-quality benchmarks, it must 1) be statewide; 2) be eligible to child care centers and family child care homes; 3) include quality improvement indicators that cover learning environments and curriculum, teacher/practitioner standards, and family partnerships and strengthening; 4) use training or on-site consultation to help child care programs attain or maintain quality improvement standards beyond licensing; 5) offer financial incentives for maintaining or increasing quality to child care centers and family child care homes; 6) include quality assessments of child care centers and family child care homes; and 7) use symbols or simple icons that indicate levels of quality as part of resource and referral/consumer education services to parents seeking child care. For FY 2011, a baseline of 17 states had implemented a QRIS that met all outlined high quality benchmarks. The baseline was calculated using FY 2012-2013 State Plans that were submitted in September 2011. In FY 2014, 29 states had a QRIS that met high quality benchmarks, meeting the previously established target. States expanded from pilot programs to statewide-systems and increased availability to quality information, leading them to meet more components of the QRIS measure. States were also supported by targeted technical assistance through state specific benchmarks and goals. The FY 2014 results show that states continue to make progress toward implementing QRIS that meet high-quality benchmarks, and the ACF Office of Child Care (OCC) has established a target of 32 states for FY 2015.
Currently, many states meet some, but not all seven, of the outlined benchmarks. States are making significant progress toward implementing a comprehensive QRIS that meets all outlined quality benchmarks; however, their progress is masked by the single figure reported. To provide a more complete picture of QRIS implementation and improvements across the country, OCC is closely tracking the progress of states that may not meet all quality benchmarks, but that have demonstrated improvements by increasing the number of benchmarks reached. For example, as of FY 2014, at least six states have incorporated six quality benchmarks and at least six states have incorporated five quality benchmarks. Between FY 2011 and FY 2014, 27 states and territories have made progress on at least one of the components of the measure. In addition, targeted technical assistance provided by the new National Center on Early Childhood Quality Assurance, as well as other technical assistance partners funded by ACF, will continue to help states work toward their goal of improving their QRIS.
Also as part of this Priority Goal, the ACF Office of Head Start (OHS) is striving to increase the percentage of Head Start children in high quality classrooms. Progress is measured by reducing the proportion of Head Start grantees scoring in the low range in any domain of the Classroom Assessment Scoring System (CLASS: Pre-K). This research-based tool measures teacher-child interaction on a seven-point scale in three broad domains: Emotional Support, Classroom Organization, and Instructional Support. OHS successfully began data collection using random samples for the CLASS: Pre-K in the first quarter of FY 2012. Analysis of the full data set of CLASS scores for the cohort of 388 Head Start grantees that received on-site monitoring in the 2011-2012 Head Start “school year” occurred in October of 2012, and OHS established a baseline of 25 percent scoring in the low range.
An analysis of CLASS scores for the most recent cohort of 404 Head Start grantees that received on-site monitoring in the 2013-2014 Head Start “school year” (FY 2014 actual result) indicates that 23 percent of grantees scored in the low range, thus meeting the target of 27 percent. All grantees scoring in the low range (below 2.5) in FY 2014 did so for the Instructional Support domain. (Nationwide for the CLASS: Pre-K tool, scores are typically higher in the domains of Emotional Support and Classroom Organization than in the domain of Instructional Support.)
The FY 2014 result is a signicant improvement relative to the previous FY 2013 result, when the number of grantees scoring below a 2.5 was 31 percent. In response to the data from the FY 2013 CLASS reviews, OHS developed a system to provide more intentional targeted assistance to those grantees that score in the low range on CLASS. OHS is continuing to flag grantees that score in the low range, conduct more analyses on the specific dimension level, which are specific elements or skill areas within each of the three domains, and providing periodic reports to its Regional Offices so they can direct their TTA to specific grantees. For example, concept development, quality of feedback, and language modeling are the three dimensions within the domain of Instructional Support. Providing TTA at the more specific dimension-level supports grantees to focus in on the skills that need improvement.
There are some challenges to making progress in these areas. In the past two decades, a growing body of evidence has established the importance of quality child care in promoting healthy child development and school readiness and success for children. However, systemic changes take time to implement, and states are at different starting points. In the FY 2016 Budget request to Congress, the President continued to build a continuum of high-quality early childhood programs, including proposing an historic investment of $82 billion over 10 years to increase the availability of high-quality child care for children under four years old. On November 19, 2014, the President signed into the law the first statutory reauthorization of the Child Care and Development Block Grant (CCDBG) program since 1996, which aims to move children receiving subsidies into high-quality child care settings. Among a comprehensive array of reforms, the new statute includes an increased focus on improving the quality of child care through systemic quality investments, which will help move states toward meeting this priority performance goal. In addition, the statute includes provisions requiring states to evaluate the measurable outcomes of their quality improvement activities. OCC is gathering information about QRIS implementation through the CCDBG Plan and the annual quality performance report, as well as providing states with targeted technical assistance through state specific technical assistance plans and goals. ACF recently announced the Early Childhood Training and Technical Assistance System, which transforms the current TA system for child care, T/TA for Head Start, and related programs into a coordinated system that will provide training, resources and materials to multiple stakeholder groups at regional, state and local levels to support school readiness. The new National Center on Early Childhood Quality Assurance will help OCC continue to support the infrastructure of an early childhood education quality improvement framework, including QRIS.
Additionally, with respect to Head Start, there are 50,000 Head Start and Early Head Start classrooms across the country in diverse settings ranging from New York City to the bottom of the Grand Canyon. Changing teacher behavior and practices at the ground level to improve the quality of the classroom is a formidable challenge, particularly in highly rural areas, American Indian and Alaska Native programs, and Migrant and Seasonal Head Start programs where finding qualified staff can be difficult due to more limited access to higher education. OHS is using multiple approaches to address this challenge, including policy levers, training and technical assistance, and professional development efforts.
Statement:
By December 31, 2015, reduce the annual adult combustible tobacco consumption in the United States from 1,342 cigarette equivalents per capita to 1,174 cigarette equivalents per capita, which will represent an approximate 12% decrease from the 2012 baseline.
Description:
Smoking and second hand smoke is the leading preventable cause of death in the United States, killing more than an estimated 480,000 people in the U.S. each year. For every smoker who dies from a smoking-attributable disease, another 30 live with a serious smoking-related disease. Smoking costs the U.S. more than $300 billion a year, including nearly $170 billion in direct medical costs, and more than $156 billion in lost productivity. An estimated 58 million nonsmoking Americans are exposed to secondhand smoke, which causes more than 41,000 deaths in non-smoking adults each year . While smoking among U.S. adults is down significantly from a decade ago, the decline in adult smoking rates has slowed, concurrent with reductions in state investments in tobacco control program. Fortunately, people who stop smoking greatly reduce their risk for disease and premature death. Smoking cessation lowers the risk for lung and other types of cancer; it reduces the risk for coronary heart disease, stroke, and peripheral vascular disease. .
In 2010, HHS issued Ending the Epidemic – A Tobacco Control Strategic Action Plan, outlining a set of comprehensive actions framed around four key Healthy People 2020 tobacco control objectives:
1) reduce tobacco use
2) reduce the initiation of tobacco use
3) increase successful cessation attempts by smokers
4) reduce the proportion of nonsmokers exposed to secondhand smoke.
The National Prevention Strategy, released in 2011, includes tobacco control as one of seven priorities across the U.S. Government.
In 2012, cigarette and smokeless tobacco companies spent more than $9.6 billion, more than $1 million per hour that year, on advertising and promotional expenses in the United States to attract new users, retain current users, increase consumption, and generate favorable attitudes toward smoking. There is also a growing concern regarding new tobacco products that are being marketed to smokers as alternatives for use in smoke-free environments. Dual use of cigarettes and other tobacco products can maintain tobacco addiction and use among smokers who might otherwise quit. The marketing of purported reduced-risk products may increase overall tobacco use. Consumer mistaken perceptions of the “safety” of these products may pose a continuing obstacle for tobacco control.
States continue to reduce funding for comprehensive tobacco control. Research has shown that progress to prevent initiation and promote cessation in comprehensive programs is reversed when funding is no longer sustained.
HHS engages with multiple stakeholders in implementing tobacco control activities, which include: Congress, the public, minority communities, groups affected by tobacco-related health disparities, state and local tobacco control officials, tobacco control and public health non-governmental organizations, the scientific & research community, and businesses.
The U.S. Congress has provided direction and support for tobacco control activities in the following legislative actions:
• The Patient Protection and Affordable Care Act
• The American Recovery and Reinvestment Act (ARRA)
• The Family Smoking Prevention and Tobacco Control Act (FSPTCA)
• The Children’s Health Insurance Program Reauthorization Act (CHIPRA)
HHS oversees tobacco control and prevention committees covered by the Federal Advisory Committee Act. All meetings of these committees are open to the public and offer opportunities for stakeholder feedback.
Statement:
By December 31, 2015, decrease the rate of Salmonella Enteritidis illness in the population from 2.6 cases per 100,000 (2007-2009 baseline) to 1.9 cases per 100,000.
Description:
Salmonella is the leading known cause of bacterial foodborne illness and death in the United States. Each year in the United States, Salmonella causes an estimated 1.2 million illnesses, including fever and diarrhea, and between 400 and 500 deaths. Salmonella serotype Enteritidis (SE), a subtype of Salmonella, is now the most common type of Salmonella in the United States and accounts for approximately 20% of all Salmonella cases in humans. The most significant sources of foodborne SE infections are shell eggs (FDA-regulated) and broiler chickens (USDA-regulated). Therefore, reducing SE illness from shell eggs is the most appropriate FDA strategy for reducing illness from SE. Preventing Salmonella infections depends on actions taken by regulatory agencies, the food industry and consumers to reduce contamination of food, as well as actions taken for detecting and responding to outbreaks. As part of the shared vision to reduce foodborne illness, HHS's Food and Drug Administration (FDA) has developed a Priority Goal to reduce Salmonella contamination in shell eggs, and the Centers for Disease Control and Prevention (CDC) is working with FDA to gather more data to better estimate sources of illness. Additionally, USDA, FDA and CDC are involved in many interagency efforts, including the Interagency Food Safety Analytics Collaboration (IFSAC). This interagency collaboration is working to improve methods used to estimate the proportion of foodborne illnesses associated with specific sources.
Strategic Objectives
Strategic Objective:
Statement:
Reduce the occurrence of infectious diseases
Description:
Addressing infectious diseases - including vaccine-preventable diseases, foodborne illnesses, HIV/AIDS and associated sexually transmitted infections, hepatitis, tuberculosis, health care-associated infections, novel influenza viruses, and infections transmitted by animals and insects - is an HHS priority. HHS is working with its governmental and nongovernmental partners to strengthen basic and applied research, surveillance, diagnosis, and treatment efforts to reduce the burden of infectious diseases in the U.S. and throughout the world.
Agency Priority Goals
Statement: To reduce the national rate of healthcare-associated infections (HAIs) by September 30, 2015 by demonstrating a 10% reduction in national hospital-acquired catheter-associated urinary tract infections (CAUTI) from the current SIR of 1.03 to a target SIR of 0.92.
Description: At any given time, about one in every 25 hospitalized patients has a healthcare-associated infection while over 1 million HAIs occur across the U.S. healthcare system every year. These infections can lead to significant morbidity and mortality, with tens of thousands of lives lost each year. Of these hospital-acquired events, catheter-associated urinary tract infections (CAUTI) are among the most common. Research has shown that a significant portion of these infections can be prevented, avoiding patient morbidity and mortality from this HAI while reducing costs accrued to the healthcare system. The HAI Agency Priority Goal is to reduce the national rate of HAI by demonstrating significant, quantitative and measurable reductions in hospital-acquired CAUTI. As such; the FY2014-15 HAI Agency Priority Goal (APG) is to reduce the national CAUTI standardized infection ratio by 10% by September 2015 over the current 2012 baseline of 1.03. Of note, this SIR baseline was changed from 1.02 to 1.03 in this goal. This reflects the fact that the CDC released preliminary final numbers for 2012 in September 2013, the time at which this goal was written. However, hospitals still had through the end of the year to report final data to NHSN. Accounting for the last three months of data submitted by some hospitals caused a slight adjustment in the final (and thus baseline) 2012 SIR from 1.02 to 1.03. We make this adjustment in the HAI.APG to reflect the finalized SIR and to maintain consistency with other HAI reports moving forward. As we carry this portion of the goal from the FY2011-13 goal, a concerted effort between the Centers for Medicare and Medicaid Services (CMS), Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), and Office of the Assistant Secretary of Health (OASH) will continue to be a crucial to meeting goal targets. The main US Department of Health and Human Services (HHS) operating divisions that constitute this workgroup will focus on applying their HAI programmatic efforts in a way that aligns strategy and metrics, provides consistent messaging to its audience, uses data to target those facilities in most need of improvement, and creates synergy to achieve CAUTI reduction outcomes. We will continue to use combined HHS programmatic levers to contribute to the achievement of CAUTI targets. These initiatives include: Attention to several factors are necessary to assess progress toward goals in this new period. As in the previous HAI goal and consistent with a measurement strategy used by a majority of hospitals that participate in national HAI reporting initiatives, this goal will use the standardized infection ratio (SIR) as the measure, NHSN, the CDC-run infection surveillance system as the primary data source and report data points on a biannual basis. A six month lag in data will remain in order to ensure the most complete and accurate data being reported out and minimize statistically insignificant variations in the data. Lessons learned from the previous goal allow us to predict potential changes in the CAUTI SIR trend in the months following January 2015 now that CMS' Hospital Inpatient Quality Reporting (HIQR) program requires participating hospitals to report CAUTI in non-intensive care units to receive their full annual payment update. The influx of new CAUTI reporters in the middle of the previous 2011-13 HAI.APG was identified as one but not the sole, etiology behind an increase in the CAUTI SIR over the life of this goal. The differences in CAUTI SIRs in ICU and non-ICU settings along with the influx of new reporters among non-ICU locations in 2015 may impact this goal. The degree to which this could again be a factor again is unknown especially since through programmatic outreach, many hospitals already report non-ICU CAUTI data to NHSN voluntarily. We also anticipate application of the new CAUTI definition, which went into effect January 1, 2015, to the APG data we will report in subsequent quarters. Because our baseline CAUTI SIR was calculated using the old CAUTI definition, a strategy to ensure continuity and validity of new SIR data across this goal has been established. The CDC will construct a new SIR by applying the new CAUTI definition to our current baseline SIR and data points proceeding January 1, 2015. In other words, we will translate SIR data including our baseline data prior to January 1st to SIR data that is reflective of the changes in the CAUTI definition. We will also be able to illustrate the CAUTI SIR baseline and trending data by applying the new vs the old definition in order to demonstrate the degree of difference or lack thereof resulting from this definitional change. CDC has changed the CAUTI definition in response to input from stakeholders and scientific data.The HAI Workgroup will present full details on the definition change in relation to this goal and our targeted CAUTI SIR reductions to HHS leadership in November of 2015. Lastly, analysis of the CAUTI data continues to reveal marked difference in reductions between intensive care and non-intensive care units. Intensive care units have significantly higher SIRs, higher number of catheter-days, and show less reductions in these indicators of progress than in the non ICU setting. The difference in CAUTI reductions between ICUs and non-ICU settings have been highlighted in analysis of both NHSN and CUSP for CAUTI data. Given the fact that sicker patients are admitted in ICUs, retaining a urinary catheter for longer may be a rooted in practice necessity or provider belief that it is a necessity and so concentrating on behavioral and systems process change may need to be further emphasized as we work in this setting to reduce CAUTI. The 10% goal for CAUTI reduction in this APG effort represents a composite goal that reflects greater reductions in non-ICU settings and lesser reductions in ICUs. Improvements in CAUTI however, have been demonstrated in large scale improvement programs when actively engaged in embedding evidence-based infection control protocol and a culture of safety unit and facility-wide. It’s also important to note that preliminary projections through the first three quarters of 2015 continue to show a fall in the CAUTI SIR and an on-track trajectory for achieving the CAUTI goal target.
Statement: By December 31, 2015, decrease the rate of Salmonella Enteritidis illness in the population from 2.6 cases per 100,000 (2007-2009 baseline) to 1.9 cases per 100,000.
Description: Salmonella is the leading known cause of bacterial foodborne illness and death in the United States. Each year in the United States, Salmonella causes an estimated 1.2 million illnesses, including fever and diarrhea, and between 400 and 500 deaths. Salmonella serotype Enteritidis (SE), a subtype of Salmonella, is now the most common type of Salmonella in the United States and accounts for approximately 20% of all Salmonella cases in humans. The most significant sources of foodborne SE infections are shell eggs (FDA-regulated) and broiler chickens (USDA-regulated). Therefore, reducing SE illness from shell eggs is the most appropriate FDA strategy for reducing illness from SE. Preventing Salmonella infections depends on actions taken by regulatory agencies, the food industry and consumers to reduce contamination of food, as well as actions taken for detecting and responding to outbreaks. As part of the shared vision to reduce foodborne illness, HHS's Food and Drug Administration (FDA) has developed a Priority Goal to reduce Salmonella contamination in shell eggs, and the Centers for Disease Control and Prevention (CDC) is working with FDA to gather more data to better estimate sources of illness. Additionally, USDA, FDA and CDC are involved in many interagency efforts, including the Interagency Food Safety Analytics Collaboration (IFSAC). This interagency collaboration is working to improve methods used to estimate the proportion of foodborne illnesses associated with specific sources.
