ck17-1701 attachment 1 - activities.pdf

FOA# CK17-1701

PPHF 2017: Epidemiology and Laboratory Capacity (ELC/EIP) –

Emerging Infections Programs – Primary

Financed in Part by 2017 Prevention and Public Health Funds

ATTACHMENT 1 – EIP ACTIVITY DESCRIPTIONS

Table of Contents:

Page Section Title

2 A General EIP Function and Structure

6 B Active Bacterial Core Surveillance (ABCs)

15 C Foodborne Disease Active Surveillance Network (FoodNet)

23 D Influenza

31 E Healthcare-Associated Infections and Antimicrobial Resistance

43 F Human Papillomavirus (HPV-IMPACT)

48 G Lyme and Other Vectorborne Diseases (TickNET)

50 H Rotavirus

52 I Prion Disease

57 J Arbovirus

60 K Congenital Cytomegalovirus

ATTACHMENT 1, SECTION A

General EIP Function and Structure

Background

EIPs are population-based centers of excellence established through a network of state health departments collaborating with academic institutions; local health departments; public health and clinical laboratories; infection control professionals; and healthcare providers. The state health departments, collaborating institutions/organizations, and CDC together make up the EIP network.

EIPs assist in local, state, and national efforts to prevent, control, and monitor the public health impact of infectious diseases. Activities of the EIPs fall into the following general categories: (1) active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) flexible response to public health emergencies and newly emerging issues.

EIP sites must establish and maintain general, crosscutting functions and structures in order to successfully conduct the programmatic surveillance and research activities. These are outlined in detail in Strategies and Activities section, below. This general function and structure includes particularly, scientific, programmatic, and business/administrative oversight and support.

Using the metaphor of a tree with roots, trunk, and branches, (see main FOA Background section and recent Emerging Infectious Diseases article at http://wwwnc.cdc.gov/eid/article/21/9/15-0619 , the trunk is the capacity and functionality needed to sustain the network and ensure it can adapt (the General EIP

Function and Structure activity described in this Appendix), while the branches are disease area-specific activities (described in Appendices II-XI).

Purpose

The purpose of this general EIP function and structure activity is to support EIP sites to establish and maintain key crosscutting scientific, programmatic, and business/administrative capacity. This is intended to include staff, activities, and related costs that are essential to assuring general EIP infrastructure that are not supported by the applicant’s Indirect Cost Rate Agreement and that are better allocated to General EIP Function & Structure than allocated across one or multiple programmatic activities.

Note to current EIP grantees under expiring FOA CK12-1201 (applicants that are not current EIP grantees - should disregard this paragraph):

Current EIP grantees under expiring FOA CK12-1201 also receive a portion of their general capacity support via the Affordable Care Act/Prevention and Public Health Fund (PPHF)-specific EIP cooperative agreement FOA CK12-1209. Current EIP grantees can expect to have that PPHF support continue via FOA CK12-1209 at current levels until that cooperative agreement expires on September

29, 2017. On September 30, 2017, all costs/activities funded via CK12-1209 will be transitioned to and supported under this new FOA CK17-xxxx beginning with the 2nd budget period of this FOA (that begins January 1, 2018). Therefore, current EIP grantees should include in their budget for this General

EIP Function and Structure activity of FOA CK17-xxxx, continuation of CK12-1209 costs/activities only for September 30, 2017 – December 31, 2017.

http://wwwnc.cdc.gov/eid/article/21/9/15-0619

Outcomes

Robust EIP infrastructure and crosscutting activities that will ensure a highly functional platform/foundation for conducting EIP programmatic activities and achieving the public health outcomes for EIP.

Strategies and Activities

1. Scientific, Programmatic, and Business/Administrative Oversight and Coordination. Ensure effective scientific, programmatic, and business/administrative leadership, management, coordination, execution, and continuity of EIP activities overall. Organize staffing and related support structure to effectively manage crosscutting functions and to adequately support grantee’s portfolio of programmatic activities. This includes scientific and programmatic coordination and management of crosscutting fields such as culture-independent diagnostic testing (CIDT), and advanced molecular detection (AMD), and information technology (IT).

2. Populations/Catchment Areas. EIP programmatic activities are conducted in defined populations

(as appropriate) that may include an entire state, a geographically defined area within a state, or a population defined by a healthcare delivery system. Assure populations for each EIP activity are appropriately determined and are of adequate/appropriate size and composition necessary for each activity. The population base may vary by activity and may change over time as needs evolve.

3. Flexibility and Efficiency. Organize resources in a manner that allows for flexibility to respond to new public health issues as they arise and for optimal efficiency across multiple projects conducted in one or more facilities within a site. As a manifestation of EIP capacity for flexible response, each EIP will be expected to participate in a workgroup convened on short notice to review newly emerging infectious disease issues. Should that group determine that EIPs could help guide the response to that issue in the short-term, each EIP is expected to contribute to rapid study design and initiate and complete the relevant study in a very short period of time (e.g., within one month of its proposal). In this proposal, describe how applicant will ensure (1) the surge capacity that would be used to participate in workgroups convened on short notice to review newly emerging infectious disease issues and (2) the surge capacity that would be used, if the workgroup determines that EIPs could help guide the response to that issue in the short-term, to contribute to rapid study design and initiate and complete relevant studies in a timely manner.

4. Collaborations and Partnerships. Develop and operate the EIP site to function effectively as a member of the national network. Participate actively in EIP working groups to help establish network priorities, coordinate projects, monitor progress, and, when appropriate, ensure standardized implementation of activities across sites. Establish and maintain working relationships with local partners, including but not limited to, academic centers, health departments, infection control practitioners, hospitals, healthcare providers, public and private laboratories, research organizations, tribal organizations (if Native American/Alaskan Native populations are subject of any EIP activities), and other Federal and state government agencies.

5. Training. Incorporate training such as infectious disease fellowships for clinicians, laboratorians, and researchers, as well as other training opportunities for public health students and local public health professionals. Opportunities can include, but are not limited to, fellowships, educational conferences or seminars, thesis advising or mentoring, and work study or research assistant positions.

6. Data Management. Collect, manage, analyze, and interpret data from EIP projects; publish and disseminate important public health information resulting from EIP projects in collaboration with

CDC and other EIP sites as appropriate. Ensure and maintain ability and capacity to conduct medical record reviews, surveys, laboratory audits, and analysis of hospital admissions and discharge data. Work with CDC programs and the network to ensure quality assurance.

Work with CDC programs and the network to assure compliance with CDC’s Policy on Public

Health Research and Non-research Data Management and Access. The goal of the policy is to ensure public access to federally funded public health data. This specifically requires development of Data Management Plans (DMPs) for each EIP activity that includes collection of public health data. DMPs should be developed jointly by CDC and EIP grantees within the first

6 months after award and updated as appropriate throughout the life cycle of the data. DMPs should include:

o Descriptions of the data to be produced o How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights) o Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represents, and potential limitations for use o Plans for archival and long-term preservation of the data, or explanation of why long-term preservation and access cannot be provided.

7. Information Systems. Information systems and technology are critical to maintaining and improving the collection, quality, and management of data resulting from EIP activities.

Recognizing this, EIPs are adopting an EIP IT Strategy. The EIP IT Strategy focuses broadly on improving and modernizing information systems and adopting and taking advantage of electronic data exchange. As part of this cooperative agreement, grantees should ensure there are adequate resources dedicated to EIP IT projects and focused on implementing the EIP IT

Strategy. Grantees should also maintain appropriate attendance and involvement on EIP IT

Workgroup web meetings. EIP IT activities could, for one or more projects, work toward interoperability and integration among systems. This could include, for example, transitioning from standalone databases to the state integrated surveillance information systems, and enabling standalone databases to send and receive data from other databases or the integrated system.

Electronic data exchange, which includes electronic laboratory reporting (ELR), receiving data from an Immunization Information System (IIS), and electronic case reporting (eCR) from electronic health records, should be a priority. Grantees should make sure EIP projects use existing ELR and work with their state ELR program to prioritize new feeds. Systems used for some EIP projects should be enhanced to receive data from the state IIS. Also, grantees should participate in the national effort to define eCR, including planning for promising pilot projects with one or more partners.

8. Laboratory Specimens. As culture-independent diagnostic testing becomes more prevalent, work with CDC and other EIP network sites to develop and implement strategies to 1) sustain the availability of a certain number of clinical isolates and 2) provide for a bank of appropriate specimens for culture-independent testing. In general, provide specimens to CDC or other appropriate laboratories for evaluation when required by EIP protocols (e.g., for studies, evaluation of diagnostics, etc.).

9. Program Evaluation. Assure capacity for general EIP program evaluation and performance measurement. Metrics/measures of effectiveness for individual EIP activities may be developed in collaboration with CDC and/or independently. Some EIP activities have established performance metrics that must be used. Refer to specific guidance in each of the programmatic appendices.

10. Human Subjects. Ensure appropriate local review of EIP activities and provide local IRB status and/or determination of all research projects undertaken. For activities involving research on human subjects, each institution that participates in human subjects research is required to review each protocol annually and submit current copies of IRB approval letters in the annual non-competitive continuation applications and to PGO as determinations are made during the year.

For specific EIP studies that involve human subjects, obtain institutional review board approval prior to the commencement of study activities and assure subjects are recruited according to study protocols.

11. Office of Management and Budget Paperwork Reduction Act (OMB-PRA). Work with CDC scientists to obtain OMB-PRA approvals, as needed.

12. Dual Use Research of Concern (DURC). Comply with the responsibilities for the PI as described in the United States Government Policy for Institutional Oversight of Life Science

(DURC). See http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf).

http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf

ATTACHMENT 1 – SECTION B

Active Bacterial Core surveillance (ABCs)

Background

Active Bacterial Core surveillance (ABCs) was established through EIP in 1995 to assess the disease burden of invasive bacterial infections in the community that primarily manifest as bloodstream infections and meningitis. ABCs conducts active, laboratory, population-based surveillance for invasive group A Streptococcus (GAS), Haemophilus influenzae, Neisseria meningitidis, group B Streptococcus

(GBS) and Streptococcus pneumoniae. ABCs also serves as a platform to conduct special studies related to all these infections. Despite their importance, not all of the infections captured under ABCs are reportable to CDC. Even for those infections included in CDC’s National Notifiable Disease

Surveillance System (NNDSS), case counts may be underestimated because they rely on reporting by laboratories and clinicians whereas ABCs tries to actively identify 100% of the cases within the surveillance area. Additionally, epidemiologic data collected by health departments are often incomplete because of the resources required to collect them and the inflexibility of the system to capture variables of interest. Unlike NNDSS, ABCs also collects isolates that are serotyped and tested for antimicrobial susceptibility. These attributes allow ABCs to fulfill two critical objectives: 1) to determine the incidence and epidemiologic characteristics of important invasive diseases and 2) to determine molecular epidemiologic patterns and microbiologic characteristics of these invasive infections.

For routine surveillance, a case of invasive bacterial disease is defined as isolation of H. influenzae, N.

meningitidis, GAS, GBS, or S. pneumoniae from a normally sterile body site (e.g., blood, joint, pleural and cerebrospinal fluid) in a resident of the surveillance area. Additionally, cases include ill persons from whom GAS is isolated from a wound or other tissue in the presence of necrotizing fasciitis (NF) or streptococcal toxic shock syndrome (STSS). Maternal cases of GBS are also included if GBS has been isolated from the placenta or amniotic fluid in the setting of fetal death. As stated, the goal is to detect

100% of laboratory-confirmed cases by actively contacting all clinical laboratories that routinely process specimens from residents of the surveillance area. Audits are performed regularly to ensure that all cases are captured. U.S. census data are used to calculate disease incidence rates within the ABCs population.

Through medical record review for each case-patient, demographics, clinical course, outcome, infection type, underlying conditions and vaccination history are collected. An isolate from the first positive culture is collected for most cases. Molecular typing and antimicrobial susceptibility testing are performed on collected isolates either at CDC or other reference laboratories.

In addition to conducting surveillance and special studies for ABCs pathogens, a key feature of ABCs is its flexibility to respond to public health emergencies and conduct surveillance for other emerging threats. After the 2001 anthrax attack, the ABCs infrastructure was used to establish and test a more sensitive and timely system for identifying inhalation anthrax. After SARS was discovered in 2002, the

EIP infrastructure assisted with surveillance activities and the investigation of suspected cases. During the 2009 H1N1 influenza pandemic, early recognition of IPD among H1N1 patients increased emphasis on pneumococcal prevention strategies. Due to rising rates of infections, special surveillance and studies related to pertussis and legionellosis were added to ABCs in 2011.

The ABCs Steering Committee is responsible for helping determine the overall scientific direction of

ABCs. This includes reviewing priorities, supporting pathogen committees, reviewing protocols or proposals, monitoring the development and implementation of ABCs programs and projects and identifying and involving key stakeholders in ABCs programs. The Steering Committee includes representatives from CDC and each EIP grantee.

Other National Public Health Priorities and Strategies

Results from ABCs surveillance have been used in the development and pre-licensure evaluation of multiple vaccines. Post-licensure, ABCs data have been used to formulate national policy recommendations developed by the Advisory Committee on Immunization Practices (ACIP) and to determine the real-world impact of vaccines through vaccine effectiveness studies. ABCs has also had an impact on other prevention-related policies and practices, including guidelines for preventing perinatal GBS infections and preventing invasive GAS in household and healthcare settings. ABCs data have also been used to track antimicrobial resistance. ABCs data were used in CDC’s “Antibiotic

Resistance Threats in the United States, 2013” report and to inform the National Strategy for Combating

Antimicrobial Resistant Bacteria. ABCs data are also used to evaluate “Healthy People” goals for disease reduction.

Purpose

While disease rates have declined for many ABCs pathogens, they remain an important cause of severe bacterial infections. ABCs will implement active, laboratory, population-based surveillance and conduct special studies for invasive GAS, H. influenzae, N.meningitidis, GBS and S. pneumoniae in order to monitor their disease burden, track antimicrobial resistance and evaluate prevention strategies.

Enhanced pertussis and legionellosis surveillance and special studies will be done to better understand rising disease rates and evaluate prevention strategies to reverse these rising trends.

Outcomes

Provide new knowledge

Surveillance and special studies for ABCs pathogens are intended to enhance our understanding of the disease burden, risk factors, molecular epidemiology and antimicrobial resistance of these pathogens and to evaluate prevention measures. The knowledge will be used to inform policy and prioritize prevention programs at the national level. It is also likely to enhance prevention efforts at the site level.

Develop staff expertise

ABCs site personnel will develop expertise in the epidemiology of ABCs pathogens and in developing skills to conduct data abstractions, management and analysis. Formal and informal programs will be implemented to train new staff and to continuously educate existing staff since case ascertainment, data abstractions and data management methods are likely to change over the 5 year period.

Control outbreaks of infectious diseases

The ABCs infrastructure will assist health departments in their detection and control of outbreaks.

The data are often used to understand baseline rates and to help determine when situations require further investigation. Additionally, EIP/ABCs infrastructure has often been used to investigate outbreaks of non-ABCs pathogens, as described above.

Develop/modify guidelines

ABCs data will be used to develop and evaluate prevention guidelines. For instance, recommendations for routine use of pneumococcal conjugate vaccine in adults aged ≥65 years old will be under review in 2018 by ACIP. Data from ABCs surveillance and special studies will likely be used to inform any revisions made to those recommendations. There will also be opportunities to evaluate the effectiveness of serogroup B meningococcal (MenB) and pertussis vaccines.

Develop/modify intervention recommendations

ABCs will be used to evaluate B. pertussis post-exposure prophylaxis recommendations. ABCs will also be used to evaluate a Clinical Decision Support tool embedded into electronic medical records that incorporates CDC guidelines to prevent perinatal GBS disease.

Strategies and Activities

ABCs Core Activities: REQUIRED

1. Conduct active, laboratory, and population-based surveillance for invasive bacterial disease due to group A Streptococcus (GAS), group B Streptococcus (GBS), Haemophilus influenzae, Neisseria meningitidis, and Streptococcus pneumoniae. The goal of surveillance is to identify 100% of case-patients (i.e. not a sample) that reside in the surveillance catchment area. A case of invasive bacterial disease is defined as isolation of H. influenzae, N. meningitidis, GAS, GBS, or S.

pneumoniae from a normally sterile body site. Body sites include, but are not limited to, blood, cerebrospinal fluid, pleural fluid, peritoneal fluid, pericardial fluid, bone, joint fluid, muscle/fascia/tendon (group A Streptococcus only), lymph node, brain, heart, vascular tissue, liver, spleen, vitreous fluid, kidney, pancreas, and ovary. The definition also includes GAS isolated from a wound or other tissue in the presence of necrotizing fasciitis (NF) or streptococcal toxic shock syndrome (STSS). Maternal cases of GBS are also included if GBS has been isolated from the placenta or amniotic fluid in the setting of fetal death. Surveillance activities include:

a. Identify patients who meet the case definition by establishing contact with all laboratories that regularly process specimens from residents of the catchment area (the laboratories may be located within or outside the catchment area). Case identification may occur through multiple means, including electronic laboratory messaging, receiving electronic line lists, phone calls, or paper reports. Audits (at least annual) should be conducted to assure that

100% of cases are being captured. Audits should include review of the primary data source at every reporting site (e.g. computer-generated electronic printouts, log books, etc.). If data are being generated electronically, a review of data queries (i.e. what pathogens and sterile sites are being captured) should be done. In addition to the annual audit, every 2-3 years each site should perform an evaluation of their overall surveillance methodologies to ensure they are capturing all cases of invasive disease in catchment area residents for each pathogen under surveillance. This includes identifying laboratories located both within and outside the

ABCs catchment area that process specimens from residents of the catchment area as well as identifying facilities and/or state/local health departments that serve residents of the catchment area. Routine communication with each laboratory and facility/health department that contributes to ABCs cases is needed to ensure that ongoing surveillance is active- and population-based surveillance.

b. Complete standardized case report forms through review of medical records that includes information on demographics, clinical course, outcome, infection type, underlying conditions and vaccination history.

c. Collect of isolates for all pathogens under surveillance (GAS, GBS, H. influenzae, N.

meningitidis and S. pneumoniae) and ship to CDC labs on a monthly or bi-monthly basis.

d. Conduct periodic (every 1-2 years) laboratory surveys to assess use of culture independent diagnostics on sterile site specimens. If a decision is made by the ABCs Steering Committee to include such cases in the case definition for all or some of the ABCs pathogens, then sites will be required to perform surveillance activities for those cases.

2. On an annual basis, collect vital statistics records to enhance the quality of ABCs data. Submit the data to CDC between October and December of the following year (e.g. October 2017 for the 2016 surveillance year). The vital statistics collected or reviewed include:

a. Number of live births to surveillance area residents and within surveillance area counties, stratified by birthweight and gestational age.

b. Maternal and paternal race and ethnicity from birth certificates from case-patients <5 years of age for which race or ethnicity is missing from the medical record.

c. Review in-state death registries to determine outcomes for patients with unknown outcomes.

3. Geocode all ABCs cases to the census tract level as a means of capturing area-level socioeconomic factors, such as poverty, educational level, household crowding, and access to healthcare. CDC and site regulations will determine what data may be transmitted to CDC.

4. Provide timely responses to reports and requests for information to assist in preliminary & final analyses, reports, and data close-outs.

Other ABCs Core Activities: REQUIRED

1. Participate in ABCs Steering Committee (every 2 months), Surveillance Officer (monthly), and

Pathogen Committee conference calls (as needed).

2. Participate in annual ABCs Steering Committee and Surveillance Officer in-person meetings.

3. GBS-related activity: Collect additional infant and maternal information on early- and late-onset

GBS disease.

4. Pneumococcal-related activities:

a. Evaluate the effectiveness of the 13-valent pneumococcal conjugate vaccine for prevention of S. pneumoniae infections among adults using a case-control methodology. Collaborate with CDC to evaluate methods for case and control enrollment and enroll cases and controls, which could include collaboration with the Center for Medicare and Medicaid Services as well as geocoding of cases and controls.

b. Evaluate trends in hospitalizations for all cause and pneumococcal-specific community-acquired pneumonia using state-based hospital discharge data.

c. Perform surveillance for non-invasive pneumococcal pneumonia among adults by identifying cases with a positive urinary antigen test and clinically or radiographically-confirmed pneumonia within the designated surveillance area. Surveillance activities include collection of case report form data. To adjust for testing practices within hospitals and use of pneumococcal urine antigen tests by hospitals: 1) Use ICD-coded discharge data from hospitals that perform urine antigen testing to assess the frequency of such testing among patients hospitalized with pneumonia, and 2) Assess the proportion of pneumonia hospitalizations within the catchment area that are admitted to hospitals where non-invasive pneumococcal surveillance is being conducted.

d. Collect additional demographic, medical and vaccination history information on all invasive pneumococcal infections in children aged 3 months through 59 months with an isolate available for serotyping. This includes contacting parents to identify healthcare providers who provide immunizations to their children, contacting all identified providers to ascertain

PCV13 vaccination status, and review of state vaccine registries to obtain complete vaccine information for cases of invasive pneumococcal disease.

5. H. influenzae-related activity: Contact healthcare providers or state vaccine registries to obtain complete vaccine information for cases of Hib disease age <5 years to monitor impact of new vaccines.

6. N. meningitidis-related activity: Evaluate the effectiveness of the serogroup B meningococcal

(MenB) vaccines for prevention of serogroup B meningococcal disease among adolescents, likely in the form of a case control study. Collaborate with CDC to develop the protocol and methods for case and control enrollment.

7. Legionellosis surveillance: Perform at least annual audits of laboratories conducting Legionella testing within the ABCs legionellosis surveillance catchment area to ensure that all laboratory-confirmed cases of legionellosis are being identified by the state-based reporting systems.

8. Work to integrate ABCs data needs with sites’ changing landscape of access to electronic medical records and public health records. Maintain flexibility to rapidly respond to changes in core surveillance. Sites must have the ability to quickly (within three months) modify data collection methods and site databases to respond to changes in ABCs surveillance. Changes may include addition or deletion of variables submitted to CDC.

Additional ABCs Activities: OPTIONAL

These activities may be restricted to sites that have successfully participated in core activities for at least two years, except as noted.

1. If culture independent diagnostic tests (CIDTs) are not included in the ABCs case definition, then sites may elect to expand surveillance for invasive bacterial infections for ABCs pathogens to include patients who test positive by nucleic acid tests obtained from sterile site specimens. This would include gathering data on the type of test used and how it was validated. Including these cases will be required if the ABCs case definition is expanded by the ABCs Steering Committee to include

CIDTs.

2. GBS-related activities:

a. Implement and evaluate a clinical decision support (CDS) tool at 1-2 hospitals. A link to the tool would be embedded within the hospital’s electronic medical records and incorporates

CDC guidelines for providing intrapartum prophylaxis to mothers in order to prevent early-onset newborn GBS disease. The evaluation piece includes measuring compliance with guidelines before and after implementation of the CDS.

b. Participate in discussions on the feasibility of and methods for conducting surveillance for non-invasive GBS disease in order to inform disease burden estimates needed in consideration of vaccine development. Participate in a pilot to conduct surveillance for non-invasive GBS disease if deemed feasible and worthwhile by the ABCs Steering Committee.

c. Conduct analyses and studies that provide the evidence base for vaccine development.

d. Conduct analyses and studies to assess and update current perinatal prevention guidelines.

3. Pneumococcal-related activities:

a. Complete studies of nasopharyngeal colonization with S. pneumoniae among children targeted for vaccination with 13-valent pneumococcal conjugate vaccine. Sites with baseline data are encouraged to evaluate the effects of the new pneumococcal conjugate vaccine after it is introduced into the routine infant immunization program.

b. Launch studies of nasopharyngeal colonization with S. pneumoniae among adults. These studies will assist in evaluating the indirect effects of vaccinating children with PCV13 and the direct effects of vaccinating adults.

c. Collect urine specimens that would be used in the development of a serotype-specific pneumococcal urine antigen test. Urine could be collected from invasive cases or non-invasive pneumococcal cases. Sites may also choose to collect isolates from sputum cultures which would be used to determine the pneumococcal-specific serotype. Collection of specimens would not have to be population-based, but could occur at select facilities.

4. Conduct expanded surveillance for H. influenzae neonatal sepsis and H. influenzae in pregnant and post-partum women.

5. Participate in special studies evaluating meningococcal disease epidemiology, outcomes (e.g., short-and long-term sequelae), clinical manifestations (including non-invasive disease, such as urethritis) and prevention and control strategies.

6. Legionellosis-related activities:

a. Collect urine and respiratory specimens for the evaluation of Legionella urine assays under development that 1) Detect non-Legionella pneumophila serogroup 1 (Lp1) infections and 2)

Detect Lp1 strain types. This would involve collecting paired urine and respiratory specimens from patients at select laboratories (i.e. does not need to be population-based) and would not require additional collection of patient information.

b. Conduct a study to understand differences in legionellosis testing practices across hospitals and regions. This would entail measuring the proportion of patients tested for Legionnaires’ disease (by urine antigen or respiratory culture) with admitting or discharge diagnoses related to pneumonia at select facilities. Facilities would be selected based on incidence rates in the region (high, medium and low incidence areas would be selected) and hospital characteristics

(level of acuity, size, etc.).

c. Evaluate novel legionellosis prevention plans (for example cooling tower registration and reporting regulations, introduction of monochloramine into municipal water systems) including the environmental and public health impacts and unintended consequences.

d. Conduct a survey of cooling towers or potable water systems to capture information on water safety and legionellosis prevention plans. This may include 1) an evaluation of the presence

(or absence) of legionellosis prevention plans, 2) an evaluation of the uptake and costs of recently passed primary prevention guidance: American Society of Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE) 188 Standard - Legionellosis: Risk Management for Water Systems (see: http://www.cdc.gov/legionella/health-depts/ashrae-faqs.html ), 3) an evaluation of environmental proxies for Legionella in water (such as temperature, disinfectant, pH), and/or 4) an evaluation of legionella colonization.

e. Explore avenues for incorporation of ASHRAE-188 into local or state licensing/accreditation

/inspection of high risk facilities (e.g., hotels, healthcare, longterm care facilities).

f. Expand and evaluate a new “toolkit” translating the industry standard (ASHRAE 188) for end users (building owners, operators, local public health, etc.).

g. Compare facilities that have had legionellosis outbreaks or colonization to those that have not to identify facility-level environmental and non-environmental risk factors for outbreaks.

h. Explore the application of spatial, temporal, or space-time scan statistics to Legionnaires’ disease case occurrence to enhance early and rapid detection of clusters, particularly in urban areas affected by high or increasing incidence of Legionnaires’ disease.

i. Conduct an investigation to identify risk factors for sporadic Legionnaires’ disease (i.e. case control study, case series or other study design).

7. GAS-related activities:

a. Conduct supplemental surveillance for severe GAS infections. Participating sites will either

a) conduct enhanced surveillance for streptococcal toxic shock syndrome (STSS) and necrotizing (NF) using a single page supplemental form; b) conduct enhanced surveillance for NF including collection of special reports (imaging, pathology, or surgical); c) conduct enhanced surveillance for NF using ICD-9/10 codes; or d) combination of options above.

b. Conduct a study to identify potential human genetic factors associated with severe presentations of GAS such as NF and STSS. After appropriate IRB approvals, participating sites will retrospectively and prospectively contact persons (cases) who have had NF or

STSS to obtain consent to enroll them and to mail potential participants saliva collection kits.

Genomics work will be completed by external partners.

8. Conduct surveillance for neonatal sepsis in children less than three days old (first 72 hours of life).

This would include the optional collection of isolates, with a particular emphasis on gram negative pathogens, such as E. Coli.

9. Conduct surveillance and special studies related to antimicrobial resistant infections:

a. Establish and implement methods for monitoring potential complications from antibiotic stewardship efforts aimed at reducing unnecessary antibiotic use (e.g., complications from reduced treatment of otitis media).

b. Develop and evaluate programs related to appropriate antibiotic prescribing for community-associated invasive and non-invasive infections.

c. Participate in developing and conducting risk factor studies related to community-associated antimicrobial-resistant infections.

d. Conduct pharyngitis surveillance with associated isolate collection in 1-2 ABCs sites in order to compare GAS emmtype and resistance profiles between pharyngitis and invasive GAS infections. Where possible, correlation between microbiologic profiles and local antibiotic use patterns will be evaluated.

e. Conduct analyses and studies to evaluate the relationship between antibiotic use and resistance.

10. Perform enhanced surveillance for Bordetella pertussis:

a. Utilize state-based pertussis reporting systems to conduct enhanced surveillance for

Bordetella pertussis that is characterized by enhanced case ascertainment and augmented data collection.

b. Follow-up on all serology-positive pertussis laboratory results in addition to persons PCR and culture positive for B. pertussis.

c. Collect complete information on clinical course of infection, vaccination history (DTP/DTaP and Tdap), laboratory testing, and other epidemiologic information of interest (e.g., source of infection) as outlined in the case report form instruction sheet. Incorporate new variables as agreed on by CDC, participating sites, and/or the pertussis pathogen committee.

d. Collect isolates of Bordetella pertussis, when available, and periodically ship to CDC for further laboratory characterization.

e. Collect clinical specimens/DNA extracts that are PCR positive for Bordetella pertussis

(based on specifications provided by CDC) and periodically ship to CDC for further laboratory characterization.

f. Utilize state immunization registries and other methods outlined in the case report form instruction sheet to obtain/verify pertussis vaccination history; collect maternal Tdap vaccination history for all infant cases <1 year of age.

g. Conduct annual audits of laboratories (commercial, public health and/or hospital laboratories) conducting testing for B. pertussis to ensure the identification of all laboratory-confirmed cases of B. pertussis.

h. Build and strengthen pertussis case finding infrastructure in order to conduct special studies including evaluations of pertussis prevention and control strategies.

i. When available, collect epidemiologic information and specimens on other Bordetella species (specifically, B. parapertussis, B. bronchiseptica, and B. holmesii).

j. Participate in routine conference calls with CDC and other participating sites to standardize surveillance methodology and address issues.

11. Prospectively complete expanded medical record review of hospitalized pertussis cases (all ages) identified through Enhanced Pertussis Surveillance to better understand reasons for hospitalization, severity of illness, underlying medical conditions, factors associated with treatment, and outcomes.

12. Evaluate secondary transmission of B. pertussis among household contacts following a 5-day course of Azithromycin post-exposure prophylaxis and duration of pertussis PCR and serology positivity among cases and household contacts.

a. Enroll pertussis cases identified through EPS and their household contacts (all ages);

household contacts will be recommended PEP based on existing local public health guidelines and as part of routine follow-up and case investigation.

b. Conduct study visits at two time points (enrollment and 2-3 weeks post-enrollment) to interview and collect nasopharyngeal and blood samples from consenting, eligible household contacts; conduct an additional telephone interview 2-3 weeks post second visit on a subset of eligible participants.

c. Utilize CDC-developed data management systems and routinely transmit study data to CDC.

d. Participate in routine conference calls with CDC and other participating sites to discuss progress, monitor enrollment and address methodology-related questions.

e. For case-patients and a subset of eligible household contacts, conduct additional specimen collection (nasopharyngeal and blood samples) at up to 7 time points within 1 year post enrollment to assess duration of PCR and serology positivity.

13. Assess the impact of pertussis vaccines (DTaP and Tdap) as well as other pertussis prevention and control strategies.

a. Develop protocol and identify appropriate methodology and sample size in collaboration with CDC and the pertussis pathogen committee.

b. Initiate/conduct evaluation as funding permits.

14. Disseminated gonococcal infection (DGI): Since late 2015, several reports of cases of disseminated gonococcal infection (DGI) in the Atlanta, Georgia metropolitan area suggest that this syndrome may be on the rise in Georgia and possibly elsewhere. While DGI is thought to be a relatively rare condition, a retrospective review of sterile site cultures of Neisseria gonorrhoeae from laboratories in a defined surveillance area for DGI would help define the burden of disease and investigate recent trends. Prospectively, collection of sterile site isolates from DGI cases would allow both susceptibility and whole genome sequence testing to better describe DGI epidemiology and molecular epidemiology, and inform prevention and control strategies. Proposals could include a retrospective review of recent DGI cases in a defined population and a plan for prospective surveillance, including collection of isolates, in conjunction with other ABCs activities.

15. Participate in other activities as determined appropriate and important for the ABCs sites by the

ABCs Steering Committee.

Evaluation and Performance Measurement

Routine ABCs activities:

1. Participate in conference calls related to ABCs (i.e., >1 site participant per call): 90%

2. Identify all labs located within and adjacent to the ABCs surveillance area that test a significant proportion of isolates from surveillance area residents, performed prior to initiating ABCs surveillance and periodically (e.g., every 2-3 years): 100%

3. Complete at least annual audits of all clinical laboratories within the ABCs surveillance area and of labs outside of the surveillance area that test a significant proportion of isolates from residents of the

ABCs surveillance area to verify completeness of case ascertainment: 100%

4. Submit surveillance data electronically to CDC (in CDC’s secure format) on a monthly basis. Obtain final case counts from the previous year by April of the following year (i.e., April 2017 for 2016 surveillance year). Obtain final case report form data from the previous year by November of the following year (i.e., November 2017 for 2016 surveillance year): 100%

5. Obtain isolates from cases and ship them to CDC laboratories on a specified schedule for serotyping and other laboratory characterization: >85%

6. Conduct quality checks of case report form data. Sites should select ≥10% of case report forms

(stratified by facility and/or region) to be re-abstracted by a second reviewer. An analysis of discrepancies should be used to train staff conducting case report form reviews and recurring issues should be reported to CDC so methods across the network may be improved. These second abstractions may be done throughout the year or batched on a biannual or annual basis. A brief (1-2 page) report of findings should be sent to CDC at the same time final case report data are sent—the

November of the following year (i.e., November 2017 for 2016 surveillance year).

Special or optional ABCs studies:

1. Proportion of eligible cases enrolled in special studies, to be determined for each study by ABCs sites and CDC.

2. Proportion of cases and controls enrolled in special studies (e.g., vaccine effectiveness) with provider verified vaccination status reported: >95%

Budget Note: For any/all activities (required and optional) under this appendix, provide one combined budget that incorporates the costs for all activities.

ATTACHMENT 1, SECTION C

Foodborne Diseases Active Surveillance Network (FoodNet)

Background

The Foodborne Diseases Active Surveillance Network (FoodNet) provides a foundation for food safety policy and illness prevention in the United States. Since 1996, FoodNet has conducted active, population-based surveillance at select US sites for laboratory-confirmed infections of 9 bacterial and parasitic pathogens transmitted commonly through food (Campylobacter, Cyclospora, Cryptosporidium, Listeria monocytogenes, Salmonella, Shiga toxin-producing Escherichia coli (STEC), Shigella, Vibrio, and Yersinia). FoodNet also conducts active surveillance for pediatric cases of Hemolytic Uremic

Syndrome (HUS) through a network of nephrologists and infection control practitioners and by hospital discharge data review.

FoodNet is the principal foodborne disease component of the Centers for Disease Control and

Prevention’s (CDC) Emerging Infections Program (EIP) and is a collaborative project among CDC, state health departments, the United States Department of Agriculture’s Food Safety and Inspection Service

(USDA-FSIS), and the United States Food and Drug Administration (FDA). FoodNet’s activities are guided by four main objectives: 1) Determine the burden of foodborne illness in the United States, 2)

Monitor trends in the burden of specific foodborne illness over time, 3) Attribute the burden of foodborne illness to specific foods and settings, and 4) Disseminate information that can lead to improvements in public health practice and the development of interventions to reduce the burden of foodborne illness.

Through FoodNet, state and federal scientists collaborate to monitor trends in enteric illnesses, identify their sources, and implement special studies. FoodNet’s major contributions include establishment of reliable, active population-based surveillance of enteric diseases; development and implementation of epidemiologic studies to determine risk and protective factors for sporadic enteric infections; population and laboratory surveys that describe the features of gastrointestinal illnesses, medical care–seeking behavior, frequency of eating various foods, and laboratory practices; and development of a surveillance and research platform that can be adapted to address emerging issues.

Other Nat’l Public Health Priorities and Strategies

- Healthy People 2020 (http://www.healthypeople.gov/2020/topics-objectives/topic/healthcare-associated-infections; EIP FoodNet provides data for measuring progress in reduction in incidence of select infections)

- Department of Health and Human Services Priority Goals (EIP FoodNet provides data for measuring progress in priority goals associated with reducing foodborne illness in the population)

- National Strategy for Combating Antibiotic-Resistant Bacteria

(https://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf)

- CDC Winnable Battles Initiative (Food safety:

http://www.cdc.gov/WinnableBattles/FoodSafety/index.html)

Purpose

Conduct active surveillance and research studies aimed at reducing morbidity and mortality due to diseases commonly transmitted by food and understanding sources of these infections.

http://www.healthypeople.gov/2020/topics-objectives/topic/healthcare-associated-infections http://www.healthypeople.gov/2020/topics-objectives/topic/healthcare-associated-infections https://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf http://www.cdc.gov/WinnableBattles/FoodSafety/index.html

Outcomes

Provide new knowledge

Information provided through FoodNet is instrumental in the understanding and control of foodborne illness. Data are used to understand trends in diseases commonly transmitted by food, and monitor those trends over time to assess the impact of food safety control measures. Since many foodborne illness cases go unreported, data from FoodNet help to fill in gap of underreporting and inform estimates of the true burden of foodborne illness in the United States. In an era of changing laboratory diagnostic practices, close contact with clinical laboratories provides information needed to accurately count cases and inform national case definitions. Research studies provide new information on risk factors for foodborne diseases that can inform the development of regulatory and preventive measures aimed at reducing incidence of these infections. Through this EIP activity, grantees will contribute to the estimation of the total number of foodborne illnesses, monitoring of incidence trends, and development of studies to attribute illnesses to specific sources by establishing a system of active surveillance for selected pathogens, and routine, standardized, reporting of data elements. Grantees will contribute information about laboratory testing practices to determine the impact of culture-independent methods on trends in enteric diseases. Grantees will participate in research studies to understand risk factors for selected foodborne diseases, and prevalence of acute gastrointestinal illness in the general population.

Develop staff expertise

Staff working in FoodNet sites will develop expertise in active surveillance methods, data management, and development of studies to identify risk factors for foodborne illness. In addition, they will establish strong partnerships with clinical laboratories, hospitals, health care practitioners, and academic institutions. Partnerships will provide the foundation of a strong and flexible network upon which to expand surveillance or conduct additional studies.

Control outbreaks of infectious diseases

Knowledge and skills gained through establishment of an active surveillance system will result in faster and more complete case detection and facilitate faster outbreak detection. Risk factors identified through research studies will facilitate identification of illness sources.

Develop/modify treatment guidelines

Information gained through active surveillance and research studies will provide knowledge in the control and clinical treatment of infections by pathogens transmitted commonly through food.

Develop/modify intervention recommendations

Information gained through active surveillance and research studies will be used to inform the development and evaluate the effectiveness of regulations and interventions aimed at reducing the burden of select foodborne illnesses.

Strateg…