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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Office of Health Information Technology: Division of State and Community Assistance American Recovery and Reinvestment Act (ARRA) of 2009 Funding Opportunity Health Information Technology Implementation for Health Center Controlled Networks NEW COMPETITION Announcement Number HRSA-10-154 Catalog of Federal Domestic Assistance (CFDA) No. 93.703 PROGRAM GUIDANCE Fiscal Year 2010 Application Due Date: February 5, 2010 Release Date: December 9, 2009 Date of Issuance: December 9, 2009 Christie Brown Public Health Analyst Division of Health Information Technology State and Community Assistance Office of Health Information Technology, HRSA Telephone: 315. 662.7933 Fax: 301.443.1330 firstname.lastname@example.com Authority: The American Recovery and Reinvestment Act of 2009, P.L. 111-5. 1 Guidance Table of Contents I. FUNDING OPPORTUNITY DESCRIPTION ................................................................................................................... 4 PURPOSE .................................................................................................................................................................... 4 AUTHORITY ............................................................................................................................................................... 4 BACKGROUND ........................................................................................................................................................... 4 II. AWARD INFORMATION ................................................................................................................................................. 8 1. TYPE OF AWARD................................................................................................................................................... 9 2. SUMMARY OF FUNDING..................................................................................................................................... 9 III. ELIGIBILITY INFORMATION .....................................................................................................................................11 1. ELIGIBLE APPLICANTS .....................................................................................................................................11 2. COST SHARING AND MATCHING ....................................................................................................................11 3. OTHER...................................................................................................................................................................12 IV. APPLICATION AND SUBMISSION INFORMATION.................................................................................................12 1. APPLICATION MATERIALS AND REQUIRED ELECTRONIC SUBMISSION INFORMATION...............12 2. CONTENT AND FORM OF APPLICATION SUBMISSION ............................................................................13 APPLICATION FORMAT REQUIREMENTS .........................................................................................................13 I. APPLICATION FACE PAGE ..............................................................................................................................18 II. TABLE OF CONTENTS ......................................................................................................................................18 III.APPLICATION CHECKLIST ..............................................................................................................................18 IV. BUDGET ...............................................................................................................................................................18 V. BUDGET JUSTIFICATION ................................................................................................................................20 VI. STAFFING PLAN AND PERSONNEL REQUIREMENTS ..............................................................................22 VII. ASSURANCES ....................................................................................................................................................22 VIII. CERTIFICATIONS ..........................................................................................................................................22 IX. PROJECT ABSTRACT .........................................................................................................................................22 X. PROGRAM NARRATIVE FOR CATEGORY 1 EHR AND CATEGORY 2 HIT INNOVATION PROJECT ..23 XI. ATTACHMENTS ..................................................................................................................................................31 3. SUBMISSION DATES AND TIMES.....................................................................................................................31 4. INTERGOVERNMENTAL REVIEW ....................................................................................................................32 2 5. FUNDING RESTRICTIONS ................................................................................................................................33 6. OTHER SUBMISSION REQUIREMENTS .........................................................................................................33 V. APPLICATION REVIEW INFORMATION ...................................................................................................................34 1. REVIEW CRITERIA .............................................................................................................................................34 2. REVIEW AND SELECTION PROCESS...............................................................................................................39 3. ANTICIPATED ANNOUNCEMENT AND AWARD DATES ..............................................................................39 VI. AWARD ADMINISTRATION INFORMATION ............................................................................................................39 1. AWARD NOTICES ................................................................................................................................................40 2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS ................................................................40 3. REPORTING .........................................................................................................................................................42 4. FINAL REPORT....................................................................................................................................................46 5. PERFORMANCE REVIEW...................................................................................................................................46 VII. AGENCY CONTACTS ....................................................................................................................................................47 VIII. OTHER INFORMATION .............................................................................................................................................48 IX. TIPS FOR WRITING A STRONG APPLICATION .......................................................................................................52 APPENDIX A: MEMORANDUM OF AGREEMENT ........................................................................................................54 APPENDIX B: STANDARD TERMS AND CONDITIONS ................................................................................................55 APPENDIX C: RESOURCES FOR APPLICANTS.............................................................................................................55 APPENDIX D: HIT BUDGET TECHNICAL ASSISTANCE .............................................................................................63 APPENDIX E: ENVIRONMENTAL INFORMATION & DOCUMENTATION ..............................................................64 3 I. Funding Opportunity Description Purpose The American Recovery and Reinvestment Act (ARRA or Recovery Act), signed into law February 17, 2009, provides $1.5 billion in grants for construction, renovation and equipment, and for the acquisition of health information technology systems, for health centers, including health center controlled networks, receiving operating grants under Section 330 of the Public Health Service (PHS) Act, as amended (42 U.S.C. 254b). The Recovery Act was enacted to: preserve and create jobs; promote economic recovery; help people most impacted by the recession; increase economic efficiency by investing in technological advances in science and health; promote long-term economic benefits by investing in transportation, environmental protection and other infrastructure; and preserve essential services in States and local governments. Additional information on the Recovery Act can be found at http://www.recovery.gov. Information on activities related to the Recovery Act at the U.S. Department of Health and Human Services can be accessed at http://www.hhs.gov/recovery. These funds made available by the Recovery Act will support the acquisition, implementation and meaningful use of electronic health records (EHRs) and other health information technology (HIT) by health centers through health center controlled networks (HCCNs), over the next two years. The purpose of this one-time funding grant is to enhance the HCCN grantees' organizational and information technology capacity to provide additional HIT services in support of the ARRA- funded acquisitions of EHR and HIT systems by health centers and HCCNs. For types of projects, please see Section II (Award Information). Applicants should be aware these funds are for new activities. HCCNs that are currently or have been previously supported are eligible to apply for this funding as long as they clearly delineate the new activities from the existing ones. In terms of participants, scope is defined at the community health center level. Authority This grant program is being issued by the Health Resources and Services Administration (HRSA), U.S. Department of Health and Human Services (HHS). Projects are overseen by HRSA's Division of HIT State and Community Assistance (DHITSCA) within the Office of Health Information Technology (OHIT). The funding for this opportunity is authorized by P.L. 111-5, the ―American Recovery and Reinvestment Act of 2009.‖ Background The mission of HRSA's OHIT is to enhance the quality and efficiency of primary and preventive care as a safety net through the effective use of HIT. These enhancements should result in 4 measurable improvements in patient outcomes and in reductions of health disparities. Common examples of HIT may include disease registry systems, care management systems, clinical messaging systems, personal health record systems, electronic health records (EHRs) and health information exchanges (HIEs). HRSA envisions HIT will have an impact on its safety net community in the following ways: a. Enhance safety net providers' capacity to measure and effectively report on the quality of care and the health outcomes in health centers. b. Reduce health care costs that result from inefficiency, medical errors, inappropriate care and incomplete information. c. Increase the availability and transparency of information related to the health care needs of the patient and support physician decision making. d. Prepare health centers and other safety net providers to participate in pay-for-performance plans/systems. e. Support the ability to provide a rapid response to both natural and man-made disasters, including those due to bioterrorist acts. f. Further develop continuity of care across settings for health center and for other safety net patients as they move from outpatient to urgent, emergency, and inpatient care. To be successful in the health care arena, it is essential that health centers have state of the art information systems. According to several recent studies, health centers have quickly identified technology's potential to improve the efficiency and quality of their patients' care. [National Opinion Research Center, University of Chicago for U.S. Department of Health & Human Services, Office of the Assistant Secretary for Planning and Evaluation. Community Health Center Information Systems Assessment: Issues and Opportunities Final Report. October, 2005.] This funding opportunity builds on health center innovations in chronic care management, EHRs, patient registries, and in quality improvement. HRSA's goal is not simply to collect data, but to use the data to improve individual and population health. Studies of HCCNs implementing EHR in the safety net community have shown that they ―deliver additional value by providing strategies for building capacity and setting expectations that recognize the individual circumstances among community clinics and health centers. They also offer the operational and technical infrastructure support services, educational resources, stability and economies of scale that help alleviate the burden that small safety-net providers face in pursuing EHR adoption alone.‖ [California HealthCare Foundation, Creating EHR Networks in the Safety Net. March, 2008.] Grantees will be expected to enhance resources available in the existing OHIT-developed Health IT toolbox to serve the community of HRSA-funded health care providers seeking to implement health IT to improve quality of care and enhance efficiencies within their organizations or networks. The toolbox is designed to support the needs of stakeholders ranging from the front line staff to senior management implementing the health information system. In addition to utilizing the support of these centers, HRSA-funded programs participating in health IT activities are strongly encouraged to utilize and contribute to the continued development and improvement of these resources that advance the knowledge, dissemination and replication of successful HIT models. To access the Health IT Toolbox, go to http://healthit.ahrq.gov/toolbox. For more information on the Health IT Toolbox, please contact firstname.lastname@example.com. Program Expectations for Successful Applicants Funded Under ARRA 5 Any EHR system purchased or enhanced with these funds must be certified by an organization recognized by the Secretary of HHS, and the purchasing process must be executed consistently with Federal regulations for grantee procurement. The ARRA provides for a process whereby the Secretary develops the definition of ―meaningful use of certified EHRs.‖ The ARRA requires that for the purposes of EHR incentive payments, meaningful use must include the use of electronic prescribing and the electronic exchange of health information to improve the quality of health care and the submission of clinical quality measures. The Act also requires the Secretary to specify the means by which health professionals can demonstrate that they are meaningfully using EHRs. Until such time as these definitions and requirements have been finalized, grantees are expected – as part of assessing their EHR readiness and formulating their strategic plans – to time their EHR procurement appropriately to ensure that the EHR purchased with this grant funding is able to support the meaningful use of certified EHRs. This entails having EHR functionality in place to support their EHR in the context of a health outcomes driven system that promotes patient engagement, reduction of health disparities, improved safety, increased efficiency, coordination of care, and improved population health. Up-to-date information on the definitions and requirements of meaningful use for EHRs will be posted at: http://healthit.hhs.gov and select ―HealthIT/Recovery.‖ Finally, grantees must be able to use their EHR systems to collect and report health outcome information such as clinical measures required by the annual Uniform Data System (UDS) reporting as well as other measures required by other regulatory agencies. To be able to generate ad-hoc and predefined queries and reports of practice management and clinical data, grantees are required to use a flexible, user operated report writing tool that is either integrated with the PMS/EHR system or provided as an external tool by a 3rd party, capable of accessing the files created by such system. Successful applicants will also have new reporting requirements as required under ARRA. See Appendix B for ARRA standard terms and conditions. Additional Program Expectations Based on a strong history of collaboration and an active quality improvement program, successful applicants will be expected to engage in or demonstrate current progress of the following activities related to EHR integration and HIT integration: 1. Proper Due Diligence Any EHR system purchased with these funds must be certified by an organization recognized by the Secretary of HHS, and the purchasing process must be executed consistently with Federal regulations for grantee procurement. In addition, it is essential to conduct thorough due diligence and to purchase systems with features needed to improve population health, such as structured data collection, registry functions, quality measures and reporting, and decision support tools. HRSA recommends that applicants review the functional specifications that it has created for procuring EHR software and products. The functional specifications can be found at: http://www.hrsa.gov/healthit/ehrguidelines.htm. Applicants awarded a grant are required to follow Federal regulations for grantee procurement as cited in 45 CFR Part 74 or 45 CFR Part 92, as applicable. 6 In addition, this is a HCCN model that focuses on the integration of functions, the sharing of data to improve the health center operations, and on the maximizing efficiencies. Over time, HRSA encourages HCCNs to continue this integrated model regardless of the different vendors that their health centers might use. However, because this is a two year project period to implement complex systems, HRSA strongly recommends the use of a single vendor and platform for this funding opportunity. If the applicant proposes the use of more than one EHR vendor and platform, then the applicant should clearly describe: the reason for this decision, the HCCN's ability to successfully implement and support an EHR using more than one platform, and any specific challenges that have been addressed or are currently in place related to the complexities of using more than one platform. 2. Multi-Disciplinary Focused and Deliberate Implementation Successful applicants will be expected to demonstrate that an integrated and collaborative HIT infrastructure will be developed, with a balanced skill set of clinicians and IT staff, through the following phases: A final planning phase where the HCCN will finalize an HIT implementation plan and complete contract negotiations with a vendor. These are not planning grants. Therefore, the implementation plan shall not include extensive planning activities that should already have been completed such as: conducting readiness assessments, workflow analyses, due diligence in selecting a vendor, business planning, and the determination of specific HCCN HIT function(s). A testing phase where the plan will be thoroughly tested and modified as necessary. During this phase (and/or during the final planning phase as well), funds may be used for the acquisition of health information technology, such as the purchase of software, licenses, and hardware, as well as to obtain implementation assistance and any necessary technical staffing. The testing activities should reflect the plans for implementation and roll-out. The HIT roll-out may begin by site, by clinician, and/or by specialty. An infrastructure building phase where grant funds will be used to not only build infrastructure but also to help transition workflow. A secure platform for the communication and sharing of clinical and other key data will be established during this phase. Projects should support the move to a clinical information system through an integrated system with a common architecture. This will provide the best clinical and administrative solution to the marketplace and will eliminate both disparate clinical database sources and the fragmentation of clinical data and information. This data should facilitate the development of at least three performance outcome measures, two of which HRSA has defined to include diabetes control and child immunization for Category 1 – EHR (see the ―Evaluative Measures‖ section for a definition of these performance measures). A roll-out phase where the HIT will be implemented by participants in the HIT project in a coordinated and integrated approach that includes adequate staffing at the HCCN and site level. The HIT roll-out may begin by site, by clinician, and/or by specialty. These grant funds shall not be used for the ongoing maintenance of technology. 7 A post implementation/roll-out evaluation that reveals how well the HIT project meets its purpose and objectives and to understand what has worked and what has not in terms of the acquisition of health information technology systems by health centers and HCCNs. Although a formal evaluation is not required, lessons learned from feedback help everyone involved in HIT implementation and adoption improve upon what they are doing. In addition, evaluations help justify investment in health IT projects by demonstrating project impacts and outcomes. All grantees will be required to submit a post implementation/roll-out evaluation and share their lessons learned with other HCCNs and health centers. HRSA strongly encourages grantees to review the Health IT Adoption Toolbox that HRSA created at www.healthit.ahrq.gov/toolbox for tools and resources for evaluations. 3. Quality Improvement The HIT systems will enhance HCCNs' capacity to measure and effectively report on the quality of care and the health outcomes in health centers and will further enable quality improvement activities to improve such outcomes; specifically, it will enable HCCNs to demonstrate the impact of HIT on enhancing the effectiveness, efficiency, safety and quality on their health center delivery system. 1. Effectiveness. The extent to which integrating a clinical quality improvement program with HIT will improve both health outcomes and systems of care at the HCCNs' member health centers. For example, a HCCN may use clinical decision support systems to generate reminders that promote preventive care to help manage chronic diseases and to improve population health. 2. Efficiency. The extent to which inefficiencies such as lost medical records, lab results, and inadequate appointment systems, are eliminated through the combination of HIT and a clinical quality improvement program. Applicants should quantify projected time saved, increases in revenue and other quantifiable efficiencies resulting from the investment, as well as increased tracking and reporting of patients' treatment and health outcomes. 3. Safety and Quality. The extent to which mechanisms, such as computerized provider order entry (CPOE), enhance patient safety and improve risk management practices by preventing medication and other medical errors. 4. Sustainability It should be noted that this is one-time money. Funds available for this project will not finance all the costs associated with the implementation of an HIT nor will they cover the costs of ongoing operational and maintenance cost. It is expected that HCCNs will focus on creating sustainable business models for deploying and maintaining HIT, as well as for enhancing the capacity of health centers to engage in strategic partnerships that leverage other HIT initiatives and resources. The latter include knowledge, experience, funding already present in the HCCN's state(s) and/or community(s) and/or region(s), and participation in pay-for-performance. II. Award Information 8 1. Type of Award Funding will be provided in the form of a grant with a two year project period. 2. Summary of Funding This program will provide funding during the Federal fiscal year 2010. Approximately $88 million is expected to be available to fund up to 36 awards. The project period will be 2 years in length. Category 1 will provide approximately $78 million to fund up to 26 HCCNs for EHR implementation, at a maximum of $3 Million for each project. Category 2 will provide approximately $10 million to fund up to 10 HCCNs to implement HIT innovative projects other than EHR at a maximum of $1 Million for each project. There is no year one and year two maximum award. This is a two year project/budget period. The grantee will receive all funds upfront and will be expected to complete a 2 year budget period. Applications may not exceed a total amount of $3 Million. HRSA expects that recipients will be able to sustain the project beyond the project period therefore, it is expected that HCCNs will focus on creating sustainable business models for deploying and maintaining HIT, as well as for enhancing the capacity of health centers to engage in strategic partnerships that leverage other HIT initiatives and resources. The latter include knowledge, experience, funding already present in the HCCN's state(s) and/or community(s) and/or region(s), and participation in pay-for-performance. HRSA requests specific information on sustainability and on the decreasing reliance on Federal funds for each year in the section of the guidance entitled: ―Impact‖. Please see ―Funding Restrictions‖ for information regarding allowable use of funds. Types of Projects Category 1: Electronic Health Record Implementations The EHR Implementation Project is for those eligible applicants that are: 1) in the final planning stages of adopting a certified EHR and have selected a single vendor and platform; 2) for those who are expanding their EHR capabilities, such as but not limited to: adding computerized physician order entry (CPOE), clinical decision support (CDS); creating interfaces; and developing tools to report on clinical benchmarks (such as Uniform Data System (UDS), HRSA clinical core measures, or National Quality Forum Measures) of an implemented certified EHR to prepare health centers for meaningful use; and/or 3) increasing their network capacity or information technology infrastructure to support the adoption of certified EHR to more health centers, sites or providers. Category 2: HIT Innovation Implementations HIT Innovation Implementations are targeted towards eligible applicants that have a certified EHR in place. HIT innovation projects include but are not limited to: health information exchange (HIE) projects; data warehouse functionality; electronic prescribing projects; telehealth projects; electronic oral health records; increasing HCCN infrastructure and information technology capacity to support additional health centers, sites, and providers. With regard to telehealth, applicants may propose projects that build upon or enhance existing HIT systems to create interoperable information systems that facilitate the provision of telehealth 9 services. For example, school-based programs might consider projects that partner with schools and other providers in the community to expand access to services, such as mental health or dental health services, through telehealth technologies that employ interoperable information systems. Applicants who wish to implement telehealth-related projects should demonstrate a clear understanding of the potential operational and legal challenges in doing so. If expanding on an already established data warehouse, then the applicant should be prepared to show when the data warehouse was implemented, the current information it contains, and how the Network or the health center members currently use the data from the data warehouse. The applicant should clearly identify what the expansion will include. Expansion of a data warehouse may include a new Master Patient Index, additional measures/data being collected and stored, and/or a dashboard or IT program used for benchmarking clinical outcomes. Some applicants may wish to share data and engage in electronic HIE horizontally within their HCCN or vertically with partners outside the HCCN. Sharing of data is expected to improve quality by easing transitions in care, reducing duplicate testing, and providing missing data for medical decision making. The Office of the National Coordinator of Health Information Technology describes HIE as the movement of health-related data – clinical and/or administrative – according to an agreed upon set of interoperable standards, processes and activities across independently operating organizations in a manner that protects the privacy and security of an individual's information. Participants may be geographically defined or be non- geographic communities of affiliation. Applicants may wish to propose a Master Patient Index as part of their overall HIE project. Applicants applying to do HIE must indicate that they have conducted thorough planning. These organizations should be in the final stages of planning for HIE and be ready to begin implementing the HIE within six months. They should be prepared to show that they are in at least the final parts of Stage 3 of the eHealth Initiative's six–stage framework for tracking the development of HIEs, http://www.ehealthinitiative.org/HIESurvey/2008StateOfTheField.mspx. According to this model, activities such as ―recognition of the need for HIE,‖ basic organization and governance structures, ―defining shared vision and goals and objectives,‖ setting up funding sources, writing of a business plan for HIE, and defining needs and requirements have already been completed. If expanding an HIE, then the applicant should be prepared to show that they are in at least the final parts of Stage 4 of the eHealth Initiative's six-stage framework for tracking and development of HIEs. This includes already having the infrastructure in place (hardware, software, etc.) to host an HIE, and the applicant should provide evidence that information exchange is already occurring. The applicant should state what types of information are currently exchanged, what healthcare organizations are exchanging that information, and how the information is being exchanged (e.g., via EHRs, data warehouse, etc). The applicant should clearly identify what the expansion will include. Expansion of an HIE may include bringing on new partners, building new interfaces, or exchanging additional measures and/or data. This is not a planning grant; there should be limited planning activities to decide on how the expansion will occur, who will be the additional partners, and/or what new information will be exchanged. The applicant should tailor their budget accordingly, and it should be reasonable. 10 While HIE development is a multi-year process, HRSA anticipates that funding can be used to implement one discrete step in advancing a health information exchange. The project selected should be feasible in the specified time period and with the resources allocated. General Consideration In selecting applications for funding, special consideration will be given to geographic distribution, including urban and rural. III. Eligibility Information 1. Eligible Applicants Eligible applicants are limited to the following subset of Section 330 grantees: A Network controlled by and acting on behalf of the health center(s), as defined and funded under Section 330(e)(1)(C) of the PHS Act, as amended. At the request of all the member health centers, a HCCN may apply for direct funds if it is at least majority controlled and, as applicable, at least majority owned, by such health centers as defined and funded under Section 330(e)(1)(C). For the purposes of this grant opportunity, the term ―controlled‖ means to have the authority collectively to appoint a minimum of 51 percent of the HCCN's board members. A health center, as defined and funded under Section 330 of the Public Health Service (PHS) Act, as amended (42 U.S.C. 254b), applying on behalf of a managed care Network or plan, that has received Federal grants under subsection 330(e)(1)(A) for at least the two consecutive preceding years; or, A health center as defined and funded under Section 330 of the Public Health Service (PHS) Act, as amended (42 U.S.C.§ 254b), applying on behalf of a practice management Network. HCCNs must consist of at least three collaborator organizations. For further information on what constitutes this relationship, see Section VIII. Other Information – Definitions – Collaborators or HCCN Members and Health Center Controlled Network. HRSA is limiting funding through this announcement only to HCCN's, because the HCCN model focuses on integration of functions, sharing of data to improve health center operations and maximizing efficiencies. Acquiring and implementing HIT is a very costly endeavor. HCCNs can provide HIT infrastructure and support that health centers need to effectively implement EHR and other HIT systems and ensure that they have the tools available to prepare for meaningful use. As of July 2009, HRSA currently supports 38 HCCNs for various HIT activities from EHR implementation to advanced HIT technologies, such as personal health records and electronic health information exchange. Approximately 400 health centers are current members or obtain HIT services from HCCNs. 2. Cost Sharing / Matching Cost sharing or matching funds are not required components for this funding opportunity. However, applicants are strongly encouraged to demonstrate cost participation as an indicator of community and organizational support for the project and the likelihood that the project will 11 continue after Federal grant support has ended. Cost participation may be in the form of cash or in-kind contributions (e.g., equipment, personnel, building space, indirect costs). Applicants are expected to maximize the use of non-Federal funds to the greatest extent possible and to present a plan for decreasing dependence on Federal funds to assure the long-term sustainability of the program. Applicants are encouraged to explore the flexibility provided under the recent self-referral safe harbor for Federally Qualified Health Centers (FQHC) providers that protects remuneration in the form of goods, items, services, donations, loans or combination thereof to a qualifying health center from an individual or an entity. For more information, go to http://oig.hhs.gov/fraud/safeharborregulations.asp. Applicants should also describe how they will work with their proposed partners to share costs. Note that the reasonableness of the total budget and the extent to which other appropriate resources are obtained and leveraged within the budget are both key elements in the review of the proposed project. 3. Other Applications that exceed the ceiling amount will be considered non-responsive and will not be considered for funding under this announcement. An applicant may not exceed the following amounts for the proposed project. Further, an application may not exceed a total amount of $3 Million. Category 1: (EHR) - $3 Million Category 2: (HIT Innovation Project) - $1 Million Any application that fails to satisfy the deadline requirements referenced in Section IV.3 will be considered non-responsive and will not be considered for funding under this announcement. All applicants must ensure that the community-based boards of the collaborating centers/members are knowledgeable and supportive of the HCCN's activities. All applicants are expected to have a Memorandum of Agreement (MOA) signed by all CEOs and Board Chairs of the HCCN members. (See the Appendix A: Memorandum of Agreement, as well as definition of ―HCCN members‖ in Section VIII). Throughout the application the applicant shall, wherever appropriate, describe the program's strategic plan, policies, and initiative(s) that demonstrate a commitment to providing culturally and linguistically competent health care and to developing culturally and linguistically competent health care providers, faculty, staff, and program participants. This includes participation in, and support of, programs that focus on cross-cultural health communication approaches as strategies to educate health care providers serving diverse patients, families, and communities. IV. Application and Submission Information 1. Application Materials and Required Electronic Submission Information HRSA is requiring applicants for this funding opportunity to apply electronically through Grants.gov. All applicants must submit in this manner unless the applicant is granted a written exemption from this requirement in advance by the Director of HRSA's Division of Grants Policy or designee. Grantees must request an exemption in writing from email@example.com 12 and provide details as to why they are technologically unable to submit electronically through the Grants.gov portal. Make sure that you specify the announcement number for which you are seeking relief and include specific information, including any tracking or anecdotal information received from Grants.gov and/or the HRSA Call Center, in your justification request. As indicated in this guidance, HRSA and its Grants Application Center (GAC) will only accept paper applications from applicants that received prior written approval. Refer to HRSA's Electronic Submission User Guide, which can be found at http://www.hrsa.gov/grants/userguide.htm, for detailed application and submission instructions. Pay particular attention to Section 3, which provides detailed information on the competitive application and submission process. Applicants must submit proposals according to the instructions found in the User Guide referenced above, using this guidance in conjunction with Public Health Service (PHS) Application Form 5161-1. These forms contain additional general information and instructions for grant applications, proposal narratives, and budgets. These forms may be obtained from the following sites by: (1) Downloading from http://www.hrsa.gov/grants/forms.htm Or (2) Contacting the HRSA Grants Application Center at: The Legin Group, Inc. 910 Clopper Road Suite 155 South Gaithersburg, MD 20878 Telephone: 877-477-2123 email@example.com Instructions for preparing portions of the application that must accompany Application Form 5161-1 appear in the ―Application Format‖ section below. Pre-Application Conference Call HRSA will hold one pre-application conference call for potential applicants. The conference call will provide an overview of this program guidance and will include an opportunity for organizations to ask questions. The pre-application call information is as follows: 2 PM ET on December 18, 2009 Call in number: 888-810-8164 Passcode: HCCN The replay number for the pre application call is: 800-839-3419. The replay recording will be available until February 5, 2010. 2. Content and Form of Application Submission Application Format Requirements 13 See Section 5 of the aforementioned User Guide for detailed application submission instructions. These instructions must be followed. The total size of all uploaded files may not exceed the equivalent of 80 pages when printed by HRSA, approximately 10 MB. This 80-page limit includes the abstract, project and budget narratives, attachments, and letters of commitment and support. Standard forms are NOT included in the page limit. Applications that exceed the specified limits (approximately 10 MB, or that exceed 80 pages when printed by HRSA) will be deemed non-compliant. All non-compliant applications will be returned to the applicant without further consideration. Application Format Applications for funding must consist of the following documents in the following order: 14 SF-424 Non-Construction – Table of Contents It is mandatory to follow the instructions provided in this section to ensure that your application can be printed efficiently and consistently for review. Failure to follow the instructions may make your application non-compliant. Non-compliant applications will not be given any consideration and those particular applicants will be notified. For electronic submissions, applicants only have to number the electronic attachment pages sequentially, resetting the numbering for each attachment, i.e., start at page 1 for each attachment. Do not attempt to number standard OMB approved form pages. For electronic submissions no table of contents is required for the entire application. HRSA will construct an electronic table of contents in the order specified. When providing any electronic attachment with several pages, add table of content page specific to the attachment. Such page will not be counted towards the page limit. For paper submissions (when allowed), number each section sequentially, resetting the page number for each section. i.e., start at page 1 for each section. Do not attempt to number standard OMB approved form pages. For paper submissions ensure that the order of the forms and attachments is as specified below. Form Application Section Instruction HRSA/Program Guidelines Type Application for Federal Form Pages 1, 2 & 3 of the SF-424 face page. Not counted in the page limit Assistance (SF-424) Project Summary/Abstract Attachment Can be uploaded on page 2 of SF-424 - Required attachment. Counted in Box 15 the page limit. Refer to guidance for detailed instructions. Provide table of contents specific to this document only as the first page Additional Congressional District Attachment Can be uploaded on page 2 of SF-424 - As applicable to HRSA; not Box 16 counted in the page limit HHS Checklist Form PHS-5161 Form Pages 1 & 2 of the HHS checklist. Not counted in the page limit Project Narrative Attachment Form Supports the upload of Project Narrative Not counted in the page limit Form document Project Narrative Attachment Can be uploaded in Project Narrative Required attachment. Counted in Attachment form. the page limit. Refer to guidance 15 Form Application Section Instruction HRSA/Program Guidelines Type for detailed instructions. Provide table of contents specific to this document only as the first page SF-424A Budget Information - FormPage 1 & 2 supports structured budget for Not counted in the page limit Non-Construction Programs the request of non-construction related funds SF-424B Assurances - Non- Form Supports assurances for non-construction Not counted in the page limit Construction Programs programs Disclosure of Lobbying Activities Form Supports structured data for lobbying Not counted in the page limit (SF-LLL) activities. Other Attachments Form Form Supports up to 15 numbered attachments. Not counted in the page limit This form only contains the attachment list Attachments 1-7 Attachment Can be uploaded in Other Attachments Refer to the attachment table form 1-15 provided below for specific sequence. Counted in the page limit To ensure that attachments are organized and printed in a consistent manner, follow the order provided below. Note that these instructions may vary across programs. Evidence of Non Profit status and invention related documents, if applicable, must be provided in the other attachment form. Additional supporting documents, if applicable, can be provided using the available rows. Do not use the rows assigned to a specific purpose in the program guidance. Merge similar documents into a single document. Where several pages are expected in the attachment, ensure that you place a table of contents cover page specific to the attachment. Table of contents page will not be counted in the page limit. Attachment Number Attachment Description (Program Guidelines) Attachment 1 Tables, charts, etc. Attachment 2 Staffing plan and personnel requirements; job descriptions for key personnel: 16 Attachment Number Attachment Description (Program Guidelines) Provide a staffing plan that discusses the staffing requirements necessary to accomplish the project. Staffing needs should be explained and should have a direct link to activities proposed in the project narrative and budget portion of your application. Provide the job descriptions for key personnel listed in the application. For purposes of this grant application, key personnel is defined as persons funded by this grant or persons conducting activities central to this grant program. Attachment 3 Biographical sketches of key personnel: Provide biographical sketches or resumes for persons occupying the key positions described in the application. Resumes and/or sketches should be brief (1-2 pages). In the event that a biographical sketch is included for an identified individual who is not yet hired, please include a letter of commitment from that person with the biographical sketch. Attachment 4 Letters of agreement and/or descriptions of proposed/existing contracts. Attachment 5 Project organizational chart: Provide an organizational chart of the HCCN that depicts the relationship among the members and includes the governing board. Attachment 6 Other relevant documents (i.e., dated letters of support). Be sure each additional attachment is clearly labeled. Include only letters of support which specifically indicate a commitment to the project. Attachment 7 Environmental Information & Documentation checklist (See Appendix E). 17 Note the following specific information related to your submission. Application Format i. Application Face Page Public Health Service (PHS) Application Form 5161-1 provided with the application package. Prepare this page according to instructions provided in the form itself. For information pertaining to the Catalog of Federal Domestic Assistance, the Catalog of Federal Domestic Assistance Number is 93.703. DUNS Number All applicant organizations are required to have a Data Universal Numbering System (DUNS) number in order to apply for a grant from the Federal Government. The DUNS number is a unique nine-character identification number provided by the commercial company, Dun and Bradstreet. There is no charge to obtain a DUNS number. Information about obtaining a DUNS number can be found at http://www.hrsa.gov/grants/dunsccr.htm or call 1-866-705- 5711. Please include the DUNS number in item 8c on the application face page. Applications will not be reviewed without a DUNS number. Additionally, the applicant organization is required to register with the Federal Government's Central Contractor Registry (CCR) in order to do electronic business with the Federal Government. Information about registering with the CCR can be found at http://www.hrsa.gov/grants/dunsccr.htm. ii. Table of Contents The application should be presented in the order of the Table of Contents provided earlier. Again, for electronic applications, no table of contents is necessary as it will be generated by the system. (Note: the Table of Contents will not be counted in the page limit.) iii. Application Checklist Application Form 5161-1 provided with the application package. iv. Budget Questions about the budget or fiscal matters should be directed to the Agency's Grants Management Specialist for the program as listed under guidance ―Section VII- Agency Contacts.‖ The budget forms (PHS 5161-1, SF-424A, pages 1 and 2) that are part of the application should be included in this section of the application. The budget justification narrative should remain under ―Section V- Budget Justification‖ of the application. Budget Information and Instructions for Completing the SF-424A 18 NOTE: Please follow the instructions found here rather than using the information found in PHS Form 5161-1. For Section A and Section B below, view both sections as separate pages; the columns do not align for these sections. SF-424A: Section A – Budget Summary Line 1, Column a: Enter HIT Implementation for HCCNs Line 1, Column b: Enter 93.703. Line 1, Columns c and d: Leave blank (not applicable for new applications). Line 1, Columns e and f: Enter the Project Costs for the first year of the project from Federal and non-Federal sources. Line 1, Column g: Enter the total for Columns ―e‖ and ―f‖. Line 2-5: Enter ―Year 2‖ on line two with the corresponding request for Federal in 2e and projected non-Federal for Year 2 in 2f with the total in 2g on third line. SF-424A: Section B – Budget Categories Section B: Include Federal break-down of expenses only. Line 6, column marked 1: Enter the amount of Federal support requested for each Object Class Category, rows ―a‖ through ―h‖ for program year one. Enter the total of ―a‖ through ―h‖ into row ―i‖. Note: See funding restrictions under Use of Funds section. Columns marked 2 and 3: Repeat above for line 6 for program year two. Line 6, Item j (Indirect Costs): Specify the amount of Indirect Charges. For indirect costs, note: if requesting indirect costs then include a copy of your indirect cost rate agreement with the Division of Cost Allocation as an attachment to the application. If the applicant does not have an indirect cost rate agreement negotiated, but plans to negotiate one as soon as notification of an award occurs, then it is possible to request up to 10% of direct salaries and wages ONLY. If the recipient fails to provide a timely proposal, indirect costs paid in anticipation of establishment of a rate will be disallowed. Refer to http://rates.psc.gov/ for further information. Line 6, Item k: The amount on Line 6 ―k‖ should be the same as the amount in Section A, Line 1, Column ―e‖ above, and Block 15a of the Face Page, SF-424. Line 7, Column 1: Leave blank. SF-424A: Section C – Non-Federal Resources Line 8, Column a: Enter HIT Implementation for HCCNs. 19 Line 8, Columns b, c, and d: Enter the value of cash and in-kind contributions contributed by the applicant, State and other sources and insert the total(s) in Column ―e‖. These figures correspond with those on the Face Page, Blocks 15 ―b‖, ―c‖, ―d‖, and ―e‖. Line 12, Column e: Enter the total of Columns ―b‖, ―c‖, and ―d‖. This amount should be the same as that shown in Section A, Line 1, Column ―f‖. Use Column ―a‖ rows to label each program year (one year per line) with corresponding projections in columns ―b‖, ―c‖, ―d‖ and ―e‖. SF-424A: Section D – Forecasted Cash Needs This section does not apply. Leave this section blank. SF-424A: Section E – Budget Estimates of Federal Funds Needed For Balance of the Project Leave blank. SF-424A: Section F – Other Budget Information Lines 21-23 can be left blank. This information is identified in the narrative justification. v. Budget Justification Provide a narrative that explains the amounts requested for each line in the budget. The budget justification should specifically describe how each item will support the achievement of proposed objectives. The budget period is a two-year budget period. However, the applicant must submit one-year budgets and budget justifications for each of the subsequent project period years at the time of application. Line item information must be provided to explain the costs entered in appropriate form, Application Form 5161-1. The budget justification must clearly describe each cost element and explain how each cost contributes to meeting the project's objectives/goals. Be very careful about showing how each item in the ―other‖ category is justified. The budget justification MUST be concise. Do NOT use the justification to expand the project narrative. Further, an application may not exceed a total amount of $3 Million. Category 1: (EHR) – Up to $3 Million Category 2: (HIT Innovation Project) – Up to $1 Million Line item information must be provided to explain the costs entered in Application Form 5161-1. The budget should depict Federal and non-Federal expenses as well as HCCN and health center expenses related to the cost elements of the project. Note: Implementing HIT (be it EHR or any other HIT) is a very expensive venture. It is recommended that HCCNs plan carefully around the budget. In addition to HRSA's online HIT Toolbox, Appendix D - HIT Budget Technical Assistance is provided to applicants for 20 items to consider in creating their budgets. In addition, please see Section IV.5 ―Use of Funds‖ section for health centers versus HCCN costs. Budget for Multi-Year Grant Award This announcement is inviting applications for two-year project and budget periods. Include the following in the Budget Justification narrative: Personnel Costs: Personnel costs should be explained by listing each staff member who will be supported from funds, name (if possible), position title, percent full time equivalency, and annual salary. Indirect Costs: Indirect costs are those costs incurred for common or joint objectives which cannot be readily identified but are necessary to the operations of the organization, e.g., the cost of operating and maintaining facilities, depreciation, and administrative salaries. For institutions subject to OMB Circular A-21, the term ―facilities and administration‖ is used to denote indirect costs. If an organization applying for an assistance award does not have an indirect cost rate, the applicant may wish to obtain one through HHS's Division of Cost Allocation (DCA). Visit DCA's website at: http://rates.psc.gov/ to learn more about rate agreements, the process for applying for them, and the regional offices which negotiate them. Fringe Benefits: List the components that comprise the fringe benefit rate, for example health insurance, taxes, unemployment insurance, life insurance, retirement plan, tuition reimbursement. The fringe benefits should be directly proportional to that portion of personnel costs that are allocated for the project. Travel: List travel costs according to local and long distance travel. For local travel, the mileage rate, number of miles, reason for travel and staff member/consumers completing the travel should be outlined. The budget should also reflect the travel expenses associated with participating in meetings and other proposed trainings or workshops. Equipment: List equipment costs and provide justification for the need of the equipment to carry out the program's goals. Extensive justification and a detailed status of current equipment must be provided when requesting funds for the purchase of computers and furniture items that meet the definition of equipment (a unit cost of $5000 and a useful life of one or more years). Supplies: List the items that the project will use. In this category, separate office supplies from medical and educational purchases. Office supplies could include paper, pencils, and the like; medical supplies are syringes, blood tubes, plastic gloves, etc.; and educational supplies may be pamphlets and educational videotapes. Remember, they must be listed separately. Subcontracts: To the extent possible, all subcontract budgets and justifications should be standardized, and contract budgets should be presented by using the same object class 21 categories contained in the Standard Form 424A. Provide a clear explanation as to the purpose of each contract, how the costs were estimated, and the specific contract deliverables. Other: Put all costs that do not fit into any other category into this category and provide an explanation of each cost in this category. vi. Staffing Plan and Personnel Requirements Applicants must present a staffing plan and provide a justification for the plan that includes education and experience qualifications and rationale for the amount of time being requested for each staff position. Position descriptions that include the roles, responsibilities, and qualifications of proposed project staff must be included in Attachment 2. Copies of biographical sketches for any key employed personnel that will be assigned to work on the proposed project must be included in Attachment 3, and a CV must be submitted for the project director. Wherever appropriate, the applicant shall describe a plan to recruit and retain staff, health care providers, faculty, and students with demonstrated experience serving the specific target population and familiarity with the culture and literacy level of the particular target group. vii. Assurances Application Form 5161-1 provided with the application package. viii. Certifications Application Form 5161-1 provided with the application package. ix. Project Abstract Provide a summary of the application. Because the abstract is often distributed to provide information to the public and Congress, please prepare this so that it is clear, accurate, concise, and without reference to other parts of the application. It must include: a. A brief description of the proposed grant project, including the needs to be addressed, the proposed services, and the population group(s) to be served. b. The overall summary scope (scope is based on participation by organization, not sites) of the project by filling in the following statements: The total number of organizations impacted by this proposal is Y, of which X are Section 330 grantees. The total number of sites impacted by this proposal are Y of which X are Section 330 sites. The total number of patients impacted by this proposal are Y of which X are Section 330 patients. c. A description of the clinical impact of implementing the EHR/HIT upon the target population. Also, please place the following at the top of the abstract: 22 Project Title State the category the applicant is applying for (Category 1 - EHR or Category 2 - HIT Innovation Project) Applicant Name Address Contact Phone Numbers (Voice, Fax) E-Mail Address Web Site Address, if applicable The project abstract must be single-spaced and limited to one page in length. x. Program Narrative for Category 1 - EHR and Category 2 - HIT Innovation Project This section provides a comprehensive framework and description of all aspects of the proposed program. It should be succinct, self-explanatory, and well-organized so that reviewers can understand the proposed project. Use the following section headers for the Narrative: INTRODUCTION This section should briefly describe the purpose of the proposed project. NEEDS ASSESSMENT This section outlines the needs of the proposed project. The target population and its unmet health needs must be described and documented in this section. Demographic data should be used and cited whenever possible to support the information provided. This section should help reviewers understand the community and/or organization that will be served by the proposed project. Below are some suggestions to include in this section. A. Project Scope: Using a table format, include the specific Section 330 health centers by organization as follows: Organization Name, Uniform Data System (UDS)Number, number of sites per organization, number of patients, number of medical provider FTE (see http://bphc.hrsa.gov/uds/manual/table5.htm), the number of software licenses over the project period, and, if appropriate, the date of when the MOA was signed. B. Assurance of New Activity for those Previously Funded: Clearly indicate the health centers, including UDS number, or other organizations which are included in other previously funded scopes under the HCCN program for HIT and delineate the new activity being done. For each organization, indicate number of sites per organization that have an implemented EHR or other HIT under a prior scope (indicate grant number), 23 number of sites per organization that will be implementing EHR or other HIT under this scope of project, C. Marketplace Assessment: Describe factors affecting the success of the project. Stronger applicants will provide strong evidence of coordination of this project with other national, regional, state and/or local HIT or other relevant initiatives. RESPONSE Describe methods that will be used to meet the program requirements and expectations in this grant announcement. The project plan should be supported by a two-year work plan that shows how the implementation of an EHR/HIT will support the organizations' business and clinical operations. Below are some suggested areas to address: A. Readiness to Apply: Provide evidence of the readiness of the HCCN to apply for an implementation grant in terms of: 1. Vision: Describe the extent to which the proposed technology will increase health outcomes and allow for population health management, including a commitment to serving the specific target population and familiarity with the culture and literacy level of the particular target group. 2. Strategic Planning: Provide a brief overview of the HCCN's multi-year strategic planning process and evidence that this is part of the participating centers' long term strategic and business plans. 3. Other: Identify other critical aspects of readiness activities completed such as the workflow analysis and the identification of specific HIT functions the HCCN will provide related to this project versus the functions that will remain at the health center level. Applicants should remember this is a HCCN model. B. Due Diligence: Provide evidence that the due diligence of vendor selection is complete and name the selected vendor. This may include information related to activities of creating a request of proposal, evaluating the product, negotiating the contract, legal review of any vendor supplied contract, etc. Thorough due diligence includes at a minimum: 1. Key Features to Improve Patient Care in a Health Center: Provide evidence that the system selected will include key features essential to caring for safety net populations, such as registry functions, decision support tools that include actionable reminders, and quality measures and UDS reporting. That is, the applicant must include evidence that reports can be generated from the system(s) to document population based health outcomes. Grantees are expected to secure a flexible, user operated report writing tool that is either integrated with the PMS/EHR system or provided as an external tool by a 3rd party, capable of accessing the files created by such system. The HRSA EHR selection guidelines for health centers can be found at: http://www.hrsa.gov/healthit/ehrguidelines.htm. 24 2. Standards and Interoperability: Describe how the proposed technology complies with existing Federal and industry standards. Category 1 and Category 2 projects that wish to build upon an existing electronic health record system must have a certified EHR system in place that is certified by a body recognized by the Secretary of HHS. State the certification date of the EHR. In addition, explain how the proposed technology complies with HIPAA to address the privacy of patients and the confidentiality of information transmitted. Include information on how the system(s) under consideration are capable of unidirectional and bidirectional communications with other systems, such as practice management systems, and laboratory information systems (LIS) using the Health Level 7 (HL7) messaging standard. Data should be integrated or interfaced using a common structure, data elements, business rules and practices in order to facilitate a future health information exchange across a state or a regional marketplace. Include information, as it is available, related to plans to interface with entities in and external to the HCCN, and indicate how such plans are included in the business model and/or in the strategic plan. Category 2 projects that will expand HIE are strongly encouraged to use Healthcare Information Technology Standard Panel (HITSP) recognized standards (http://hitsp.org/) in order to more easily exchange data with outside organizations, such as Regional Health Information Organizations. C. Implementation Process: Based on the completed workflow analysis, describe how the implementation will take place. Will it be by specialty, by site, or by provider panel? Include a description of the implementation team comprised of staff from each project site that includes (but is not limited to) clinicians and IT leadership as well as information on the HCCN resources (e.g., training, staffing, vendor management, and leadership) in place to help ensure successful implementation of the HIT at each site. Describe the HCCN's experience with the implementation model and/or process it presents and how it integrates lessons learned into future roll-outs. Include information on the HIT roll-out should it include simultaneous roll-out with a practice management system. This simultaneous roll-out can occur successfully in experienced and established HCCNs, but likely poses significant challenges for those with less demonstrated expertise. D. Work Plan: Describe the activities or steps that will be used to achieve and evaluate the scope of the proposed project, and use a time line that includes each activity and identifies responsible staff. Structure the work plan in a table format according to the aforementioned phases (planning, testing, infrastructure, and roll-out) that identifies: 1. Goals how clinical and business practices will look after implementation (i.e., the desired end product); 2. Objectives; 3. Key action steps for each objective; 4. Responsible entity person, committees, etc.; 5. Timetable; and 25 6. Cost by Objective. E. Resolution of Challenges: Discuss the challenges that are likely to be encountered in designing and in implementing the activities described in the work plan and describe approaches that will be used to resolve such challenges. The challenges to consider include, but are not limited, to the following: 1. Collaboration and sharing of data: Integrating functions among different organizations while meeting their diverse needs in terms of size, organizational capacity and finances can easily go astray, if the members do not all agree in advance and do not have a common set of principles and history of working together. Due to the complexity of HIT, it is strongly not recommended to have HIT as the first integrated function among centers. Likewise, while health information exchange may serve as a goal, it is not recommended that HIE and EHR implementation occur at the same time. 2. Clinician Acceptance, Support, and Involvement: It is imperative to have clinician involvement throughout the planning, implementation, and continuous evaluation of any HIT system. It is important that clinicians have an understanding of the challenges in project implementation and that they demonstrate competence and willingness to meet those challenges. It is critical to commit resources for training staff and technical support to operate and maintain the system. It is important that the HCCN assure the technology is integrated into clinician practice and that issues of a potential decrease in productivity during implementation are planned for prior to implementation. 3. Consumer (Patients) Acceptance, Support and Involvement: It is also imperative to have consumer involvement throughout the planning, implementation, and continuous evaluation of any HIT system. Include policies and initiatives that demonstrate a commitment to providing culturally and linguistically competent health care and to developing culturally and linguistically competent health care providers, faculty, staff, and program participants. This includes participation in and support of programs that focus on cross-cultural health communication approaches as strategies to educate health care providers serving diverse patients, families, and communities. 4. Contingency Planning and Business Recovery Process in the event of a business interruption at the Network level: Include information on the development of back up systems that ensure the continuity of the EHR/HIT system implementation and continuity of care (24/7) should an event occur by chance or unforeseen circumstances related to the HCCN such as a disaster. 5. Taking on too much. Focus. As stated earlier, the use of a single vendor and platform is strongly recommended. Include information on the EHR/HIT roll-out should it include simultaneous roll-out with a practice management system. This simultaneous roll-out can occur successfully in experienced and established 26 HCCNs but likely poses significant challenges for those with less demonstrated expertise. For Category 2 projects, it is strongly recommended that applicants do not implement multiple innovative HIT projects during the 2-year project period. Focus on what is reasonable in terms of time, coordination and costs. EVALUATIVE MEASURES With quality initiatives occurring within the broader health care community, the Health Resources and Services Administration (HRSA) is incorporating quality-related measures that place greater emphasis on health outcomes and demonstrate the value of care delivered by health centers. Performance reporting can result in the ability of the HCCNs to make evidence-based statements about the impact of health centers on improving access to cost- effective primary care for the nation's underserved populations. Ultimately, using HIT as a tool, networks should have the ability to track over time improved quality of care delivered to their patient populations, improved health outcomes, and improved systems of care. Thus, the applicant must provide a balanced set of at least three proposed performance measures (process and outcome), that represents the health centers in the scope of this grant and, that reflect improved health outcomes and systems of care. Each measure must have baseline data (stated with a numerator, denominator and as a percent) at the time of application; this will allow computation of percentage increases in measures over time. The applicant must also describe the method to monitor and to evaluate the project results as per the program expectation described earlier in terms of post implementation/roll-out evaluation. This begins with defining what a ―successful implementation‖ is for this project based in input from the health centers. Also, applicants must include a customer satisfaction process (HCCN to health center) that describes: how the HCCN addresses issues, how often, and how formally, etc. with its member centers. Describe activities that enable the HCCN to evaluate or better understand the feedback and experiences of its health center customers. For Category 1 (EHR) Projects: Applicants must have at least three performance measures, two of which must be the child immunization and diabetes control measures as defined by the Uniform Data System (UDS). See http://bphc.hrsa.gov/uds/2008manual/default.htm. Other performance indicators or measures may be selected from the HRSA Core Clinical Measures Set. See http://www.hrsa.gov/quality/coremeasures.htm. These measures also align with the National Quality Forum (NQF). The applicant may also choose to create their own third performance measure. For Category 2 Innovation Projects: If the UDS measures on childhood immunizations and diabetes do not best represent the 27 outcomes of the proposed project, then the applicant may wish to select at least three more appropriate performance measures. The applicant may use any of the HRSA's Core Clinical Measures, NQF measures, or any other nationally recognized performance measures that would show health improvements created by the proposed project. The applicant may also choose to create their own performance measures. IMPACT A. Overall: This will be critical later on with customer satisfaction. Describe the quantifiable difference that the project expects to make on the business and on the clinical operations of the participating organizations. Include a description of clinical changes that will result from the EHR/HIT implementation to address need, as well as the anticipated impact that this project will have on patients served by the grantee. Address what change in clinical practice the HCCN is seeking to make. Explain how the HCCN will know whether or not such change is an improvement. Since implementing HIT is a challenging endeavor, it is important that this be part of both an organization's strategic plan and its business plan. Identify the quantifiable difference that the project expects to make including each of the following (an example of an expanded EHR or HIT system may involve additional functionality added to the system): Number of additional Health Centers/sites/providers with a certified EHR. Number of additional Health Centers/sites/providers with an expanded certified EHR. Number of additional Health Centers/sites/providers with an expanded HIT System other than an EHR (specify what kind). Number of created or retained FTEs. B. Meaningful Use: It is imperative that the EHR/HIT system implemented have the functionality to allow health centers to actively participate in the enhanced payments to be available via Medicare and Medicaid for meaningful use. Include information on the various types of functionality of the EHR/HIT system (areas such as data element collection, measure reporting, CPOE, CDS, etc.) that will prepare the health centers for participation in Medicare or Medicaid incentive payments C. Sustainability: This is one-time money. Grant funds will not pay for ongoing operational and maintenance cost. It is important that the HCCN and its participating health centers have a plan for how the project will be sustained during and after a period of Federal grant funding, especially the ongoing maintenance and operational costs. Provide a brief overview of the financial capabilities and financing of the project following the full drawdown of Federal funds. RESOURCES AND CAPABILITIES A. Adequacy of staff and management: Describe the plan for managing the project. The application should designate both a project director who has day-to-day responsibility for the technical, administrative, evaluation, and financial aspects of the project and a principal investigator who has overall responsibility for the project. The project director may be the same as the principal investigator. Describe how the 28 applicant has analyzed the adequacy of its technical staff and explain how this system will be maintained once it is up and running. The adequacy of technical staff is critical for successful implementation. To ensure the EHR/HIT is facilitating the HCCN's clinical objectives, it is important that the technical project director work closely with the lead clinician. The HCCN's strategy to improve patient health outcomes should always inform technical decisions regarding the EHR/HIT. B. CIO, Leadership, and Key Staff: Include evidence that a CIO and helpdesk is already in place. Provide a short description of the responsibilities of key staff members, and note the full-time equivalent (FTE) each staff person must devote to the project. Identify who in a leadership position, within the application organization, will be involved in the project, and describe what his/her specific role and time commitment will be. The CIO will provide technology vision and leadership for developing and implementing the EHR and HIT innovations that support the enterprise in a constantly changing and intensely competitive marketplace. In addition, the HCCN will have in place appropriate clinical leadership and should address the existing clinical committees, structures, and potential clinical ―champions.‖ Include a description of the implementation team comprised of staff from each project site that includes (but is not limited to) clinicians and IT leadership, as well as information on the HCCN resources (e.g., training, staffing, vendor management, and leadership) in place to help ensure successful implementation of the EHR/HIT at each site. Describe the HCCN's experience with the implementation model and/or process it presents and how it integrates lessons learned into future roll-outs. C. Organizational Information: Provide organizational information on the applicant's current mission, structure, vision, and activities. Describe how these contribute to its ability to execute the program requirements. Some areas to consider are: 1. Past experience with strong engagement in quality improvement programs. Provide a brief description and documentation of results from participation in the Health Disparities Collaboratives or equivalent clinical quality improvement program. Results do not just include the participation in the Collaboratives, but rather the actual use of data to improve care. Examples of results include the centers' success in decreasing their average Hemoglobin A1C or increase their immunization or other preventive care rates. Remember this is not about the technology; it is about using the technology effectively to improve the centers' operation. 2. Ability to foster collaboration internal to the HCCN, particularly around the sharing of data. If appropriate, expand on the challenges mentioned earlier around fostering collaboration and sharing data among diverse organizations. The applicant may choose to include a description of how it may foster a vision and cohesion within the HCCN. The applicant may also choose to discuss the relationship between all partners/HCCNs members/sub-contractors on the project 29 including the level of involvement of the boards among the HCCN members in the planning, development, and performance of the proposed project. Elements of internal collaboration include: a. Business arrangements among HCCN entities. b. Demonstrated commitment to the development, implementation, and operation of the HCCN. Commitment includes time, financial support, expertise, and other resources devoted to achieving the goals and objectives of the HCCN and of the EHR/HIT implementation project. c. Signed MOA inclusive of all elements as outlined in Appendix A. d. An explanation as to the appropriateness of the entity as an internal collaborator to the HCCN and what expertise they bring to the HCCN. e. An outline of the roles and responsibilities, within the HCCN, of each member. f. A description of the governance structure for the HCCN that demonstrates there is an effective, independent HCCN-driven leadership in place. Applicants must demonstrate that the governing body, rather than an individual HCCN member, will make financial and programmatic decisions. 3. Ability to foster collaboration external to the Network. Describe the ability of the organization to build partnerships outside of the HCCN and how these partnerships will further the success of the project. Include information on the ability of this organization to build partnerships with state and/or local entities, other HCCNs, Regional Extension Centers (to be established), other health centers, Quality Improvement Organizations, and/or the State Primary Care Association. Elements of external collaboration include (a-f) described above only modified to pertain to entities external to the membership of the HCCN. For HIE, describe prior collaboration with any outside entities with which you will exchange data. NETWORK IT FUNCTION HCCNs should be experienced with integrating IT functions prior to implementing an EHR. This experience means that this essential mission critical function is performed at the HCCN level for the HCCN members enabling the center to perform their business and clinical operations more efficiently. Thus, the activity is either shared or integrated at the HCCN level and is not duplicated at the member/collaborator level. Provide evidence that HCCN has such experience. For more information, see definition of Operational Network. 30 xi. Attachments Please provide the following items to complete the content of the application. Please note that these are supplementary in nature and are not intended to be a continuation of the project narrative. Be sure each attachment is clearly labeled. 1) Attachment 1: Tables, Charts, etc. To give further details about the proposal. 2) Attachment 2: Job Descriptions for Key Personnel Keep each to one page in length as much as is possible. Item 6 in the Program Narrative section of the PHS Form 5161-1 provides some guidance on items to include in a job description. 3) Attachment 3: Biographical Sketches of Key Personnel Include biographical sketches for persons occupying the key positions described in Attachment 2, not to exceed two pages in length. In the event that a biographical sketch is included for an identified individual who is not yet hired, please include a letter of commitment from that person with the biographical sketch. 4) Attachment 4: Letters of Agreement and/or Description(s) of Proposed/Existing Contracts (project specific) Provide any documents that describe working relationships between the applicant agency and other agencies and programs cited in the proposal. Documents that confirm actual or pending contractual agreements should clearly describe the roles of the subcontractors and any deliverable. Letters of agreements must be dated. 5) Attachment 5: Project Organizational Chart Provide a one-page figure that depicts the organizational structure of the project, including subcontractors and other significant collaborators. 6) Attachment 6: Other Relevant Documents Include here any other documents that are relevant to the application, including letters of supports. Letters of support must be dated. 7) Attachment 7: Environmental Information & Documentation checklist See Appendix E, beginning on page 63. Include only letters of support which specifically indicate a commitment to the project/program (in-kind services, dollars, staff, space, equipment, etc.). Letters of agreements and support must be dated. List all other support letters on one page. 3. Submission Dates and Times Application Due Date 31 The due date for applications under this grant announcement is February 5, 2010 at 8:00 P.M. ET. Applications will be considered as meeting the deadline if they are received and validated by Grants.gov on or before the due date and time. Please allow time for the validation process. Please consult Section 3 of the Electronic Submission User Guide for detailed instructions on submission requirements. The Chief Grants Management Officer (CGMO) or designee may authorize an extension of published deadlines when justified by circumstances such as acts of God (e.g., floods or hurricanes), widespread disruptions of mail service, or other disruptions of services, such as a prolonged blackout. The authorizing official will determine the affected geographical area(s). Applications must be submitted by 8:00 P.M. ET. To ensure that you have adequate time to follow procedures and successfully submit the application, we recommend you register immediately in Grants.gov and complete the forms as soon as possible, as this is a new process and may take some time. Please refer to http://www.hrsa.gov/grants/electronicsubmission.htm for important specific information on registering, and Section 3 of HRSA's Electronic Submission User Guide (http://www.hrsa.gov/grants/userguide.htm) for important information on applying through Grants.gov. Late applications: Applications which do not meet the criteria above are considered late applications. Health Resources and Services Administration (HRSA) shall notify each late applicant that its application will not be considered in the current competition. 4. Intergovernmental Review The Health Information Technology Implementation for Health Center Controlled Networks is a program subject to the provisions of Executive Order 12372, as implemented by 45 CFR 100. Executive Order 12372 allows States the option of setting up a system for reviewing applications from within their States for assistance under certain Federal programs. Application packages made available under this guidance will contain a listing of States which have chosen to set up such a review system and will provide a State Single Point of Contact (SPOC) for the review. Information on states affected by this program and State Points of Contact may also be obtained from the Grants Management Officer listed in the Agency Contacts section, as well as from the following Web site: http://www.whitehouse.gov/omb/grants/spoc.html. All applicants other than Federally recognized Native American Tribal Groups should contact their SPOC as early as possible to alert them to the prospective applications and receive any necessary instructions on the State process used under this Executive Order. Letters from the State Single Point of Contact (SPOC) in response to Executive Order 12372 are due sixty days after the application due date. 32 5. Funding Restrictions Applicants responding to this announcement may request funding for a project period of up to 2 years. Approximately $88 Million is expected to be available to fund up to 36 awards. Category 1 will provide approximately $78 million to fund up to 26 HCCNs for EHR implementation, at a maximum of $3 Million for each project. Category 2 will provide approximately $10 million to fund up to 10 HCCNs to implement HIT Innovative projects other than EHR at a maximum of $1 Million for each project. Further, an application may not exceed a total amount of $3 Million. Use of Funds Funds awarded under this program may be used to purchase or lease equipment, which may include data and information systems as well as training and technical assistance related to the provision of HIT services. Funds may also be used for the initial purchase of software. The use of HRSA funds to purchase new EHR software and products is limited to certified software and products by a certifying body that is recognized by the Secretary of HHS, which will be a key component in achieving meaningful use. Grantees are strongly encouraged to use Health Information Technology Standards Panel (HITSP) ―recognized standards‖ regardless of the type of product they are purchasing. Federal funds may not be used for recurring costs such as rent, software maintenance, telecommunications, and utilities. These funds may not be used to individual collaborator uses, such as equipment purchase at the center level or center staffing, etc. Funds from this grant may not be used for direct patient care. Reviewers will consider the budget's dependency solely on Federal funds. HRSA recommends that these grant funds comprise no more than 60 percent of the total approved cost of the project (sum of the HRSA share and the non-Federal share) with approximately 40 percent of the total costs of the proposal being supported with other funds. In the event that a participating health center ceases its membership in the HCCN itself, then any such Federal funds used to benefit that center shall be treated in accordance with the Memorandum of Agreement set forth by the HCCN for purposes of this project. 6. Other Submission Requirements As stated in Section IV.1, except in rare cases, HRSA will no longer accept applications for grant opportunities in paper form. Applicants submitting for this funding opportunity are required to submit electronically through Grants.gov. To submit an application electronically, please use the http://www.Grants.gov (―Apply for Grants‖) website. When using Grants.gov, you will be able to download a copy of the application package, complete it off-line, and then upload and submit the application via the Grants.gov site. As soon as you read this, whether you plan on applying for a HRSA grant later this month or later this year, it is incumbent that your organization immediately register in Grants.gov and become familiar with the Grants.gov site application process. If you do not complete the 33 registration process, you will be unable to submit an application. The registration process can take up to one month, so you need to begin immediately. To be able to successfully register in Grants.gov, it is necessary that you complete all of the following required actions: • Obtain an organizational Data Universal Number System (DUNS) number. • Register the organization with Central Contractor Registry (CCR). • Identify the organization's E-Business POC (Point of Contact). • Confirm the organization's CCR ―Marketing Partner ID Number (M-PIN)‖ password. • Register an Authorized Organization Representative (AOR). • Obtain a username and password from the Grants.gov Credential Provider. Instructions on how to register, tutorials and FAQs are available on the Grants.gov web site at www.grants.gov. Assistance is also available from the Grants.gov help desk at email@example.com or by phone at 1-800-518-4726. Formal submission of the electronic application: Applications completed online are considered formally submitted when the Authorizing Official (AO) electronically submits the application to HRSA through Grants.gov. Applications will be considered as having met the deadline if the application has been successfully transmitted electronically by your organization's Authorizing Official through Grants.gov on or before the deadline date and time. It is incumbent on applicants to ensure that the AO is available to submit the application to HRSA by the application due date. We will not accept submission or re-submission of incomplete, rejected, or otherwise delayed applications after the deadline. Again, please understand that we will not consider additional information and/or materials submitted after your initial application. You must therefore ensure that all materials are submitted together. Further information on the HRSA electronic submission policy can be obtained at http://www.hrsa.gov/grants/electronicsubmission.htm. V. Application Review Information 1. Review Criteria Procedures for assessing the technical merit of grant applications have been instituted to provide for an objective review of applications and to assist the applicant in understanding the standards against which each application will be judged. Critical indicators have been developed for each review criterion to assist the applicant in presenting pertinent information related to that criterion and to provide the reviewer with a standard for evaluation. Review criteria are outlined below with specific detail and scoring points. 34 Review Criteria are used to review and rank applications. The Health Information Technology Implementation for Health Center Controlled Networks Funding Opportunity has 7 review criteria: (10 points) Criterion 1: NEED (25 points) Criterion 2: RESPONSE (10 points) Criterion 3: EVALUATIVE MEASURES (10 points) Criterion 4: IMPACT (25 points) Criterion 5: RESOURCES/CAPABILITIES (10 points) Criterion 6: NETWORK IT FUNCTION (10 points) Criterion 7: SUPPORT REQUESTED Applicants should pay strict attention to addressing all these criteria, as they are the basis upon which the reviewers will evaluate their application. Criterion 1: NEED (10 points): The extent to which the application describes the problem and associated contributing factors to the problem, as well as the anticipated impact that this project will have on specific health outcome measures for patients served by the grantee. In addition, Program is interested in the extent to which the applicant: Clearly identifies the target population that the project will impact. Includes project participants, using a table format, include the specific project participants by organization including: Organization Name, UDS #, # of sites per organization, # patients, # provider FTE, the number of software licenses over the project period, and, if appropriate, the date of when the MOA was signed. Describes project relationship to marketplace assessments, including linkages to community HIT initiatives. If applicable. For currently or previously funded HCCN, clearly distinguishes new activities versus the currently or previously supported activities. Criterion 2: RESPONSE (25 points): The extent to which the proposed project responds to the "Purpose" included in the program description. The clarity of the proposed goals and objectives and their relationship to the identified project. The extent to which the activities (scientific or other) described in the application is capable of addressing the problem and attaining the project objectives. In addition, Program is interested in the extent to which the applicant: Readiness to Apply (5 points) Vision and Long Term Strategic Planning. Provides a vision for how the proposed technology will increase health outcomes and allow for population health management. Provides evidence the project is part of the HCCN's long-term business and clinical strategy. Clearly identifies the specific HIT function(s) that will occur at the HCCN level versus the health center. 35 For an HIE, describes what information/data will be exchanged and what healthcare organizations will be part of the exchange. Due Diligence and Deployment (8 points) Procedures for implementing EHR/HIT project. Provides very clear evidence of the due diligence on the vendor selection process such that the product selected (the applicant should have named the vendor) includes essential key features to improve patient care in a health center, such as registry functions, decision support tools, and population-based health outcomes system reports capability, including information on any existing database or plans to build a database to help to generate such reports. Provides evidence of having or plans to secure a flexible, user operated report writing tool that is either integrated with the PMS/EHR system or provided as an external tool by a 3rd party, capable of accessing the files created by such system. Provides information on the vendor selection process that includes and describes the leadership role of clinicians in this process and states the selected vendor product. Describes how the proposed technology complies with existing Federal and industry standards, such as certification and protects patient privacy and confidentiality. Includes description of compliance with Federal privacy regulations as part of the HIPAA. For HIE, describes how the proposed technology will incorporate HITSP recognized standards. For projects building off an existing EHR: Identifies a certified EHR system already in place. Describes how the proposed technology will integrate with other internal IT systems in the center, such as the practice management system (PMS). Describes forethought as to any future plan for interfaces and connectivity to external entities, such as lab, pharmacy, and possibly hospitals. Describes a solid implementation strategy in place to help ensure successful implementation and roll-out of the EHR/HIT at each site. Work Plan (4 points) Activities or steps that will be used to achieve and evaluate the scope of the proposed project. Provides an achievable work plan table by phase (planning, testing, infrastructure, and roll-out), and in so doing, describes how the project will be managed and how work elements incorporate many of the budget line items proposed for the EHR/HIT implementation. Show staffing in place to support project activities. Outlines very clear action steps and responsible entities. Outlines a timetable that is reasonable for the project. Resolution of Challenges (8 points) Approaches that will be used to resolve challenges in designing and implementing work plan activities. Describes how the HCCN and project participants will collaborate and share data. Describes the business recovery process in the event of an interruption at the HCCN level, including the development of back-up systems to ensure the HIT implementation and continuity of care. Provides evidence of clinician acceptance, support, and involvement including: 36 Clinician and providers in planning, implementation, and continuous evaluation. Clinicians' and providers' understanding of challenges in implementation. Clinician leadership of due diligence activities. Clinicians and providers demonstrating competence with regards to the HIT activities and willingness to meet those challenges. Staff training and system operation and maintenance technical support resources. Planning to address decreased productivity during implementation. Knowledge and preparation of meaningful use. Provides evidence of consumer (patient) acceptance, support, and involvement. Criterion 3: EVALUATIVE MEASURES (10 points): The effectiveness of the method proposed to monitor and evaluate the project results. Evaluative measures must be able to assess 1) to what extent the program objectives have been met and 2) to what extent these can be attributed to the project. In addition, Program is interested in the extent to which the applicant provides: Three performance outcome measures; two of which HRSA defines to include diabetes control and child immunization for Category 1 and as optional for Category 2, depending on applicability to innovation project. Solid baseline data (not measures) provided in the application that includes numerator, denominator and percent, as well as source of the data; clinical outcome measures should be aligned with the UDS Manual if applicable. A description how the proposed project will enable the applicant to measure improvements in these outcome areas. A clear definition of a ―successful‖ implementation based on input and a description on the HCCN's ability to obtain and act on feedback from its customers (health centers, not patients). Criterion 4: IMPACT (10 points): Program is interested in the extent to which the applicant: Submits a proposal that will impact the business and clinical operations of the participating organizations in terms of efficiency, effectiveness, and safety (please see page 8 for definitions of efficiency, effectiveness, and safety). Includes a description of clinical changes that will result from the EHR/HIT implementation as well as the anticipated impact that this project will have on patients. Describes the plans for sustainability beyond Federal funding. Describes other HIT funding available to the HCCN. Describes the functionality of the EHR/HIT system to prepare health centers for participation in Medicare and Medicaid incentives for meaningful use. Criterion 5: RESOURCES/CAPABILITIES (25 points): The extent to which project personnel (including clinical, financial administrative, IS) are qualified by training and/or experience to implement and carry out the projects. The capabilities of the applicant organization, and quality and availability of facilities and personnel to fulfill the needs and requirements of the proposed project. In addition, Program is interested in the extent 37 to which the applicant: Describes how HCCN leaders have experience in large scale IT design and roll-out, including having a CIO in place, customer service, managing vendor products and relationships, and the ability to foster collaboration among diverse organizations particularly around the sharing of data. Consists of participating organizations that are experienced with clinical quality improvement programs, such as using and demonstrating the results of the Health Disparities Collaboratives (HDCs) to improve the clinical and business operations. Involves clinicians from across the HCCN in the planning and implementation of all HIT activities across the centers. Describes any existing quality improvement (QI) committees at the HCCN level and clinician involvement in this or related committees/workgroups. Describes experience in integrating, sharing, or collaborating among different organizations. Demonstrates commitment (as evidenced by the contribution of time, resources, cash, etc.) from each of the collaborators in the strategic planning process, work plan, budget spreadsheet and accompanying narrative and MOA. Substantiates and describes elements of collaboration for both internal and external collaborators to include: business arrangements, an outline of the roles and responsibilities within or with the HCCN for each member or entity, and expertise brought to the HCCN. Identifies adequate governance structure in its MOA and provides evidence of an appropriate governance/committee/advisory structure that demonstrates there is an effective, independent HCCN-driven leadership in place for the project. Also, the extent to which the applicant's MOA describes process and ability for governance structures to address and resolve conflict among members and accounts for potential but appropriate course of action if a health center ceases participation in the EHR/HIT project having received direct Federal EHR/HIT grant support funds in year one. (See Appendix A.) Substantiates and describes elements of collaboration for both internal and external collaborators to include: business arrangements, measurable commitment, an outline of the roles and responsibilities within or with the HCCN for each member or entity, and expertise brought to the HCCN. Criterion 6: NETWORK IT FUNCTION (10 points): The extent to which the proposal describes the current HIT infrastructure and experience with integrating IT functions prior to implementing an EHR/HIT system within the HCCN. In addition, Program is interested in the extent to which the applicant: Describes IT functions in place that are integrated. Provides a history of previously shared and/or collaborated IT functions at the HCCN level as applicable. If IT functions are not integrated at the HCCN level, but are integrated among project sites, then explain and describe such functions including a history of the length of time of the integrated functions as well as evidence of such integration among the HCCN centers. In addition to the above, for Category 2 projects, identifies and describes all of the HIT 38 systems and supporting infrastructure currently in place. A certified EHR that can collect data and generate data reports in an organized way must be in place. Criterion 7: SUPPORT REQUESTED (10 points): The reasonableness of the proposed budget in relation to the objectives, the complexity of the activities, and the anticipated results. In addition, Program is interested in the extent to which the applicant: Proposes a reasonable budget in relation to the objective, complexity of the activities, and anticipated results (including the number of organizations and sites that will have adopted the EHR/HIT with the Federal investment). Includes an illustrative table depicting Federal and non-Federal expenses as well as HCCN and health center expenses related to costs associated with: pre- implementation and readiness; implementation and staffing costs; and, acquisition and implementation costs. Demonstrates decreasing reliance on the Federal funding by the end of the project period, such as securing non-Federal funds to support the project, including the contributions, provided by the members. For Category 2, shows that the project is cost effective and feasible. For example, funds for a proposed HIE should allow the applicant to make a discrete advance in progress toward the full ability to exchange information. 2. Review and Selection Process The Division of Independent Review is responsible for managing objective reviews within HRSA. Applications competing for Federal funds receive an objective and independent review performed by a committee of experts qualified by training and experience in particular fields or disciplines related to the program being reviewed. In selecting review committee members, other factors in addition to training and experience may be considered to improve the balance of the committee, e.g., geographic distribution. Each reviewer is screened to avoid conflicts of interest and is responsible for providing an objective, unbiased evaluation based on the review criteria noted above. The committee provides expert advice on the merits of each application to program officials responsible for final selections for award. Applications that pass the initial HRSA eligibility screening will be reviewed and rated by a panel based on the program elements and review criteria presented in relevant sections of this program announcement. The review criteria are designed to enable the review panel to assess the quality of a proposed project and determine the likelihood of its success. The criteria are closely related to each other and are considered as a whole in judging the overall quality of an application. 3. Anticipated Announcement and Award Dates The anticipated date of award for the Health Information Technology Implementation for HCCNs Grant is June 1, 2010. VI. Award Administration Information 39 1. Award Notices Each applicant will receive written notification of the outcome of the objective review process, including a summary of the expert committee's assessment of the application's merits and weaknesses, and whether the application was selected for funding. Applicants who are selected for funding may be required to respond in a satisfactory manner to Conditions placed on their application before funding can proceed. Letters of notification do not provide authorization to begin performance. The Notice of Grant Award sets forth the amount of funds granted, the terms and conditions of the grant, the effective date of the grant, the budget period for which initial support will be given, the non-Federal share to be provided (if applicable), and the total project period for which support is contemplated. Once signed by the Grants Management Officer, it is sent to the applicant agency's Authorized Representative and reflects the only authorizing document. It will be sent prior to the start date of July 1, 2010. 2. Administrative and National Policy Requirements Successful applicants must comply with the administrative requirements outlined in 45 CFR Part 74 (non-governmental) or 45 CFR Part 92 (governmental), as appropriate. HRSA grant awards are subject to the requirements of the HHS Grants Policy Statement (HHS GPS) that are applicable to the grant based on recipient type and purpose of award. This includes, as applicable, any requirements in Parts I and II of the HHS GPS that apply to the award. The HHS GPS is available at http://www.hrsa.gov/grants/. The general terms and conditions in the HHS GPS will apply as indicated, unless there are statutory, regulatory, or award-specific requirements to the contrary (as specified in the Notice of Grant Award). ARRA-funded awards are also subject to the HHS Standard Terms and Conditions as described in Appendix B (or see http://www.hhs.gov/recovery/grantscontracts/recoverytermsconditions.html). HRSA is committed to ensuring access to quality health care for all. Quality care means access to services, information, materials delivered by competent providers in a manner that factors in the language needs, cultural richness, and diversity of populations served. Quality also means that, where appropriate, data collection instruments used should adhere to culturally competent and linguistically appropriate norms. For additional information and guidance, refer to the National Standards on Culturally and Linguistically Appropriate Services in Health Care published by HHS. This document is available online at http://www.omhrc.gov/CLAS. Awards issued under this guidance are subject to the requirements of Section 106 (g) of the Trafficking Victims Protection Act of 2000, as amended (22 U.S.C. 7104). For the full text of the award term, go to http://www.hrsa.gov/grants/trafficking.htm. If you are unable to access this link, please contact the Grants Management Specialist identified in this guidance to obtain a copy of the Term. 40 National Environmental Policy Act (NEPA) Compliance The National Environmental Policy Act (NEPA), 42 U. S. C. §4321-4370d requires, among other things, that Federal agencies consider the environmental impacts of any Federal action. In order to comply with the requirements of the American Recovery and Reinvestment Act and NEPA regulations, applicants will submit a completed Environmental Information and Documentation checklist for the HRSA to review and approve. Checklist: Grantees are required to submit a brief explanation supporting each response of ―yes‖ or ―no‖. Grantees will be required to complete and submit the attached checklist and receive HRSA approval prior to commencing grant funded work. See Appendix E, Environmental Information & Documentation. While the purchase of most equipment supporting social services or training is usually Categorically Excluded under NEPA, equipment containing or using mercury, radioactive sources, ozone depleting or other hazardous substances or materials constitute extraordinary circumstances and require specific environmental review because of the potential to cause a significant environmental effect. Equipment falling within this category should be separately listed on the checklist, and efforts to mitigate their waste or effects should be addressed in Section E. Mitigation of the checklist. While the cost for minor work to install equipment (such as routing wires or affixing monitors) would also be Categorically Excluded under NEPA, installation involving alterations and renovations (demolition of walls, reconfiguring rooms), setting up temporary trailers, etc., will require an Environmental Assessment (EA). Should any extraordinary circumstances be found, HRSA may determine that an Environmental Assessment is necessary. The grantee will be allowed to utilize grant funding to develop a draft EA, which HRSA will review and may adopt in final. It is advised that if the applicant does not possess in-house expertise in environmental compliance, the services of a consultant with the appropriate expertise be secured. Requirements on the contents of an EA can be found in regulations promulgated by the Council on Environmental Quality (CEQ) at 40 CFR. Part 1508 (and may be found on the web at http://ceq.hss.doe.gov/nepa/regs/ceq/toc_ceq.htm). Note that 40 C. F. R. § 1508.9 indicates that the EA is a concise document. It is HRSA's intention to adhere strongly to this instruction and to require only enough analysis to accomplish the objectives specified by the regulation. Grantees will be required to complete and submit a draft EA and receive HRSA approval prior to commencing grant funded work. Healthy People 2010 Healthy People 2010 is a national initiative led by HHS that sets priorities for all HRSA programs. The initiative has two major goals to: (1) Increase the quality and years of a healthy life; and (2) Eliminate our country's health disparities. The program consists of 28 focus areas and 467 objectives. HRSA has actively participated in the work groups of all the focus areas and is committed to the achievement of the Healthy People 2010 goals. 41 Applicants must summarize the relationship of their projects and identify which of their programs objectives and/or sub-objectives relate to the goals of the Healthy People 2010 initiative. Copies of the Healthy People 2010 may be obtained from the Superintendent of Documents or downloaded at the Healthy People 2010 website: http://www.health.gov/healthypeople/document/. The Public Health Service strongly encourages all award recipients to provide a smoke-free workplace and to promote the non-use of all tobacco products. Further, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. 3. Reporting The Recovery Act reporting requirements apply to ARRA funds only and do not extend to existing, non-ARRA funded activities or contracts. In instances where the agency chooses to supplement existing activities or contracts with ARRA funds, the ARRA funds must be reported on separately, and grantees must comply with ARRA requirements with respect to those funds. Please refer to pages 43-45 for specific ARRA-specific reporting requirements. All successful applicants under this guidance must comply with the following reporting and review activities: a. Audit Requirements Comply with audit requirements of Office of Management and Budget (OMB) Circular A-133. Information on the scope, frequency, and other aspects of the audits can be found on the Internet at www.whitehouse.gov/omb/circulars. Recipients agree to separately identify the expenditures for each grant award funded under ARRA on the Schedule of Expenditures of Federal Awards (SEFA) and the Data Collection Form (SF-SAC) required by Office of Management and Budget Circular A- 133.‖ This identification on the SEFA and SF-SAC shall include the Federal award number, the Catalog of Federal Domestic Assistance (CFDA) number, and amount such that separate accountability and disclosure is provided for ARRA funds by Federal award number consistent with the recipient reports required by ARRA Section 1512(c). (2CFR 215.26, 45 CFR 74.26, and 45 CFR 92.26). b. Payment Management Requirements Submit a quarterly electronic PSC-272 via the Payment Management System. The report identifies cash expenditures against the authorized funds for the grant. Failure to submit the report may result in the inability to access grant funds. The PSC-272 Certification page should be faxed to the PMS contact at the fax number listed on the PSC-272 form, or it may be submitted to the: 42 Division of Payment Management HHS/ASAM/PSC/FMS/DPM PO Box 6021 Rockville, MD 20852 Telephone: (877) 614-5533 c. Status Reports 1. Submit a Financial Status Report. A financial status report is required within 90 days of the end of each budget period. The report is an accounting of expenditures under the project that year. More specific information will be included in the award notice. 2. Quarterly Reporting: The American Reinvestment and Recovery Act grants administered by HRSA will have separate reporting requirements and funding categories (grantees will need to be able to track these funds separately from a health center's or HCCN's current Section 330 funds). See Appendix B for ARRA terms and conditions. Successful applicants under this guidance will be required to report quarterly on data elements prescribed by the Recovery Act, including reporting on the number of jobs created and retained, funds obligated and expended, projects and activities, and detailed information on subcontracts and subgrants. Grantees must continue to comply with the usual and customary reporting requirements of the Health Center Controlled Network Program, in addition to specific Recovery Act reporting. The usual and customary reporting of the HCCN program includes information such as but not limited to status project implementations, accomplishments, barriers and lessons learned. Recipients of Recovery Act funding will be required to provide periodic reports to ensure that funds are used for authorized purposes and instances of fraud, waste, error, and abuse are mitigated. Recovery Act funds can be used in conjunction with other funding as necessary to complete projects, but tracking and reporting must be separate to meet the reporting requirements of the Recovery Act. Grantees will be required to provide periodic reports on the impact of funding including: Number of health centers with new or expanded certified electronic health records Number of new full-time equivalents (FTEs) Projected number of jobs created and retained Project completion status (% complete) Actual versus projected budget information—uses of funds Quantifiable progress in terms of number of providers, patients and health centers implementing the HIT initiative Quantifiable difference this project will make in terms of health outcomes in a specific area 43 3. ARRA-Specific Reporting Requirements. Quarterly reports must be compliant with the provisions set in the Recovery Act. Recipients of Federal awards from funds authorized under Division A of the ARRA must comply with all requirements specified in Division A of the ARRA (Public Law 111-5), http://frwebgate.access.gpo.gov/cgi- bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf, including reporting requirements outlined in Section 1512 of the Act. For purposes of reporting, ARRA recipients must report on ARRA sub-recipient (sub-grantee and sub-contractor) activities as specified below. All information required by Section 1512 of the Recovery Act must be submitted through FederalReporting.gov. ARRA grantees must register for FederalReporting.gov. In order to register, you must have a DUNS number and a Central Contractor Registry (CCR) number. The website's registration function will be available no later than August 27, 2009, and prompt registration is encouraged. Recovery Act funds can be used in conjunction with other funding as necessary to complete projects, but tracking and reporting must be separate to meet the reporting requirements of the Recovery Act. Recipients of Recovery Act funding will be required to provide quarterly reports to ensure that funds are used for authorized purposes and instances of fraud, waste, error, and abuse are mitigated. As required by the Recovery Act, recipients are required to report the following information to the federal agency providing the award 10 days after the end of each calendar quarter; submission dates will be January 10, April 10, July 10, and October 10. These reports will include the following data elements, as prescribed by the Recovery Act: (1) The total amount of Recovery Act funds. (2) The amount of Recovery Act funds received that were obligated and expended to projects or activities. This reporting will also include unobligated allotment balances to facilitate reconciliations. (3) A detailed list of all projects or activities for which Recovery Act funds were obligated and expended, including: a. The name of the project or activity; b. A description of the project or activity; c. An evaluation of the completion status of the project or activity; and d. An estimate of the number of jobs created and the number of jobs retained by the project or activity. (4) Detailed information on any subcontracts or subgrants awarded by the recipient to include the data elements required to comply with the Federal Funding Accountability and Transparency Act of 2006 (P.L. 109-282) 44 http://frwebgate.access.gpo.gov/cgi- bin/getdoc.cgi?dbname=109_cong_public_laws&docid=f:publ282.109.pdf (5) For any sub-award equal to or larger than $25,000, the following information: The name of the entity receiving the sub-award; The amount of the sub-award; The transaction type (sub-grant or sub-contract); The North American Industry Classification System code or Catalog of Federal Domestic Assistance (CFDA) number; Program source (if known); An award title descriptive of the purpose of each funding action; The location of the entity receiving the award; The primary location of performance under the award, including the city, State, congressional district, or country (if non-U.S.); and A unique identifier of the entity receiving the award and of the parent entity of the recipient, should the entity be owned by another entity. (6) All sub-awards less than $25,000 or to individuals may be reported in the aggregate, as prescribed by HHS. (7) Recipients must account for each ARRA award and sub-award (sub-grant and sub-contract) separately. Recipients will draw down ARRA funds on an award-specific basis. Pooling or commingling of ARRA award funds with other funds for drawdown or other purposes is not permitted. (8) Recipients must account for each ARRA award separately by referencing the assigned CFDA number for each award. The definition of terms and data elements, as well as any specific instructions for reporting, including required formats, will be provided in subsequent guidance issued by HHS. Note that all data contained in each quarterly report should be cumulative in order to encompass the total amount of funds spent to date. Primary recipients (grantees) are required to report an estimate of jobs directly created or retained by project and activity or contract. Recipients will be required to report an aggregate number for the cumulative jobs created or retained for the quarter in a separate numeric field. Recipients will also be asked to provide a narrative description of the employment impact. For the purposes of the HIT funding under the Recovery Act, the following definitions will be used: Created jobs include new direct hire positions created and filled or previously existing unfilled positions that are filled as a result of HIT funding. Retained jobs include those positions preserved from layoffs or terminations and those restored to full-time as a result of HIT funding; an existing position that would not have been continued to be filled were it not for Recovery Act funding. A job cannot be counted as both created and retained. 45 Created and retained FTEs include both direct hire and contractual staff. FTEs are calculated as total hours worked in jobs created or retained, divided by the number of hours in a full-time schedule. The FTE estimates must be reported cumulatively each calendar quarter. Grantees may submit reports to Federal Reporting.gov using any of the following methods: (1) Online data entry in a Web browser; (2) Excel spreadsheet; or (3) Custom software system extract in Extensible Markup Language (XML). Federal agencies will initiate a review of the quarterly report data after formal submission by the recipients and sub-recipients. During the recipient and sub- recipient review period (i.e., day 11 to day 23 of the reporting month), Federal agencies will have access to review the data and should begin initial reviews at this time. However, the official agency review process begins on the 23rd day of the reporting month and runs until the 30th day of the reporting month. During this period, the Federal agency will be responsible for reviewing data submitted by recipients and sub-recipients. Where an agency identifies a data quality issue with respect to information submitted by the recipient or sub-recipient, the Federal agency is required to alert the relevant recipient and sub-recipient of the nature of the problem identified by the Federal agency. All corrections by recipients and subrecipients during this phase of the review must be transmitted by the 30th day of the reporting month. A grantee's noncompliance with ARRA reporting requirements is considered a violation of the award agreement because awards made with Recovery Act funds have a term requiring compliance with Section 1512 of the Act. The agency may use any customary remedial actions necessary to ensure compliance, including withholding funds, termination, or suspension and debarment as appropriate. 4. Final Report The project's final report and any products developed through the grant are to be provided to the Division of Grants Management Operations (DGMO) within 90 days of the end of the project period. The DGMO will forward these materials to the Project Officer. 5. Performance Review The Office of Regional Operations (ORO), formerly the Office of Performance Review (OPR), serves as the regional component of HRSA by providing leadership on HRSA's mission, goals, priorities and initiatives in the regions, States and Territories. ORO will provide assistance to grant recipients in partnership with HRSA program leaders within the Bureaus/Offices in the conduct of site visits for recipients with new programs, those recipients needing follow-up technical assistance as well as those recipients which are experiencing problems meeting program requirements or demonstrating operational performance issues. Bureaus/Office program leaders will determine which programs to visit and will enlist the assistance of ORO regional components in the pre-planning and conduct of those visits. As 46 part of this effort, HRSA recipients may be asked to participate in an on-site visit to their HRSA funded program(s) by a review team from one of the ten ORO regional divisions and, if required, staff from the Bureau/Office making the award. ORO works collaboratively with grantees and HRSA Bureaus/Offices to ensure that recipients are able to adequately address the identified performance measures based on the type of program(s). ORO will also seek to identify, collect, and disseminate leading/innovative practices. These visits will also provide an opportunity for HRSA recipients to offer direct feedback to the agency about the impact of HRSA policies on program implementation and performance within communities and States. VII. Agency Contacts Applicants may obtain additional information regarding business, administrative, or fiscal issues related to this grant announcement by contacting: Sarah Morgan Grants Management Specialist Division of Grants Management Operations Office of Federal Assistance Management, HRSA Parklawn Building, Room 11A-02 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-5484 Fax: (301) 443-6343 Email: email@example.com Additional information related to the overall program issues as well as technical assistance regarding this funding announcement may be obtained by contacting: Christie Brown Senior Program Specialist Health Resources and Services Administration Office of Health Information Technology Division of HIT State and Community Assistance Parklawn Building, Room 7A- 26 5600 Fishers Lane Rockville, MD 20857 Telephone: (315) 662-7933 Fax: (301) 443-1330 Email: firstname.lastname@example.com 47 This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application1 by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist. This restriction applies unless: (i) the communication is purely logistical; (ii) the communication is made at a widely attended gathering; (iii) the communication is to or from a Federal agency official and another Federal Government employee; (iv) the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or (v) the communication is initiated by the Federal agency official. For additional information see http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09- 24.pdf . VIII. Other Information DEFINITIONS For purposes of this guidance, the following definitions will be used. Assessments: Generally, assessments form the basis or justification for a proposal including identification of the specific strengths and weaknesses of the marketplace and collaborators in light of the HCCN's mission and goals. A readiness assessment should evaluate the administrative, clinical, financial, etc. capabilities, resources, skills, and systems of each of the participants in the delivery system. These assessments should be completed prior to submission of an application (evidence should be included in the application, that this activity is inherent in the organizations' business and strategic plan). This is NOT a planning grant. Chronic Care Model: The Chronic Care Model is a population-based model that relies on knowing which health center (330) patients have an illness, assuring that they receive evidence- based care, and actively aiding them to participate in their own care, having critical clinical information and productivity system to guide and inform care, and a care system based on patterns of need and clinical outcomes. For more information, see http://www.healthdisparities.net/hdc/html/about.hdcModels.aspx or http://www.improvingchroniccare.org. 1 Formal Application includes the preliminary application and letter of intent phases of the program. 48 Collaborators or HCCN Members: Entities (such as health centers, safety net providers, hospitals, universities, etc.) that have a relationship evidenced by ALL of the following: (i) business arrangement, (ii) commitment to the development, implementation, and operation of the proposed HCCN, and (iii) a signed MOA. This commitment includes time, financial support, expertise, and other resources devoted to achieving the goals and objectives of the HCCN. Core Area: Core area encompasses one of the following: administrative, clinical, managed care, financial, and information systems. HCCNs can be engaged in activities around all of the core areas as long as they are appropriate to the respective marketplace and the available resources. Electronic Health Record (EHR): A real-time patient health record with access to evidence- based decision support tools that can be used to aid clinicians in decision-making. The EHR can automate and streamline a clinician's workflow, ensuring that all clinical information is communicated. It can also prevent delays in response that result in gaps in care. The EHR can also support the collection of data for uses other than clinical care, such as billing, quality management, outcome reporting, and public health disease surveillance and reporting. Source: Office of the National Coordinator of Health Information Technology, http://healthit.hhs.gov/portal/server.pt?open=512&objID=1256&parentname=CommunityPage& parentid=2&mode=2&in_hi_userid=10741&cached=true. Function: A function is identified as a specific activity within one of the core areas as defined above. For example, within the core area of clinical activities, a function may include the sharing of common clinical protocols and guidelines among HCCN members; within the core area of administration, a function may include centralization of credentialing across the HCCN. HCCNs can be engaged in a number of functions within a core area(s), as long as they are appropriate to the respective marketplace and the available resources. Health Center Controlled Network (HCCN): Network controlled by and acting on behalf of the health center(s), as defined and funded under Section 330(e)(1)(C) of the PHS Act. The term ―controlled‖ means to have the authority collectively to appoint a minimum of 51 percent of the Network's board members in the Network. The HCCN must consist of at least 3 collaborator organizations. HCCNs, for purposes of this grant opportunity may also be a health center, as defined and funded under Section 330 of the Public Health Service (PHS) Act, as amended (42 U.S.C. 254b), applying on behalf of a managed care Network or plan, that has received Federal grants under subsection 330(e)(1)(A) for at least the two consecutive preceding years; or a health center as defined and funded under Section 330 of the Public Health Service (PHS) Act, as amended (42 U.S.C.§ 254b), applying on behalf of a Practice Management Network. Operational Networks: Operational Networks are HCCNs that can demonstrate that an essential mission critical function is performed at the network level for the HCCN members enabling the member's center to perform their business and clinical operations more efficiently. This means that the activity is either shared or integrated at the HCCN level and is not duplicated at the member/collaborator level. Operational Networks demonstrate the following characteristics: 49 Evidence of formal structure of the HCCN has been in place for a minimum of two years (articles of incorporation, bylaws, etc.) Identification of leadership structure and core HCCN staff (e.g., executive management staff). Evidence that one core function (administrative, clinical, finance, managed care and/or IS) is currently fully integrated and functioning for organizational members at the HCCN level. Documentation of outcomes indicator achieved through the integration of the function. A strategic plan is in place that outlines the long range (multi-year) goals and objectives of the HCCN. Declining dependence on Federal funds for the HCCN activities. Health Disparities Collaborative (HDC): HDCs provides a systems-approach proactive way of caring for people with chronic illness by implementing two models: the Chronic Care Model and the Model for Improvement. The population-based Chronic Care Model requires knowing which patients have an illness or need preventive services, ensures delivery of evidence-based care, and actively aids patients and families to participate in their own care. It consists of six basic elements, which include patient self-management, clinical decision support, delivery system design, clinical information systems, health care organization and community resources and policies, and enables health centers to test changes and implement improvements in each of these components. The Model for Improvement is a rapid-cycle approach to testing possible improvements while documenting how the quality improvements are being institutionalized. Health Information Exchange (HIE): The electronic movement of health-related information among organizations according to nationally recognized standards. The types of data involved in HIE may include demographic data and patient medical history, data on medical conditions, diagnoses, procedures, allergies and therapies collected at the point of care, as well as data collected and used for administrative purposes such as claims. Health Information Exchange Economic Sustainability Panel: Final Report; Prepared for the US Department of Health and Human Services, Office of the National Coordinator for Health Information Technology. April, 2009. Prepared by NORC at the University of Chicago. Page 4. Accessed at http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10731_865324_0_0_18/HI E%20Sustainability%20Paper%20-%20Final%20-2.pdf. Health Information Technology (HIT): The term ‗health information technology' means hardware, software, integrated technologies or related licenses, intellectual property, upgrades, or packaged solutions sold as services that are designed for or support the use by health care entities or patients for the electronic creation, maintenance, access, or exchange of health information. Source: Sec. 3000(5) in the PHS Act as enacted by section 13101 of the American Recovery and Reinvestment Act (P.L. 111-5). Horizontal Integration: Includes activities designed to improve operational efficiencies among a group of Health Centers or a group of Health Centers and other primary care safety net providers within the same marketplace having a similar mission. 50 Integrating, Integrated: To make into a whole by bringing all parts together; to join with something else. [Integrating/integrated can also be used interchangeably with consolidating/consolidated.] Marketplace: A geographic area where the majority of health care services (primary, hospital, and specialty services) for a defined population are located. This geographic area is usually considerably broader than the current service area of an individual health center and includes an expanded patient population, as well as a broader range of payers and providers. Marketplace Analysis: A dynamic, iterative process that systematically assesses the supply and demand for a defined service(s)/product(s) in a specific marketplace and makes an estimate of future opportunities and challenges in that marketplace. Outcome Indicators: Outcome indicators are specific items of data that are tracked to measure how well a HCCN is achieving an outcome over a defined period of time. For additional information on outcome indicators, see http://bphc.hrsa.gov/uds/2008manual/default.htm. Outcomes: Outcomes describe the benefits or changes for individuals or populations as a result of HCCN activities. They may relate to behavior, skills, knowledge, attitudes, conditions, or other attributes. For example, an outcome would be a 20 percent increase in the number of low- income parents getting their children immunized after receiving information through a HCCN sponsored public awareness campaign. Personal Health Record (PHR): An electronic Personal Health Record (―ePHR‖) is a universally accessible, layperson comprehensible, lifelong tool for managing relevant health information, promoting health maintenance and assisting with chronic disease management via an interactive, common data set of electronic health information and e-health tools. The ePHR is owned, managed, and shared by the individual or his or her legal proxy(s) and must be secure to protect the privacy and confidentiality of the health information it contains. It is not a legal record unless, so defined and is subject to various legal limitations. Source: Health Information Management Information System Society. www.himss.org Provider: A provider is the individual who assumes primary responsibility for assessing the patient and documenting services in the patient's record. (See Bureau of Primary Health Care Uniform Data Systems Manual 2008 for full definition of the term ―provider‖ at: http://bphc.hrsa.gov/uds/2008manual/default.htm). Quality Care: The degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. Institute of Medicine. Lohr KN, editor(s). Medicare: a strategy for quality assurance. Vol. 1.Washington (DC): National Academy Press; 1990. p. 21. Quality health care means doing the right thing, at the right time, in the right way, for the right person—and having the best possible results. From: U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality; http://www.ahrq.gov/consumer/qnt/qntqlook.htm. 51 Statewide: A HCCN is considered statewide if it has every 330 funded community health center in the State as a member. Vertical Integration: Includes activities designed to achieve improvements in the continuum of care through the integration of primary specialty, and hospital services for current and/or planned patients of Federally-supported and other safety net programs. IX. Tips for Writing a Strong Application Include DUNS Number. You must include a DUNS Number to have your application reviewed. Applications will not be reviewed without a DUNS number. To obtain a DUNS number, access www.dnb.com/us or call 1-866-705-5711. Please include the DUNS number in item 8c on the application face page. Register in Grants.gov Immediately. In order to register in Grants.gov, you must have a DUNS number and be registered in the CCR. See instructions for more information on registering in Grants.gov. Keep your audience in mind. Reviewers will use only the information contained in the application to assess the application. Be sure the application and responses to the program requirements and expectations are complete and clearly written. Do not assume that reviewers are familiar with the applicant organization, service area, barriers to health care, or health care needs in your community. Keep the review criteria in mind when writing the application. Start preparing the application early. Allow plenty of time to gather required information from various sources. Follow the instructions in this guidance carefully. Place all information in the order requested in the guidance. Avoid the risk of having reviewers hunt through your application for information. Be brief, concise, and clear. Make your points understandable. Provide accurate and honest information, including candid accounts of problems and realistic plans to address them. If any required information or data is omitted, explain why. Make sure the information provided in each table, chart, attachment, etc. is consistent with the proposal narrative and information in other tables. Your budget should reflect back to the proposed activities, and all forms should be filled in accurately and completely. Be organized and logical. Many applications fail to receive a high score, because the reviewers cannot follow the thought process of the applicant or because parts of the application do not fit together. Be careful in the use of attachments. Do not use the attachments for information that is required in the body of the application. Be sure to cross-reference all tables and attachments to 52 the appropriate text in the application. Be sure to upload the attachments in the order indicated in the forms. Carefully proofread the application. Misspellings and grammatical errors will impede reviewers in understanding the application. Be sure that page limits are followed. Limit the use of abbreviations and acronyms, and define each one at its first use and periodically throughout application. Make sure you submit your application in final form, without markups. Print out and carefully review an electronic application to ensure accuracy and completion. When submitting electronically, print out the application before submitting it to ensure appropriate formatting and adherence to page limit requirements. Check to ensure that all attachments are included before sending the application forward. Ensure that all information is submitted at the same time. We will not consider additional information and/or materials submitted after your initial submission, nor will we accept e- mailed applications or supplemental materials once your application has been received. 53 APPENDIX A: MEMORANDUM OF AGREEMENT (MOA) A fully executed MOA submitted with the application (as Attachment 4) should address the following: a. Specific documentation for a methodology of collaborator/HCCN member investment of resources, including in-kind resources, staff, cash, etc. b. Evidence that the members are exploring certain function(s) at a collaborative/shared/integrated level (as appropriate). c. Evidence of long-term commitment (i.e., 3 to 5 years). d. Health center and member board buy-in as evidenced by signatures of all CEOs and board chairs. An MOA signed by all CEOs and Board Chairs of the HCCN members should include or address, at a minimum, the following: 1. In the MOA, an applicant's governing board should explicitly certify or identify the following: a. The collaborating health centers are participating in the development, or further development, of an HIT development project as defined above. b. The collaborating health centers are participating in the development of an integrated HIT. c. The mission of the HCCN is to ensure access for the medically underserved, including the uninsured and underinsured. d. The HIT development project is comprised of three or more health center members. e. The provision of services/programs through the HIT development project will not result in the diminution of the level or quality of health services currently being provided to the medically underserved population. f. An individual whose primary responsibility is the work plan and overall leadership of the HCCN. 2. A description of the governance/decision-making of the HCCN, including composition of boards/advisory committees. [NOTE: Health center collaborators must maintain a minimum of 51 percent control over the HCCN.] a. The MOA should describe how leadership of the activities will be managed, including identification of the individual with responsibility for overseeing the implementation of the work plan. b. The MOA should provide clear roles and responsibilities for clinician and consumer involvement regarding the proposed work plan. c. A description of the role (if any) of such structures in resolving conflict among diverse members of a HCCN. 3. A statement that establishes concrete commitment of resources from each of the collaborators to the development, or further development, of the HIT and the HCCN (cash, annual dues, membership fees, full-time equivalents, in-kind resources, etc.). Indicate if commitment is annual, one-time, etc. 4. A description of the HIT development project's goals, objectives, and timetable. 5. A description of the HIT development project's membership policies (i.e., membership renewals, penalties, terminations, amendments). 54 APPENDIX B: Department of Health and Human Services Standard Terms and Conditions American Recovery and Reinvestment Act of 2009 Division A Funds 1. HHS Standard Terms and Conditions HHS grantees must comply with all terms and conditions outlined in their grant award, including grant policy terms and conditions contained in applicable Department of Health and Human Services (HHS) Grant Policy Statements, and requirements imposed by program statutes and regulations and HHS grant administration regulations, as applicable, unless they conflict or are superseded by the following terms and conditions implementing the American Recovery and Reinvestment Act of 2009 (ARRA) requirements below. In addition to the standard terms and conditions of award, recipients receiving funds under Division A of ARRA must abide by the terms and conditions set out below. The terms and conditions below concerning civil rights obligations and disclosure of fraud and misconduct are reminders rather than new requirements, but the other requirements are new and are specifically imposed for awards funded under ARRA. Recipients are responsible for contacting their HHS grant/program managers for any needed clarifications. 2. Preference for Quick Start Activities In using funds for this award for infrastructure investment, recipients shall give preference to activities that can be started and completed expeditiously, including a goal of using at least 50 percent of the funds for activities that can be initiated not later than 120 days after the date of the enactment of ARRA. Recipients shall also use grant funds in a manner that maximizes job creation and economic benefit. (ARRA Sec. 1602) 3. Limit on Funds None of the funds appropriated or otherwise made available in ARRA may be used by any State or local government, or any private entity, for any casino or other gambling establishment, aquarium, zoo, golf course, or swimming pool. (ARRA Sec. 1604) 4. ARRA: One-Time Funding Unless otherwise specified, ARRA funding to existent or new awardees should be considered one-time funding. 5. Civil Rights Obligations While ARRA has not modified awardees' civil rights obligations, which are referenced in the HHS' Grants Policy Statement, these obligations remain a requirement of Federal law. Recipients and sub-recipients of ARRA funds or other Federal financial assistance must comply with Title VI of the Civil Rights Act of 1964 (prohibiting race, color, and national origin discrimination), Section 504 of the Rehabilitation Act of 1973 (prohibiting disability discrimination), Title IX of the Education Amendments of 1972 (prohibiting sex discrimination in education and training programs), and the Age Discrimination Act of 1975 (prohibiting age 55 discrimination in the provision of services). For further information and technical assistance, please contact the HHS Office for Civil Rights at (202) 619-0403, firstname.lastname@example.com, or http://www.hhs.gov/ocr/civilrights/. 6. Disclosure of Fraud or Misconduct Each recipient or sub-recipient awarded funds made available under the ARRA shall promptly refer to the HHS Office of Inspector General any credible evidence that a principal investigator, employee, agent, contractor, sub-recipient, subcontractor, or other person has submitted a false claim under the False Claims Act or has committed a criminal or civil violation of laws pertaining to fraud, conflict of interest, bribery, gratuity, or similar misconduct involving those funds. The HHS Office of Inspector General can be reached at http://www.oig.hhs.gov/fraud/hotline/. 7. Responsibilities for Informing Sub-recipients Recipients agree to separately identify to each sub-recipient, and document at the time of sub- award and at the time of disbursement of funds, the Federal award number, any special CFDA number assigned for ARRA purposes, and amount of ARRA funds. 8. Recovery Act Transactions listed in Schedule of Expenditures of Federal Awards and Recipient Responsibilities for Informing Sub-recipients (a) To maximize the transparency and accountability of funds authorized under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5) (Recovery Act) as required by Congress and in accordance with 45 CFR 74.21 and 92.20 "Uniform Administrative Requirements for Grants and Agreements," as applicable, and OMB A-102 Common Rules provisions, recipients agree to maintain records that identify adequately the source and application of Recovery Act funds. (b) For recipients covered by the Single Audit Act Amendments of 1996 and OMB Circular A- 133, "Audits of States, Local Governments, and Non-Profit Organizations," recipients agree to separately identify the expenditures for Federal awards under the Recovery Act on the Schedule of Expenditures of Federal Awards (SEFA) and the Data Collection Form (SF-SAC) required by OMB Circular A-133. This shall be accomplished by identifying expenditures for Federal awards made under Recovery Act separately on the SEFA, and as separate rows under Item 9 of Part III on the SF-SAC by CFDA number, and inclusion of the prefix "ARRA-" in identifying the name of the Federal program on the SEFA and as the first characters in Item 9d of Part III on the SF-SAC. (c) Recipients agree to separately identify to each sub-recipient, and document at the time of sub- award and at the time of disbursement of funds, the Federal award number, CFDA number, and amount of Recovery Act funds. When a recipient awards Recovery Act funds for an existing program, the information furnished to sub-recipients shall distinguish the sub-awards of incremental Recovery Act funds from regular sub-awards under the existing program. (d) Recipients agree to require their sub-recipients to include on their SEFA information to specifically identify Recovery Act funding similar to the requirements for the recipient SEFA described above. This information is needed to allow the recipient to properly monitor sub- recipient expenditure of ARRA funds, as well as oversight by the Federal awarding agencies, Offices of Inspector General, and the Government Accountability Office. 56 Recipient Reporting Reporting and Registration Requirements under Section 1512 of the American Recovery and Reinvestment Act of 2009, Public Law 111-5 (a) This award requires the recipient to complete projects or activities which are funded under the American Recovery and Reinvestment Act of 2009 ("Recovery Act") and to report on use of Recovery Act funds provided through this award. Information from these reports will be made available to the public. (b) The reports are due no later than ten calendar days after each calendar quarter in which the recipient receives the assistance award funded in whole or in part by the Recovery Act. (c) Recipients and their first-tier recipients must maintain current registrations in the Central Contractor Registration (www.ccr.gov) at all times during which they have active Federal awards funded with Recovery Act funds. A Dun and Bradstreet Data Universal Numbering System (DUNS) Number (www.dnb.com/us) is one of the requirements for registration in the Central Contractor Registration. (d) The recipient shall report the information described in section 1512(c), using the reporting instructions and data elements that will be provided online at www.FederalReporting.gov, and ensure that any information that is pre-filled is corrected or updated as needed. 57 APPENDIX C: RESOURCES FOR APPLICANTS Federal Government Agencies/Organizations Health Resources and Services Administration (HRSA) http://www.hrsa.gov/healthit/ The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, is the primary Federal agency for improving access to health care services for people who are uninsured, isolated or medically vulnerable. Agency for Healthcare Research and Quality http://healthit.ahrq.gov/ The mission of Agency for Healthcare Research and Quality is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Department of Veterans Affairs http://www1.va.gov/vha_oi/ The goal of the Department of Veterans Affairs is to provide excellence in patient care, veterans' benefits and customer satisfaction. Indian Health Service http://www.ihs.gov/CIO/InfoTech_index.asp The mission of the Indian Health Service is to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives to the highest level. Office of the National Coordinator for Health Information Technology (ONC) http://www.healthit.hhs.gov/ The Office of the National Coordinator for Health Information Technology provides leadership for the development and nationwide implementation of an interoperable health information technology infrastructure to improve the quality and efficiency of health care and the ability of consumers to manage their care and safety. Health Alert Network (HAN) http://www2a.cdc.gov/han/Index.asp The Network is a project being developed at the Centers for Disease Control and Prevention (CDC) as part of its Public Health Emergency Preparedness & Response Program. The project is intended to ensure communications capacity at all local and state health departments through full Internet connectivity and training. That capacity will ensure the ability to broadcast and receive health alerts at every level of the public health system. Health Disparities Collaborative http://www.healthdisparities.net The Health Disparities Collaborative Web site is home for a community of learners who are committed to improving systems of health care. Using the methodology of the Planned Care Model and the Model for Improvement in the context of Community Oriented Primary Care, health centers are making a positive difference in the lives of hundreds of thousands of Americans. National Committee on Vital and Health Statistics (NCVHS) 58 http://www.ncvhs.hhs.gov/ The NCVHS is the advisory body to HHS and Congress on health information policy. NCVHS has taken a critical leadership role in driving the creation of a National Health Information Network, including the creation of the report "Information for Health: A Strategy for Building a National Health Information Network," which was published in November 2001. The Chair of the committee's health information Network workgroup is John R. Lumpkin, MD, MPH. The lead staff member to the workgroup is Mary Jo Deering, PhD. National Electronic Disease Surveillance System (NEDSS) http://www.cdc.gov/nedss/ The system is an initiative that promotes the use of data and information system standards to advance the development of efficient, integrated, and interoperable surveillance systems at Federal, state and local levels. This broad initiative is designed to facilitate the electronic transfer of appropriate information from clinical information systems in the health care industry to public health departments, reduce provider burden in the provision of information, and enhance both the timeliness and quality of information provided. National Immunization Program (NIP) http://www.cdc.gov/vaccines/ The program is committed to promoting the development and maintenance of state- and community-based computerized registries that capture immunization information on all children. Working with the National Vaccine Advisory Committee (NVAC), NIP has identified minimum core immunization data elements that enable consistent data collection by immunization registry systems. Public Health Information Network (PHIN) http://www.cdc.gov/PHIN/ The Network is a framework for crosscutting and unifying data streams for the early detection of public health issues and emergencies. PHIN is composed of five key components: detection and monitoring, data analysis, knowledge management, alerting and response. Through defined data and vocabulary standards and strong collaborative relationships, the Public Health Information Network will enable consistent exchange of response, health and disease tracking data among public health partners. Industry & Trade Associations American Health Information Management Association (AHIMA) http://www.ahima.org/ The association represents the community of professionals engaged in health information management, providing support to members and strengthening the industry and profession. It represents more than 45,000 specially educated health information management professionals who work throughout the healthcare industry. These professionals serve the healthcare industry and the public by managing, analyzing and utilizing data vital for patient care-and making it accessible to healthcare providers when needed to diagnose, treat and care for patients. American Medical Informatics Association (AMIA) http://www.amia.org/ The association has a membership of individuals, institutions and corporations dedicated to developing and using information technologies to improve health care. AMIA was formed in 59 1990 by the merger of three organizations: the American Association for Medical Systems and Informatics, the American College of Medical Informatics, and the Symposium on Computer Applications in Medical Care. The 3,200 members of AMIA include physicians, nurses, computer and information scientists, biomedical engineers, medical librarians, and academic researchers and educators. AMIA is the official United States representative organization to the International Medical Informatics Association. American Nursing Informatics Association http://www.ania.org/ The organization provides a forum and networking opportunities for nurses working in healthcare informatics, facilitating the integration of data and knowledge to support care of patients and decision-making for nurses and other providers. The group focuses on integrating nursing science, computer science and information science to manage and communicate data and information in nursing practice. Association of Medical Directors of Information Systems (AMDIS) http://www.amdis.org/ The association is a forum for growth and development of chief medical information officers and other physicians entering positions of responsibility in medical informatics and information technology. AMDIS presents lessons learned from leaders in the field today, provides a body of information needed to be an effective information systems leader and acts as a vehicle to forge important industry connections. College of Healthcare Information Management Executives (CHIME) http://www.cio-chime.org/ The association's aims are to serve the professional needs of healthcare chief information officers and to advance the strategic application of information technology in innovative ways that improve the effectiveness of healthcare delivery. CHIME provides networking, education and career development while also supporting easy access to current IT trends, research and information pertaining to the use of IT in healthcare. Healthcare Information and Management Systems Society (HIMSS) http://www.himss.org The association is focused on providing leadership for the optimal use of healthcare information technology and management systems by framing public policy and industry practices through initiatives in advocacy, education and professional development. Among the initiatives are a series of new programs to support and accelerate healthcare standards development, definition of an electronic medical record and involvement of the healthcare IT vendor community in building a minimum set of functions and features into IT software products. National Association of Health Data Organizations (NAHDO) http://www.nahdo.org/ The association is a membership organization dedicated to strengthening the nation's health information system. NAHDO serves as a broker of expertise for the development and enhancement of statewide and national health information systems. NAHDO brings together a network of state, Federal, and private sector technical and policy leaders and consultants to expand health systems development and shape responsible health information policies. National Alliance for Health Information Technology (NAHIT) 60 http://www.nahit.org The alliance is a diverse partnership of leaders from all healthcare sectors working to advance the adoption and implementation of healthcare information technology to achieve measurable improvements in patient safety, quality and efficiency. The alliance acts as a convener in the efforts to achieve consensus on IT standards and other important issues, bringing together senior executives to overcome barriers and accumulate a critical network of technical and intellectual knowledge and leadership. Healthcare Foundations/Research-based Organizations All Kids Count (AKC) http://www.allkidscount.org/connections-akc.html This project, funded by the Robert Wood Johnson Foundation, started in 1992 with the development and implementation of immunization registries. The current phase is one of communication and integration to foster integration/linkage of child health information systems, specifically including immunization registries and other systems that have both clinical and Public health importance. One of its major activities is AKC Connections, a collaboration of state and local health departments moving toward integration of health information systems such as immunization registries and screening initiatives for certain childhood problems. California HealthCare Foundation http://www.chcf.org/topics/index.cfm?topic=CL108 The California HealthCare Foundation is an independent philanthropy committed to improving the way health care is delivered and financed in California, and helping consumers make informed health care and coverage decisions. Formed in 1996, its goal is to ensure that all Californians have access to affordable, quality health care. Center for Health Information Technology http://www.centerforhit.org/ The center, a division of the American Academy of Family Physicians (AAFP), promotes and facilitates adoption and optimal use of health information technology among AAFP members and other office-based clinicians. Initial work is focused on overcoming barriers of high cost, complexity and lack of standardization, all of which stand in the way of small medical practices attempting to acquire and effectively use IT in their offices. Certification Commission for Healthcare Information Technology http://www.cchit.org/ The mission of the Certification Commission for Healthcare Information Technology is to accelerate the adoption of health information technology by creating an efficient, credible and sustainable product certification program. Connecting for Health http://www.connectingforhealth.org/ Connecting for Health is a public-private collaborative of the Markle Foundation that will advance an interconnected, electronic national health information infrastructure by focusing on adopting national clinical data standards for interoperability, ensuring secure and private transmission of medical information and working to understand consumers' needs and expectations from an interconnected health information system. 61 The eHealth Initiative http://www.ehealthinitiative.org/ This public-private sector collaborative effort for public health focuses on bringing about an interconnected electronic health information infrastructure by promoting the adoption of clinical data standards and interoperability. The initiative of more than 100 members includes involvement of the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), public health agencies, providers, standards organizations, and health care IT suppliers. Among its aims is to develop and implement strategies to transmit electronic data of public health importance (for example lab results, microbiology results, orders, and chief complaint data) using interoperable standards and the CDC's National Electronic Disease Surveillance System (NEDSS). Included in the site is a toolkit for HIE value and sustainability (http://toolkit.ehealthinitiative.org/) National Center for Emergency Medicine Informatics http://www.ncemi.org/ The not-for-profit center is focused on advancement of emergency medicine through the application of information technology. The organization is driven by the belief that the greatest advances in medicine over the next two decades will result from the application of the tools and principles of information science to the problems of clinical medicine. New developments in informatics will drive advances in clinical care, medical administration, medical research, and medical education. Public Health Informatics Institute http://www.phii.org/ The Public Health Informatics Institute is a program of the Robert Wood Johnson Foundation whose goal is to foster collaboration among public health agencies in the conception, design, acquisition, and deployment of software tools in order to eliminate redundant efforts, speed up development processes and reduce costs. Current initiatives include defining common requirements and developing tools to exchange information on a) Defining Common Requirements-jointly sponsored with APHL, a group of 16 state and local public health laboratories have joined together to address the urgent need to update or acquire new public health laboratory information management systems to enhance bioterrorism preparedness. b) Developing the Exchange - a web-enabled tool to assist public health agencies in making effective IT investment decisions by rating vendor products and their capabilities. Partners: ASTHO, NACCHO, APHL, NAPHSIS, CSTE, APHCIO. 62 APPENDIX D: HIT BUDGET TECHNICAL ASSISTANCE Cost factors to consider when budgeting for an EHR may include but are not limited to the following listed below. Pre-Implementation/Readiness costs may include workflow assessment and change management (e.g., planning for loss of staff productivity, communication and training for patient involvement). EHR Implementation Costs: Software Costs may include EHR Application cost, Operating Systems, Office Productivity, EHR Maintenance, EHR Support, other software, Help desk application, Computer based training, EHR web portal, and/or EHR portal maintenance. Infrastructure Clinical Facility Costs may include Wireless LAN infrastructure, LAN switches (closets), Router, Tablets, Table Docking Stations, Tablet Batteries (spare), Tablet keyboards, Docking racks, Desktop PCs, Scanners, Patient ID Card Systems, Patient ID Card readers, Cameras (patient ID), Network printers, Cabling-access points, and/or Network transport link to data center. Data Center Infrastructure Costs may include Servers - applications, database, reporting, etc., VPN Router, Core switches, Desktop switches, Data replication, AN - applications, database, reporting, SAN - document management, Backup library, Backup software, Firewall anti- malware, Server racks, Space acquisition, Power upgrades, UPS, Fire suppression, Cooling/HVAC, Physical security, Management consoles, Backup media, Fax server, Data center construction, and/or Network transport (WAN links). Implementation staffing costs may include Core team training, End user training, Vendor project management, Client project management, Client infrastructure project management, Workflow assessment and redesign, Installation and configuration, Data migration, Paper chart conversion, Configuration, Interface development (all vendors), Staff: CIO, Staff System Admin, Staff Network Admin. 63 APPENDIX E: ENVIRONMENTAL INFORMATION & DOCUMENTATION OMB No. 0915-xxxx Expiration Date: Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The OMB control number for this project is 0915-xxxx. Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10-33, Rockville, Maryland, 20857. DEPARTMENT OF HEALTH AND HUMAN FOR HRSA USE ONLY SERVICES Grantee Name Health Resources and Services Application Administration Grant Number Tracking # ENVIRONMENTAL INFORMATION AND Project # Project Type DOCUMENTATION (EID) Project Title Grantee Authorized Official: Phone: Email: Grantee EID Preparer: Phone: Email Address: A. USE OF NATURAL RESOURCES This set of criteria is concerned with the use and accessibility of nonrenewable natural resources such as land, minerals, and fuels as well as the flow resources (water and air) which are constantly renewed but in which short-term or local shortages might occur. 1. Is there a controversy with respect to environmental effects of the action based on reasonable and substantial issues? [_] Yes [_] No If yes explain: 2. Will the action not comply with local and State land use planning? [_] Yes [_] No If yes explain: 3. Is the action significantly greater in scope than normal for the area, or will it have significant unusual characteristics? [_] Yes [_] No If yes explain: 4. Will the action change traditional use of the land parcel (by rezoning, etc.)? [_] Yes [_] No If yes, complete the following: Present Zoning:____________________ 64 Present Use of Site:_______________ Proposed Zoning:___________________ 5. Will the action involve the purchase, construction or lease of new facilities (including portable facilities and trailers), or substantially increase the capacity of an existing health care facility? [_] Yes [_] No If yes explain: 6. Will the action alter the use of other land by related development of stores, roads or site changes? [_] Yes [_] No If yes explain: a) Generate new stores? [_] Yes [_] No If yes explain: b) Cause new roads? [_] Yes [_] No If yes explain: c) Cause new parking? [_] Yes [_] No If yes explain: 7. Is the action located in either a 100-year or, for critical actions, a 500-year floodplain? [_] Yes [_] No Attach a Flood Insurance Rate Map to this document. Clearly mark the location of the facility, and the NFIP Panel Number. FIRMettes can be generated electronically at no cost at http://www.msc.fema.gov. The FIRMette module is located in the upper left hand corner, while the tutorial is at the lower right hand corner of the webpage. (If Flood Insurance Rate Maps do not exist for the project site, a floodplain survey or consultation may be required.) 8. Will the proposed action adversely impact flood flows in a floodplain or support development in a floodplain? [_] Yes [_] No If yes explain: 9. Will the action include the use of wetlands (swamps, marshes, etc.)? [_] Yes [_] No If yes explain: 10. Will the action decrease the volume of water in a lake, river table, reservoir, etc.? [_] Yes [_] No If yes explain: 65 11. Will the action change traditional use of a body of water? [_] Yes [_] No If yes explain: 12. Will the action violate a Section 404 (Clean Water Act) permit for actions in a wetland and/or Section 10 (Rivers and Harbors Act) permit for actions in a stream or river? (Activities in or near a wetland or river may require a permit from the U.S. Army Corps of Engineers or U.S. Coast Guard. Includes: construction in or near any wet or dry waterway, stream crossings, intake structures, outfalls, etc.) [_] Yes [_] No If yes explain: 13. Will the action use land for purposes unsuitable to its physical characteristics? Consider these items: Soil borings have/have not been completed. Proposed facility will/will not have foundations similar to other facilities in the area. The facility is/is not in a flood plain. [_] Yes [_] No If yes explain: 14. Will the action adversely impact a Wilderness Area (Wilderness Areas are specifically designated areas of land)? [_] Yes [_] No If yes explain: 15. Will the action have significant adverse direct or indirect effects on park land, other public lands, or areas of recognized scenic or recreational value? (For example, consider how your activity will affect the view?) [_] Yes [_] No If yes explain: 16. Will the action block access to known mineral deposits? (Sand, gravel, clay, stone, or other common building materials are not considered mineral deposits.) [_] Yes [_] No If yes explain: 17. Will the action increase fuel and mineral consumption in State by more than 1% annually? [_] Yes [_] No Est. annual fuel requirements: ________ gallons of fuel ________ cubic feet of natural gas ________ tons of coal ________ kWh of electricity Expected source(s) of these fuels: B. POLLUTION This set of criteria concerns the processes that generate pollution. These include the introduction of pollutants into the environment, changes in the flow of energy through the environment, and changes in the composition of environments through the augmentation or deletion of substances that are naturally present. The criteria are also directly concerned with the production and one-time use of materials and 66 the proper disposal of wastes. 1. Will the action increase identifiable ambient air pollution levels from a new emission source or from existing sources? [_] Yes [_] No If yes explain: 2. Will the action increase identifiable ambient air pollution levels through a major increase in the number of or use of automobiles, trucks, etc.? [_] Yes [_] No Approximate number of new employees: ______ 3. Will the action exceed city or State health standards with exhausts from fume hoods? [_] Yes [_] No If yes explain: 4. Will the action require major sedimentation and erosion control measures? (Consider earth disturbing activities including construction or expansion of a parking lot.) [_] Yes [_] No If yes explain: 5. Will the action involve: a) Dredging or swamp drainage? [_] Yes [_] No If yes explain: b) Construction of a waste treatment plant? [_] Yes [_] No If yes describe capacity and location: c) Discharge of untreated human waste directly into a lake, river, etc.? [_] Yes [_] No If yes explain: d) Discharge of laboratory wastes or biohazard wastes directly into a lake, river, etc.? If Yes Describe: 6. Will the action overload existing waste treatment plants due to new loads (water volume, chemicals, toxicity, etc.)? [_] Yes [_] No If yes, please obtain and submit a connection permit or other approval from local sewer authority. 7. Will the action cause soil erosion (after completion of construction phase) or leaching of foreign substances (such as salt) into soil? [_] Yes [_] No If yes explain: 67 8. Will the action allow seepage of contaminants into the water table? [_] Yes [_] No If yes explain: 9. Will the action place stress upon an identified earthquake fault? [_] Yes [_] No If yes, please include a statement from a structural engineer. 10. Will the action create an identifiable change in aquatic life by discharge of hot water? [_] Yes [_] No If yes explain: 11. Will the action impact an EPA designated sole source aquifer? (Designation of sole source aquifer puts restrictions and conditions on Federal expenditures, projects, and grants.) [_] Yes [_] No If yes explain: 12. Will the action decrease the percolation on more than one acre of land? [_] Yes [_] No If yes explain: 13. Will the action violate a storm water permit or a wastewater discharge permit either for construction or on-going operations? (Earth disturbing activities may require a Notice of Intent (NOI) to be covered under a storm water general permit or individual permit from the EPA or other agency and a storm water control plan, including some parking lot construction activities. A discharge of wastewater to the environment may require a permit from Tribal, local or State authorities, or EPA.) [_] Yes [_] No If yes explain: 14. Will the action involve the sale or transfer of real property, on which any hazardous substance was stored for one year or more, known to have been released, or disposed of? (Provide relevant documentation for any hazardous substance releases. See 40 CFR 373.2(b), 302.4, and 261.30 for reportable quantities.) [_] Yes [_] No If yes explain: Consider the following statements prior to answering questions 17-19: Facility will/will not emit noises in excess of local noise standards. Is facility near a wildlife sanctuary? Are outdoor animal facilities included? Facility will/will not contain x-ray machines. Facility will/will not meet Atomic Energy Commission standards. 15. Will the action produce noises considered offensive to a human population? [_] Yes [_] No If yes explain: 16. Will the action create sounds that result in changes in behavior patterns of animals? [_] Yes [_] No 68 If yes explain: 17. Will the action introduce major new sources of unshielded radiation? [_] Yes [_] No If yes explain: 18. Will the action cause shock waves and/or vibration (after construction phase)? [_] Yes [_] No If yes explain: 19. Will the action change the direction and wind velocity as to affect the local population (i.e., high-rise building)? [_] Yes [_] No If yes explain: 20. Will the action cause a new, large volume of production of non-recycled items? [_] Yes [_] No If yes explain: 21. Will the action result in the non-recycling of recyclable items such as laboratory glassware, animal cages, and office paper? [_] Yes [_] No If yes explain: If no, indicate number of: Glassware-washing machines: _____ Cage-washing machines: _____ 22. Will the action generate solid wastes that cannot be properly disposed of by existing facilities? [_] Yes [_] No If yes, describe proposed methods and disposal sites. 23. Will the action dispose of solid wastes in polluting landfills, wells, caves, etc.? [_] Yes [_] No If yes explain: 24. Will the action require storage of waste pending technology for safe disposal? [_] Yes [_] No If yes explain: 25. Will the action not comply with Federal, State, and local requirements for waste handling, transportation, or disposal methods? [_] Yes [_] No 69 If yes, describe proposed methods: C. POPULATIONS This section of the initial criteria addresses changes in human and plant populations. NOTE: For these criteria, the affected area is defined as being greater than 160 acres in size. 1. Will the action result in a 5% change in the density of the local population? [_] Yes [_] No If yes: Est. local population: ____________ Number of new employees: _______ 2. Will the action result in an alteration of transportation, health, education, and/or welfare service? [_] Yes [_] No If yes explain: 3. Will the action result in a change in social service needs by altering population�s age pattern (new schools, etc.)? [_] Yes [_] No If yes explain: 4. Will the action result in a 5% change in the transient population? [_] Yes [_] No If yes, include estimated number of: Visitors: _______________ Patients: _______________ Students: ______________ 5. Will the action result in changes in genetic engineering directed at the human population? [_] Yes [_] No If yes explain: 6. Will the action result in a violation of local, State, or Federal standards pertaining to population densities or conservation of plants and animals? [_] Yes [_] No If yes explain. Also describe any approvals needed or submit those already obtained: D. HUMAN SERVICES As society has evolved, traditional self-sufficient human communities have given way to dense populations that depend upon the development and application of technology. Man�s highly complex, technological environments are maintained by a variety of services, ranging from the provision of the basic necessities of food and water to complex systems of economic exchange. These services are largely interdependent, and their complexities must be considered. NOTE: In this section, the human environment impacted upon is defined as less than 160 acres in size. 1. Could the action disrupt food supplies for over 48 hours? [_] Yes [_] No If yes explain: 70 2. Could the action disrupt water supplies for over 48 hours? [_] Yes [_] No If yes explain: 3. Could the action disrupt electrical power for over 48 hours? [_] Yes [_] No If yes explain: 4. Could the action disrupt heating supplies (natural gas, heating oil) for over 48 hours? [_] Yes [_] No If yes explain: 5. Could the action deprive population of housing for over 48 hours? [_] Yes [_] No If yes explain: 6. Could the action disrupt removal of sewage for over 12 hours? [_] Yes [_] No If yes explain: 7. Could the action disrupt removal of solid waste (trash) for over 7 days? [_] Yes [_] No If yes explain: 8. Could the action disrupt existing health services� response in case of a disaster? [_] Yes [_] No If yes explain: 9. Could the action disrupt telephone, telegraph, radio, or mail service for over 2 weeks? [_] Yes [_] No If yes explain: 10. Could the action disrupt transit service for over 2 weeks? [_] Yes [_] No If yes explain: 11. Will the action use more than 5% of remaining electrical capacity? (Will the project require electrical upgrades?) [_] Yes [_] No If yes: Estimated daily usage is ____ kWh. Please obtain and submit an approval letter from local utility or plant engineer. 71 12. Will the action use more than 5% of remaining water? [_] Yes [_] No If yes: Estimated daily usage is ____ gallons. Please obtain and submit an approval letter from local utility or plant engineer. 13. Will the action use more than 5% of available capacity of the sewage treatment system (branch lines, mains, plants)? [_] Yes [_] No Estimated daily flow is ____ gallons. Please obtain and submit an approval letter from local utility. 14. Will the action use more than 5% of available capacity of trash disposal system (collection, incinerator plant, and landfill)? Also clearly explain proposed handling and disposal of chemical wastes, biohazards, syringes, and other special wastes. [_] Yes [_] No If yes explain: 15. Will the action use more than 5% of available heating fuel (gas, coal or heating oil)? [_] Yes [_] No Annual quantities have already been described. Explain which of these fuels, if any, are in short supply. 16. Will the action decrease by 5% the food delivery system by removal of retail food stores etc.? [_] Yes [_] No If yes explain: 17. Will the action decrease by 5% the area�s domestic housing by demolition, closing, etc.? [_] Yes [_] No If yes explain: Will any housing be demolished, closed, etc.? 18. Will the action decrease by more than 5% the use of existing transit systems (bus, train, etc.)? [_] Yes [_] No If yes explain: Relate to extent of new employment. 19. Will the action decrease accessibility to routine health services by altering point-of-service delivery? [_] Yes [_] No If yes explain: 20. Will the action increase by more than 5% the patient load of the area's routine care services? [_] Yes [_] No If yes explain: 21. Will the action change the availability of social services by opening or closing facilities? [_] Yes [_] No If yes explain: 72 22. Will the action increase by more than 5% the number of social services recipients (through unemployment)? [_] Yes [_] No If yes explain: 23. Will the action cause discontinuation of existing stops or train stations? [_] Yes [_] No If yes explain: 24. Will the action increase by more than 5% the annual volume of telephone, telegraph, or mail? [_] Yes [_] No If yes explain: 25. Will the action eliminate employment sources for 10% of the population? [_] Yes [_] No If yes explain: 26. Will the action change school enrollment by more than 5%? [_] Yes [_] No If yes explain: E. HUMAN VALUES The fifth set of criteria is directed toward human values concerning the environmental qualities generally agreed upon to the extent that they are stated in statutes, standards, or regulations. 1. Will the action involve the purchase, construction, alteration, renovation, or lease of real property or portion of real property that is more that 50 years old? Will the action encroach upon any historical, architectural, or archeological cultural property? Will the proposed action adversely affect properties listed, or eligible for listing, on the National Register of Historic Places? [Buildings, archaeological sites, National Historic Landmarks; objects of significance to a Tribe including graves, funerary objects, and traditional cultural properties.] [_] Yes [_] No If yes explain: Obtain and submit clearance letters from State Historic Preservation Officer. For assistance, consult with the State Historic Preservation Officer (SHPO) or the Tribal Historic Preservation Officer (THPO)] 2. Will the action be likely to adversely affect a plant or animal species listed on the Federal or applicable State list of endangered or threatened species or a specific critical habitat of an endangered or threatened species? (Discovering an endangered or threatened species in the project area will stop the project, and the Endangered Species Act has significant fines and penalties for violations.) [_] Yes [_] No If yes explain: For assistance, consult with the State Historic Preservation Officer (SHPO) or the Tribal Historic Preservation Officer (THPO) 3. Will the action convert significant agricultural lands to non-agricultural uses and exceed 160-point score on the farmland impact rating? 73 [_] Yes [_] No If yes explain: 4. Will the action directly affect a Coastal Zone in a manner inconsistent with the State Coastal Zone Management Plan? (All Federal programs or projects in the coastal zone must comply with the consistency provisions of the Act. Each coastal State should have a State office to manage its coastal zone development and use. ) [_] Yes [_] No If yes explain: 5. Will the action adversely affect a wild, scenic, or recreational river area or create conditions inconsistent with the character of the river? (A consideration for activities that are in or near any wild and scenic waterway including construction of stream/river crossings, intake structures, outfalls, etc.) [_] Yes [_] No If yes explain: F. Mitigative Measures Please discuss any mitigative measures undertaken to minimize any environmental impacts. For example, utilizing EPEAT or EnergyStar guidance as part of IT selection and purchase criteria, or incorporating Sustainable Design or Leadership in Energy and Environmental Design (LEED) standards into alteration/repair/renovation or new construction project. Discuss Mitigative Measures: ENVIRONMENTAL INFORMATION AND DOCUMENTATION CERTIFICATION [_] I certify that to the best of my knowledge and ability the information presented herein is true and correct (enter appropriate information in the shaded blanks): Signature (Type Full Name) Title or Position Phone # Date (Grantee or responsible, knowledgeable person who completed this document) Signature (Type Full Name) Title or Position Phone # Date (Grantee Authorized Representative) 74
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