J.23-B_KCER_SOW.pdf

CMS-2016-ESRD-NETWORKS Attachment J.23-B Special Project KCER Statement of Work

Statement of Work (SOW)

Kidney Community Emergency Response (KCER) Program

Table of Contents I. Background

A. Purpose

B. Technical Considerations

II. Requirements/Tasks To Be Performed

Task 1. National Lead for the Kidney Community Emergency Response (KCER) Program

Subtask 1.A. Develop, Implement, Maintain, and/or Enhance the Existing Infrastructure of the KCER Program to Ensure Efficient and Effective Operations

Subtask 1.B. Develop and Implement a Strategic Plan

Subtask 1.C. Internal Quality Control Program

Subtask 1.D. Establish KCER Team and Workgroup Structure

Task 2. Foster Patient and Family Engagement in Emergency/Disaster Planning and Management at the National Level

Subtask 2.A. Develop and Recruit Members for a National KCER Patient and Family Engagement Learning and Action Network (N-KPFE-LAN)

Subtask 2.B. Convene the N-KPFE-LAN

Task 3. Emergency and Disaster Education/Technical Assistance for ESRD Networks, Dialysis Facilities, and Patients

Subtask 3.A. Provision of Emergency and Disaster Education/Technical Assistance for ESRD Networks

Subtask 3.B. Provision of Emergency and Disaster Education/Technical Assistance for Dialysis Facilities

Subtask 3.C. Provision of Emergency and Disaster Education/Technical Assistance for Dialysis Patients

Task 4. KCER Responsibilities for Emergency/Disaster Management

Subtask 4.A. KCER Responsibilities in the Hazard Mitigation and Preparedness Phase

Subtask 4.B. KCER Responsibility in the Emergency/Disaster Response Phase

Subtask 4.C. KCER Responsibilities in the Emergency/Disaster Recovery Phase

Task 5. Treatment and Medicine Recall Notification

Task 6. Maintain a Centralized Website for the KCER Program

Subtask 6.A. Internet Presence—Maintaining Government Standards

Subtask 6.B. Establish, Maintain, and Enhance an Emergency/Disaster Resource Library— Facilitate Exchange of ESRD Network, Dialysis Facility, and Patient Information, Tools, Resources, and Other Materials

Task 7. Plan and Facilitate a National KCER Summit

Subtask 7.A. Planning Committee

Subtask 7.B. Development and Implementation of KCER Summit

Subtask 7.C. Evaluation of KCER Summit

Subtask 7.D. Post-Summit Responsibilities

Task 8. Provide Emergency and Disaster Expertise and Leadership for the CMS ESRD Network Program

Task 9. Transition Plan

B. Reporting Requirements

B.1. KCER Contractor Progress Calls

B.2. Monthly Progress and Status Reports

B.3. Annual Executive Summary

C. Period of Performance

D. Key Personnel Requirements

III. Quality Assurance

A. Special Project Evaluation Criteria

B. Special Project Monitoring

I. Background

The purpose of this Statement of Work (SOW) is to delineate tasks to be carried out by an End Stage Renal Disease Network Organization (ESRD Network) contractor in conducting a Special Project that supports the achievement of national quality of care goals as specifically applied to the dialysis patient and meets statutory requirements as set forth in Section 1881 of the Social Security Act and the Omnibus Budget Reconciliation Act of 1986.

The KCER Program has been in existence since January 2006. The KCER Coalition was created in the aftermath of Hurricane Katrina in recognition of the essential work performed by the ESRD Networks in the tracking and placement of dialysis patients during the extended recovery period post–Hurricane Katrina. The After-Action Report (AAR) prepared following Katrina concluded that the government should create an emergency management program whose sole focus would be on the care and treatment of the dialysis patient. The government recognized that due to the life and death nature of dialysis treatment and the complexity of the dialysis treatment itself, an organized centralized approach is essential in providing optimal treatment locations for displaced patients and preventing emergency room overload by dialysis patients during a period of already stressed emergency room capacity.

During the past decade, the KCER Program has developed from a coalition of ESRD Network and kidney community stakeholders to an emergency management program that is relied on by the CMS Emergency Preparedness and Response Organization (EPRO) as well as the Office of the Assistant Secretary for Preparedness and Response (ASPR) team within the Department of Health and Human Services (HHS) to provide information on the effects of emergencies and disasters on the dialysis community. The KCER contractor is the coordinator and central point of contact for the dialysis community in emergency and disaster situations and other national crises that affect the well-being of the dialysis community. For example, at the request of the renal community, KCER convened a national meeting in 2013–2014 to address the national saline solution shortage, and in 2014–2015, the peritoneal solution shortage. The KCER Program brought together the 18 ESRD Networks, federal stakeholders (the Centers for Disease Control and Prevention [CDC], the Food and Drug Administration [FDA], HHS/ASPR, Veterans Administration (VA) and Institute of Medicine (IOM),Federal Emergency Management Agency (FEMA), manufacturers of dialysis supplies and equipment, large dialysis organizations (LDOs) and small dialysis organizations, independent dialysis facilities, and national kidney organizations (National Renal Administrators Association (NRAA), American Nephrology Nurses Association (ANNA), National Kidney Foundation (NKF) to broker workable solutions to these issues. These problems have not been fully resolved, but the KCER Program continues to coordinate national efforts on behalf of the ESRD Networks, dialysis facilities, and patients.

Additionally, since the outbreak of the Ebola crisis in 2014, the KCER Program has been a key player in bringing the clinical issues/concerns of the dialysis community to the ongoing federal Ebola task force.

During the 2013–2015 contract cycle, the KCER Program (1) expanded and renewed collaborative relationships; (2) improved the resiliency of communication; (3) improved the resiliency of data retrieval; (4) enhanced ESRD Network preparedness through education/training and implementation of national emergency exercises; (5) enhanced preparations for patients; (6) and brought the ESRD Network Program into compliance with federal emergency and disaster regulations and standardized procedures, processes, and communication strategies across all 18 ESRD Networks. Each Network has a Comprehensive Emergency Management Plan (CEMP). These plans are expected to be in full compliance with the following (1) the 14 National Incident Management System (NIMS) Implementation Objectives for Healthcare Organizations: and (2) the National Fire Protection Association (NFPA): Standard 99-12 Health Care Emergency Management, and Standard 1600, Disaster/Emergency Management and Business Continuity Programs.

The KCER Program accomplishes this work through its ongoing relationships with the renal stakeholder community, including but not limited to federal partners (HHS/ASPR, FEMA, CDC, FDA, VA, IOM, LDOs, small dialysis organizations, independent dialysis organizations, professional physician groups, national kidney organizations, and the 18 ESRD Networks.

The tasks described in this SOW are intended to align the activities of this Special Project with the HHS National Strategy for Emergency Preparedness and the CMS Strategic Plan for Emergency Management, to support the 18 ESRD Networks in the implementation of Network-specific emergency management requirements as described in the ESRD Network SOW (2016– 2020), and to maintain and build on the past work of the KCER Program.

A. Purpose

The purpose of this (SOW) is to delineate tasks to be carried out by an End Stage Renal Disease Network Organization (ESRD Network) contractor to perform the work of the Kidney Community Emergency Response Program (KCER). As directed in this SOW, the KCER contractor shall play a leadership and coordinating role at the national level for the ESRD Network Program related to emergency and disaster situations.

Specifically, the contractor awarded this Special Project is charged with the centralized coordination of efforts to ensure the safety of dialysis patients through the development and maintenance of an emergency management infrastructure whose primary mission is to coordinate access to and continuity of care and services for dialysis patients. The KCER contractor shall collaboratively develop, disseminate, implement, and maintain a coordinated emergency/disaster preparedness and response infrastructure for the kidney community. The KCER contractor shall function as the leading authority on emergency preparedness for the kidney community by providing organization and guidance that seamlessly bridges emergency management stakeholders and the ESRD community nationwide.

B. Technical Considerations

I. Independently and not as an agent of the government, the KCER contractor shall furnish all of the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the government, as needed to perform the requirements of the KCER SOW.

II. All work performed under this contract is subject to inspection and final acceptance by the CMS Contracting Officer or another duly authorized representative of the government. The CMS Contracting Officer’s Representative (COR) is a duly authorized representative of the government and is responsible for inspection and acceptance of all items to be delivered under this contract.

III. System Security Background: The Federal Information Security Management Act (FISMA), Section 3544(a) (1) (A) (ii), describes federal agency security responsibilities as including "information systems used or operated by an agency or by a contractor of an agency or other organization on behalf of an agency." Section 3544(b) requires that each agency provide information security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source.

A comprehensive CMS Information Security website that includes links to laws and regulations, policies, standards, procedures, guidelines, and tools, and many other links for publications, templates, and forms can be found at: http://www.cms.hhs.gov/lnformationSecurity.

The activities of the KCER contractor shall adhere to the QualityNet systems security policies and procedures as set forth in, but not limited to, the following documents (posted on http://esrdncc.org/ under the Cyber Tyger downloads), unless otherwise directed by CMS:

• CMS Information Security Acceptable Risk Safeguards (ARS)

• QualityNet System Security Policy Handbook

• QualityNet Incident Response Procedures

• QualityNet Identification and Authentication Policy

• ESRD Network Infrastructure and Support Manual

• ESRD Network Administration and Disaster Recovery Handbook

• QualityNet Exchange User Guide

• Remedy AR System User Guide.

IV. The KCER contractor shall complete a Data Use Agreement (DUA) with CMS prior to access to or receipt of any data. Data that CMS provides to the KCER contractor (and any applicable subcontractors) under this SOW shall be used, duplicated, or disclosed only for the purposes of this SOW unless the COR specifically permits another use in writing after approval by CMS Central Office. Requests for uses of data other than for the purposes of this SOW will not be considered until the required amendments have been made to the DUA.

Certificates of Destruction: At the conclusion of the use of CMS data or the expiration of the DUA (whichever comes first), the KCER contractor shall fill out and submit to CMS a Certificate of Destruction (COD). The COD certifies that the KCER contractor has destroyed the http://www.cms.hhs.gov/lnformationSecurity/ data covered by the DUA and that data has not been used for any other purpose that was not covered in the DUA.

Approved destruction methods for hard copy data:

Secure shredding Burning Use of a bonded destruction service.

Approved destruction methods for soft copy data:

Delete from:

Network Workstation

Removable storage device Empty recycle bin.

V. Section 508 Compliance: The KCER contractor shall comply with the following Electronic and Information Technology Accessibility Standards (Section 508) standards, policies, and procedures:

29 U.S.C. 794d (Rehabilitation Act as amended) 36 CFR 1194 (508 Standards) 36 CFR 1194.21 (a-I), Software Applications and Operating Systems 36 CFR 1194.22 (a-p), Web-based Internet Information and Applications 36 CFR 1194.31 (a-f), Functional Performance Criteria 36 CFR 1194.41 (a-c), Information, Documentation and Support.

http://www.access-board.gov/sec508/508standards.htm (508 standards) FAR 39.2 (Section 508) CMS/HHS Standards, policies and procedures (Section 508) Section a. Information Technology - General Information: http://www.cms.hhs.gov/InfoTechGenInfo.

The full text of these provisions can be accessed electronically at http://www.section508.gov

VI. The KCER contractor shall request access and connectivity to all QualityNet resources, including CROWNWeb, needed to satisfy the Tasks, Subtasks, and Deliverables defined in the KCER SOW and Schedule of Deliverables (SOD). CMS will provide the ESRD NCC contractor with access to the necessary repository metadata, ESRD registry and claims data, and documentation required to perform the assigned tasks.

VII. All action items assigned to the KCER contractor shall become Deliverables under the KCER SOW. When an action item is not already included in the SOD, the due date shall be agreed upon between the COR, CMS Subject Matter Expert (SME), and the KCER contractor.

http://www.access-board.gov/sec508/508standards.htm http://www.cms.hhs.gov/InfoTechGenInfo http://www.section508.gov/

Such new action items are often the result of regularly scheduled status meetings, impromptu meetings, and/or requests via email or phone.

VIII. All software, documentation, and written products created under the KCER SOW shall become the sole property of CMS.

IX. All materials and equipment purchased under the KCER SOW shall become the sole property of CMS.

X. The KCER contractor shall adhere to the confidentiality and disclosure requirements set forth in Section 1160, Title X1, of the Social Security Act; 42 CFR, Part 480, of the Code of Federal Regulations; and other administrative directives.

XI. Any data given to the KCER contractor by the government shall be used only for the performance of the Special Project unless the Contracting Officer specifically permits another use, in writing. If the Contracting Officer permits the KCER contractor the use of government-supplied data for a purpose other than solely for the performance of this Special Project, and if such use could result in a commercially viable product, the Contracting Officer may negotiate a financial benefit to the government. This benefit will most often be in the form of a reduction in the price of the Special Project; however, the Contracting Officer may negotiate any other benefit he/she determines is adequate compensation for the use of the data.

XII. Upon the request of the Contracting Officer, or the expiration of this Special Project, whichever shall come first, the KCER contractor shall return or destroy all data given to the contractor by the government, unless the Contracting Officer directs that the data be retained by the KCER contractor for a specific period of time; such period shall be subject to the agreement of the KCER contractor. The KCER contractor shall retain no copies of the data, or parts thereof, in any form, when the Contracting Officer directs that the data be returned or destroyed. If the data are to be destroyed, the KCER contractor shall furnish direct further evidence of such destruction in a form that the Contracting Officer shall determine is adequate.

XIII. The KCER contractor shall comply with all CMS guidelines regarding the appropriate de-identification of data related to both individuals and practices, consistent with agency privacy guidelines concerning disclosure of ESRD Network data.

XIV. The KCER contractor is encouraged to use social media and related technologies (third-party websites and applications [TPWAs]) to communicate its messages. Some TPWAs, such as yammer.com, twitter.com, and linkedin.com, have been approved for use in supporting CMS business. The KCER contractor shall have COR and CMS SME approval before using any TPWA to ensure that the selected TPWA supports the goals of the ESRD Network Program and is appropriate and safe for use by the KCER contractor.

II. Requirements/Tasks To Be Performed Task 1. National Lead for the Kidney Community Emergency Response (KCER) Program

Under the direction of CMS, the leadership, oversight, and management of the national ESRD emergency and disaster program is delegated to the KCER contractor. The KCER Program is the national presence for ESRD-related emergency and disaster response, and as such is responsible for convening and coordinating national stakeholders in an organized approach to ESRD-related emergency/disaster management. These national stakeholders include, but are not limited to, federal partners (HHS/ASPR, FEMA, CDC, FDA, VA, and IOM); the large (FMC, Davita, DCI) and small dialysis organizations; independent dialysis organizations; professional physician groups; national kidney organizations (NRAA, ANNA, NKF); and the 18 ESRD Networks.

These partners are critical to the successful management of any emergency or disaster situation.

In fact, without these stakeholders there would not be an emergency/disaster response program.

The KCER contractor, as the subject matter expert in emergency and disaster planning for the ESRD Network Program, is responsible for providing leadership and support to the 18 ESRD Networks and the ESRD community as a whole. As the nucleus of the emergency management infrastructure for the dialysis community, the KCER contractor shall support the Networks in their contractual requirements for emergency/disaster management. The Networks’ prime responsibility lies with quality improvement, and as such minimal resources can be applied to emergency/disaster preparedness and management. Therefore, it is expected that the KCER contractor will provide extensive support to the Networks to ensure their ability to support dialysis clinics and patients during the emergency/disaster response and recovery phases.

The KCER contractor shall provide templates, educational support, and 1:1 guidance to the ESRD Networks in the development and implementation of a Comprehensive Emergency Management Plan (CEMP). The plan will address the specific needs of the Network as well as incorporating the needs/vulnerabilities of the dialysis facilities within its geographic area of responsibility.

The KCER contractor shall also either directly or through the ESRD Networks provide support to dialysis facilities through the provision of emergency management education and technical assistance in support of each dialysis facility’s requirement under the ESRD Conditions for Coverage at 42 CFR §494.60(d) to develop a comprehensive emergency management plan for the facility; test its operability annually; contact its local disaster management agency at least annually; and provide orientation and training to patients on emergency response. The welfare of the dialysis patient is the central focus in all emergency/disaster situations and central to the mission of the KCER Program.

Consistent with these general principles, the KCER contractor shall at minimum:

• Develop and implement an effective infrastructure for the KCER Program

• Recruit and convene national stakeholders within an organizational structure that effectively serves the ESRD population

• Develop a comprehensive Strategic Plan that incorporates approaches to all of the

Tasks and Subtasks of this SOW

• Develop a Patient Learning and Action Network (LAN) that lays the foundation for the integration of the patient voice in emergency/disaster preparedness and management

• Develop, implement, maintain, and/or enhance an effective communication strategy that allows for ease of use by the ESRD Networks, dialysis facilities, and patients

• Develop, maintain, and enhance a system for treatment and medicine recall notifications related to dialysis services

• Provide educational opportunities for ESRD Networks, dialysis facilities, and patients based on an assessment of needs, and in a format and venue that is user-friendly and appropriate to the audience

• Convene workgroups to develop tools and resources to support the work of the ESRD Networks, dialysis facilities, and patients relative to emergency/disaster preparedness and management

• Promote and disseminate tools and resources to individuals with ESRD, dialysis facilities, ESRD Networks, and federal, state, and local emergency workers

• Integrate into the Strategic Plan a marketing plan that integrates the concepts of partnership and collaboration across the spectrum of KCER stakeholders, including patients, dialysis facilities, LDOs, ESRD Networks, and federal and state partners

• Test and refine the national response strategy that has been put into place to coordinate the needs of the dialysis population at the federal, state, and local levels

• Plan and implement emergency preparedness tabletop or functional exercise as directed by CMS

• Maintain and enhance a state-of-the-art centralized website for the KCER Program to serve the ESRD Networks, dialysis facilities, and patients

• Convene a workgroup to plan and implement an annual KCER Summit which is ideally held in conjunction with the CMS QualityNet Conference.

Subtask 1.A. Develop, Implement, Maintain, and/or Enhance the Existing Infrastructure of the KCER Program to Ensure Efficient and Effective Operations

The KCER contractor shall:

• Provide to CMS the resumes and credentials of at minimum a KCER Program Director and Assistant Director who are emergency management professionals at start of contract (SOC) for approval

• Establish and or/continue the current emergency and disaster hotline number by SOC

• Develop a committee structure, and recruit appropriate members from among relevant stakeholders to ensure the continuity of the KCER Program within 45 days Post Contract Award (PCA)

• Establish relationships with federal partners (CMS/EPRO, HHS/ASPR), LDOs, and other stakeholders within 15 days PCA

• Maintain and enhance the KCER website by SOC.

Subtask 1.B. Develop and Implement a Strategic Plan

In developing a Strategic Plan, the contractor shall identify program management activities that shall be used to set priorities, focus energy and resources, strengthen operations, ensure that program staff and other stakeholders are working toward common goals, establish agreement around intended outcomes/results, and assess and adjust the KCER Program’s direction in response to a changing environment. The Strategic Plan shall serve as a disciplined effort that produces fundamental decisions and actions that shape and guide what the KCER Program is, who it serves, what it does, and why it does it, with a focus on the future. The Strategic Plan shall clearly articulate not only where the program is going and the actions needed to make progress, but also how it will know if it is successful.

The Strategic Plan shall also identify ongoing strategic management activities and processes that the KCER Program shall use to systematically coordinate and align resources and actions with its mission, vision, and strategy. Strategic management activities shall be designed to transform the static plan into a system that provides performance feedback for decision making and enables the Strategic Plan to evolve and grow as requirements and other circumstances change.

Specifically:

• The KCER Program Strategic Plan shall encompass the mission, vision, and goals of the Program inclusive of all the tasks of this SOW.

• The Strategic Plan shall incorporate a marketing approach that integrates the concepts of partnership and collaboration across the spectrum of KCER stakeholders, including patients, dialysis facilities, LDOs, ESRD Networks, and federal and state partners.

• The Strategic Plan shall be submitted 45 days PCA and updated annually or as changes in the KCER Program occur.

Subtask 1.C. Internal Quality Control Program

The objectives of the Internal Quality Control (IQC) Program are to support and foster continuous quality improvement in KCER processes in order to improve the timeliness, effectiveness, efficiency, and management control of KCER activities.

In support of these objectives:

• The KCER contractor shall develop a written IQC Plan that encompasses the work to be performed under this contract including administrative functions, financial management, and activities in support of this SOW.

• Each of the important milestones and Deliverables included in the SOW and SOD shall be reflected in the IQC tracking system.

• The KCER contractor shall have in place an internal reporting system for all IQC activities, and shall at minimum make reports available to its Network’s Board of Directors (BOD).

• KCER’s IQC Program shall include built-in processes for rapid identification and correction of problems.

• KCER’s IQC Plan shall be submitted to the COR for review no later than 45 days PCA and annually thereafter.

• The KCER contractor shall supply IQC progress reports to the COR in the Monthly Progress and Status Report, documenting adherence to established processes and response to problems that arise in performing contract requirements at least quarterly and more often if problems continue.

Subtask 1.D. Establish KCER Team and Workgroup Structure

The KCER contractor shall establish a national KCER Response Team to assist in the development and oversight of a national emergency and disaster program for the ESRD Network Program within 45 calendar days PCA.

The KCER Response Team shall include representatives of any of the 18 ESRD Networks that volunteer to participate; patients from the KCER N-KPFE-LAN (see Subtask 2.A); as well as representatives of other partners from the kidney community, which may include patient and professional organizations; practitioners serving patients with kidney failure; independent dialysis facilities; transplant centers; LDOs; hospitals; suppliers; state emergency planning and response agencies; State Survey Agencies; and federal agencies such as HHS/ASPR, the FDA, the CDC, and FEMA. The KCER contractor shall provide a recruitment plan (15 days PCA) and a final list of members with affiliations 45 days PCA

The KCER contractor shall configure the KCER Response Team members to provide support, guidance, and expertise in the development and implementation of an infrastructure to support the dialysis community in times of emergency and disaster. The KCER Contractor will provide a written description of the KCER Response Team and Workgroups within 45 days PCA. At a minimum, the KCER contractor shall develop the following workgroups and recruit subject matter experts (SMEs) in each of these areas, including at least one patient SME per workgroup:

• Communication Workgroup: This Workgroup will improve or enhance the use of communication technologies to ensure that information is available to help the kidney community provide continuity of care during the response and recovery phase of an emergency or disaster.

• Facility Operations Workgroup: This Workgroup will facilitate cooperative planning among the wide variety of dialysis facilities, ESRD Networks, and community disaster planners, and assist with facility preparation, response, and recovery efforts.

• Pandemic and Infectious Disease workgroup: This Workgroup will develop and disseminate plans to support the kidney community’s ability to care for patients in the event of emerging and widespread infectious disease. Additionally, this focus group will collaborate with federal, state, and local agencies and other stakeholders to ensure that emergency management plans and pandemic preparedness plans address the needs of dialysis patients.

• Physician Expert Workgroup: This Workgroup will provide nephrology expertise and management for patients with kidney failure and patients with a kidney transplant during a large-scale crisis. The KCER Program shall function as the conduit through which this physician group will become affiliated with the HHS/ASPR Multi-Specialty Enhancement Team (MSET) as soon as HHS completes the charter for this group.

• Clinical Practice Workgroup: Composed of physicians, nurse practitioners, certified nephrology nurses, social workers, dietitians, facility administrators, and patients, this group will take an interdisciplinary approach to emergency and disaster planning and response, and its members will serve as resident experts in the clinical arena.

• Training and Exercise Workgroup: Training responsibilities include development of a training program to enhance the kidney community’s response to emergencies and disasters with a focus on improving response capabilities, and development of training materials. Exercise responsibilities include development of exercises and drills to test the ability to implement the Strategic Plan.

• Executive Oversight Workgroup: The Leaders of the Workgroups shall meet periodically to discuss their projects and update others on progress, potential overlaps, challenges, and successes.

The KCER contractor shall:

• Schedule at least quarterly conference calls with each Focus Group

• Provide a schedule of meeting dates for the calendar year to group members, the COR, and the CMS SME within 45 calendar days PCA and annually thereafter

• Provide an agenda for each meeting at least 5 calendar days prior to the meeting

• Provide meeting minutes inclusive of action items within 7 calendar days after each meeting is held.

Task 2. Foster Patient and Family Engagement in Emergency/Disaster Planning and Management at the National Level

There is a consensus in the current literature that patient and family engagement involves including “the perspectives of patients and families directly into the planning, delivery and evaluation of health care, thereby improving the quality and safety of the care provided.”1 While patient and family engagement may be implemented differently in different healthcare settings, all activities should support the patient’s values, preferences, and expressed needs; “provide

1 Institute for Patient-and Family-Centered Care (2011). Advancing the Practice of Patient-and Family-Centered Care in Hospitals: How to Get Started... Retrieved May 1, 2015, from: http://www.ipfcc.org/pdf/getting_started.pdf http://www.ipfcc.org/pdf/getting_started.pdf clear, high quality information and education for the patient and family; include coordinated and integrated care and involvement of family members and friends, as appropriate”2; and incorporate “the core concepts of dignity and respect, information sharing, active patient participation in their care, and collaboration.”1

The KCER contractor shall incorporate the patient’s voice in all of its activities and encourage a patient perspective within the emergency and disaster community as a whole. Specifically, the KCER contractor shall implement interventions at the national level to foster patient and family involvement in the area of emergency management.

Subtask 2.A. Develop and Recruit Members for a National KCER Patient and Family Engagement Learning and Action Network (N-KPFE-LAN)

The KCER contractor shall convene a National KCER Patient and Family Engagement LAN (N- KPFE-LAN) with patient, family, and/or caregiver representation from each Network during the base year of 2016.

Specifically:

• The members of the N-KPFE-LAN shall be drawn from the patient, family, and caregiver SMEs participating in the individual ESRD Networks’ Patient Engagement LANs, from the N-PFE-LAN, or directly from dialysis facilities. It is important to recruit individual SMEs who have expressed an interest in working on national emergency/disaster initiatives.

• The KCER shall develop an innovative marketing plan to recruit at least 20 SMEs

• The KCER contractor shall hold the first meeting within 90 days PCA.

• KCER shall continue with the N-KPFE-LANs in Option Years 1 through 4, building on the successes and lessons learned in the base year.

• The N-KPFE-LAN shall be consumer-driven, with topics chosen by the participating patient, family, and/or caregiver Subject matter experts (SMEs). These SMEs shall provide a patient perspective for efforts to improve emergency/disaster preparedness and response for the ESRD population ensuring the inclusion of the patient perspective on national emergency and disaster preparedness, response and recovery situations on a national level.

Subtask 2.B. Convene the N-KPFE-LAN

Recognizing the importance of the patient story, the KCER contractor shall incorporate all aspects of an “All Teach, All Learn” environment and utilize technology such as the Web, on-

2 Committee on Quality of Health Care in America, Institute of Medicine. (2001). Crossing the Quality Chasm: A New Health System for the 21st century. Washington, DC: National Academy Press.

line learning, videos, and social media in new and inventive ways. The N-KPFE- LAN shall develop tools and resources at the national level that may be utilized at the local/regional level.

Additionally, the N-KPFE-LAN shall develop recommendations for emergency/disaster management activities that can be spread to the wider community. The N-KPFE- LAN may draw on facilitators from high performing ESRD Networks and other stakeholders, including advocacy groups, government leaders, and national experts to provide advice and guidance on promoting patient engagement.

In carrying out these activities, the KCER contractor shall:

• Incorporate into the KCER Program Strategic Plan the thinking of the patient, family, and/or caregiver SMEs from the N-KPFE-LAN relative to the activities needed to develop, enhance, and sustain the N-KPFE-LAN

• Utilize innovative technology to engage workgroup participation, create connections, and increase participant sharing, such as social media and techniques for effective meeting management

• Develop and implement strategies for mentoring N-KPFE LAN members in order to increase autonomy within the N-KPFE-LAN structure

• Support the development and launch of at least one national Emergency/Disaster Quality Improvement Activity (QIA) or emergency/disaster campaign on patient-selected topics, providing best practices, tools, and resources by the beginning of the third quarter.

• Establish a national central resource hub for access to the materials and information created by the LAN, which will enhance availability for CMS beneficiaries, and create the Resource Hub on the KCER website.

• Include the LAN members as planners and participators in the KCER National Summit;

identify Summit topics developed by the N-KPFE-LAN and share with the ESRD community at large

• Include at least one patient SME as a member of each of the Workgroups as described in Task 2

• Mail and/or email invitations, agendas, and other meeting information to participants as required to do the work of the N-KPFE-LAN; duplicate and distribute materials and/or files prior to each meeting as needed

• Provide a copy of meeting agenda 5 calendar days prior to each meeting, and minutes to the N-KPFE-LAN members, the COR, and the CMS SME electronically within 7 calendar days after each meeting; provide a list of participants attending each LAN meeting as part of meeting minutes

• Establish and maintain a mailing and/or email list for participants; send letters/ /listserv messages as appropriate.

Task 3. Emergency and Disaster Education/Technical Assistance for ESRD Networks, Dialysis Facilities, and Patients

The KCER contractor shall work with the ESRD Networks, dialysis facilities, and patients to improve the care and services to be provided to dialysis patients during emergency and disaster situations through the provision of educational webinars, educational tools and resources, and technical assistance. The KCER contractor shall determine the most cost-effective strategies for reaching dialysis facilities and patients in lieu of working through the ESRD Networks, which unlike past years have limited resources to facilitate this work. This work is progressive, with the base contract year viewed as a development year and Option Years 1–4 as a period of implementation, evaluation, refinement, and identification of promising practices.

In carrying out these activities, the KCER contractor shall:

• Convene a national workgroup composed of representatives from the ESRD Networks, LDOs, independent facilities, federal partners, renal partners, and patients to assist with the creation of an educational plan and its implementation. The workgroup shall be convened within 15 days PCA.

• Develop a written educational plan based on the assessment of the educational needs of the ESRD Networks, dialysis facilities, and patients. The plan shall address all three levels of responsibility (Networks, dialysis facilities, and patients) and shall include a formal needs assessment, implementation strategies, and evaluation methodology. The plan shall be re-evaluated and updated annually or whenever significant environmental changes indicate a need for revision. The plan is due 60 days PCA and annually thereafter.

• Demonstrate the best strategies for effectively working with dialysis facilities and patients. Given that there are almost 6,000 dialysis facilities and 500,000 dialysis patients, it is not reasonable to assume the KCER Program will be able to individually interact with everyone at the local level. Full-scale national emergency and disaster campaigns should be considered. Engagement of the ESRD Networks (if Network resources allow), the LDOs, and independent facilities shall be undertaken in a creative and comprehensive manner, understanding that this approach is new to the ESRD community.

Subtask 3.A. Provision of Emergency and Disaster Education/Technical Assistance for ESRD Networks

The 18 ESRD Networks are the foundation of the CMS ESRD emergency management structure at the local level. The 2016–2020 ESRD Network contract describes the Networks’ responsibilities for emergency and disaster management (C.3.13). It is a prime responsibility of the KCER contractor to support the Networks in fulfilling their contract responsibilities. The KCER contractor and the Networks will work together during actual emergency and disaster situations to support the provision of care and services by dialysis facilities for patients.

In carrying out these activities, the KCER contractor shall:

• Conduct educational activities that support the ESRD Networks’ development of a CEMP inclusive of a Hazard Vulnerability Analysis (HVA) that meets the HHS standards within 15 days of contract award

• Provide a CEMP and HVA Template (meeting HHS requirements) for voluntary use by the ESRD Networks and post to the KCER website (http://kcercoalition.com) by SOC

• Provide the CEMP evaluation criteria for the ESRD Networks and post to the KCER website (http://kcercoalition.com) by SOC

• Centrally catalogue COR-approved ESRD Network CEMPs; provide a spreadsheet of received CEMPS and HVAs by the end of the first quarter of each year and update as needed

• Review the Networks’ CEMPs to become knowledgeable about each Network’s unique approach to the management of emergency/disaster situations and identify areas of potential weakness/vulnerability in the plan; consolidate this information onto a spreadsheet and provide to COR no later than 45 days after the Network’s core contract stipulated deliverable date for the CEMP

• Provide written feedback, if requested by the CORs or ESRD Networks, on the CEMP and HVA based on the Standard Content Element (SCE) Evaluation Tool within 10 days of the request.

• Provide a template for the standardized reporting of activities during an emergency situation (Emergency Situational Status Report). Educate the ESRD Networks on its use.

The template shall include at minimum: (1) number of facilities and patients affected by the emergency situation (information to be obtained from CROWNWeb); (2) facility open and closed status; (3) alternate treatment schedules; (4) brief situational awareness narrative report; and (4) functional status of the ESRD Network. Consider future development of a Web-based tool. Post the template on the KCER website no later than 60 days PCA.

• Develop a Standard Operating Procedure (SOP) for the use of the Emergency Situational Status Report no later than 60 days PCA. Provide in- service on the use of the Tool and the SOP within 75 days PCA/

Based on CMS directions, develop a national tabletop or functional emergency exercise that is compliant with National Homeland Security Exercise and Evaluation Program (HSEEP) standards; rrequest ESRD Network volunteers to participate in the planning and implementation of the exercise at least 6 months prior to the date set for the national exercise

• Provide technical assistance to individual ESRD Networks that request assistance in the development and implementation of a tabletop exercise that is relevant to the types of emergency situations that would be prevalent within the Network’s geographic coverage area

• Provide education and technical assistance to the ESRD Networks in the development of AARs

• Provide education and a PowerPoint template to be used by the ESRD Networks in fulfilling their responsibility to provide an orientation to their designated back-up Network; post the template to the KCER website

• Provide education and technical assistance on the use of a standardized template for a Memorandum of Agreement (MOA) for a back-up ESRD Network; post the template to the KCER website http://kcercoalition.com/ http://kcercoalition.com/

• Provide annual education and technical assistance for ESRD Networks in obtaining a Government Emergency Telephone System (GETS) card to facilitate communication during an emergency/disaster situation

• Instruct ESRD Networks on how to conduct a quarterly test of the GETS card

• Provide technical assistance and educational tools and resources to the ESRD Networks to support any activity they may pursue in support of education for dialysis facilities, beneficiaries with kidney failure, and local federal, state, and regional emergency workers); post tools and resources to the KCER website.

Subtask 3.B. Provision of Emergency and Disaster Education/Technical Assistance for Dialysis Facilities

The KCER contractor shall make emergency and disaster information available to dialysis facilities based on the results of the needs assessment, and in concert with its marketing plan.

Working closely with the ESRD Networks, LDOs, and individual dialysis facilities, the KCER contractor in concert with CMS will determine the best approach to support the individual dialysis facilities in the fulfillment of their regulatory responsibilities for emergency/disaster preparedness and management at the facility level.

The contractor shall be prepared to conduct a national education program once the Proposed Rules—42 CFR Parts 413, 416, 418 et al. Medicare and Medicaid Programs: Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers— are enacted.

In carrying out these activities, the KCER contractor shall:

• Implement the educational strategies identified through the work of the patient LANN-KPFE- LAN and consistent with the KCER educational plan.

• Recruit at least 10 dialysis facilities representing different regions of the country to function as pilot facilities for: (1) testing of the effectiveness of educational material, (2) testing of dissemination approaches, and (3) testing of effective presentation styles, e.g., pamphlets, games, lobby days, video presentations, etc.

• Provide national education on the requirements of the ESRD Conditions for Coverage regarding emergency management plans, requirement for annual testing, and patient education

• Provide technical assistance to dialysis facilities in promoting and disseminating tools and resources to beneficiaries with kidney failure, and local federal, state, and regional emergency workers.

Subtask 3.C. Provision of Emergency and Disaster Education/Technical Assistance for Dialysis Patients

The KCER contractor shall establish a communication infrastructure for ongoing and meaningful interactions with dialysis patients.

Specifically:

• The KCER contractor shall request from the ESRD NCC a download of new facility listings on a regular basis and establish DUAs as required

• Based on the results of the needs assessment and predetermined marketing plan approach, determine the optimal time for sharing emergency and disaster information with new dialysis patients as well as the preferred method of distribution (e.g., USPS, electronic via e-mail, through dialysis facility staff, etc.)

• At minimum, the New Dialysis Patient Packet shall include a letter of introduction from KCER; the 2015 version of the CMS Booklet: “Getting Ready for Emergencies:

A Guide for People on Dialysis”; the ESRD Network and KCER hotline numbers;

details on how to access the KCER website; and information on how to join the

KCER N-KPFE-LAN.

• Utilizing an internal quality improvement process (e.g., environmental scan or needs assessment), the KCER contractor shall determine the needs of the community for additional educational information. For each of the needed educational materials identified, the contractor shall set a goal for development and distribution of the material, determine the effectiveness of the distribution method, and evaluate the overall effectiveness of the campaign/strategy. In fulfilling this requirement, the contractor shall utilize to the extent possible and practical information that is already available through CMS, the ESRD Networks, LDOs, other federal agencies, and other renal partners and stakeholders.

• The KCER contractor shall distribute information through the most effective and efficient approaches possible (e.g., through meetings/trainings opportunities such as those sponsored by the Networks, the ESRD NCC, QIOs, other federal agencies, and other renal partners especially LDOs and beneficiary representative groups.

• The KCER contractor shall utilize the KCER N-KPFE-LAN membership to gain patient input on the development and dissemination of educational materials and on the most effective communication strategies.

Task 4. KCER Responsibilities for Emergency/Disaster Management

Under the direction of CMS, the leadership, oversight, and management of the national ESRD emergency and disaster response program is delegated to the KCER Program. The KCER contractor is the national presence for ESRD-related emergency and disaster response, and as such is responsible for convening and coordinating national stakeholders in an organized approach to ESRD-related emergency/disaster management. The national stakeholders include but not limited to federal partners (HHS/ASPR, FEMA, CDC, FDA, VA, and IOM); the LDOs;

independent dialysis organizations; professional physician groups; national kidney organizations (NRAA, ANNA, NKF); and the 18 ESRD Networks. These stakeholders are critical to the successful management of any emergency situation. The KCER contractor shall convene a Kick- Off Meeting with key stakeholders within 5 days PCA.

Although the ESRD Networks are the backbone of the ESRD national emergency/disaster response program, limited Network funding for the 2016–2020 contract period may require the KCER contractor to assume a more comprehensive role in the ESRD Network Program’s responses to emergency/disaster situations.

Of equal importance to emergency/disaster management is the strength of the KCER Program’s relationship with CMS/EPRO, HHS/ASPR, and the LDOs. The health of these relationships is paramount to the successful management of any ESRD-related emergency/disaster situation.

The subtasks of Task 4 address the three phases of emergency/disaster management and the KCER Program’s responsibility within each of these phases:

• Hazard Mitigation and Preparedness Phase

• Emergency/Disaster Response Phase

• Emergency/Disaster Recovery Phase.

Subtask 4.A. KCER Responsibilities in the Hazard Mitigation and Preparedness Phase

This subtask addresses activities and responsibilities of the KCER contractor during the hazard mitigation and preparedness phase of emergency management. The activities of this phase encompass 6 areas: (1) hazard assessment; (2) hazard mitigation; (3) effective communication planning prior to an event; (4) assessing for availability of emergency generators; (5) record management; and (6) employee and patient preparedness.

It should be noted that some of the requirements of this Subtask overlap with the requirements of Subtask 3.A. of this SOW.

In carrying out these activities, the KCER contractor shall:

• Establish relationships/partnerships with CMS/EPRO and HHS/ASPR as the major federal partners in emergency/disaster management; ensure ongoing involvement with these entities; include engagement strategies in the Strategic Plan

• Establish ongoing relationships with the 18 ESRD Networks that are supportive and collaborative; include engagement strategies in the Strategic Plan.

• Establish relationships/partnerships with the LDOs to ensure their ongoing involvement.

Include engagement strategies in the Strategic Plan

• Develop guidelines and a template for Network-specific CEMPs that include Network-specific HVA Plans; post on the KCER website

• Develop and implement educational activities and provide technical assistance to the Networks in the development of their CEMPs

• Review the Networks’ CEMPs to become knowledgeable about each Network’s unique approach to the management of emergency/disaster…