J.24-B_NCC_SOW.pdf

Attachment J.24 – B September 29, 2015

ESRD NCC SOW

Statement of Work ESRD National Coordinating Center

December 1, 2015, to November 30, 2016, and Four Option Years

Table of Contents

I. Background A. Purpose B. Technical Considerations

II. Requirements A. Requirements/Tasks To Be Performed

Task 1. Support for Clinical AIM 1 Subtask 1.A. Foster Patient and Family Engagement at the National Level

Subtask 1.A.1. Develop and Recruit Members for a National Patient and Family Engagement Learning and Action Network (NPFE-LAN) Subtask 1.A.2. Enhance and Sustain the NPFE-LAN Subtask 1.A.3. Spread the Work of the NPFE-LAN and Affinity Groups

Subtask 1.B. Improved Grievant Experience of Care and Evaluation and Resolution of Grievances

Subtask 1.B.1. ESRD Grievant Satisfaction Survey Subtask 1.B.2. Administration of the Grievant Satisfaction Survey Subtask 1.B.3. Process for the Administration of the Grievant Satisfaction Survey Subtask 1.B.4. Analysis of National Grievance Data Subtask 1.B.5. Development of Grievance-Related CMS Publications Subtask 1.B.6. ESRD Patient Contact Utility (PCU)

Subtask 1.C. ICH CAHPS Subtask 1.C.1. Data Support for ICH CAHPS Subtask 1.C.2. Clinical Support for ICH CAHPS

Subtask 1.D. Supporting Facility Vascular Access Reporting, Spread of Best Practices, and Provision of Technical Support

Subtask 1.D.1. Fistula First Catheter Last Workgroup Coalition Subtask 1.D.2. Data Support for the Increased Use of AVFs and Decreased Use of Catheters . 23

Subtask 1.E. Reduce HAIs Subtask 1.E.1. Establish National HAI LAN Subtask 1.E.2. Data Support for HAI Vaccination QIA

Task 2. Support for Clinical AIM 2 Subtask 2.A. Network Population Health Focused Pilot Project Data Support Subtask 2.B. Network Population Health Focused Pilot Project Clinical Support

Task 3. Support for Clinical AIM 3 Subtask 3.A. Support for the ESRD QIP, Dialysis Facility Compare, Star Ratings, and Dialysis Facility Reports for Performance Improvement Subtask 3.B. Clinical Support for ESRD QIP Projects

Task 4. Maintenance, Enhancement, Security of the ESRD Network Program Data Warehouse Subtask 4.A. Data Warehouse Subtask 4.B. Support for CROWNWeb Subtask 4.C. Participation in CROWNWeb User Group Meetings Subtask 4.D. ESRD Network Dashboard Data Support Subtask 4.E. Support for Clinical AIM Data Analysis

NCC SOW Version 3.0 Page 1 of 62

Subtask 4.F. Clinical AIMs Data Extract, Reporting Business Requirements, and Development . 34 Subtask 4.G. Support for Change Management Subtask 4.H. Infrastructure Operations Support Subtask 4.I. ESRD Security Compliance

Subtask 4.I.1. Certification by Information System Security Officer (ISSO) for Compliance with CMS Systems Security Requirements Subtask 4.I.2. Administer Security Program Subtask 4.I.3. Correct Deficiencies Subtask 4.I.4. Security Review and Verification

Task 5. ESRD NCC Project Management and Communications Subtask 5.A. Strategic Plan Subtask 5.B. Internal Quality Improvement Program Subtask 5.C. Comprehensive Progress and Status Report Subtask 5.D. Change of Key Personnel

Task 6. End of Contract Transition Task 7. National Coordinating Role for the ESRD Network Program

Subtask 7.A. Plan, Facilitate, Participate in National/Regional/Local Meetings Subtask 7.B. Serve as Lead ESRD Program Planner/Organizer for the CMS Annual QualityNet Conference Subtask 7.C. Actively Participate in and/or Attend National and Regional Meetings Subtask 7.D. Support ESRD Network Refresh of Standard Computer Hardware and Software Subtask 7.E. Clinical AIM Resource Library—Facilitate Exchange of ESRD Network and Patient Information, Tools, Resources, and Other Materials Subtask 7.F. Clinical AIMs Marketing and Social Media Responsibilities

Task 8. Development, Lead Authorship, Limited Printing, and Distribution of the Directory of ESRD Network Organizations

Subtask 8.A. Collection of Information for Directory of ESRD Network Organizations Subtask 8.B. Organization, Editing, Design of Directory of ESRD Network Organizations Subtask 8.C. Limited Printing and Distribution of Directory of ESRD Network Organizations

Task 9. Development, Lead Authorship, Printing, and Distribution of the End Stage Renal Disease Network Organization Program Summary Annual Report

Subtask 9.A. Project Initiation, Designation of NCC Lead Author, Collecting Data for Summary Annual Report Subtask 9.B. Preparation of Final Draft of Summary Annual Report Subtask 9.C. Photocopying and Distribution of Summary Annual Report

Task 10. Maintenance and Ongoing Development/Enhancement of a Centralized Website for the ESRD Network Program, Including All ESRD-Related Special Projects

Subtask 10.A. Maintain a Centralized Website for the ESRD Network Program, Including All Special Projects Subtask 10.B. Update the Website

Task 11. Maintain a System for the Identification of all New Dialysis Patients and Distribute New ESRD Patient Orientation Packets (NEPOPs) Monthly to New Patients

Subtask 11.A. Maintain a System for the Identification of All New Dialysis Patients Subtask 11.A.1. Data Support to Monitor and Evaluate New Patient Mailing Datasets

Subtask 11.B. Maintain a System for the Monthly Distribution of NEPOPs Subtask 11.C. Maintain a System for Tracking and Trending Sent and Returned Packets and Reasons for Return Subtask 11.D. Provide Ongoing Education to Network Staff on the NEPOP and NEMO Systems Subtask 11.E. Evaluation and Performance Review of NEPOP Mailing Subcontractor

Subtask 11.E.1. Monthly Evaluation Process Specific to NEPOP Mailing Subcontractor

NCC SOW Version 3.0 Page 2 of 62

Subtask 11.E.2. Annual On-Site Visit of NEPOP Mailing Subcontractor Subtask 11.F. Develop, Implement, and Evaluate a Pilot Program to Test an Alternate Method for Distributing New Patient Orientation Material

Task 12. Provide Administrative Support to CMS as Requested Subtask 12.A. Provide Administrative Support to CMS “Executive Office Hours” Series Subtask 12.B. Provide Administrative Support to AIM SMEs for Community of Practice (CoP) Meetings for AIMs 1, 2 and 3 of the Core Contract SOW Subtask 12.C. Provide Additional Administrative Support to CMS ESRD Network Program Director and the ESRD NCC COR as Requested Subtask 12.D. Develop Documents at CMS’ Request Subtask 12.E. Provide Paper Reduction Act (PRA) Assistance as Requested Subtask 12.F. Physician Consultants

B. Reporting Requirements B.1. CMS/ESRD NCC Contractor Progress Calls B.2. Monthly Reports B.3. Annual Summary

C. Period of Performance D. Key Personnel Requirements

III. Quality Assurance A. Contract Evaluation Criteria B. Contract Monitoring

NCC SOW Version 3.0 Page 3 of 62

I. Background

The ESRD Network Program serves as a primary resource for the Centers for Medicare and Medicaid Services (CMS) in support of achieving national quality improvement goals to improve the quality of care for individuals with End Stage Renal Disease (ESRD.) The creation, responsibilities, and statutory requirements of the ESRD organizations can be found in Section 1881 of the Social Security Act and the Omnibus Budget Reconciliation Act of 1986.

The ESRD Network Program’s current contract cycle (January 1, 2013–December 31, 2015) builds on both the Administration’s health care initiatives and a growing understanding of how to improve the quality of care and services for the dialysis patient.

Implementing the aims of the U.S. Departments of Health and Human Services (HHS) National Quality Strategy will require unprecedented collaboration and action among all stakeholders within the renal community including patients/families, primary care physicians, nephrologists, infectious disease specialists, vascular surgeons, hospitals, State Survey Agencies, independent dialysis providers, and the large dialysis organizations, among others. The ESRD Networks provide a local infrastructure to achieve national goals that result in measurable improvement in the care and services provided to Medicare ESRD patients and their families. The Networks will serve as the conveners and implementers of quality improvement activities in each of their jurisdictions and are uniquely positioned to build sustainable Learning and Action Networks (LANs) and other quality improvement activities. The ESRD NCC (National Coordinating Center) shall serve as a convener and implementer at the national level and provide leadership/support across the three AIM areas included in the Network contract.

The ESRD National Coordinating Center (NCC) is referenced in Section C.3.10 of the ESRD Network core contract. The ESRD NCC serves as the hub for the 18 ESRD Networks. The main role of the ESRD NCC is to lead improvement in the three core contract AIMs. The NCC does this by engaging partners, serving as subject matter experts and providing technical assistance to the Networks. They also collect, analyze, and report data to CMS and the Networks in support of core contract goals, national priorities, and supporting national Patient and Family Engagement and Clinical AIMs LANs.

The goal of the ESRD NCC is to provide leadership, coordination and support for the achievement of common quality improvement goals for the 18 Networks, while providing a single communications and organizational vehicle for the Government to achieve the strategic goals of the ESRD Network Program.

The ESRD NCC contractor shall bring together resources from diverse sources to increase the efficiency and success of the ESRD Network Program and to improve cost-effectiveness through the consolidation of activities that are common across all Networks. The ESRD NCC contractor shall coordinate national activities including:

• Providing education and training in support of CMS initiatives

• Developing and distributing technical and educational materials to members of the ESRD community, including providers and patients/families

NCC SOW Version 3.0 Page 4 of 62

• Collecting, synthesizing, analyzing, reporting, and publishing standardized data for use by the Networks and CMS

• Serving as a liaison between the Networks and the Quality Incentive Program/CROWNWeb data validation contractor

• Coordinating, refining, and promoting tools and resources; developing new tools when appropriate and necessary; distributing communications about tools and resources

• Developing and distributing the ESRD Network Program’s annual report to Congress

• Developing and maintaining an effective national website for the ESRD Network

Program that advances ESRD Network contract goals

• At the direction of CMS, identify disparities in the delivery of ESRD care and effective interventions with a particular focus on the Network SOW AIM areas and sharing this information with the Networks (for example, data mining of grievance information;

access to care as it relates to the patient satisfaction survey; summary data for annual report; and vascular access data)

• Overseeing the distribution and publication revision of New Patient Orientation Packets (NEPOPs) for all new dialysis patients in the country

• Providing leadership/support for the clinical AIMs of the ESRD Network core contract SOW at the national level, including, but not limited to, vascular access goals, reducing preventable hospitalizations, and reducing infectious risk goals

• Providing coordination, leadership and modeling of best practices for the development, support, and convening of LANs.

The ESRD NCC contractor shall support the Networks’ efforts to fulfill the requirements of the ESRD Network core contract SOW with respect to the achievement of the AIMs, Tasks, and Sub-Tasks described in the core contract in support of the National Quality Strategy and the statutory requirements as set forth in Section 1881 of the Social Security Act and the Omnibus Budget Reconciliation Act of 1986.

A. Purpose

The purpose of this Special Project: “ESRD- National Coordinating Center (NCC)” is to support and coordinate for the ESRD Network Program at a national level. This includes conducting activities designed to increase efficiency and reduce redundancy, identifying and spreading best practices, acting as a facilitator in incorporating the patient voice in driving quality improvement efforts at the local and national level. Additionally, the NCC is charged with assisting and supporting the 18 ESRD Networks in carrying out contract activities as detailed in the ESRD Network core contract.

NCC SOW Version 3.0 Page 5 of 62

B. Technical Considerations

I. Independently and not as an agent of the Government, the ESRD NCC 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 ESRD

NCC 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 ESRD NCC 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 ESRD NCC contractor shall complete a Data Use Agreement (DUA) with CMS prior to access to or receipt of any data covered by the ESRD NCC SOW. Data that CMS provides to the ESRD NCC contractor (and any applicable subcontractors) under this SOW shall be used, duplicated, or disclosed only for the purposes of this SOW unless the Contracting Officer specifically permits another use in writing. 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.

NCC SOW Version 3.0 Page 6 of 62 http://www.cms.hhs.gov/lnformationSecurity/ http://esrdncc.org/

Certificates of Destruction: At the conclusion of the use of CMS data or the expiration of the DUA (whichever comes first), the ESRD NCC contractor shall fill out and submit to CMS a Certificate of Destruction (COD). The COD certifies that the ESRD NCC contractor has destroyed the 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 hardcopy data:

• Secure shredding

• Burning

• Use of a bonded destruction service.

Approved destruction methods for softcopy data:

• Delete from:

o Network o Workstation

• Removable storage device

• Empty recycle bin.

V. Section 508 Compliance: The ESRD NCC 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 ESRD NCC contractor shall request access and connectivity to all Quality Net resources, including CROWNWeb, needed to satisfy the Tasks and Deliverables defined in the ESRD NCC SOW. 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 ESRD NCC contractor shall become Deliverables under the ESRD NCC SOW. When an action item is not already included in the Schedule of Deliverables, the due date shall be agreed upon between the COR and the ESRD NCC contractor. Such new action items are often the result of regularly scheduled status meetings, impromptu meetings, and/or requests via e-mail or phone.

NCC SOW Version 3.0 Page 7 of 62 http://www.access-board.gov/sec508/508standards.htm http://www.cms.hhs.gov/InfoTechGenInfo http://www.section508.gov/

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

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

X. The ESRD NCC 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 ESRD NCC contractor by the Government shall be used only for the performance of the tasks in the SOW unless the Contracting Officer specifically permits another use, in writing. If the Contracting Officer permits the ESRD NCC contractor the use of Government-supplied data for a purpose other than solely for the performance of the tasks in this SOW, 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 contract; 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 contract, whichever shall come first, the ESRD NCC 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 ESRD NCC contractor for a specific period of time; such period shall be subject to the agreement of the ESRD NCC contractor. The ESRD NCC 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 ESRD NCC contractor shall furnish direct further evidence of such destruction in a form that the Contracting Officer shall determine is adequate.

XIII. The ESRD NCC 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 Network data.

XIV. The ESRD NCC 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 ESRD NCC contractor must have COR 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 ESRD NCC contractor.

NCC SOW Version 3.0 Page 8 of 62

II. Requirements

A. Requirements/Tasks To Be Performed

Task 1. Support for Clinical AIM 1

Subtask 1.A. Foster Patient and Family Engagement 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 various array of healthcare settings, all activities should support the patient’s values, preferences, and expressed needs;

“provide 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 ESRD NCC contractor shall provide support for the National Patient and Family Engagement Learning and Action Network (NPFE-LAN). The NPFE-LAN shall include patient, family, and/or caregiver representation from 100% of the ESRD Networks during the Base Contract Year of 2016. The members of the NPFE-LAN shall be Subject Matter Experts (SMEs) drawn from a subset of each Network’s recruited SMEs as specified in Section C.4.1 of the ESRD Network core contract SOW for 2016–2020. The ESRD NCC shall build on the successes and lessons learned in the 2013–2015 contract cycle. The NPFE-LAN shall be patient-driven, with strategies and interventions for designated projects developed by the participating patient, family, and/or caregiver SMEs. These SMEs will provide a patient perspective for efforts to improve health care for the ESRD population and, in accordance with recent quality efforts at the national level, to improve the safety, timeliness, and equity of ESRD care while promoting a person-centered approach to care.

The ESRD NCC contractor, in concert with the individual ESRD Networks, shall incorporate the patient’s voice in all of its activities and encourage a patient perspective within the renal community as a whole. Specifically, the NCC shall support at a national level the incorporation of the patient voice in the Networks’ mandatory Quality Improvement Activities (QIAs), including support for incorporating the perspective of patient, family, and/or caregiver SMEs in the development and implementation of interventions in the following three areas: (1) improve

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

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.

NCC SOW Version 3.0 Page 9 of 62 http://www.ipfcc.org/pdf/getting_started.pdf the grievance process at the facility level; (2) support for the Consumer Assessment of Healthcare Providers and Systems In-Center Hemodialysis Survey (ICH CAHPS); and (3) healthcare-associated infections (HAIs). A fourth topic area and QIA shall be independently selected and developed by the SMEs.

Subtask 1.A.1. Develop and Recruit Members for a National Patient and Family Engagement Learning and Action Network (NPFE-LAN)

The ESRD NCC contractor shall convene a NPFE-LAN with patient, family, and/or caregiver representation from each of the 18 Networks during the Base Contract Year. In the ESRD Network core contract SOW, each Network is required to recruit a subset of 5 of their selected 15 SMEs who have an interest in participating in the NPFE-LAN.

The NPFE-LAN members shall serve on the 4 separate Affinity Groups formed to address the 3 QIA topic areas and the one independent QIA topic. The ESRD NCC contractor shall recruit at least 10 Network SMEs for each Affinity Group—recognizing that because of attrition additional SMEs who are not originally selected for the NPFE-LAN may be asked to serve at a later date.

Specifically:

• The ESRD NCC contractor shall develop an innovative marketing plan to initially inspire at least 40 SMEs from the Network-selected pool of candidates to participate in the NPFE-LAN by December 31st of the Base Year and each subsequent Option Years.

• The members of the NPFE-LAN shall be drawn from the patient, family, and caregiver SMEs participating in the individual ESRD Networks QIAs within 90 calendar days post-contact award (PCA).

• The ESRD NCC contractor shall hold the first meeting (kick-off meeting) of the National PFE-LAN no later than February 28th of the Base Contract Year and each subsequent Option Year.

• The NCC shall arrange meetings with the NPFE-LAN every 3 months through the Base Contract Year and in Option Years 1 through 4, building on the successes and lessons learned in the Base Contract Year.

Subtask 1.A.2. Enhance and Sustain the NPFE-LAN

Recognizing the importance of the patient story, the ESRD NCC contractor shall incorporate all aspects of an “All Teach, All Learn” environment and utilize technology such as the Web, on-line learning, videos, and social media in new and inventive ways. The NPFE-LAN shall refine and promote best practice interventions and strategies developed by the Networks for universal use in the 3 mandatory QIA areas. Additionally, the NPFE-LAN shall continue the enhancement and/or development of tools and resources for the mandatory projects as well as the independent SME-directed QIA that may be tested, spread, and utilized by the wider renal community. The NPFE-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.

NCC SOW Version 3.0 Page 10 of 62

In carrying out these activities, the ESRD NCC contractor shall:

• Ensure that the NPFE-LAN is patient-driven, with interventions and strategies for the mandatory projects reviewed and refined by the participating patient, family, and/or caregiver SMEs. These SMEs shall provide the patient perspective.

• Develop an additional QIA that is independent of the mandatory projects, ensuring that the topic selection and the project plan are driven by the SMEs with technical guidance from the ESRD NCC.

• Develop, implement, and sustain an Affinity Group structure from the NFPE-LAN membership. Each Affinity Group shall be established with a common interest and goal, acting together as a group focused on topics for a specific purpose linked to a desired clinical outcome by March 31st of the Base Contract Year and each subsequent Option Years. Specifically: separate Affinity Groups shall be focused on each of the three mandatory areas: improve the grievance process at the facility level; support for ICH CAHPS; healthcare-associated infections (HAIs); the fourth Affinity Group shall be focused on the development of the SME-selected topic for a QIA project.

• Incorporate into the ESRD NCC Strategic Plan the thinking of the patient, family, and/or caregiver SMEs from the NPFE-LAN relative to the activities needed to develop, enhance, and sustain the NPFE-LAN and the Affinity Groups.

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

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

• Support the 3 Affinity Groups focused on the 3 mandatory QIAs in identifying best practices and unique tools and resources that might lend themselves to national usage, no later than June 30th in the Base Contract Year and each subsequent Option Year.

• Support the development and launch of at least one national QIA on a SME-selected topic, developing best practices, tools, and resources no later than September 30th in the Base Contract Year and each subsequent Option Year.

• Establish a national central resource hub on the ESRD NCC website for access to the materials and information refined and approved by the NPFE-LAN, which will enhance availability for ESRD patients and facilities no later than November 30th of the Base Contract Year updated monthly.

• Include the NPFE-LAN members as planners and participators in the CMS QualityNet conference; identify conference topics developed by the NPFE-LAN and share with the ESRD community at large.

• Mail and/or email invitations, agendas, and other meeting information to NPFE-LAN participants as required; duplicate and distribute materials and/or files prior to each meeting.

• Provide a copy of meeting agenda 3 calendar days prior to each meeting, and minutes to the NPFE-LAN members and the COR electronically within 7 calendar days after each meeting; provide a list of participants attending each NPFE-LAN meeting as part of meeting minutes.

NCC SOW Version 3.0 Page 11 of 62

• Establish and maintain a mailing and/or email list for participants update in March and August of the Base Contract Year and each subsequent Option Year; send letters/listserv messages as appropriate.

• Respond within 2 business days of receipt of communication from any NPFE-LAN member.

Subtask 1.A.3. Spread the Work of the NPFE-LAN and Affinity Groups

Requirements for QIAs in the three mandatory focus areas are found in the following sections of the ESRD Network core contract SOW: Section C.4.1.B.1 Evaluate and Resolve Grievances (Grievance QIA); Section C.4.1.B.3 Promote Use of ICH CAHPS (ICH CAHPS QIA); and Section C.4.1.E. Patient Safety: Healthcare-Associated Infections (HAI BSI [Bloodstream Infection] QIA and HAI Vaccination QIA). The NPFE-LAN shall develop national QIA Affinity Groups in these focus areas. Additionally a fourth Affinity Group shall be developed for the SME-selected topic area.

In carrying out these activities, the ESRD NCC shall:

• Develop a NPFE-LAN strategic plan no later than September 30th in the Base Contract Year and each subsequent Option Year with the identified SMEs and CMS leadership through detailed meetings. Each Affinity Group will be established with a common interest and goal, acting together as a group focused on topics for a specific purpose, linked to a desired clinical outcome. For example, an Affinity Group may be established to focus on decreasing infection rates; this group would focus its attention on reviewing and recommending resources, such as videos and social marketing campaigns, to inform and educate patients regarding changes in behavior to impact desired outcomes.

• Create a method to test tools and resources on the specific outcomes relative to each Affinity Group’s outcome goal no later than November 30th in the Base Contract Year and each subsequent Option Year. In order to test and measure the outcome of the tools and resources, the ESRD NCC contractor shall request assistance from groups of Networks defined by the NPFE-LAN as pilot zones as directed by CMS. Network participation in pilot zone testing is optional and will be recognized as work above and beyond their SOW, if they choose to participate.

• Collect tools or resources that are shown to positively impact the specified outcomes, share them through the ESRD NCC CoP meeting series for Network consideration of use in QIAs, and promote nationally via the centralized resource hub for patient engagement materials with formal acknowledgement of Network contributions.

• Enhance and sustain strategies for mentoring NPFE-LAN members in order to increase autonomy within the NPFE-LAN structure, including the realization of the end goal of having an independently patient-run NPFE-LAN.

• Support the development and launch of at least one national QIA campaign through the Affinity Group on a patient-selected topic, developing best practices, tools, and resources; the project may extend beyond a calendar year as long as goals for interim measures are specified and achieved

• Enhance and support a national central resource hub for access to the materials and information reviewed, approved, and or refined by the NPFE-LAN and Affinity Groups

NCC SOW Version 3.0 Page 12 of 62 to enhance availability for ESRD patients; work with the NPFE-LAN and CMS to develop dissemination and spread strategies that support the integration of these tools and tactics in the ESRD community at large.

• Conduct “All Teach, All Learn” pacing events, to include at least one NPFE-LAN Summit at which topics identified through the NPFE-LAN are shared with patients and other stakeholders from the ESRD community at large. These events may be held in person or as virtual events by audio conferencing or Web conferencing and shall address all strategic areas identified in the PFE section of the ESRD Network core contract SOW.

• Mail and/or e-mail invitations, agendas, and other meeting information to NPFE-LAN participants; duplicate and distribute materials and/or files prior to each meeting, as needed

• Provide a copy of NPFE-LAN minutes to the COR and invitees electronically within 7 business days after each meeting; provide a list of participants attending each NPFE-LAN meeting as part of meeting minutes

• Establish and maintain a mailing and/or e-mail list for NPFE-LAN participants; send letters/e-mails/listserv messages

• Manage and maintain NPFE-LAN membership roster, updating and recruiting patient representatives as needed

• Track and trend attendance and take action, when necessary, if patients become less engaged; assist in patient outreach as needed when such situations arise

• Maintain a current database of SMEs willing to provide input, review materials, and/or participate in CMS focus groups or LANs.

Subtask 1.B. Improved Grievant Experience of Care and Evaluation and Resolution of Grievances

The ESRD NCC contractor shall support the continued implementation, evaluation, and enhancement of a multi-level process to evaluate grievant satisfaction within the grievance process. Additionally, the ESRD NCC contractor shall support CMS in the collection and analysis of grievance data to improve the process.

Grievance data is currently captured by the Networks in the Patient Contact Utility (PCU). The data obtained from the PCU will support the analysis of national grievance data.

The ESRD NCC contractor shall understand the elements collected from the PCU and establish a data exchange process to load PCU data into the server dedicated to grievance and satisfaction data collection. Data shall be received electronically on a monthly basis in an agreed upon format, under the direction of CMS. The ESRD NCC shall monitor the timely receipt of the data from each Network in the agreed upon format; and provide a cumulative report of Network submission of PCU data to CMS within 10 business days of receipt date.

At the direction of CMS, the ESRD NCC contractor shall provide guidance or data support related to national trending of information collected in the PCU. Reports may be developed at the Network or national level to identify and monitor trends related to:

• Involuntary discharges

NCC SOW Version 3.0 Page 13 of 62

• Involuntary transfers

• Averted IVDs

• Averted IVTs

• Failures to place.

Subtask 1.B.1. ESRD Grievant Satisfaction Survey

Each ESRD Network is required to evaluate and respond to grievances received from ESRD patients, individuals acting on behalf of ESRD patients, and other sources. Network responsibilities under C.4.1.B.1 of the Network core contract SOW for 2016 focus on conducting activities to meet, in an efficient and effective manner, regulatory and statutory requirements and to conduct quality improvement efforts relative to the grievance process. To this end, the ESRD NCC contractor shall work with the Networks under the leadership of CMS to conduct a Grievant Satisfaction Survey relative to satisfaction with the grievance process. The ESRD NCC shall identify through the grievant survey the following:

• Grievant satisfaction with the Network in resolving the grievance

• Grievant experience with the Network’s’ grievance process with respect to:

o Customer service o Collecting feedback on the grievant’s personal experience in filing the grievance

• Grievant overall satisfaction with the ESRD Network Program and available resources

• Grievant knowledge and understanding of the Network grievance resolution process.

Subtask 1.B.2. Administration of the Grievant Satisfaction Survey

The CMS process for administration of the Grievant Satisfaction Survey requires that an independent third party administrator be subcontracted by the ESRD NCC contractor in order to maintain objectivity and impartiality across all 18 Networks inclusive of the Network that holds the ESRD NCC contract. The ESRD NCC will subcontract with an independent third party administrator 60 calendar days PCA. This subcontractor shall perform the following tasks and activities to administer the Grievant Satisfaction Survey initially and then on a monthly, ongoing schedule:

• Initial setup of survey using a system that supports consistent scripting for survey administration as well as quality oversight monitoring

• Grievance data processing and sample selection

• Pre-notification letter mailing

• Monthly survey administration

• Monthly quality control reporting

• Monthly survey administration reporting and data access.

The ESRD NCC contractor shall conduct regular performance monitoring and evaluation of the subcontractor based on monthly status reports inclusive of quality improvement measures, monthly teleconferences, and annual on-site evaluation visits. The ESRD NCC contractor shall

NCC SOW Version 3.0 Page 14 of 62 report monthly on the administration of the Grievance Satisfaction Survey to the COR in the Monthly Status and Progress Report.

All work performed under this subcontractor agreement is subject to inspection and final acceptance by the ESRD NCC contractor. As a federal contractor of CMS, the NCC contractor holds ultimate responsibility for the quality and completeness of the work.

The Federal Information Security Management Act (FISMA), Section 3544(a) (1) (A) (ii), describes federal agency security responsibilities as regarding the handling of personal health information (PHI) and personally identifiable information (PII). The subcontractor shall adhere to these standards in dealing with mailing files that contain patient data provided by the ESRD NCC contractor and on-site storage of information. Any data given to the subcontractor by the ESRD NCC contractor shall be used only for the performance of the prescribed tasks. The subcontractor shall have a business continuity plan in place to be implemented in the event of a disaster that requires survey administration to be transitioned to another location.

Subtask 1.B.3. Process for the Administration of the Grievant Satisfaction Survey

Under the supervision and oversight of the ESRD NCC contractor, the subcontractor shall administer the survey to approximately 384 participants on an annual basis. The survey shall be administered in both the English and Spanish languages.

Subtask 1.B.3.1 Initial Preparation for Survey Administration

The ESRD NCC contractor shall ensure that the subcontractor completes the following preparation activities within 5 business days of the start of contract (SOC):

• Assign a resource team that includes: Consultant, Project Manager, Report Coordinator, and Patient Data File Coordinator.

• Provide, for review and comment, a project timeline and deliverables checklist at project kick-off, building in direct communication with the ESRD NCC project manager.

• Hold a kick-off meeting.

The ESRD NCC contractor shall ensure that the designated subcontractor completes the following preparation activities within 30 calendar days of contract start and reports completion dates to the ESRD NCC contractor accordingly:

• Describe administration practices to optimize response rates and user experience

• Describe methods utilized to protect the security of survey responses and protect against duplicate or unauthorized response

• Ensure that an internal server can securely store PHI included in Network grievant data

• Evaluate the data file and ensure that a valid and reliable sampling methodology is applied

• Load the survey into an internal computer-assisted telephone interview (CATI) system.

NCC SOW Version 3.0 Page 15 of 62

• Pilot test the CATI system, administering the survey in English and Spanish

• Submit an analysis of pilot test findings to the ESRD NCC contractor

• Provide documentation of values and definitions of survey response choices to be used as a key in determining meaning of results data.

Within 30 calendar days and prior to the beginning of survey administration, the ESRD NCC contractor shall ensure that the subcontractor hires and trains qualified staffs that possess the capacity to:

• Administer the survey in English and Spanish.

• Identify remarks regarding abuse, neglect, exploitation, patient rights violations, fraud, lawsuits, people mentioned by name in a negative way, fear for life,threats of suicide, and illegal actions.

• Score 100% on competency testing.

The ESRD NCC shall report completion of subcontractor preparatory activities and staffing to the COR within 10 business days of each activity.

Subtask 1.B.3.2 Survey Administration

Within 30 calendar days of approval by the Office of Management and Budget (OMB) and CMS and by the 12th calendar day of each month, the ESRD NCC contractor shall submit Network grievant data to the subcontractor to be loaded into the CATI system to support the administration of the survey and the pre-notification mailing process.

Within 4 business days of receipt of data, the ESRD NCC contractor shall ensure that the subcontractor completes the following activities to prepare and distribute pre-notification letter mailings:

• Populate letters with applicable information for each grievant included in the data extract

• Prepare letters in appropriate envelopes for USPS standard mailing with the correct postage

• Mail letters via USPS standard mailing

The subcontractor shall contact grievants using live agents to administer the survey from 9 a.m.

to 7 p.m. in each time zone, for up to five call attempts over the course of three calendar weeks (Sunday to Saturday). Survey administration shall begin on the 7th calendar day following the mailing of the pre-notification letter.

The ESRD NCC contractor shall oversee implementation of survey administration and is responsible and accountable for the performance of the subcontractor through monthly progress and/or outcome reports to CMS.

NCC SOW Version 3.0 Page 16 of 62

Subtask 1.B.4. Analysis of National Grievance Data

By the 5th business day after the close of the monthly survey administration period, the subcontractor shall submit raw survey data files to the ESRD NCC contractor as well as summary and trending reports of the survey results to address the following:

• Grievant satisfaction with the Network in resolving the grievance

• Grievant experience with the Network’s’ grievance process with respect to:

o Customer service o The grievant’s personal experience in filing the grievance

• Grievant overall satisfaction with the ESRD Network Program and available resources

• Grievant knowledge and understanding of the Network complaint resolution process.

Beginning September 30th of the Base Contract Year and every three months through Option Year 4, the ESRD NCC shall provide summary and trending reports which analyze overall survey satisfaction scores by state, by Network, and nationally to identify if overall satisfaction goals (≥ 80% of respondents having a satisfied or very satisfied response) are met utilizing the survey scoring methodology. The reports shall also provide an analysis and trending of individual satisfaction items. The ESRD NCC shall provide data support and guidance to the Networks.

Subtask 1.B.5. Development of Grievance-Related CMS Publications

The ESRD NCC contractor shall support the development/revision of grievance-related CMS publications, at the request and direction of CMS.

Subtask 1.B.6. ESRD Patient Contact Utility (PCU) The purpose of this subtask is to provide clinical and technical input to support the implementation, maintenance, and ongoing performance of the End Stage Renal Disease (ESRD) Patient Contact Utility (PCU) to support the ESRD Network Program. Additionally, when deemed appropriate by CMS provide ESRD subject matter expertise on ESRD application systems, including: CROWNWeb, ESRD QIP, REMIS, PCU, EIDM, Serena, and Remedy.

The Key Personnel required to perform this task are as follows:

NCC SOW Version 3.0 Page 17 of 62

Systems Analyst

Contributes to the evaluation, analysis, and development of recommended solutions. Resolves complex problems, which require an in-depth knowledge of subject matter related to the designated field or discipline. Applies principles and methods of the subject matter to specialized solutions. Areas of expertise may include business process reengineering, performance management, statistical process control, individual and organizational assessment and evaluation, process modeling and simulation, strategic and business planning, change management, and organizational development.

Required Skill Level(s): Any Level - Senior, Mid-level, Junior, Entry

Subject Matter Expert

Provides insight and advice concerning strategic direction and applicability of up to date, industry standard solutions based on in-depth understanding of the latest developments.

Responsible for providing high level vision to program/project manager or leadership to influence objectives of complex efforts.

Provides guidance on the functional procedures/processes/policies reflecting detailed knowledge of functional areas. May lead in-depth research in support of studies and analyses and facilitate refining of stakeholder business requirements.

Required Skill Level(s): Senior, Mid-level

1. The contractor will ensure that the PCU Workgroup continues during this contract period to help align expectations of the ESRD Networks and Centers for Medicare and Medicaid Services (CMS). The contractor will also maintain optimal operability of the PCU 3.0 system and implement any additional enhancements and/or versions of the ESRD PCU.

This Workgroup will continue to monitor the progress of the alignment of the PCU with the requirements of the SOW and ensure that the PCU meets the needs of all Networks operationally in order to meet contract requirements related to entering and tracking Grievance data.

2. The contactor will provide orientation and training on the PCU to all Network Staff and

CMS Network Contracting Officer Representative(CORs)/Subject Matter Experts (SMEs). In addition, continuously monitor PCU utilization and performance/maintenance/user issues through meetings with each Network to ensure proper understanding of PCU 3.0 and provide timely updates to the PCU 3.0 application for any identified enhancements that may be needed for the system. The contractor will

NCC SOW Version 3.0 Page 18 of 62 also ensure that all new patient services staff that are on boarded after the initial Network-wide training are provided with the PCU 3.0 training.

3. The contractor will provide any updates and/or corrections to the Patient Care Utility Manual with definitions, directions and screen shot examples for proper data entry, and sample report displays for redistribution to each Network.

4. The contractor will ensure that the PCU aligns operationally with the Grievance J-8 attachment and ensure that all Networks are uniformed in entering all grievance date into the PCU.

5. The contractor will provide recommendations for a web-based portal; collaborate with CMS-ISG Software Engineering Division to create a project plan.

6. The contractor will transition/import data from the PCU when the centralized CMS designated system becomes available.

7. The contractor will provide to the Networks all the requirements related to the PCU 3.0 and any projected future versions during the contract period to ensure Network staff and CMS Network CORs/SMEs have complete understanding of the field level requirements.

8. The contractor will at the request of CMS perform data analysis and provide findings/summary reporting of all requested ESRD Grievance data entered into the ESRD

PCU.

9. As ESRD Network Program SME, coordinate on behalf of CMS; stakeholder review requirements documents, and management of associated issues and action items, including but not limited to, the PCU or other CMS designated system for concerns/grievances to be utilized by the ESRD Network and make recommendations to the Requirements contractor regarding any changes and enhancements to these systems as deemed appropriate by CMS. For example:

a. The Contractor may review and maintain peer review comments/discussions to ensure proper vetting has been completed for each change request and submit them to CMS for awareness.

b. The contractor may support cross-project communications regarding requirement changes, especially with regard to system/application-level interfaces.

c. The contractor may ensure that all requirements include draft visual graphics, storyboards, case scenarios, business processes and flows and/or data modeling as fitting for the topic, when directed by CMS.

d. The contractor may ensure the CORs/SMEs have complete understanding of the field level requirements.

NCC SOW Version 3.0 Page 19 of 62

The contractor in accordance with the deliverable schedule will report on…