SOW_07102015_REDLINE.docx

End Stage Renal Disease Network

CMS-2012-ESRD-DQC

Firm Fixed Price (FFP) Competitive

Table of Contents

SECTION C – STATEMENT OF WORK

C.1. PURPOSE OF STATEMENT OF WORK (SOW)

The purpose of this Statement of Work (SOW) is to delineate tasks to be conducted by each End- Stage Renal Disease (ESRD) Network Organization contractor in support of achieving national quality improvement goals and statutory requirements as set forth in Section 1881 of the Social Security Act and the Omnibus Budget Reconciliation Act of 1986. The term “Network” is used in this SOW to refer to the ESRD Network contractor who shall be a QIO-like entity. The tasks described in this SOW are intended to align Network activities with the Department of Health and Human Services (HHS) National Quality Strategy (NQS), the Centers for Medicare & Medicaid Services (CMS)Three-Part Aim (Better Care, Better Health, Lower Cost), and other CMS priorities designed to result in improvements in the care of individuals with ESRD.

C.2. CONTRACT PERFORMANCE OBJECTIVES

This section outlines the role of the ESRD Network and how the NQS principles should be applied to the ESRD SOW.

C.2.1.Domains

The Network shall promote positive change relative to Three-Part Aim outlined in the NQS and CMS priorities. These Aims are interpreted for purposes of this SOW as:

AIM 1: Better Care for the Individual through Patient and Family Centered Care AIM 2: Better Health for the ESRD Population AIM 3: Reduce Costs of ESRD Care by Improving Care.

The three Aims are subdivided into multiple domains, as defined in this SOW. (See Table 1.) Many factors influence these domains, including patient characteristics, patients’ social support/environment, and aspects of the healthcare delivery system. To substantively impact these domains, the Network may need to deploy interventions that target patients, dialysis/transplant providers, other providers, and/or stakeholders.

The Network shall incorporate a focus on disparities in conducting all of the activities outlined in this SOW. In each domain, the Network shall analyze data and implement interventions aimed at reducing disparities. All projects shall use innovative approaches and rapid cycle improvement that incorporates boundariliness, unconditional teamwork, and are customer-focused and sustainable to achieve the strategic goals of the ESRD Network Program.

Contracting Officer’s Representative (COR) is an individual, designated and authorized in writing by the contracting officer to perform specific technical or administrative functions including acknowledgment, acceptance and/or approval of deliverables.

CMS Subject Matter Expert (CMS SME) is an individual who may assist the COR by performing the following:

· Interaction with the contractor on behalf of the COR, while avoiding providing technical direction;

· Monitoring and evaluating the contractor’s performance and providing feedback to the COR;

· Keeping the COR informed of substantive communications with the contractor;

· Assisting the COR with the inspection and evaluation of products and services delivered by the Contractor;

· Notifying promptly the COR of any actual or potential contractor performance issues.

Table 1: AIMs, Domains, and Sub-Domains

Involve Patients/Families/Caregivers in CMS Meetings

Support the ESRD National Coordinating Center (NCC) Patient and Family Engagement Learning and Action Network (LAN)

Conduct QIA to improve Facility Grievance process

Promote Use of In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) and/or Any Similar Survey Identified by CMS

Address Issues Identified through Data Analysis

Recommend Sanctions

Address Patients at Risk for IVD/IVT and Failure to Place

Report data on Access to Dialysis Care Monthly

Vascular Access Management

Reduce Catheter Rates for Prevalent Patients

Support Facility Vascular Access Reporting

Spread Best Practices

Provide Technical Support in the Area of Vascular Access

Establish HAILAN

1) Reduce Rates of Dialysis Events(HAI/bloodstream infection (BSI)/Sepsis)

2) Increase Hepatitis B (HBV)and Pneumococcal Vaccination Rates

Project A: Reducing Hospital Utilization or Project B: Improve Transplant Referrals or Project C: Promote Appropriate Home Dialysis or Project D: Support Improvement in Quality of Life

For Option Year (OY)3 – OY4 all Network will conduct Project A; additional Network selected project may occur

Conduct Quality Improvement Activities (QIA) to assist Facilities in Improving their Performance on ESRD QIP Measures

Assist CMS in Monitoring the Quality of and Access to Dialysis Care

Assist Patients and Caregivers in Understanding the ESRD QIP

2) Conduct Data Quality QIA for NHSN with hospitals and dialysis facilities

3) Provide necessary CW functions as directed by SOW

C.2.2.A Role of Network The Networks are critical to achieving bold CMS goals for healthcare transformation and the aims of the NQS.

The successful Networks will be patient care navigators and lead transformation by:

Serving as conveners, organizers, motivators, and change agents;

Leveraging technology to provide outreach and education;

Serving as partners in quality improvement with patients, practitioners, healthcare providers, other healthcare organizations, and other stakeholders;

Securing commitments to create collaborative relationships with other stakeholders and partners Achieving and measuring changes at the patient level through data collection, analysis, and monitoring for improvement;

Disseminating and spreading best practices including those relating to clinical care, quality improvement techniques, and data collection through information exchange; and Participating in the development of a CMS national framework for providing emergency preparedness services.

The Network is uniquely positioned to ensure full participation of the ESRD community in achieving the aims of the NQS. Therefore, this SOW emphasizes:

Network relationship with Medicare patients Ensuring representation of Medicare patients in shared decision making related to ESRD care in order to promote person-centeredness and family engagement (NQS Principle 1) Protecting Medicare patients’ access to and quality of dialysis care, especially among vulnerable populations (NQS Principle 3) Network relationship with ESRD facilities (NQS Principle 4) Identifying opportunities for quality improvement at the individual facility level and providing technical assistance (NQS Principle 5) Promoting all modalities of care, including home modalities and transplantation, as appropriate, to promote patient independence and improve clinical outcomes(NQS Principle 5) Facilitating processes to promote care coordination between different care settings(NQS Principle 8) Ensuring accurate, complete, consistent, and timely data collection, analysis, and reporting by facilities in accordance with national standards and the ESRD QIP (NQS Principle 6). This also includes the submission of Master Account Holder information for all new facilities to the ESRD Network Coordination and sharing across 18 Networks Using standardized procedures to collect data and address grievances to promote consistency across Networks (NQS Principle 6) Collaborating to share information such as patient migration across Networks to promote care coordination (NQS Principle 8) Coordinating with regional Quality Improvement Organizations (QIO) and Hospital Engagement Networks (HEN), as well as other recognized subject matter experts in the quality improvement field Sharing information to promote care coordination for ESRD patients (NQS Principle 8) Sharing best practices to improve quality of care for ESRD patients, including Network involvement in LANs (NQS Principle 5) Network acting on behalf of CMS Conveying information from CMS to facilities on HHS and CMS goals, strategies, policies, and procedures including the ESRD QIP Maintaining integrity of information and tone of messaging consistent with CMS expectations for entities acting on behalf of the agency Interpreting and conveying to CMS or its designee information relevant to the ESRD healthcare system to assist with monitoring and evaluation of policy and program impacts, including the effects of the ESRD QIP.

C.2.2.B Network activities:

Networks will continue several specific functions through the base and four (4) OYs for the contract. Networks will provide Patient-oriented engagement activities through the Patient and Family Engagement (C.4.1.) and Patient Experience of Care section of the contract. These activities shall include, but not be limited to:

1) Selection of a diverse group of 15 Patient subject matter experts (SME), and integration of these individuals in to the Grievance, ICH CAHPS, and HAI QIAs, at a minimum;

2) Conduct Patient Engagement at the Facility Level;

3) Process of Grievances and Access-to-Care issues;

4) Facilitate grievances and access-to-care cases;

5) Supply the ESRD NCC with patient contact information for those that have agreed to participate in the CMS Grievance Satisfaction Survey;

6) Conduct a QIA directed at one area of the ICH CAHPS survey results;

A major function of the Networks will be to conduct a number of QIAs. These QIAs are listed below: For each of year of the contract, Networks will have eight (8) QIAs. During OYs 3 and 4, all Networks will work on a National Hospital Care Coordination QIA developed during the first three (3) years of the contract. CMS will decide which of seven (7) of the other QIAs will not be completed during OY3 and OY4.

Table 2.QIAs for Base and Option Years

Note: Grievance= Grievance template in J.7; QIA SF=QIA Short Form in J.7; AIM2 Checklist= AIM2 Checklist in J.7; QIP QIA= QIP QIA form in J.7

For each of the three AIMs evaluation for each of these QIAs shall be based on achievement of results recorded on the October Data Input Form (DIF) within eachby September of the contract period. For the each AIM QIA for the base contract period, unless otherwise specified, all QIA Short Forms (Attachment J.7) and or the AIM2 Checklist shall be reviewed by the CMS SME and approved by the COR by the last business day of March. During the 4th Quarter (SepOct-NovDec) of each contact period, Networks will re-assess the membership of the QIAs, and identify potential new facilities or populations to replace those that have achieved success (i.e., those that have achieved the QIA goal). Networks will also re-assess their interventions methods and activities and revise them as necessary. Networks shall provide updated QIA target facility/populations lists to the NCC by the last working day in NovemberDecember of for the subsequent contract period. During the Option years all QIA Short Forms and/or the AIM2 checklist, as appropriate, shall be reviewed by the CMS SME and approved by the COR by the last business day in January.

Additionally, Networks will conduct the process of supporting CMS-designated data systems (e.g. CROWNWeb, NHSN, and Patient Contact Utility) and utilizing such systems to support the Patient services and Quality Improvement functions of this contract.

C.3. GENERAL REQUIREMENTS

C.3.1. Compliance

The Network shall comply with all requirements outlined in this SOW, all additional instructions from CMS, and all relevant statutory and regulatory requirements.

C.3.2. Independence

The Network, acting independently and not as an agent of the Federal Government, shall furnish the necessary personnel, materials, services, facilities, and supplies (except as otherwise specified in the contract) and otherwise do all things necessary for, or incident to, the performance of work as set forth by this SOW.

C.3.3. Organizational Structure

The ESRD Network shall establish an organizational structure that supports the Network’s operations and meets all statutory requirements. The corporate structure shall include at minimum a Network Council, Board of Directors (BOD), Medical Review Board, and Patient Advisory Committee. The Patient Advisory Committee may be comprised in part or whole by the 15 SMEs denoted in section C.4.1.A.1. The Network shall have a designated Executive Director. The Executive Director shall devote sufficient time to the Network to ensure satisfactory performance of the contract. The Executive Director shall ensure the appropriate staff hours and staff expertise to ensure satisfactory completion of the contract. The Network shall employ a full-time Registered Nurse (RN) with nephrology experience, and a full-time Master of Social Work (MSW)-level Social Worker with experience in Case Review as a component of the Network staff. The Network shall maintain on file all CMS-furnished ESRD Network Nondisclosure Statements signed by all Network employees and affiliates.

The Network shall disclose all actual, apparent, and potential conflicts of interest to the Contracting Officer during the term of the contract. The Network shall have programs in place to identify, evaluate, and mitigate all actual, apparent, and potential conflicts of interest that preclude, or would appear to preclude, the Network from rendering impartial assistance or advice on work performed under the Network contract.

No member of any Network board, council, committee, or subcommittee member may review the ESRD services of a provider in which he or she has a direct or indirect financial interest, as described in §1126(a) and (b) of the Social Security Act; with which he or she has or had any professional involvement; from which he or she has received reimbursement; or to which he or she has supplied goods. See §1881(c) (1) (C) of the Social Security Act.

C.3.3.A. Network Council

The Network shall establish and maintain a Network Council that meets the statutory requirements of §1881(c) of the Social Security Act. The Network Council shall:

Be composed of individuals representing renal dialysis and transplant centers located in the Network service area;

Be representative of the geographic distribution and types of dialysis facilities and transplant centers in the Network service area;

Include at least two dialysis and/or transplant patients receiving services in the Network service area who are representative of the geographic and cultural diversity of the communities served by the dialysis and transplant centers in the Network service area.

At minimum, the Network Council shall meet at least once a year in-person, by teleconference or by electronic communication to provide input into the activities of the Network and serve as a liaison between the Network and ESRD providers.

C.3.3.B.Board of Directors

The Network shall establish a governing body (BOD) that sets overall policy and direction for the Network and retains oversight responsibility. The BOD must comply with Section H.210 of this contract.

The Network shall:

Specify the number of members on its governing body (BOD), which shall not exceed 20 members except when appropriate justification is provided to CMS Establish the responsibilities of the members of the governing body and delineate these in bylaws that are reviewed annually and updated as necessary. These responsibilities shall include, at minimum:

Attendance and participation with at least two-thirds of members in participation at each meeting;

Participation in an ongoing training program that addresses ethics, compliance with CMS goals, cultural competence, healthcare disparities, Other relevant topics; and participation in one or more subcommittees of the BOD;

Establish committees and subcommittees to support the governing body, as deemed necessary by the governing body Specify in writing the roles and responsibilities of the governing body and its committees and any subcommittees, including the relationship of the Board with its committees and any subcommittees Document committee meetings, decisions, and actions Publish on its website information identifying governing body members including those serving on any committees and subcommittees. The published information should include at minimum:

Number of members Length of appointment Term limitations When appointments are made What percentage of governing body, committee, or subcommittee members is typically appointed each year Names, affiliations, and compensation (as compensation is permitted) of members.

The membership of the BOD shall consist of ESRD stakeholders from the Network’s service area, including at least two patient representatives. Section 1881(c) (1) (A) (i) of the Social Security Act requires a minimum of at least two consumer representatives on the governing body. The patient members shall be representative of the diversity of the ESRD population in the Network service area including, but not limited to, diversity in treatment modality, race/ethnicity, education, economic status, gender, rural/urban residence, and other relevant factors to the extent possible.

The Network shall adopt policies ensuring the diversity of the non-patient BOD members. To the extent possible, the non-patient members of the BOD shall include representatives from the various healthcare settings relevant to the ESRD population (e.g., Dialysis Facilities, Transplant Centers, Hospitals, and Nursing Homes) and from a range of professional disciplines as well as individuals from diverse racial/ethnic and socioeconomic backgrounds and individuals with non–healthcare backgrounds.

The BOD shall meet as necessary to ensure the successful operation of the Network. At a minimum, the BOD shall meet at least semi-annually in-person, by teleconference or by electronic communication. In addition, the Executive Committee (EC) of the BOD shall meet as necessary to ensure the smooth operation of the activities of the BOD.

At minimum, the BOD or its EC shall:

Supervise and be responsible for the performance of Network staff in meeting SOW requirements and deliverables and responding to any CMS requests;

Supervise and be responsible for the financial operation of the Network, including the IQI Program, as detailed in Section C.3.1 of this SOW;

Review and approve the Annual Report prior to submission to the Contracting Officer’s Representative (COR);

Approve requests for modifications to the Network's contract that involve requests for additional funding and/or staffing;

Review and approve any recommendations from the Medical Review Board (MRB) for sanctions to be imposed on ESRD facilities prior to submission to CMS.

C.3.3.C. Medical Review Board The Network shall establish a committee that meets the statutory requirements of §1881(c) of the Social Security Act to function as the Network's Medical Review Board (MRB). The MRB shall be composed of at least two patient representatives, as well as representatives of the professional disciplines engaged in ESRD care. The professional representatives shall include one or more of each of the following: nephrologists, vascular and transplant surgeons, registered nurses with experience in the care of patients with kidney disease, dietitians, and social workers. MRB members shall be qualified to evaluate the quality and appropriateness of care delivered to patients with ESRD.

The MRB shall meet at least semi-annually. Meetings shall be held in-person, by teleconference or by electronic communication.

The functions of the MRB shall include the following:

· Serving as an advisory panel to the Network on the care and appropriate placement of ESRD patients on dialysis in the Network service area;

· Serving as an advisory panel for all Network QIAs;

· Assisting Network staff in the development, implementation, and evaluation of all QIAs;

· Working with Network staff to recommend sanctions to CMS for dialysis facilities when the criteria for a sanction recommendation are met.

C.3.3.D. Patient Advisory Council

The Network shall establish a Patient Advisory Council (PAC) consisting of at least 15 patients. PAC members that shall be representative of the diversity of the ESRD population in the Network service area including, but not limited to, diversity in treatment modality, race/ethnicity, gender, education, economic status, rural/urban residence, and other relevant factors to the extent possible. PAC members shall be of at least 18 years of age, and may be any patient, and/or caregiver or family member directly associated with an ESRD patient. The PAC may establish one or more PAC committees and/or subcommittees, with PAC members able to serve on more than one committee or subcommittee. The PAC will meet at least semi-annually and with enough frequency to provide input to fulfill the designated functions of the PAC. The meetings shall be held by teleconference or by electronic communication.

The Network shall annually contact at least 25% of the dialysis facilities within its Network for recommendations or patient volunteers to serve on the PAC. The Network shall provide an annual updated listing of PAC members to the COR by February 1 of each contract period. The functions of the PAC include, but are not limited to:

Providing input into the development of informational and educational materials for patients and families/caregivers;

Offering a patient perspective on the selection and development of Network QIAs for which Patient Engagement is required;

Offering a patient perspective to the Network in interpreting the results of all Network QIAs and the development of interventions.

C.3.3.E. Other Committees and Subcommittees

The Network shall establish other committees or subcommittees as appropriate to meet the requirements of the SOW. To the fullest extent possible, the membership of these committees/subcommittees shall represent the diversity of the patient and practitioner community.

C.3.3.F. Network Staff

The Network shall employ sufficient staff to perform the work requirements of the SOW. At minimum, the staff shall include:

Key Personnel: The Executive Director, who is responsible (under the general direction of the BOD) for the overall management, supervision, and coordination of contract requirements, including meeting deliverable due dates. The Executive Director is responsible for the overall operation of the Network, including program development, business and fiscal management, oversight of the IQI Program, staffing (including staff training, hiring, and firing), and liaison with Network committees, CMS, the State Survey Agency(ies) in the Network’s service area, the QIO(s) in the Network’s service area, and other renal-related agencies/organizations.

Sufficient support staff (including a full-time registered nurse with nephrology experience, a full-time MSW-level Social Worker with Case Review experience, and other personnel with experience in program planning, implementation, data analysis, and evaluation) to conduct the activities and responsibilities in the Network’s contract and in other CMS directives.

The Network shall require all employees to sign CMS-furnished ESRD Network Nondisclosure Statements and maintain a file of all signed forms. A copy of the Network Staffing Plan shall be provided to the COR by COB, February 1st of each contract period.

C.3.4. Communication Requirements

The Network shall work with patients and providers in its service area to improve the quality of care and quality of life of ESRD patients by providing informational material and technical assistance on ESRD-related issues. All Network correspondence to patients and to providers for distribution to patients shall be clear, concise, well-organized, and easily understood on the first reading by readers who are literate in English, regardless of functional or health literacy status and professional or academic background. Materials shall be appropriately translated for non-English speakers, as applicable. In addition, all Network correspondence to patients and facilities for distribution to patients shall contain the following language: “To file a grievance please contact [insert Network name] at [insert Network phone number, e-mail address, mailing address, and website URL].”

The Network shall perform the following functions:

Maintain a national user-friendly, toll-free telephone number: The Network’s toll-free number shall be answered by a staff person during normal working hours. After hours, the system shall allow messages to be left. Systems shall be in place to ensure that a Network staff member can be reached by telephone in the event of an emergency or disaster.

Maintain a Network website: The Network website must be Section 508 compliant and follow all CMS standards and guidelines. The Network website shall include, at a minimum: a description of the Network grievance processes; a list of the Network’s goals; the Network’s most recent Annual Report; a link to the Dialysis Facility Compare website (http:www.medicare.gov/dialysis); information on all Network committees, including information on how to become a member of each committee; a link to the ESRD QIP site and other specified federal websites as directed by CMS; and, in the event of an emergency or disaster, the open and closed case status of providers and other information to assist patients and providers.

Prepare a cover letter for the New ESRD Patient Orientation Package (NEPOP): Using Network stationary, the Network shall make a letter available for duplication and distribution to new ESRD patients in the Network’s service area. The letter shall be in English and be provided to the ESRD NCC to distribute in the NEPOP, with a copy to the Network's COR when the content is revised or as otherwise directed by CMS. The letter shall:

Explain the role of Network;

Give the Network’s toll free number, mailing address, and website address;

Provide the address(es) and phone number(s) for the State Survey Agency(ies) in the Network’s service area;

Provide information on the functions of State Survey Agencies, including the role of the State Survey Agency in receiving and investigating grievances;

Include information on how to contact the Network in order to file a grievance (phone number, e-mail address, and mailing address).

Investigate and resolve situations in which NEPOPs are undeliverable: Using an IQI process, the Network shall track the error rate for distribution of the packet on initial mailing, and set an acceptable target for the error rate. The Network shall report on these activities monthly on the COR Monthly Report, and include any activities taken to decrease the undeliverable rate.

Provide educational information: The Network shall report monthly all education activities and assessments of materials provided on the COR monthly Report. The Network shall provide information on the following:

The educational materials provided during the month of reporting;

How the Network determined that education activities were effective, including the results of that assessment;

What educational materials are planned for the following month:

The process for distributing informational material shall be based on a thorough knowledge of the specific needs of the ESRD patient population in the Network’s service area. The Network shall use an IQI process to determine the need for educational/informational materials for its community, determine the most effective method of distribution for each type of material, and evaluate the overall effectiveness of the materials and the method of distribution.

To the extent possible and practical, the Network shall utilize information that is already available through CMS, other CMS contractors (e.g., other Networks, the ESRD NCC, QIOs), other federal agencies, renal partners (e.g., renal advocacy groups, provider groups, and provider associations), and other sources. As applicable, the Network shall utilize the PAC and Network Council in fulfilling these requirements. Educational/outreach materials must include information on:

The role of the ESRD Network;

The Network’s process for receiving, reporting, resolving, and tracking patient grievances;

The Network’s role in facilitating patient’s access to care;

Treatment options and new ESRD technologies available to patients, with an emphasis on those that have been shown to support patient independence (e.g., transplantation, home therapies, in-center self-care);

Information to educate facilities/patients on the actions to take during emergency and disaster situations;

Information to educate and encourage patients to achieve their maximum level of rehabilitation and to participate in activities that shall improve their quality of life (e.g., vocational rehabilitation programs, volunteerism);

Contact information for state/regional vocational rehabilitation programs available in the Network’s service area;

Information on vascular access procedures;

The Network’s toll-free number, mailing address, and website address;

Information on how to access and use the Dialysis Facility Compare website;

Information on how to interpret a facility’s ESRD QIP Performance Score Certificate;

Information on all Network committees, including information on how to become a member of each committee;

Information on the importance of receiving vaccinations (including HBV, influenza, and pneumococcal vaccinations) and information related to the importance of disease management, the Welcome to Medicare Physical, heart-healthy living, diabetes self-management, and (if requested) smoking cessation;

Information on the benefits of the Medicare Prescription Drug Program (Medicare Part D) how to enroll, and any other guidance or materials related to this program of specific benefit to the individual with ESRD, as directed by CMS.

In all written communications for internal and external audiences, the Network shall comply with the required guidance in Attachment J.2, Style Guide for the ESRD Network Program. The Network’s internal audience consists of Network staff members and members of Network Boards and committees. External audiences include ESRD patients, family members and other caregivers, physicians and other practitioners, dialysis facilities and other providers, Network subcontractors, CMS, other federal and state agencies, and other members of the renal community. In addition, the Network shall adhere to all requirements in Attachment J.3, Manuscript Review.

C.3.5. Data Confidentiality and Disclosure

The Network shall adhere to the confidentiality and disclosure requirements set forth in the most recent versions of the following:

Section 1160 of the Social Security Act;

42 Code of Federal Regulations (CFR) Part 480;

45 CFR Parts 160 and 164, as they pertain to “oversight” agencies;

Section H of this contract;

All J Attachments to this contract;

The QNet System Security Policy Handbook; and Other administrative directives.

C.3.6. Information Collection/Survey Activities

Unless otherwise specified, a Network seeking to conduct surveys or collect data as a part of any of the activities included in this SOW shall do so only with prior approval of the COR and in accordance with the Paperwork Reduction Act, Attachment J.3 of this contract, and other administrative directives. No funds from this contract shall be used for data collection activities not specified in this contract without prior approval from the COR and in accordance with other CMS administrative guidance.

C.3.7. Reporting to CMS and Others

As applicable, the Network shall maintain meeting minutes required for the tasks identified in the SOW and the Schedule of Deliverables (SOD). These minutes shall be available on request by CMS. As specified in this contract and approved by CMS, the Network may conduct data analysis and produce data reports relevant to the local provider community and/or CMS. The Network shall maintain a repository of all data acquired and reports generated.

The Network shall use CMS-approved templates, if provided, for reporting deliverables outlined in the SOD. The Network shall adhere to all requirements in Attachment J.4, Reporting Requirements, to manage and report work performed under this SOW. The Network shall submit the following reports to the CMS SME and to the COR for approval and a copy simultaneously to the CMS SME.

Dashboard Input Form (DIF): The Network shall utilize the CMS approved template and criteria for the Dashboard Input Form (DIF). The Network shall update the Dashboard with the latest available data by the 15th calendar day of each month. If the 15th calendar day falls on a Saturday, the DIF will be due on Friday; if the 15th falls on a Sunday, the DIF will be due on Monday, or the next business day, if the Monday is a Federal Holiday. The Network shall not be more than one month behind in reporting information on Network-controlled projects on the CMS Dashboard Input Form (DIF). Being one month behind refers to after the data is available to the Network. Data received by the Network which include more than one month’s data in the release shall report all months results in the DIF, after that have been received. Networks have the ability to change previously entered results for two-months prior to the current reporting month (“Two-month rule”).

Monthly Progress and Status Report: The Network shall use the CMS-approved template for its monthly reports. The reports shall be submitted three business days prior to the scheduled monthly calls. The reports shall reflect the previous month’s activities and data.

Annual Report: The Network shall submit an Annual Report of Network Activities during the second quarter of the year for the previous year’s work using the template provided in J.4, Reporting Requirements. A draft of the Annual Report is due on the 30th calendar day of April and a final version shall be submitted to the COR for approval by the 15th calendar day of June. The Annual Report shall be sent to the ESRD NCC within two weeks of COR approval by the Network. The Network shall post a copy of its report on its website and notify the COR when this is completed.

Semi-Annual Cost Report: Each semi-annual cost report shall be submitted so they are received by CMS no later than close of business on the 15th working day of February and August after the close of each semi-annual cost reporting period. For the final semi-annual period of this contract, the report shall be received by the last business day of November of OY4. For purposes of this requirement, “close of business” is defined as 5pm local prevailing time at CMS Central Office in Baltimore, Maryland, on the due date (Eastern Standard or Eastern Daylight Time, as applicable). For purposes of this requirement, “working days” shall be defined as all calendar days except Saturday, Sunday, and federal holidays as observed by the Federal Government. The cost information supplied should reflect actual costs incurred for the period, and be supported by Network financial records/general ledger and similar documentation. See also Section F of this SOW, Schedule of Deliverables. The semi-annual cost report template and instructions for use can be found Attachment J.4, Reporting Requirements.

C.3.8. Meetings

The Network shall host, participate in, and attend meetings as directed in this SOW. Networks shall receive CMS approval for all in-person meetings (e.g., LAN Meetings) prior to January 1 of the year in which the meeting will occur. The Network shall submit title(s), objective(s), and list of attendees for the annual QualityNet conference, LAN meetings, and/ or other conferences 30 days prior to scheduled meetings and conferences. ESRD Network meetings shall include, but are not limited to, the following:

Contract post-award teleconference with CMS within 30 days of beginning of the base year.

Monthly meetings with the COR. Each Network shall prepare an agenda and meeting minutes for each meeting. The meeting shall address each AIM of the SOW, as presented on the COR Monthly Report (see Attachment J.4) —progress in complying with Section F, Schedule of Deliverables, and other contract requirements—and shall include a review of the Network IQI Plan. The IQI Plan and progress updates shall be provided to the COR electronically to allow for a WebEx-based meeting in which the COR is able to see the Network’s progress if requested by the COR.

Every other month Teleconference meeting with the State Survey Agency. The Network shall prepare an agenda and meeting minutes for each meeting, soliciting agenda items from all participants (surveyors, Network staff, CMS staff, and patient representative when appropriate) prior to the meeting.

The annual QualityNet Conference or another CMS quality meeting(s) designated by CMS as requiring in-person Network participation. Network staff is expected to participate in QualityNet meetings as presenters and/or conveners of learning sessions as directed by CMS.

National meetings related to Network task areas requiring Network attendance and participation as directed by CMS.

Meetings related to the ESRD QIP as directed by CMS.

Other national meetings as specified in this SOW or as directed by CMS.

In addition, the Network shall participate in a QIO LAN if it advances the Network’s ability to advocate for better coordinated care and improved quality of care for ESRD patients in the QIO’s jurisdiction. The Network shall report its involvement with its QIO counterparts in the Monthly Progress and Status Report where appropriate.

C.3.9. Network Collaborations

C.3.9.A. Collaboration with National Coordinating Center

The ESRD NCC functions as a knowledge repository of Network-generated information (including best practices and lessons learned), and performs aggregate data analysis and interpretation of data from the Networks.

The Network shall:

Assist with the ESRD NCC’s knowledge repository and data analysis function by submitting data generated from its activities to the ESRD NCC as specified by CMS;

Focus its activities based on trends detected or analyses performed by the ESRD NCC as directed by CMS;

Participate in the collection and dissemination of best practices and other forms of knowledge transfer.

These best practices and information shall be made available to the ESRD NCC as directed by CMS.

C.3.9.B. Collaboration with State Survey Agency/Agencies

The Network shall establish an ongoing working relationship with each State Survey Agency in the Network’s service area. This working relationship shall involve regularly scheduled teleconference meetings, a defined manner of communication, and establishment of mutually agreeable goals to help carry out each organization’s legislative or regulatory responsibilities (as permitted by statute, regulations, or other CMS policy guidance).

The Network shall communicate with the State Survey Agency, CMS ESRD Network Program staff, and Regional Office Survey and Certification staff on a formal basis (at a minimum, on an every other month basis) and share issues and/or findings related to quality, access to, and coordination of care. The Network must promptly contact the State Survey Agency and coordinate management of a response plan when the issue reported may result in harm to the patient. Whenever communication is initiated by the by the Network or the State Survey Agency regarding facility performance or survey activities, the Network shall keep all information shared during the communication in the strictest confidence. A breach of confidentiality could result in CMS requesting a Performance Improvement Plan (PIP).

C.3.9.C. Collaboration with CMS Components The Network is required to work with CMS components to support CMS quality and patient safety goals and priorities.

Collaboration with CMS components will include:

Conveying to facilities information from CMS on HHS and CMS goals, strategies, policies, procedures, and initiatives, including the ESRD QIP;

Maintaining the integrity of information and tone of messaging consistent with CMS expectations for entities acting on behalf of the agency;

Interpreting and conveying to CMS or its designee information relevant to the ESRD healthcare system to assist with monitoring and evaluating the impact of policies and programs, including the effects of the ESRD QIP.

C.3.9.D. Collaboration with QIO-QIN’s The Network is required to work with QIO-QIN’s as stakeholders, as directed throughout this SOW; making reasonable efforts to include at least one QIO-QIN where directed by this SOW.

C.3.10. Participate in Workgroups

The Network shall participate in workgroup activities related to the Three AIMs of the SOW, which may include, at a minimum, Kidney Community Emergency Response Program (KCER) workgroups, the ESRD NCC Data Committee, or ad hoc committees or teams as established and agreed upon by the Network and CMS as the Network workload allows.

C.3.11. Recommendations for Sanctions

The Network shall recommend sanctions pursuant to §1881(c) (2) of the Social Security Act and procedures outlined in Attachment J.5, Recommendations for Sanctions. The Network shall conduct a thorough review of a facility reporting more than two IVD/IVTs per month or three IVD/IVTs per quarter to ensure regulatory or statutory compliance and to consider exercising its authority to recommend sanctions.

In addition, the Network shall consider recommending sanctions for facilities that:

Engage in inappropriate practice patterns;

Demonstrate a pattern of not accepting the Network’s offers of technical assistance;

Demonstrate a pattern of non-adherence to Network recommendations;

Do not meet Network-determined benchmarks as required by CMS;

Do not meet CMS and Network goals relative to clinical performance measures and ESRD QIP measures;

Have QIAs that do not demonstrate results of continuous quality improvement for those clinical areas with benchmarked standards.

The Network shall report any facilities being recommended for sanctions on the COR Monthly report and provide the COR detailed documentation that supports the recommendation.

C.3.12. Reporting of Discrimination

If it is suspected that care is being compromised or denied due to discrimination on the basis of race, color, national origin, disability, age, sex (gender), or religion, the Network shall refer the case to the Office for Civil Rights (OCR) for investigation. The Network shall also notify the CMS COR, CMS SME, and Contracting Officer.

C.3.13. Emergency and Disaster Responsibilities of the Network

The 18 Networks are the foundation of the CMS ESRD emergency management structure. Under the direction of CMS, KCER is the national presence for ESRD-related emergency and disaster response. Each Network is encouraged to assign staff to participate in one or more of the KCER committees.

Within 45 days of contract award, the Network will submit an emergency/disaster plan to its COR. The plan will be based on input from and knowledge of the emergency preparedness officials in the states within the Network service area, dialysis facility staff, and ESRD patients. Once the plan is approved by the COR, the Network shall submit the approved plan to KCER. The Network shall review the plan annually, revising it as necessary and providing the COR and KCER with the revised document.

The Network shall cooperate with KCER in coordinating emergency preparedness, response, and recovery activities for the renal community inclusive of reporting open/closed facilities, alterations in dialysis facility schedules, and missing patients.

The Network shall provide technical assistance to dialysis facilities when needed so that facilities develop feasible, comprehensive emergency/disaster plans. The Network may wish to utilize the Facility Emergency Plan Checklist developed by KCER.

The Network shall annually participate in an emergency preparedness exercise that is relevant to the types of emergency situations that would be prevalent within the Network’s geography. Network participation shall be by teleconference, minimally, or may participate in person if the exercise is within their service area. Each Network shall coordinate with KCER and other Networks for the exercise as directed by CMS. The Network may request that local stakeholders (e.g., state disaster agencies, State Survey Agencies, CMS Regional Office Divisions of Survey & Certification) participate in the emergency exercise .At the completion of the exercise, in a template provided by KCER, the Network shall perform and document the results of an assessment of strengths, weaknesses, opportunities for improvement, and lessons learned in an After Action Report (AAR). The Network shall submit the completed AAR to the COR no later than 30 calendar days following completion of the exercise. Once the AAR is approved by the COR, the Network shall submit the approved AAR to KCER.

The Network shall have a Memorandum of Agreement (MOA) with a back-up Network and provide an annual orientation…