section c. statement of work

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End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

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 Network Organization (ESRD Network) 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. 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 CMS Three Aims, and other CMS priorities designed to result in improvements in the care of individuals with ESRD.

Background information on the ESRD Network Program can be found in the Medicare ESRD

Network Organizations Manual (ESRD Network Manual).

C.2. CONTRACT PERFORMANCE OBJECTIVES

This section outlines the objectives, priorities, and strategies of the ESRD Network Program and the role of the Network in carrying out activities as reflected in this SOW.

C.2.1. Domains

The Network shall promote positive change relative to three AIMs outlined in the NQS and CMS priorities. The AIMs are interpreted for purposes of this SOW as:

AIM 1: Better Care for the Individual through Beneficiary 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 health care delivery system. To substantively impact these domains, the Network may need to deploy interventions that target patients, dialysis/transplant providers, other providers, and other 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.

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Table 1. AIMS, Domains, and Sub-Domains

AIM

AIM 1: Better

Care for the

Individual through

Beneficiary and

Family Centered

Care

AIM 2: Better

Health for the

ESRD

Population

Domain

Patient and Family

Engagement

Patient Experience of Care

Patient-Appropriate

Access to In-Center

Dialysis Care

Vascular Access

Management

Patient Safety:

Healthcare-Acquired

Infections (HAIs)

Population Health

Innovation Pilot

Project

Sub-Domain

Foster Patient and Family Engagement at the Facility

Level

Involve Patients/Families in CMS Meetings

Convene Patient Engagement Learning and Action

Network (LAN)

Evaluate and Resolve Grievances

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

Decrease Involuntary Discharges (IVDs) and

Involuntary Transfers (IVTs)

Address Patients at Risk for IVD/IVT and Failure to

Place

Generate Monthly Access to Dialysis Care Reports

Improve Arteriovenous (AV) Fistula Rates for

Prevalent Patients

Reduce Catheter Rates for Prevalent Patients

Support Facility Vascular Access Reporting

Spread Best Practices

Provide Technical Support in the Area of Vascular

Access

Recommend Sanctions

Support National Healthcare Safety Network (NHSN)

Establish HAI LAN

Reduce Rates of Dialysis Facility Events

Reduce Identified Disparity through :

Project A: Increase Hepatitis B (HBV), Influenza, and

Pneumococcal Vaccination Rates or

Project B: Improve Dialysis Care Coordination with a

Focus on Reducing Hospital Utilization or

Project C: Improve Transplant Coordination or

Project D: Promote Appropriate Home Dialysis in

Qualified Beneficiaries or

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AIM 3: Reduce

Costs of ESRD

Care by

Improving Care

Support for ESRD

Quality Incentive

Program (QIP) and

Performance

Improvement on

QIP Measures

Support for Facility

Data Submission to

CROWNWeb,

NHSN, and/or Other

CMS-Designated

Data Collection

System(s)

Project E: Support Improvement in Quality of Life

Assist Facilities in Understanding and Complying with QIP Processes and Requirements

Assist Facilities in Improving their Performance on

QIP Measures

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

Assist Beneficiaries and Caregivers in Understanding the QIP

C.2.2. Role of Network

The Networks are critical to achieving bold CMS goals for health care transformation. 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 beneficiaries, practitioners, health care providers, other health care organizations, and other stakeholders

Securing commitments to create collaborative relationships

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

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 beneficiaries

Ensuring representation of Medicare beneficiaries in shared decision making related to ESRD care in order to promote person-centeredness and family engagement (NQS Principle 1)

 Protecting Medicare beneficiaries’ access to and quality of dialysis care, especially among vulnerable populations (NQS Principle 3).

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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 ).

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 (QIOs) and 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 health care system to assist with monitoring and evaluation of policy and program impacts including the effects of the ESRD QIP.

C.3. GENERAL REQUIREMENTS

C.3.1. Internal Quality Control (IQC) Program

The objectives of the IQC Program are to support and foster continuous quality improvement in

Network processes in order to improve the timeliness, effectiveness, efficiency, and management control of Network activities.

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

The Network shall have an internal reporting system for all IQC activities, and shall make reports available to its Medical Review Board (MRB) and, on request, to CMS.

The Network IQC Program shall include built-in processes for rapid identification and correction of problems.

The Network IQC Plan shall be submitted to the Contracting Officer’s Representative (COR) for review no later than 45 days after the beginning of the contract year, unless otherwise directed by

CMS. Upon request by the COR, the Network shall supply IQC reports and analyses to document adherence to established processes and response to problems that arise in performing contract requirements.

C.3.2. 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.3.3. 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.3.4. Corporate Structure

The Network shall establish a corporate structure that supports the Network’s operations and meets all statutory requirements. The corporate structure shall include a Network Council, Board of

Directors, Medical Review Board, and Patient Advisory Committee at a minimum. Network key personnel (Executive Director, Quality Improvement Director, Patient Services Director, and Data

Manager) are required. The Network shall maintain on file all CMS-furnished ESRD Network

Nondisclosure Statements signed by all Network employees and affiliates. All aspects of the corporate structure must meet ESRD Network Manual requirements. (See the ESRD Network

Manual for additional information.)

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C.3.5. 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 process; 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 provided to the National Coordinating Center (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

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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 IQC 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 quarterly.

Provide educational information: The Network shall determine the most effective strategies for the distribution of informational materials, utilizing the basic principles of marketing and consumer engagement. 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 IQC process to determine the need for educational/informational materials for its community, to determine the most effective method of distribution for each type of material, and to 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 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 Patient Advisory Committee 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

 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 and encourage patients to achieve their maximum level of rehabilitation and to participate in activities that will 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 QIP Performance Score

Certificate

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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 training, and (if requested) smoking cessation

Information on the benefits of the Medicare Prescription Drug Program

(Medicare Part D) and on 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.

C.3.6. Data Confidentiality and Disclosure

Pursuant to §1881(c)(8) of the Social Security Act, the Network must comply with the QIO data confidentiality requirements found in §1160 of the Act and 42 CFR, Part 480.

C.3.7. 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 pre-approval of the COR and in accordance with the Paperwork Reduction Act, the ESRD Network Manual, and other administrative directives.

C.3.8. Network Reporting

As applicable, the Network shall maintain meeting minutes required for the tasks identified in the

SOW and the Schedule of Deliverables. The Network shall report to CMS as directed in the SOW and in the Schedule of Deliverables. 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. No new data collection may be implemented by the Network without CMS approval.

The Network shall report to CMS as directed in Section F – Schedule of Deliverables. The

Network shall adhere to all requirements in the ESRD Network Manual to manage and report work performed under this SOW.

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The Network shall submit the following reports to the COR and Government Task Leader (GTL) for approval:

Monthly Reports

Quarterly Progress and Status Reports

Semi-Annual Cost Report

Annual Report of Network Activities

Other deliverables as directed by this SOW and the Schedule of Deliverables.

C.3.9. Meetings

The Network shall host, participate in, and attend meetings as directed in Section F – Schedule of

Deliverables. ESRD Network meetings shall include:

Contract post-award Meeting with CMS

Monthly Meetings with the COR/GTL: The Network shall prepare an agenda and meeting minutes for each meeting. The meeting shall address each AIM—progress in meeting the Deliverable schedule and other contract requirements—and shall include a review of the Network IQC Plan. The IQC Plan and progress updates shall be provided to the COR/GTL 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.

The annual QualityNet conference or another CMS quality meeting(s) designated by

CMS as requiring in-person Network participation. The Networks are 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

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

At least one QIO community-based LAN: The Network shall participate in the QIO

LAN to advocate for better coordinated care and improved quality of care for ESRD patients in the QIO’s state/jurisdiction. If the Network covers more than one state/jurisdiction, the Network shall actively engage with at least one of the QIO LANs in the Network’s service area.

Meetings related to the ESRD QIP as directed by CMS.

C.3.10. Collaboration with Network Coordinating Center

The Network Coordinating Center ( NCC) will function as a knowledge repository of Network- generated information (including best practices and lessons learned) and perform aggregate data analysis and interpretation of data from the Networks.

The Network shall:

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

Focus its activities based on trends detected or analyses performed by the NCC as

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 directed by CMS

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

C.3.11. Collaboration with State Survey Agency

The Network shall engage the State Survey Agency as a partner in achieving common goals to improve access to and quality of care for dialysis patients. Regular two-way communication shall be maintained.

The Network shall communicate with the State Survey Agency and CMS (ESRD Network Program staff and Survey and Certification staff) on a formal basis at a minimum of every other month and share issues and/or findings related to quality, access 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.

The State Survey Agency shall be invited to participate as a member of the Network Patient

Engagement LAN.

C.3.12. Sanctions

The Network shall recommend sanctions pursuant to §1881(c)(2) of the Social Security Act and procedures outlined in the ESRD Network Manual. The Network shall conduct a thorough review of a facility reporting more than 2 IVD/IVTs per month or 3 IVD/IVTs per quarter, to ensure regulatory/statutory compliance and consider exercising its authority to recommend sanctions against recalcitrant facilities. Network interventions shall primarily focus on beneficiaries and their families/caregivers as well as facility process improvements. The Network shall consider recommending sanctions for facilities that:

Endanger the lives of patients being treated for ESRD, and/or 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

Do not demonstrate evidence of effective quality improvement activities that result in continuous quality improvement for those clinical areas in which the facility is not meeting benchmarked national standards.

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C.3.13. Reporting of Discrimination

If it is suspected that care is being compromised or denied due to discrimination on the basis of race, color, religion, national origin, age, sex, familial status, sexual orientation, gender identity, disability, or veteran status, the case should be referred to the Office for Civil Rights (OCR) for investigation. The CMS COR, GTL, and Contracting Officer must also be notified.

C.3.14. Emergency Preparedness

The Network shall provide an Emergency Preparedness Plan to CMS and cooperate with the NCC in coordinating emergency preparedness activities for the renal community. The Network shall provide technical assistance to dialysis facilities when needed so that facilities develop feasible, comprehensive emergency plans. The Network shall comply with the emergency preparedness duties outlined in the ESRD Network Manual.

The Network shall participate in an annual emergency preparedness drill in conjunction with the

NCC. The Network shall coordinate the date and activity with the appropriate local stakeholders

(state disaster agencies, State Survey Agencies, CMS Regional Office Division of Survey &

Certification, etc.) and the NCC utilizing data to support the selection of the focus of the drill that is deemed most important to the Network’s service area (e.g., earthquake, tornado, terrorist activity). At the completion of the drill, the Network shall perform and document the results of an assessment of strengths, weaknesses, opportunities for improvement, and lessons learned. Copies of the assessment will be sent to the NCC, GTL, and COR within 30 calendar days of the completion of the drill.

C.3.15. Data Systems

The Network shall not develop software products for use by facilities or other Networks without written prior approval from CMS. In addition, 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.3.16. Infrastructure Operations Support and Data Management

Unless otherwise directed by CMS, the Network shall adhere to the most current version of the policies and procedures outlined and posted on the QualityNet and NCC websites. These include, but are not limited to, the ESRD Network Infrastructure Operations and Support Manual, the

ESRD Network Information Technology (IT) Administrator Manual, the SDPS Database Systems

Administrator Guide, the QualityNet System Security Policy, and the QualityNet Incident

Response Procedures. The Network shall comply with all present and future statutes as well as federal, Department of Health and Human Services (DHHS), and CMS regulations and program

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CMS-2012-ESRD-FFPRENEWAL instructions relating to providing a secure computer operations environment. Additional policies and procedures may be released, requiring the Network to comply.

The Network shall maintain all necessary documentation that meets or exceeds the performance standards specified in the Infrastructure Operations Support and Data Management chapter of the

ESRD Network Manual and deliverables specified in Section F – Schedule of Deliverables.

C.3.17. Hardware/Software

CMS, either directly or through a CMS contractor, shall provide each Network with a file/print server, a domain controller, a database server, and a workstation and/or laptop for each 0.5 or greater full-time-equivalent (FTE) employee. The servers, workstations, and laptops shall be equipped with a standard operating system and a software suite following approved CMS Federal

Desktop Core Configuration (FDCC) standards. If the Network requires additional hardware and/or software, the Network must receive approval from the Engineering Review Board (ERB). The

Network must pay for the additional equipment and software out of Network contract funds. No additional hardware peripherals or non-approved software may be connected or installed to any

Government Furnished Equipment (GFE) without prior written approval by CMS.

C.3.18. Security

C.3.18.A. Certification by Information System Security Officer (ISSO) for

Compliance with CMS Systems Security Requirements

The Network ISSO or equivalent, also referred to as the Security Point of Contact (SPOC), shall assist the CMS QualityNet ISSO in the security certification of existing controls and compliance with the CMS systems security requirements as described in the CMS Acceptable Risk Safeguards

(ARS) and the Federal Information Security Management Act (FISMA), Title III of the E-

Government Act of 2002 (Public Law 107-347, 44 U.S.C. Ch 36).

C.3.18.B. Administer Security Program

The Network shall comply with all CMS security program requirements as specified in the CMS

Information Security (IS) “Virtual Handbook” (a collection of CMS policies, procedures, standards, and guidelines that implements the CMS Information Security Program) and the

QualityNet Security Policy. The Virtual Handbook can be found at http://www.cms.hhs.gov/informationsecurity and the QualityNet Security Policy is located at http://qualitynet.org/ .

The Network shall comply with all security controls outlined in the CMS Information Security (IS)

Acceptable Risk Safeguards (ARS) for “Moderate” systems. Appropriate references are the CMS

IS ARS, Appendix B, and the CMS System Security Levels by Information Type (located at http://www.cms.hhs.gov/informationSecurity in the Info Security Library).

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The Network shall comply with the CMS Policy for the Information Security Program (PISP) and all CMS methodologies, policies, standards, and procedures contained in the CMS PISP unless otherwise directed by CMS in writing.

The Network shall comply with CMS and OIG audits, reviews, evaluations, tests, and assessments of Network systems, processes, and facilities. The Network shall provide all related artifacts upon request. The Network shall deliver the artifacts using the format and method prescribed by CMS.

The Network shall visit the CMS security website ( http://sww.cms.hhs.gov/informationsecurity ) at least every 30 calendar days for updates.

The Network shall visit the QualityNet Conference website ( http://www.qualitynetonline.com/ ) with appropriate frequency for QualityNet Program and Security briefings and training opportunities.

The Network shall participate in CMS Security Best Practices conferences and audio conferences as directed by CMS.

The Network shall document its compliance with CMS security requirements and maintain such documentation in the Network System Security Plan (SSP) and the Information Security (IS) Risk

Assessment (RA) as directed by CMS.

C.3.18.C. Correct Deficiencies

The Network shall correct any security deficiencies, conditions, weaknesses, findings, or gaps identified by all audits, reviews, evaluations, tests, and assessments, including but not limited to

Office of Inspector General (OIG) audits, self-assessments, Network internal review, Network security audits, and vulnerability assessments in a timely manner.

C.3.18.D. Security Review and Verification

The Network shall comply with the CMS Security Assessment and Authorization (SA&A) methodology, policies, standards, procedures, and guidelines for contractor facilities and systems

( http://www.cms.hhs.gov/InformationSecurity/14_standards.asp

).

The Network shall conduct or undergo, as specifically selected and directed by CMS, an independent evaluation and test of its systems security program in accordance with CMS Reporting

Standard for Information Security testing and adhere to the prescribed template

( http://www.cms.hhs.gov/InformationSecurity/14_standards.asp

) The Network shall support CMS validation and accreditation of contractor systems and facilities in accordance with CMS’ SA&A methodology.

The Network shall provide annual certification in accordance with SA&A methodology that certifies it has examined the management, operational, and technical controls for its systems supporting the Network contract function and considers these controls adequate to meet CMS’ security standards and requirements.

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C.4. AIMS AND DOMAINS

C.4.1. AIM 1: Better Care for the Individual through Beneficiary and Family

Centered Care

CMS strives to promote health care that is respectful of and responsive to individual patient preferences, needs, and values. Network patient-centered domains to achieve AIM 1 are:

Patient and Family Engagement

Patient Experience of Care

Patient-Appropriate Access to In-Center Dialysis Care

Vascular Access Management

Patient Safety: Healthcare-Acquired Infections (HAIs).

In CMS’ view, most Network activities will be enhanced by the patient’s voice. The Network shall take a two-tiered approach to incorporating the patient’s voice in the activities of the Network and the renal community as a whole. The two tiers are: (1) engagement at the dialysis facility level to foster patient and family involvement; (2) development and implementation of a beneficiary and family centered care focused LAN to promote patient and family involvement at the Network level.

Both tiers are essential and work together to promote beneficiary and family engagement to improve quality of care.

In addition, the Network shall collaborate with the appropriate State Survey Agency(ies) to support patient and family engagement.

Patient Subject Matter Experts (Patient SMEs) are committed and informed patients who are representative of the demographic characteristics of the Network’s service area, and who participate in the Network-convened Patient Engagement LAN. These patients will provide a patient perspective for Network improvement activities. The Network shall:

Provide at least 20% of facilities located in the Network area with Patient SME agreement forms to identify patients to participate in Patient and Family Engagement activities within 30 days of contract award

Recruit at least 10 Patient SMEs for within 60 days of contract award, three of whom must be eligible patients on the transplant waitlist

Submit a list of Patient SMEs who have signed agreement forms to CMS. (See the

ESRD Network Manual.)

Document the active participation of Patient SMEs and their contributions in the

Monthly Reports. Provide an update on the number of participants who remain active in Patient and Family Engagement activities including the Patient LAN throughout the course of the contract. Active involvement can be demonstrated by multiple means including lists of attendance at meetings, webcasts, conference calls; documented requests for technical assistance; documented requests for resources; or an attestation of participation signed by the participant.

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C.4.1.A. Patient and Family Engagement

C.4.1.A.1. Foster Patient and Family Engagement at the Facility Level

The Network shall assist providers in adjusting to the heightened focus on patient and family centered care, aiming to help them optimize customer service. Specifically, the Network shall:

Develop and submit to the COR within 30 days of the start of the contract a marketing plan that integrates the concepts of family engagement and patient-centered care. (See the

ESRD Network Manual.)

Fully implement the marketing plan within 120 days of contract award

As part of any onsite visits to dialysis facilities, incorporate discussion, education, and evaluation of how the dialysis facility has implemented patient and family centered care.

For example:

 Review and discuss with the facility whether the Quality Assurance

Performance Improvement Program includes patient and family participation

Review for the presence of patient and family meetings (e.g., patient council, support groups, vocational rehabilitation groups, new patient adjustment groups)

Review and discuss patient and family involvement in the governing body of the facility

Review and discuss policy and procedures related to family participation in the patient’s care such as involvement in the development of the individualized plan of care and cannulation

Determine the percentage of patients and/or family members/caregivers who participate in plan of care meetings

By the 4 th

Quarter of the base contract year, synthesize information on dialysis facilities’ patient and family engagement in the Network service area to determine needs and future social marketing efforts for Option

Years 1 and 2.

C.4.1.A.2 Involve Patients/Families in CMS Meetings

The Network shall incorporate patients/family members into CMS meetings as follows and record attendance in the meeting minutes:

Attendance by at least one Patient SME, family member, and/or caregiver in one

CORmonthly monitoring meeting per quarter. In one COR/Network monthly meeting per quarter, the Network will dedicate an agenda item(s) to patient-related topic(s) and provide the attending Patient SME(s) with a 10 minute opportunity to address the agenda topic, raise additional for discussion and/or provide an agenda item for the next quarter meeting.

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Attendance by at least one Patient SME, family member, and/or caregiver at the Network’s annual evaluation site visit. During the Network’s annual evaluation site visit, the Network and its COR will dedicate at least an hour of time to provide the attending Patient SME(s) with an overview of Network operations, an overview of CMS oversight and an opportunity for the Network and/or COR to answer Patient SME questions.

Participation in other CMS meetings as directed. See the ESRD Network Manual for additional guidance.

C.4.1.A.3. Convene/Support Patient LAN

LANs are mechanisms by which large-scale improvement around a given aim is achieved through the use of various change methodologies, tools, and/or time-bounded initiatives. LANs manage knowledge as a valuable resource. They engage leaders around an action-based agenda. LANs create opportunities for in-depth learning and problem solving. While all dialysis facilities and other ESRD providers in a given state or ESRD Network service area may not receive direct ESRD

Network interventions, LANs create an opportunity for communities, with assistance and guidance from the ESRD Network, to harness the knowledge, skills, and abilities of community partners to reach a critical mass of the appropriate stakeholders in the community concerned with a common aim(s).

The Network shall develop and facilitate a sustainable Patient Engagement LAN in the Network area to promote patient and family engagement. The LAN shall be patient-driven with topics chosen by the Patient Subject Matter Experts (Patient SMEs) participating in the LAN. Patient

SMEs are committed and informed patients who are representative of the demographic characteristics of the Network’s service area, and who participate in the Network-convened Patient

Engagement LAN. These patients will provide a patient perspective for Network improvement activities.

As directed by CMS and as resources allow, the Network shall also participate in any CMSsupported and/or facilitated LANs that function to support ESRD Network activities at the local level through spreading knowledge gained from counterparts across the country such as any applicable QIO LANs, dialysis facilities and other ESRD providers, large dialysis organizations

(LDOs), the National Institutes of Health National Kidney Disease Education Program

(NIH/NKDEP), the Centers for Disease Control and Prevention (CDC), the United States Renal

Data System (USRDS), and the University of Michigan Kidney Epidemiology and Cost Center

(UMKECC).

CMS staff will participate in the Patient Engagement LAN on a consistent basis.

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The Network shall:

Develop and submit to CMS within 30 days of the start of the contract a Patient

Learning and Action Network Plan. The Plan shall include, at a minimum, the

Patient SME participation list; additional stakeholders included in the LAN (e.g., family members/caregivers, practitioners, providers, patient advocacy groups, local/state/federal government representatives, and other renal community members); the intended roles of the LAN participants; frequency of meetings; proposed patient-driven area(s) of focus; and the intended result of LAN activities with target milestones. (See the ESRD Network Manual.)

Document the active participation of Patient SMEs and their contributions to LAN activities in the Monthly Reports.

Provide an update on the number of participants who remain active in the LAN throughout the course of the initiative. Active involvement can be demonstrated by multiple means including lists of attendance at meetings, webcasts, conference calls; documented requests for technical assistance; documented requests for resources; or an attestation of participation signed by the participant.

At the regional level, the input from Patient SMEs and their family members and/or caregivers will be used by the LAN to help guide Network activities. The Network shall use technology such as conference calls or webinars to conduct meetings; schedule meetings when patients can likely attend; and help patients understand how they can best contribute and add value to the meetings.

During the base contract year, the Network shall establish the LAN with 10 or more patients. The

Network shall maintain 100% membership with 60% attending required meetings and activities throughout the course of the project.

The Network shall ensure that at least four LAN meetings are held with patient participation during the base contract year, documenting the goals and accomplishments of the meetings. A copy of the minutes of these meeting shall be provided to the COR and GTL electronically within 15 days of each meeting.

The Patient Engagement LAN, including the 10 Patient SMEs as well as providers and other stakeholders, shall accomplish the following for each contract year:

Identify ways to spread best practices and design and implement a Quality

Improvement Activity (QIA) that promotes patient-centered care and protects the interest of beneficiaries, such as a QIA that focuses on empowering patients to share in decision-making, enhancing quality of life, and exploring treatment modalities including home dialysis. The Network shall submit a QIA Plan for COR approval by the end of the 2 nd Quarter for the base contract year, and by the end of the 1 st Quarter for Option Years 1 and 2. The QIA Plan must incorporate sound methodology as provided by the ESRD Network Manual, and shall identify a single primary process or outcome measure for evaluation purposes. The QIA methodology shall impact at least

10% of the Network population, and the Network shall demonstrate at least a 5% relative improvement on the pre-specified primary measure by the end of the 4 th

Quarter of the contract year. Additional measures can be employed at the Network’s

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 and Patient SMEs’ discretion. Monthly results from the QIA shall be provided to CMS electronically as directed by CMS.

Ensure implementation of at least two campaigns developed by the LAN by the end of the 2 nd Quarter of the base contract year, and two additional campaigns by the end of the 1 st Quarter of Option Years 1 and 2. Campaigns must include development of educational materials intended for beneficiaries such as materials focused on health literacy, effectively navigating the dialysis system, treatment modalities, disease management, heart healthy living, ways to optimize quality of life, patient safety, promoting vaccinations, reducing disparities, increasing appropriate transplant referrals, reducing IVDs, or other patient-centered goals. The campaigns must be approved by the COR, and must incorporate sound methodology. For each campaign, the Network shall identify a single primary process or outcome measure for evaluation purposes. The campaign methodology shall impact at least 20% of the Network-area population, and the Network shall demonstrate at least a 10% relative improvement on the pre-specified primary measure for each campaign. Additional measures can be employed at the Network’s and Patient SMEs’ discretion. Monthly results from each campaign shall be provided to CMS electronically as directed by CMS.

The Network shall report monthly on the activities conducted by the LAN in the Monthly Report.

The LAN component of the report shall include information that addresses the following questions:

What activities were completed during the reporting period? What new learning was generated, and how was the learning shared with other stakeholders in the Network’s service area?

In addition, the Network shall enlist 3 of the 10 participating Patient SMEs and/or their families/caregivers to serve as representatives on the NCC Patient LAN by the end of the 1 st

Quarter of the base contract year. Participating Patient SMEs and their families will interact by teleconference or webcast with the NCC at least quarterly. At the national level, the input from participating Patient SMEs will be used in the development of national materials designed to improve care.

As requested by CMS, the Network shall enlist any 3 of the 10 Patient SMEs and/or their families/caregivers to provide feedback for the ESRD QIP and any ESRD QIP materials.

C.4.1.A.4. Contract Monitoring and Evaluation: C.4.1.A Patient and Family Engagement

CMS will monitor the Network on a quarterly basis using the minimum performance criteria specified in the following table.

Table 2: Minimum Performance Criteria for C.4.1.A. Patient and Family Engagement

Measure

Patient and family engagement in CMS

At least one

Patient SME, family member,

Quarter 1

At least one

COR monthly call attended by a Patient

Minimum Performance Criteria

Quarter 2

At least one

COR monthly call attended by a Patient

Quarter 3

At least one

COR monthly call attended by a

Quarter 4

At least one

COR monthly call attended by a Patient

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CMS-2012-ESRD-FFPRENEWAL meetings

Patient and family engagement in CMS meetings

Patient

Engagement

LAN – commitments secured and participant engagement

Patient

Engagement

LAN –

Network activities and outputs and/or caregiver attends at least one

COR monthly monitoring meeting per quarter

At least one

Patient SME, family member, and/or caregiver attends at least one day of the CMS evaluation site visit

Maintain100

% membership with 60% attending required meeting and activities throughout the course of the project; recruit to replace lost members as applicable

Implement a

QIA developed by the LAN that promotes patientcentered care and protects the interest of

SME, family member, and/or caregiver

N/A

Maintain

100% membership with 60% attending required meeting and activities throughout the course of the project

SME, family member, and/or caregiver

N/A

Maintain

100% membership with 60% attending required meeting and activities throughout the course of the project

Develop QIA Project must be started by the end of 2nd

Quarter.

If project started in the

1st Quarter, evidence of improvement over baseline

Patient SME, family member, and/or caregiver

SME, family member, and/or caregiver

At least one

Patient SME, family member, and/or caregiver attends at least one day of the CMS evaluation site visit

Maintain

100% membership with 60% attending required meeting and activities throughout the course of the project

N/A

Maintain

100% membership with 60% attending required meeting and activities throughout the course of the project

Any improvement over the previous quarter

>5% relative improvement over the course of the project during the contract period

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Patient

Engagement

LAN –

Outreach

Campaigns beneficiaries

QIA(s) shall be COR- approved, and shall identify a single primary process or outcome measure for evaluation purposes

Implement at least two campaigns developed by the LAN that impact at least 20% of the Network population per campaign

Develop campaigns and establish goals

C.4.1.B. Patient Experience of Care must be demonstrated by end of 2 nd

Quarter

Both campaigns shall be started by the end of the 2nd

Quarter; report any evidence toward goal achievement

Demonstrate d progress toward goal(s), or goal(s) achieved

>10% relative improvement per campaign

C.4.1.B.1. Evaluate and Resolve Grievances

The Network’s case review responsibilities shall include the review of grievances and Quality of

Care Reviews.

The sources of grievances are beneficiaries and family members/caregivers. The sources for

Quality of Care Reviews include beneficiaries and individuals other than beneficiaries, e.g., State

Surveyors, family members/caregivers, and CMS staff. The Network shall utilize a number of tools intended to address the identified concerns, including implementation of QIAs and, for grievances, surveying of beneficiary/family member/caregiver satisfaction with the grievance process and outcome.

Network responsibilities under C.4.1.B.shall focus on conducting activities to meet, in an efficient and effective manner, regulatory and statutory requirements and to foster Network quality improvement efforts relative to the grievance process. To this end, the Network shall work with the

NCC to conduct patient satisfaction surveys relative to satisfaction with the grievance process.

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The Network shall also work collaboratively with the appropriate State Survey Agency(ies) to maximize the linkage between case review information obtained during investigation of a grievance and the survey process. The information obtained from the grievance process, satisfaction survey data, and the collaboration with the State Survey Agency will foster quality improvement at the state and local levels.

Evaluation and resolution of grievances includes a structured investigation of processes of a dialysis facility/transplant center, and may include medical record review, review of policies and procedures, and review of staffing plans. (See the ESRD Network Manual.)

The Network shall:

 Inform patients of the Network’s role in receiving, reporting, resolving, and tracking patient grievances in accordance with the communications requirements in C.3.5.

Adhere to the definition of grievances and the grievance resolution process described in the ESRD Network Manual

Enter data on grievances into the Network Contact Utility (NCU) tool or other

CMS-designated database. The Network shall document patient grievances directly reported to the Network by patients and/or grievances reported to facilities by patients.

Perform grievance review and assist in the resolution of grievances

 Document the patient’s perceptions of the reason for filing the grievance

Document what steps were taken by the facility and Network to resolve each grievance and whether the resolution was satisfactory to the patient

Include a summary of grievance review activities and findings in the Monthly

Report. The Network shall provide detailed findings and statistics related to any specific facility with a trend identified. The Network shall adhere to established timeframes set forth in Section F – Schedule of Deliverables.

Perform Quality of Care Reviews (peer reviews): The Network through its MRB shall, as appropriate, evaluate the quality of care delivered to beneficiaries based on medical record review, interviews with facility physicians and other staff, review of policy and procedures, etc.

Maintain review timeliness for all cases at or greater than 90%

Networks will ensure that 100% of all beneficiary data for filed grievances be submitted to the NCC.At the end of the 1 st and 3 rd Quarters, conduct a focused audit of all grievances received to identify systemic issues and trends. Potential quality of care concerns found during the audit shall be documented in the CMSdesignated system as part of the grievance review process.

Adhere to the required investigatory and documentation elements in 100% of grievance cases. (See the ESRD Network Manual for the required investigatory documentation elements.)Investigate whether any grievance is potentially related to the ESRD QIP or PPS incentives or may be indicative of disparities in care

Using 1 st Quarter findings, identify one grievance trend to address by implementing a QIA with at least 5 facilities with the highest numbers of grievances in that trend area. The Network shall develop a QIA Plan and submit it for COR approval within 120 days from the start of the contract period. The QIA

Plan shall reflect sound methodology, and shall identify a single primary process

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CMS-2012-ESRD-FFPRENEWAL or outcome measure for evaluation purposes. The Network shall follow up to ensure that the actions specified in the plan have been taken and were successful.

The Network shall demonstrate at least a 1 percentage point improvement in the identified facilities from baseline to the end of the base contract year. (At CMS’ direction, the QIA shall be expanded to include at least 20% of the facilities in the

Network’s service area, and the Network shall demonstrate a minimum 10% relative improvement on the pre-specified measure.) Furthermore, upon completion of the project, the Network shall determine if the QIA can be applied system-wide. This determination is based on whether the intervention activities deployed can have an impact beyond the individual beneficiaries and providers involved in the QIA, can result in tangible improvement to a system or process, and will improve the quality of health care for Medicare beneficiaries in the

Network’s service area. The QIA results shall be reported to CMS in the Monthly

Report.

Promptly contact the State Survey Agency and coordinate management of a

 response plan when the issue reported may result in imminent harm to the patient

Work with, and implement activities to support, the CMS Ombudsman as directed by CMS, and provide aggregated data for the Ombudsman Report.

C.4.1.B.2. Contract Monitoring and Evaluation: C.4.1.B.1. Evaluate and Resolve Grievances

CMS will monitor the Network on a quarterly basis using the minimum performance criteria specified in the following table.

Table 3: Minimum Performance Criteria for C.4.1.B.1. Evaluate and Resolve Grievances

Measure Minimum Performance Criteria

Timeliness of review

Beneficiary grievances per quarter

Beneficiary satisfaction with the grievance process

Timeliness of review

Beneficiary grievances per quarter

Satisfaction

Survey results

Quarter 1

Timeliness of review for

>90% of cases

Network reviews >6 beneficiary grievances per quarter

N/A

Quarter 2

Timeliness of review for

>90% of cases

Network reviews >6 beneficiary grievances per quarter

N/A

Quarter 3

Timeliness of review for

>90% of cases

Network reviews >6 beneficiary grievances per quarter

N/A

Quarter 4

Timeliness of review for

>90% of cases

Network reviews >6 beneficiary grievances per quarter

At least 80% of respondents to Satisfaction

Survey indicate they are satisfied or very satisfied by end of evaluation

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Quality

Improvement

Activity

(QIA)

Grievance management

Develop a

QIA with at least 5 facilities based on data entered into NCU

100% of grievance cases adhere to the required investigator y and documentat ion elements according to the

ESRD

Network

Manual

Baseline quarter

100% of grievance cases were investigated and appropriately documented in the NCU tool or other CMSdesignated system

Demonstrate progress toward at least

1 percentage point improvement, or at CMS direction toward 10% improvement

100% of grievance cases were investigated and appropriately documented in the NCU tool or other

CMSdesignated system

Demonstrate progress toward at least

1 percentage point improvement, or at CMS direction toward 10% improvement

100% of grievance cases were investigated and appropriately documented in the NCU tool or other

CMSdesignated system period**

Achieve at least 1 percentage point improvement, or 10% improvement if required by

CMS

Based on a

CMS comprehensiv e review,

100% of grievance cases were investigated and documented appropriately*

**

*When the denominator is an odd number, the denominator will be rolled down to the next whole number.

**This includes cases available from January 1, 2013, through the end of the base contract year evaluation period. Thereafter the measure is based on data from the end of the previous evaluation period to the end of the current evaluation period.

***The comprehensive review criteria differ from the quarterly review criteria. See the ESRD

Manual.

C.4.1.B.3. Promote Use of ICH CAHPs and/or Any Similar Survey Identified by CMS

The Network shall encourage outpatient hemodialysis facilities to utilize the ICH CAHPS tool following the AHRQ guidelines posted at http://www.cahps.ahrq.gov

and to report ICH CAHPS information as directed by CMS . The Network shall inform providers of ESRD QIP Patient

Experience of Care Survey usage measure requirements and encourage provider activities to successfully fulfill the measurement requirements starting within 90 days of the effective date of

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CMS-2012-ESRD-FFPRENEWAL this contract. Any requirements in this section also apply to any other similar survey identified by

CMS, including quality of life surveys, for any modality.

During the base year of this contract, the Network shall track the number of facilities that are utilizing the ICH CAHPS tool and provide that information to CMS in an electronic format, as directed. At the direction of CMS, during Option Year 1 and/or Option Year 2, the Network shall develop a QIA based on the results from the ICH CAHPS. Patient involvement and approval must be demonstrated in the QIA provided to the COR for approval.

The COR-approved QIA shall incorporate sound methodology as provided by the ESRD Network

Manual, and shall identify a single primary process or outcome measure for evaluation purposes.

The QIA methodology shall impact at least 10% of the Network population and a minimum of 20 dialysis facilities, and the Network shall demonstrate at least a 5% relative improvement on the pre-specified primary measure. Additional measures can be employed at the Network’s and patients’ discretion. Monthly results from the QIA shall be provided to CMS electronically as directed by CMS.

C.4.1.B.4. Address Issues Identified through Data Analysis

The Network shall track provider participation in administering the ICH CAHPS. As ICH CAHPS data become available, the Network shall assist facilities with interpretation of results and development of action plans to improve patients’ experience of care. The Network shall assist facilities with conducting trend analyses to evaluate for disparities in care. These data will assist facilities in capturing improvement over time.

C.4.1.C. Patient-Appropriate Access to In-Center Dialysis Care

CMS strives to assure appropriate access to in-center dialysis care for ESRD patients who require life-sustaining dialysis treatment and who are not candidates for home modalities. It is the responsibility of the Network to work with individual facilities to identify and address issues related to difficulties in placing patients in dialysis facilities, and in identifying patients at risk for

IVD/IVT or failure to place.

C.4.1.C.1. Decrease IVDs and IVTs

The Network shall:

Process data submitted by facilities on IVDs/IVTs and enter the data into the NCU tool or other CMS-designated system within 5 days of notification by the facility of an IVD/IVT

Use the appropriate terms and definitions/criteria for documenting IVDs/IVTs per the ESRD Network Manual

Investigate any IVD/IVT and document the investigation in the NCU tool or other

CMS-designated system

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Respond to patient and/or facility report of IVDs/IVTs within 5 business days to begin resolution efforts. See the ESRD Network Manual for detailed tasks/procedures.

Document characteristics of patients that may be indicative of disparities in care, including race, ethnicity, new ESRD versus established patient, as defined in the

ESRD Network Manual, including those that may be related to the ESRD QIP or the PPS.

The Network shall work with and encourage facilities to avert IVDs/IVTs whenever possible to ensure the Network goal of providing patient and family centered care.

C.4.1.C.2. Address Patients at Risk for IVD/IVT and Failure to Place

The Network shall:

Based on interactions with patients and/or facilities, investigate and document any patients perceived by the Network to be at risk for IVD/IVT and/or failure to place as a new patient in the NCU database, or other CMS-designated system, within 24 hours of receiving the information.,

Document characteristics of patients, including race, ethnicity, incident versus prevalent patient, as defined in the ESRD Network Manual, including those that may be related to the ESRD QIP or the PPS,

Work with dialysis facilities to facilitate the placement of patients, including the option of home dialysis if appropriate, with the goal of ensuring that all patients in the Network’s service area have access to dialysis care in the appropriate care setting, including the option of home dialysis if appropriate. The Network shall contact CMS to discuss exclusions as defined in the ESRD Network Manual.

C.4.1.C.3. Contract Monitoring and Evaluation: C.4.1.C.1. Decrease IVDs and IVTs and

C.4.1.C.2. Address Patients at Risk for IVD/IVT and Failure to Place

CMS will monitor the Network on a quarterly basis using the minimum performance criteria specified in the following table.

Table 4: Minimum Performance Criteria for C.4.1.C.1. Decrease IVDs and IVTs and

C.4.1.C.2. Address Patients at Risk for IVD/IVT and Failure to Place

Measure

Reduce IVDs/IVTs Number of

IVDs/IVTs

Minimum Performance Criteria

Quarter 1 Quarter 2 Quarter 3 Quarter 4

Baseline quarter using NCU data*

At least 5% fewer or 1 less

IVD/IVT, whichever

At least 5% fewer or 1 less

IVD/IVT, whichever

At least 5% fewer or 1 less

IVD/IVT, whichever is

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CMS-2012-ESRD-FFPRENEWAL is greater, compared with the previous quarter* is greater, compared with the previous quarter* greater, compared with the previous quarter*

Avert potential

IVDs/IVTs

Percent of potential

IVDs/IVTs averted

Baseline quarter using NCU data*

At least 5% fewer or 1 less

IVD/IVT, whichever is greater, compared with the previous

At least 5% fewer or 1 less

IVD/IVT, whichever is greater, compared with the previous

At least 5% fewer or 1 less

IVD/IVT, whichever is greater, compared with the previous quarter** quarter** quarter**

*If the Network is at 0% for any quarter, the Network shall sustain this level within 5% or 1 person, whichever is greater, for the following quarters.

**If the Network is at 100% for any quarter, the Network shall sustain this level within 5% or 1 person, whichever is greater, for the following quarters.

C.4.1.C.4. Generate Monthly Access to Dialysis Care Reports

The Network shall generate monthly reports for the Network service area that interpret and synthesize available summary statistics on beneficiaries who were involuntarily discharged or transferred or were at risk for IVD/IVT or failure to place during the contract period. The Network shall submit these reports to CMS and the appropriate State Survey Agency(ies). (See the ESRD

Network Manual.)

C.4.1.D. Vascular Access Management

AV fistula use has increased steadily from 34.1% of prevalent hemodialysis patients in December

2003 to 59.6% of prevalent patients in August 2011, with two Networks exceeding the Fistula First

Breakthrough Initiative (FFBI) target rate of 66%. Over the combined life of the FFBI, all ESRD

Networks and every state have demonstrated improvement. Despite this, the goal of at least 66%

AV fistula use has not yet been achieved nationally. Although rates of AV fistula use among prevalent patients vary across states and Networks, this variation has decreased overall over time.

Factors contributing to the remaining variations brought to light in the 2011 FFBI Report include physician vascular access choice, patient characteristics, and the degree to which patients begin chronic dialysis with a permanent access. For example, Networks with the highest rates of AV fistula use (>60%) among prevalent patients had on average higher percentages of patients who were male, Hispanic, and/or white than Networks with lower rates of AVF use. Nationally, more

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81% of incident dialysis patients began dialysis using a catheter in 2011, although the Northeastern and Northwestern regions had higher percentages of incident patients with AV fistulas.

C.4.1.D.1. Improve AV Fistula Rates for Prevalent Patients

Through this SOW, the ESRD Networks are charged with achieving and sustaining the goal of at least a 68% AV fistula-in-use rate for prevalent patients. Using the October data that are available in December of the prior calendar year as a baseline, the Network shall reduce its quality deficit by

20% by the end of the 3 rd Quarter of the base contract year unless the expected improvement is less than the floor of 1.0 percentage point or greater than the ceiling of 4.0 percentage points, in which case the floor or ceiling shall apply. Monthly goals will be established based on a linear projection toward meeting the evaluation goal. The Network shall achieve at least 75% of its monthly goal each month. Failure to comply with contract expectations is defined as failing to meet 75% of the monthly goal in any three consecutive months.

C.4.1.D.2. Reduce Catheter Rates for Prevalent Patients

The Network shall also track long-term catheter use rates (catheter in use >90 days) via the FFBI

Dashboard and shall target a Network reduction in the rate of long-term catheter use among prevalent patients by at least 2 percentage points in dialysis facilities that have a >10% rate of longterm (>90 days) catheter use in prevalent patients at baseline. Monthly goals will be established based on a linear projection toward meeting the evaluation goal. The Network shall strive to achieve at least 75% of its monthly goal each month. Failure to comply with contract expectations is defined as failing to meet 75% of the monthly goal in any three consecutive months.

C.4.1.D.3. Support Facility Vascular Access Reporting

The Network shall support 100% of applicable dialysis facilities in the submission of vascular access data, as required by CMS, using the Fistula First data collection tool or another method(s) as provided by CMS .

(See the ESRD Network Manual for a list of exclusions.) The Network shall be responsible for knowing the fistula use rates of all facilities in its service area and for reporting to the Network’s COR if there is a concern with facility reporting.

C.4.1.D.4. Spread Best Practices

Additionally, successful interventions and system changes shall be spread to the other facilities in the Network’s service area and shared with the NCC, any appropriate LAN, and other Networks.

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C.4.1.D.5. Provide Technical Support in the Area of Vascular Access

The Network shall provide, but is not limited to, the following technical support activities for dialysis facilities in the area of vascular access:

Targeted technical assistance for lower performing providers

Root cause analyses

Implementation of evidenced-based interventions: Over the years, a number of interventions have been employed and several best practices have emerged. The

Network shall propose the intervention(s) that it plans to use in achieving the AV fistula-in-use goal based on the assessment of the population served and regional considerations that may be indicative of disparities in care. The FFBI Annual

Report and the Fistula First website ( www.fistulafirst.org

) provide information that can be used by the Network as it considers the most appropriate intervention(s) for its service area. The Network shall include interventions aimed at decreasing the use of catheters in an effort to promote catheters last and fistulas first. The

Network shall evaluate the effectiveness of all implemented interventions.

C.4.1.D.6. Recommend Sanctions

The Network shall recommend sanctions as appropriate. (See C.3.12. Sanctions.)

C.4.1.D.7. Contract Monitoring and Evaluation: C.4.1.D. Vascular Access Management

CMS will monitor the Network on a quarterly basis using the minimum performance criteria specified in the following table.

Table 5: Minimum Performance Criteria for C.4.1.D. Vascular Access Management

Measure

Vascular access–

AVF monthly goals

Vascular access –

AVF 3 rd

Quarter goal

Meet at least

75% of monthly goal.

Reduce quality deficit by 20% unless the expected improvement is less than the floor of 1.0

Quarter 1

Monthly goal improvement

N/A

Minimum Performance Criteria

Quarter 2

Monthly goal improvement

N/A

Quarter 3

Monthly goal improvement

Achieve

Network goal per SOW

Quarter 4

Monthly goal improvement

Continued improvement

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Vascular access – monthly catheter goal percentage point or greater than the ceiling of 4.0 percentage points, in which case the floor or ceiling shall apply

For designated intervention facilities, the

Network meets at least 75% of monthly goal .

Monthly goal improvement

Monthly goal improvement

Monthly goal improvement

Monthly goal improvement

Vascular access – 3 rd

Quarter catheter goal

Vascular access – facility reporting

Reduce catheter in use >90 days rates by >2 percentage points for facilities that have long-term catheter use rates >10% at baseline

Submission of vascular access data from 100% of applicable facilities

N/A

Quarterly demonstrate

100% monthly reporting

N/A

Quarterly demonstrate

100% monthly reporting

Achieve goal Continued

Quarterly demonstrate

100% monthly reporting improvement

Quarterly demonstrate

100% monthly reporting

C.4.1.E. Patient Safety: HAIs

The March 1, 2011, issue of the Morbidity and Mortality Weekly Report published by the Centers for Disease Control and Prevention (CDC) noted that there were 25,000 fewer central-lineassociated bloodstream infections (CLABSIs) in U.S. intensive care units in 2009 compared with

2001, a 58% reduction ( http://www.cdc.gov/mmwr/pdf/wk/mm60e0301.pdf

). This represents up to

6,000 lives saved and $414 million in cost savings in 2009, and approximately $1.8 billion in cumulative costs savings since 2001. Unfortunately, the CDC also noted that a substantial number of CLABSIs continue to occur in outpatient hemodialysis centers, identifying an important focus area for expanded prevention efforts. CLABSI prevention in dialysis facilities will require increased adherence to current inpatient CLABSI prevention recommendations, development and

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End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL implementation of additional prevention strategies specific to the dialysis environment, and collection and analysis of data. Critical to hemodialysis patients are efforts to reduce central line use (as outlined in C.4.1.D. Vascular Access Management) and improved maintenance of longterm central lines for patients unable to attain another access type.

The Secretary of Health and Human Services has launched the Partnership for Patients campaign, which focuses on reducing healthcare-associated conditions including HAIs such as bloodstream infections, referred to as Dialysis Facility Events in the NHSN. The Partnership for Patients is a public-private partnership that offers support to physicians, nurses, and other clinicians working in all care settings to make patient care safer and support effective transitions of patients from hospitals to other settings. The Partnership is an important part of CMS’ work to improve the quality of care available to Medicare beneficiaries. The Networks will contribute to this goal by working to reduce rates of HAIs, referred to as Dialysis Facility Events.

C.4.1.E.1. Support NHSN

In support of the 2014 QIP requirement, the Network shall ensure that at least 90% of all facilities in the Network service area are successfully enrolled in the NHSN database within the base contract year. The Network will be measured monthly. Monthly goals will be established based on a linear projection toward meeting the evaluation goal. The Network shall achieve at least 75% of its monthly goal each month Failure to comply with contract expectations is defined as failing to meet 75% of the monthly goal in any three consecutive months.

In addition, by the end of the base contract year, 80% of facilities must be reporting Dialysis

Facility Event data for at least six consecutive months. Monthly goals will be established based on a linear projection toward meeting the evaluation goal. The Network shall strive to achieve at least

75% of its monthly goal each month. Failure to comply with contract expectations is defined as failing to meet 75% of the monthly goal in any three consecutive months.

The Network shall provide education and support to the dialysis facilities in the NHSN enrollment process. Additionally, the Network shall assist facilities in ensuring that data are entered into the

NHSN database accurately and in a timely manner.

The Network shall establish itself as the group administrator for the NHSN database system for the dialysis facilities in the Network’s service area. In addition, the Network shall obtain group administrator rights from every facility in the Network’s service area. The Network shall conduct at least one QIA per contract year to reduce Dialysis Facility Event rates by at least a 5% relative improvement in the reporting facilities. The Network shall utilize the CDC intervention materials developed to reduce infection rates as a primary intervention.

At least 80% of all facilities in the Network’s service area shall be successfully reporting at least six consecutive months of Dialysis Facility Event data to NHSN within the base contract. CMS anticipates that many facilities will work to achieve the ultimate goal of NHSN reporting for 12 months of the year in order to receive the incentives associated with the ESRD QIP. As a result,

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CMS-2012-ESRD-FFPRENEWAL many facilities are likely to develop best practices in reporting, will be willing to share information, and will be seeking the advice of others on how to achieve success.

C.4.1.E.2. Establish HAI LAN

To develop and spread best practices, The Network shall establish and support an HAI LAN that is open to all facilities in the Network’s service area. CMS has charged the QIOs with establishing

HAI LANs that are primarily focused on the reduction of HAIs in the hospital setting. CMS is encouraging Networks to consult with the local QIO(s) to determine if there are potential areas of synergy between the LANs, related to sharing change packages, tools, experience reporting to

NHSN, and other potential commonalities. CMS working in collaboration with CDC and the NCC will provide guidance to the Network for facilities participating in the LAN.

C.4.1.E.3. Reduce Rates of Dialysis Facility Events

The Network shall work through facilities to reduce Dialysis Facility Event rates in outpatient facilities by:

Working in collaboration with CMS and CDC to increase NHSN enrollment by actively promoting awareness of, access to, and use of CDC technical assistance in enrolling facilities and reporting data

Sharing best practices in the area of reducing HAIs (Dialysis Facility Events).

At the direction of CMS, the Network shall develop and implement a COR-approved QIA based on infection data obtained from the NHSN database for each contract year. The COR-approved QIA shall be based on sound methodology as provided in the ESRD Network Manual, and shall utilize

Dialysis Facility Event reduction as its single measure for evaluation purposes. Additional, nonevaluation measures may be added at the Network’s discretion. The QIA methodology shall impact at least 20% of the Network-area facilities reporting Dialysis Facility Event data, with a minimum of 5% of the Network population included. The QIA shall demonstrate at least a 5% relative improvement on the Dialysis Facility Event primary measure. Monthly results from the QIA shall be provided to CMS electronically as directed by CMS.

C.4.1.E.4. Contract Monitoring and Evaluation: C.4.1.E. Patient Safety: HAIs

CMS will monitor the Network on a quarterly basis using the minimum performance criteria specified in the following table.

Table 6: Minimum Performance Criteria for C.4.1.E. Patient Safety: HAIs

Measure Minimum Performance Criteria

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Network assistance in NHSN database enrollment

Ensuring reporting of Dialysis

Facility

Event data

Reduce

HAIs

>90% of all facilities in the

Network service area successfully enroll in the

NHSN database

9 80 % of facilities must be reporting

Dialysis

Facility Event data for at least six consecutive months

Develop and implement a

QIA based on infection data obtained from the NHSN database that impacts at least

20% of the

Network-area facilities reporting

Dialysis

Facility Event data, with a minimum of

5% of the

Network population included.

Quarter 1

Baseline: number of providers with successful enrollment in

NHSN database

Baseline quarter: number of facilities reporting

Baseline quarter based on NSHN data

Quarter 2

Meet at least

75% of monthly goal each month,

Meet at least

75% of monthly goal.

.

Progress toward goal

Quarter 3

Meet at least

75% of monthly goal each month ,

Quarter 4

>90% of all facilities in the Network service area successfully enrolled

Meet at least

75% of monthly goal.

Progress toward goal

> 80% of facilities reporting

Dialysis

Event data for at least six consecutive months

>5% relative improvement on the

Dialysis

Facility

Event primary measure

C.4.2. AIM 2: Better Health for the ESRD Population

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The Network’s activities to promote AIM 2 shall focus on improving the quality of and access to

ESRD care through a Population Health Innovation Pilot Project in one of the following areas that are pre-approved as CMS priorities:

Increase HBV, Influenza, and Pneumococcal Vaccination Rates

Improve Dialysis Care Coordination with a Focus on Reducing Hospital Utilization

Improve Transplant Coordination

Promote Appropriate Home Dialysis in Qualified Beneficiaries

Support Improvement in Quality of Life.

Each Network shall conduct one project and shall achieve the pre-specified outcome(s) for all evaluation measures (1 to 3 measures per topic) for the topic chosen as well as demonstrate reduction in an identified disparity.

The objective of the Innovation Pilot Projects is to support achievement of 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.

C.4.2.A. Population Health Innovation Pilot Projects: Technical Considerations

The Network’s Innovation Pilot Project shall adhere to the confidentiality and disclosure requirements set forth in Section 1881 of the Social Security Act, the Omnibus Budget

Reconciliation Act of 1986, and all applicable CMS administrative directives.

Any data given to the Network by the Government shall be used only for the performance of the

Innovation Pilot Projects unless the Contracting Officer specifically permits another use in writing.

If the Contracting Officer permits the Network the use of Government-supplied data for a purpose other than solely for the performance of this Innovation Pilot Project and, if such use could result in a commercially viable product, the Contracting Officer may negotiate a financial benefit to the

Government. This benefit should most often be in the form of a reduction in the price of the

Innovation Pilot Projects; however, the Contracting Officer may negotiate any other benefits he/she determines is adequate compensation for the use of the data.

Upon the request of the Contracting Officer, or the expiration of these Innovation Pilot Projects, whichever shall come first, the Network shall return or destroy all data given to the Network by the

Government. However, the Contracting Officer may direct that the data be retained by the Network for a specific period of time, which period shall be subject to the agreement of the Network. If the data are to be destroyed, the Network shall furnish direct evidence of such destruction in a form that the Contracting Officer shall determine is adequate.

The Network shall comply with all CMS guidelines regarding the appropriate de-identification of data related to both individuals and facilities, consistent with the guidelines concerning disclosure of ESRD data.

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C.4.2.B. Population Health Innovation Pilot Projects: Requirements

The Network shall work with its MRB, Network Council, Patient Advisory Committee, and, as appropriate, external stakeholders such as QIO(s), provider and practitioner associations, and beneficiary groups, to develop one Innovation Pilot Project that utilizes innovation to advance the purpose and strategic goals of the ESRD Network Program. These projects are directly aligned with areas of health care identified in the NQS and CMS goals. The Network shall identify data sources and stakeholders, and specify appropriate measurable outcomes and evaluation tools as part of the proposal phase. Data gleaned from these projects shall be used to impact quality improvement in the care delivered to ESRD beneficiaries as well as to identify trends that may be indicative of disparities in care.

The Network shall select a focus for its Population Health Innovation Pilot Project based on: (a) the opportunity for improvement and (b) an identified disparity.

As the first step in choosing a focus for its Population Health Innovation Pilot Project, the Network shall select one of the five CMS-approved project areas. The Network shall then determine, using

4 th Quarter 2012 data, whether <85% of the target population demonstrated the desired outcome(s) for the selected project area. If >85% of the target population demonstrated the desired outcome(s), the Network shall select one of the other project areas that met the <85% criterion.

The Network shall then conduct a disparity assessment for its chosen project area using data for the

4 th Quarter of 2012. Disparities shall be assessed in the following order:

Race (African American vs. White)

Ethnicity (Hispanic vs. Non-Hispanic)

Facility Location (Urban vs. Rural)

Gender (Male vs. Female)

Age (Younger than Age 65 vs. 65 and older).

The highest ordered disparity with at least 5 percentage points difference between the designated categories will be utilized for the project. For example, if for improving transplant coordination there is a 3 percentage point disparity for Race and a 10 percentage point disparity for Ethnicity, the project would focus on Ethnicity. For project areas with multiple outcomes, disparities are assessed using a simple average (mean) of findings for the various outcomes.

The Network shall inform the COR and GTL of the topic area chosen by February 15, 2013, in writing with explicit explanation of the process and data used to derived the selection. The baseline data collection and analysis for the selected project shall be completed by March 31, 2013.

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C.4.2.C. Population Health Innovation Pilot Projects: Contract Monitoring and

Evaluation

The Population Health Innovation Pilot Projects present new opportunities for the Networks to improve the quality and efficiency of services rendered to Medicare beneficiaries through learning activities associated with review and analysis of Medicare data (i.e., data from CROWNWeb,

KDQOL, and other CMS-sanctioned data collection systems), input from providers, beneficiaries, and other experts in the field, employment of proven quality improvement techniques, and identification and spread of best practices.

The bold and innovative approach to change involved in the Population Health Innovation Pilot

Projects does not lend itself well to the traditional forms of contract evaluation, which are more suited for assessing performance by the Network alone rather than engagement in collaborative partnerships to strive for maximal, sustainable improvement. Evaluation remains, nonetheless, important as such high expectations require quantitative and qualitative measures of accountability to ensure forward progress and prudent use of limited resources. Quantitative evaluation of the

Innovation Pilot projects shall be based on successfully reducing the disparity for the outcome measure(s) by at least 1 percentage point, and achieving the pre-specified thresholds for each project area. Failure in either quantitative component shall result in an unsuccessful evaluation for the project.

In addition to any approved metrics, the following attributes will serve as the basis for assessing performance:

Rapid Cycle Improvement in Quality Improvement Activities and Outputs: The

Network shall regularly reassess the value of the interventions and technical assistance used for the project. The Network shall make interim adjustments based on the feedback it receives from its participants and CMS as well as from its own performance monitoring toward achieving contractual bold goals. This will include how details on how well the Network builds a system for monitoring performance and how well it uses rapid cycle improvement to make adjustments to achieve ever higher performance and remove defects

Customer Focus and Value of the Quality Improvement Activities to Beneficiaries,

Participants, and CMS: The Network shall regularly seek to meet the needs of its customers, involving beneficiaries and other stakeholders in all aspects of quality improvement activities. Customer input should help to shape the design and ongoing operations of activities. Beneficiaries representing the diversity of the population served shall be actively engaged in activities. Solicitation of customer feedback may focus on questions such as: How relevant were the topics to the work of the participants? How well did the project meet the needs of beneficiaries, other participants, and CMS? What was the perceived quality of the activities as reported by the beneficiaries, participants, and CMS? What are suggested areas of improvement?

Ability to Prepare the Field to Sustain the Improvement : Early on in the project the

Network shall begin establishing a plan to increase the probability that the quality improvement(s) are maintained or improvement continues when the Network completes its formal work with the participants. The Network shall be expected to provide a framework and education for the project participants that will allow them to

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Value Placed on Innovation: The Network shall demonstrate solicitation and/or creation of new ideas that maximize improvement for the project participants. This includes designing a mechanism by which all entities the Network works with and/or has contact with as part of the project are able to contribute ideas that may be of value to the Network’s improvement work. It may also include the development of one or more new products, services, or features for the benefit of the project participants.

Commitment to Boundarilessness: The Network shall demonstrate the ability to identify and engage multiple entities to impact improvement for patients and/or providers. This includes but is not limited to entities outside of CMS such as state, local, and national health care organizations, patient advocacy groups, professional associations, and others.

Unconditional Teamwork: The Network shall demonstrate its ability to work with other

Networks and stakeholders to spread improvement activities that are working. The

Network is expected to demonstrate sharing of best practices with other Networks as well as project participants and partners.

The Network shall demonstrate a reduction in the identified disparity in addition to achieving the outcome(s) designated in Tables 7A–7E. The Network shall achieve a reduction in disparity by at least 1 percentage point; improvement in the value for the less-advantaged group is insufficient to warrant successful evaluation. For example, if the transplant referral rate improves from 28 percent to 33 percent for patients classified as Hispanic, while the Non-Hispanic referral rate improves from 38 percent to 47 percent, this would be insufficient to warrant receiving a successful evaluation for this project due to a failure to reduce the disparity.

In addition to meeting the general disparity reduction requirement and the specified measure(s) performance criteria associated with the project area, the Network shall demonstrate positive improvement over the course of the project. The Network shall strive to achieve at least a 0.1 percentage point increase in the value of the measure(s) each month. Failure to comply with contract expectations is defined as failing to achieve at least a 0.1 percentage point increase in any two consecutive months. This requirement does not apply to the disparity reduction. Data for the selected project shall be reported to CMS monthly as directed by CMS through this SOW or through supplemental CMS communication.

The Network shall be monitored and measured for improvement on an ongoing basis through data reported to CMS and COR review. Failure to meet all requirements of a chosen project, including but not limited to data reporting for all components of the project, specific requirements related to disparity determination, and achievement of required evaluation goals, will be referred to the

Contracting Officer for determination of appropriate contract action. The Network may not opt for a different project after the end of the first quarter of the contract period.

Throughout this Innovation Pilot Project, the Network shall provide leadership and subject matter expert guidance for the project’s quality improvement efforts in collaboration with the GTL and

COR. The Network shall submit all required reports and deliverables in accordance with Section F

– Schedule of Deliverables.

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C.4.2.D. Project A: Increase HBV, Influenza, and Pneumococcal Vaccination Rates

The Network shall identify at least 10 low-performing facilities to participate in the project. All measures must be implemented in all facilities in the target group.

The Network shall use the tool provided by CMS to establish the baseline by the end of the first quarter of the base contract year, and for all measurement throughout the project.

Facility Staff Influenza Vaccination: The Network shall achieve a 10 percentage point increase over baseline by the end of the 3 rd contract quarter or the Network evaluation, whichever is later.

Patient HBV and Pneumococcal Vaccination: The Network shall achieve a 5 percentage point increase by the end of the 3 rd contract quarter or the Network evaluation, whichever is later, for each of the two vaccine types.

Table 7A: Minimum Performance Criteria for Project A: Increase HBV, Influenza, and

Pneumococcal Vaccination Rates

Measure Measure

Definition Quarter 1

Minimum Performance Criteria

Interim Monthly

Progress

Evaluation

Staff influenza vaccination

Proportion of eligible staff who received influenza vaccination

Establish baseline

Maintain positive performance as defined by SOW

Achieve at least a

10 percentage point increase*

Achieve at least a 5 percentage point increase*

Patient hepatitis B vaccination

Patient pneumococcal vaccination

Proportion of eligible patients who received HBV vaccination

Proportion of eligible patients who received

Establish baseline

Establish baseline

Maintain positive performance as defined by SOW

Maintain positive performance as defined by SOW pneumococcal vaccination

*By end of 3 rd contract quarter or Network evaluation, whichever is later.

Achieve at least a 5 percentage point increase*

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C.4.2.E. Project B: Dialysis Care Coordination with a Focus on Reducing Hospital

Utilization

The Network shall work with a sufficient number of facilities to sustain at least 1,000 ESRD patients throughout the project (i.e., at baseline and for each month). The patient population at the target facilities shall have an aggregate standardized hospitalization ratio >25% at baseline.

Measurement will be obtained from CMS-specified Hospitalization measures in CROWNWeb, with data reported to CMS for the targeted facility population on a monthly basis.

The project shall achieve at least a 2 percentage point reduction in the hospitalization ratio by the end of the 3 rd contract quarter or the Network evaluation, whichever is later.

Table 7B: Minimum Performance Criteria for Project B: Improve Dialysis Care

Coordination with a Focus on Reducing Hospital Utilization

Measure Minimum Performance Criteria

Quarter 1 Interim Monthly Evaluation

Hospital admission rate

Number of inpatient admits/number

Progress

Establish baseline Maintain positive performance as defined by SOW of patients

*By end of 3 rd contract quarter or Network evaluation, whichever is later.

Achieve at least a

2 percentage point reduction*

C.4.2.F. Project C: Improve Transplant Coordination

The project shall include at least 10% of dialysis facilities in the Network’s service area, which shall represent at least 8% of the eligible ESRD patient population regardless of modality. The baseline transplant referral rate in the target population shall be less than 50% of eligible patients.

The project shall demonstrate at least a 5 percentage point increase in the rate of transplant referrals for eligible patients by the end of the 3rd contract quarter or the Network evaluation, whichever is later. Measurement shall be obtained from a CMS-specified Transplant Referral measure in

CROWNWeb. Data for the targeted population shall be reported to CMS on a monthly basis as directed by this SOW or through supplemental CMS communication.

Table 7C: Minimum Performance Criteria for Project C: Improve Transplant

Coordination

Measure Minimum Performance Criteria

Quarter 1 Interim Monthly

Progress

Transplant referral

Percent of eligible patients referred

Establish baseline Maintain positive performance as for transplant defined by SOW

*By end of 3 rd contract quarter or Network evaluation, whichever is later.

Evaluation

Achieve at least a 5 percentage point increase*

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C.4.2.G. Project D: Promote Appropriate Home Dialysis in Qualified Beneficiaries

The Network shall work with a sufficient number of facilities to include at least 10% of the

Network area in-center hemodialysis patient population at baseline and throughout the project. The

Network shall demonstrate at least a 7 percentage point improvement in the appropriate use of home dialysis by qualified beneficiaries by the end of the 3 rd contract quarter or the Network evaluation, whichever is later. Measurement shall be obtained from a CMS-specified Modality measure in CROWNWeb. Data for the targeted population shall be reported to CMS on a monthly basis as directed by this SOW or through supplemental CMS communication.

Table 7D. Minimum Performance Criteria for C.4.2.G. Project D: Promote Appropriate

Home Dialysis in Qualified Beneficiaries

Measure

Promote home dialysis in qualified beneficiarie

Increase percent of eligible patients receiving home hemodialysis or

Minimum Performance Criteria

Quarter 1 Interim Monthly Evaluation

Progress

Establish baseline Maintain positive performance as defined by SOW s peritoneal dialysis

*By end of 3 rd contract quarter or Network evaluation, whichever is later.

Achieve at least a

7 percentage point increase*

C.4.2.H. Project E: Support Improvement in Quality of Life

The Network shall include a sufficient number of dialysis facilities to comprise a patient population that represents at least 10% of the Network in-center hemodialysis population. The Network shall use the CMS-mandated KDQOL measures for this project. The Network has the option for this topic of demonstrating improvement on the overall KDQOL score by at least 10 percentage points,

OR improving the score for each of the renal-specific subcomponents by at least 6 percentage points. Improvement for either option shall be achieved by the end of the 3 rd contract quarter or the

Network evaluation, whichever is later. Moreover, whether using the overall KDQOL score or the three subcomponent measures, the Network shall utilize only the CMS-sanctioned KDQOL assessment tool. The Network shall provide monthly data updates for this project to CMS as specified by future communication.

Table 7E. Minimum Performance Criteria for C.4.2.H. Project E: Support Improvement in

Quality of Life

Measure Minimum Performance Criteria

Quarter 1 Interim Monthly

Progress

Evaluation

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Overall quality of life

KDQOL items

1–36

Establish baseline Maintain positive performance as defined by SOW

Achieve at least

10 percentage point improvement*

*By end of 3 rd contract quarter or Network evaluation, whichever is later.

OR

Measure

Ability to accomplish desired tasks

Depression and anxiety

KDQOL items

13–16

KDQOL items

17–28

Minimum Performance Criteria

Quarter 1 Interim Monthly Evaluation

Progress

Establish baseline Maintain positive

Establish baseline performance as defined by SOW

Maintain positive performance as

Achieve at least 6 percentage point improvement*

Achieve at least 6 percentage point improvement*

How much kidney disease interferes with

KDQOL items

29–36

Establish baseline defined by SOW

Maintain positive performance as defined by SOW daily life

*By end of 3 rd contract quarter or Network evaluation, whichever is later.

Achieve at least 6 percentage point improvement*

C.4.3. AIM 3: Reduce Costs of ESRD Care by Improving Care

The ESRD QIP continues a long tradition of work by CMS to improve the quality of care for beneficiaries with ESRD. Since 1978, Medicare has worked through the ESRD Networks to monitor and improve the quality of care furnished to ESRD beneficiaries. Since 2001, CMS has published information for consumers about the quality of dialysis care on the Dialysis Facility

Compare website at http://www.medicare.gov

.

Section 153(c) of Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) requires, among other things, that CMS select measures, develop a scoring methodology, and implement a payment reduction scale that relates to facility performance. A percentage of the facility’s dialysis payment is contingent on the facility’s actual performance on a specific set of measures.

Under AIM 3: Reduce Costs of ESRD Care by Improving Care, the Network shall support the

ESRD QIP, facility performance improvement on QIP measures, and facility data submission for

CROWNWeb, the NHSN, and/or other CMS-designated data collection system(s).

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C.4.3.A. Support for ESRD QIP and Performance Improvement on QIP Measures

C.4.3.A.1. Assist Facilities in Understanding and Complying with QIP Processes and

Requirements

The Network shall assist facilities in understanding and complying with QIP processes and requirements. Network activities shall include, but are not limited to:

Ensuring that all Network staff are fully knowledgeable on ESRD QIP measures and specifications (updated in the Federal Register and on the QualityNet website),

CROWNWeb, NHSN, and other resources available to facilities regarding the QIP

 Supporting facilities’ efforts to submit accurate quality data

Encouraging appropriate and timely completion of QIP requirements via

CROWNWeb and/or other CMS-designated mechanisms including, but not limited to, NHSN data submission, attestations regarding the Mineral Metabolism

Monitoring measure, and administration of the ICH CAHPS

Registering provider Master Account Holders to access http://www.dialysisreports.org

or another website designated by CMS to provide

ESRD QIP Performance Score Reports (PSRs) to facilities and provide updated lists of credentialed users to the CMS-designated QIP contractor every quarter.

Notifying facilities of the procedures required to access their QIP PSRs. The

Network shall monitor the PSR access report and contact providers that have not accessed the report within 5 days of the report being made available. The Network shall encourage facilities to review their reports and to submit necessary clarification questions or formal inquiries during the annual 30-day preview period.

Assisting facilities in accessing, printing, and posting the Performance Score

Certificate (PSC) each year within 5 business days of the CMS release date

Informing CMS if a PSC has not been posted.

C.4.3.A.2. Assist Facilities in Improving their Performance on QIP Measures

The Network shall assist facilities in improving their QIP measure rates by performing activities that include, but are not limited to:

Providing technical assistance for any facilities in its service area requesting assistance in quality improvement efforts related to topics addressed by QIP measures including, but not limited to, training providers on these efforts and helping them implement and monitor these quality improvement efforts

Collaborating with stakeholders to achieve improvements on QIP measures on behalf of beneficiaries

Joining existing initiatives/collaboratives identified by the Network or the NCC

(e.g., national or state-level collaboratives focusing on HAI prevention, vaccinations, etc.)

Spreading knowledge and innovations learned in collaboration with facilities

Providing feedback to facilities on areas of improvement for QIP measures based

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 on data analysis of QIP measure rates

Educating State Surveyors on monthly calls to ensure that they are knowledgeable about QIP measures and can reinforce with facilities the Network’s education on the QIP

Answering facility questions regarding the ESRD QIP and providing any necessary plain-language materials to aid in their understanding.

C.4.3.A.3. Assist CMS in Monitoring the Quality of and Access to Dialysis Care

The Network shall assist CMS in monitoring the quality of and access to dialysis care as follows:

The Network shall provide feedback to CMS or its designees regarding potential changes in practices reported to or observed by the Network that may adversely impact beneficiaries. Such practice changes include, but are not limited to, changes in access to care and/or the admission or transferring practices of facilities. The

Network shall monitor grievances, clinical data, anecdotal reports, and other sources available to the Network to identify these changes. These monitoring activities and findings shall be reported to CMS in the Monthly Report.

The Network shall enter into a data use agreement (DUA) with the CMSdesignated monitoring and evaluation contractor and share and receive monitoring data as directed by CMS.

If CMS identifies potential and actual adverse impacts on beneficiaries, the

Network shall intervene as directed by CMS to protect patient safety, promote access to care, and ensure that facilities are meeting adequate standard of care.

The Network shall use resources produced by the Learning Network Project contractor as directed by CMS including those intended to improve the consistency of data collection and analysis across Networks.

The Network shall assist CMS in encouraging facilities to report and update data on patient co-morbidities, hemoglobin levels, and anemia management drug dosage via claims.

The Network shall provide facility insight and feedback regarding the QIP to CMS when and in the form requested by CMS.

C.4.3.A.4. Assist Beneficiaries and Caregivers in Understanding the QIP

The Network shall assist beneficiaries and their caregivers in understanding the QIP by performing activities that include, but are not limited to:

Making plain-language information available to beneficiaries and their caregivers regarding the purpose of the QIP, the measures set, and the performance of facilities in the Network’s service area, including producing and distributing PSC educational materials

Being available to answer beneficiary questions regarding the QIP.

The Network shall provide beneficiary insight and feedback regarding the QIP to CMS when and in the form requested by CMS.

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C.4.3.B. Support for Facility Data Submission to CROWNWeb, NHSN, and/or Other

CMS-Designated Data System(s)

The Network shall:

Oversee the timely and accurate submission of data into CROWNWeb using the

CROWNWeb Reports

Resolve out-of-scope patients

Assist with Notifications and Accretions to ensure resolution within 30 days

Serve as a resource for CROWNWeb facility users requiring training, data definitions, submission requirements, etc.

SECTION D – PACKING AND MARKING

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D.1 Packing, Marking and Shipping

All deliverables required under this contract shall be packages, marked and shipped in accordance with Government specifications set forth in Section F of this contract. The

ESRD contractor shall guarantee that all required materials shall be delivered in immediate unable and acceptable condition.

SECTION E – INSPECTION AND ACCEPTANCE

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E.1 FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

52.246-4 www.arnet.gov/far/fac.html

Inspection of Services – Fixed Price (August 1996)

E.2 Acceptance by the Contracting Officer Representative

All items to be delivered to the Contracting Officer Representative (COR) will be deemed to have been accepted 45 calendar days after date of delivery, except as otherwise specified in this contract if written approval or disapproval has not been given within such period.

The COR acceptance or revision to the items submitted shall be within the general scope of work in this contract.

E.3 Performance Improvement Plan (PIP)

In the event the ESRD contractor fails to meet its contract requirements for acceptability, a

PIP may be required. (See http://www.cms.gov/manuals/110 )

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SECTION F – DELIVERABLES OR PERFORMANCE

F.1 Period of Performance

The period of performance of the ESRD Network contract is:

Base Year Performance Period:

Option 1:

Option 2:

January 1, 2013 through December 31, 2013

January 1, 2014 through December 31, 2014

January 1, 2015 through December 31, 2015

F.2 FAR 52.217-9 Option to Extend the Term of the Contract (MAR 2000)

This contract may be extended for two (2) option years (Options 1 and 2 as listed above) in accordance with Section I, FAR Clause 52.217-9 “Option to Extend the Term of the Contract.”

The Government may extend the term of this contract by written notice to the Contractor within

60 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

If the Government exercises this option, the extended contract shall be considered to include this option clause.

The total duration of this contract, including the exercise of any options under this clause, shall not exceed 38 months.

F.3 Schedule of Deliverables

The Network shall submit all required reports and deliverables in accordance with the Delivery Schedule and Reporting Instructions unless otherwise specified by CMS. CMS reserves the right to modify deliverable date by up to 60 days beyond the dates listed in the Delivery Schedule and Reporting

Instructions. CMS CORs, Contracting Officers, or other CMS designees shall authorize the changed deliverable date by listing the new deliverable date in an e-mail to the contractor. Entitled: “Competitive

End Stage Renal Disease Network Statement of Work ”.

Days = calendar days, including holidays

Business days = weekdays, excluding holidays

IAW = in accordance with

DAGC = days after Government comments

ELT = electronically

QTY = quantity

HC = hard copy

CO = Contracting Officer

COR = Contracting Officer’s Representative

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GTL= Government Task Leader

ISSO = Information Systems Security Officer

NCC = Network Coordinating Center

BOD = Board of Directors

MRB = Medical Review Board

NC = Network Council

PAC = Patient Advisory Committee

QIA = Quality Improvement Activity

SA = State Survey Agency

SPOC = Security Point of Contact

Contract period = Base Year or one of two Option Years of period performance

Satisfactory performance under this contract shall be deemed to occur upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, in accordance with the delivery schedule stated below.

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Table F.1. ESRD Network Schedule of Deliverables for the Performance Period of January 1, 2013, through December 31, 2013:

Deliveries or Performance Reports/Items to be Furnished and Delivery Schedule

Notes Type Item Number Item Description Recipient and

Reporting

Mechanism

C.3.1. General Requirements: Internal Quality Control (IQC)

1 Internal Quality ELT to COR

Control (IQC) Plan

ELT to GTL

Due Date(s) Data Source

45 days after the beginning of each contract period, unless otherwise directed by

CMS

Network

C.3.4 General Requirements: Network Organization

2 Identification of NC, ELT to COR

BOD, MRB, and

PAC members ELT to GTL

3 Bylaws

4 Network staffing appropriate to complete the contract

ELT to COR

ELT to GTL

ELT to COR

ELT to GTL

February 1 of each contract period

February 1 of each contract period

February 1 of each contract period

Network

Network

Network

ESRD

Network

Manual

ESRD

Network

Manual

ESRD

Network

Manual

ESRD

Network

Manual

Core

Core

Core

Core

C.3.5 General Requirements: Network Communications

5 Network communications:

ELT to COR

National user-friendly toll-free phone

ELT to GTL

Throughout contract as based on annual

Network ESRD

Network

Manual

Core

Page | 48

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description Recipient and

Reporting

Mechanism

6 number; Network website; NEPOP letter; Investigate undeliverable

NEPOPs

Network educational information:

Patient/provider needs assessment;

Written education plan; Materials provided; Evaluation of efforts and materials

ELT to COR

ELT to GTL

C.3.8 General Requirements: Network Reporting

7 Network committee ELT to COR minutes

ELT to GTL

Due Date(s) Data Source evaluation

Throughout contract as based on annual evaluation

Network

8

9

Monthly Reports

Semi-Annual Cost

Report

ELT to COR

ELT to GTL

ELT to COR

3 business days after any committee

(NC, BOD,

MRB, PAC) meeting

3 business days prior to scheduled monthly meeting/call with COR and GTL

15 th

working day of the 2 nd

Network

Network

Network

Notes Type

ESRD

Network

Manual

Core

Core

ESRD

Network

Manual

Core

ESRD

Network

Core

Page | 49

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

10

11

Draft Annual Report of Network Activities

Final Annual Report of Network activities and publication of approved Annual

Report on Network website

C.3.9 General Requirements: Network Meetings

Recipient and

Reporting

Mechanism

ELT to COR

ELT to GTL

ELT to

Contracting

Officer

ELT to NCC

Due Date(s)

ELT to GTL calendar month after close of each semiannual cost reporting period.

ELT to COR

ELT to GTL

April 30, of each contract period

June 15, of each contract period

Data Source

Network

Network

COR checks

Network website

12 Conduct Post-Award

Meeting with

OAGM/QIG

ELT to COR

ELT to GTL

30 days after the beginning of the contract period, unless otherwise directed by

CMS

Notes

Manual

ESRD

Network

Manual

ESRD

Network

Manual

ESRD

Network

Manual

Network website

Type

Core

Core

Core

Page | 50

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

13 Submit title(s), objective(s), and list of attendees for annual QualityNet conference, LAN meetings, and/ or other conferences

Recipient and

Reporting

Mechanism

ELT to COR

ELT to

GTLGTL

C.3.11 General Requirements: State Survey Agency(ies)

14 Conduct bi-monthly ELT to COR meetings/calls

ELT to GTL

15 Report collaboration with SA(s)

ELT to COR

ELT to GTL

Due Date(s) Data Source

30 days prior to scheduled meetings/ conference

Bi-monthly, except as issues related to quality of care arise

Monthly

Network

Network

Notes

ESRD

Network

Manual

ESRD

Network

Manual

ESRD

Network

Manual

C.3.12 General Requirements: Sanctions

16 Recommend sanctions for recalcitrant facilities

ELT to GTL

ELT to SA as directed by

CMS

C.3.13 General Requirements: Reporting Discrimination

17 Refer suspected discrimination cases to Office for Civil

Rights (OCR) for investigation

ELT to COR

ELT to GTL

ELT to

Monthly CROWNWeb for clinical outcomes;;

NCU for information on

IVD/IVT/failure to place

ESRD

Network

Manual

Report immediately to COR; document in

Monthly

Patient and/or family member/caregiver

ESRD

Network

Manual

Type

Core

Core

Core

Core

Core

Page | 51

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

Contracting

Officer

ELT to OCR

C.3.14 General Requirements: Emergency Preparedness

18

Recipient and

Reporting

Mechanism

Provide Emergency

Plan that cooperates and comply with emergency preparedness duties and KCER

ELT to COR

ELT to GTL

ELT to NCC

ELT to Backup Network

ELT to Backup Network

COR

19 Participate in annual emergency preparedness drill in conjunction with the

NCC

ELT to COR

ELT to GTL

ELT to NCC

Due Date(s) Data Source

Report

15 days after the beginning of the contract period; reviewed quarterly; updated as needed

Copies of the assessment will be sent to the NCC,

GTL, and

COR within 30 calendar days of the completion of the drill.

Network

Network

C.3.16 – 3.18 General Requirements: IT System/Software Maintenance

Notes Type

ESRD

Network

Manual

Core

ESRD

Network

Manual

Core

Page | 52

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

20

21

22

23

Log of daily incremental back-up and weekly full backup Tape

Validation and

Rotation Schedule

Log of offsite storage of back-up media and rotation schedule

List of assigned

Network Information

Technology (IT) staff with required information

Completion of

Remedy ticket assignments

Recipient and

Reporting

Mechanism

ELT as directed by the

CMS

QualityNet

ISSO COR

ELT to CMS

QNet ISSO

ELT as directed by the

CMS

QualityNet

ISSO COR

ELT to CMS

QNet ISSO

ELT as directed by the

CMS

QualityNet

ISSO COR

ELT to CMS

QNet ISSO

Remedy AR

System COR ,

HCQIS

Infrastructure

Contractor

Due Date(s) Data Source

On request

Or

On request Template will be provided by CMS

QNet ISSO; logs maintained locally by IT staff/SPOC

January 24 of each contract period; also, within 5 days of any change to data within the Plan.

As assigned to Network

IT staff through

Remedy

Action

Template will be provided by CMS

QNet ISSO; logs maintained locally by IT staff/SPOC

Template will be provided by CMS

QNet ISSO

Notes

ESRD

Network

Manual

ESRD

Network

Manual

ESRD

Network

Manual

ESRD

Network

Manual

Type

Core

Core

Core

Core

Page | 53

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

24

25

26

Recipient and

Reporting

Mechanism

Due Date(s)

Maintenance of systems and software in compliance with applicable configuration requirements

Update Remedy inventory for all procured and received

Government Property

(including hardware and software)

Maintain HHS-22 process within

Remedy

List of all purchased and leased equipment in HHS-565 submission Final

Memorandums or Remedy AR

System COR,

HCQIS

Infrastructure

Contractor

Submit HHS-

22 for approval via

Remedy; updated record in Remedy

Inventory

Module. COR,

CMS

Government

Property

Administrator

ELT to CMS

Government

Property

Administrator

Request (AR)

System

Must be completed within the designated timeframe

As released

As required

(i.e., when

Government

Property

(including hardware and software) is received)

October 31 of each contract period or upon request,

Data Source Notes Type

Core

Core

Core

Page | 54

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

27

C.3.18 General Requirements: Network Security

28 Network System

Security Plan (SSP)

29

Report

Update Remedy inventory for all

Government Property

(including hardware and software) transferred. Maintain

HHS-22 process within Remedy and Information

Security (IS) Risk

Assessment (RA)

Recipient and

Reporting

Mechanism

ELT to

Contracting

Officer

Submit HHS-

22 for approval via

Remedy; update record in Remedy

Inventory

Module to

COR, CMS

Government

Property

Administrator

ELT to CMS

QNet ISSO

Business Continuity and Contingency Plan

(BCCP) that demonstrates how the organization shall establish, maintain,

ELT as directed by the

CMS QNet

ISSO COR

ELT to CMS

Due Date(s) upon contract termination or normal contract conclusion

As required

(i.e., when

Government

Property

(including hardware and software) is transferred, retired or disposed)

May 28 of each contract period; also, within 15 days of any change

May 28 of each contract period; also, within 15 days of any change

Data Source

Template will be provided by CMS

QNet ISSO

Template will be provided by CMS

QNet ISSO

Notes

ESRD

Network

Manual

ESRD

Network

Manual

Type

Core

Core

Core

Page | 55

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

30

31 and effectively implement plans for emergency response, back-up operations, and post-disaster recovery for organizational information systems to ensure the availability of critical information resources and continuity of operations in emergency situations

Daily record of visitors (i.e., personnel external to the Network)

List of active and inactive QNet user accounts with required data

Recipient and

Reporting

Mechanism

QNet ISSO

ELT as directed by the

CMS QNet

ISSO to COR

ELT to CMS

QNet

QualityNet

ISSO

ELT as directed by the

CMS QNet

QualityNet

ISSO to COR

ELT CMS

Due Date(s)

Upon request Logs maintained locally by IT staff/SPOC; template will be provided by CMS

QNet ISSO

January 24 of each contract period, certification; also, within 5 days of any change to

Data Source

Logs maintained locally; template will be provided by CMS QNet

ISSO

Notes

ESRD

Network

Manual

ESRD

Network

Manual

Type

Core

Core

Page | 56

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

32

33

34

QNet Security

Awareness Training

(SAT)

QNet Security

Awareness Training

(SAT) Certification

Letter

Record of security incident response

Recipient and

Reporting

Mechanism

QNet

QualityNet

ISSO

ELT to QNet

Security Team

ELT as directed by the

CMS

QualityNet

ISSO COR

ELT to CMS

QNet

ISSOCOR

QNet

ELT to CMS

QNet ISSO

Submit additional artifacts on request.

Submit

Incident

Report in

Remedy AR; submit artifacts; ELT as directed by

Due Date(s) Data Source data; or upon request.

Before

Network employee receives a

QNet User

Account and on request

April 30 of each contract period

Monthly; also, as required (i.e., when a security incident occurs)

Logs maintained locally by IT staff/SPOC with required data and artifacts; templatewill be provided by CMS

QNet ISSO

Template will be provided by CMS

QNet ISSO

Template will be provided by CMS

QNet ISSO

Notes

ESRD

Network

Manual

ESRD

Network

Manual

ESRD

Network

Manual

Type

Core

Core

Core

Page | 57

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description Recipient and

Reporting

Mechanism the CMS

QNet ISSO to

CMS QNet

ISSO and

QNet Security

Team

C4.1A. AIM 1: Beneficiary and Family Engagement

35 Attendance by 1 ELT to COR

Patient SME/family member/caregiver at

Network’s annual evaluation and other

CMS meetings as directed

ELT to GTL

36

37

Develop Marketing

Plan for engagement of beneficiaries and families/caregivers at the facility level

Develop a report of synthesis of activities and learning of this activity in preparation for next contract year

ELT to COR

ELT to GTL

ELT to COR

ELT to GTL

38 Develop Patient

Learning and Action

Network Plan

ELT to COR

ELT to GTL

Due Date(s) Data Source

At Network evaluation and as required

30 calendar days from start of contract period

November

30, 2013

November

30, 2014

(Option Year

1)

30 calendar days from start of contract

Notes Type

Signed affidavit required

Core

Core

Core

Core

Page | 58

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

39

40

41

42

Provide 20% of facilities located in the Network area with patient representative forms to identify 10 patients to participate in activities

Identify at least 10

Patient Subject

Matter Experts to serve as patient representatives on the

Network Patient

Engagement LAN and NCC Patient

LAN

Provide meeting minutes of Patient

Engagement LAN, highlighting Patient

Subject Matter

Experts’ contributions

Identify 3 of the 10

Patient Subject

Matter Experts to participate in designing QI projects/spreading practices and

Recipient and

Reporting

Mechanism

Due Date(s) Data Source

ELT to COR

ELT to GTL

ELT to NCC

ELT to COR

ELT to GTL

ELT to NCC

ELT to COR

ELT to GTL

ELT to NCC

ELT to COR

ELT to GTL

ELT to NCC period

February 1 of each contract period

March 1of each contract period

Within 15 days of each of required meetings

March 1,

2013

March 3,

2014 (Option

Year 1)

Notes Type

Patient

SME participation form; ESRD

Network

Manual

Core

ESRD

Network

Manual

Core

ESRD

Network

Manual

Core

ESRD

Network

Manual

Core

Page | 59

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

43

Recipient and

Reporting

Mechanism development of at least two of the identified campaign or education materials and to serve on a national level as representatives on the

NCC Patient LAN

Implement a QI project developed by the LAN that promotes patientcentered care and protects the interest of beneficiaries

ELT to COR

ELT to GTL

44 Implement two campaigns developed by the LAN which impact at least 20% of the Network population per campaign

ELT to COR

ELT to GTL

Due Date(s) Data Source

March 4,

2015

(Option Year

2)

June 30, 2013

(Base

Contact)

March 31,

2014 (Option

Year 1)

March 31,

2015

(Option Year

2)

June 30, 2013

(Base

Contact)

March 31,

2014

(Option Year

1)

March 31,

2015

Notes Type

ESRD

Network

Manual

Performance

ESRD

Network

Manual

Performance

Page | 60

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

45 B&FE Monthly

Report, to include:

Attendance by 1 patient SME/Family member in 1 COR monthly monitoring meeting per quarter

Documentation of implementation of

Marketing Plan

Documentation of

Patient LAN Plan

Documentation of collaboration with

SA(s) to facilitate patient engagement

Invitation of 3 of 10

Patient SMEs to each of 4 Network meetings

Documentation of maintenance of patient participation/activities in Patient LAN

If Network makes any on-site visits, document compliant

Recipient and

Reporting

Mechanism

Due Date(s) Data Source

ELT to COR

ELT to GTL

(Option Year

2)

Monthly of each contract period

Notes Type

Core

Page | 61

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description Recipient and

Reporting

Mechanism with C.4.1.A

C.4.1.B.1. Evaluate and Resolve Grievances

46 Enter grievance data into Network Contact

Utility (NCU) or other CMSdesignated system

ELT to COR

ELT to GTL

Due Date(s) Data Source

Within 1 day of receipt of grievance

NCU or other

CMS-designated system

47

48

49

50

Conduct grievance review and document procedures for resolution and document if the grievance was resolved to the satisfaction of the patient

Report statistics on grievance case reviews

Networks will ensure that 100% of all beneficiary data for filed grievances be submitted to the

NCC.

Achieve at least 80% of Satisfaction Survey respondents with

Satisfied or Very

ELT to COR

ELT to GTL

ELT to COR

ELT to GTL

ELT to COR

ELT to GTL

ELT Survey contractor

Within 30 days of receipt of grievance, reported monthly

Monthly of each contract period

Monthly of each contract period

NCU

At evaluation Dashboard

Notes

ESRD

Network

Manual

ESRD

Network

Manual

ESRD

Network

Manual

Network provides data to survey

Type

Core

Core

Core

Core

Performance

Page | 62

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

51

52

Recipient and

Reporting

Mechanism

Satisfied responses

Perform Quality of

Care Reviews

Perform focused audit to identify systemic issues and trends

ELT to COR

ELT to GTL

ELT to SA (as needed)

ELT to COR

ELT to GTL

Due Date(s) Data Source

As needed or as instructed by CMS

53 ELT to COR

ELT to GTL

March 1,

2013 of each contract period

October 1 of each contract period

April 2 of contract period

NCU

NCU

54

Identify one grievance trend to address in five facilities with the highest number of grievances in that trend area and develop a QIA

Provide impact analysis of interventions

May 1 st

of each contract period June

1 st

of each contract period

August 1 of each contract

Notes contractor

ESRD

Network

Manual

Type

Core

ESRD

Network

Manual

Core

ESRD

Network

Manual

Performance

Core

Page | 63

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description Recipient and

Reporting

Mechanism

Due Date(s)

55

56

Contact SA(s)SA to coordinate management of a response plan to resolve patient issue

Provide Ombudsman

Report

ELT to COR

ELT to GTL

ELT to COR

ELT to GTL period.

October 1 of each contract period

Within 2 days of identified issue or trend, as needed

February 13 of each contract period

C.4.1.B.2 Support ICH CAHPS

57 Notify providers of

ESRD QIP requirements for ICH

CAHPS survey completion

58 Track ICH CAHPS participation by facilities

ELT to COR

ELT to GTL

59 At CMS direction, develop and implement CAPHS

QIA

ELT to COR

ELT to GTL

C.4.1.C.1 Assess Involuntary Discharges/Involuntary Transfers

60 Initiate investigations into any IVD/IVT; document

ELT to COR

ELT to GTL

ELT to COR

ELT to GTL

April 2 of each contract period

TBD

Within 24 hours of reported

Data Source

Dashboard

NCU

Notes Type

ESRD

Network

Manual

Core

ESRD

Network

Manual

Core

ESRD

Network

Manual

Core

Performance

ESRD

Network

Manual

Performance

ESRD

Network

Manual

Core

Page | 64

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

61

Recipient and

Reporting

Mechanism characteristics of patients, including race, ethnicity, new

ESRD versus established patients

Track performance on

IVD/IVT occurrence and investigations

ELT to COR

ELT to GTL

Due Date(s) Data Source

IVD/IVT.

Report

Monthly of each contract period

Report

Monthly of each contract period

C.4.1.C.2 Patients at Risk for IVD/IVT and Failure to Place

62 Initiate investigations ELT to COR into any incidences of failure to place for a new or established

ELT to GTL patient; document characteristics of patients, including race, ethnicity, new

ESRD versus established patients

63 Track performance on avoidance of

IVDs/IVTs/failures to place and

ELT to COR

ELT to GTL investigations

C.4.1.C.3. Generate Regular Access to Dialysis Care Report

64 Provide Access to

Dialysis Care Report

ELT to COR

ELT to GTL

C.4.1.D. Vascular Access Management

Monthly of each contract period and within 24 hours of reported

IVD/IVT

Monthly of each contract period

Monthly of each contract period

NCU

NCU

Notes

ESRD

Network

Manual

ESRD

Network

Manual

Type

Performance

Core

ESRD

Network

Manual

Performance

ESRD

Network

Manual

Core

Page | 65

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

65

66

67

68

For AVF-in-use rate, meet performance requirements specified by SOW

Using the October data of the prior calendar year as a baseline, improve AV fistula rate for prevalent patients by reducing quality deficit by 20%, unless the expected improvement is less than the floor of 1.0 percentage point or greater than the ceiling of 4.0 percentage points, in which case the floor or ceiling shall apply

For >90 day catheter use, meet performance requirements as specified by SOW

Using the October data of the prior calendar year as a baseline, achieve a

Recipient and

Reporting

Mechanism

ELT to COR

ELT to GTL

ELT to COR

ELT to GTL

ELT to COR

ELT to GTL

ELT to COR

ELT to GTL

Due Date(s) Data Source

Monthly of each contract period

By

October15 of each contract each period

Monthly of each contract period

By October

15 of each contract year

Dashboard

Dashboard

Dashboard

Dashboard

Notes Type

Performance

ESRD

Network

Manual

Performance

ESRD

Network

Manual

Performance

Performance

Page | 66

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description Recipient and

Reporting

Mechanism

69 goal of 2 percentage point reduction in use of catheters >90 days for prevalent patients in facilities with baseline rates higher than 10%

Support 100% of applicable dialysis facilities in submission of vascular access data

ELT to COR

ELT to GTL

C.4.1.E. Reduction of Healthcare Acquired Infections

70 Provide a report on ELT to COR the consultation with local stakeholders, ELT to GTL

71 including QIOs working on HAI initiatives

Convene a workgroup with facility participation and develop a framework for HAI LAN

ELT to COR

ELT to GTL

72 Obtain group administrator rights from each facility

ELT to COR

ELT to GTL

Due Date(s) Data Source

Monthly

April 1 of each contract period, then report progress monthly

No later than

April 1 of each contract period, then report progress monthly

February 1 of each contract period, then report

Dashboard

Notes Type

ESRD

Network

Manual

Core

ESRD

Network

Manual

Core

ESRD

Network

Manual

Performance

Core

Page | 67

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

73

74

75

76

Educate facilities on the framework of

NHSN enrollment

Recipient and

Reporting

Mechanism

Due Date(s) Data Source

ELT to COR

ELT to GTL

ELT to COR

ELT to GTL progress monthly

Monthly

Progress reported of each contract period

December 31 of each contract period

>080 % of facilities enrolled in and reporting to NHSN for at least 6 consecutive months by December 31,

2013

For enrollment and reporting of data in

NHSN, meet performance requirements as specified by SOW

At CMS’ direction, develop and implement a QIA based on infection data obtained from the NHSN database that impacts at least

20% of the Networkarea facilities

ELT to COR

ELT to GTL

ELT to COR

ELT to GTL

Progress reported monthly of each contract period

Monthly

Progress reported of each contract period

Dashboard

Dashboard

Notes Type

ESRD

Network

Manual

Core

ESRD

Network

Manual

Performance

Performance

Performance

Page | 68

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description Recipient and

Reporting

Mechanism reporting Dialysis

Facility Event data, with a minimum of

5% of the Network population included

C.4.2.A. AIM 2: Innovation Projects

77 Identify AIM 2

Innovation Pilot

Project topic and

78 disparity

Demonstrate improvement as required for the AIM

2 Innovations Pilot

ELT to COR

ELT to GTL

ELT to COR

ELT to GTL

Project including implementation of disparity reduction.

Network may choose any of five (5) projects, with a requirement that all measures within the project must achieve the designated outcome as specified in C.4.2

C.4.3. AIM 3: Reduce Costs of ESRD Care by Improving Care

79 Document training of

Network staff on

ELT to COR

ESRD QIP measures, ELT to GTL

Due Date(s) Data Source

February 15 of each contract period

Monthly

Progress reported of each contract period

Monthly of each contract period

Dashboard

Notes Type

Core

Performance

Core

Page | 69

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

80

Recipient and

Reporting

Mechanism measure specifications,

CROWNWeb, and resources available to facilities

QIP Monthly

Activities Report, to include:

Technical assistance provided to support

QIP requirements related measures, number of facilities assisted, and efforts to ensure timely/appropriate data by facilities

Facility assistance with accessing, posting, and printing

QIP PSR as requested

Document participation in any existing collaborative identified by Network or NCC for QIP activities

Document activities to spread best practices/innovations

ELT to COR

ELT to GTL

Due Date(s) Data Source

Monthly of each contract period

Notes Type

Core

Page | 70

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

81

82

83

Recipient and

Reporting

Mechanism learned from QIP activities

Provide feedback information on areas of QIP to facilities

Provide documentation of facilities intervention as directed by CMS on QIP information to dialysis patients

Document QIPrelated topics on monthly calls with

SA(s)

Provide feedback of

QIP measure impact on patients

Notify facilities to review their QIP

Performance Score

Report (PSRs) during the -day30- open period

Register provider master account holders to access the

QIP score accounts

Provide updated

MAH lists for

ELT to COR

ELT to GTL

ELT to COR

Due Date(s) Data Source

Within 5 days of score release

Ongoing

Quarterly of each contract

Notes Type

ESRD

Network

Manual

Core

Core

Core

Page | 71

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description credentialed users

Recipient and

Reporting

Mechanism

ELT to GTL

ELT to QIP contractor

ELT to COR

ELT to GTL

84

85

Identify intervention(s) to work with stakeholders in implementing or impacting State Plans related to achieving

QIP performance measure outcomes.

Obtain DUA with

CMS QIP monitoring and evaluation contractor

ELT to COR

ELT to GTL

86 Document use of

LAN resources in

QIP activities

ELT to COR

ELT to GTL

C.4.3.B. Support facility data submission for CROWNWeb

87 Provide documentation of number of out-of-

ELT to COR

ELT to GTL

88 scopes patients resolved

Use CROWNWeb data to provide technical assistance to

ELT to COR

ELT to GTL

Due Date(s) Data Source period

Progress reported quarterly of each contract period

February 15 of each contract period

Monthly of each contract period

Monthly of each contract period

Within 7 days of monthly review of

NCC

CROWNWeb

CROWNWeb

Notes

ESRD

Network

Manual

Core

ESRD

Network

Manual

ESRD

Network

Manual

Type

Core

Core

Core

Core

Page | 72

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item Number Item Description

89

Recipient and

Reporting

Mechanism facilities not submitting data on

QIP measure rates, including attestation of NHSN, into

CROWNWeb in a timely and accurate manner

Assist CROWNWeb facility users with resources for training, data definitions, submission requirements, etc.

ELT to COR

ELT to GTL

Due Date(s) Data Source

CROWNWeb

Reports in each contract period

As needed CROWNWeb

Notes

ESRD

Network

Manual

Type

Core

Table 2 – Conflict of Interest Schedule of Deliverables: ESRD Network Schedule of Deliverables for the Performance Period of

January 1, 2013, through December 31, 2013

Page | 73

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item

No.

Item Description Recipient and

Reporting

Mechanism

Due Date(s)

Conflict of Interest Identification

1

2

3

Submission of proposed contract or other agreement with provider of services or health plan for services related to the proposed provider or health plan’s Medicare reimbursement

Contracting

Officer and

Conflict of

Interest

Specialist

ELT

COR/GTL

At least 30 days prior to the planned execution date of the agreement

H.11.C.3(c)

Submission of report listing the agreements entered into with a provider of services or health plan and with federal, state or local government agencies

H.11.3.C.3 (d)

Submission of documentation that

Contracting

Officer and

Conflict of

Interest

Specialist

ELT

COR/GTL

Contracting

Officer and

June 28, 2013

At least 30 days prior to the planned execution date

Data Source Evaluation

(of Deliverable)

Notes

Page | 74

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item

No.

Item Description Recipient and

Reporting

Mechanism

Network’s subcontractors have

Conflict of

Interest mitigated any conflict or potential conflict

Specialist

ELT

COR/GTL

H.11.C.4

Due Date(s) of the agreement

Conflict of Interest Disclosure

4

5.

Submit Organizational

Conflicts of Interest

Certificate in accordance with

H.11.D.1 and H.11.D.2

(a)

Submit Ownership

Interest Information

H.11.D.1(g)

Contracting

Officer and

Conflict of

Interest

Specialist

ELT

COR/GTL

ELT

COR/GTL

Upon submission of technical proposal

Upon request for revisions from CO

Updates included in June

28, 2013 report

45 days before any change in the information submitted in accordance

H.4.2

With Technical Proposal

Updates included in June

28, 2013 report

Personnel Changes Requiring Conflict of Interest

6. Submission of resume Contracting Prior to engaging the

Data Source Evaluation

(of Deliverable)

Notes

Page | 75

End Stage Renal Disease Network

CMS-2012-ESRD-FFPRENEWAL

Item

No.

Item Description Recipient and

Reporting

Mechanism or CV and additional information in

Officer and

Conflict of accordance with paragraph H.11.F

Interest

Specialist

ELT

COR/GTL

Start-Ups, Acquisitions and Affiliations

7. Provide notification of Contracting intent to start-up Officer and acquire or affiliate with or be acquired by

Conflict of

Interest another business

Specialist

H.11.G

ELT

COR/GTL

Due Date(s) services of the replacement personnel in accordance with paragraph H.6

As soon as possible but no case later than 60 days before the projected start up date

Data Source Evaluation

(of Deliverable)

Notes

Page | 76

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