Attachment_J.1_-_Statement_of_Work.docx

Attachment J.1

Statement of Work (SOW) End-Stage Renal Disease Quality Incentive Program (ESRD QIP) Data Validity and Reliability

I. Background

The End-Stage Renal Disease Quality Incentive Program (ESRD QIP) is the first Federal Value-Based Purchasing (VBP) program where providers are paid based on the quality of care they provide to Medicare beneficiaries and not just on quantity of services provided. Effective January 1, 2012, Section 153(c) of the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008, mandated that ESRD QIP (1) identify specified quality measures for providers of renal dialysis services, (2) establish performance standards for providers of renal dialysis services and (3) calculate performance of providers of renal dialysis services based on established measures and performance standards, (4) issue payment reductions of up to 2 percent for those providers that do not meet performance standards and (5) establish procedures for making this information publicly available.

Each year ESRD QIP uses the formal rulemaking process to propose and finalize a set of performance measures for providers of renal dialysis services. Data used to calculate performance measure score results is collected using a variety of sources such as Medicare claims, Consolidated Renal Operations in a Web-Enabled Network (CROWNWeb), the Centers for Disease Control and Prevention (CDC) National Health Safety Network (NHSN), In-Center Hemodialysis (ICH) Consumer Assessment of Healthcare Providers Systems (CAPHS) survey and other standardized data sources to calculate performance and determine which facilities are subject to a payment adjustment.

One of the critical elements of the ESRD QIP’s success is ensuring the completeness and accuracy of data submitted to calculate facility performance. Beginning with Payment Year (PY) 2016, we begin validating data submitted to CROWNWeb by sampling no more than 10 records from 300 randomly selected facilities. Beginning with PY 2020, we begin to deduct 10 points from facilities total performance score (TPS) if the facility was selected for validation but failed to successfully participate in the validation. In PY 2017 we conducted a feasibility study to validate data reported to the CDC NHSN dialysis event module. Beginning in PY 2019, we randomly selected 35 facilities to participate in an NHSN dialysis event validation study and recently finalized policy to increase the number of facilities to 150 in PY 2021 and 300 facilities in PY 2022.

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A. Purpose

The purpose of this SOW is to obtain services to support the statutorily required validation of data entered into CROWNWeb and the National Health and Safety Network (NHSN). Specifically, support is needed to implement a methodology to validate data elements entered into CROWNWeb that are required to calculate ESRD QIP measures. The methodology must be consistent with requirements finalized in the ESRD Perspective Payment System Final rules.

B. Technical Considerations

B.1 - The Contractor, independently and not as an agent of the Government, shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the requirements of the SOW.

B.2 - The Contractor (and any applicable Subcontractors) shall comply with Federal Acquisition Regulations (FAR), Part 52 Section 227.14, Rights in Data Clause. The full text of the FAR can be found at www.arnet.gov/far.

B.3 - All work performed under this contract is subject to inspection and final acceptance by the CMS Contracting Officer or the duly authorized representative of the Government. The CMS Contracting Officer’s Representative (COR) is a duly authorized representative of the Government and is responsible for inspection and acceptance of all items to be delivered under this contract.

B.4 - The Contractor shall identify key personnel with the extensive experience and expertise to satisfy the tasks/subtasks contained in the SOW. The Contractor shall notify the CMS COR of any changes to the status of key personnel within two business days of a key personnel change (see Schedule of Deliverables (SOD), item 1).

B.5 – System Security Background: The Federal Information Security Management Act (FISMA), Section 3544(a)(1)(A)(ii) describes Federal agency security responsibilities as including “information systems used or operated by an agency or by a Contractor of an agency or other organization on behalf of an agency.” Section 3544(b) requires that each agency provide information security for the information and “information systems that support the operations and assets of the agency, including those provided or managed by another agency, Contractor, or other source.”

A comprehensive website for CMS Information Security, which includes Laws and Regulations, Policies, Standards, Procedures, Guidelines and Tools, and many other links for publications, templates, and forms, is found at: https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information- Technology/InformationSecurity/Information-Security-Library.html. The available information includes, but is not limited to:

· CMS Information Security Policy

· CMS Policy for the Information Security Program

· CMS Information Security Acceptable Risk Safeguards (ARS)

IT Contractors within CMS are required to comply with the following standards, policies, and procedures below.

FEDERAL STANDARDS, POLICIES AND PROCEDURES, AND GUIDANCE

· 45 C.F.R. Part 160, 162, and 164 Health Insurance Portability and Accountability Act (HIPAA): Health Insurance Reform: Security Standards; Final Rule February 20, 2003

· 5 U.S.C. § 552a as amended Privacy Act of 1974

· OMB Circular A-130 Management of Federal Information Resources, Appendix III, "Security of Federal Automated Information Systems"

· Government Auditing Standards (http://www.gao.gov/yellowbook)

· The Federal Information Security Management Act of 2002 (FISMA)

· Federal Information Systems Controls Audit Manual (FISCAM)

· ANSI/EIA-649-B-2011 Configuration Management Standard April 2011

· Public Law 93-579, as amended

· Rehabilitation Act, Section 508, Accessibility Standards

· 29 U.S.C § 794d (Rehabilitation Act as amended)

· 36 CRF 1194 (508 Standards)

· https://www.section508.gov/

· NIST Special Publication (SP) 800-12, An Introduction to Computer Security: The NIST Handbook

· NIST SP 800-16, Information Technology Security Training Requirements: A Role-and Performance-Based Model

· NIST SP 800-50, Building an Information Technology Security Training and Awareness Program

· NIST SP 800-53, Recommended Security Controls for Federal Information Systems

· NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems

NOTE: The above refer to the most current issuance of the subject documents.

The activities of the Contractor shall adhere to the CMS and QualityNet systems security Policies and procedures set forth in, but not limited to, the following documents (some of which are posted on www.esrdncc.org under the CyberTyger downloads), unless otherwise directed by CMS:

· QualityNet Incident Response Procedures Version 5 (PDF)

· QualityNet Security Site Visit and Checklist (PowerPoint)

· QualityNet Security Site Visit and Checklist Version 2 (PDF)

· QualityNet System Security Policy Handbook Version 6 (PDF)

· ESRD Infrastructure IT Administrator Manual Version 3 (PDF)

· QualityNet ESRD Networks Infrastructure Support Manual (PDF)

· CyberWatch Newsletters (PDF)

· CMS Information Security (IS) Acceptable Risk Safeguards (ARS)

· Medicare ESRD Network Organizations Manual

· QualityNet Exchange User Guide

· Remedy Action Request (AR) System User Guide

The Contractor shall protect all Personally Identifiable Information (PII) and Protected Health Information (PHI) at its facility and during transport of information. The following chart describes the required marking and handling of information and deliverables containing PII and/or PHI during transport.

Transport of Sensitive or Greater Information Types such as Personally Identifiable Information (PII) and Protected Health Information (PHI)

Special handling requirements are necessary to protect the information contained within.”

Certified Mail with return receipt in tamper- Cover Sheet or each page clearly identified, i.e., “footer”: “Caution: This report contains sensitive information. Special handling requirements are sensitive information is stored on non-digital media.

Class Mail in tamper- evident packaging Cover Sheet or each page clearly identified, i.e., “footer”: “Caution: This report contains sensitive information. Special handling requirements are necessary to protect the information contained within.”

B.6 - The Contractor shall enter into a Data Use Agreement (DUA) with CMS Office of Information Services (OIS) within 30 days post contract award and prior to the access or receipt of any data covered by the SOW (see SOD, item 2). Data that CMS provides to the Contractor (and any applicable Subcontractors) under this SOW shall be used, duplicated, or disclosed only for the purposes of this SOW unless the CMS COR specifically permits another use in writing and the appropriate amendments have been made to the DUA.

Certificates of Destruction: At the conclusion of the use of CMS data or the expiration of the DUA, or the end of the Contract Period of Performance (whichever one comes first), the Contractor shall enter and submit to CMS a Certificate of Destruction (COD). The COD certifies that the Contractor has destroyed the data covered by the DUA and that data has not been used for any other purpose outside of which was covered in the DUA.

· Approved destruction methods for hardcopy data

· Shred

· Burn

· Use of a bonded destruction service

· Approved destruction methods for softcopy data

· Delete off

· Network

· Workstation

· Removable storage device

· Empty Recycle bin

B.7 – Within 30 days post award, the Contractor shall request connectivity to all CMS and/or QualityNet resources needed to satisfy tasks and deliverables defined in the SOW (see SOD, item 3). CMS will provide the Contractor with access to all of the necessary repository metadata and documentation required to perform the assigned tasks.

B.8 - The Contractor (and any applicable Subcontractors) shall work collaboratively with all other CMS Contractors that support ESRD Information Technology and Program needs.

B.9 - All action items assigned to the Contractor shall become deliverables under the SOW with due dates agreed upon between the CMS COR and the Contractor. These action items are often the result of regularly scheduled status meetings, impromptu meetings and/or requests via email or phone. These deliverables shall be charged under the task/subtask to which they apply. The Contractor will not be assigned any deliverables which do not fit within the context of the SOW.

B.10 - All software, documentation, and written products created under the SOW shall become the sole property of CMS.

B.11 – Section 508 - Accessibility of Electronic and Information Technology

This SOW is subject to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by the workforce Investment Act of 1998 (P.L. 105-220).

Specifically, subsection 508(a)(1) requires that when the Federal Government procures Electronic and Information Technology (EIT), the EIT must allow Federal employees and individuals of the public with disabilities comparable access to and use of information and data that is provided to Federal employees and individuals of the public without disabilities.

The EIT accessibility standards at 36 CFR Part 1194 were developed by the Architectural and Transportation Barriers Compliance Board ("Access Board") and apply to contracts and task/delivery orders, awarded under indefinite quantity contracts on or after June 25, 2001.

Each Electronic and Information Technology (EIT) product or service furnished under this contract shall comply with the Electronic and Information Technology Accessibility Standards (36 CFR 1194), as specified in the contract, as a minimum. If the Contracting Officer determines any furnished product or service is not in compliance with the contract, the Contracting Officer will promptly inform the Contractor in writing. The Contractor shall, without charge to the Government, repair or replace the non-compliant products or services within the period of time to be specified by the Government in writing. If such repair or replacement is not completed within the time specified, the Government shall have the following recourses:

· Cancellation of the contract, delivery or task order, purchase or line item without termination liabilities; or

· In the case of custom Electronic and Information Technology (EIT) being developed by a Contractor for the Government, the Government shall have the right to have any necessary changes made or repairs performed by itself or by another firm for the noncompliant EIT, with the Contractor liable for reimbursement to the Government for any expenses incurred thereby. The Contractor must ensure that all EIT products that are less than fully compliant with the accessibility standards are provided pursuant to extensive market research and are the most current compliant products or services available to satisfy the contract requirements.

For every EIT product or service accepted under this contact by the Government that does not comply with 36 CFR 1194, the Contractor shall, at the discretion of the Government, make every effort to replace or upgrade it with a compliant equivalent product or service; if commercially available and cost neutral, on either a contract specified refresh cycle for the product or service, or on a contract effective option/renewal date; whichever shall occur first.

The Contractor shall comply with the standards, policies, and procedures below. In the event of conflicts between the referenced documents and this SOW, the SOW shall take precedence.

Rehabilitation Act, Section 508 Accessibility Standards

· 29 U.S.C. 794d (Rehabilitation Act as amended)

· 36 CFR 1194 (508 Standards)

· https://www.section508.gov/

· FAR 39.2 (Section 508)

· CMS/HHS Standards, policies and procedures (Section 508)

In addition, all contract deliverables are subject to these 508 standards as applicable:

· Regardless of format, all Web content or communications materials produced, including text, audio or video - must conform to applicable Section 508 standards to allow Federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities.

· All Contractors (including Sub-Contractors) or consultants responsible for preparing or posting content must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents above.

· Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the Contractor or consultant.

The following Section 508 provisions apply to the content or communications material identified in this SOW:

36 CFR Part 1194.21 a - l 36 CFR Part 1194.22 a – p 36 CFR Part 1194.23 a – k 36 CFR Part 1194.24 a – e 36 CFR Part 1194.25 a – j 36 CFR Part 1194.26 a - d 36 CFR Part 1194.31 a - f 36 CFR Part 1194.41 a – c

The Contractor shall provide a completed Section 508 Product Assessment Template and the Contractor shall state exactly how proposed EIT deliverable(s) meet or do not meet the applicable standards.

C. General Business Considerations

C.1 - The Contractor shall have specialized understanding and extensive working knowledge of both ESRD clinical issues and the CMS ESRD Network Program and the ESRD QIP. The Contractor shall have strong project management skills to effectively manage and perform the tasks in the SOW.

C.2 – As of January 19, 2009, all Federal Contractors and Sub-Contractors are required to use the U.S. Citizenship and Immigration Services’ E-Verify system to verify their employees’ eligibility to legally work in the United States. This new rule (Executive Order 12989) directs Federal agencies to require Federal Contractors electronically verify the eligibility of their employees. In accordance with FAR 1.108(d), this new rule applies to Solicitations issued and Contracts awarded after the effective date of January 19, 2009. The acquisition threshold for this rule requires the insertion of the E-Verify clause for prime Federal Contracts with a Period of Performance longer than 120 days and a value above the simplified acquisition threshold (which is $150,000). This SOW is affected by the rule. Within 30 days post award and as new staff are added to the contract, the Contractor shall provide written verification that their employees are eligible to legally work in the United States (see SOD, item 4).

C.3 – The Contractor shall not be held responsible for any delays, shifts in priorities on the part of CMS, past-due tasks owned by other Contractor(s), or episodes where insufficient requirements have been defined which prohibit the Contractor from successfully executing tasks and/or delivering products as specified in the SOW.

II. Requirements

A. Requirements/Tasks to be Performed

The following tasks shall be listed in a Project Management Plan (PMP) and Schedule for the duration of the work using CMS-approved Project Management software (e.g.

Microsoft Project) to establish, maintain, support, and document work activities.

1. Task 1: Project Management, Communication, and Equipment Procurement

2. Task 2: Data Validation Methodology and Sampling Plan

3. Task 3: Gather Data

4. Task 4: Analyze Data

5. Task 5: Submit Results Reports and Recommendations for Improvement

6. Task 6: Case Review Data Validation

7. Task 7: Postage and Copying

The PMP and Schedule shall include all deliverables and delivery dates listed in Section F Schedule of Deliverables.

TASK 1 - Project Management, Communication and Equipment Procurement

The Contractor shall provide administrative, project management, communications functions, and procure equipment to connect to ESRD QualityNet and CROWN suite of applications to manage all activities, tasks, and subtasks described in the SOW. Additionally, the Contractor must adhere to system and personnel security controls, and data use agreements for access to CMS ESRD systems.

Task 1A - Project Kick-off Meeting, Project Management, and Planning Session

The Contractor shall meet with the COR and other appropriate CMS personnel to obtain a mutual understanding of the work and expected outcomes of the contract as well as requirements necessary to perform the assigned tasks and to meet the deliverable schedule. This Project Kick-Off Meeting shall be held by conference call or video teleconference within 5 business days following contract award (SOD, item 5). The Contractor will prepare a written agenda 2 business days prior to the Kick-Off meeting (SOD, item 6); to introduce the Contractor’s team and outlining the Contractor’s understanding of the tasks and deliverables required.

The Contractor shall provide CMS a detailed written summary of the meeting within 7 calendar days after the Kick-Off Meeting has concluded (SOD, item 7). The completion of the meeting will result in (but is not limited to) the following:

· Introduction of Contractor and Government personnel performing work related to this study

· Development of a list of any required Government Furnished Information (GFI)

· Review by the Contractor of its understanding of the work to be accomplished under the SOW to ensure that all parties have a common understanding of the work to be performed and of the respective responsibilities and obligations of each of the parties to that end

· Review by both CMS and the Contractor of the agreed-upon method to resolve, track, and report on risks and issues.

The Contractor shall prepare and submit a detailed Project Management Plan (PMP) and Schedule within 30 days following contract award and as it is changed (SOD, item 8). This PMP, with sufficient detail at the task level and indicating any and all critical paths, shall be maintained for the duration of the assigned tasks using Microsoft Project or other software application approved by CMS. The PMP and Schedule shall be updated as necessary to reflect changes (including staff changes) and work progress. An updated PMP and Schedule shall be delivered to the CMS COR after each change with an explanation of the changes/updates that occurred. All permanent changes made to the PMP and Schedule must be approved by the COR. These documents shall also be made available to CMS upon request.

At minimum, the PMP and Schedule shall include:

· Organization chart with names of all staff (including applicable Sub- Contractors) showing responsibilities and reporting chain of Contractor personnel

· Detailed listing of staff members with description of duties, contact information, and the percentage of full-time employment (FTE) they are dedicated to this project

· Resource planning by activity (including hours and names of staff)

· Key milestones and deliverables with due dates

· Identification of critical path(s)

· Task/Subtask detailed descriptions

· Description of assumptions and constraints

· Key assumptions

· Risks

· Risk Mitigation strategies.

Task 1B – Participation in CMS/Contractor Status Meetings

The Contractor shall arrange bi-weekly conference calls with the CMS COR, key CMS personnel, key personnel from Sub-Contractor(s) if applicable, and any other required ESRD Contractors and/or the CDC to discuss specific task activities, timelines, upcoming activities, and any other concerns/problems with meeting dates on action items and deliverables. Of particular interest are issues in obtaining and validating data, which require prompt notification to CMS in addition to documentation in monthly status reports. A detailed summary of each call, including action items, shall be provided to the CMS COR within 2 business days of each call (SOD, item 9). CMS reserves the right to reschedule these progress calls to fit within current schedules and workloads. These calls will be conducted via teleconference

Task 1C - ESRD Community Collaboration

The Contractor will perform as an independent and objective service provider to CMS. Data validation activities will require collaborative working relationships with several CMS Contractors and ESRD stakeholders, including, but not limited to the CMS ESRD CROWNWeb Customer Help Desk Contractor, CDC, ESRD Networks, ESRD providers, CROWNWeb Electronic Data Interchange (EDI) submitters and Single User Interface (SUI) submitters, ESRD measurement development contractors and ESRD QIP support contractors to facilitate the exchange of ideas, problems, and solutions to achieve and execute an effective assessment of data validity.

Task 1D –Monthly Status Reports

The Contractor shall submit monthly administrative progress reports outlining all work accomplished during the previous month.

At a minimum, such reports shall cover the following items:

1. An account of work accomplished during the month (data collection activities, difficulties encountered and potential future problems, actual and possible delays in deliverables, remedial action taken, unresolved issues etc.;

2. Costs associated with the activities during the month (including subcontractor cost expended);

3. Activities planned for the coming month;

4. Contractor expectations of the COR or other CMS staff during the coming quarter (e.g. review of deliverables submitted, delivery of data or other items); and

5. The status of the budget (actual cost vs. projected, percentage of cost expended) Description of planned versus actual resource consumption by major task area, using the management plan as a reference point; and

6. Brief description of substantive findings to date, if any.

The Report shall be submitted within 15 days following the end of the month with copies to the COR and Contracting Specialist on a monthly basis.

Task 1E - End of Contract Transition

During performance of this contract, should termination or non-renewal of a Period of Performance or option year occur, CMS may require the Successor Contractor to provide transition services beginning at the earliest mutually agreeable date. During this period, the Incumbent Contractor shall work with the Successor Contractor, CMS staff, as well as other identified CMS Contractors to ensure continued operation of the Tasks in the SOW.

Prior to commencement of transition, CMS will request a Contract Transition Plan from the Incumbent Contractor. The Contract Transition Plan shall outline the provision for ensuring uninterrupted service to the ESRD Program, be effectively and efficiently administered, and be completed within a reasonable timeframe (SOD, item 11). The Successor Contractor shall cooperate fully with the Incumbent Contractor, as directed by the COR, to ensure that all services provided to the Government continue without interruption.

If this contract is transitioned to a Successor Contractor, at that time the Incumbent Contractor shall prepare and deliver comprehensive technical documentation for all business processes and CMS-owned software applications covered by this Contract; and, at the direction of CMS, forward the same complete technical documentation to any other Contractor(s) (SOD, item 12). The Contractor shall further be available to transition with any Contractor(s) in order to make the Successor Contractor(s) conversant in/with the applications and processes covered by this Contract in order that these functions may be provided to CMS and the ESRD Network community without any interruption of service.

At the end of this Contract, the Contractor shall provide to CMS or Successor Contractor(s) as directed by CMS, the following:

· Updated documentation for all business processes covered in this SOW;

· All patient records, user records, and appropriate data and files shall be turned over to the Successor Contractor or appropriate organization as directed by the CMS COR and Contracting Officer.

· Data shall be turned over in a form that the Successor Contractor(s) or appropriate organization can use; this includes documentation of the data system, hardware specifications, databases, and any and all customized software and procedures that were created to manage the data and processes.

· Equipment, programs, and methods shall be transferred to CMS or to designated Successor Contractor(s) in good operating condition. Equipment shall be returned to CMS for the purpose of inspection and inventory validation that the property has been received.

· The Contractor shall provide person(s) knowledgeable in each Task/Subtask of this Contract to work with CMS and the Successor Contractor(s) on an as- needed basis during the transition of the work during a timeframe agreed upon by all parties.

Task 1F – Business Continuity and Contingency Plan (BCCP)

Within 60 days of contract award, the Contractor shall provide CMS with an updated contingency plan showing roles and responsibilities required for all tasks in the SOW (SOD, item 13). The plan will provide documented procedures for making backup copies of software, operating data, and user processes for recovering these data and returning all systems to an operational level in the event they are lost, destroyed, or otherwise inoperable. This information applies to all CMS systems and databases, including those provided by Contractors, which fulfill mission critical business functions, whether they are an IT facility, communications network, major application, or standalone workstation.

Task 1G – Procurement of Equipment to connect to QualityNet and CROWN applications

The Contractor shall provide robust IT infrastructure with the procurement of necessary hardware and software to support the success of the SOW. The Contractor shall comply with the CMS Engineering Review Board (ERB) process for obtaining additional hardware, software and services as outlined in the “Procurement Process for CMS and CMS Support Contractors” in the “ERB User’s Guide.” The contractor shall submit a Procurement Plan for CMS approval within 15 days of contract award (SOD, item 14). Copies of all ERB requests and invoices for each procurement shall be submitted monthly (SOD, item 15). All procurements of hardware and of software shall adhere to the QualityNet standards set forth by the Division of Systems Architecture and Data Management (DSADM) within CMS.

The Contractor shall develop an Inventory List with all hardware, software, equipment, and storage furniture purchased on behalf of CMS and submit to CMS monthly (SOD, item 16). The inventory documentation shall include at the minimum, but is not limited to, an itemized list of the following:

· Computer hardware (brand, model number, cost, serial number) for all workstations, laptops, servers, printers, and other required hardware

· Software (title, version, cost, license number and duration)

· Office equipment including file cabinets, copier, locks, etc. (cost)

At the conclusion of the ESRD QIP Data Validity and Reliability Contract, all property procured by the Contractor on behalf of CMS shall become the sole property of CMS.

Task 1H – Project Communication and Presentations

The Contractor shall prepare meeting and presentation materials for use in ad hoc project communications to stakeholders (SOD, item 17). The Contractor shall present to the stakeholders at the ad hoc meetings. Examples of communications are: announcement of project, presenting results of validity testing, and other project information as requested by the COR. All presentation material shall be sent to the CMS COR as directed by the COR. A summary of the meeting shall be sent to the CMS COR within 5 business days of the meeting (SOD, item 18).

TASK 2 - Data Validation Methodology and Sampling Plan

The Contractor shall develop a Methodology Plan for successfully determining the quality of data in the CROWNWeb and the National Healthcare Safety Network (NHSN) dialysis component. CMS will review and comment on the proposed methods, and the Contractor shall finalize the project methodology within 30 days of contract awardtwo weeks after the project “Kick-off” meeting.

The following parameters shall be used to guide the design.

· The validation methodology and sampling plan for CROWNWeb and NHSN validation dialysis component shall comply with all requirements and limitations described in the ESRD PPS final rules and align with data validation best practices.

· The Contractor will conduct a power analysis to estimate the ability of the proposed methodology to assess the accuracy of the data entered into CROWNWeb and NHSN dialysis component.

· At a minimum, the methodology must clearly describe:

· How targeted sampling will be used

· The sampling strategy

· Specific data elements

· Process for requesting and collecting data

· Process used to review medical records

· Tests of reviewer agreement (Kappa or similar test)

· Adjudication of reviewer differences in coding

· Electronic systems used to code

· Matching digital data with reviewer data

· Data cleaning and aggregation process

· Data analysis approach

· Process used to share individualized validation results with facilities that participated in the validation

· A detailed outline or mock-up of the final results report; indicate expected contents including dummy tables and charts that will be delivered by the Contractor in its validation and findings reports to be completed under Task 5.

· At minimum, the Contractor shall include data elements in the CROWNWeb and in NHSN validation that are required to calculate measures that primarily rely on CROWNWeb as a primary data source and are required to calculate NHSN blood stream infection (BSI) measure. Beginning in CY 2019, the following measures utilize CROWNWeb as a primary data source:

· Kt/V—dialysis adequacy

· Hypercalcemia

· Ultrafiltration

· Clinical Depression and Follow-Up

· The Contractor shall be limited to no more than two requests for medical records per participating facility to encourage participation in the validation study. However, this restriction is not intended to limit the Contractor in contacting facilities to complete the records intake process and rectify any missing or illegible records once the facility has begun study participation.

The Contractor shall offer to assume the cost of records collection from facilities.

Within 30 days of contract award, the Contractor shall prepare the following written deliverables for Task 2:

1. Updated Data Dictionary with complete definition of data sets and data elements to be validated and traced to/from source records for both CROWNWeb and NHSN data (SOD, item 19)

2. Validation Methodology Plan (SOD, item 20)

3. Updated Interface Control Document (ICD) to support all data elements included in the project and define specifications for CROWNWeb and NHSN data extracts that will be required to complete the validation study (SOD, item 21).

Within 60 days of contract award, the Contractor shall prepare the following written deliverables for Task 2:

1. Analysis Plan (SOD, item 22).

TASK 3 – Gather Data

Based on the Contractor’s methodology and test plans approved by CMS under Task 2, the Contractor shall obtain copies of patient records (paper/fax/electronically) directly from the participating facilities to support the analysis that will be performed under Task

4. The Contractor shall additionally request and obtain the data extracts from CROWNWeb and NHSN based on the specifications developed by the Contractor under Task 2. The contractor shall support the completion of Supporting Statements A and B of our annual Paperwork Reduction Act (PRA) package that accompanies our CY ESRD PPS proposed and final rule submissions (SOD, item 27). Both supporting statements describe the purpose, scope and benefits of collecting information. It also includes a copy of the actual tools that will be used to collect data. All data collection tools must be approved before they can be used to request any information from the public. Final OMB approval numbers must be placed on all data collection materials.

The Contractor shall prepare the following deliverables:

1. Within 60 days after contract award, draft a communication to all facilities for CMS approval that describes the data validation study, cites the CMS ESRD QIP program authority for the study and subsequent requests for medical records, and explains the intended benefits of participation and penalty for failure to participate (SOD, item 23).

2. Within 120 days post award, draft a facility-specific Medical Records Request letter for CMS approval to request copies of patient medical records for the identified sample from each facility and provide instructions for secure marking, handling and delivery of records to the Contractor (SOD, item 24). Facilities will have 60 days from the date of request to submit to Contractor its copies of each medical record corresponding to the period covered in the sample. The letter shall:

a. Identify types of clinical source records to be submitted and identify all data elements that must be included in those records for the validation study.

b. Identify the targeted selected patients whose records will be validated.

c. Identify the time frame for which medical records are requested

3. Update the Validation Compliance Log as required and submit upon conclusion of the data gathering period (SOD, item 25). CMS will use this log to assign penalties to ESRD QIP scores.

a. Track, log and securely store all source records obtained for the validation study

b. Identify all missing data elements for which source documentation could not be obtained, and record the facility’s rationale for unavailability and consider possible exclusion from study

c. Store medical records in a secure and controlled manner and in compliance with all HIPPA requirements.

4. Within 30 days of CMS’ approval of the contractor’s data validation methodology and sampling plan delivered under Task 2, draft memos to request Data Extract files from CMS CROWNWeb and NHSN in accordance with ICD and analytical implementation plan (SOD, item 26).

TASK 4 – Analyze Data

The Contractor shall:

· Maintain the data processing environment for analysis to compare source records obtained from the facilities to the electronic records maintained in CROWNWeb and NHSN.

· Perform data validation analysis using any tools/programs/tabulation methods selected by the Contractor and approved by CMS for processing the records.

· Maintain repository of data collected during contract performance and deliver final data as part of contract close out (SOD, item 28). The data repository shall include:

· Data collected by Contractor’s clinicians performing medical records abstraction from source data provided by facilities

· Documentation of abstraction methods and coding used to identify source records

· Statistical program data files used for sampling and analysis

· Collected copies of all PHI/PII records provided by facilities.

TASK 5 – Submit Results Reports and Recommendations for Improvement

The Contractor shall establish a methodology for reporting facility specific to CROWNWeb and NHSN validation results to facilities. At minimum, the reports shall include:

· Error Rates found in the sample:

· Aggregated by Facility, with data element level disaggregation

· Aggregated by Data Element including all facilities

· Aggregated by submitter type [Batch Submitting Organization (BSO), National Renal Administrators’ Association (NRAA), Independent]

· Disaggregated by data elements used in the Clinical Performance Measures (CPM)

· Stratify results by access types, by location where administered

· Extent of errors due to

· Missing data elements

· Discrepancies in data entered

· Unavailability of source records and reason for unavailability (e.g., record retrieval from storage not feasible in paper copy, or cost-prohibitive, unwillingness to participate, unique situations related to selected patient)

· Extrapolate from the sample and provide estimates of the error rate for all data in CROWNWeb).

The Contractor shall prepare the following written deliverables:

· The Final Report shall summarize all findings during period of assessment and include any recommendations for process improvement to improve the reliability of CPM data submission in CROWNWeb and NHSN. A draft of the Final Report is due 45 days prior to the end of the period of performance. The revised Final report is due 20 days prior to the end of the period of performance (SOD, item 29). The final report should include:

· Methodology, including sampling and analytic approaches

· Trends in validity and reliability of data over time

· Definitions of data elements

· Recommendations for training users

· Recommendations for future validation studies

· A public facing validation report that provides a high-level summary of CROWN Web and NHSN validation findings.

· Within the last 30 days of the period of performance, facility-specific results reports to be shared with the facilities that participated in the CROWN Web and NHSN validation (SOD, item 30). These reports shall contain information on the facility’s data quality on each measure validated, including information that the facility can use to compare its own performance to the norm for all facilities included in the study. The intent of these reports are to provide not only a “report card” to the facility but to guide them in training staff on data entry.

Within the last 30 days of the period of performance, the Contractor shall deliver up to three briefings to CMS management or other stakeholders summarizing the results of the data validation study (SOD, item 31).

Upon CMS request, the Contractor shall provide technical expert consultation in preparation of CMS white papers, Position papers, briefings, presentations, to articulate options for improving CROWNWeb and NHSN data reliability and validity (SOD, item 32).

TASK 6 - Case Review Data Validation

With the National implementation of CROWNWeb in June 2012, the data entry responsibilities for the CMS administrative forms (CMS -2728, -2744 and -2746) transferred from the ESRD Networks to the dialysis facilities. In this decentralized approach, questions periodically arise in regard to the accuracy of these forms.

Questions come in through the help desk and through a CMS CROWN Data Discrepancy Services (CDDS) Contractor. Some questions require validation of CROWNWeb information/data through a comparison to the actual patient medical record. An example of an issue that would require action is an incoming request to delete a CMS-2728 form from the CROWNWeb system. The Contractor shall have capacity to review up to 180 cases per month, with each case validation review taking between 15 and 30 minutes.

In order to perform these types of case validation reviews, a copy of the medical record must be obtained from the dialysis facility for data verification. The breadth of documentation needed from the Medical record will vary according to the specific case and issue at hand. Some cases will require the validation of one or two data items. The extent of Medical Record information needed for each case shall be assessed prior to requesting the information from the dialysis facility. CROWNWeb “Read Only” Access will be available to data validation reviewers.

The methods used to request the case review data validation information from the facility, to complete the review, and recommend corrections shall be developed and submitted to the COR for approval. A draft of the case review data validation process will be submitted to the COR within 45 days of the contract award (SOD, item 33), with a final document (SOD, item 34) due 30 days later (on day 75 of contract). The Contractor will track the problems encountered and include a summary of progress and potential solutions (as applicable) in the monthly status report (SOD, item 10). Observations of common errors derived from these reviews and suggestions for training should be considered for inclusion in the final report (SOD, item 29)

Medical record components that may assist in validating a given 2728 for deletion/correction include patient encounter, history and physical, clinical information, and physician orders. Specific information that may be needed include the following:

· Responsible ProviderForm Type (Initial, Re-entitlement, Supplemental)

· Patient Identifiers/Demographics (e.g., race, ethnicity)

· Current Medical Coverage

· Primary Cause of Renal Failure

· Co-morbid Condition(s)

· Lab values/dates

· Date Regular Chronic Dialysis Began

· Date Patient Started Chronic Dialysis at Current Facility

· Treatment setting & type

· Transplant options notification

· Training Dates

· Physician and/or Physician Signature Date

· Patient Signature Date.

If a discrepancy is identified, a data correction recommendation shall be made to CMS. These recommendations shall be provided on a case by case basis. Recommendations will be delivered to CMS via a spreadsheet on a weekly basis (SOD, item 35). Status of cases not requiring any correction will also be noted in the spreadsheet with an explanation. Cases should be targeted for resolution within 30 days for instances where a simple confirmation of one or two data elements is required. More complex validation cases should target a 45 day resolution time frame. Cases in progress for greater than 45 days should be listed in a separate heading in the spreadsheet with a notation reflecting the outstanding issues/barriers.

Coordination between the Contractor and CDDS and will be necessary for process development and service level agreements.

TASK 7 – Postage and Copying

· The Contractor shall administer reasonable reimbursements to the providers of costs associated with photocopying and mailing medical records to the Contractor as approved by CMS.

· The Contractor shall ensure that the most economical and secure handling of medical records is used for mailing. In addition, the Contractor shall track the medical records from the time of request through their destruction.

· The Contractor shall position photocopying and mailing medical records as the least desirable method for this collection; instead encouraging use of QualityNet and faxing.

B. Report Requirements

All Report Requirements are contained in Attachment B, Section F Schedule of Deliverables. Submissions shall be made in an electronic format, using applicable security standards for PHI/PII data, and printable by the recipient, unless otherwise directed by CMS. Final key deliverables must also be submitted in hardcopy to CMS upon request and if identified in the Schedule of Deliverables. All materials are the property of CMS.

All documents submitted to CMS become FINAL only after the CMS COR has provided written approval of such to the Contractor within 30 days of receipt of the final document(s) from the Contractor and is within the official contract period of performance. As mutually agreed upon by CMS and the Contractor, the COR may extend the date for any deliverable out 60 days provided the extension granted is in writing from the COR to the Contractor. Deliverables where extensions over 60 days are necessary must seek written approval from the CMS Contracting Officer.

Refer to the chart in SOW section I.B.5 titled “Transport of Sensitive or greater information types such as Personally Identifiable Information (PII) and Protected Health Information (PHI)” to ensure that the transport of deliverables containing PII and/or PHI do not create a CMS security incident.

B.1 Draft Deliverables For all draft materials/products where the intent is to distribute outside of CMS, or to any other CMS Contractors, the Contractor will first submit draft materials to the COR for pre-approval prior to distribution. These materials should be sent to the COR fifteen (15) days before planned use/distribution unless otherwise specified in writing by the CMS COR.

B.2 Final Deliverables The Contractor shall submit the final version of all materials/products that are intended for distribution outside of CMS, or any CMS Contractors, to the COR at least six (6) days prior to use/distribution unless otherwise specified in writing by the COR.

C. Location of Performance

The Contractor shall perform all services at the Contractor’s location and furnish all personnel, supervision, management, materials, services, equipment and facilities (except such materials, equipment and facilities provided by the Government) necessary to perform the services required under this SOW.

D. Government Property

The Contractor shall acquire the hardware, software, and equipment identified in Task 1G for performance of this SOW. The Government shall provide network connectivity between the Contractor’s facility and the QualityNet infrastructure and applications.

E. Personnel Requirements

Contractor personnel shall possess the experience and expertise to satisfy the requirements of the SOW. Contractor personnel shall include clinicians with experience in nephrology and with an understanding of medical record review and abstraction, personnel experienced in data validation, statistics and sampling procedures, and personnel with knowledge and specialized understanding of data reliability assessment, use of analytical tools and/or instruments, and presentation and reporting of analytical data. The Contractor shall provide for and ensure that the following key personnel position are filled at date of contract award and shall notify CMS within 48 hours if any Key Personnel position becomes vacant during the Period of Performance.

Required Key Personnel: Project Manager ESRD Clinical Data/Medical Records Specialist Statistician/Programmer

III. Quality Assurance

Quality Assurance by CMS may include inspection of Deliverables; review and approval of interim or draft reports; progress meetings; and/or review and approval of progress at prescribed points before authorization to continue is to be given to the Contractor.

Progress meetings shall be held between the Contractor and CMS on a recurrent basis via teleconference; the dates and times of these meetings shall be mutually agreed upon by the COR and the Contractor. Evaluation criteria and monitoring are described below.

A. Evaluation Criteria

CMS will continuously monitor the Contractor during the period of performance for this SOW. The purpose of the performance review is for CMS to assess the Contractor’s overall performance to date.

CMS shall utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final Contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm.

An assessment of…