Attachment_1_-_Statement_of_Work.pdf

Maintenance and Oversight Support of the CMS Data Element Library RFP-CMS-2015-150741 Attachment 1

SECTION C – STATEMENT OF WORK/SERVICES

Section 1: Background and Purpose

1. A. — Background

The Centers for Medicare & Medicaid Services (CMS) strive to ensure that the American public receives the highest quality of health care. In the quest for optimal high-quality care, the current health care system must be continuously evaluated to address performance gaps, identify and incentivize opportunities for improvement, and reduce unintended consequences that may arise with treating a large health care population. Recognizing performance gaps and the opportunities available for improvement and acting on those opportunities can improve the quality of care provided to the beneficiaries we serve.

Large gaps exist between the goal of high-quality care for every patient, during every episode of care, and the actual delivery of care in our health care system. CMS has many important opportunities to help health professionals, patients, and all of the stakeholders in our health care system turn promising new ideas into action, helping to close the existing gaps in the delivery of quality care. Effective, coordinated, safe, and well communicated patient-centered transitions in care remain priority areas for quality improvement, appropriately falling within the six overarching goals of the CMS Quality Strategy. Closing gaps in quality related to care coordination remains a high priority as transitions in care remain vulnerable points in time during a patient’s episode of care. Health information technology (HIT) can play an invaluable role in fostering seamless transitions through its ability to enable effectively communicated and coordinated care. While lending to quality outcomes health information technology can also serve to reduce provider burden.

CMS is completing the development and implementation of a publically accessible data element repository, the CMS Assessment Data Element Library (the Library). This repository is intended to serve as a centralized and authoritative resource for CMS’s required Long Term and Post- Acute Care (LTPAC) assessment data elements (e.g., questions and their response codes) and their associated mappings to HIT standards. The overarching intent is for the Library to aide in CMS’s efforts toward ensuring data element uniformity and to aide in the acceleration of long-term and post-acute care provider adoption of HIT and health information exchange and the interoperability of data through the use of uniform assessment data elements.

Researchers, software developers, providers, vendors and others will be able to reference and utilize content within the Library for multiple purposes including health information technology-related activities, quality measurement, and research. A major goal of the Library is to foster safe, coordinated transitions in care across the continuum of health care services, and into the community-based services environment, by providing resources that can aid in the acceleration of post-acute care’s adoption and implementation of health information technology and healthcare information exchange.

In the absence of a financial incentive program for LTPAC providers to adopt electronic health record (EHR) systems, CMS provides, as one of the functional outputs of the Library, the alignment of technology standards with LTPAC assessment instruments such as the Minimum Data Set (MDS), the Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) , the Long-term Care Hospital (LTCH) Continuity Assessment Record & Evaluation (CARE) Data Set (LCDS), and the Outcome and Assessment Information Set (OASIS). These standards promote provider EHR adoption within the LTPAC community and participation in health information exchange (HIE) across provider settings in the LTPAC environment. By aligning LTPAC assessment instruments with each other and with HIT standards, CMS and the public can identify data elements suitable for data re-use and interoperable EHR information exchange.

Specifically, the Library is based on a relational database and the relational mappings that are intended to support harmonization, reduce duplication of data entry by providers, improve information flow between care settings, and strengthen data integrity for quality reporting.

CMS’s required LTPAC assessment instruments are built from discrete, specified assessment-driven questions and response codes.

The nearly 4,600 discrete data elements included in the Library at this time are derived from the following assessment tools and instruments:

• Continuity Assessment Record & Evaluation Tool

• Minimum Data Set

• Long-Term Care Hospital Continuity Assessment Record & Evaluation Data Set

• Outcome and Assessment Information Set Inpatient Rehabilitation Facility Patient

Assessment Instrument It is anticipated that the inventory of items will expand, and that the Library will eventually grow to include data elements from assessments beyond LTPAC.

The Library contains mappings of the discrete data elements to associated attributes, to similar data elements in all of the instruments, and to national vocabulary standards (e.g., Logical Observation Identifiers Names and Codes (LOINC) and Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT). The Library integrates the relationship of the data elements to Health Level 7 (HL7) standard Clinical Document Architecture (CDA) templates and the Quality Data Model (QDM), and future interoperability technology standards, for example, Fast Healthcare Interoperability Resources (FHIR®). It serves as a searchable, centralized repository for managing and curating data elements from all CMS assessment instruments. Because of the nature of its resources, the Library will reduce data capture burden on providers by offering EHR-compatible assessment data elements that are readily extractable for quality measure reporting and, at the same time, compatible with current data submission requirements for CMS. This approach allows providers to capitalize on the use of HIT to submit to CMS the required data elements. Over its lifetime, the Library will expand incrementally as new priorities develop and data elements evolve. It will be a resource for providers, software developers, vendors, measure developers, implementers, and analysts who develop quality measures and standards for information exchange.

Standardization of data and the alignment of standards as provided by the Library are the foundation for interoperable EHR implementation in disparate settings. This has the potential to impact global change across the health care system including home and community based services (HCBS). Compatible standards facilitate improvements related to reducing overall provider burden by allowing the use and reuse of appropriate health care data. By supporting eventual development of compatible EHRs based on these standards, data collected by CMS could then be reused and transferred between care settings, as well as enabling clinical decision support. Thus, standardization has implications with regards to improving care coordination, payment methodology and payment reform, quality improvement, survey and certification, and research. Improvements could be applied to ensure care coordination and quality improvement across various care delivery settings including but not limited to acute care hospitals, ambulatory settings, and inpatient rehabilitation facilities(IRF) long-term care hospitals, skilled nursing facilities (SNFs), nursing facilities (NFs), end-stage renal disease (ESRD) facilities, home health agencies (HHA), hospice care and HCBS.

Overall, the goals of the Library include:

• To facilitate the maintenance of uniformity across CMS assessments and quality measures

• To serve as an authoritative resource for patient assessment data elements

• To promote the sharing of electronic patient assessment data sets and information standards

• To influence and support industry efforts to promote EHR interoperability and care coordination

The CMS Assessment (Data Element) Library Data Council (CALDC) is the oversight council assigned to act as the change control board for the data elements within the Library. The CALDC provides guidance, direction and issue resolution related to the maintenance of the Library’s data elements. The role of the CALDC is to ensure that data element standardization includes data element oversight such that the integrity of the discrete, standardized data elements is protected. Standardized, uniform assessment-based data has the ability to enable significant strides towards harmonizing information requested by CMS from across the spectrum of care services and settings that is to be used for purposes including but not limited to: quality measurement, Medicare payment determination, care planning and other regulatory purposes, as well as the ability to enable the interoperability of health information across provider settings.

Therefore, the role of the CALDC’s oversight is paramount.

This project is to obtain services to maintain and update CMS’s publically available assessment data element Library which is intended to serve CMS and the public as a centralized repository and resource for the various CMS assessment tools’ data elements and their associated HIT standards. The intent is for the Library to aide in CMS’s efforts toward ensuring data element uniformity and to aide in the acceleration of LTPAC provider adoption of HIT use, e.g., EHRs, and HIE. This contract is specified to include the ongoing maintenance of CMS’s assessment-based data element inventory, and its associated relational data base, including the relational mappings of the items to the standards needed to ensure EHR compatibility and interoperable data transfers. Such ongoing oversight and maintenance of the Library’s data base must be accomplished in accordance with CMS’s standards and guidelines for the hosting of the electronic Library in the CMS environment: therefore, the library tool software and database design will be managed by various support contractors within the Information Systems Group, or other contractors. Contractors that support the software and database design must follow specified guidelines and requirements embedded within the CMS eXpedited Life Cycle (XLC) as these are considered best practices. Such requirements are followed for any updates to the Library’s infrastructure so as to provide assurance that stakeholders have access to a viable product that meets their needs and that the contractor has sufficient guidelines for meeting contractual requirements. The Contractor shall, from time to time, be required to interface with the various contractors involved in the software and database management. Further, this project is to obtain services to support the Library’s oversight council, the CALDC. The Contractor will serve in the CALDC’s “Governance Support Team” and “Librarian” roles.

This project supports the administration of the Quality Improvement Organization (QIO) Program. The Social Security Act, as set forth in Part B of Title XI - Section 1862(g), established the Utilization and Quality Control Peer Review Organization Program, now known as the QIO (Quality Improvement Organization) Program. The statutory mission of the QIO Program is to improve the effectiveness, efficiency, economy, and quality of services delivered to Medicare beneficiaries.

1. B. — Purpose and Scope:

The purpose of this Contract is to obtain services to maintain, update, and ensure quality-related process improvements of the CMS hosted CMS Data Element Library, and to directly support the processes related to the Library’s oversight council, the CALDC.

CMS’s overarching goal is to further establish the publically available, centralized repository of CMS’s assessment data elements in the Library which serves as a resource tool for CMS and the public. The Library is primarily intended to support CMS’s evolution toward the implementation of standardized/uniform assessment items across care settings. It is, therefore, intended to support CMS’s aim to substitute, over time, dissimilar data elements in the legacy instruments with uniform, standardized ,“best of breed,” data elements and scales. Dissimilar, outdated or non-optimal data elements could be updated, retained or retired from use.

The Library houses the full inventory of CMS’ assessment data elements (data items) of approximately 4,600 in total; related value sets, code sets and measurement scales. It provides relational mappings of similar items; mappings of the assessment items/responses to their associated HIT standards-based vocabularies and mappings to electronic clinical documents such as the interoperable Improving Massachusetts Post-acute Care Transfers (IMPACT) Tool. The Contractor will support the Library as it continues in its evolution to support interoperable information exchange.

A major purpose of the Library stems from CMS’s anticipation that health care providers will be generating and sending uniform assessment based data elements across providers and potentially to CMS from their EHRs in the future. The Library has been purposefully designed to ensure, that the data elements and their relational attributes, such as their associated HIT standards are available as outputs. The Library is specifically designed to serve as a resource that provides for the application of HIT standards to CMS’s assessment data elements, enabling streamlined workflows. Data could be collected once in an EHR, and be available (securely and appropriately) to multiple, authorized, end-users for purposes of care planning, clinical decision support, better care coordination, quality measurement and reporting, payment, regulatory compliance, as well as comparative effective research (CER). These activities are dependent upon data element uniformity. Therefore, by ensuring the proper maintenance of uniform data elements and ensuring the provision of up-to-date HIT Standards, the Library is intended to facilitate EHR adoption by the LTPAC industry and HIE; ultimately, supporting interoperable data exchange through a centralized publishing of uniform data elements, their standards and mapping to clinical document architecture.

Therefore, the Contractor shall provide ongoing support to CMS’s electronically available, public facing data element Library to ensure that it is maintained with CMS’s selected (up-to-date) data elements. The Contractor shall directly support, as part of the maintenance process, all activities directed to ensure data uniformity and the maintenance of each data element’s associated attributes. Maintenance activities include updating all relational mappings and procuring updated HIT Standards. The Contractor will ensure that the Library serves the public and CMS’s purposes, and will comply with the requirements necessary for CMS to host the Library electronically in CMS’s systems environment.

Specifically, as part of the ongoing maintenance of the Library, the Contractor shall be expected to reference current recommended vocabulary standards used for reporting data from certified

EHRs (e.g. race, ethnicity, gender, payer) and collaborate with the Office of the Assistant Secretary for Planning & Evaluation (ASPE) to build on work completed and work in progress to apply federally-recognized standard vocabulary and values sets to the MDS, OASIS, LCDS, CARE and IRF-PAI. (e.g. LOINC SNOMED-CT). The Contractor will be expected to continuously monitor the Library’s inventory of data elements to identify lags in updated HIT standards, as well as gaps related to such standards, and shall resolve such gaps in vocabulary standards, e.g., LOINC Codes from Regenstrief.

The Contractor shall explore options for building on work in progress or completed under the Office of the National Coordinator (ONC), such as the Beacon Communities and Standards and Interoperability (S&I) Framework Longitudinal Care Coordination (LCC) and Electronic Long Terms Services and Support (eLTSS) Workgroups efforts. Additionally, the Contractor shall collaborate, as needed and as directed by the Government Task Lead (GTL) or Contracting Officer’s Representative (COR), with ONC to ensure compatibility with Federal standards for interoperability.

The Contractor shall demonstrate their knowledgebase related to the current flow of the PAC environment’s electronically submitted assessment data for purposes of payment, quality reporting, regulatory compliance, and so forth to inform CMS of opportunities for alignment with those health care provider environments that are required to participate in HIE and EHR use, such as with eligible hospitals. The Contractor shall collaborate with CMS subject matter experts to gain additional knowledge of data flows for all LTPAC providers to CMS, e.g. nursing homes, home health agencies, inpatient rehabilitation facilities, long term care hospitals and hospice programs.

The Contractor shall possess the following expertise and knowledge in at least these domains:

• Knowledge of the current submission system (the Quality Improvement and Evaluation System (QIES) Assessment Submission and Processing System (ASAP)) and the submission specifications used for the submission of the CMS LTPAC assessment instruments.

• Knowledge pertaining to HIT and vocabulary standards and Consolidated CDA (C- CDA).The Contractor shall possess expert-level knowledge related to the current flow of the PAC environment’s electronically submitted assessment data for purposes of payment, quality reporting, regulatory compliance, and so forth to inform CMS of opportunities for alignment with those health care provider environments that are required to participate in HIE and EHR use, such as with eligible hospitals.

o The data flows, for purposes of payment, quality reporting, regulatory compliance, are significantly different from the data flows for hospitals and physicians to CMS.

Using this knowledge the contractor shall be able to identify functionalities that the Library can provide that address opportunities to advance LTPAC settings adoption and participation in HIT and HIE related activities that will foster improved clinical care services such as clinical decision support, care coordination and seamless transfers in care;

enable quality monitoring of care services, while simultaneously serving to reduce provider burden.

• The contractor must be able to provide relational mapping updates to the Library data base as the data elements contained within it are added, modified or deleted to include, but not limited to:

o LTPAC assessment data element relationships o Associated HIT standards relational mappings o Mappings to electronic clinical documents

To aid in this cross-usage, the Contractor shall engage in activities that are intended to maximize the capabilities of the Library in accelerating HIT/HIE adoption by LTPAC providers. Therefore, the Contractor must possess knowledge/resources pertaining to:

o Strategy and solutions related to EHR-generated LTPAC clinical quality measures

(CQMs) to include in Meaningful Use Stage3 (MU3);

o Representation in Standards Development Organizations;

o Capacity to identify and update mappings within the Library to updated C-CDA and future interoperability standards as needed;

o Engagement with resources such as those provided by Regenstrief so as to enable the procurement of standards, and so forth.

In addition to knowledge pertaining to the content held within the library, the Contractor is also expected to possess or have access to resources that can ensure:

• Adherence/collaboration with the technical support contractor ( in accordance with the CMS XLC requirements and CMS IT processes and standard operating procedures (SOPs)) in activities related to the Library’s technical maintenance and upkeep

• Compliance with the XLC and Technical Reference Architecture (TRA)

• Adherence to the technical architecture processes as defined by the Healthcare Quality

Information System( HCQIS) Information Systems Group (ISG) and the Office of Information Services so as to continued compliance with the CMS Technical Reference Architecture TRA

Therefore, through a deep understanding the LTPAC assessment reporting process, and its associated complexities and dependencies, the Contractor shall provide both recommendation, strategies and solutions to CMS on how it can maximize or expand upon the current functions of the Library to support LTPAC cross-usage of both HIT transmission and the LTPAC current transmission system, through the QIES ASAP.

To aid in this cross-usage, the Contractor shall engage in activities that are intended to maximize the capabilities of the Library in accelerating HIT/HIE adoption by LTPAC providers such as providing strategy and solutions related to EHR-generated LTPAC clinical quality measures (CQMs) to include in MU Stage3 (MU3); ensure representation in Standards Development Organizations; identifying and updating mappings within the Library to updated Consolidated CDA (C-CDA) and future interoperability standards as needed; engagement with resources such as those provided by Regenstrief aimed at obtaining standards, and so forth. Further, the Contractor shall also provide draft language for potential inclusion in CMS’ Notice of Proposed Rulemaking (NPRM) and Final Rule related to EHR incentives.

The Contractor shall also ensure that the Library oversight process is systematically carried out and will directly participate in the oversight activities in its role as the Governance Support Team (GST). The GST carries out administrative-support functions, such as those associated with the “Librarian” role. The Contractor shall ensure process improvement and enhancements to the oversight process as its activities evolve over time.

Specifically, the GST role will be to directly ensure the maintenance of the SharePoint site that hosts the CALDC’s documents and where oversight activities are tracked and announced. The GST is responsible for logging, vetting, and communicating all incoming data element Change Requests (CR) and Issue Forms from the CMS stakeholders for changes to the Library via the Library CR/Issue Tracker. The GST is responsible for ensuring and facilitating all CALDC workgroup (WG) communication mechanisms are in place and carries them out via the established governance process.

We may refer to the CMS Assessment (Data Element) Library as the Data Element Library or the Library; and the standardized assessment-based data collection vehicles as tools, assessment tools, instruments, assessments, or records, and item sets. We may refer to the assessment-related domains found in the assessment tools as “sections” or as subsets. Assessment questions are interchangeably referred to as items or data elements and responses may be referred to as data elements or item responses and scales.

All products, including software and all utilities (proprietary and non-proprietary) developed to support the activities and deliverables of this contract are the property of CMS. The Contractor shall deliver all products of this contract at the request of CMS and upon termination of this contract.

Section 2: General Project Requirements

2. A. — Project Management: Project Plan and Monthly Progress Reports: The Contractor shall:

The Contractor shall provide CMS with a project plan (See 2.A.1), with updates to the project plan and monthly progress. Both the Initial Project Plan and the Progress Reports shall be able to be broken down into two (2) separate documents to include the following: Tasks relevant to the CMS Data Element Library Tasks relevant and Tasks relevant to the CMS Assessment Library Data Council (Tasks.)

• Schedule, procure conference call line and/or webinar links, for status meetings participate and coordinate recurring meetings at direction of COR/GTL, as well as ad-hoc meetings. Meeting coordination includes pre- and post-meeting activities (i.e., participant selection, meeting invites, call-in numbers, scheduling, agendas, meeting materials, minutes, and action items). Scheduled meetings will include at a minimum:

o Weekly One weekly status meeting pertaining to the Library One weekly status meeting pertaining to the CALDC One Contract Leadership meeting no less than (NLT) twice monthly One Library help desk meeting NLT twice monthly o Please note that frequency of meetings can be increased or decreased at any time by the contract COR/GTL, depending on the needs of the contract work. Calls are anticipated to last approximately 60 minutes.

o The Contractor shall be responsible for providing meeting minutes and deliverables for all activities no later than 3 business days following each meeting.

Deliverable #1: One weekly status meeting pertaining to the Library/minutes Deliverable #2: One weekly status meeting pertaining to the Library/minutes Deliverable #3: One Contract Leadership meeting NLT twice monthly/minutes Deliverable #4: One Library help desk meeting NLT twice monthly/minutes

2. A.1. — Project Management: The Contractor shall:

The Contractor shall develop a strategy and a subsequent Work Plan for all tasks in this contract.

These are to be discussed at the regularly scheduled contract status meetings. Updates to the Work Plan will be reflected in the updated Project Plan listed in Task 2.A.1, Deliverable 2.A.1.6

• Develop and submit a Project Management Plan that supports the project work related to the CALDC process and general maintenance and updates to the Library.

• Deliver, as part of the Project Management Plan, a Microsoft Project schedule authored on a template which CMS will provide as part of the initial government furnished information (GFI) transmittal showing the formal work breakdown structure, timeline, project milestones, critical path, and dependencies. The Microsoft Project schedule will be updated as appropriate.

• Provide updates to the final plan as appropriate

Deliverable #5: Initial Strategy/Draft Project Management Plan Deliverable #6: Final Strategy Project Management Plan

2. B. — Kick-off Meeting: The Contractor shall:

• Hold and lead an annual, in-person contract Kickoff Meeting at CMS in Baltimore, MD.

Travel will be limited to no more than 3 contractor staff members. The meeting shall occur with the CMS -COR and others as identified by the CMS -COR. The Contractor shall present to the CMS COR the process and timeline for meeting SOW requirements, in addition to the goals, challenges, and objectives for the tasks associated with the Library and the CALDC. The Contractor shall deliver materials for the kickoff meeting, including the agenda and any meeting materials including slide briefings or handouts, to the COR and GTL a minimum of two business days before the meeting. At the kickoff meeting, the Contractor shall work with CMS personnel to develop a project plan.

• The Kick-off Meeting shall include at a minimum the following information:

1. A list and timeline of all deliverables necessary to ensure completion of the activities described in the Statement of Work.

2. Reporting Expectations

3. Other general contract expectations and milestones

Deliverable #7: Kickoff Meeting Agenda and Materials (i.e., agenda, minutes, presentation and conference line)

Section 3: General Requirements: CMS DATA Element Library and CMS Assessment Library Data Council

3. A. — Basic Requirements: The Contractor shall:

• Provide for the ongoing technical maintenance of the data elements contained within the Data Element Library, e.g., the addition of new data elements, updates to existing, and the retirement of those that will no longer be used.

• Be able to provide software and data architecture consultative support if such need is identified

• Ensure upkeep of corresponding HIT standards

• Follow the process model as established by the CALDC Charter for Library maintenance procedures (see Appendix A: CMS Assessment (Data Element) Library Governance Framework)

• Enable the oversight process ( as established in the CALDC charter) to facilitate efficient and effective governance of the updates to the Library’s inventory

• Ensure that all requirements are adhered to

• Respond to and integrate new requirements as identified by CMS COR/program lead

• Provide public outreach, trainings, manuals or other attributes that will enhance the successful use of the Library

• Identify improved processes related to the Library’s established maintenance and change control processes (see Appendix A)

3. B. — CMS Data Element Library: Fundamental Activities: The Contractor shall support these fundamental activities:

The data elements deployed by CMS and thus captured in the Library, allow for the standardization and uniformity of its data collection vehicles. The data elements are used in various data collection vehicles, which include: the LTCH CARE Data Set; IRF PAI, OASIS, MDS and the Care Tool, for the purposes of quality measurement, care planning, payment and certification purposes. Any updates to these data collection vehicles and future standardized data elements used by CMS shall also be included in the Library.

These data collection vehicles provide for standardized patient assessment collection. When the data elements within these vehicles are deployed in multiple provider setting types they enable standardized data collection across settings. This allows for the implementation of quality measurement across settings, which in turn enables cross-setting quality analysis. Further, the deployment of uniform data elements facilitates a provider’s capability to re-purpose assessment information for outputs such as health information exchange. Electronic HIE can serve to ensure effective, patient centered, care coordination during transitions in care. Thus, in addition to the Library serving as a data element repository, the upkeep of its relational mappings to HIT standards and electronic clinical documents/formats is also vital to the provider industry’s ability to engage in HIE.

Therefore, the Contractor shall:

• Provide maintenance of the contents of the Data Element Library’s assessment data elements, and the associated relational mappings as a result of approved change requests or maintenance quality checks

• Provide updates to business requirements associated with the maintenance services of the Library

• Update any corresponding manuals and support public engagement activities that may be associated with the Library

Specific fundamental and maintenance-related activities that are to be provided by the Contractor are further provided under Section 4. CMS Data Element Library General & CMS Assessment Library Data Council: Maintenance.

Deliverable #8: Perform quarterly quality control checks of Library inventory and associated mappings/artifacts Deliverable #9: Update the Library’s inventory, all associated artifacts and mappings

Deliverable #10: Perform quarterly reviews of business requirements and process flows, and update as appropriate Deliverable #11: Perform semi-annual reviews of any manuals or communications materials Deliverable #12: Update manuals, communications and engagement materials in alignment with approved updates to the Library

3. C. — Coordination: The Contractor shall:

• Facilitate collaboration among CMS components, as well as with other entities, agencies, and CMS contractors related to data element maintenance and efforts toward data element uniformity via the CALDC oversight/governance process. (see Appendix A:

CMS Assessment (Data Element) Library Governance Framework for process flow)

• Ensure collaboration with entities such as ONC, ASPE, National Library of Medicine (NLM) and Regenstrief to ensure the procurement of updated standards and engagement in policy development related to HIT.

• Participate in CMS Lean Process Improvement activities, such as leading and coordinating current state and future state mappings of improved processes related to Library maintenance and data element governance.

Deliverable 13: Facilitate communication and collaborative activities in adherence to CR Process flow Deliverable 14: Facilitate collaboration with outside entities as necessary for Library maintenance activities at the direction of the COR/GRL Deliverable 15: Participate in a once per year LEAN-associated activity for process improvements. May coordinate this in-person activity with annual kick-off meetings

3. C.1. — Coordination: Other Contractors: The Contractor shall:

• CMS contractors will rely on the Library as a resource for quality measurement development and other purposes. Therefore, the Contractor shall be expected to provide technical support to other CMS contractors related to the Library, the CALDC and HIT, if needed. Technical support may include providing technical expertise pertaining to HIT, HIE, C-CDA, electronic CQMs (eCQMs), etc., to other CMS GTLs and contractors.

The Contractor shall work with other CMS contractors or other stakeholders and stewards, as needed, to ensure successful application of the Library and the oversight process.

Deliverable #16: Provide Technical support to contractors within 5 days or as directed by the COR/program lead

3. D — Ad Hoc Requests from CMS: The Contractor shall:

Perform ad hoc requests under this contract pertaining to the maintenance of the Library and adhoc requests under this contract pertaining to the CALDC. The ad hoc requests are forecasted to generally come from unforeseeable activities related to maintenance activities associated with the Library and its oversight council as well as intermittent support to CMS contractors utilizing the Library. Such unforeseeable activities may include, but are not limited to, identifying and analyzing unintended consequences resulting from the Library’s implementation, resolving technical issues pertaining to the content within the Library, or other functions directly related to the Library; communications such as responses in the form of briefings and reports to other Agencies, such as ONC, preparation of briefing documents (pre/post rulemaking or when requested by CMS leadership), unexpected issues related to the mappings within the Library or unexpected issues related to the associated HIT standards.

In summary, the Contractor shall:

• Resolve technical issues within a period of time as directed by the COR

• Provide technical support

• Complete communications, such as briefing related requests

• Occasionally, requests may require immediate turn –around of materials and COR will inform the Contractor of the timeline/deadline.

Deliverable #17: Ad hoc: Resolve identified technical issues Deliverable #18: Ad hoc: Provide technical support to users identified Deliverable #19: Ad hoc: Prepare communications

Section 4: CMS Data Element Library & CMS Assessment Library Data Council:

Maintenance

The CMS Data Element Library is designed to serve as a resource that aids in the development of CMS’s data collection vehicles. It is also intended to facilitate the application of uniform assessment items across settings for multiple purposes such as the implementation of cross-setting quality measurement, and fostering the engagement of long-term and post-acute care (LTPAC) in HIT and HIE.

4. A.1— General Maintenance:

• Ensure the functional and technical integrity and maintenance of the data elements and their associated attributes that are housed within, updated or added to the CMS Data Element Library

• Performed in accordance with the processes as set forth by the CALDC (See Appendix A)

• Contribute to the development of uniform data collection vehicles in its technical support of the Library and the oversight and governance process through its role as the Governance Support Team.

• Serve as the curator for updates to the Library’s inventory of data elements.

Updates/maintenance shall include, but are not limited to:

o Changes to data elements or their associated HIT standards or relational mappings o Retirement of data elements and their associated relational mappings, e.g. C-CDA o Addition of new data elements and the integration of their associated standards and relational mappings

• Provide updates to any attributes, including updated associative relational mappings and inclusion of HIT standards

• Procure updates to HIT standards as needed through the appropriate Standards

Development Organizations

• Ensure that the Library is technically sound, supports the functional characteristics, and operational activities necessary to meet the public and CMS’s requirements, such as:

o Inclusion of the various CMS assessment data elements and their attributes o Provide updates to the relational mappings provided in the Library, including:

o associated standards-based vocabularies o Related code sets, value sets and measurement scales.

o Mapping to standards and C-CDA o Implementation guides o Ensure that the data element attributes, artifacts and associations are captured as functional outputs of the Library’s mapping, such as:

Identification of existing, new/revised data items Identification of data elements that may differ at the data element level but are congruent, and are (or will be) used in a common quality measure, e.g. data elements in cross setting measures.

Identification of data elements used to calculate measures Coding response options and/or requirements Specifications related to item set used for data collection Associated HIT standards Similarity/relational associations among the discrete data elements o Ensure that prior to publication of any updates all appropriate testing has been performed and issues resolved o Ensure that all quality assurance and other activities are performed in compliance with the Expedited Life Cycle (XLC) Standards as established by

CMS.

o Meet CMS’s and the public’s use case requirements as established through requirements development o Other attributes, requirements and associations as provided by CMS o Continuation of its comprehensive attributes, e.g. that it remains publicly available;

remains hosted within the CMS environment and in accordance with the requirements associated with the use of the CMS public platform.

• Collaborate with other CMS components or entities in the development or modification of the assessment data elements within the data collection tools.

• Work with CMS Contractors and partners, including the NLM, and the ONC to align priorities related to the publicly available Library and ensure alignment of current vocabulary work with this SOW.

• Adherence/collaboration with the technical support contractor ( in accordance with the CMS XLC requirements and CMS IT processes and standard operating procedures (SOPs)) in activities related to the Library’s technical maintenance and upkeep

• Although the Library will have been implemented, the Contractor is expected to be both familiar and in compliance with the XLC and Technical Reference Architecture (TRA) with sufficient expertise on staff for consult if necessary. The Contractor shall adhere to technical architecture processes as defined by the HCQIS Information Systems Group (ISG) and the Office of Information Services and shall be in compliance with the CMS TRA and supplements.

Deliverable #20: Review Library inventory and mappings & perform necessary updates Deliverable #21: Provide updates to the Library inventory and all associative mappings, HIT standards, etc.

Deliverable #22: Evaluate Library following updates for functional integrity and respond to any issues that are identified

4. A.2—General Maintenance and Support: Oversight and Governance Processes of the CMS Assessment Library Data Council (CALDC):

The CALDC serves as an executive Library governance board. The Contractor shall provide direct support to the CALDC in the role of Governance Support Team (GST) and Librarian. The contractor shall ensure the requirements of the GST are met as established by the CALDC. In this role, the Contractor will ensure that the process implemented to ensure efficient and successful governance of the Library is carried out. The GST and Librarian have been defined by the CALDC and are laid out in the CMS Assessment (Data Element) Library Governance Framework which is attached in Appendix A.

In summary, the activities and responsibilities associated with the GST include:

• Log, vet, and communicate all incoming CRs and issues from the CMS stakeholders for changes to the Library via the Library CR/Issue Tracker, workgroup (WG) communication mechanisms, and/or other sources of Library CR/issue input

• Communicate CR/issue status with the submitter of the Library CR/issue item as well as the appropriate WG (i.e., Library Management, Stewards, Standards, Communications) as the CR/item proceeds through the governance process

• Coordinate LMWG/CALDC meetings

• Support the CALDC WG (initially, the Library Management Workgroup (LMWG))

Leads in representing Library issues to the CALDC for deliberation on decisions and confirmation of other decisions.

• The CALDC may be unable to resolve issues as the Library governance board;

therefore, the GST will track unresolved issues that may be escalated to Center for Medicare (CM)/Center for Clinical Standards and Quality (CCSQ) data governance boards (e.g., the Quality Measurement Task Force) for review

• Identify and track timelines related to Library updates in relation to item set changes due to approved CRs

• Provide quarterly reviews to include assessment and recommendations related to:

o Oversight/Governance process improvement o Updates to the oversight workflow/change control o Identification of quality improvement to the oversight process o Other activities identified in the report update

4. A.2— General Maintenance and Support: Oversight and Governance Processes of the CMS Assessment Library Data Council (CALDC): Deliverables:

Deliverable #23: Process improvement reports Deliverable #24: 24.1- Receive and disseminate initiating Library CR/issue Notices Deliverable #24: 24.2- Review/respond/log Library CR/issue submissions Deliverable #24: 24.3- Review Library CR/issue and track course of action Deliverable #24: 24.4- Reply to submitters via email and log status in CR/Issue Tracker Deliverable #24: 24.5- Deliver CRs/issues and notify CALDC/workgroups Deliverable #24: 24.6- Develop CALDC/workgroup CR review materials Deliverable #24: 24.7- Track and maintain log of all Library CR/issues and outcomes Deliverable #24: 24.8- Convene Library Workgroups Deliverable #24: 24.9- Prepare and disseminate Library CR/issues outcomes Deliverable #24: 24.10- Deliver outcomes/decisions from LWG to CALDC Deliverable #24: 24.11- Provide Summaries of recommend Library updates and Distribute Deliverable #24: 24.12- Conduct meetings with Stewards and LMWG/representatives

4. B. — Maintenance: Relational Mappings and Standards:

Provide ongoing maintenance of standards so as to:

• Ensure the Library retains up-to-date inclusion of standardized data elements and their associated attributes such as electronic specification (eSpecifications), relational mappings and activities associated with supporting electronic data transmission and interoperability and monitor for gaps.

• Ensure that the CMS Assessment Data Element Library repository structure retains its function to house the CMS data elements and mapping relationships for use by implementers, measure developers, software vendors, providers and analysts.

• When updates to assessment instruments take place, update the Library with the new Standards and associated mappings

• On a regular basis through iterative reviews, examine the Library’s contents for refinements including additions to the Quality Data Model (QDM) as the use of standardized data elements/LTPAC data set(s) and the CMS Assessment Data Library evolve.

• Identify which assessment data elements have no applicable standards so as to identify where it must obtain Federally-adopted Standards Development Organization (SDO) standards.

• As part of maintenance and oversight ensure the continuation of:

o Relational mapping of the standardized assessment instrument data elements:

Maintain the identification of the data elements that are harmonized or match exactly, similar in meaning or different in meaning and not comparable.

o Gap Analysis and Mapping to Standards: Maintain and update mappings to C- CDA (Consolidated Clinical Document Architecture), the Quality Data Model (QDM), and an intermediate format specification for EHR extraction. Gaps will be noted where standards do not support HIT-related mapping. The intermediate format may be “green-Clinical Document Architecture green (CDA)” or a similar solution known as HL7 (FHIR®) Draft Standard for Trial Use (DSTU) R1.

o CDA templates: Maintain mappings of harmonized and similar data element mappings to model of meaning templates in C-CDA. Mapping to CDA templates will support interoperable information exchange between providers and will promote continuity of care.

o Data types in the QDM: Maintain harmonized and similar data element will be mapped to QDM, the foundation for e-Specification of quality measures.

o Simple business-name data elements: Where able, provide input on the implementation of the full C-CDA standard is complex because it is covers the full range of clinical use cases. Input should include strategies for extracting priority assessment elements using an intermediate format specification (green CDA or FHIR).

o E-Specification (see 3.B.1. Data Element HIT Specifications)

• Provide recommendations for developing additional C-CDA templates, new or updated

QDM data types, and updated intermediate specification (such as FHIR®) to support the specification of EHR-compatible prioritized data sets.

• As necessary, submit additional/modified templates through the standards process. The process includes identifying the HIT standard(s) requiring updating, submission of a project scope statement to the HL7 Structured Documents Work Group (SDWG), creating and updating templates and value sets, incorporating public feedback from stakeholders and subject matter experts such as the Standards and Interoperability (S&I) Framework and developing a draft updated Implementation Guide for C-CDA. For missing coded terminology, we will make requests to appropriate Standards Developing Organizations (SDOs) for updates or additions to existing terminology standards.

Deliverable #25: Update Library with new standards and mappings Deliverable #26: Perform iterative reviews of the Library’s contents Deliverable #27: Perform gap analysis with new data element inventory Deliverable #28: Implement mapping updates & include HIT Standards Deliverable #29: Submit additional/modified templates through the standards process

4. C. — Maintenance: Relational Mappings and Data Element HIT Specifications

Electronic specifications (e-Specifications) for the assessment instruments data elements provides for date elements in the Library to be mapped to terminologies that align with the Federal Advisory Committee Act (FACA) HIT Standards Committee (HITSC) Vocabulary Task Force recommendations for quality measures and standards suitable for inclusion in Meaningful Use (MU). These recommended terminologies include: RxNorm, International Classification of Diseases (ICD)-9, ICD-10, SNOMED-CT, and LOINC. For example, a medication data element will be e-specified to align with the RxNorm code system and value sets recommended in HL7 standard specifications.

The Contractor shall provide e-Specification updates and maintenance and provide data element specifications and mappings to close any e-Specification gaps. This work should align with the overall capacity of the Library, to support the following functional outputs

• Following the identification of gaps as provided under Tasks 4.B. the. Contractor shall work to apply Federally-recognized interoperability standards (e.g. LOINC, SNOMED- CT) to the existing Federally-mandated assessment instruments (LCDS, CARE,MDS, OASIS, IRF-PAI) and their respective content.

• The Library’s assessment data elements/response items shall be eSpecified so that the data can be captured, as discrete data in an Electronic Medical Record (EMR)/ EHR system. The eSpecifications shall map data elements to specific vocabulary code sets (e.g. ICD-9, ICD-10, SNOMED-CT, LOINC,) where appropriate. Mapping to EHR data, shall include mapping to discrete or structured data (for example, many vendors may capture some piece of data in free text, but that is not acceptable to CMS).

• The assessment data elements/response items shall be mapped to internationally recognized structures, such as those used for CDA, HL7 and others to advance the interoperability of the data between, clinicians, health care settings and between systems to improve the continuity of care for the patient.

• The Contractor shall implement “green”, or a simplified and easier to implement, uniform, eSpecified data element and clinical documents.

• Assessment data elements that are to be used with Quality Measures (QMs) shall be mapped to the QDM.

Deliverable #30: Resolve gaps in standards/specifications and apply federally-recognized interoperability standards Deliverable #31: Provide e-specifications and data elements mapping to specific vocabulary code sets where appropriate Deliverable #32: Data elements/response items shall be mapped to internationally recognized interoperability standards Deliverable #33: Include in the Library “green” e-specified/emerging interoperability standards, such as FHIR for data element and clinical documents Deliverable #34: Provide QMs e-specifications and mappings as requested by COR/program lead to QDM

4. D. — Summary Report:

The Summary Report of updates to the Library as outgrowth of any new/revised data collection instruments or data elements shall include, but is not limited to, the following:

• Quarterly summary capture of update activities related to the Library’s maintenance.

Deliverable #35:…