Attachment_2_-Task_Order_2_-_Modeling_Voting_and_Medical_Devices_SOW.doc

Performance Work Statement Task Order 2

Title: Modeling Voting and Medical Device Standards LAB REQUESTING SERVICE: Information Technology Laboratory, Systems and Software Division

BACKGROUND

The mission of the National Institute of Standards and Technology (NIST), Software and Systems Division (SSD) is to develop software testing tools and methods that improve quality, conformance to standards and correctness. The Division also participates with industry in the development of forward-looking standards relative to the elections and healthcare industries. The Division's programs also respond to industry, consortia, and standards groups needs by concentrating on key areas at the forefront of technology and assisting in the transfer of technology and expertise to industry.

The demand for correct, reliable, robust and interoperable software and transparent data is crucial to our nation’s cyberinfrastructures – particularly in the areas of US Elections and Health Care. In particular, standards that promote interoperable software enable greater security and transparency, as well as foster greater choice in the marketplace for election and medical device equipment.

This task order seeks to contribute to the elections and healthcare industries by promoting the use of transparent and common data standards within the respective domains. In each industry, these standards promote interoperability of domain specific data through common models and exchange formats, which enable interoperability between devices from different manufacturers. The models also enable conformance test generation, significantly reducing the cost of testing and promoting interoperability among manufacturer implementations. There is a strong need for this interoperability, given that both US election officials and healthcare professionals are often locked into proprietary approaches that make necessary change more expensive and difficult.

The NIST SSD requires project leadership and technical staff support from the Contractor in the areas of standards and technology development and adoption, measurement, and development of software testing tools to improve the quality and correctness of software used in the elections and healthcare industries. The task order focuses on two similar efforts: (1) NIST’s efforts to build a common data format for election systems. NIST’s work with election systems standards is specified in the HAVA and is a collaborative effort with election system manufacturers, election officials, and election researchers/observers; and (2) NIST’s efforts to build a Health IT Standards Testing Infrastructure (TI). The Health IT Standards Testing Infrastructure is a collaborative effort to help ensure interoperability among all healthcare providers, hospitals, clinical laboratories, pharmacies, payers, and others.

OBJECTIVES/PURPOSE

The purpose of this task order is to develop software to promote the adoption of appropriate standards and achieve interoperability of both elections systems and medical device systems. In elections systems, NIST SSD and the IEEE VSSC/1622 are working together to create election data models and associated XML data formats as the basis for IEEE standards for common data formats for election systems. NIST plans to facilitate adoption of the standards and guidelines by developing reference test implementations and translations between manufacturer formats. In medical devices, NIST will also develop models and software to promote the adoption of IEEE 11073 Health informatics -- Personal health device communication standards and achieve interoperability of medical devices, e.g., medical device interoperability with healthcare information systems (EHRs) using ANSI-accredited Health Level Seven (HL7) messaging standards and medical device-to-device interoperability using the IEEE 11073 standard. NIST SSD and HL7 are working to ensure that HL7 conformance can be defined and measured at appropriate levels, by building tools that will promote consistent definitions and reuse of conformant models and artifacts (e.g., profiles, templates, message types, codes, examples) within HL7 implementations.

GENERAL REQUIREMENTS:

The Contractor shall support NIST SSD in the collaboration with the election industry and IEEE VSSC/1622 to analyze election data requirements and build tools to advance the adoption of VSSC/1622 standards. Specifically:

· Building data models of election data as used in current election equipment and in election processes in US states that can serve as an overall model for use in developing use cases;

· Generating data formats in XML and JSON based on the data models and use cases;

· Providing technical leadership for transforming current voting equipment proprietary formats and other formats such as Pew’s VIP or OASIS EML into these formats.

The Contractor shall also support NIST SSD in the collaboration with industry, healthcare informatics-related standards organizations, consortia, and government agencies to build tools and prototypes to advance the adoption of standard medical device protocols. By collaborating with Health Level Seven (HL7) and IEEE 11073 members we help ensure that HL7 messaging and medical device conformance can be defined and measured at an appropriate level. The model to be developed will help support web-based tool set that integrates testing tools/activities of various SDOs, consortia and other organizations for medical devices

SPECIFIC REQUIREMENTS:

Task 1: Modeling: IEEE VSSC/1622

1. Apply modeling and development expertise to build a comprehensive model of election data as used in US elections

a. Using existing IEEE/VSSC and other models created for common election systems, using the VVSGs developed for the EAC, and working with subject matter experts in IEEE VSSC/1622, develop an initial UML model according to major election subsystems, including the 1622.2 election management system model and the developing 1622.7 electronic pollbook model.

b. Based on feedback from the model, partition the election subsystems and create use cases to support major data flows centered on major election subsystems.

c. Based on feedback from use cases, election subsystem partitioning, and IEEE VSSC/1622 review, fully document the model and continue development of a formatted, printable glossary of classes, attributes, and relationships used in the model such that it can also be viewed via a Web interface by state election officials and election system developers and the public.

d. Enable translation of various formats/representations directly from UML model (e.g., XML schema, JSON, JAVA bindings, etc.); package and make such formatted information available to public via Web interface download.

e. Examine the developing Pew VIP formats and provide options for inclusion in the optimized model or translation to/from optimized model.

f. Examine vendor import/export formats and provide options for translations to/from optimized model.

The models of common election subsystems, EAC VVSGs, the Pew VIP XML formats, and vendor import/export formats will be provided to the Contractor.

Deliverables:

The Contractor shall deliver the following:

· UML Model of common election subsystems (MagicDraw)

· Ad-hoc recommendation for election subsystems partitions, use cases (MS Word, MS Powerpoint, PDF)

· Optimized UML Model (MagicDraw)

· Associated glossary of class/attributes in model (MS Word, PDF, HTML)

· Various encoded (formatted) files (downloadable from Tool Web Site) Task is due 30 September 2016.

Task 2: Standards Development – P1622

1. Develop and deliver (tied to UML model tasks above) capability to automatically generate input to the paper-based standard (IEEE VSSC/1622) meeting rigid IEEE publication requirements.

a. Develop methodologies to produce 100% or as close to 100% as feasible given IEEE formatting requirements

2. Participate in IEEE VSSC/1622Working Group (TCons and F2F/live; may involve travel) – as approved by project COR to obtain understanding, domain expertise and obtain modeling requirements and needed by-products as identified by manufacturers, election officials, and other election experts.

3. Present UML model and associated use cases to the IEEE VSSC/1622working groups and gather feedback.

4. Develop and deliver professional findings, recommendations, and status in various formats (e.g., MS Powerpoint, UML, MS Word, etc).

a. Contribute toward Common Data Format research/findings papers and proposals to advance Voting modeling and testing work.

b. Propose and make recommendations to project advancements (ad-hoc as knowledge base grows) to project lead (and team members as appropriate)

Deliverables:

The Contractor shall deliver the following:

· IEEE approved/formatted Standard(s)

· Powerpoint/Slide sets (as needed).

· Ad-hoc Recommendation Documentation (MS Word)

· Ad-hoc Documentation (MS/OpenOffice Word) as needed

Task is due 30 September 2016.

Task 3: Modeling: ISO/IEEE 11073

1. Apply modeling and development expertise to -10201 (Domain Information Model)

a. Complete (first comprehensive, Industry and SDO vetted, electronic version), maintain and expand based on iterative testing and Industry adoption of 11073-10201 DIM UML Model

b. Provide modeling "hooks" and/or integration into other related medical device standards where appropriate (e.g, ASTM, AAMI/UML, HL7, IEEE)

c. Develop and maintain model to meet objectives defined in "DIM goal model"

d. Maintain and keep up to date "golden repository" used as core of automatic generation of MDC artifacts

e. Enable translation of various formats/representations directly from UML modes (e.g., XML, JSON, ASN.1, etc); make such formatted information available to public via Web interface download (with option by user of download format file-type)

2. Provide modeling expertise/advice/recommendations to MDC (and related NIST/ITL/SSD conformance/validation/interoperability work) as appropriate

a. Model exemplar device modalities in support of project goals (e.g., Patient Controlled Analgesia Pump) that comes as a pre-built profile with "Device Editor" web-based modeling and profile builder toolkit

Deliverables:

The Contractor shall deliver the following:

· Maintained UML DIM Model (Major.Minor version number); to include supporting models (MetaInformation, Nomenclature, DeviceProfile, etc,)

· DIM Editor and Profile Builder Tool enabling users to build standard-compliant profiles and detailing the results of the use case scenario implementation(s) (did it work?)

· Validatable XML Schemas (used as a basis for DIM Editor and Profile builder Tool)

· Various encoded (formatted) files (downloadable from Tool Web Site)

· API for interacting with DIM objects

· User Interface to enable viewing of metadata regarding DIM classes and attributes Task is due 30 September 2016.

Task 4: Software Development - Web application development DIM Editor, 11073-10201, and any new interface(s)

1. Develop Web -based tool that shall be available 24 x 7 x 365 days that at a minimum provides interfaces for:

a. Dim Editor: User workspace within web-based tool the enables standard-compliant user creation, edit, reload of a device profile/specializations - which is x73 compliant

b. "x73" Interface (tab within tool) that provides strict representation of DIM and standard output format (e.g., XML)

c. UML model (with ability to download in multiple formats [e.g., to enable consistent sharing and communication of DIM model]

d. Conformance statements (as defined in -10201 Conformance Section)

e. Hook/query into -10101 (Nomenclature/RTMMS) to enable presentation of constrained 'value set' of terminology and co-constraints for level of tree being defined

f. Linkage to Rosetta Terminology Mapping Management System web service to obtain 11073-10101 (Nomenclature) information made available within the DIM Editor software tool

2. Contribute software application and tool expertise to NIST/ITL /SSD team

a. Recommend, demonstrate, and provide tutorials on particular software applications, languages, and tools that apply directly/in-directly to project goals

b. Present and discuss progress and plans to joint HL7 Healthcare Device and IEEE 11073 Point of Care Working Groups at each (of the three) tri-annual meetings.

c. Develop prototype version of a ‘Model Manager’ building on (and eventually supplanting) web application that shall feed back into UML editing tool and have an XMI and/or MagicDraw API (application programming interface) Deliverables:

The Contractor shall deliver the following:

· Web Based (HTML), Access controlled Software tool (Java)

· Summary XML (Rosetta Containment Hierarchy) representation of a device profile

· Detailed report of containment and terminology

· Comprehensive representation of Device Profile

· Enumerations (backed by model in Task 3)

· Version 1 of ‘Model Manager’

· Conformance statements in machine readable and human-readable formats to include XML, JSON, and PDFs at a minimum

· Ad-hoc Recommendation Documentation (MS/OpenOffice Word) and tool help documentation (available in software tool)

· Presentations providing progress, plans, and issues a minimum of three times per year Task is due 30 September 2016.

Task 5: Standards Development

1. Develop and deliver (tied to UML model tasks above) capability to automatically generate paper-based standard (11073-10201) meeting rigid IEEE publication requirements

a. Develop methodologies to produce 100% or as close to 100% as feasible given IEEE formatting requirements

b. Work with Project lead to vet the resultant file through the corresponding SDO (i.e., IEEE)

2. Participate in SDO and Device Domain Working Groups (TeleConferences and F2F/live; likely to involve travel to joint HL7 and IEEE working group meetings tri-annually) - as approved by project COR to obtain understanding, MD domain expertise and obtain modeling requirements and needed by-products as identified by vendor/manufacturers, clinical users, and SDOs (including at a minimum x73, HL7 Healthcare Devices)

3. Evaluate, determine feasibility, and depending of findings generate partial HL7 message segments that also meet and communicate x73 semantics

a. Develop partial HL7 messages and x73 PDUs for use with other MDC validation and conformance tools (e.g., IHE-PCD V2 Pre-connectathon and connectathon)

4. Work with and provide expertise ITL/SSD/MDC SIMD project team and other related-NIST endeavor

a. Body Area Networks

b. Personal Area Networks

c. ASTM-ICE work

d. Medical Device Security

5. Develop and deliver professional findings, recommendations, and status in various formats (e.g., MS Power Point, UML, etc).

a. Contribute toward SIMD research/findings papers and proposals to advance MDC semantic Interoperability test work

b. Propose and make recommendations and presentations to project advancements (ad-hoc as knowledge base grows) to project lead (and team members as appropriate)

c. Recommend approach and plan for extension of DIM Editor to Personal Health Devices (PHD) Deliverables:

The Contractor shall deliver the following:

· IEEE approved/formatted Standard(s) (to include print format)

· PowerPoint/Slide sets (as needed, with a minimum of three times per year in conjunction with joint HL7/IEEE working group meetings).

· Application Protocol Data Units (APDUs) - BER/MDER encoded HL7 encoded OBX segments (meeting IHE-PCD TF Vols. 2 and 3 requirements

· Ad-hoc Recommendation Documentation (MS Word)

· DIM Editor documentation displayable from profile builder software tool

· Ad-hoc Documentation (MS/Open Office Word) as needed

Task is due 30 September 2016.

QUALIFICATIONS OF CONTRACTOR STAFF

It is expected that this task order will require the work of two (2) Contractor employees. All Contractor personnel working under this task order shall be designated as Key Personnel. The combination of Contractor Key Personnel working under this task order must meet the following minimum qualifications:

The staff proposed for this task must have formal training in the following areas or demonstrated experience in the areas. Contractor will submit resumes of proposed staff.

· Experience with the IEEE 11073 Health informatics -- Personal health device communication standard – 2Years

· Experience with the IEEE VSSC/1622 Common Data Format – 2 years

· Pew Voting Information Project (VIP) standard – 1 year

· Voluntary Voting System Guidelines version 1.0, 1.1, and 2.0, requirements for election systems – 2 years

· NIST UML IEEE 11073 Model – 2 years

· UML Modeling – 10 Years

· XML Schemas – 10 Years

· HL7 Patient Care Device Standards – 2 Years

· Java Programming - 10 Years

· JSON Programming – 10 Years

· MagicDraw Case Tool - 10 Years

· NIST UML IEEE 11073 Model – 2 Years

PERIOD OF PERFORMANCE

The period of performance shall be 1 October 2015 to 30 September 2016.

PLACE OF PERFORMANCE

The Contractor’s staff must work primarily on-site at NIST Gaithersburg but may also work by arrangement at the contractor’s primary business location.

GOVERNMENT FURNISHED PROPERTY

The Government will provide the following Government Furnished Property (GFP) for the Contractor’s use throughout the period of performance of this task order:

1. Office space to include desk and chair;

2. All computing hardware, software and networking resources;

3. Access to NIST campus during working hours; non-working hour access may be granted on a need basis. Working hours are Monday through Friday between 7:00 AM and 5:00 PM.

DELIVERABLES

Number/

Reference

Optimized UML models Glossary of classes, attributes used in models Various encoded (formatted) files (downloadable from Tool Web Site) MS Word, MS Powerpoint, or PDF

MagicDraw File

MS Word, PDF, HTML

XML, JSON, Java, MS Word, PDF, HTML

1 February 2016 30 September 2016

Powerpoint/Slide sets (as needed) Project Presentation MS Word, PDF PowerPoint

Power Point

30 September 2016 30 September 2016 Monthly

Various encoded (formatted) files (downloadable from Tool Web Site) XML Schemas

API for interacting with DIM objects

User Interface to view metadata regarding DIM classes and attributes

MagicDraw File, UML, XMI

XML

XML (validated)

Java (or as recommended by contractor)

Java, HTML

1..n

1..n

Version releases at a minimum of 2 times per year (i.e., approximately each 6 months after start) with the final version 30 September 2016 30 September 2016 Version releases at a minimum of 3 times per year (four, eight, and twelve months) with final versions 30 September 2016

30 September 2016 with pre-version(s) at a minimum of 8 months after start

Formatted (XML) Device Specializations (downloadable from Tool Web Site) Electronic Model of DIM (Industry/SDO vetted)

Project Presentations

DIM Editor web-based software tool with ‘Model Manager’ software embedded

Conformance Statements

MS Word Document

XML

UML, XMI

Power Point

HTML, Java (primarily)

PDF and machine code/software

1 February 2016 30 September 2016 Minimum of two versions release (each 6 months after start) w/ final version 30 September 2016 Tri-annually in conjunction and prior to joint HL7 and IEEE Working Group Meetings

Version releases at a minimum of 3 times per year (i.e., approximately every 4 months) with the final version 30 September 2016 1 September 2016

Recommendation Document(s)

PowerPoint/Slide sets (as needed) Project Presentation

PHD Recommendation Document(s)

Encoded OBX segments

PDF

PowerPoint and MS Word

PowerPoint

Power Point

MS Word

BER/MDER and HL7 (OBX segments) 1..3

1 (with maximum of 4)

Many Review version no later than 9 months after start; Final version 30 September 2016 1 February 2016 Minimum 1, 9 months after start, or as requested in conjunction and prior to tri-annual joint HL7/IEEE Working Group Meetings

Minimum 30 September 2016 (or as requested by SDO [IEEE] not to exceed versions produced every 3 months in conjunction with IEEE/HL7 working group meetings (4 per year)

1 September 2016 Various as functionality developed – with minimum first APDUs encoded by 8 months after start of contract

ATTACHMENTS

There are not any attachments associated with this task order.

INSPECTION/ACCEPTANCE OF DELIVERABLES

As tasks and deliverables are completed, the Contractor shall submit the deliverables for review by the COR. The COR will provide comments on any given deliverable within five business days after the receipt of deliverables. The Contractor shall revise and resubmit the deliverable(s) in accordance with the COR’s comments and resubmit for COR review and further comment/approval. All revisions shall be made at no additional cost to the Government.

TRAVEL

Medical Device:

· 3 Conus trips required to attend Face-to-Face Working Group meetings Voting:

· One trip to Mountain View California for the next 1622 meeting (tentatively hosted by Google), length of stay would be 3 nights.

· One trip to Columbus Ohio for working on the electronic pollbook standard, length of stay would be 2 nights.

· One trip to Washington DC (NIST), length of stay would be 2 nights.

INVOICES

The Contracting Officer will negotiate a deliverable based payment schedule with the successful offeror prior to award of the task order.

QUALITY ASSURANCE SURVEILLANCE PLAN

The purpose of this plan is to provide a quality assurance surveillance plan for the work to be conducted under this task order. The plan provides a basis for the NIST COR to evaluate the quality of the Contractor's performance. The oversight outlined in this plan will help to ensure that the topics and assessment are maintained at the required levels through the Period of Performance. Further, this plan provides the NIST COR with a proactive way to avoid unacceptable or deficient performance.

Performance Standards:

1. Quality Level: By monitoring the Contractor, the NIST COR will determine whether the Performance Standards set forth in the task order have been attained. Performance Standards for all tasks are specified in the Performance Requirements Summary of the Performance Work Statement.

2. Frequency: During the performance of this task order, the NIST COR takes periodic measurements (i.e., conduct surveillance), as specified, and will analyze whether the frequency of measurement is appropriate for the work being performed. Adjustments may only be made by a modification to the task order.

3. Management Responsiveness: The NIST COR will determine whether the Contractor has managed the Contract effectively and efficiently with successful completion of the topics and assessment as specified in the Performance Standards set forth in the Performance Requirements Summary.

PERFORMANCE REQUIREMENTS SUMMARY

Task 1: Modeling IEEE VSSC/1622 Desired Output: UML Models meeting the specifications of the IEEE P1622. Able to generate XML Schemas and APIs into the model. Web-based views of varying views of the model and associated glossary. Input provided to TIC through meetings, email and other discussion opportunities. Meetings attended as required. Phone and email discussions held as needed.

Monitoring Method: Reviewed by COR/TIC.

Performance Standard: Valid UML model can generate XML schemas, JSON, and SPIs. The Contractor responds promptly to phone calls and emails and is in attendance at meetings. Any written communication is in grammatically correct English and delivered on time in correct format.

Task 2: Standards Development – IEEE VSSC/1622 Desired Output: Paper-based representations of the Model as readable VSSC/1622 guidelines and standards.

Monitoring Method: Reviewed by COR/TIC.

Performance Standard: The software management is functionally correct, well-documented and easy to use. The software management system is in-line with industry-acceptable practices and techniques. Source code and software release will be made publicly available. The paper-based standard is easy to read, grammatically correct.

Task 3: Modeling: ISO/IEEE 11073

Desired Output: UML Model meeting the specifications of the IEEE 11073. Able to generate XML Schemas and APIs into the model. Input provided to TIC through meetings, email and other discussion opportunities. Meetings attended as required. Phone and email discussions held as needed.

Monitoring Method: Reviewed by COR/TIC.

Performance Standard: Valid UML model can generate XML schemas and SPIs. The Contractor responds promptly to phone calls and emails and is in attendance at meetings. Any written communication is in grammatically correct English and delivered on time in correct format.

Task 4: Software Development - Web application development DIM Editor, MyDevice, x73, and any new interface(s)

Desired Output: Software management is provided to all developers and projects. The software tools provide the capability in accordance with the IEEE11073 Standard.

Monitoring Method: Reviewed by COR/TIC.

Performance Standard: The software management is functionally correct, well-documented and easy to use. The software management system is in-line with industry-acceptable practices and techniques. Source code and software release will be made publicly available.

Task 5: Standards Development

Desired Output: Paper-based representations of the Model as a readable 11073 standard.

Monitoring Method: Reviewed by COR/TIC.

Performance Standard: The software management is functionally correct, well-documented and easy to use. The software management system is in-line with industry-acceptable practices and techniques. Source code and software release will be made publicly available. The paper-based standard is easy to read, grammatically correct.