36C77620R0002-038.docx

Tele-ICU

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

DATE: 2/25/2020

Contents

PERFORMANCE WORK STATEMENT (PWS)

1.0 BACKGROUND

The National Tele-ICU Program has implemented a Tele-ICU to enable improved patient care through remote intensivist expertise and alerting algorithms based upon large population patient management experience. There are currently two (2) Clinical Observation and Operation centers (CORES), seven (7) Sub- Clinical Observation and Operation centers (Sub-Hubs), and forty-four (44) Medical Center consisting of a total of over five hundred (500) clinical beds. The program is continuing to expand and provide support and coverage to VHA facilities in need of their services. Currently, there are over one thousand six hundred (1600) Intensive Care beds in the VA, leaving over 1000 beds that do not have Tele-ICU coverage.

The Tele-ICU capability which is otherwise known as Tele-ICU by the Department of Veterans Affairs. Tele-ICU is a means of leveraging scarce clinical specialist resources: highly skilled and experienced senior ICU nurses and staff-level intensivists. The goal is to provide consistent care for all VHA ICU monitored patients regardless of location, time of day, hospital, unit size, structure or VISN location. Tele-ICU is a means of bringing the “center of excellence” to the patient. The benefits include improved patient care, reduced ICU and hospital mortality for critically ill patients, reduced complications and adverse events, improved benchmarking, improved supervision and teaching on off-hours, enhanced staff, patient and family satisfaction, and improved use of resources.

Tele-ICU combines high-speed, high-resolution video-conferencing with an array of centralized real-time electronic monitoring systems that supplement traditional bedside monitoring tools and help the Tele-ICU physicians identify clinical changes and provide proactive treatment plans. Using this technology, VHA uses clinicians to monitor more than four hundred ICU patients distributed across multiple remote ICUs. The Tele-ICU Cores for VHA are located in Cincinnati, Ohio and Minneapolis, MN and houses a team consisting of board- certified intensivists, advanced practice registered nurses, critical care registered nurses and administrative support staff. The Tele-ICU command centers for VHA are responsible for the oversight of expansion sites in multiple VISNs nation-wide. Each Tele-ICU clinician uses integrated workstations and monitors capable of accessing every patient in monitored ICUs by utilizing:

0. A display of real-time automated visual alerts identifying patients with critical abnormal physiological parameters.

0. Near Real-time bedside physiologic monitor and wave-form displays.

0. Real-time electronic clinical information systems and bedside flow sheet data linked to all electronic bedside medical equipment.

0. Full access to the electronic (patient) health record using VHA proprietary software VistA/CPRS (including note-writing and order-entry).

0. Two-way high-resolution audio-visual display connected to each patient’s room.

0. A specially configured ICU oriented data dashboard for rapid access to key patient data.

The government will furnish physiologic monitor displays and computer access to the EHR. The Tele-ICU solution provider shall provide integration as specified herein to these VA furnished systems.

1.1 DESCRIPTION OF SERVICES

The contractor shall provide all personnel, hardware, equipment, supplies, facilities, transportation, tools, materials, supervision, other items and non-personal services necessary to perform implementations, maintenance and support for the VHA Tele-ICU Program to include participating beds throughout the VA.

The contractor shall be the primary contact for the customer associated with this contract for all implementation, maintenance and support activities and concerns or reported issues that interface with the prime contractor’s intellectual property and/or sub-licenses the prime contractor has obtained which are associated with the prime contractor’s intellectual property, if required for intellectual property to perform. The contractor shall perform to the standards in this contract.

The vision for all future contract actions with the prime contractor is to ensure that all Tele-ICU capabilities are procured as an integrated “turn-key” system in which all the various pieces that comprise the Tele-ICU Program are purchased under this contract vehicle. The integration of all Tele-ICU capabilities under this unified contract vehicle shall include but is not limited to the pre-existing audio/visual capabilities currently provided.

2.0 APPLICABLE DOCUMENTS

In the performance of the tasks associated with this PWS, the Contractor shall comply with the following:

1 44 U.S.C. § 3541, “Federal Information Security Management Act (FISMA) of 2002” 2 Federal Information Processing Standards (FIPS) Publication 140-2, “Security Requirements For Cryptographic Modules” 3 FIPS Pub 201-2, “Personal Identity Verification of Federal Employees and Contractors,” August 2013 4 10 U.S.C. § 2224, "Defense Information Assurance Program" 5 Carnegie Mellon Software Engineering Institute, Capability Maturity Model® Integration for Development (CMMI-DEV), Version 1.3 November 2010; and Carnegie Mellon Software Engineering Institute, Capability Maturity Model® Integration for Acquisition (CMMI-ACQ), Version 1.3 November 2010 6 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974” 7 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964” 8 VA Directive 0710, “Personnel Security and Suitability Program,” June 4, 2010, http://www.va.gov/vapubs/ 9 VA Handbook 0710, Personnel Security and Suitability Security Program, May 2, 2016, http://www.va.gov/vapubs 10 VA Directive and Handbook 6102, “Internet/Intranet Services,” July 15, 2008 11 36 C.F.R. Part 1194 “Electronic and Information Technology Accessibility Standards,” July 1, 2003 12 Office of Management and Budget (OMB) Circular A-130, “Managing Federal Information as a Strategic Resource,” July 28, 2016 13 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)” 14 An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, October 2008 15 Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998 16 Homeland Security Presidential Directive (12) (HSPD-12), August 27, 2004 17 VA Directive 6500, “Managing Information Security Risk: VA Information Security Program,” September 20, 2012 18 VA Handbook 6500, “Risk Management Framework for VA Information Systems – Tier 3: VA Information Security Program,” March 10, 2015 19 VA Handbook 6500.1, “Electronic Media Sanitization,” November 03, 2008 20 VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal Information (SPI)”, October, 28, 2015 21 VA Handbook 6500.3, “Assessment, Authorization, And Continuous Monitoring Of VA Information Systems,” February 3, 2014 22 VA Handbook 6500.5, “Incorporating Security and Privacy in System Development Lifecycle”, March 22, 2010 23 VA Handbook 6500.6, “Contract Security,” March 12, 2010 24 VA Handbook 6500.8, “Information System Contingency Planning”, April 6, 2011 25 OI&T ProPath Process Methodology (reference process maps at http://www.va.gov/PROPATH/Maps.asp and templates at http://www.va.gov/PROPATH/Templates.asp 26 One-VA Technical Reference Model (TRM) (reference at http://www.va.gov/trm/TRMHomePage.asp) 27 National Institute Standards and Technology (NIST) Special Publications (SP) 28 VA Directive 6508, “Implementation of Privacy Threshold Analysis and Privacy Impact Assessment,” October 15, 2014 29 VA Handbook 6508.1, “Procedures for Privacy Threshold Analysis and Privacy Impact Assessment,” July 30, 2015 30 VA Directive 6300, Records and Information Management, February 26, 2009 31 VA Handbook, 6300.1, Records Management Procedures, March 24, 2010 32 OMB Memorandum, “Transition to IPv6”, September 28, 2010 33 VA Directive 0735, Homeland Security Presidential Directive 12 (HSPD-12) Program, October 26, 2015 34 VA Handbook 0735, Homeland Security Presidential Directive 12 (HSPD-12) Program, March 24, 2014 35 OMB Memorandum M-06-18, Acquisition of Products and Services for Implementation of HSPD-12, June 30, 2006 36 OMB Memorandum 05-24, Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors, August 5, 2005 37 OMB memorandum M-11-11, “Continued Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors, February 3, 2011 38 OMB Memorandum, Guidance for Homeland Security Presidential Directive (HSPD) 12 Implementation, May 23, 2008 39 Federal Identity, Credential, and Access Management (FICAM) Roadmap and Implementation Guidance, December 2, 2011 40 NIST SP 800-116, A Recommendation for the Use of Personal Identity Verification (PIV) Credentials in Physical Access Control Systems, November 20, 2008 41 OMB Memorandum M-07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information, May 22, 2007 42 NIST SP 800-63-2, Electronic Authentication Guideline, August 2013 43 NIST SP 800-157, Guidelines for Derived PIV Credentials, December 2014 44 NIST SP 800-164, Guidelines on Hardware-Rooted Security in Mobile Devices (Draft), October 2012 45 Draft National Institute of Standards and Technology Interagency Report (NISTIR) 7981 Mobile, PIV, and Authentication, March 2014 46 VA Memorandum, VAIQ #7100147, Continued Implementation of Homeland Security Presidential Directive 12 (HSPD-12), April 29, 2011 (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514) 47 VA Memorandum, VAIQ # 7011145, VA Identity Management Policy, June 28, 2010 (reference Enterprise Architecture Section, PIV/IAM (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514) 48 IAM Identity Management Business Requirements Guidance document, May 2013, (reference Enterprise Architecture Section, PIV/IAM (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514) 49 Trusted Internet Connections (TIC) Reference Architecture Document, Version 2.0, Federal Interagency Technical Reference Architectures, Department of Homeland Security, October 1, 2013, https://www.fedramp.gov/files/2015/04/TIC_Ref_Arch_v2-0_2013.pdf 50 OMB Memorandum M-08-05, “Implementation of Trusted Internet Connections (TIC), November 20, 2007 51 OMB Memorandum M-08-23, Securing the Federal Government’s Domain Name System Infrastructure, August 22, 2008 52 VA Memorandum, VAIQ #7497987, Compliance – Electronic Product Environmental Assessment Tool (EPEAT) – IT Electronic Equipment, August 11, 2014 (reference Document Libraries, EPEAT/Green Purchasing Section, https://www.voa.va.gov/documentlistpublic.aspx?NodeID=552) 53 Sections 524 and 525 of the Energy Independence and Security Act of 2007, (Public Law 110–140), December 19, 2007 54 Section 104 of the Energy Policy Act of 2005, (Public Law 109–58), August 8, 2005 55 Executive Order 13693, “Planning for Federal Sustainability in the Next Decade”, dated March 19, 2015 56 Executive Order 13221, “Energy-Efficient Standby Power Devices,” August 2, 2001 57 VA Directive 0058, “VA Green Purchasing Program”, July 19, 2013 58 VA Handbook 0058, “VA Green Purchasing Program”, July 19, 2013 59 Office of Information Security (OIS) VAIQ #7424808 Memorandum, “Remote Access”, January 15, 2014, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28 60 Clinger-Cohen Act of 1996, 40 U.S.C. §11101 and §11103 61 VA Memorandum, “Implementation of Federal Personal Identity Verification (PIV) Credentials for Federal and Contractor Access to VA IT Systems”, (VAIQ# 7614373) July 9, 2015, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28 62 VA Memorandum “Mandatory Use of PIV Multifactor Authentication to VA Information System” (VAIQ# 7613595), June 30, 2015, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28 63 VA Memorandum “Mandatory Use of PIV Multifactor Authentication for Users with Elevated Privileges” (VAIQ# 7613597), June 30, 2015; https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28 64 “Veteran Focused Integration Process (VIP) Guide 1.0”, December, 2015, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 65 “VIP Release Process Guide”, Version 1.4, May 2016, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4411 66 “POLARIS User Guide”, Version 1.2, February 2016, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4412

3.0 SCOPE OF WORK

The Veterans Health Administration (VHA), in coordination with the National Tele-Intensive Care (Tele-ICU) Program, desires to offer its healthcare system; including but not limited to, all medical centers (MC), community-based outpatient clinics (CBOCs), COREs, and Sub-hubs, a consolidated product procurement vehicle containing products at competitive prices. The purpose of this Request for Proposal (RFP) is to create an Indefinite Delivery, Indefinite Quantity (IDIQ) Contract which will allow all VHA and Tele-ICU Program affiliated facilities to purchase a full line of Tele-ICU products and services at a firm fixed price as determined in this agreement.

The contractor shall provide all personnel, hardware, equipment, supplies, facilities, transportation, tools, materials, labor, on-site training, maintenance, technical support, project management, supervision and other items and non-personal services necessary to perform the effort defined in this Performance Work Statement (PWS). The contractor shall perform to the standards in this contract. The contractor shall include all travel and expenses, software, software licenses, interface software, and associated components hardware and implementation and support services required for the installation, maintenance, and support of a Tele-ICU system.

The contractor shall ensure integration of all hardware and software as appropriate to deliver a Tele-ICU solution, and the specific requirements outline in Attachment B In addition, the contractor shall ensure that all installation and implementation services for hardware, software, and any necessary interface and license (for each bed and/or mobile cart) are provided as appropriate as specified in this contract to include interface engine coding (and new mapping interfaces), to deliver the complete Tele-ICU capability as defined in the PWS.

The contractor shall be the prime contact for the customer associated with this contract for all maintenance and support concerns or reported issues that interface with the prime contractor’s intellectual property, sub-contracted hardware, and/or sub-licenses the prime contractor has obtained which are associated with the prime contractor’s intellectual property, if required for intellectual property to perform.

The prime contractor shall install at a minimum, the three (3) distinct configurations of Tele- ICU participating beds as specified herein. The contractor shall ensure all required software and support services are provided for the software configurations and hardware installation, which include the following:

· Configuration 1 | Intensive Care Unit (ICU): Defined as a bed license and associated hardware assigned to a VHA ICU unit bed that will have full capabilities to integrate and interface with the prime contractor’s intellectual property and guarantees availability of reports.

· Configuration 2 | Acute Care: Defined as a bed license and associated hardware assigned to a VHA Acute Care unit bed that will have full capabilities to integrate and interface with the prime contractor’s intellectual property but will have limited availability of reports.

· Configuration 3 | Audio-Visual (A/V) only: Defined as a bed license and associated hardware assigned to a VHA Emergency Department or other unit bed that will have Tele-ICU software installed to a mobile cart or patient room that will allow audio-visual capabilities only. The A/V only license and hardware are used in consultative services and does not interface with the full capabilities of the prime contractor’s intellectual property, meaning functionality is limited.

The contractor shall provide Help Desk Telephone Support for all Tele-ICU software, proprietary interfaces, and/or uptime reliability as summarized in PWS. The following tasks shall be performed as needed.

a) Support Service and License Fees – Virtual ICU (or Tele-ICU) Software The contractor shall furnish software, interface software licenses, third-party software licenses and all required support service for the Virtual ICU/Tele-ICU software and required equipment/hardware for the base and all option periods as exercised to include but not limited to the following:

· Tele-ICU software suite and all required support services

· Severity Score and Mortality Prediction tool

· Medication Database software

· All required integration and interface software and support services

· All required analytic software and required support services

· All other required third-party software, hardware and all required support services in accordance with the terms and conditions specified herein to operate this turn-key program to enable seamless support for the VHA Tele-ICU program

· All other required third-party equipment/hardware and all required support services in accordance with the terms and conditions specified herein to operate this turn-key software to enable seamless support for the VHA Tele-ICU program

b) Installation –Tele-ICU Software and Hardware The contractor shall perform software and hardware installation, configuration, implementation, and testing of the Tele CU software at any VHA facility throughout the entire period of performance to include but not limited to the following:

· Tele-ICU software suite and all required support services

· Severity Score and Mortality Prediction tool

· Medication Database software

· All required integration and interface software and support services

· All necessary analytic software and required support services

· All other required third-party software, hardware, and all required support services in accordance with the terms and conditions specified herein to operate this turn-key software to enable seamless support for the VHA Tele-ICU program

c) Interfaces – Software and Hardware The contractor shall furnish the following interface licenses and necessary components for Tele-ICU interfaces and integration. The contractor shall provide any software and hardware that is required beyond VA furnished components to deliver a complete, turn-key Tele- ICU solution to include but not limited to the following:

· Medical Device Interfaces and/or integration for all monitored facilities via HL-7 messages

· Tele-ICU Vendor Analytic Database Integration Extraction interface

· Two-way audio-visual interface software and hardware that connects, via required and installed equipment/hardware at the patient site, to all monitored beds

· All other required third-party software interfaces and all required support services in accordance with the terms and conditions specified herein to operate the turn-key software to enable seamless support for the VHA Tele-ICU Program

d) Interfaces – Installation/Implementation The contractor shall complete the installation, configuration and implementation of all interfaces identified for the Tele-ICU to include but not limited to the following:

· ICU-CIS (Computer Information System) interface for all monitored facilities via HL-7 messages

· Medical Device Interfaces and/or integration for all monitored facilities via HL-7 messages

· Tele-ICU Vendor Analytic Database Integration Extraction interface

· All interfaces and features as described in Attachment B

· Two-way audio-visual interface software and hardware that connects, via required and installed equipment/hardware at the patient site, to all monitored beds

· All other required third-party software interfaces and all required support services in accordance with the terms and conditions specified herein to operate the turn-key software to enable seamless support for the VHA Tele-ICU program

e) Special Services

· The contractor shall provide copies of the Operator/User/Service Manual for the total number of quantities listed for each item at each location. Included in the contract price under the appropriate item.

· The contractor shall provide a manual/rubric, complete with pass/fail criteria and certification documents, to use during Acceptance Testing for both Staging and Production

· Warranty Service, maintenance, and Support

f) Special Services – Modifications, Maintenance, and Support Services The contractor shall provide annual maintenance and repair services as specified herein.

The Contractor shall provide a detailed implementation plan, i outlining the process for migrating the current system to the new platform. This plan shall outline the level of effort required by the vendor, VA clinical and technical staff, and all other resources required as part of the project. This plan shall include a rough order of magnitude (ROM) timeline to migrate the current national infrastructure which support the current participating facilities. It shall also include the ROM timeline for replacing the two Cores, 7 Sub- hubs, and 45 facilities covering north of five hundred ICU beds. It shall also include the ROM timeline for Clinical and Technical education.

Please Note the Following.

It is possible that changes in federal law, statute, regulation (to include VA-specific regulations), policy, guidance, standards of care, best practices, and/or technical requirements to enhance and/or ensure patient safety may result in the need for updates, modifications, changes, and/or replacement of any hardware and/or software solutions provided under this effort in order to comply with any/all such changes.

Should any such changes occur during the course of performance for this effort which may result in the need to modify the contract’s terms and conditions they will be addressed accordingly, to include (but not limited to) revising the PWS to accommodate any/all respective changes in required contract performance, potential submission and consideration of Requests for Equitable Adjustment if appropriate (note that submission of any REA’s shall not constitute and/or result in automatic acceptance and/or approval of same by the Government), as well as the receipt of proposals from performing contractors with respect to any changes to provided hardware, software, support services, warranty costs, etc. which may be considered, negotiated, and potentially added to the base contract PWS requirements via contract modification.

4.0 PERFORMANCE DETAILS

4.1 PERFORMANCE PERIOD

The IDIQ contract will have a ten (10) year ordering period and fifteen (15) year effective period. The Contractor must provide the products and services defined by this contract for the life of the resulting IDIQ.

The Contractor shall provide support 24 hours per day, 7 days per week, and 365 days per year. Normal hours of work are defined as Monday through Friday from 7:00 a.m. to 7:00 p.m. Eastern Standard Time, excluding Federal holidays or as otherwise arranged with the Contracting Officer’s Representative (COR).

There are ten (10) Federal holidays set by law (USC Title 5 Section 6103) that VA follows: Under current definitions, four are set by date:

New Year's Day January 1

Independence Day July 4

Veterans Day November 11

Christmas Day December 25

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six are set by a day of the week and month:

4.2 PLACE OF PERFORMANCE

Tasks under this Scope of Work shall be performed on-site any Department of Veteran’s Affair Medical Centers (VAMCs) and/or may be performed remotely at Contractor facilities. Work may be performed at remote locations other than Contractor’s facilities with prior approval of the Contracting Officer’s representative (COR). In the event that contractor’s services are required and the problem cannot be resolved over the phone or remotely, then an authorized representative of the company will commence work onsite within the designated time identified in Section 7.2.2 and will proceed progressively to rectify the problem without undue delay, and without any additional cost to the government, provided the contractor has first secured the prior written authorization and approval for such remedial work/performance from the COR.

4.3 TRAVEL

All Contractor transportation, lodging, and subsistence expenses incurred by the Contractor shall be incorporated into the Contractor’s fees and are the sole responsibility of the Contractor. Travel will be scheduled at the most cost-effective rate and fare, and by the most cost-effective mode of travel in accordance with the General Services Administration. Allow-Strategic Acquisition Center ability of travel costs will be determined in accordance with FAR 31.205-46 and the Contractor’s travel policy. All travel shall be approved in advance by the COR or designated project or facility representative. Travel will be identified at the task order level.

5.0 SPECIFIC TASKS AND DELIVERABLES

5.1 IMPLEMENTATION

5.1.1 KICKOFF MEETING

The Contractor shall attend any implementation, upgrades, maintenance, and technical support Kickoff Meeting where implementation, upgrades, maintenance, and support shall be discussed in detail. The meeting will be scheduled and coordinated by the vendor and COR or designated VHA point of contact (POC) within seven (7) days after each purchase order issuance. The Contractor shall coordinate participation from all contracted project resources and sub-contracted project resources.

5.1.2 SITE ASSESSMENT

The Contractor shall conduct an onsite assessment at the VHA Facility. This assessment will include evaluating each location that the audio/video (A/V) endpoints will be located in and assessing the compatibility level of all peripheral technology currently installed at the VHA facility that will be required to interface with the Tele-ICU system (i.e. CIS, Physiological Bedside Monitors, etc.). The site assessment shall also include existing A/V hardware that is installed and as to whether it shall be reused or removed by the contractor during the installation period.

5.1.2.1 SITE ASSESSMENT REPORT

The contractor shall provide a documented report to the Tele-ICU Program and the individual VHA facility outlining what room modifications are necessary to install the A/V endpoints in the desired location (i.e. the relocation of low voltage cable, the desired location of electrical outlets). The contractor shall provide a compatibility requirements document outlining the configurations or features for facility specific medical system necessary for full integration with the Tele-ICU program. (i.e. CIS, Physiological Bedside Monitors, etc.). The contract shall clearly define all modifications to current medical systems and technology which are required to meet this level of functionality.

The contractor shall conduct period calls with the necessary Tele-ICU team members and the VHA facility reviewing the Site Assessment Report. The contractor shall make any necessary changes to the Site Assessment Report and provide an updated document to the Tele-ICU team. This process should be followed until all parties have a mutually agreed upon report.

This document should be reviewed and signed off on by the respective VHA facility who is implementing the Tele-ICU system

5.1.2.2 SITE ASSESSMENT COST PROPOSAL

The contractor shall provide a cost proposal for the VHA facility implementing Tele-ICU, outlining the specific quantities and contracting line items (CLINs), that are going to be needed to successfully implement Tele-ICU.

5.1.3 PROJECT MANAGEMENT

The Tele-ICU contractor is responsible for providing project management services from the date of notice to proceed through the final acceptance of the Tele-ICU system. Project management services shall include but are not limited to:

· Create the project plan and regular updates to this plan.

· The project plan shall include the implementation approach, timeline and tools to be used for tracking project activities, risks, milestones, resources, and other project activities.

· Facilitate project meetings, record decisions made, actions assigned, and distribute meeting notes.

· Provide a primary point of contact (Contractor Project Manager) for all project related activity.

· Manage the overall progress of implementation at individual VHA facilities.

· Initiate corrective action as course corrections become necessary.

· Ensure that the correct contractor employees are assigned and available for all necessary activities.

· In collaboration with VHA project team, contractor must track the schedule of tasks that are kept on schedule and identify tasks (including those that are VA responsibilities) at risk of falling off schedule.

· Provide regular reports (service reports, project progress reports)

· Present escalating issues presented by VHA COR and government Contracting Officer (CO).

· Manage technical risks and recommendations on risk minimization.

5.1.3.1 PROJECT SCHEDULE

The contractor shall develop a project schedule based on mutually agreed upon milestones and deadlines. The project schedule shall include all milestones and dates of completion for tracking of project progress. This schedule shall be reviewed and agreed upon prior to any work or scheduled tasks taking place. It is the contractor’s responsibility to manage changes to the project schedule and provide updated project scheduled to the internal and external project resources. The project schedule shall identify the responsible resources for each project task.

Discovery of issues needing resolution and delaying the timeline due to unforeseen conditions must be documented in the project plan maintained by the contractor. The planned date for the activity or milestone and the actual date should be noted along with the reason for the delay in the master project plan. This timeline will be reviewed on a monthly-basis at a minimum, and opportunities for acceleration will be pursued when possible. The results of these reviews shall be documented and any necessary adjustments to the contract shall be completed.

5.1.3.2 IMPLEMENTATION RESOURCES

The contractor shall provide the VA with consistent resources throughout the scope of the project. These resources shall hold all appropriate training and certifications to ensure the quality of work provided. If project resources require change during an on-going implementation, the contractor shall notify the project team during the next project update call and provide all contact information for the new resource as required by the VA.

5.1.3.3 PROJECT UPDATE CALLS

The contractor shall schedule and coordinate project update calls at an interval agreed upon by the VA resources and contractor resources. The update calls shall be run by the contractor and all agendas and minutes are to be developed and shared with all project resources prior to the calls.

5.1.4 DELIVERY SCHEDULE

The contractor shall provide a turn key solution for the installation of a Tele-ICU program. All hardware, software, implementation services, and installation services shall be delivered at the earliest mutually agreed upon date as per the task order issued and follow the agreed upon project timeline.

5.1.5 IMPLEMENTATION SOFTWARE AND HARDWARE

The contractor shall furnish the software, hardware, interfaces and interface licenses for the systems listed below for all expansion participating beds required for this effort, which are critical to the operations of the Tele-ICU program. Upon completion of this installation each monitored facility shall have the same exact software components necessary for a total integrated system. The contractor shall provide any upgrades/version changes/updates to the interfaces and software for upon final acceptance of the above at each location and during the authorized option renewal periods for support service at no additional cost to the government which shall include the following:

a) Tele-ICU Software: The contractor shall install Tele-ICU licenses as appropriate to complete full functionality of all Tele-ICU software and systems in this PWS. All software components shall be installed in accordance with the purchase order and project plan.

b) Interfaces - ICU-CIS (Computer Information Systems): The contractor shall interface their software to the ICU-CIS systems as appropriate to provide full interoperability and complete functionality of all software and systems specified in the PWS. All customer identified data contained in the ICU-CIS system must be populated into the Tele-ICU application via HL-7 (Health Level 7) messages.

c) Interfaces - Medical Device Software: The Tele-ICU vendor side Medical Device Interfaces shall capture medical device data via HL-7 messages from devices listed upon go-live. Any necessary components or versioning on the medical device manufacturer’s side of the interface that the VA must furnish must be identified by the Tele-ICU contractor in its proposal.

d) Interfaces - Analytic Database Integration Extraction: The Analytic Database Integration Extraction Interface shall allow the separately procured Analytics system to receive all Tele-ICU data. The contractor is responsible for exporting all data from the Tele-ICU software to the Analytics System.

e) Audio-Visual Conferencing Equipment and\ Integration: The contractor shall furnish the hardware, interfaces, and interface licenses for the software required to interface the Tele-ICU software with furnished Audio/Video equipment.

The integration of the audio-visual conferencing equipment shall include the capability to communicate with each ICU room. Communication includes visual communication through cameras and audio communication via microphones and speakers. Functionality of the Tele-ICU application shall include the ability to control the remotely located cameras (pan, tilt, zoom) and control audio communication (open or closed). Communications with the Tele-ICU application can be quickly enabled from the bedroom via activation of an alert button. Audio-visual control and functionality within the Tele-ICU application shall be intuitive and user friendly. Users must be able to easily associate audio-visual communications with the patient currently being charted in the Tele-ICU application. This task shall include the complete installation, implementation, configuration and testing of the interface with the audio-visual conferencing equipment at each facility and at the Tele-ICU. For specific technical requirement and features, refer to Attachment B- Technical Requirements and Features.

All software furnished under this contract shall be site licenses and shall include all upgrades, version changes and/or updates to the software at no additional cost to the government during the warranty period and throughout the duration of this contract

5.1.6 IMPLEMENTATION SERVICES

The implementation services shall include but are not limited to, administering conference calls and meetings to provide direction and consultation to the VHA facility POCs aiding in the setup of the required interfaces. The services should also include full validation testing, verifying that the data that is being received is accurate and correct.

5.1.6.1 INSTALLATION SERVICES

The contractor shall provide a turn-key solution for the installation of the A/V endpoints at the VHA facility in the agreed upon location based on the Site Assessment Report. The services shall include but not limited to the pulling of low voltage and high voltage cable to the desired location outlined in the site assessment, installation of braces or supports to ensure proper mounting of equipment can be completed. The installation services shall also include the proper removal of existing A/V Tele-ICU hardware.

The installation services shall include full validation testing, verifying that the appropriate A/V sessions are connecting to the Tele-ICU program and that the quality of A/V is up to the quality that the Tele-ICU program requires. This validation testing shall include a signed documenting notating VAs approval.

5.1.6.2 INTERFACE SERVICES

The contractor shall provide a turn-key solution for the installation and implementation of the required Tele-ICU interfaces which shall include but not limited to the following HL7 interfaces: Laboratory, Flowsheet (CIS), Vitals (Physiologic Bedside Monitoring), Pharmacy, Admission Discharge Transfer (ADT). (See attachment B)

The contractor shall be able to provide an interface, that follows HL-7 standards, from the VHA facility CIS manufacturers which includes but not limited Philips Healthcare, PICIS, CliniComp, and Cerner. The contract shall also provide an interface to current and future electronic medical records, including CPRS/VISTA and Cerner.

PWS

5.1.7 TESTING

5.1.7.1 Testing and Certification

Upon completing installation of the system at each site for new installs and in the instance of an application upgrade, the contractor shall pre-test the Staging System as installed/upgraded and Production System as installed/upgraded. After pre-testing of the Staging and Production systems, the contractor shall notify the VHA COR via e-mail that the system is ready for acceptance testing. Submission of this notification of system readiness shall be accomplished by the contractor independently for the Staging and Production system as the vendor determines the system is ready for Government Acceptance Testing. Government Acceptance Testing can be initiated in stages as each system components are ready to test. This process is to avoid extended Staging test times and extended Production downtimes. Upon completion of the pre-test by the contractor, each component shall be fully functional, all interfaces are operational and the Tele-ICU is communicating with all identified facilities and bedsides within the VA.

The contractor shall confirm that the new Tele-ICU meets the Government’s performance requirements set forth in the PWS, including but not limited to remote viewing and the capture of all data elements from all resources.

Upon written notification from the contractor, the COR shall confer with the VHA Tele-ICU Technical Team, to include but not limited to, the Chief Health Informatics Officer, Biomedical Engineering and Clinical Application Specialist, to verify applicability and readiness for acceptance testing. Once confirmed, the COR will issue written instructions to the VHA POC to assign a technical team staff to begin acceptance testing. The COR will also notify in writing the contractor’s Program Manager of the decision. Once acceptance testing is completed by the VHA designated technical team representative, the COR will receive written correspondence of the findings, including all documentation copies, from the Tele-ICU technical POC or other designated technical team representative.

5.1.7.2 Acceptance Testing

The Staging System and Production System shall be tested independently, at the appropriate time, by a designated Tele-ICU technical team representative. Staging System acceptance testing may take a significant amount of time and resources depending on complexity of upgraded components. Time will vary with each install or upgrade instance. This time line will be agreed upon by Tele-ICU and the contractor’s Program Manager and each upgrade/install timeline will be identified in the specific project plan. The contractor will design and provide specific scenarios for testing to ensure thorough Staging System acceptance testing and to ensure each scenario is labeled as pass or fail. After staging acceptance testing is completed, the Tele-ICU technical team representative will notify the contractor and the Tele-ICU COR of testing results. Any staging scenario identified as failed will be evaluated and resolved by contractor support at no additional cost to the Government. The specific failed scenario will be re-tested after first being addressed and re-certified by the contractor’s designated representative (or representatives). The contractor shall identify Testing Scenarios to ensure all components of the upgraded system are evaluated during Government Acceptance Testing. The Production system shall be upgraded during a designated day and time as agreed to between the VHA COR and the contractor’s designated Program Manager. The contractor shall designate a representative to be on-site in the Tele-ICU command center for the Production System upgrade. During a production system upgrade, the production system will be taken offline for an estimated amount of time as communicated by the contractor’s Program Manager and/or other Contractor designated representative based on experience with installing the upgrade and understanding of the Tele-ICU production environment. During the downtime for the Production System Upgrade, the contractor shall certify each component of the system as ready for Production. In the Production environment, Government acceptance testing is a process of validation of system components through the production clinical workflow. The Production System will be wholly certified as upgraded at the completion of the Production upgrade by the designated contractor representative. The contractor representative shall address any issues that arise during the upgrade to the Production System environment. The VHA COR will be notified in writing of successful completion of the system upgrade, by the Tele-ICU POC or other designated technical team representative, after the designated clinical team representative(s) has successfully interfaced into the application. After the Production System is fully upgraded and clinical functions resume, the Contractor Technical Support shall be in place for any issue that arises after the system has gone live to ensure full functionality of the Tele-ICU software and associated components. Any identified system issues will be reported to the contractor’s designated technical support team and a ticket number assigned. The contractor will communicate an expected time for resolution and will work with Tele-ICU identified Tele-ICU Technical Team resources as need to resolve issues in the Staging and/or Production environment. The contractor will communicate via email when issues are resolved and tickets are closed.

5.1.7.3 Testing coordination

All testing to the Tele-ICU software delivered shall be coordinated with the testing for the interface software and hardware delivered.

5.1.8 PROJECT CLOSURE

The contractor shall ensure a project closure call is held at the completion of each independent project. This closeout call shall review the project activities, review support model and documentation, and confirm all project activities are complete and closed out. The contractor shall ensure that the VA staff is provide all required documentation to move into the sustainment phase of the medical system and device lifecycle.

5.2 SUSTAINMENT

5.2.1 SUSTAINMENT OF SOFTWARE/LICENSES/INTERFACES/HARDWARE

The contractor shall provide a turn-key solution for the sustainment of all interfaces, software, and A/V hardware associated with the Tele-ICU program including but not limited to Severity Score and Mortality Prediction Tool, Medication Database software, Analytics Tool, Command Center, and the specific type of tele-ICU license.

The contractor shall provide all maintenance and support services to ensure that the system is functioning as intended and must include all latest version changes. All new software versions shall be covered in the maintenance services including all subsequent versions designed to replace the version installed under this contract. Maintenance and support systems shall be provided during the entire warranty period for each location as well as during the authorized Option Renewal periods.

The contractor shall distribute maintenance updates or releases by using an appropriate electronic, or printed media to the COR. Notification of the above shall also be provided to the government Contracting Officer (CO). The contractor may also offer access to maintenance copies through its website, provided notice of maintenance updates and/or releases is first provided to either the CO and/or the COR.

All maintenance services shall be provided by the contractor in a timely manner in accordance with the requirements in the Response times section outlined in section 5.2.4.4. Any prolonged delay in resolving software problems or other major contract performance issues may be documented in the Contractor Performance Assessment System (CPARS).

CONTRACTOR PERFORMANCE ASSESSMENT RATING SYSTEM (CPARS): Required Registration with Contractor Performance Assessment Rating System (CPARS).

· As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed the dollar threshold specified in the FAR and may share those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database. The CPARS database information is shared with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal Agencies.

· Each contractor whose contract award is estimated to exceed the dollar threshold specified in the FAR shall be required to register with the Contractor Performance Assessment Rating System (CPARS) database at the following https://www.cpars.gov/ or by calling (207) 438-1690. Registration should occur no later than thirty days after contract award, and must be kept current should there be any change to the contractor’s registered representative.

· For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract when the final report will be completed. The report shall be assigned in CPARS to the contractor’s designated representative for comment. The contractor representative will have thirty days to submit any comments and re-assign the report to the VA contracting officer

· Failure to have a current registration in the CPARS database, or to re-assign the report to the VA contracting officer within those thirty days, will result in the Government’s evaluation being placed on file in the database with a statement that the contractor failed to respond

5.2.1.1 LICENSE RENEWALS

The contractor shall provide notification of due dates and expected costs for all interface, software, and licensure associated with the Tele-ICU program one hundred eighty (180) days prior to expiration of existing period of performance. The contractor shall only bill for active licenses which are in use.

5.2.1.2WARRANTY EXPIRATION

The software, interfaces, A/V hardware and accessories shall be covered under the manufacturer’s warranty and shall include all parts and labor for a minimum of one year following go-live by the VAMC. This warranty must include all Preventative Maintenance and services as required by the manufacturer.