36C10G19R0013-001.docx

VA NEW ENGLAND HEALTHCARE SYSTEM

STATEMENT OF WORK

Temperature Monitoring System

November 2018 I.

OBJECTIVE

This document highlights the requirements, technical specifications, and services being requested by the Department of Veterans Affairs (VA) medical centers listed below for consideration towards purchase of a Temperature Monitoring solution. This temperature monitoring system will replace, supplement or create new areas for temperature monitoring at the medical centers listed below. Offerors under this proposal shall provide all labor, material, parts, tools, software, project management and equipment necessary to furnish and install a fully functional Temperature Monitoring Solution in each of the following medical centers.

· VA Maine Healthcare System (1 VA Center Augusta, ME 04330)

· White River Junction VA Medical Center (215 North Main Street White River Junction, VT 05009)

· Bedford VA Medical Center (200 Springs Road Bedford, MA 01730)

· VA Boston Healthcare System

· Jamaica Plain Campus (150 South Huntington Ave Jamaica Plain, MA 01230)

· West Roxbury Campus (1400 VFW Parkway West Roxbury, MA 02132)

· Brockton Campus (940 Belmont Street Brockton, MA 02301)

· Manchester VA Medical Center (718 Smyth Road Manchester, NH 03104)

· Providence VA Medical Center (830 Chalkstone Ave Providence, RI 02908)

· VA Connecticut Healthcare System

· West Haven Campus (950 Campbell Ave West Haven, CT 06516)

· Newington Campus (555 Willard Ave Newington, CT 06111)

· OPTIONAL: VA Central Western Massachusetts (421 North Main Street Leeds, MA 01053)

II. REQUIREMENTS

The Contractor shall provide a Temperature/Environmental Monitoring solution to VISN 1 in the form of software, hardware, and project management services that can satisfy the functional requirements.

Technical requirements

· Temperature & Humidity Tags

· Contractor should be able to provide Temperature and/or Humidity Tags that allow for 24/7 monitoring for the following use cases:

· Laboratory Refrigerators, Freezers, Water Baths and Incubators

· Pharmacy Medication Storage (Refrigerators & Freezers)

· Ward Equipment (Nursing) Refrigerators & Freezers (Medication Storage, Patient Nutrition), Incubators, Blanket Warmers

· Room Level Monitoring – Temperature & Humidity (Sterile Storage, Operating Room Environment & IT Closets)

· Nutrition & Food Service – Food Transport Carts, Refrigerators, Freezers

· Contractor should be able to quote based off the tag amounts listed in Attachment A - Schedule of Supplies or Services. Of note, these are estimated amounts and may need to be edited after completion of the Hardware Deployment Design Document for each facility.

· Central Western MA is an optional facility as site currently has a temperature and humidity solution installed. A site visit should be conducted at this facility to determine if any additional hardware/tags are required.

· The Contractor shall install supporting hardware and components to blend in (or not be visible at all), at the facility.

· The system should be able to create reports for the end user to verify temperatures and humidity levels for individual tags or systems.

· The system should be able to communicate with the end user if the device being monitored goes out of range. This communicate should have the capability to be done via text, pager, phone or email.

· If a device goes out of range, the system should be able to record what mitigation procedures were followed to correct. These mitigation processes should be able to be seen on the reports.

· The installation plan shall support the addition of future applications and the expansion to additional areas (e.g., zones, floors, new buildings, etc.)

· The Contractor shall install components to have minimal impact on the business operations of the facility and meet applicable infection control and health and safety requirements such as Joint Commission and Infection Control Risk Assessment (ICRA) findings and standards.

· The Contractor should indicate the calibration and service requirements for the system. Long term these services should be able to be offered by the Contractor to support the system.

· Optional Requirement: BACnet Capability to interface with current hard-wired solutions already installed in the VISN Facility’s listed above

· Optional Requirement: Ability to interface with Aladdin Food Service Carts

· Wireless / Networking Technology Requirements

· The system should use existing Wi-Fi Infrastructure at each facility as the core communication between tag and reader. The Contractor shall add supplemental technologies as required where Wi-Fi is not available or insufficient to achieve the resolution (i.e. granularity) objectives of the Temperature Monitoring Application.

· WIFI needs to be FIPS 104-2 Complaint

· 900MHz solutions can be utilized/quoted if cheaper or more efficient than the use of VA wireless technology.

· As part of the Preliminary Hardware Deployment Design Document (see Section 2.0) the Contractor shall provide draft documentation of the Server configuration and architecture that will be configured and optimized to meet the needs of VISN 1 and its Facilities. This draft documentation shall include:

· A diagram that lays out the server requirements at each location along with:

a. Expected bandwidth utilization for the WAN links

b. Expected application latency requirements

c. Server specification (including power, BTUs, and network connections)

d. Provide the specification for the number of tags that can be supported per server

· All servers provided must operate using a fully supported operating system. For example, if the server is Microsoft Windows-based, the operating system must be Microsoft Windows Server 2012 or newer.

· Temperature data must be stored for several years based off certification requirements. System must have ability to backup and archive data for each facility listed.

· Software should be TRM approved: http://trm.oit.va.gov/.

· The Offeror is required to submit the following documentation along with their proposal.

· A complete VA Directive 6550 Pre-Procurement Assessment form. See attachment B.

Project Administration

· The Contractor shall provide a single point of contact (Implementation Manager) to oversee the overall Temperature Monitoring implementation for the VISN. The Contractor Implementation Manager shall be responsible for:

· Effectively communicating the project progress to VHA and Contractor team members

· Ensuring proper documentation is delivered to VHA

· Coordinating, escalating, and resolving Contractor-related project issues

· Representing the Contractor in status meetings and providing timely status reports

· The Contractor shall produce a Contractor Project Management Plan (CPMP) which includes the approach, timeline and tools to be used in execution of the contract. The CPMP shall be updated and amended as outlined in the deliverables table. The Contractor shall update and maintain the COR-approved CPMP throughout the period of performance. The CPMP shall contain:

· A comprehensive Project Schedule including milestones and deliverable dates for the deployment of each Application at each VISN Facility. The Project Schedule shall be broken out by facility and application

· The Contractor shall conduct a project kick-off meeting within 15 days after Task Order (TO) award to introduce the Government team to the Contractor’s overall operating plans and approach to this TO. The Contractor shall present its draft Contractor Project Management Plan (CPMP) for review with the Government. The Contractor shall update the CPMP based on the outcomes of the kick-off meeting.

· The Contractor shall perform post-award Site Assessments of each VISN Facility deploying Temperature Monitoring to collect the information necessary for successful implementation.

· Following the Site Assessment, the Contractor shall develop a Hardware Deployment Design Document for each VISN Facility prior to beginning the hardware installation process or delivery of any items to the sites. The Preliminary Hardware Deployment Design Document shall illustrate how the Contractor will design the layout of hardware for the Temperature Monitoring product. This document should be completed based off on-site visits by the Contract at each facility listed in this Statement of Work. The Preliminary Hardware Deployment Design Document shall be broken out by area and follow the VA review process. The contractor will be permitted 5 business days to address any comments provided by the VA.

· The Contractor shall submit the Preliminary Hardware Design Documents in the form of Facility Drawings that include markups noting location, type and quantity of any and all equipment that need to be installed (and how it ties back to the system). The Contractor shall clearly indicate how coverage is achieved in each required area for the purposes of understanding the design and architecture for troubleshooting purposes.

· Guidance and instructions on tag placement

· Method for taking corrective actions on misplaced tags, defective tags, assets that cannot be located, incorrect information in the database, and other errors that can occur during the tagging and commissioning process

· A schedule (not to interrupt business operations) to tag and commission all assets

· The Contractor shall also update the CPMP schedule based on any findings from the Site Surveys.

· The Contractor shall install the TM Application in accordance with the approved Preliminary Hardware Deployment Design Document. The Contractor shall report on installation progress, including delays, risks, and future tasks during Weekly Meetings with the COR and in the Monthly Status Reports.

· The Contractor shall create a VISN Acceptance Test Plan to define testing methodology, test scripts, and test metrics for Product Validation Testing (PVT). Product Validation Testing should occur after installation is complete and prior to training.

· At the completion of each Facility Acceptance Testing, a Facility Test Report should be provided to the COR.

· The Contractor shall provide onsite and/or web based training for all applicable applications at each VISN Facility following the completion of Application Testing acceptance. If onsite training is selected, then the training sessions shall be conducted at the VA facility. The Contractor shall schedule and complete training events in accordance with the Facility Training Plan. The Contractor shall submit a Training Plan for each VISN Facility for review and approval by the COR. The Training Plan shall include, at a minimum:

· Training locations, training dates, and training times

· Format, method and / or delivery of training (e.g. onsite, web based)

· Training audience (e.g. technical repair, system user, system administrator)

· Instructor profile and content information

· Once training is completed, the Contractor shall include in the Monthly Progress report the following:

· Facility-specific list of the attendees for each training session

· The Contractor shall conduct in-process review meetings on a weekly basis utilizing the updated CPMP to update the VA on Contractor project status, schedule, risks, risk mitigation, issues and issue resolution plans.

· On a monthly basis, the Contractor shall submit a Monthly Progress Report to include:

· Completed activities for the reporting period

· Planned activities for the next reporting period

· Tracking of current issues and risks

· The Contractor shall order and have all of the necessary hardware and software components delivered to the specific VISN facility locations. The Contractor shall ensure that a copy of the signed Receiving Report is furnished to the COR once components are delivered. The Contractor shall submit a copy of the final signed Receiving Reports for each Facility and a consolidated VISN summary Receiving Report to include:

· Confirmation of the order and delivery of the components

· Reconciliation (if any) of what was planned to be delivered versus what was actually delivered

· Details of where items were delivered, what time they were delivered, and who from the Government received them

III. SERVICE

· The Contractor shall provide Warranty services for one year on all hardware and software following the completion of acceptance testing at each facility. A Facility Warranty Status Report will be delivered in accordance with the start of each warranty period.

· Service and Operator Manuals – The vendor shall provide the following documentation for the proposed system:

· Two (2) copies of operator's instruction manuals per facility

· Two (2) copies of complete technical service manuals including detailed troubleshooting guides, necessary diagnostic software, service keys, schematic diagrams, and parts lists per facility

IV. EVALUATION CRITERIA

Offerors will be evaluated on the following factors. There is no specific ranking for any factors listed:

· General System Offering (Functional Capabilities and Technical Performance as Outlined Above)

· Training Plan

· Anticipated Reliability and Serviceability

· Past Performance

· Human Factors Design (i.e. Ease of Use, Intuitive Operation, Capabilities, and Workflow Efficiencies)

· Implementation Management and Schedule

· Price It is understood that every Offeror’s product(s) may differ from the specifications outlined in this document. As such, Offerors are encouraged to propose these variances. It is required that each Offeror clearly identify how they meet the specifications listed above. It is also required that, whenever a variance from these specifications occurs, the proposed item meets or exceeds the specified characteristics or level of performance. The Offeror shall also identify each product line item that differs from the specifications and list its associated cost.

V. FURTHER CONSIDERATION

Offeror’s are provided the opportunity to obtain further details from the VA New England Healthcare System in order to better tailor the product quote(s). All requests for information derived from any Offeror will be shared with each Contracted vendor per the standardized contracting rule set.

VA NEW ENGLAND HEALTHCARE SYSTEM

Attachment A – Deliverables Required for Quotation

Hardware – quote amounts based on estimates below (per site)

Software

Additional Items / Costs

Attachment B – VA DIRECTIVE 6550 PRE_PROCURMENT ASSESSMENT

The Offeror shall provide an answer to each of the questions in the attached document, providing the reason why where noted for each device in the system. The Offeror shall also provide the configuration guide that supports all answers on this attachment in a separate file as part of their proposal.

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6550 App A - Medical Device Pre-Procurement Assessment_FINAL.pdf

VA DIRECTIVE

6550 APPENDIX A

A-1

VA Medical Equipment Pre-Procurement Assessment

(*Indicates field is completed by Biomedical Engineering)

*Equipment Category (VA-MDNS): *Vendor:

*Requesting Service: *Model:

*Requestor: Vendor Contact (name, phone number, email):

*Installation Location: (Room- Bldg- Division):

If server based, specify rack space and power requirements:

*Biomedical Engineering Point of Contact:

*MDIA VLAN Number for Installation:

*Equipment Description (laymans description of equipment function and systems it communicates with)

*If Biomedical Engineering is NOT the Primary System Manager for system management and maintenance, please note the responsible department below.

Instructions: Please use the Comment Balloon feature in Adobe© to annotate text that cannot fit inside the provided area.

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Nov. 2017

Medical Device /System Configuration

What OS version and Service Pack does the system utilize (e.g. Win7SP1, Win Svr 2008, Linux)?

Is the OS version supported by its vendor, i.e., updates, patches, etc.? Yes No

Does the system use a database application to operate? Yes No

If yes, specify which application/version:

Is the database encrypted? Yes No

Membership in the facility’s Windows Domain is: Required Not Recommended Is a desktop web browser required to access the medical system/application? Yes No

If yes, specify which browsers and versions are supported:

If yes, does it require the use of https: and the VA SSL certificates – explain below:

If a browser is required, does it require a specific version of Java? Yes No If yes, specify the version and indicated if it is the most current version:

If yes, specify configuration requirements:

If Windows based, can the system use the National Medical Device Update Server for OS patches? Yes No

If no, specify how OS patching will be accomplished:

Can critical and routine OS and system security patches be applied as they become available without prior vendor approval? Yes No

If no, specify how approval notification to VA will be accomplished:

Is Active X required for client operation? Yes No

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VA DIRECTIVE

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*Can the device support the use of McAfee Anti-Virus (AV) software?

If no, what AV packages and versions are supported and describe the mechanism to provide updates.

*Can USB ports be disabled on the device without compromising operation? Yes No

*Can auto run be disabled for portable media? Yes No *Can VA install host-based security components such as a firewall, host intrusion prevention system (HIPS), anti-malware software, and/ or any other security suite software required to operate on the VA production network?

Yes No

If yes, which of the above components may be installed and managed by VA?

*If “No” is the response to any of the above questions regarding updates and anti-virus software, please explain further for each item in the space below.

Authentication and User Account

Is an administrator account required to operate the device? Yes No Is a power user account required to operate the device? Yes No

Can the device be made to require individual user authentication? Yes No

Does the device support strong user password accounts? Yes No

Does the device support password aging? Yes No

Does the device support auto logoff? Yes No

Does the device support session lock? Yes No Does the system support the use of Active Directory for user authentication? Yes No

If yes, specify configuration requirements, LDAP etc.:

Does the system support the use of PIV/Smart Card only authentication? Yes No

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VA DIRECTIVE 6550

APPENDIX A

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Data Handling

Specify which Electronic Protected Health Information ePHI data elements are stored on the device (e.g., last name, SSN, DOB):

How many sensitive records can be stored on the device?

How long will they be retained?

Is ePHI encrypted prior to transmission? Yes No If yes, what is the encryption mechanism(s)?

What is the media used for long term storage?

How is data transmitted to the storage repository (e.g. LAN, DVD, USB, etc.)?

Is ePHI stored only on a drive partition or a separate drive to assist with end-of-life media sanitization? Yes No

Will the medical device require data backups? Yes No If yes, specify how the system and data are backed up and what media is used:

Where will backups be stored and secured?

Does the device have the ability to assign unique ID numbers (accession numbers) instead of using patient identifying information, e.g., Social Security Number?

If yes, how is it generated?

Does the device utilize a laptop for system operation? Yes No If so, can the laptop be encrypted without impacting clinical functionality? Yes No

If yes, what encryption software can be used?

0 1-100 100-500 500-1000 1000+

Per Transaction <1 Week <1 Month <1 Quarter <1 Year Indefinitely

Describe backup process:

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A-5

Networking

What are the LAN bandwidth requirements for full connectivity/performance?

Provide a comprehensive list of all TCP and UDP ports that are required for operation:

How many fixed IP addresses does the device require?

Is the device compatible with IPv6? Yes No Vendors’ products should be designed such that only IP ports required for the intended operation of the device are active.

Are unused IP ports closed or disabled?

Can this be accomplished without impacting system operation? Yes No Vendors’ products should be designed such that only services required for the intended operation of the device are active.

Are unused services (e.g., Telnet, IIS, etc.) disabled?

Can this be accomplished without impacting system operation? Yes No Provide a comprehensive list of all services that are required for system operation:

Can the device be serviced remotely? Yes No Does the vendor have an existing Site to Site (S2S) VPN tunnel? Yes No Does the vendor have an existing individual user VPN account(s)? Yes No What remote access software does the system utilize (e.g. DameWare, PC Anywhere, etc.)?

Does the device require connection to the Internet to operate? Yes No If yes, please justify and provide connection info (IP, port, protocol and traffic direction):

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What are the WAN bandwidth requirements for full connectivity/performance?

Wireless

Does the device utilize wireless communication? Yes No If yes, what protocols are used?

Does the device utilize a wireless encryption protocol? Yes No

If yes, which protocol is used?

Are any ePHI data elements transmitted via the wireless link? Yes No

Integration with VA Healthcare Information Systems (if applicable) *Has the device been validated with VA’s Clinical Procedures package? Yes No

*Has the device been validated with VA’s Vista Imaging? Yes No

*Does the device have bi-directional HL7 interface? Yes No List all other systems that the device will communicate with in order to operate properly, e.g. VistA, domain controllers, vendor’s support network, etc.:

Additional Risk Factors:

If yes, list each element, e.g. last name, DOB, SSN, etc.

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The encryption module must have FIPS 140-2 certification. Provide certificate number:

Signature Page

Equipment Category (VA-MDNS): Vendor:

Requesting Service: Model:

Chief, Biomedical Engineering Date

Concur

Area Manager Date

Information Security Officer Date

Territory 1 Director of IT Operations Date

Additional Comments

Non-Concur

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A ut om at ic al ly fi lle d

Requestor:

Vendor Contact ie name phone number email:

Installation Location Room BldgDivision:

If server based specify rack space and power requirements:

Biomedical Engineering Point of Contact:

MDIA VLAN Number for Installation:

Equipment Description ie laymans description of equipment function and systems it communicates with:

What OS version and Service Pack does the system utilize eg Win7SP1 Win Svr 2008 Linux:

If yes specify which applicationversion:

If yes specify which browsers and versions are supported:

If yes does it require the use of https and the VA SSL certificates explain below:

If yes specify the version and indicated if it is the most current version:

If yes specify configuration requirements:

If no specify how OS patching will be accomplished:

If no specify how approval notification to VA will be accomplished:

If no what AV packages and versions are supported and describe the mechanism to provide updates:

If yes specify which gold image components may be installed and managed by VA:

If yes specify configuration requirements LDAP etc:

Specify which Electronic Protected Health Information ePHI data elements are stored on the device eg last name SSN DOB:

If yes what is the encryption mechanisms:

What is the media used for long term storage:

How is data transmitted to the storage repository eg LAN DVD USB etc:

Where will backups be stored and secured:

If yes how is it generated:

If yes what encryption software can be used:

What are the LAN bandwidth requirements for full connectivityperformance:

What are the WAN bandwidth requirements for full connectivityperformance:

Provide a comprehensive list of all TCP and UDP ports that are required for operation:

How many fixed IP addresses does the device require:

Provide a comprehensive list of all services that are required for system operation:

What remote access SW does the system utilize eg DameWare PC Anywhere etc:

If yes please justify and provide connection info IP port protocol and traffic direction:

If yes what protocols are used:

The encryption module must have FIPS 1402 certification Provide certificate number:

List all other systems that the device will communicate with in order to operate properly eg VistA domain controllers vendors support network etc:

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Equipment Category VAMDNS:

Vendor:

Requesting Service:

Model:

If yes specify how the system and data are backed up and what media is used Describe backup process data centers are lights out so this needs to be known up front:

Describe backup process:

If yes which protocol is used:

If Yes, list each element:

Non Bio-Med POC:

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