36C24122Q0405.docx

GENERAL INFORMATION

SET-ASIDE

BROCKTON VAMC

940 BELMONT STREET

BROCKTON MA

CONTACT INFORMATION

VAMC PROVIDENCE

830 Chalkstone Ave

Providence, RI 02980

POINT OF CONTACT*

Contract Specialist Keri Reeves keri.reeves@va.gov keri.reeves@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

Presolicitation Notice Presolicitation Notice

DESCRIPTION

Presolicitation Notice

Pre-solicitation Notice of Intent to Sole Source

Pre-Solicitation Notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source contract with:

Spectrum Medical Inc.

481 Munn Rd E Fort Mill, SC 29715-8408 ueiSAM: NJ5NZVSJATB8

This is not a solicitation. The Department of Veterans Affairs intends to negotiate to purchase Quantum Perfusion Information System. The contractor will provide the required parts and labor.

Since the intent is to procure this on a sole source basis, no solicitation will be posted to FedBizOps (FBO).

The following is the system that will be supported by this procurement in accordance with the statement of work attached.

The authority for this action is FAR 6.302.1-1 Only One Responsible source and no other supplies or services will satisfy agency requirements.

The NAICS 541511. The size standard is $30M. The PSC/FSC is N065.

Interested persons may contact the Contract Specialist by email at keri.reeves@va.gov regarding this procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer.

Response must be received by 06/10/2022 NLT 10:00am EST.

Spectrum Medical Quantum Perfusion Information System For VA Boston Healthcare System West Roxbury campus Operating Rooms

2237#: 523-22-2-7077-0015_SEPG#: 157296

A. Hardware and Software:

Quantity 3 Spectrum Medical Quantum 15” Workstation with 115mm Mounting arm kit Quantum Workstation Specifications:

Hardware: Manufactured from medical grade aluminum materials and with the latest capacitance touch-screen technologies, the Medically Approved Quantum Workstation complies with the very latest medical and safety regulations in accordance with ISO 62304 and 60601.

Dimensions: Width 375mm, Height 298mm, Depth 107mm;

Mounting: 75mm VESA

Software:

OS - Windows 10 IoT Enterprise 2019 LTSC (Anti-Virus to be managed by VA BHS) Application Code - Spectrum Medical proprietary Viper application code.

Electronics:

Main - Processor Intel Atom E3845 Quad-Core 1.91 GHz

Memory - 4GB DDR3, 64GB Solid State Drive, 2GB (or greater) SD Card

Display Size - 15” Portrait Mode with LED Backlight Resolution - 768x1024 (XGA)

Battery & Weight Battery - 2 x 14.4V 6600 mAh Li-ion, Run-time: > 90 minutes Weight - 7.8 kg / 17 lb

Communications Serial / USB: 3 – USB /Serial Wired LAN: 1 – 10/100Mbps Wi-Fi: 1 – 802.11a/b/g/n compatible, dual-band 2.4/5 GHz, dual-antenna

Quantity 2 Spectrum Medical Hb-SO2 Twin 2.0m Sensor kits 9/16"(3/8 x 3/32)

B. Quantum Implementation and Integration Services to include:

Spectrum Medical appointed senior leadership team to oversee the implementation process and to coordinate with the VA Boston Healthcare System an implementation plan with agreed Project Milestones leading to a target implementation date.

Planning, execution, implementation and training to ensure a successful deployment of a Spectrum Medical Quantum Perfusion at VA Boston Healthcare System, West Roxbury campus VA Boston Healthcare System(BHS) will provide server software and hardware that meet or exceed Spectrum Medical Vision software requirements. Production and test environments will be required. Spectrum Medical will perform a site survey to identify ORs, mounting locations within each OR, network connectivity (wired or WiFi), WiFi survey to determine coverage if wireless connectivity to be used.

Spectrum Medical and VA BHS will work collaboratively to configure and test medical device HL7 interfaces. VA BHS will provide all Interfaces. The requirements for all interfaces will be agreed up by both Spectrum Medical and the VA BHS and will utilize the standardized interface specification by the VA BHS VISTA/Cerner It is understood that minor changes will be needed to support the integration of the Spectrum Medical Quantum system, but none to the extent that will require any financial outlay by VA BHS for interface customization required to allow Quantum to function appropriately as expected.

VA BHS Clinical Engineering Technical staff will provide and setup the virtual servers for the Vision servers (production and test). VA BHS will install Windows Server 2019 and MS SQL Server 2019 software on the Vision servers. Spectrum Medical will connect to the Vision servers remotely through SecureLink and install and configure the Vision application software.

Spectrum Medical will connect the Quantum units in the ORs. Each Quantum will be connected to the appropriate devices to receive serial data. Spectrum Medical will provide the mounting hardware and serial cabling required for each location.

Integration will include all parts, materials, and labor to enable data collection from all physiologic monitors and ancillary devices located in the VA Boston Healthcare System, West Roxbury campus Operating rooms and support near real-time transfer of data to the Quantum Informatics software for remote trending analysis (LIVE VUE) and the deployment of clinician developed active Patient Safety Strategies.

Spectrum Medical will configure each Quantum to communicate with the Vision server.

Spectrum Medical EMR Support will train the clinical staff on the configuration and use of the Quantum monitor, Vision and LiveVue.

The first phase of on-site training will consist of training hospital designated clinical system administrators or “super users” to become familiar with the full range of Quantum’s capabilities leading to an understanding of methodologies and techniques for clinical implementation, system configuration and the use of higher-level system functionalities to maximize system performance in the clinical setting. During this first phase of training the Spectrum Medical team will provide the necessary customization to support customer required workflow and clinical practice.

End user training will be a combination of on-line study and examination, and on-site clinical training. Following completion of both the customization process and server software installation (including completion of all necessary validation testing within a test environment), a “credentialed” Spectrum Medical team will arrive on-site to provide final end-user training before the pre-agreed “go-live” date.

Following “system go-live” Spectrum Medical will provide during the first year up to 60 days of additional consultancy at no cost to the VA Boston Healthcare System. This consultancy will support the clinician teams with the implementation of best practice strategies, real time data analytics and the implementation of a Q.A. / Q.I. program.

1.a. Spectrum Medical Deliverables

• Quantum monitors

• Serial cables and mounting solutions for each of the Quantum monitors

• Vision and LiveVue software

• HL7 interfaces on the Vision server

• Training for clinical staff

b. Milestones

• Quantum monitors installed and communicating with devices

• Vision server software installed

• HL7 ADT data received on the Vision server and available on the Quantum monitor

• HL7 outbound interfaces from VA BHS VISTA/CERNER received on the VISION server and available on the Quantum Monitor.

• HL7 inbound interfaces to VA BHS VISTA/CERNER received on the VISION server and available in VA BHS VISTA/CERNER

• LiveVue displaying active cases

• Perfusion report available on the Vision server and can be printed

c. Completion Criteria and Final Acceptance Acceptance Criteria

• Quantum hardware installed

• Device connectivity tested and verified

• VISION and LIVE VUE software installed and tested

• Software Usability for intended Task by VA BHS

• Remote access verified

• ADT HL7 message tested

• PDF document printed and/or sent to VA BHS VISTA/CERNER

• Training completed

2. Staffing Roles and Responsibilities

a. Both Spectrum Medical and the VA BHS will provide the following roles:

• Project Manager – acts as the single point of contact for the project, manage project timelines, provides status reports

• Technical Support – provides technical support for Windows Server software, MS SQL Server database software, wireless and network connectivity

• Spectrum Medical EMR Support - trains and supports end users of the clinical-user interface

• Interface Support – Implements and supports integration and interfaces messages between the VA BHS VISTA/CERNER and the Vision application server

b. Spectrum Medical Responsibilities

• Primary Project management

• On-site Quantum installation and connectivity to OR devices and network per requirements identified during site visit outlined in section 5 (Schedule)

• Application installation on Vision servers

• Provide Quantum integration of interfaces outlined in each Phase with existing VA BHS VISTA/CERNER standard interface specifications

• Testing support

• Training

• Ongoing support

c. VA BHS Responsibilities

• Assign Clinical, IT and BioMedical/Clinical Engineering point of contact

• Identify clinical users and super-users

• Identify Quantum locations and mounting solutions.

• Purchase production and test server hardware for the Vision web application and databases

• Install and configure Windows Server 2019 R2 and SQL Server 2019 on the Vision servers

• Provide Backup and Virus Detection support for all Viper related servers.

• Provide secure remote access to server

• Provide Customer-side integration of interfaces outlined in each Phase with existing VA BHS VISTA/CERNER standard interface specifications.

• Clinicians in super-user and end-user roles

• Testing support

• Ongoing Support

3. Key Assumptions

• Network connectivity in the ORs for the Quantum monitors – Ethernet

• Availability of key VA BHS VISTA/CERNER interface resources for inbound/outbound Anesthesia Interfaces.

4. Risks/Assumptions

• Serial connections to the Quantum that are too long or cause a tripping hazard may require the use of a network to serial converter (Ethernet to serial converter from Moxa).

5. Schedule

Site survey - WiFi (ORs, Pre-Op, PACU)

Spectrum Medical with IT support

Equipment testing (electrical / bio-med)

Biomedical

Live and Warehouse database config

Application install

Setup ADT test and production interfaces

Spectrum Medical and Interface Analyst

Test ADT message to Vision server

Spectrum Medical and Interface Analyst

Test ADT message to VIPER

Spectrum Medical and Interface Analyst

Setup ORU test and production interfaces

Spectrum Medical and Interface Analyst

Test ORU message to Vision server

Spectrum Medical and Interface Analyst

Test ORU message to Viper

Spectrum Medical and Interface Analyst

Test EHR Interfaces (outbound)

Spectrum Medical and Interface Analyst

Test EHR Interfaces (inbound)

Spectrum Medical and Interface Analyst

HL7 ADT patient requests

Spectrum Medical and Clinical support

HL7 Lab requests

Spectrum Medical and Clinical support

PDF document printing / saving to SD

Spectrum Medical and Clinical support

PDF document delivery to EMR

Spectrum Medical and Clinical support

OR device connections to VIPER

Spectrum Medical with Biomedical support

Chart Setup

Spectrum Medical and Clinical support

Chart review and sign-off

Spectrum Medical and Clinical support

Viper install

Spectrum Medical

Viper testing

Spectrum Medical and Clinical support

Viper device connectivity

Spectrum Medical and Clinical support

Ongoing support

C. First year of Spectrum Medical Sentinel Product Support for the Spectrum Medical Quantum Perfusion Technologies

· Annual P.M. Services (including Travel, Labor and Replacement Parts)

· Telephone Support (within standard working hours)

· Annual Software Updates (all Quantum modules)

· Extended Life-Time Warranty: On all Quantum Perfusion Modules including Associated Accessories (e.g. sensors, cable assemblies) for its 10-year life at no cost to the customer. Quantum products beyond economic repair will be replaced with latest “new build” technologies.

· Emergency Loan Equipment: For all products that cannot be repaired within 24 hours of being returned to a Spectrum Medical Service Center.

· Accidental Damage Coverage: On all Quantum Perfusion Modules including Associated Accessories (e.g. sensors, cable assemblies) for its 10-year life at no cost to the customer. Quantum products beyond economic repair will be replaced with latest “new build” technologies.

· Remote On-Line Support: Integrated within the VISION Server System and with VPN access, the Sentinel maintenance application provides a capability to support the remote monitoring and fault diagnosis of all Quantum systems network connected to the local VISION server.

· Quantum Instant Access: To maximize operational up time of the Quantum Perfusion Management System, Spectrum Medical will deploy a pre-agreed “bonded inventory” of critical Quantum modules to be held within a secure hospital location. Customers will have immediate 24-hour access to this bonded stock and more importantly, prior approval from Spectrum Medical will not be required.

4. Nominal Codes/Non-Inventory Annual License Subscription First year of annual Software and Maintenance Subscription License is to be paid 100% at the time of Server Installation The Software Maintenance package is included within the annual subscription license free of charge subject to Spectrum Medical having access to the VISION Server Application via VPN. The Software Maintenance package will cover the Quantum Informatics solution for the following activities:

· Corrective – diagnosing and fixing errors or omissions within the software.

· Adaptive – updates to the software to consider environmental changes such as changes to the Server OS, VIPER Clinical Apps and protocol changes to third party device driver software.

· Preventative – updates to the software that will enhance maintainability and reliability.

· Version Updates – maintained to latest software version and all system enhancements.

· Access - with VPN access to the VISION server Spectrum Medical can provide remote diagnostic monitoring of the installed hardware, installed software, network integrity, database uploads and database maintenance.

· Support - telephone support (e.g. configuration updates) will be provided within standard working hours or as defined in the Master Agreement.

· Training - software deployment is subject to prior customer approval and training via webinar or in-house at Spectrum Medical is included free of charge.

· Configuration updates via VPN.

· Reports are provided free of charge in the first year following Server Installation. Beyond the first-year customer requests for both reports and dashboards will be quoted on an individual basis.

Records Management Language for Contracts When Federal agencies acquire goods or services, they need to determine what Federal records management requirements should be included in the contract. Federal contractors often create, send, or receive Federal records. Federal contracts should provide clear legal obligations describing how the contract employees must handle Federal records.

Agency records officers, procurement counsel, and acquisitions officers must discuss how to integrate records management obligations into their existing procurement processes. NARA has developed the following language to be included as an agency-specific term and condition in Federal contracts for a variety of services and products. The majority of contracts should include language on records management obligations, but each contract should be evaluated individually. For example, the data-rights paragraph (Paragraph 10 below) may not be appropriate for all contracts. Instead, agencies may be better served by one of the established data-rights clauses in the Federal Acquisition Regulations.

This language should not replace specific records management requirements included within Federal information system contracts.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. [Agency] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [Agency] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy.

8. The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The [Agency] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [Agency] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

D. Flowdown of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

Records Management Language for Contracts | National Archives

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