36C25720Q0239-001.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 60

549-20-1-205-0064

36C25720Q0239 01-31-2020

Shantelle Mayfield 210-694-6330 02-07-2020

1000AM EST

Department of Veterans Affairs

VISN17 Network Contracting Activity

7400 Merton Minter Blvd. (10N17/90C)

San Antonio TX 78229

X 100

X

334510

1250 Employees

N/A

X

North Texas Veterans Health Care System

Attn: Logistics

4500 Lancaster Road

Dallas TX 75216

VISN17 Network Contracting Activity

San Antonio TX 78229

This is accomplished through the

Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

This solicitation is for the brand-name or equal purchase of

LIVMOR Halo Plus System.

The Government intends to award a firm-fixed price IDIQ contract to the Lowest Price Technically Acceptable (LPTA) vendor under the set-aside category SDVOSB.

Period of Performance: 02/14/2020 through 02/13/2022

See schedule for additional information.

$0.00

See CONTINUATION Page

X X

Michael J. Tusinger

Contracting Officer

36C25720Q0239

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (JUN 2016)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (OCT 2019)

C.4 52.216-18 ORDERING (OCT 1995)

C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.7 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.8 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.9 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.10 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-

OWNED SMALL BUSINESS SET-ASIDE (JUL 2019) (DEVIATION)

C.11 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.12 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.13 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.14 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.15 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN

2008)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 GRAY MARKET LANGUAGE (MAY 2016)

E.5 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (DEC 2019)

E.7 52.214-21 DESCRIPTIVE LITERATURE (APR 2002)

E.8 52.216-1 TYPE OF CONTRACT (APR 1984)

E.9 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.10 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (JAN 2008) 58

E.11 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (OCT 2018)

E.12 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C257 Michael J. Tusinger

VISN17 Network Contracting Activity

7400 Merton Minter Blvd. (10N17/90C)

San Antonio TX 78229

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Upon receipt of Items.

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment

Requests.

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

Statement of Work (“SOW”)

Equipment Procurement for LIVMOR, Inc.

Cardiology Section, Medicine Service (111-A) VA North Texas Healthcare System

1) General:

This statement of work defines the effort required for VA North Texas Healthcare System (VANTHCS), Cardiology Section of Medicine Service (“Facility”) to procure LIVMOR Halo+ Remote Patient

Monitoring Systems (“RPM System”, “System”, “Halo+ System”, “Halo+”). LIVMOR, Inc.

(“Contractor”) shall provide the RPM System which includes a Wi-Fi Enabled Wearable Device (“Halo”, “Halo Wearable”), Cellular enabled Tablet Wi-Fi Hotspot and Control Hub (“Tablet”), Wi-Fi Enabled

Blood Pressure Cuff, Wi-Fi Enabled Weight Scale as well as the physician and patient (“User”) online data portal (“Portal”, “HeartView”).

2) Description of Work:

The Contractor shall provide all resources necessary to accomplish the deliverables described in the statement of work (SOW), except as may otherwise be specified. The Contractor will deliver the specified quantity of RPM systems to Facility to provide remote patient monitoring capabilities (“Device and HeartView Services”). In conjunction with delivery of RPM Systems to the Facility, Contractor will create an instance of the data portal (“HeartView”) with a dedicated server partition for the Facility. Contractor will also provide educational materials, such as user guides, an on-site demo as well as training (at the request of the Facility). The System will allow for remote capture of physiological data. Contractor will provide adjudicated results of the physiological data that will be verified by the provider. Through the HeartView Services this data can be viewed by both physician and patient. At the request of the Facility, this data can be downloaded via PDF.

3) On-site Equipment and training:

Contractor will provide on-site training regarding standard operating procedures of the System.

Training will include a demonstration of how to use all the listed features of the System as well as any applicable User configuration.

4) Manufacturer:

LIVMOR, Inc.

5) Model:

Halo+ Remote Patient Monitoring System & Database Portal for online viewing of data

6) Location:

5B668

Dallas VA Medical Center at 4500 S. Lancaster Rd. Dallas TX 75216

7) Quantity:

IDIQ Contract for base year plus 1 years; minimum quantity 50 units/year, maximum quantity

1,000 units/year. Dallas VA Medical Center will request the devices when needed.

8) Justification:

Chronic disease burden can be alleviated with lifestyle management. Using the Halo+ system to capture, track and report data, each patient and physician can be empowered to develop and execute a data driven care plan. The advanced, easy to use hardware, coupled with cellular data connectivity and an intuitive HeartView portal means patients can live out their care plan outside of the hospital setting while still having their biometric data reviewed by their trusted physician.

Additionally, the tablet interface allows for real-time feedback, patient education, coaching and communication with their care team. Taken together, the Halo+ system empowers patients, in partnership with their physician, to own their health. With better patient engagement, a VA facility can expect better outcomes and lower costs of care.

9) Salient Characteristics:

As laid out in the general description, the Halo+ System is comprised of four (4) hardware components (Devices) and an online data portal (Heartview) for User data viewing (and at the request of the VA, data download via PDF), health tracking and education. Each system includes advanced security protocol using Samsung Knox applications. The System is comprised of the following:

Device Features.

a. Wrist worn wearable device,

i. Accelerometer and optical sensors with sampling rate of at least 100Hz,

ii. Bluetooth, Wi-Fi, NFC and microphone

iii. Continuous and auto-recording capabilities

iv. Minimum operating time of 10 hours when recording continuously at 100Hz

v. Allows for Over-The-Air (OTA) upgrades

b. Cellular enabled tablet, SIM card and 4G LTE data plan with hot spot functionality enabled.

c. Wi-Fi enabled blood pressure cuff, with programmable frequency of measurement & multi profile capability.

d. Wi-Fi enabled smart weight scale with multi profile capability.

e. Wireless transmission of blood glucose measurements.

Device Services.

In connection with the Systems purchased under this Agreement, the Contractor will provide the following services (the “Device Services”):

a. Ensure all devices in each Halo+ System are adequately charged, configured, and paired he LIVMOR Tablet Wi-Fi Hotspot and Control Hub prior to shipment to the Facility.

b. Provide appropriate user manuals and educational material for the Facility.

c. Update Halo+ Systems or components of the system from time to time as necessary.

d. Provide 24/7 service and technical support for Facility via telephone.

HeartView Features.

a. Online data portal for viewing with comprehensive view of photoplethysmogram (PPG) signal and backend analytics, such as beat annotations and inter-rate variability plots

b. Patient and Physician View included dashboard of most recent measurements and trending information for each of the following biomarkers:

i. Blood Pressure

ii. Weight

iii. Blood Glucose

iv. Heart Rate

v. Heart Rate Variability (HRV)

vi. Stress

vii. Activity (step count)

HeartView Services.

In connection with the Systems purchased under this Agreement, the Contractor will provide the following services (the “HeartView Services”):

a. Provide appropriate tools and displays to view User data and information for the Facility and User.

b. At the request of the Facility, provide Facility with the ability generate reports in PDF format, summarizing such data.

c. Reports can be adjudicated at the request of the provider.

d. Provide the ability to manage User accounts including the ability to maintain appropriate access permissions and account terminations based on Facility’s requirements.

e. Provide the ability for a User to view their own data.

f. Maintain Facility’s and User’s data in a secure and access-controlled environment consistent with applicable requirements imposed on “business associates” pursuant to the

Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

g. Provide a user manual, training sessions, and access to online information on existing and new features for the Facility and Users.

h. Provide onboarding and educational support on-site at Facility’s premises.

i. Provide 24/7 service and technical support for Facility via telephone.

Security Features.

Security certifications, including FIPS 140-2 & DISA approved STIG, installed on wearable device and tablet. Additional security features and protocols:

a. Data-in-transit protection achieved with Advanced VPNs, Certificate Management, and

Common Criteria mode.

b. Data-at-rest protection achieved with the Knox Workspace and Sensitive Data Protection.

c. Authentication achieved with the Client Certificate Manager and user authentication methods that include biometrics.

d. Secure boot achieved with a hardware-backed Root of Trust and Trusted Boot.

e. Platform integrity achieved with the Real-Time Kernel Protection, Device Health

Attestation, and Secure lockdown on tampering.

f. App Whitelisting achieved with Advanced App Management.

g. Security policy enforcement achieved with a full complement of EMM policies built on a

Knox SDK.

h. External interface protection achieved with Granular Device Management.

i. Device Update achieved with Device Software Update Management.

j. Event collection for enterprise analysis achieved with Audit Logs.

k. Incident Response achieved with custom lock screen info, remote data wipe, auto-wipe after a number of unsuccessful log-in attempts, and remote factory reset.

System Summary.

Together, the system incorporates the following functions:

a. Continuous heart rate and heart rate variability monitoring

b. Blood pressure (Spot measurement)

c. Weight (Spot measurement)

d. Blood glucose monitoring

e. Body mass index (BMI) calculation

f. Health coaching / Reminders

g. Goal Tracking

10) Physician and Patient Benefits:

The LIVMOR HALO+ system is built to provide a whole human picture of health and do it remotely. The entire system is integrated to provide continuous remote patient monitoring. By delivering continuity of data for the physician, a tailored care plan can be prescribed, implemented and managed with each individual patient. Moreover, the system can be used for extended periods of time; meeting the needs of patients and care teams who can benefit most from lifestyle and chronic care management. Given the capabilities the system (see Salient

Characteristics) it can be leveraged to take actions to:

a. Help Improve patient engagement

b. Help identify, monitor and improve hypertension

c. Help lower obesity / manage weight

d. Help prevent chronic disease

e. Help educate and promote healthy lifestyle choices (diet, exercise, stress management)

11) Training Hours of Performance:

Work shall occur Monday – Friday during normal duty hours unless authorized by Cardiology.

12) Technical Phone Support Hours of Performance:

24 hours/day, 7 days/week

Note: Technical support is defined as service to ensure marketed hardware, software and service features of the Halo+ systems are functioning as described. Any health-related inquiries will be directed to the Facility. Any emergency health-related inquiries will be directed to call 911.

LIVMOR does not maintain any medical personnel on staff.

13) Ordering, Shipping, Business Admin Hours of Performance:

Monday – Friday 8AM CST – 5PM CST. Except federal holidays. Orders may be placed via purchase order. Orders will be acknowledged within 2 business days and delivered in 14 business days.

14) On-site Check-in Requirements:

The Contractor Rep must report to the Biomedical Engineering Department to obtain a badge and sign in with the Biomedical Engineering Service before work begins. Upon completion of work, the Rep must report to the Biomedical Engineering Service to sign out.

15) Period of Performance:

Period of performance shall be done in a reasonable time frame (no longer than 60 days after receipt of order) unless unseen circumstances arise which need to be discussed with Biomed representative. For avoidance of doubt, period of performance is defined as the period between formal purchase order from Facility being submitted to the Contractor, to the fulfillment of such purchase order.

16) Place of Performance:

Dallas VA Medical Center at 4500 S. Lancaster Rd. Dallas TX 75216

17) Documentation:

Contractor shall furnish a detailed field service report upon completion of work to Cardiology

Staff. Payment will not be processed until a properly completed service report is received. This includes any service needs discovered through the technical support. For avoidance of doubt, if a user calls technical service and a replacement hardware component is required, LIVMOR shall provide a summary to the Facility prior to furnishing replacement. Any replacements or repairs will be facilitated on site at the Place of Performance. The service report shall contain, at a minimum, the following information (as applicable):

a. Date and time of contractor’s arrival on station

b. Type, model and serial number (s) of all equipment on which maintenance was performed

c. Total time spent performing maintenance and travel time

d. Detailed narrative description of the services required

e. Copies of all test reports

f. Complete list of parts replaced

g. Date and time the repair was completed

h. Cost Estimate of all labor (including travel), parts/supplies, and shipping charges

Note: The service report shall itemize every item in the specification. Each item shall state the

"as found" condition or values, the "calibrated to" or "adjusted to" values, the factory design tolerances, and a complete description of all work performed concerning the items

18) Contracting Officer Technical Representatives:

All work coordination shall be made through the Purchasing agent. The Contractor shall be provided a copy of the letter of delegation authorizing the purchasing agent at the commencement of the term of the contract. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer.

19) Information technology security requirements:

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. The contractor shall comply with all Federal laws and regulations the VA has developed when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor. The information made available to the contractor by VA for the performance of this contract will be used only for the purposes of performance under this contract. The certification and accreditation requirements do not apply to this requirement and a security accreditation package is not required.

20) Security Statement:

a. The CO and the Contractor will assure that- No other information except what is in this contract will be shared with the contractor in any follow up communication.

b. Biomedical Engineering shall perform virus scans on all removable media prior to use on

VA medical equipment. This includes all types of removable media, including media

(e.g., USB devices, CDs, dongles, etc.) that has been issued by VA, media not issued by

VA, and media brought in by Contractors or independent service organizations. Within accordance of VA Directive 6500, Information Security Program, September 2007

c. Sensitive VA information is contained within the systems covered by this contract.

d. The Contractor will not transfer any VA information to a location outside the VA and only to VA locations determined by the VA System Administrator. The information in these systems may be covered by the Privacy Act 1974 which contains criminal penalties of abuse of information.

e. During onsite service, the Contractor shall be chaperoned by VA Personnel. However, the Contractor shall not be issued a User ID/Password.

f. Non-volatile memory devices, working or non-working, shall NOT be re-deployed until data has been destroyed according NIST SP 800-88 guidelines. For magnetic devices and media, the data destruction will be by degaussing. Other forms of cleansing will be used for non-magnetic media. System on-boarding will entail new user credentials being added to HeartView and paired with corresponding devices. Off-boarding will be at the direction of the Facility. Upon confirmation of off-boarding the devices will be remotely wiped of any/all PHI or sensitive information and a fresh profile of the stock operating environment will be flashed. All PHI can be downloaded at the request of the Facility for records keeping and archival purposes.

g. Vendor will perform product patch, “bug fix,” service pack installation and upgrades to the current installed version through remote access to complete the repair(s) and preventive maintenance.

h. The Contractor shall sign a Business Associate Agreement with the VA.

i. The COR is responsible for the actions of the Contractor during the repair.

j. Because the Contractor is chaperoned, the Contractor does not need to take VA Privacy or Information Security training. A background investigation is not required. The

Contractor and all VA employees are required to immediately report any security violations to the Information Security Officer (214-857-0512). No other security statements are required.

21) NARA Records Management Language for Contracts (May 2017):

a. 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.

b. 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.

c. 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.

d. Facility 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 Facility 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.

e. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Facility. The agency must report promptly to NARA in accordance with 36 CFR 1230.

f. 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 Facility 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).

g. 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 Facility guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

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

i. The Contractor shall not create or maintain any records containing any non-public

Facility information that are not specifically tied to or authorized by the contract.

j. 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.

k. The Facility 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

Facility 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.

l. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for

Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

22) Safety Requirements:

In the performance of this contract, the Contractor shall take such safety precautions as the

Contracting Officer may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer Representative shall notify the Contractor of any safety issues and the action necessary to correct these issues. Such notice, when served to the

Contractor or his representative at the work site shall be deemed sufficient for the corrective actions to be taken. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the Contractor in default.

23) Invoicing:

Payment to be made monthly in arrears by certified invoices and must contain the contract number in addition to the requirements detailed in 52.212-4 (G) to be considered valid. All invoices shall be submitted to the VA Financial Service Center and emailed to the CO. All invoices will reference the purchase order number assigned to the contract.

24) Billing address:

VA FSC

PO Box 149971

Austin, TX 78714

Purchase Descriptions.

The purchase description should identify the requirement in terms that enable contractors to offer commercial supplies or services. The description should not be restrictive and not be limited to one product peculiar to a manufacturer (e.g., by manufacturer, brand name and Part Number) unless it is essential to the

Government’s minimum requirement.

A purchase description should include the following characteristics based on the requirement to adequately describe the Government’s needs:

a.

Common Nomenclature (commercial description):

Remote Wi-Fi enabled patient monitoring system and Database Portal for online viewing of data. The System will allow for remote capture of physiological data. Contractor will provide adjudicated results of the physiological data that will be verified by the provider.

b.

Kind of material (i.e., type, grade, alternatives, etc.):

Wi-Fi enabled wearable device (i.e. watch, headband, etc), Cellular enabled Tablet Wi-Fi Hotspot and Control Hub such as a tablet, Wi-Fi enabled blood Wi-Fi Enabled Blood Pressure Cuff, Wi-Fi Enabled Weight Scale as well as the physician and patient online data portal to view results.

c.

Electrical Data (i.e., 110 v, 60 Hz, 3 Ph, etc.):

Wearable Device: Accelerometer and optical sensors with sampling rate of at least 100Hz; Bluetooth, Wi-Fi, NFC and microphone, continuous and auto-recording capabilities, minimum operating time of 10 hours when recording continuously at 100Hz, allows for Over-The-Air (OTA) upgrades Control Hub (Tablet): Cellular, SIM card and 4G LTE data plan with hot spot functionality enabled.

Wi-Fi enabled blood pressure cuff: programmable frequency of measurement & multi profile capability.

Wi-Fi enabled smart weight scale: with multi profile capability and wireless transmission of blood glucose measurements.

d. Dimensions, size, capacity:

Portable, wearable, remote, continuous monitoring with a minimum operating time of 10 hours.

e. Principles of operation:

Data Portal: Online data portal for viewing with comprehensive view of photo-plethysmogram (PPG) signal and backend analytics, such as beat annotations and inter-rate variability plots. Patient and Physician view included dashboard of most recent measurements and trending information for each of the following biomarkers due to wireless transmission of the devises:

i. Blood Pressure

ii. Weight

iii. Blood Glucose

iv. Heart Rate

v. Heart Rate Variability (HRV)

vi. Stress

vii. Activity

Contractor will create an instance of the data portal with a dedicated server partition for the Facility. Contractor will also provide educational materials, such as user guides, an on-site demo as well as training (at the request of the Facility).

The System will allow for remote capture of physiological data. Contractor will provide adjudicated results of the physiological data that will be verified by the provider.

Through the server this data can be viewed by both physician and patient. At the request of the Facility, this data can be downloaded via PDF.

f.

Restrictive environmental conditions:

The equipment must be able to provide a hot spot for veterans living in rural areas.

g. Intended use:

The system would be utilized in multi-specialties for veterans in Cardiology, Vascular Surgery, Endocrine, and Internal Medicine. It would be directed at those patients who need continuous monitoring for rehab and allowing patients to tele-rehab for those who live in rural areas and travel a long way for appointments. In congestive heart failure, it will provide real time data on patients whose vitals need to be managed very accurately and routinely with real time data.

Provide diabetic glucose measurements, blood pressure, and EKG readings for Cardiology and Internal Medicine.

Provide physicians will real time data on patients they place on home exercise plans for health improvement and ways to adjust such plans as needed real time.

h.

Equipment with which the item is used with (N/A if not applicable):

Wearable Wi-Fi Enable Device, Wi-Fi Hot spot Tablet, Wi-Fi Blood pressure cuff, Wi-Fi enabled scale that all send data to the online data portal for physicians and veterans with results to be verified by the provider.

i. End item application:

The system is built to provide a whole human picture of health and do it remotely. The entire system is integrated to provide continuous remote patient monitoring. By delivering continuity of data for the physician, a tailored care plan can be prescribed, implemented and managed with each individual patient without having to come into the hospital or clinic. Moreover, the system can be used for extended periods of time; meeting the needs of patients and care teams who can benefit most from lifestyle and chronic care management.

Given the capabilities it can be leveraged to take actions to:

Help Improve patient engagement

a. Help identify, monitor and improve hypertension

b. Help lower obesity / manage weight

c. Help prevent chronic disease

d. Help educate and promote healthy lifestyle choices (diet, exercise, stress management) j.

Original equipment manufacturer part number:

LIVMOR Halo+ System (no specific number) k.

Other pertinent information that describes the item, material or service required:

Chronic disease burden can be alleviated with lifestyle management. Using a remote patient system to capture, track and report data, each patient and physician can be empowered to develop and execute a data driven care plan.

The advanced, easy to use hardware, coupled with cellular data connectivity and an intuitive online server means patients can live out their care plan outside of the hospital setting while still having their biometric data reviewed by their trusted physician. Additionally, the tablet interface allows for real-time feedback, patient education, coaching and communication with their care team. Taken together, the system empowers patients, in partnership with their physician, to own their health. With better patient engagement, a VA facility can expect better outcomes and lower costs of care.

Data Portal: Online data portal for viewing with comprehensive view of photo-plethysmogram (PPG) signal and backend analytics, such as beat annotations and inter-rate variability plots. Patient and Physician view included dashboard of most recent measurements and trending information for each of the following biomarkers:

viii. Blood Pressure

ix. Weight

x. Blood Glucose

xi. Heart Rate

xii. Heart Rate Variability (HRV)

xiii. Stress

xiv. Activity

At the request of the Facility, provide Facility with the ability generate reports in PDF format, summarizing such data and provide the ability for a veteran to receive a hard copy of their health measurements.

Technical Phone Support is to be 24 hours/day, 7 days a week for our Veterans having issues with the hardware, software, and service features of the system from the vendor.

B.2 PRICE/COST SCHEDULE

This is a Single Award, Firm-Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ) Contract.

The guaranteed minimum award amount for this contract is $100,000.00. The maximum aggregate value of orders that can be placed under this contract is $500,000.00. The

Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

Ordering Period:

POP Begin: 02-14-2020

POP End: 02-13-2022

DELIVERY – North Texas Veterans Health Care System (NTXVHCS).

Dallas VA Medical Center

4500 S. Lancaster Rd.

Dallas, TX 75216

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

1.00 EA ____________

LIVMOR Halo+ System: LIVMOR Halo (Wearable) LIVMOR Tablet Device, 4G LTE

Enabled w/ SIM Card Digital Blood Pressure Cuff Digital Weight Scale LOCAL STOCK NUMBER: LIVMOR Halo+ System

LIVMOR Service and Support (12 Months) HeartView Web Portal Access Mobile

Device Data Package 24/7 Technical Phone Support

LOCAL STOCK NUMBER: LIVMOR SERV

Dedicated Server (up to 5,000 users) (Annual fee)

LOCAL STOCK NUMBER: SERVER

On-Site training, demo & associated materials (one-time fee)

LOCAL STOCK NUMBER: TRAINING

HEARTVIEW WEB PORTAL ACCESS WITH ADJUDICATION

LOCAL STOCK NUMBER: HEARTVIEW

B.3 DELIVERY SCHEDULE

ITEM NUMBER DELIVERY DATE

ALL SHIP TO: Department of Veterans Affairs North Texas VA Health Care System 4500 South Lancaster Road Dallas, TX 75216 United States

30 Days ARO

MARK

FOR:

Logistics Service POC: Jenna Loutsch 214-857-3789 Jenna.Loutsch@va.gov

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST DEC 2011

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS

AND REQUIREMENT TO INFORM EMPLOYEES OF

WHISTLEBLOWER RIGHTS

APR 2014

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

MAY 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

JUL 2016

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

DEC 2013

C.2 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (JUN 2016)

(a) Definitions. As used in this clause—

Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

Federal contract information means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public Web sites) or simple transactional information, such as necessary to process payments.

Information means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information

(44 U.S.C. 3502).

Safeguarding means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures. (1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial items, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

(End of Clause)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS

(OCT 2019)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or

Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or

Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further

Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or

Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L.

115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video

Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting

Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[X] (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with

Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

[] (2) 52.203-13, Contractor Code of Business Ethics and Conduct (OCT 2015) (41 U.S.C.

3509).

[] (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment

Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the

American Recovery and Reinvestment Act of 2009.)

[X] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards

(Oct 2018) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved]

[] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts

(OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors

Debarred, Suspended, or Proposed for Debarment. (OCT 2015) (31 U.S.C. 6101 note).

[X] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(Oct 2018) (41 U.S.C. 2313).

[] (10) [Reserved]

[] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (NOV 2011) (15

U.S.C. 657a).

[] (ii) Alternate I (NOV 2011) of 52.219-3.

[] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business

Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (ii) Alternate I (JAN 2011) of 52.219-4.

[] (13) [Reserved]

[] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644).

[] (ii) Alternate I (NOV 2011).

[] (iii) Alternate II (NOV 2011).

[] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

[] (ii) Alternate I (Oct 1995) of 52.219-7.

[] (iii) Alternate II (Mar 2004) of 52.219-7.

[X] (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

[] (17)(i) 52.219-9, Small Business Subcontracting Plan (AUG 2018) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (JAN 2017) of 52.219-9.

[] (v) Alternate IV (AUG 2018) of 52.219-9.

[] (18) 52.219-13, Notice of Set-Aside of Orders (NOV 2011) (15 U.S.C. 644(r)).

[] (19) 52.219-14, Limitations on Subcontracting (JAN 2017) (15 U.S.C. 637(a)(14)).

[] (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

[] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside

(OCT 2019) (15 U.S.C. 657f).

[X] (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15

U.S.C 632(a)(2)).

[] (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically

Disadvantaged Women-Owned Small Business Concerns (DEC 2015) (15 U.S.C. 637(m)).

[] (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small

Business Concerns Eligible Under the Women-Owned Small Business Program (DEC 2015) (15

U.S.C. 637(m)).

[X] (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

[X] (26) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (OCT 2019)

(E.O. 13126).

[X] (27) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (28)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (ii) Alternate I (FEB 1999) of 52.222-26.

[X] (29)(i) 52.222-35, Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212).

[] (ii) Alternate I (JULY 2014) of 52.222-35.

[X] (30)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C.

793).

[] (ii) Alternate I (JULY 2014) of 52.222-36.

[X] (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

[X] (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act

(DEC 2010) (E.O. 13496).

[X] (33)(i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).

[] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

[X] (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

[] (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-

Designated Items (May 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential

Hydrofluorocarbons (JUN 2016) (E.O. 13693).

[] (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and

Air Conditioners (JUN 2016) (E.O. 13693).

[] (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014)

(E.O.s 13423 and 13514).

[] (ii) Alternate I (OCT 2015) of 52.223-13.

[] (39)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-14.

[] (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007)(42 U.S.C.

8259b).

[] (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT

2015) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-16.

[X] (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving

(AUG 2011)

[] (43) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

[] (44) 52.223-21, Foams (JUN 2016) (E.O. 13693).

[] (45) (i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

[] (ii) Alternate I (JAN 2017) of 52.224-3.

[] (46) 52.225-1, Buy American—Supplies (MAY…