36C26124Q0198.docx

36C26124Q0198

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.

UEI:

EFT:

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C261-24-AP-0322

612-24-1-145-0009 36C26124Q0198 01-05-2024 Janetra Johnson 559-225-6100 01-10-2024

5PM

PST

Department of Veterans Affairs Network Contracting Office (NCO21) VA Central California Health Care System 855 M Street, Suite 1020 Fresno

CA

93721 X 334510 1250 Employees N/A X ** See Delivery Schedule **

Department of Veterans Affairs Network Contracting Office (NCO21) VA Central California Health Care System 855 M Street, Suite 1020 Fresno

CA

93721

FMS-VA-2(101) Financial Services Center

PO BOX 149971

Austin

TX

78714-9971 See CONTINUATION Page BRAND NAME ONLY- Bertec Balance Advantage Computerized Dynamic Posturography (CDP)/IVR system Pay particular attention to addendums to FAR 52.212-1 and 52.212-2 for submission instructions and requirements.

Complete, sign and return VAAR 852.219-76, VA Notice on Subcontracting Certification.

QUOTES ARE DUE: SEE BLOCK #8

Point of Contact: JANETRA.JOHNSON@VA.GOV See CONTINUATION Page X Amanda J. Hildreth

VA-VHA-RPOW-2023-0070

Table of Contents

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 36C261 Amanda J. Hildreth

Network Contracting Office (NCO21) VA Central California Health Care System 855 M Street, Suite 1020 Fresno CA 93721

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

3. INVOICES: Invoices shall be submitted in arrears:

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.

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

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.

All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. VA's Electronic Invoice Presentment and Payment System - The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website:

http://www.tungsten-network.com/US/en/veterans-affairs/ to register and begin submitting electronic invoices, free of charge. The Department of Veterans Affairs Tungsten Number is: AAA544240062 (this allows you to file invoices online for free.)

More information on the VA Financial Services Center is available at: http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

If you have questions about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

• Tungsten e-Invoice Setup Information: 1-877-489-6135

• Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

• FSC e-Invoice Contact Information: 1-877-353-9791

• FSC e-invoice email: vafsccshd@va.gov B.2 Statement of Work (SOW)

Bertec Balance Advantage CDP/IVR Procurement

Project VA Northern California Health Care System needs a new CDP (Computerized Dynamic Posturography) system, installation, training and warranty for its Audiology departments at McClellan, CA.

Contract Type Brand Name Period of Performance

FY2024

Background VA Northern California Health Care System needs a new CDP (Computerized Dynamic Posturography) system, installation, training and warranty for its Audiology departments at McClellan, CA. This requirement is needed to meet all the audiologic and vestibular assessment needs of our veteran population at VANCHCS and to prevent needing to refer veterans out for CITC.

System Requirements Contractor shall provide the following products:

1) Essential/significant physical, functional, or performance characteristics.

a) Computerized Dynamic Posturography (CDP)/IVR System

· Library of immersive virtual reality environments with real-time adjustable parameters such as rock wall, checkerboard room, optokinetic stripes (horizonal and vertical with adjustable width and speed), grocery aisle, flight simulator

· CDP system software

· Dedicated computer

· Touchscreen monitor

· Wireless keyboard

· Pointing device/mouse

· Color printer

· Dynamic base with dual-balance force plate

· Visual surround immersive screen

· LCD projector

· Integrated safety harness structure

· Height adjustable workstation on wheels

· Foam balance pad

· Trainings

· Quick Training

· Mobility

· Closed Chain

· Weight Shifting

· Immersive Vision

· Optokinetec Visual

· Seated

· Protocols

· Dynamic:

· Sensory Organization Test (SOT)

· Motor Control Test (MCT)

· Adaptation Test (ADT)

· Static:

· Limits of Stability (LOS)

· Rhythmic Weight Shift (RWS)

· Unilateral Stance (US)

· Weight Bearing Squat (WBS)

· Low 4” step height onto dual balance force plate

· Over 180 degree horizontal field of view, over 90 degree vertical field of view

· Balance plate

· Concussion Balance Test Option

· Concussion Balance Test software

· Automatic storage of balance performance data for comparison over time

· Standardized four-condition assessment for high volume baseline screening

· Standardized eight-condition assessment for clinical follow up

· Individual test results can be compared to age-related normative data

· Kit includes wall chart, headlamp and foam pad

· Vision Interactive Monitor

· All-In-One touchscreen workstation

· Workstation on wheels

· Dynamic Visual Acuity Test Option

· Dynamic Visual Acuity Test software

· Dedicated portable laptop

· Wireless and light weight head tracker

· Patient-specific baseline comparison

· Automatic sensor calibration

· Touch screen display and remote control

· Dedicated product case for portability and storage

· Wireless-computerized Vestibular ocular reflex (VOR) training exercises with selectable controls for velocity and direction of head movement

· Adjustable elastic head band

· Triaxial gyroscope, accelerometer and compass sensors

· Computerized Gaze Stabilization (GST) and Dynamic Visual Acuity (DVA) tests

· Portable Longer Force Plate

· Portable Longer Force Plate software

· Standardized protocols with normative data

· Dual balance plate, 500 lb. load capacity

· Foam balance pad

· Stackable, interlocking blocks

· Wooden rocker board

· Training

· Quick Training

· Mobility

· Closed Chain

· Weight Shifting

· Seated Training

· Assessment Protocols

· Modified Clinical Test of Sensory

· Interaction on Balance (mCTSIB)

· Limits of Stability (LOS)

· Rhythmic Weight Shift (RWS)

· Unilateral Stance (US)

· Weight Bearing Squat (WBS)

· Sit to Stand

· Step Up and Over

· Step Quick Turn

· Tandem Walk

· Walk Across

· Forward Lunge

· Head Shake – Sensory Organization Test (HS-SOT) Option

· Head HS-SOT software

· Standardized two condition protocol

· Headband, elastic fabric band with Velcro fastener Transmitter fits in elastic pocket on headband. Can be laundered.

b) Compatibility

· HS-SOT software and components compatible with CDP system with transmitter

· Longer Force plate USB compatible with CDP system

· Concussion Balance Test software and components compatible with longer force plate system

c) Dimensions

· Screen: (74”W x 42”D x 105”H)

· 18” x 20” balance plate

· HS-SOT headband: 35 mm x 60 mm x 15 mm (1.38 x 2.36 x 0.59 in.) Weighs 28 grams (0.98 oz.)

· Longer Force plate: 20” x 60” plate, 1.5” height

· Stackable, interlocking blocks, 4”, 8”, 12”

· Foam balance pad: 18” x 20” x 4”

· Interactive Vision Monitor – 60 in

d) Industry Standard – Yes

e) Purpose VA Northern California Health Care System, Audiology department is putting in significant efforts to ensure we are able to meet all the audiologic and vestibular assessment needs of our veteran population at VANCHCS and to prevent needing to refer veterans out for CITC. Completing the construction of our full vestibular clinic is integral in achieving this. We have the space required for the equipment already, and the plans for renovating our McClellan audiology space have taken into account the space requirements for this large piece of equipment. Clinicians currently have access to four-fifths of a standard dizziness and imbalance protocol, and this equipment would complete the test battery and set a standard of complete care, bringing us in line with best practice recommendations for evaluating this population. McClellan outpatient clinic would greatly benefit from Computerized Dynamic Posturography (CDP) equipment due to a high demand of patient need.

f) Governing Body or Organization – Veterans Health Administration

g) Complete generic identification – Bertec Balance Advantage Computerized Dynamic Posturography (CDP)/IVR system

h) Applicable model/make/catalog number – 97P-0036

i) Manufacturer name – Bertec

j) Warranty - One-year parts and labor with ongoing support on all equipment.

k) Installation/Training

· White glove service for installation and functionality

· Online educational product videos for clinician

· Includes training for 2 clinical end user on equipment to training facility, airfare and room/board

· In-service to walk staff through how to use system: conduct/create tests.

l) Security Patented and HIPAA compliant patient database with merge and sync capabilities across all systems

Technical Requirements Solution shall have the following requirements:

· One Bertec Balance Advantage CDP/IVR with:

· Immersive virtual environment with real-time adjustable parameters

· Rock wall

· Checkerboard Room

· Optokinetic stripes (horizonal and vertical, adjustable width and speed)

· Grocery aisle (real-time adjustable parameters)

· Flight simulator

· Castle Corridor

· Bertec Balance Advantage Software

· Dedicated computer, touchscreen monitor, wireless keyboard and pointing device/mouse, color printer

· Dynamic base with dual-balance force plate (Low 4” step height, High-sensitivity)

· Visual surround immersive screen (74”W x 42”D x 105”H) with LCD projector

· Integrated safety harness structure

· Height adjustable clinician workstation

· One-year parts and labor with ongoing support (Warranty)

· Foam balance pad (18” x 20” x 4”)

· One Head Shake – Sensory Organization Test (HS-SOT) Options including:

· HS-SOT software, to be added to Bertec® CDP/IVR™ system

· Head worn transmitter Receiver module, to be added to Bertec® Balance Advantage® CDP/IVR™ system computer

· Sensor Wireless, Inertial Measurement Unit (IMU). Triaxial gyroscope, accelerometer, and compass sensors. 2.4 GHz DSSS communication interface. 35 mm x 60 mm x 15 mm (1.38 x 2.36 x 0.59 in.) Weighs 28 grams (0.98 oz.)

· Supply voltage, +5 v USB

· Rechargeable Lithium-Polymer Battery

· USB 2.0, 2.4 GHz DSSS Wireless

· Communication Interfaces, (FCC certified) Sampling Frequency 175 Hz

· Communication Range, up to 200 feet

· Use per charge, up to five hours

· Charging Device, USB cabler (included)

· Headband, elastic fabric band with velcro fastener Transmitter fits in elastic pocket on headband. (package of 100 supplied with purchase)

· One Bertec Vision Advantages (BVAs) with:

· Wireless, lightweight head-worn sensor

· Bertec Vision Advantage Software

· Touch screen display and remote control

· Wireless-computerized VOR training exercises with selectable controls for velocity and direction of head movement

· Computerized Gaze Stabilization (GST) and Dynamic Visual Acuity (DVA) tests

· Headband: adjustable elastic band

· Triaxial gyroscope, accelerometer and compass sensors

· Dedicated product case for portability and storage of system

· Online educational product videos for clinicians

· One Bertec Vision Trainer (BVT)

· One Bertec Balance Advantage Essential Portable 18x20x1

· Bertec® Balance Advantage® software

· Dual balance plate, 500 lb. load capacity, low 1.5” profile

· Standardized protocols with normative data

· Extended 20” x 60” plate with low 1.5” profile

· One-year parts and labor with ongoing support

· Patented and HIPAA compliant patient database with merge and sync capabilities across all Bertec® Balance Advantage® products

· Portable system powered by USB

· Bertec Cobalt Option for Concussion Balance Test (Software and Kit) with:

· COBALT™ software package that can be added to Bertec® Balance Advantage® Essential® or Functional® systems.

· Protocol for eight test conditions

· Automatic storage of balance performance data for comparison over time

· Wall chart, headlamp and foam pad

· Installation services

· Freight services

Standards Requirements

· Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, Federal and VA specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

· The Contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard.

· The Contractor shall:

A. Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

B. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens.

C. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

D. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

Security Requirements The C&A requirements do not apply, and that a Security Accreditation Package is not required.

Warranty Contractor shall provide one (1) year of ongoing support and warranty after complete installation of the equipment.

All labor, time, parts, materials, equipment, travel, software updates, service manuals and supplies necessary to keep equipment operational during the warranty period shall be included. Software providing incremental new or alternative functionality to the Product is not included under this agreement. Any hardware modifications or replacements required to implement software enhancements will be at the Customer's expense and such expense is not covered.

Warranty does not cover any third party products or software separately purchased or licensed for use with a Bertec Product or for use with data generated by Bertec Products.

The Contracting Officer Representative (COR) in conjunction with NCHCS Biomedical Department shall monitor performance through routine inspections and maintain copies of all service records. Any issues will be brought up to Contractor’s service manager.

The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

Installation Contractor shall install the solutions, one at McClellan Out Patient Clinic, Audiology Department.

Contractor shall verify full functionality of the solution with VANCHCS before stating that installation has been completed.

Contractor shall coordinate installation during normal business hours, all onsite visits will be performed during the normal VANCHCS business hours (8:00 a.m. - 4:30 p.m.) Monday through Friday, except Federal holidays, unless otherwise specified. The Contractor may work outside normal business hours by arrangement with the COR if such services are provided without additional charge to the Government. Any overtime charges must be approved by the COR prior to the initiation of overtime work.

Training Contractor shall provide necessary training, user manuals and ensure competency on operation and maintenance for the equipment. Contractor shall provide clinical and technical support if additional assistance is needed.

Place of Performance

The selected vendor shall provide and install equipment at McClellan Outpatient Clinic, which is part of the VA Northern California Health Care System. The address of the site:

McClellan VA 5342 Dudley Blvd McClellan, Ca 95652

All onsite visits will be performed during the normal VANCHCS business hours (8:00 a.m. - 4:30 p.m.) Monday through Friday, except Federal holidays, unless otherwise specified. The Contractor may work outside normal business hours by arrangement with the COR if such services are provided without additional charge to the Government. Any overtime charges must be approved by the COR prior to the initiation of overtime work.

Delivery

The selected vendor shall deliver the equipment to McClellan VA, 5342 Dudley Blvd McClellan Ca. 95652

Identification, Parking, Smoking, Cellular Phone Use and VA Regulations

The Contractor shall wear visible identification at all times while on the premises onsite. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. VANCHCS will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the onsite. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search.

Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

Other Pertinent Information or Special Considerations

The Contractor must follow all HIPA rules, regulations and restrictions regarding disclosure of any personal identifying information observed during the service of the equipment.

There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts.

NOTE: Any additional charges claimed must be approved by the COR before service is completed.

Contractors must abide by VA policy, including policies under special circumstances such as the COVID 19 pandemic including mandatory masking, social distancing and screening upon entry to VA facilities.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

The C&A requirements do not apply and a Security Accreditation Package is not required.

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Custom software development and outsourced operations must be located in the U.S.to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

d. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

c. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

d. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as “Systems”), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

g. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 15 days.

h. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 10 days.

i. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology

5. SECURITY INCIDENT INVESTIGATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

6. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SP/ the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

7. TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

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 VHA records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VHA 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, the 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. VHA 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 VHA or destroyed except 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, the Contractor must report to VHA. 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 VHA 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 VHA 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 VHA policy.

8. The Contractor shall not create or maintain any records containing any non-public VHA information that is 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 VHA 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 VHA 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.

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

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] D. Flow down 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.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Bertec Balance Advantage CDP/IVR Contract Period:

POP Begin: 01-15-2024 POP End: 04-14-2024 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

LOCAL STOCK NUMBER: 97P-0036

Bertec HS-SOT Option

POP Begin: 01-15-2024 POP End: 04-14-2024 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

LOCAL STOCK NUMBER: 97P-0068

Bertec Balance Advantage BVA (Bertec Vision Advantage)

POP Begin: 01-15-2024 POP End: 04-14-2024 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

LOCAL STOCK NUMBER: 97P-0037

Bertec Virtual Foundations Course for one person. This is an interactive 2 day webinar with our Physical Therapist Trainer. CEU's and Certificate of participation is included

POP Begin: 01-15-2024 POP End: 04-14-2024 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

LOCAL STOCK NUMBER: 97P-0024-1

Bertec CDP/IVR Installation e3 Diagnostics

POP Begin: 01-15-2024 POP End: 04-14-2024 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

LOCAL STOCK NUMBER: CDP/IVR Install

Bertec CDP/IVR Freight (LTL Shipment) Crating Shipping and handling

POP Begin: 01-15-2024 POP End: 04-14-2024 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

LOCAL STOCK NUMBER: 97P-0096

Bertec Balance Advantage Essential Portable

POP Begin: 01-15-2024 POP End: 04-14-2024 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

LOCAL STOCK NUMBER: 97P-0002

Bertec Cobalt Option (Software and Kit)

POP Begin: 01-15-2024 POP End: 04-14-2024 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

LOCAL STOCK NUMBER: 97P-0049

Bertec Vision Trainer (BVT)

POP Begin: 01-15-2024 POP End: 04-14-2024 PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

LOCAL STOCK NUMBER: 95P-0001

B.4 DELIVERY SCHEDULE

VA Northern California Health Care System 10535 Hospital Way Mather, CA 95655

USA

1.00

VA Northern California Health Care System 10536 Hospital Way Mather, CA 95656

1.00

VA Northern California Health Care System 10537 Hospital Way Mather, CA 95657

1.00

VA Northern California Health Care System 10538 Hospital Way Mather, CA 95658

1.00

VA Northern California Health Care System 10539 Hospital Way Mather, CA 95659

1.00

VA Northern California Health Care System 10540 Hospital Way Mather, CA 95660

1.00

VA Northern California Health Care System 10541 Hospital Way Mather, CA 95661

1.00

VA Northern California Health Care System 10542 Hospital Way Mather, CA 95662

1.00

VA Northern California Health Care System 10543 Hospital Way Mather, CA 95663

1.00