36C24423Q0218.docx

36C24423Q0218

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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

646-23-1-233-0027 36C24423Q0218 Allan Tabliago 215-823-5800 12-20-2022 16:30

EST

00244 Department of Veterans Affairs Network Contracting Office 4 100 S. Independence Mall West 5th FL Philadelphia PA 19106 X 334510 1250 Employees N/A X See Delivery Schedule

00244 Department of Veterans Affairs Network Contracting Office 4 100 S. Independence Mall West 5th FL Philadelphia PA 19106

Austin Payment Center Department of Veterans Affairs PO Box 149971 Austin TX 78714-9971

(877) 353-9791

(512) 460-5429 See CONTINUATION Page

1. This requirement is for the purchase and delivery of HemoSphere Advanced Monitoring System for the NCO4 Network.

2. This is Brand Name Only.

3. Schedule on Page 4.

4. Instructions to Vendors on Page See CONTINUATION Page X X X

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

None

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

Name:

Phone No.:

Email:

b. GOVERNMENT: Contracting Officer 36C244 Allan TabliagoX Department of Veterans Affairs Network Contracting Office 4 100 S. Independence Mall West 5th FL

Philadelphia PA 19106

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.

https://www.tungsten-network.com/customer-campaigns/veterans ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

HEMOSPHERE ADVANCED MONITORING SYSTEM - CARDIAC WIN10 WITH SWAN-GANZ MODULE, OXIMETRY CABLE, PRESSURE CABLE FOR ACUMEN IQ / FLOTRAC, FORESIGHT, HPI, AND ACUMEN ANALYTICS Kit Contains: HEM1, HEMSGM10, HEMBAT10, HEMOXSC100, HEMPSC100, HEMTOM10, HEMFSM10, HEMDPT1000, HEMQG1000, 70CC2, 10038207001, 194371001, Acumen Analytics PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary

MANUFACTURER PART NUMBER (MPN): HEMCARDIAQ

LOCAL STOCK NUMBER: HEMCARDIAQ

HEMOSPHERE CLEARSIGHT UPGRADE Kit Contains: HEMCSM10, PC2K, EVHRS, and Windows 10

PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary

MANUFACTURER PART NUMBER (MPN): HEMCSMUPG

LOCAL STOCK NUMBER: HEMCSMUPG

PRESSURE CONTROLLER COVER - PCCVR Included with HEMAQSR2, HEMCSMUPG, EV1000CS, and EVNIUPG-US kits

PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary

MANUFACTURER PART NUMBER (MPN): PCCVR

LOCAL STOCK NUMBER: PCCVR

HEMOSPHERE ROLL STAND Accessory

PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary

MANUFACTURER PART NUMBER (MPN): HEM360Y2

LOCAL STOCK NUMBER: HEM360Y2

HEMOSPHERE 360 PROGRAM 24MO PLAN Covers Model(s) listed under "Total Protection Program Highlights"

PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary

MANUFACTURER PART NUMBER (MPN): HEM360Y2

LOCAL STOCK NUMBER: HEM360Y2

B.3 DELIVERY SCHEDULE

Attn: RCV, PO # University Dr C Pittsburgh, PA 15240 1003

USA

scott.deluisio@va.gov

Attn: RCV, PO # University Dr C Pittsburgh, PA 15240 1003

USA

Attn: RCV, PO # University Dr C Pittsburgh, PA 15240 1003

USA

Attn: RCV, PO # University Dr C Pittsburgh, PA 15240 1003

USA

Attn: RCV, PO # University Dr C Pittsburgh, PA 15240 1003

USA

Statement of Need for Hemosphere Advanced Monitoring Platform Windows 10 VA Pittsburgh Healthcare System (VAPHS) Pittsburgh VA Medical Center-University Drive University Dr. C Pittsburgh, PA 15240-1003

1. Background

1.1. VISN Wide Action Plan is requiring us to upgrade all monitors and system to a Windows 10 based system. The current EV1000 are Windows Based 7 with an unsupported OS.

1.2. These monitors include latest technology in hemodynamics monitoring by providing cardiac output, cardiac index, systemic vascular resistance, and tissue oxygenation by means of an arterial line. It provides actual metrics on fluid and cardiac status. It provides cerebral tissue oxygenation readings, vascular pressure, and flow parameters to achieve optimal tissue perfusion. Decreasing hypotensive episodes may prevent acute kidney injury, decreasing 30-day post-surgery mortality. With the new version, we can monitor advanced vascular hemodynamics as well as tissue oxygenation and continuous cardiac output by utilizing the oximetric pulmonary catheter. It provides goal-directed fluid therapy, decreasing fluid overload or hypovolemia. It increases patient safety by providing advanced hemodynamic monitoring and predictive artificial intelligence. It is expected to decrease length of stay by utilizing the early recovery software, guiding interventions to achieve goals. It can provide critical information after cardiac surgery by providing numbers without an invasive line. The Critical care service line is also interested in utilizing this technology for the cardiac surgery patients post-operatively, thus utilizing these monitors will enhance continuity of care across the peri-operative period.

2. Scope

2.1. The Pittsburgh VAMC has a brand name only request for the Edwards Life Science Hemosphere Advanced Monitoring Platform W/ Windows 10.

3. Requirement

3.1. Salient Characteristics for Brand Name Edwards Lifesciences HemoSphere Advanced Monitoring Platform

3.1.1. Individualized patient care

3.1.1.1. Full-range compatibility with noninvasive, minimally invasive and comprehensive catheter solutions allow you to pair a single monitor with the right device for your patient across different clinical settings and diverse patient profiles.

3.1.2. Comprehensive view of your patient

3.1.2.1. With a sleek and compact design, HemoSphere advanced monitoring platform offers a unique visual monitoring experience with enhanced screen clarity, intuitive navigation, and responsive touch for intelligent decision support during rapidly changing situations.

3.1.3. Acumen IQ cuff

3.1.3.1. Acumen IQ cuff unlocks Acumen Hypotension Prediction Index (HPI) software and provides continuous blood pressure and advanced haemodynamic parameters from a noninvasive finger cuff. Acumen IQ cuff gives you noninvasive access to calculated beat-to-beat haemodynamic information for a broad patient population, including patients in whom an arterial line would not typically be placed.

3.1.3.2. Parameters-HPI I Eadyn I dP/dt I CO/CI I SV/SVI I SVV I SVR/SVRI I MAP

3.1.4. ClearSight cuff

3.1.4.1. ClearSight cuff provides continuous blood pressure and advanced haemodynamic parameters from a noninvasive finger cuff. Continuous data enables you to proactively optimise perfusion through haemodynamic management.

3.1.4.2. Parameters-CO/CI | SV/SVI | SVV | SVR/SVRI | MAP

3.1.5. ForeSight tissue oximetry sensor

3.1.5.1. ForeSight system is a highly accurate, precise, and tailorable tissue oximetry system for continuous monitoring. Reliable, real-time monitoring of surgical patients provides decision support for detecting and managing hypoxic events as soon as they occur.

3.1.5.2. Parameters-StO2

3.1.6. Acumen IQ sensor

3.1.6.1. Acumen IQ sensor unlocks the Acumen Hypotension Prediction Index (HPI) software. This first-of-its-kind predictive decision support software detects the likelihood of a patient trending towards a hypotensive event*. It also attaches to any existing radial arterial line and automatically calculates key parameters every 20 seconds, reflecting rapid physiologic changes in surgical and nonsurgical patients.

3.1.6.2. Parameters-HPI | Eadyn | dP/dt | CO/CI | SV/SVI | SVV/PPV | SVR/SVRI | MAP

3.1.7. FloTrac sensor

3.1.7.1. Delivers advanced pressure and flow parameters for managing perfusion. Offers continuous insight to determine a patient’s haemodynamic status. Seamlessly connects to any existing arterial catheter.

3.1.7.2. Parameters-CO/CI | SV/SVI | SVR/SVRI | SVV/PPV | MAP

3.1.8. The Swan-Ganz catheter, with the FastCCO algorithm, enables CO and SV parameters every 20 seconds

3.1.8.1. Swan-Ganz pulmonary artery catheters provide flow, pressure, and oxygen delivery and consumption parameters. With the FastCCO algorithm, CO and SV update every 20 seconds, giving you a faster, continuous view of cardiac function for more proactive decision support in your most complex patients.

3.1.8.2. Parameters-CO20s | SV20s | CO/CI | SV/SVI | SVR/SVRI | PVR/PVRI | RVEF/EDV | SvO2 | CVP | PAP | PAOP

3.1.9. Scalable expansion modules and interchangeable cable ports

3.1.10. Wired and wireless communication

3.1.11. Multiple visual clinical support screens

3.1.12. Seamless and encrypted integration with hospital information systems

3.1.13. Hot-swappable battery

3.2. Technical Specifications

3.2.1. Weight 10 lb (4.5kg)

3.2.2. Height 11.7 in (297 mm)

3.2.3. Width 12.4 in (315 mm)

3.2.4. Depth 5.56 in (141 mm)

3.2.5. Footprint

3.2.5.1. Width 10.6 in (269 mm)

3.2.5.2. Depth 4.8 in (122 mm)

3.2.5.3. Display Active area 12.1 in (307 mm)

3.2.6. Resolution 1024 x 768 LCD

3.2.7. Electrical

3.2.7.1. Rated supply voltage 100-240 VAC, 50/60 Hz

3.2.7.2. Rated input 1.5 to 2.0 amps

3.2.8. HEMSGM10- HemoSphere Swan-Ganz module

3.2.8.1. Weight - approx. 1.0 lb (0.45 kg)

3.2.8.2. Width - 3.53 in (8.96 cm)

3.2.8.3. Height - 1.36 in (3.45 cm)

3.2.8.4. Depth - 5.36 in (13.6 cm)

3.2.9. HEMTOM10- HemoSphere module

3.2.9.1. Weight - 1.0 lb (0.45 kg)

3.2.9.2. Width - 3.5 in (9.0 cm)

3.2.9.3. Height - 1.4 in (3.5 cm)

3.2.9.4. Depth - 5.4 in (13.6 cm)

3.2.10. HEMBAT10-HemoSphere battery pack

3.2.10.1. Weight - 1.1 lbs (0.5 kg)

3.2.10.2. Width - 3.15 in (80 mm)

3.2.10.3. Cells - 4 x LiFePO4 (lithium iron phosphate)

3.2.10.4. Height - 1.38 in (35 mm)

3.2.10.5. Depth - 5.0 in (126 mm)

3.2.11. HEMOXSC100- HemoSphere oximetry cable

3.2.11.1. Weight - approx. 0.54 lbs (0.24 kg)

3.2.11.2. Length - 9.6 ft (2.9 m)

3.2.12. HEMPSC100-HemoSphere pressure cable

3.2.12.1. Weight - approx. 0.64 lbs (0.29 kg)

3.2.12.2. Length - 120 in (3048 mm)

3.2.13. Monitor (HEM1) Specifications

3.2.13.1. Weight 10 ±0.2 lbs (4.5 ±0.1 kg)

3.2.13.2. Width - 12.4 in (315 mm)

3.2.13.3. Height - 11.7 in (297 mm)

3.2.13.4. Depth - 5.56 in (141 mm)

3.2.13.5. Display

3.2.13.5.1. Active area - 12.1 in (307 mm)

3.2.13.5.2. Resolution - 1024 x 768 LCD

3.2.13.6. Operating system Windows 10 IoT

3.2.13.7. Rated supply voltage 100-240 Vac, 50/60 Hz

3.2.13.8. Rated input 1.5 to 2.0 Amps

3.2.14. Input/output

3.2.14.1. Touch screen- Projective capacitive touch

3.2.14.2. RS-232 serial port (1)- Edwards proprietary protocol: maximum data rate = 57.6 kilo baud

3.2.14.3. USB ports (2)- 1 USB 2.0, 1 USB 3.0

3.2.14.4. Ports- 1 RJ-45 Ethernet, 1 HDMI

3.2.14.5. Hospital information system connectivity-Health Level 7 (HL7); integration services are subject to local availability

3.2.14.6. DPT pressure-DPT pressure out

3.2.14.7. ECG monitor

3.2.14.8. Sync line conversion: 1V/mV;

3.2.14.9. Input voltage range +/- 10V full scale;

3.2.14.10. Resolution = ± 1 BPM;

3.2.14.11. Range = 30 to 200 BPM;

3.2.14.12. ¼ in. stereo jack; analog cable

3.2.14.13. Accuracy = ±10% or 5 BPM of the input

3.3. Table 1

Kit Contains: HEMCSM10, PC2K, EVHRS, and Windows 10

Included with HEMAQSR2, HEMCSMUPG, EV1000CS, and EVNIUPG-US kits

4. Delivery Location

4.1. Delivery should be coordinated with the COR of the contract prior to shipping of any equipment UD Delivery Attn: Government Contact – Anesthesia Department VA Pittsburgh Healthcare System University Drive C Building 1, 2A118 Pittsburgh, PA 15240

4.2. The Contractor must comply and provide all necessary information to VAPHS. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government.

4.3. Normal business hours for acceptance of deliveries are 08:00 AM-15:30 PM ET, Monday thru Friday excluding Federal Holidays. Deliveries must be coordinated in advance with COR once a ship date is established. The COR, Biomedical Engineering and/or Logistics Representative shall be the only VA entity signing for freight received on this requirement. The VA-issued purchase order number must be included in the packing slip. All items included in the requirement shall be shipped and delivered to site at same time. If deliveries must be broken into several shipments due to size, this must be coordinated in advance with the COR. Failure the coordinate shipment with COR, may result in failure to deliver on site and cause re-scheduling of delivery/freight at no charge to the government. The packing slip must include the VA-issued purchase order number.

5. Training

5.1. Any training scheduled should be coordinated with the COR and VA staff.

6. Additional Charges

6.1. There will be no additional charges with the waste management protocol listed in section 8.

7. Packaging Waste management

7.1. Contractor shall remove packaging materials and all shipping debris from site and dispose of at appropriate recycling facilities. Contractor shall collect and separate for disposal all paper, plastic, polystyrene, corrugated cardboard, packaging material in appropriate bins for recycling on site if available. Contract shall fold metal and plastic banding, flatten and place in designated areas for trash.

8. Influenza Vaccination

8.1. VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical, and administrative, paid, and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VAPHS.

8.2. Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

8.3. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

8.3.1. Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination.

8.3.2. Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine.

8.4. The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer’s Representative (COR) that all contract staff performing services at VA facilities follows VHA Directive 1192.

9. HIPAA Training Certificates

9.1. If Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the COR listed in the awarded contract.

10. Tobacco

10.1. All VA Pittsburgh property is tobacco free. Contractor personnel will comply with VA Pittsburgh tobacco and smoking policies. Violations will result in a warning and possible citation.

11. COVID-19 Related Policies

11.1. Upon entering VAPHS, per CDC and federal regulations, all personnel must wear the required PPE while on-site; at a minimum this includes a cloth mask. PPE will not be provided by VAPHS.

11.2. All individuals are required to enter through the main entrance for temperature screening. If Contractor’s temperature exceeds the designated threshold, they will be asked to leave. In the event of an FSE being forced to vacate the premises, they shall notify the necessary Biomedical Engineering staff and provide a contact for a replacement.

12. Vendor Credentialing

12.1. Vendor access to the VAPHS is by appointment only and requires credentialing through our vendor credentialing partner, Symplr at https://vcsdatabase.com/login Symplr registration is at cost to the vendor only and VAPHS is not responsible for this.

36C24423Q0218

12.2. All vendors are required to check-in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (HJH) and obtain a day badge, which will include date, time, and location of approved appointment. Company badge with photo ID is also required to be worn while onsite at any of the VAPHS sites. Vendors are only permitted to visit the location identified on their Symplr generated badge and must exit the facility promptly, checking out via their smart phone once the scheduled appointment has ended.

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SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

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)

C.2 52.222-19 CHILD LABOR—COOPERATION WITH AUTHORITIES AND REMEDIES (JAN 2022) (JUL 2020) (DEVIATION)

(a) Applicability. This clause does not apply to the extent that the Contractor is supplying end products mined, produced, or manufactured in—

(1) Israel, and the anticipated value of the acquisition is $50,000 or more;

(2) Mexico, and the anticipated value of the acquisition is $92,319 or more; or

(3) Armenia, Aruba, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Moldova, Montenegro, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Singapore, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Taiwan, Ukraine, or the United Kingdom and the anticipated value of the acquisition is $183,000 or more.

(b) Cooperation with Authorities. To enforce the laws prohibiting the manufacture or importation of products mined, produced, or manufactured by forced or indentured child labor, authorized officials may need to conduct investigations to determine whether forced or indentured child labor was used to mine, produce, or manufacture any product furnished under this contract. If the solicitation includes the provision 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products, or the equivalent at 52.212-3(i), the Contractor agrees to cooperate fully with authorized officials of the contracting agency, the Department of the Treasury, or the Department of Justice by providing reasonable access to records, documents, persons, or premises upon reasonable request by the authorized officials.

(c) Violations. The Government may impose remedies set forth in paragraph (d) for the following violations:

(1) The Contractor has submitted a false certification regarding knowledge of the use of forced or indentured child labor for listed end products.

(2) The Contractor has failed to cooperate, if required, in accordance with paragraph (b) of this clause, with an investigation of the use of forced or indentured child labor by an Inspector General, Attorney General, or the Secretary of the Treasury.

(3) The Contractor uses forced or indentured child labor in its mining, production, or manufacturing processes.

(4) The Contractor has furnished under the contract end products or components that have been mined, produced, or manufactured wholly or in part by forced or indentured child labor. (The Government will not pursue remedies at paragraph (d)(2) or paragraph (d)(3) of this clause unless sufficient evidence indicates that the Contractor knew of the violation.)

(d) Remedies.

(1) The Contracting Officer may terminate the contract.

(2) The suspending official may suspend the Contractor in accordance with procedures in FAR Subpart 9.4.

(3) The debarring official may debar the Contractor for a period not to exceed 3 years in accordance with the procedures in FAR Subpart 9.4.

(End of Clause) C.3 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

(a) The Contractor agrees to comply with any provision or clause that is incorporated herein by reference to implement agency policy applicable to acquisition of commercial items or components. The following provisions and clauses that have been checked by the Contracting Officer are incorporated by reference.

[X] 852.203–70, Commercial Advertising.

[X] 852.211–70, Equipment Operation and Maintenance Manuals.

[X] 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.

[X] 852.215–71, Evaluation Factor Commitments.

[X] 852.232–72, Electronic Submission of Payment Requests.

[X] 852.246–71, Rejected Goods.

(b) All requests for quotations, solicitations, and contracts for commercial item services to be provided to beneficiaries must include the following clause: Not Applicable (End of Clause)

C.4 VAAR 852.212-71 GRAY MARKET ITEMS (APR 2020)

(a) No gray market or remanufactured items will be acceptable. Gray market items are Original Equipment Manufacturers’ (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical equipment only for VA medical facilities.

(b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(End of Clause)

C.5 VAAR 852.212-72 GRAY MARKET AND COUNTERFEIT ITEMS (MAR 2020)

(a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided. This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory.

(b) No counterfeit supplies or equipment/parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

(c) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(End of Clause) C.6 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)

(a) This solicitation includes the clause: 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. Accordingly, any contract resulting from this solicitation will include the clause 852.215-71 Evaluation factor commitments.

(b) The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing Contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor compliance with the subcontracting commitments.

(End of Clause) C.7 VAAR 852.219-78 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (SEP 2021) (DEVIATION)

(a) Pursuant to 38 U.S.C. 8127(k)(2), the offeror certifies that—

(1) If awarded a contract (see F(a)FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows: [Offeror check the appropriate box]

(i) [ ] In the case of a contract for supplies or products (other than from a non-manufacturer of such supplies), it will not pay more than 50% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-10 or VOSBs as set forth in 852.219-11. Any work that a similarly situated VIP-listed subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(ii) [X] In the case of a contract for supplies from a nonmanufacturer, it will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) is granted. The offeror understands that, as provided in 13 CFR 121.406(b)(7), such a waiver has no effect on requirements external to the Small Business Act, such as the Buy American Act or the Trade Agreements Act.

(2) Manufacturer or nonmanufacturer representation and certification. [Offeror fill-in—check each applicable box below. The offeror must select the applicable provision below, identifying itself as either a manufacturer or nonmanufacturer]:

(i) [ ] Manufacturer or producer. The offeror certifies that it is the manufacturer or producer of the end item being procured, and the end item is manufactured or produced in the United States, in accordance with paragraph (a)(1)(i).

(ii) [X] Nonmanufacturer. The offeror certifies that it qualifies as a nonmanufacturer in accordance with the requirements of 13 CFR 121.406(b) and paragraph (a)(1)(ii). The offeror further certifies it meets each element below as required to qualify as a nonmanufacturer. [Offeror fill-in—check each box below.] [ ] The offeror certifies that it does not exceed 500 employees (or 150 employees for the Information Technology Value Added Reseller exception to NAICS code 541519, which is found at 13 CFR 121.201, footnote 18).

[ ] The offeror certifies that it is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied.

[ ] The offeror certifies that it will take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice.

(iii) [ ] The offeror certifies that it will supply the end item of a small business manufacturer, processor, or producer made in the United States, unless a waiver as provided in 13 CFR 121.406(b)(5) has been issued by SBA. [Contracting Officer fill-in or removal (see 13 CFR 121.1205). This requirement must be included for a single end item. However, if SBA has issued an applicable waiver of the nonmanufacturer rule for the end item, this requirement must be removed in the final solicitation or contract.] or [Contracting Officer tailor clause to remove one or other block under subparagraph (iii).] [ ] If this is a multiple item acquisition, the offeror certifies that at least 50% of the estimated contract value is composed of items that are manufactured by small business concerns. [Contracting Officer fill-in or removal. See 13 CFR 121.406(d) for multiple end items. If SBA has issued an applicable nonmanufacturer rule waiver, this requirement must be removed in the final solicitation or contract.]

(3) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution.

(4) If VA determines that an SDVOSB/VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following:

(i) Referral to the VA Suspension and Debarment Committee;

(ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and

(iii) Prosecution for violating section 1001 of title 18.

(b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract or to determine whether the offeror qualifies as a manufacturer or nonmanufacturer in compliance with the limitations on subcontracting requirement. Contracting Officer may, at their discretion, require the Contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the Contracting Officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed.

(c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate.

(d) Offeror completed certification/fill-in required. The formal certification must be completed, signed, and returned with the offeror’s bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award.

Certification:

I hereby certify that if awarded the contract, [insert name of offeror] qualifies as a manufacturer or nonmanufacturer as stated herein and that if awarded the contract, [insert name of offeror] will comply with the limitations on subcontracting requirement specified in the resultant contract, unless a waiver as described in 13 CFR 121.406(b)(5) is granted. I further certify that I am authorized to execute this certification on behalf of [insert name of offeror].

Printed Name of Signee:________________________________________ Printed Title of Signee:_________________________________________ Signature:___________________________________________________ Date:_____________________ Company Name and Address: ________________________________________ (End of Clause)

C.8 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

C.9 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation.

(End of Clause) (End of Addendum to 52.212-4)

C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2022)

(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 products and commercial services:

(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 (NOV 2021) (Section 1634 of Pub. L. 115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (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 products and commercial services:

[X] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[X] (8) 52.209–6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) (31 U.S.C. 6101 note).

[X] (12) 52.219–4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[X] (22) (i) 52.219–28, Post-Award Small Business Program Rerepresentation (OCT 2022) (15 U.S.C. 632(a)(2)).

[X] (28) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (JAN 2022) (E.O. 13126).

[X] (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (30)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[X] (32)(i) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

[X] (35)(i) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627).

[X] (44) 52.223–18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

[X] (48)(i) 52.225-1, Buy American—Supplies (OCT 2022) (41 U.S.C. chapter 83).

[X] (49)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (OCT 2022) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

[X] (51) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

[X] (55) 52.229–12, Tax on Certain Foreign Procurements (FEB 2021).

[X] (58) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C. 3332).

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, 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 products and commercial services: Not Applicable

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203–13, Contractor Code of Business Ethics and Conduct (NOV 2021) (41 U.S.C. 3509).

(ii) 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)).

(iii) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115–91).

(iv) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115–232).

(v) 52.219–8, Utilization of Small Business Concerns (OCT 2022) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219–8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(vii) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

(viii) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

(ix) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

(x) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

(xiii)(A) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627).

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

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-54, Employment Eligibility Verification (MAY 2022) (E. O. 12989).

(xvii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022).

(xviii) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706).

(xix)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

(B) Alternate I (JAN 2017) of 52.224-3.

(xx) 52.225–26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226–6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) (46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

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SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

See attached document: Attach 02B Price Cost Schedule--.

See attached document: Attachment 1 Single Source Justification MPT to SAT1_Redacted.

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SECTION E - SOLICITATION PROVISIONS

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO VENDORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

E.1 52.212-1 INSTRUCTIONS TO VENDORS—COMMERCIAL…