S02 - 36C25924Q0683 - Endoscope Imaging Equipment - 436.docx

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Endoscope Imaging Equipment *Brand Name or Equal to Stryker Brand*
Solicitation number
36C25924Q0683
Issued by

About this file

This document is a solicitation for endoscopic imaging equipment and support services for the Fort Harrison VA Medical Center. The Department of Veterans Affairs is seeking to purchase brand name or equal to Stryker brand imaging equipment, including cameras, displays, insufflators, and accessories. The contract includes a base year plus four one-year option periods for support services. All products must be Trade Agreements Act (TAA) compliant. Proposals are due by 3:00 PM MDT on September 25, 2024. The government may make multiple awards and intends to evaluate offers without discussions. Small business set-asides, subcontracting plans, and other socioeconomic programs may apply. The incumbent provider is Stryker, and any proposed alternate brand must be fully compatible with the Stryker products listed in the solicitation.

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36C25924Q0683

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

36C259-24-AP-4934

Stephanie Cahill 303-712-5841 09-25-2024 15:00

MDT

36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

X

339112 1000 Employees

N/A

Fort Harrison VA Medical Center

3687 Veterans Dr.

Fort Harrison MT 59636 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

Department of Veterans Affairs Financial Service Center Submit Invoices Electronically to:

http://www.tungsten.network.com 1-877-489-6135

See CONTINUATION Page Endoscopic Imaging Video Equipment and Support Services

Base plus four (4) option years for support services:

- Base Year: 9/30/2024 - 9/29/2025

- Option #1: 9/30/2025 - 9/29/2026

- Option #2: 9/30/2026 - 9/29/2027

- Option #3: 9/30/2027 - 9/29/2028

- Option #4: 9/30/2028 - 9/29/2029

Contract POC: Stephanie Cahill; Stephanie.Cahill@va.gov

Questions are to be sent to the Contract POC no later than 1500 MST, September 23, 2024.

**MUST be brand name or equal to the Stryker products listed**

*MUST be TAA compliant*

See CONTINUATION Page

Timothy Myers Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS3
B.1 CONTRACT ADMINISTRATION DATA3
**MUST BE BRAND NAME OR EQUAL TO THE STRYKER PRODUCTS LISTED BELOW**4
B.2 PRICE/COST SCHEDULE4
ITEM INFORMATION4
SECTION C - CONTRACT CLAUSES21
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)21
C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)27
C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)27
C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS27
C.5 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)28
C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)29
C.7 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)29
C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)29
C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)30
SECTION E - SOLICITATION PROVISIONS39
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)39
E.2 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)44
E.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)45
E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)63
E.5 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)66
E.6 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)67
E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)68
E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)69
E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)69

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:

To be Determined

b. GOVERNMENT: Timothy Myers, Contracting Officer 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

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

[X]
52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or
[]
52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[X] Upon Delivery and Acceptance; Monthly for Support Services

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.

Department of Veterans Affairs Financial Service Center Submit Invoice Electronically to:

http://www.tungsten-network.com 1-877-489-6135

**MUST BE BRAND NAME OR EQUAL TO THE STRYKER PRODUCTS LISTED BELOW**

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
3.00
EA
__________________
__________________

1688 AIM 4K KIT

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary

MANUFACTURER PART NUMBER (MPN): 1688011002P

2.00
EA
__________________
__________________

CONNECTED OR HUB BASE WITH DEVICE CONTROL, DICOM AND SDP1000 PRINTER KIT

MANUFACTURER PART NUMBER (MPN): 0240200312

5.00
EA
__________________
__________________

PKG 32IN 4 K OLED SURGICAL DISPLAY

MANUFACTURER PART NUMBER (MPN): 0240031300

6.00
EA
__________________
__________________

1688 AIM 4K CAMERA HEAD AND AIM 4K COUPLER KIT

MANUFACTURER PART NUMBER (MPN): 1688210122

1.00
EA
__________________
__________________

PNEUMOCLEAR CO2 CONDITIONING INSUFFLATOR KIT BOTTLE GAS

MANUFACTURER PART NUMBER (MPN): 0620050001

2.00
EA
__________________
__________________

PNEUMOCLEAR CO2 CONDITIONING INSUFFLATOR KIT HOUSE GAS

MANUFACTURER PART NUMBER (MPN): 0620050002

6.00
EA
__________________
__________________

FG, SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY, 5 MM

MANUFACTURER PART NUMBER (MPN): 0233050400

4.00
EA
__________________
__________________

PRECISION IE 4K CMT ASC ATCL4X30° 140SLK

MANUFACTURER PART NUMBER (MPN): 0502-404-030

2.00
EA
__________________
__________________

PRECISION IE 4K CMT ASC ATCL4X70° 140SLK

MANUFACTURER PART NUMBER (MPN): 0502-404-070

2.00
EA
__________________
__________________

PKG, HYSTEROSCOPE, 2.9MM 12DEG

MANUFACTURER PART NUMBER (MPN): 0502-729-012

4.00
EA
__________________
__________________

PRECISION IE 4K CMT ASC ATCL4X30° 165SLK

MANUFACTURER PART NUMBER (MPN): 0502-414-030

2.00
EA
__________________
__________________

PKG, CANNULA, 3.2MM 2 ROT. STOPCOCKS

MANUFACTURER PART NUMBER (MPN): 0502-344-560

2.00
EA
__________________
__________________

PKG, 3.2MM SPDLOCK PENCIL TIP OBTURATOR

MANUFACTURER PART NUMBER (MPN): 0502-344-500

2.00
EA
__________________
__________________

PKG, PRECISION HD 30° ATS 2.7X75 CMT SLK4K

MANUFACTURER PART NUMBER (MPN): 0502-826-030

2.00
EA
__________________
__________________

PKG, SHEATH, 2.9 MM DIAGNOSTIC INNER

MANUFACTURER PART NUMBER (MPN): 0502-729-051

2.00
EA
__________________
__________________

PKG, SHEATH, 2.9 MM DIAGNOSTIC OUTER

MANUFACTURER PART NUMBER (MPN): 0502-729-052

2.00
EA
__________________
__________________

PKG, SHEATH, 2.9 MM OPERATIVE INNER

MANUFACTURER PART NUMBER (MPN): 0502-729-061

2.00
EA
__________________
__________________

PKG, SHEATH, 2.9 MM OPERATIVE OUTER

MANUFACTURER PART NUMBER (MPN): 0502-729-062

2.00
EA
__________________
__________________

PKG, OBTURATOR, 2.9MM DIAGNOSTIC

MANUFACTURER PART NUMBER (MPN): 0502-729-050

2.00
EA
__________________
__________________

PKG, OBTURATOR, 2.9MM OPERATIVE

MANUFACTURER PART NUMBER (MPN): 0502-729-060

4.00
EA
__________________
__________________

PKG. PUMP CANNULA 5.8MM W 2 ROTATING STOPCOCKS

MANUFACTURER PART NUMBER (MPN): 0747031550

4.00
EA
__________________
__________________

PKG. PENCIL OBTURATOR 5.8MM PUMP CANNULA

MANUFACTURER PART NUMBER (MPN): 0747031510

4.00
EA
__________________
__________________

PKG PENCIL OBTURATOR

MANUFACTURER PART NUMBER (MPN): 0502577515

2.00
EA
__________________
__________________

PKG CROSSFIRE 2 CONSOLE

MANUFACTURER PART NUMBER (MPN): 0475100000

4.00
EA
__________________
__________________

PACKAGING FORMULA SHAVER HAND CONTROL

MANUFACTURER PART NUMBER (MPN): 0375704500

2.00
EA
__________________
__________________

PKG CROSSFIRE FOOTSWITCH

MANUFACTURER PART NUMBER (MPN): 0475000100

4.00
EA
__________________
__________________

PKG CANNULA 5.8MM W 2 ROTATING STOPCOCK

MANUFACTURER PART NUMBER (MPN): 502-577-550

3.00
EA
__________________
__________________

PRECISION IDEAL EYES 10MM 0° HD AC LPSC

MANUFACTURER PART NUMBER (MPN): 0502-103-010

3.00
EA
__________________
__________________

PRECISION IDEAL EYES 10MM 30° HD AC LPSC

MANUFACTURER PART NUMBER (MPN): 0502-103-030

3.00
EA
__________________
__________________

PRECISION IDEAL EYES 5.5 0° HD ACL LAP30

MANUFACTURER PART NUMBER (MPN): 0502-503-010

2.00
EA
__________________
__________________

1688 DVI FAIL-SAFE PACKAGE

MANUFACTURER PART NUMBER (MPN): 0678008007

16.00
EA
__________________
__________________

BOOM DEVICE CONTROL KIT 100FT

MANUFACTURER PART NUMBER (MPN): P47830

2.00
EA
__________________
__________________

MOUSE WHITE USB OPTICAL

MANUFACTURER PART NUMBER (MPN): 0100224675

2.00
EA
__________________
__________________

COMPONENT SP13 MEDICAL GRADE KEYBOARD ENGLISH

MANUFACTURER PART NUMBER (MPN): P11440

2.00
EA
__________________
__________________

CONNECTED OR LITE BASE INSTALLATION

MANUFACTURER PART NUMBER (MPN): 8888882060

2.00
EA
__________________
__________________

CABLE ASSY DVI M TO DVI M 15 FT

MANUFACTURER PART NUMBER (MPN): P43648

2.00
EA
__________________
__________________

CABLE DVI-D-SL-F TO HDMI-M 0.5 M

MANUFACTURER PART NUMBER (MPN): P38193

2.00
EA
__________________
__________________

DISPLAY 55IN 4K

MANUFACTURER PART NUMBER (MPN): P45952

2.00
EA
__________________
__________________

COR LITE NEC DISPLAY

MANUFACTURER PART NUMBER (MPN): P47946

2.00
EA
__________________
__________________

MOUNT PLATE PLASMA LCD

MANUFACTURER PART NUMBER (MPN): 0100224158

4.00
EA
__________________
__________________

COR LITE 4K DISPLAY HUB ON DOC

MANUFACTURER PART NUMBER (MPN): P47691

4.00
EA
__________________
__________________

COR LITE BOOM KIT

MANUFACTURER PART NUMBER (MPN): P47833

2.00
EA
__________________
__________________

CONNECTED OR LITE DOC STATION PACKAGE

MANUFACTURER PART NUMBER (MPN): 1678100400

2.00
EA
__________________
__________________

COR LITE 1688 HUB ON DOC

MANUFACTURER PART NUMBER (MPN): P47689

6.00
EA
__________________
__________________

COR LITE HD BOOM PLT HUB ON DOC

MANUFACTURER PART NUMBER (MPN): P47695

6.00
EA
__________________
__________________

COMP OPTICIS MULTI FORMAT VIDEO WALL PLATE

MANUFACTURER PART NUMBER (MPN): P44068

4.00
EA
__________________
__________________

JUNCTION BOX 10X8X4

MANUFACTURER PART NUMBER (MPN): 500020417

4.00
EA
__________________
__________________

SUSPENSION SINGLE MONITOR SERVICE KIT

MANUFACTURER PART NUMBER (MPN): P52196

4.00
EA
__________________
__________________

BOOM CAT6 CABLE KIT 100 FT

MANUFACTURER PART NUMBER (MPN): P48708

2.00
EA
__________________
__________________

COMP BARCO 21.5IN TP AND POWER SUPPLY

MANUFACTURER PART NUMBER (MPN): P39859

2.00
EA
__________________
__________________

COMP 9U WALL MOUNT 19IN CABINET

MANUFACTURER PART NUMBER (MPN): P44931

2.00
EA
__________________
__________________

COR LITE 9U RACK SHELF KIT

MANUFACTURER PART NUMBER (MPN): P48614

2.00
EA
__________________
__________________

ACCESSORIES KIT FLUSH MOUNT SPEAKER

MANUFACTURER PART NUMBER (MPN): 0680-000-239

2.00
EA
__________________
__________________

COR LITE AUDIO HUB ON DOC

MANUFACTURER PART NUMBER (MPN): P47831

2.00
EA
__________________
__________________

COR LITE FIFTH INPUT ENABLING KIT

MANUFACTURER PART NUMBER (MPN): P47694

2.00
EA
__________________
__________________

INSTALLATION-IMPLEMENTATION STAGING CHARGE

MANUFACTURER PART NUMBER (MPN): 8888888401

1.00
EA
__________________
__________________

PROJECT SERVICES

MANUFACTURER PART NUMBER (MPN): 88888888

12.00
MO
__________________
__________________

1 year of support service (base)

12.00
MO
__________________
__________________

1 year of support service (OY#1)

12.00
MO
__________________
__________________

1 year of support service (OY#2)

12.00
MO
__________________
__________________

1 year of support service (OY#3)

12.00
MO
__________________
__________________

1 year of support service (OY#4)

GRAND TOTAL
__________________

Statement of Work *Ensure bids include only TAA-compliant products*

1. SCOPE OF WORK

a. The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to perform the following:

b. All products must meet all salient characteristics defined within the SOW. All equipment and installation must meet manufacturers and VA specifications.

c. The contractor shall furnish all supplies, equipment, facilities, and services required for delivery and installation of this equipment.

d. The contractor is responsible for any missing parts and components not included in the order to carry out the installation.

2. EQUIPMENT

The equipment shall be provided and delivered by the Contractor in the space determined by the Government. All equipment delivered by the Contractor shall be FDA approved for use, in new condition, and fully operational in accordance with manufacturer literature specifications. A minimum of two (2) copies of any associated operational and/or service manuals shall be provided for all equipment listed below as applicable.

The Contractor shall provide all tools and equipment necessary to properly and safely perform the services set forth within this statement of work. This shall include, but is not limited, to all Personal Protective Equipment (PPE) which may be required for the work to be completed in a safe manner. The Contractor shall provide any equipment necessary for proper infection control measures during installation.

3. SERVICE SUPPORT

Contract should include Unlimited repairs & free shipping for all contracted equipment, 24-hour turnaround time for replacement products & loaners, Proprietary software upgrades, Comprehensive coverage & capitated monthly pricing for the contract term, Certified repair technicians using exclusive original manufacture components and New-manufacture quality inspection & field inspection conducted on all repairs in accordance with FDA Quality System Regulations (21CFR Part 820) & ISO 13485

4. DELIVERY

The shipping label and packing slip will contain the following information for ease of receipt:

1) Ship To:

a. VA Medical Center, 3687 Veterans Drive, Fort Harrison MT 59636

Delivery Hours of Operation: Monday – Friday; 0700hrs – 1500hrs; excluding all Federal Holidays.

5. INSPECTION

Upon receipt, equipment will be inspected by the Biomedical Engineering Department.

6. ACCEPTANCE

Prior to acceptance of the goods or services provided under this contract, inspection and testing will be performed by the Government in accordance with this clause. Upon delivery the equipment shall be turned over to the hospital for use. The contractor shall furnish, upon delivery, a written notice of readiness for inspection for the Contracting Officer and the requesting service.

7. TRAINING

Manufacturer to provide.

8. INVOICING AND SUPPORTING DOCUMENTATION

The supporting documentation and invoice shall be submitted within 30 days at the end of each month. Subsequent changes or corrections shall be submitted by a separate invoice. In addition to information required for submission of a ‘proper’ invoice in accordance with FAR 52.212-4 (g), all invoices must include the following information:

a. Name and Address of Contractor

b. Contractor’s Tax Identification Number

c. Date of Invoice

d. Invoice Number

e. Contract Number

f. Purchase Order Number

g. Date of Service

h. Contract Line Item Number (CLIN)

i. Description, Quantity, Unit of Measure, Unit Price and Extended Price of the items delivered

j. Total Price

9. SPECIAL WORK REQUIREMENTS

The Contractor shall comply with all Infection Control Risk Assessment requirements deemed appropriate by the Rocky Mountain Regional VA Medical Center during all portions of the work set forth in the Scope of Work.

The Contractor must comply with security, privacy, and safety issues in accordance with VA standards, policies, and directives always set forth while providing the work outlined in the Scope of Work.

10. IDENTIFICATION, PARKING, SMOKING, CELL PHONE USE AND VA REGULATIONS

If the vendor is required to facilitate in any way once the equipment has been delivered, inspected, and received on the units, the contractor's employees shall always wear visible identification while on the premises of the VA property. 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. The VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VA and on VA property. 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.

11. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD

The contractor shall comply with the Federal OSHA Blood borne Pathogens Standard. The contractor shall:

a) Have methods by which all employees are educated as to risks associated with blood borne pathogens.

b) Have policies and procedures which reduce the risk of employee exposure to blood borne pathogens.

c) Have mechanisms for employee counseling and treatment following exposure to blood borne pathogens.

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

12. SAFETY STANDARDS

Monitor & Modules comply with the Medical Device Directive:

93/42/EEC (CE0366) and with IEC 60601-1:1988 + A1:1991 + A2:1995; EN60601-1:1990 + A1:1993 + A2:1995; UL 60601-1:2003; CAN/CSA C22.2#601.1-M90 + Suppl. No 1-94 + Am.2; IEC 60601- 1-1:2000; EN 60601-1-1:2001; IEC 60601-1-2:2000 +A1:2004; EN 60601-1-2:2001 +A1:2006.

13. RECALLS

The Vendor shall immediately notify all affected VA Medical Centers and designated POC in the event of a device recall, removal, required adjustment, or required modification that is suggested or mandated by the Vendor, distributor, manufacturer, or any regulatory or government agency. The following information shall be included in this notification:

A complete item description and identification (to include lot and serial numbers where applicable); administrative identification data including order numbers and order date; reasons for recall, removal, adjustment, or modification; and Instructions for appropriate corrective action.

14. PENALTY FOR NON-PERFORMANCE

If services and products do not conform to contract requirements, the Government may require the contractor to perform the services again in conformity with contract requirements, at no additional cost to the Government, if appropriate. When the defects in services and products cannot be corrected by re-performance, the Government may:

· Reduce the contract price to reflect the reduced value of the service performed and product delivered.

15. INFORMATION SECURITY LANGUAGE

VA directive 6550 Appendix C

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

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. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be 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.

e. 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. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are following VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor while performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. 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 the contract.

e. 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.

f. 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.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

4. 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.

5. 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 SPI the contractor/subcontractor processes or maintains under this contract.

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.

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

6. CONTRACTOR 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

(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.

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SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of…

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