S02 - ATTACHMENT 1 - RFQ 36C24525Q0566 - LAPAROSCOPIC SYSTEM FOR BECKLEY VAMC - BRAND NAME OR EQUAL TO STRYKER IAW SOW - 06-11-2025.pdf

PAGE 1 OF 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. 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

36C24525Q0566 06-11-2025

MOHSIN ABBAS EMAIL ONLY 06-20-2025

3:00 PM EDT

36C245

U.S. Department of Veterans Affairs

Beckley VA Medical Center

Contracting Office (90C)

200 Veterans Avenue

Beckley WV 25801

X

339112

1000 Employees

N/A

X

517/90

U.S. Department of Veterans Affairs

Beckley VA Medical Center

Warehouse

200 Veterans Avenue

Beckley WV 25801

36C245

U.S. Department of Veterans Affairs

Beckley VA Medical Center

Contracting office (90C)

200 Veterans Avenue

Beckley WV 25801

PAYMENT WILL BE MADE BY

FSC e-Invoice Payment

Invoice must be submitted electronically https://www.fsc.va.gov/einvoice.asp

Invoice Setup Information 1-877-489-6135

See CONTINUATION Page

LAPAROSCOPIC SYSTEM FOR BECKLEY VA MEDICAL CENTER.

"BRAND NAME OR EQUAL TO STRYKER IAW SOW".

** THIS RFQ IS FOR SINGLE AWARD **

THE GOVERNMENT WILL AWARD A CONTRACT RESULTING FROM THE

SOLICITATION TO THE RESPONSIVE OFFEROR WHOSE OFFER

CONFIRMING TO THE SOLICITATION WILL BE MOST ADVANTAGEOUS TO

GOVERNMENT. ** MUST COMPLETE TRADE AGREEMENT CERTIFICATE **

* SEE DETAILS IN 52.212-2 - EVALUATION - COMMERCIAL ITEMS *

OEM DISTRIBUTOR/AUTHORIZATION LETTER FROM THE MANUFACTURER

IS REQUIRED FOR ALL QUOTES, IF NO OEM LETTER IS SUPPLIED THE

QUOTER WILL BE CONSIDERED NON-RESPONSIVE & THE VENDOR WILL

BE DISQUALIFIED AT THE TIME RFQ WILL CLOSE.

ALL QUOTATION SHALL BE SUBMITTED VIA EMAIL TO MOHSIN ABBAS

EMAIL: MOHSIN.ABBAS2@VA.GOV. SUBMISSION SHALL BE RECEIVED

NO LATER THAN JUNE 20, 2025, AT 3:00 PM EST.

See CONTINUATION Page

X X

X 1

JOSEPH KRUPA

CONTRACTING OFFICER

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

36C24525Q0566

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 IT CONTRACT SECURITY

B.3 STATEMENT OF WORK

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

B.5 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)

C.3 NOTICE – SYSTEM UPDATES MAY LAG POLICY UPDATES

C.4 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.5 52.219-9 SMALL BUSINESS SUBCONTRACTING PLAN (JAN 2025)

C.6 52.222-41 SERVICE CONTRACT LABOR STANDARDS (AUG 2018)

C.7 52.222-42 STATEMENT OF EQUIVALENT RATES FOR FEDERAL HIRES (MAY

2014)

C.8 52.222-62 PAID SICK LEAVE UNDER EXECUTIVE ORDER 13706 (JAN 2022) .. 71

C.9 VAAR 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899 (DEVIATION

(APR 2025)

C.10 52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS (JUN

2013)

C.11 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023) ... 77

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

(NOV 2018)

C.13 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.14 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 79

C.15 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

C.16 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.17 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.18 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.19 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1. WAGE DETERIMATION – 2015-4265

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.2 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION

FEB 2025)

E.4 52.225-5 TRADE AGREEMENTS (NOV 2023)

E.5 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)

E.6 52.247-34 F.O.B. DESTINATION (NOV 1991)

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.8 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.9 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.10 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.11 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.12 52.216-1 TYPE OF CONTRACT (APR 1984)

E.13 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.14 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

E.15 52.211-6 BRAND NAME OR EQUAL (AUG 1999)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C245 JOSEPH KRUPA - CS: MOHSIN ABBAS

U.S. Department of Veterans Affairs

Beckley VA Medical Center

Contracting Office (90C)

200 Veterans Avenue

Beckley WV 25801

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 & Acceptance. Upon Proper Invoices

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

Requests.

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

AMENDMENT NO DATE

B.2 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

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

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 in compliance with 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 in the course of 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 this 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 COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart

C, information and system security categorization level designations in accordance with FIPS

199 and FIPS 200 with implementation of all baseline security controls commensurate with the

FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA

Information Security Program). During the development cycle a Privacy Impact Assessment

(PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration

(FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

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

"program files" directory and silently install and uninstall.

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

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST

Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal

Information Systems, VA Handbook 6500, Information Security Program and VA Handbook

6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records

Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of

1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a

SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a

SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

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

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

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

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g.

for the convenience of VA) shall only be granted with approval of the contracting officer and the

VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A

Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA

Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally

Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification

Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the

PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program

Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA

Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

(1) Vendor must accept the system without the drive;

(2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The

ISO needs to maintain the documentation.

6. 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

COR 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.

7. 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 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least

3 relevant credit bureau reports;

(3) Data breach analysis;

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

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

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

8. SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day's notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by

VA in the event of a security incident or at any other time.

9. TRAINING

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

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

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

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

(4) Successfully complete any additional cyber security or privacy training, as required for

VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document - e.g., any role-based information security training required in accordance with NIST Special Publication

800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COR 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.

(End of Clause)

B.3 STATEMENT OF WORK

STATEMENT OF WORK (SOW)

BECKLEY LAPAROSCOPIC SYSTEM

“BRAND NAME OR EQUAL TO STRYKER IAW SOW”

A. GENERAL:

Scope of Services:

The purpose of this requirement is to replace the failing laparoscopic towers for the

Operating Rooms at the Beckley VA Medical Center. The requirement includes the cameras, controllers, carts, light sources, device controllers, transmitters, receivers, displays, insufflators, printers, and more for the three systems. The procurement shall include all parts, materials, labor, software/licenses, and travel to complete the full installation/configuration of the systems.

Location: 200 Veterans Ave, Beckley, WV 25801

Performance Period: Requested delivery within 90 days of award

B. WORK HOURS:

a. Hours of Operation: Normal business hours are Monday through Friday, 8:00 a.m. 4:00 p.m., excluding holidays. Should the Contractor require work afterhours, the Contractor shall arrange in advance with the

Contracting Officer’s Representative (COR).

b. Delivery Hours: The Warehouse is open to receive deliveries Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding holidays.

c. National Holidays: The holidays observed by the Federal Government are:

New Year’s Day, Martin Luther King Day, President’s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran’s

Day, Thanksgiving Day, and Christmas Day and any other day specifically declared by the President of the United States to be a national holiday.

Contractor may work on holidays with prior communication and coordination.

C. SPECIFICATIONS:

a. Technical Requirements

i. The procurement is for a brand name or equal solution for three comprehensive surgical video tower systems to be utilized during laparoscopic, sinuscopic, and arthroscopic cases.

ii. The Stryker brand name components include:

Description/Part Number* Qty

1788010000 PKG 1788 Camera Control Unit CCU 3

220240300 PKG L12 LED LIGHT SOURCE WITH AIM 3

0240099110K FLAT PANEL ROLL STAND KIT 1

240200412 Connected OR Hub Base System with Device Control and SDP1000 Printer

240031065 Pkg SYNK 4K Wireless Transmitter 3

240031075 Pkg SYNK 4K Wireless Receiver 3

240031311 32IN 4K OLED Surgical Display with OLED Display

Cover Kit

1788610122

PKG 1788 4K CAMERA HEAD WITH INTEGRATED

COUPLER

233050400

FG SAFELIGHT FIBER OPTIC CABLE WITH

ADVANCED IMAGING MODALITY 5 MM

0502-103-010 PRECISION IDEAL EYES 10MM 0° HD AC LPSC 6

0502-103-030 PRECISION IDEAL EYES 10MM 30° HD AC LPSC 6

0502-503-010 PRECISION IDEAL EYES 5.5 0° HD ACL LAP30 6

0502-503-030 PRECISION IDEAL EYE 5.5 30° HD ACL LAP30 6

240-099-155 Connected OR Cart 120 V 3

620050001

PNEUMOCLEAR CO2 CONDITIONING

INSUFFLATOR KIT BOTTLE GAS

0502-444-030 PRECISION IE 4K EYPC ASC ATCL4X30°140SLK 8

0502-444-070 PRECISION IE 4K EYPC ASC ATCL4X70°140SLK 3

0502-127-030

HD 2.7MMX30° ARTHROSCOPE SPEEDLOCK

A/C

747031530 PKG. PUMP CANNULA 5.8MM W 1 ROTATING ST 11

747031510 PKG. PENCIL OBTURATOR 5.8MM PUMP 11

CANNULA

0343-331-430

PKG. 4.0MM SINGLE ROTATING STOPCOCK -

WITH HOLES

0343-331-410 PKG. OBTURATOR 4.0MM PENCIL TIP 1

0502-655-010 Precision S 4K Sinuscope, Autoclavable, 4mm x 0°, 180mm Â

0502-654-045 PRECISION S 4K SINUSCOPE, ACLV,4X45°,155 3

0502-654-070 PRECISION S 4K SINUSCOPE, ACLV,4X70°,155 3

0502652010K 0502652010 Sinuscope and 0502752010 Sheath Kit 3

0502652030K 0502652030 Sinuscope and 0502752030 Sheath Kit 3

233032105

ENDOSCOPE AND CAMERA STERILIZATION

TRAY

233032108 PKG LAPAROSCOPE STERILIZATION TRAY 10

233032116 ENDOSCOPE AND HARDWARE SET TRAY 12

iii. The systems shall be able to perform the video visualization function for all laparoscopic, sinuscopic, and arthroscopic cases at the Beckley VAMC.

iv. The three systems shall be on towers/carts to allow for mobility in the operating room.

v. The system shall have advanced visualization/quality.

vi. The system shall have the ability for visualizing perfusion during open surgery.

vii. The systems shall include 2, 32inch, 4K, OLED displays. One located on the scope tower and the other to be located on an existing equipment boom.

viii. The systems’ insufflators are preferred to have integrated heating, humidification, and smoke evacuation.

ix. The system shall offer a means to export captured images off the device to be later scanned and manually uploaded into the VA

EMR.

x. The provided boom mounted monitors shall be able to connect to the existing Steris video integration system for displaying video/images in the ORs via a hardwired connection (i.e. HDMI).

xi. Contractor shall provide two copies of the operating and service manuals.

xii. Scope Requirements

1. Laparoscopes

Diameter, mm

Working

Length, mm

Direction of view, degrees

Field of View, degrees Definition Cleaning Quantity

10 330 0 75 HD Autoclavable 5

10 330 30 75 HD Autoclavable 5

5 300 0 75 HD Autoclavable 5

5 300 30 75 HD Autoclavable 5

2. Arthroscopes mm

Working

Length, mm

Direction of view, degrees Lock Type Definition Cleaning Quantity

4 140 mm 0 deg Speedlock 4K Autoclavable 8

4 140 mm 70 deg Speedlock 4K Autoclavable 3

3. Sinuscopes mm

Working

Length, mm

Direction of view, degrees

Field of

View, degrees

Definition Cleaning Quantity

4 180 0 105 4K Autoclavable 3

4 155 45 105 4K Autoclavable 3

4 155 70 105 4K Autoclavable 3

3.1 170 0 80 4K Autoclavable 3

3.1 170 30 80 4K Autoclavable 3

xiii. Networking Requirements.

1. Connection to the VA network is NOT a requirement.

2. If the proposed solution requires a VA network connection to operate, the vendor will be required to complete the VA’s required documentation.

a. Should the manufacturer of the equipment not have an approved Enterprise Risk Analysis completed, this will be required in order to fully install the system on the network.

b. Only OEM-supported operating systems shall be provided

c. Following purchase, the VA will provide specific network information for the configuration of the system.

d. If remote support is required, the Contractor must have a completed MOU/ISA.

xiv. Cleaning/Sterilization Requirements.

1. The Contractor shall provide cleaning/sterilization instructions (Instructions for Use – IFU) for the Government to determine the ability of the facility to properly process the equipment.

b. Delivery Requirements

i. Delivery is required 90 days from award of the contract.

ii. Large deliveries are to be coordinated in advance with the COR to ensure necessary planning takes place.

iii. Contractor is to provide the COR with shipment tracking information.

c. Installation Requirements

i. Full installation of the system shall be included as a part of this contract. This will include, but not be limited to:

1. Assembly and configuration of scope towers

2. Mounting of monitors on existing equipment booms.

Contractor shall provide new mounting brackets if existing bracket cannot support the new monitors. Contractor to utilize existing power present in the boom.

ii. All parts, materials, tools, labor, and travel to complete the installation shall be included as a part of this contract.

iii. Contractor is required to complete all configuration for the system to be usable.

iv. Contractor shall provide validation that the system is fully functional upon completion of the installation/implementation.

v. Patient Health Information

1. The Contractor shall safeguard patient health information.

2. The Contractor shall report to the Biomedical Engineering

Department any issues with disclosed or unsecure patient health information.

vi. Contractor shall not remove any hard-drives or storage systems containing sensitive or patient health information.

d. Training Requirements

i. Contract shall include training for the end-users in the operation of the system.

1. Training shall be on the function and use of the device, in addition to any software/applications.

2. Training shall be on-site for one day.

ii. Contract shall include training for the technical professionals

(Biomedical Equipment Support Specialists)

1. Training shall cover the maintenance, troubleshooting, and repair of the system.

2. Training shall be on-site for one day.

e. Contractor Requirements

i. All Contractor personnel performing installation services of the equipment shall have factory training and experience in the implementation of the equipment.

ii. Contractor shall provide copies of training certificates for the

Contractor personnel performing work on-site upon the request of the Government.

f. Warranty Information

i. The equipment shall have a warranty of 1 year from the full installation/acceptance of the equipment.

ii. Warranty support shall include repair of the system

iii. Warranty support shall include all parts, materials, labor, and travel to complete the repair or maintenance.

iv. Requests for warranty support shall be made to the telephone support number provided by the Contractor.

v. Warranty support requests shall be responded to within 2 days.

vi. Contractor shall perform any available system updates during the warranty period at the discretion of Biomedical Engineering.

vii. Contractor shall provide a copy of the service report, complete with test data, to the contract COR within five working days after completion of any services.

viii. Service reports shall include identifying information about the equipment, all services provided during the service visit, any issues found during the visit, the technician/engineer names of the personnel performing work, and the date service was provided.

ix. On-Site Procedures

1. Contractor personnel arriving on-site to perform work shall report to the Biomedical Engineering Department.

2. Contractor personnel shall sign in using the department’s vendor sign in sheet, filling out all required information.

3. Contractor personnel’s tool bags are subject to inspection by the Biomedical Engineering department upon arrival and upon departure.

4. Contractor personnel shall sign out upon completion of visit.

5. Prior to departure, Contractor personnel are required to, at a minimum, verbally report any issues with the equipment to the Biomedical Engineering department, especially noting if the system is still down or not fully repaired.

6. The VA campus is non-smoking. Contractor personnel are required to comply with this policy.

7. Parking. It is the responsibility of the Contractor to park in the appropriate designated parking areas.

g. Safety and Security

i. Contractor shall follow all Occupational Safety and Health

Administration (OSHA) laws and regulations. The Contractor is responsible for reporting any hazards they come across to their point of contact.

ii. Contractor shall follow all local procedures concerning infection control. Should the Contractor be unsure of the requirements, the

COR can provide the specific information and procedures.

iii. Contractor personnel shall wear visible identification at all times while on VA property. Contract personnel are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials.

iv. Property Damage

1. The contractor shall take all necessary precautions to prevent damage to any Government property.

2. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the…