36C24724Q0568.docx

36C24724Q0568

GENERAL INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Carl Vinson VA Medical Center 1826 Veterans Blvd.

Dublin GA 31021

POINT OF CONTACT*

Contracting Officer Sheryl Harris sheryl.harris5@va.gov email only

PLACE OF PERFORMANCE

Atlanta VA healthcare System

Inpatient Pharmacy Service

670 Clairmont Road

Decatur GA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. Solicitation 36C24724Q0568 is issued as a request for quotation. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-01. This solicitation is issued as A SDVOSB set-aside, the associated NAICS code is 532490 and small business size $40.0 million.

DESCRIPTION: The Department of Veterans Affairs, Networking Office 7 is looking to award a firm-fixed price purchase to lease a Modular mobile Pharmacy Compounding Cleanroom. Also, onsite implementation, installation, decommissioning, and equipment interface is required for the Atlanta VA Health Care System Pharmacy Service Pharmacy Service Line, 1670 Clairmont Road, Decatur, GA 30033.

TERMS: This requirement incorporates one or more clauses/provisions by reference, with the same force and effect as if they were given in full text. The full text of a clause or provision may be accessed at http:///www.acquisition.gov/far/index.html and http://www.va.gov/oal/library/vaar/. Offerors are encouraged to, and responsible for, reviewing the full solicitation (attached) for detailed requirement description, applicable terms and conditions, provisions, submittal instructions to offerors, and evaluation procedures prior to submitting their quotes. All Offerors must have an active registration in the System for Award Management (SAM), www.sam.gov, at the time of submittal.

QUESTIONS: Any questions pertaining to this requirement must be emailed to sheryl.harris5@va.gov no later than 1:00 PM CT, April 17, 2024, include Solicitation 36C24723Q0568 in the subject line of the email to ensure timely review and response. No questions will be accepted nor answered after this date and time. Response to questions will be posted as an amendment to the solicitation once the question period has expired. Offerors are responsible for monitoring Contracting Opportunities at www.sam.gov for any amendments to the solicitation as the government will not send notice of amendments. Representatives from potential Offerors or on behalf of potential Offerors shall not contact any VA Medical Center representative to discuss nor inquire about this solicitation.

DEADLINE: All offers/quotes must be submitted in a single email to sheryl.harris5@va.gov and received no later than 10:00 AM CT, April 22, 2024, and 36C24724Q0568 Page 5 of 28 include Solicitation 36C24724Q0568 in the subject line of the email. Offerors are encouraged to, and responsible for, reviewing the full solicitation (attached) for detailed requirement description, applicable terms and conditions, provisions, submittal instructions to offerors, and evaluation procedures prior to submitting their quotes.

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

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

36C24724Q0568 04-11-2024 Sheryl Harris email only 04-22-2024 10:00 am

CDT

Department of Veterans Affairs Carl Vinson VA Medical Center 1826 Veterans Blvd.

Dublin GA 31021 X X 532490 $40 Million N/A X See Delivery Schedule

Department of Veterans Affairs Carl Vinson VA Medical Center 1826 Veterans Blvd.

Dublin GA 31021

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Please reference B.2 Price Cost Delivery Schedule to include.

the Statment of Work.

Delivery Schedule will be 15-30 days after receipt of award.

See CONTINUATION Page x X Sheryl Harris Contracting Officer Page 1 of Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C247 Sheryl Harris Department of Veterans Affairs Carl Vinson VA Medical Center 1826 Veterans Blvd.

Dublin GA 31021

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

3. INVOICES: Invoices shall be submitted in arrears:

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

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

B.2 PRICE/COST SCHEDULE ITEM INFORMATION

14' X 48' USP 797/800 COMPLIANT MOBILE PHARMACY COMPOUNDING CLEANROOM: PREMIUM WARRANTY COVERAGE FOR MOBILE PHARMACY COMPOUNDING CLEANROOM; TRANSPORTATION, CRANING, INSTALLATION AND COMMISSIONING; DECOMMISSIONING, CRANING AND REMOVAL; SITE PREP; LOCAL ATL CONTRACTOR TO INSTALL WOODEN COVERED ENCLOSED WALKWAY LEADING OUT FROM HOSPITAL DOCK TO MAIN ENTRY INTO THE MOBLIE CLEANROOM; DEMO; HAZARDOUS EXHAUST STACK EXTENSION Contract Period: Base POP Begin: 05-01-2024 POP End: 04-30-2025

14' X 48' USP 797/800 COMPLIANT MOBILE PHARMACY COMPOUNDING CLEANROOM: PREMIUM WARRANTY COVERAGE FOR MOBILE PHARMACY COMPOUNDING CLEANROOM; TRANSPORTATION, CRANING, INSTALLATION AND COMMISSIONING; DECOMMISSIONING, CRANING AND REMOVAL; SITE PREP; LOCAL ATL CONTRACTOR TO INSTALL WOODEN COVERED ENCLOSED WALKWAY LEADING OUT FROM HOSPITAL DOCK TO MAIN ENTRY INTO THE MOBLIE CLEANROOM; DEMO; HAZARDOUS EXHAUST STACK EXTENSION Contract Period: Option 1 POP Begin: 05-01-2025 POP End: 04-30-2026

B.3 DELIVERY SCHEDULE

Atlanta VA Medical Center 1670 Clairmont Road Decatur, GA 30033

USA

12.00

404-321-6111 kendra.slaughter@va.gov

STATEMENT OF WORK

Modular Mobile Pharmacy Compounding Cleanroom USP 797/800

Introduction and Overview:

The Atlanta VA Healthcare System, Pharmacy Service Line is requesting to lease a Modular mobile Pharmacy Compounding Cleanroom. Also, onsite implementation, installation, decommissioning, and equipment interface is required.

Background:

The purpose of this contract is to provide the Atlanta VA Healthcare System with a modular mobile pharmacy cleanroom lease that is compliant with current USP 797 and USP 800 standards until construction is complete on the current cleanroom. The Atlanta VA Health Care System Pharmacy Service compounds numerous medications daily so a temporary USP 797 and USP 800 cleanroom is required to avoid any interruption to patient care services.

Objective:

The objective of this contract is to provide a modular mobile Compounding cleanroom designed and engineered to meet USP 797 and USP 800 standards and the following:

(1) Modular mobile pharmacy compounding cleanroom 14’ wide x48’ long.

(2) Hazardous exhaust that is installed and positioned 25 ft horizontal from any intakes and 10 ft above highest building rooftop along the side of facility building.

(3) A covered walkway with a ramp installed leading from the door of the facility to the entrance of the modular mobile pharmacy compounding cleanroom suite.

(4) Ensuring the modular mobile compounding cleanroom is elevated and leveled to the height of the loading dock.

This order is inclusive of all labor, materials, equipment, installation, testing, transportation, supervision necessary, and the decommissioning of all equipment and ensure the facility is returned close to the original condition.

Scope of Work:

The contractor shall provide the Atlanta Healthcare System with one modular mobile pharmacy cleanroom, to include all labor associated with install, delivery, materials, tools, equipment, and permits for timely installation of USP 797/800 compliant modular mobile pharmacy cleanroom. The contractor will provide all maintenance and repairs to ensure the cleanroom operational status meets USP 797/800 regulatory compliance and in accordance with the statement of work.

Period of Performance:

The period of performance for this contract consists of one 12-month base period with the option to extend. The contractor shall deliver the specified item(s) required under this SOW in 90 calendar days or less from date of award, unless otherwise directed by the Contracting Officer (CO).

Security Requirements for Contractor Employees:

The contractor will adhere to all HIPAA rules and regulations and Periodic software enhancements, upgrades and service will be included in the service/maintenance contract.

1.1 The contractor(s) shall insure the confidentiality of all patient and employee information and shall be held liable in the event of breach of confidentiality according to federal regulations contained in HIPPA. Any person who knowingly or willingly discloses confidential information from the VA Medical Centers may be subject to fines of up to $50,000 and may be subjected to civil litigation from the patient(s).

1.2 The contractor shall be compliant with VA Handbook 6500, Information Security Program.

1.3 Contract service shall ensure that the software application functions in conformance with the latest published edition of NFPA-99, OSHA, CDRH, JCAHO, FDA and manufacturer specifications.

Information Management:

1.1 System of Records: The Veterans Affairs system(s) of records to which the contractor(s) personnel will have access in order to maintain is “Patient Medical Records – VA (24VA136).”

1.2 1.2 System Security: The contractor(s) shall provide VA with the full assurance that security measures have been implemented which are consistent with OMB Circular A-130 and VA Departmental Standards.

1.3 Confidentiality of Patient Records: The C&A and Security

Fraud and Related Activity in Connection with Access Devices and Computers, 18 U.S.C. 1029-1030

Maintenance and Technical Support:

a. Customer service support must be available 24 hours/day, 7 days/week.

b. Contractor must have ability to troubleshoot operations remotely.

c. Provides afterhours support for problems with call-back periods not to exceed sixty (60) minutes from the placement of a call for assistance.

d. The contractor shall provide a system that maintains a minimum of 99% up time performance rate.

e. The contractor shall provide hardware necessary to connect remotely to the VA network and security system to allow the ability to dial into the system for diagnostics or upgrades. All security requirements must be met.

f. Any contractor equipment, hardware, software, and supplies must be compatible with the VA’s software and hardware used during performance of the requires services to include critical patches and antivirus updates to the COR upon request.

g. Contactor shall provide training on system operation to super users.

h. Contractor shall provide a telephonic method for the facility to call in emergency work orders for the system during any failures.

i. Upon notification of failures the contractor shall have a qualified technician at the facility within two (2) hours to conduct necessary repairs.

Decommission

a. Contractor to remove modular cleanroom within 1-2 workdays at termination of lease period including, but not limited to, preparation of interior for transport (enclosed walkway/ramp), securing equipment for transport, disconnection form access points (i.e. landings, stairs, etc.), disconnection form utilities and securing and removal of hazardous exhaust extensions and to ensure the area is returned close to the original condition.

General Requirement:

Equipment Requirement

a. 1 Modular Cleanroom

b. Overall dimensions of modular unit must be a minimum of 14’ wide by 48’ long and maximum of 16’ wide by 49’ long.

c. Modular unit must be installed to be level with dock area.

d. Modular unit must have ability for Personal Identity Verification (PIV) card reader to be installed on exterior door for VA security compliance.

e. Modular unit must be pre-wired with data jacks and allow for secure connection of VA network.

f. Modular unit must include cold water plumbing connections, an on-board water heater and drain connections.

g. Modular unit must include a HEPA filtration system and HVAC system that maintains interior temperature between 64 degrees Fahrenheit and 68 degrees Fahrenheit and relative humidity between 4% and 60%.

h. Modular unit must include an external fused electrical disconnect box with 480V, 3 phase 45% and 60%.

i. Modular unit must include all required life safety systems including, but not limited to fire alarm system, fire suppression system, unauthorized entry alarms, and emergency lighting.

j. Modular unit fire alarm system and fire suppression system must allow for connection to VA’s fire alarm system and VA’s fire suppression system, respectively.

k. Cleanroom space must be compliant with USP 797 and USP 800 standards.

l. Wall, floors, and ceilings of the modular unit must be smooth, impervious, free from cracks and crevices, non-shedding, and resistant to damage by disinfectants. Contractor must supply list of approved cleaners.

m. Non-hazardous cleanroom space must be positive pressure (+0.02 in.wc. relative to anteroom), ISO Class 7 cleanroom with minimum of 30 air exchanges per hour, HEPA filtration, hands-free door entry and interlocking pass-throughs. Contractor mut supply two ISO Class 5 laminar air flow hoods in this space.

n. Non-hazardous compounding anteroom must be positive pressure (+0.02 in.wc. relative to general work area), ISO Class 8 anteroom with hands-free sink, eyewash, and storage space for personal protective equipment (PPE).

o. Hazardous cleanroom space must be externally vented, negative pressure (-0.01 to -0.03 in.wc relative to anteroom), ISO Class 7 cleanroom with minimum of thirty (30) air exchanges per hour, HEPA filtration, hands-free door entry and interlocking pass-throughs. Contractor must supply two ISO Class 5 biological safety cabinets that are 100% exhausting in this space.

p. Hazardous compounding anteroom must be positive pressure (+0.02 in.wc. relative to general work area), ISO Class 7 anteroom with hands-free sink, eyewash, and storage space for personal protective equipment (PPE).

q. Separate hazardous medication storage room must be a negative pressure space with minimum of 12 air exchanges per hour an HEPA filtration.

r. Modular unit must include general work area outside of classified area and storage for non-hazardous medications and supplies.

s. Modular unit must include a separate entry area between the exterior and the interior of the modular unit to minimize contamination of the interior space.

t. Continuous monitoring system that provides electronic temperature, pressure, and relative humidity monitoring. Monitor system must include alarms when temperature, pressure or relative humidity are outside of acceptable range.

u. Two refrigerators (minimum of 20 cu.ft.) must be provided with continuous temperature monitoring and alarms.

v. Cleanrooms must have hands-free intercom system.

Performance Requirement

Delivery and Install

a. Delivery and installation must be coordinated with the Contracting Officer Representative (COR) to ensure installation is complete. Installation must include assistance with utility connections, leveling of modular unit, and configuring interior spaces of the modular unit.

b. The Contractor shall develop a project implementation strategy with the Atlanta VAMC to include the delivery, installation of equipment, and establishing telecommunications etc.

c. Contractor to perform initial terminal cleaning within 1-2 working days of installation and before 3rd party certification.

Description: Price/Cost Schedule

Salient Characteristics:

1. 14’ wide x 48’ long modular building, not a trailer on wheels.

2. (2) 4’ wide Laminar Air Flow hoods in the sterile buffer room.

3. (2) 4’ wide BSC’s in the Hazardous buffer room.

4. Hazardous exhaust that is installed and positioned 25 ft horizontal from any intakes and 10 ft above highest building rooftop along the side of facility building.

5. A covered walkway with a ramp installed leading from the door of the facility to the entrance of the mobile pharmacy compounding cleanroom suite.

6. Ability to add additional data jacks and electrical outlet upon request.

7. Remote monitoring/control system hosted on a secure server that enables clients to login securely to monitor their cleanroom by viewing data through Monitoring, Alarming, Historical Trending and Reporting graphical screens.

8. The system is designed to notify any registered manager or operator of alarm conditions via Voice, Email or SMS (text).

9. Security system (s) can be integrated into the VA’s systems through a “Dolphin” system.

10. Pre-certification include a “smoke test”. Pre-Certification report will be provided prior to delivery, and that report includes smoke tests for all FFU’s and Biosafety Cabinets.

Place of Performance / Place of Delivery:

Atlanta VA Healthcare System AATN: Pharmacy Service Line 1670 Clairmont RD Decatur, GA 30033

Planning, Installation, and decommissioning:

1. Contractor shall develop a project implantation strategy and shop drawing of hazardous exhaust extensions and enclosed walkway/ ramp with Atlanta VAHCS to include the preparation of space, establishing telecommunications etc Customer shall be responsible for preparation of the Customer Site for installation of the Equipment.

2. The service provider shall be required to utilize a point-to-point VPN between themselves and Atlanta VAHS, if necessary, to dial into the system for diagnostic or update purposes. All security requirements need to be met.

3. Contractor shall provide Preventative Maintenance PM check-ups increase overall system performance and extend the life. With regular, preventative care from both pharmacy staff and Modular Devices on-site and remote maintenance experts, the pharmacy will be to maximize system uptime and reduce downtime associated with unexpected failures.

4. Contractor shall provide all supplies, services, maintenance, repairs, and updates required at the time of install to provide services as described above.

5. Contractor shall decommission all equipment including removal of hazardous exhaust extensions, and enclosed walkway(ramp) at the completion of the lease.

Delivery of items:

Atlanta VA healthcare System (508) Inpatient Pharmacy Service (119) Attn: Warehouse (Dock) 1670 Clairmont Road Decatur, Georgia 30033 Open: 7-3:30pm Monday – Friday

Special Material Requirements:

There are no special materials associated with this purchase.

Acceptance:

Acceptance will be after install, set-up and initial use and verifications of performance as required.

Security Statement

• 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.

• 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.

• 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.

• 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.

• 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. Information, including, but not limited to, veteran individually identifiable information.

(ii) and personal healthcare information (PHI), gathered or created by the Contractor in the performance of this contract is the exclusive property of VA and must be received, gathered, stored, backed up, maintained, used, disclosed, and disposed of in accordance with the terms of this contract and applicable federal and VA information confidentiality and security laws, regulations, and policies, including VA Directive and Handbook number 6500.

• The Contractor shall provide access to VA information only to employees, subcontractors, and affiliates only: (1) to the extent necessary to perform the services specified in this contract, (2) to perform necessary maintenance functions for electronic storage or transmission media necessary for performance of this contract, and (3) only to individuals who first satisfy the same conditions, requirements, and restrictions that comparable VA employees must meet in order to have access to the same VA information. These restrictions include the same level of background investigations, where applicable.

• ALL VAIII AND PHI INFORMATION STORED ON BOTH VA AND NON-VA

EQUIPMENT MUST BE ENCRYPTED I ACCODRANCE WITH THE FEDERAL INFORMATION SECURITY MANAGEMENT ACT (FISMA). Federal standards established by U.S. Department of Commerce apply, including Federal Information Processing Standard 200 (FIPS200), and National Institute of Standards and Technology Special Publication 800-37, Guide for the Security Certification and Accreditation. Contractors and subcontractors shall document compliance and make the document available upon request of the Contracting Officer or COTR. Contractor and subcontractors shall allow physical inspection by VA personnel to assess its physical and environmental security controls.

• Required to sign VA National Rules of Behavior before they can be authorized access to VA information systems.

• The Contractor shall immediately (on the date of discovery of the incident) report any incident of theft, loss or comprise of VA sensitive information to the Contracting Officer, the Contracting Officer’s Technical Representative and any other VA Official designated by the Contracting Officer. This report shall be in writing and contain the fullest explanation possible and all the details of the incident available to the contractor. VA must receive notice from the contractor on the date contractor discovers incident.

• HIPPA Compliance. The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI).

• Security Considerations: A security clearance will not be required for this acquisition.

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

• There will be no exchange or sharing of VA sensitive information with the vendor. This is a prescription processing claims service and the Veteran will have the authority to share PII at his/her own choosing to process a claim for a prescription. This information will not be provided by the VA facility.

• A contractor/sub-contractor 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 and adhere to VA Privacy and Information Security and Rules of Behavior training requirements.

• 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.

• 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.

• 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.

SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS

839.201 Contract clause for Information and Information Technology Security:

a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format.

(e.g., paper, microfiche, electronic or magnetic portable media).

b. In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security.

Requirements for Unclassified Information Technology Resources.

2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008)

As prescribed in 839.201, insert the following clause:

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

G. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

H. CONTRACTOR EXPERIENCE REQUIREMENTS

Contractor personnel shall be trained in performing the installation and servicing of the projector System. Contractor personnel shall be equipped with all necessary tools, equipment, and any Personal Protective Equipment (PPE) to perform the work safely, effectively, and timely.

Contractor shall maintain adequate staffing, including key personnel, to uphold its commitments under this contract.

The contractor must notify VHA in advance and we will approve or reject proposed contractor key personnel for the performance of this contract. The contractor must inform the VHA COR, and Project Manager/Task Manager when personnel are removed from the contract for any reason. The Contractor shall remove any employee from the performance of this contract within five (5) workdays of receiving notice from the Contracting Officer that the employee's performance is unsatisfactory. All Contractor employees are subject to immediate removal from performance of this contract when they are involved in a violation of the law, VA security, confidentiality requirements and/or other disciplinary reasons.

The contractor must inform the VHA COR, and Project Manager/Task Manager when personnel are removed from the contract for any reason.

I. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. Nothing in this Order shall be considered Work for Hire.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

M. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Modular Devices Mobile Imaging Labs and Cleanrooms will have access to VA sensitive information. All Modular Devices Mobile Imaging Labs and Cleanrooms staff employed in support of their equipment is subject to VA security agreements as well as VA technical security standards to ensure patient sensitive information is protected per OIT guidelines and VA privacy standards.

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to subcontractor personnel requiring the same access.

1. Contractor Responsibilities

4. Government Responsibilities

*Contractors providing equal products shall provide descriptive literature describing equal characteristics.

36C24724Q0568

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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.