36C10G25R0011.docx

36C10G25R0011

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

02-05-2025 Darrell Williamson 202-590-2373 03-12-2025 14:00

EST

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

X

339113 800 Employees

NET 30 Days

N/A

See Delivery Orders for details

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

VAFSC

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

(see Section B.3 invoicing/payment) Austin TX 78714-8917 1 (877) 489-6135

Title: Hospital Beds for In Home Use Period of Performance (POP): Base Year and four one-year options.

See Section B.4 Price/Cost Schedule (Attachment 9) for details.

Zachary Wilcox Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

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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 36C10G Zachary Wilcox U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | Suite 400 Fredericksburg VA 22408-2697 Zachary.wilcox@va.gov Contracting Specialist Darrell Williamson U.S. Department of Veterans Affairs Strategic Acquisition Center 10300 Spotsylvania Ave., Suite 400 Fredericksburg, VA 22408 darrell.williamson@va.gov

Program Office Point of Contact (POC) – To Be Determined (TBD)

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

3. INVOICES: Invoices shall be submitted monthly in in arrears based upon delivery and acceptance.

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.

5. FSC MANDATORY ELECTRONIC INVOICE SUBMISSION: Contractors are required to submit payment requests in electronic form in accordance with the submission instructions below.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Contracting POC: Darrell Williamson, email: darrell.williamson@va.gov COR (Contracting Officers Representative): Kimberly Cowen-Tucker Contract/Task Order Number: TBD Purchase Order: #TBD

a. Vendor Electronic Invoice Submission Methods:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org).

b. Vendor e-Invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

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

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

3. FSC e-Invoice Contact Information: 1-877-353-9791

4. FSC e-Invoice email: vafsccshd@va.gov

5. See https://www.fsc.va.gov/einvoice.asp for more information.

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B.2 PAYMENT TERMS AND CONDITIONS

a) The Government is obligated only to the extent of authorized purchases made under the resultant contract/task order. The terms and conditions included in this contract apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this contract, and the Contractor’s invoice, the provisions of this contract will take precedence.

b) Purchase/Ordering Limitation:

Limited to FAR Clause 52.216-19 Order Limitations, as noted in the contract. The estimated total quantities are listed in the Schedule of Services. The quantities are estimates only, and the VA makes no guarantee regarding the actual quantities that may be purchased.

c) Delivery Tickets:

The following provisions apply to all shipments:

Inspection: Destination Acceptance: Destination Shipping: Free on Board (FOB) – Destination Ship To and Mark For : Deliveries shall be marked and shipped to various VHA locations and patient homes, as applicable, identified in each order placed against the contract.

All shipments, either single or multiple container deliveries, shall bear and contain on the delivery tickets or sales slips (external shipping labels and associated manifests or packing lists)) the following at a minimum:

(i) Name of supplier

(ii) Contract number

(iii) Date of purchase

(iv) Itemized list of supplies or services furnished

(v) Quantity, unit price, and extension of each item, less applicable discounts (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided the invoice is itemized to show this information).

(vi) Date of delivery or shipment

In the case of multiple container deliveries, a statement readable near the VA Order number will indicate total number of containers for the complete shipment (ex. “Package 1 of 2”), clearly readable on manifests and external shipping labels.

Packing Slips/Labels and Lists shall include the following:

IFCAP PO # TBD (i.e., 166-E11234)

Total number of Containers: Package ___ of ___. (i.e., Package 1 of 3)

d) Reports:

Quarterly Report:

To track compliance, VA requires the contractor to submit the quarterly report of sales in the approved format listed in contract Attachment 3 – Quarterly Sales Report (QSR) Reporting Tool based on the Government’s fiscal calendar year. See below.

The contractor agrees that they shall adhere to this requirement. The contractor shall provide a quarterly report, no later than the submission due date outlined above. Reports shall be sent electronically to the following SAC IDIQ Government points of contact until the contractor is notified, in writing, of a different point of contact as follow:

a. Project Manager;

b. Contracting Officer’s Representative;

c. Contract Specialist; and

d. Financial Management Analyst at SACPAY@va.gov;

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B.3 BUSINESS ASSOCIATE AGREEMENT

A National Business Associate Agreement (BAA) shall be established within 60 calendar days after contract award.

When the Government engages the services of contractor to create, receive, maintain, or transmit individually-identifiable health information on its behalf, the contractor becomes a business associate under HIPAA. As a result, the Government and the contractor must enter into a HIPAA-compliant Business Associate Agreement (BAA), and the contractor is both contractually liable for meeting the terms of the BAA and directly liable for compliance with the applicable requirements of the HIPAA Rules.

VHA is the only administration of the Department of Veterans Affairs (VA) that is a Covered Entity under the HIPAA Privacy Rule.

Although VHA is the Covered Entity under HIPAA, other VA Administrations and Staff Offices may have access to PHI and EPHI during performance of certain functions or activities on behalf of, or providing certain services to VHA through a Business Associate Agreement (BAA). A BAA must be in place for VHA to disclose PHI or EPHI to a VA component that is Business Associate.

Failure to comply with all aspects of HIPAA requirements applicable to Business Associates can result in non-compliance with Federal law, which carries penalties for VA and potentially for individual(s) responsible for non-compliance. All Business Associates also understand that they are subject to periodic HIPAA compliance reviews conducted by VHA.

While a BAA may be required in connection with a SAC-executed contract, as a general rule, SAC contracting officers due not have the authority to enter into a BAA. The VHA Privacy Office, VHA NDS/HIA Office, VA Facility Director, Contracting Officer, Privacy Officer, Information Security Officer, and Contracting Officer Representative work together to ensure BAAs are enacted for all Business Associates. See VHA HANDBOOK 1605.05 for more information on how BAAs are established and administered.

See RFP Attachment 5 – Sample HIPAA Business Associate Agreement

CONTRACT MINIMUM DOLLAR VALUES

The minimum guaranteed amount is $2,500.00. Orders shall be determined by department needs. The Government has no obligation to award orders beyond the minimum guaranteed amount. The Government’s obligation for the minimum guarantee amount applies only in year one ordering period of the contract. If the Contractor receives total orders for less than the minimum amount in year one, the Government will pay the difference between the amount ordered and the minimum amount guaranteed for the year one ordering period of the contract.

The ceiling for this awarded IDIQ contract will be $260,000,000.00.

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

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B.4 PRODUCT DESCRIPTON

1.0 INTRODUCTION

1. REQUIREMENTS

Veterans Health Administration’s (VHA) Prosthetic Sensory Aid Service (PSAS) has identified Hospital Beds for Home Use as a uniform preferred product for continued consolidated contracting. The purpose of consolidated contracting is to obtain user uniformity and quality products at competitive prices.

Intended Use: Hospital Beds for Home Use are electric beds used for community care/home care and is designed for disabled and elderly individuals who are being cared for outside of hospital.

Product Identification and Minimum Technical Requirements (MTR’s) Beds for Home Issuance Bed must meet the IEC standard 60601-1-11 Edition 1.0:2010 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare. Also, IEC standard 60601-2-52, Medical electrical equipment – Part 2-52: Requirements for the basic safety and essential performance of medical beds. Edition 1.0, 2009-12.

Key Elements of IEC 60601-2-52 Bed Standard

1. Changes in the gaps and clearances of side rails which have been calculated looking at percentile adult male and female head, neck, and chest dimensions.

1. The side-rails must with-hold a high force of 250N between the bars along with the lower bar and the bed frame (previously 30N).

1. Bed user manuals must specify the mattress size to reduce the risk of a patient becoming entrapped between the mattress and side rail.

1. Locking mechanism on the side rails to be more robust and with stand a 30,000-cycle test (up and down).

1. Both the safe working load (SWL) and maximum patient weight must be visible on the bed Description of Electric Hospital Bed: A bed having side rails that can be raised or lowered; and a support surface (mattress) base in jointed sections so that the bed deck, head, and foot sections, may be raised by a motor, allowing a patient to lie in various positions, as a therapeutic aid while maximizing comfort to promote rest and sleep hygiene.

Description of Pressure Re-Distribution Support Surface: Fabricated from materials for maximum pressure re-distribution that is designed to be placed directly on the existing bed frame. e.g., foam, gel, low air loss, alternating pressure, etc.

Description of Bed Side Rails: Safety devices used to reduce the risk of patients accidentally slipping, sliding, or rolling out of bed. These can be full or split and are positioned along the sides of a bed. They are attached to frame of the bed and raise/lower as the bed is raised and lowered. The rails also raise/lower for entry/egress when the bed is stationary. The rails must interface with the head/foot board to ensure there is not risk of entrapment between the rails, bed, head/footboards. The rails should allow for secure attachment to the bed frame for aiding in turning and repositioning within the bed, providing a handhold for getting into or out of bed, and providing a feeling of comfort and security (https://www.fda.gov/medical-devices/hospital-beds/guide-bed-safety-bed-rails-hospitals-nursing-homes-and-home-health-care-facts).

Description of Trapeze Bar: An item designed for use in the raising and lowering of the body without assistance; may consist of bed mounting screw, chain, and handgrip.

Description of Static Mattress: non-powered and can be made of multilayered foam, gel, or combination.

Description of Dynamic and/or Convertible Mattress: powered pressure reducing air mattress with pump.

Descriptions for bed

MTR 1a.

MTR 1b.

Advanced Electric Bed Frame with minimum length of 80 inches and width of 36 inches; Bed must have the ability to adjust both length (up to at least 84 inches) and width (up to at least 42 inches); Bed must be able to accommodate bed side rails (no mattress).

Basic Electric Bed Frame Model should be made available meeting 80” x 36” that does not require adjustable capability. (no mattress)

MTR 2a.

MTR 2b.

Advanced Electric Bed must support a patient weight of at least 400 lbs. (This means the bed must accommodate a minimum patient weight of 400 lbs. The bed would support this patient weight along with all other bed component parts and still safely operate at the bed’s safe working load.)

Basic Electric Bed must support a patient weight of at least 350 lbs.

Electric controls for head and foot sections both elevate independently as well as simultaneous movement of head and foot sections to reduce shearing. Electric control for the bed deck raises and lowers independently to allow for overall raising and lowering of bed height. Must be capable of these functions regardless of which type of rails are on the bed (i.e., full, half, or split rails) with rails in locked and upright position or with rails in down position.

Must provide patient control pendent that is fluid (liquid) resistant and controls all the electrical movements of the bed. Pendant must have back lighting, raised buttons, and attachment components for bed rail or clothing.

Must have head and foot boards comprised of a sturdy and durable material. (e.g. wood, metal, etc.)

Bed must be able to accept full rail, or 3/4 rail, or a half/split rail combo for both sides of the bed.

Pressure Redistribution Mattress (multi-layered foam, gel, air, or any combination thereof). Must be moisture resistant. Minimum sleep surface of 36” x 80” inches. Mattress must follow all federal and state fire codes and regulations and must be clearly marked with industry standard labeling.

Pressure Redistribution Mattress (multi-layered foam, gel, air, or any combination thereof). Must be moisture resistant. Minimum sleep surface of 42” x 80” inches. Mattress must follow all federal and state fire codes and regulations and must be clearly marked with industry standard labeling. *Note: Bolsters will not be considered for Dynamic/Active mattresses.

Pressure Redistribution Mattress (multi-layered foam, gel, air, or any combination thereof). Must be moisture resistant. Minimum sleep surface of 36” x 84” inches which can be accomplished with a static and/or dynamic, one-piece mattress or bolsters. Mattress must follow all federal and state fire codes and regulations and must be clearly marked with industry standard labeling. *Note: Bolsters will not be considered for Dynamic/Active mattresses.

Pressure Redistribution Mattress (multi-layered foam, gel, air, or any combination thereof). Must be moisture resistant. Minimum sleep surface of 42” x 84” inches which can be accomplished with a static and/or dynamic, one-piece mattress or bolsters. Mattress must follow all federal and state fire codes and regulations and must be clearly marked with industry standard labeling. *Note: Bolsters will not be considered for Dynamic/Active mattresses.

For head control, foot control, and elevation control must be replaceable.

Must meet all current industry IEC electrical standards, UL or ETL listed, and ISO guidelines.

All motors that control the power motor functions of the bed must have a battery back-up in the event of power outage. The battery back-up must be sufficient to raise and lower the head and foot sections as well as to raise and lower the bed deck to allow for overall raising and lowering of bed height. Battery Back Up feature must be able to perform all motor functions. (A hand crank may be provided in addition to battery back-up, but a hand crank will not be an acceptable substitution to the required battery-backup).

Bed must have a mount which supports/accepts the overhead trapeze accessory

(trapeze must integrate with bed frame trapeze mount). Weight capacity must be a minimum of 250 lbs.

Four total wheels – either two wheels with two locking casters or four wheels with four locking casters.

When the bed is raised or lowered, there is no pinch point that can damage electrical power or pendent cords.

Bed/Frame: Minimum of 10 years.

Power System/Electrical components: Minimum of 3 years.

Mattress: Minimum of 3 years.

Accessories: Minimum of 1 year.

Website and customer service telephone line with live operator for technical support. Service telephone line should be available during normal business hours, Monday - Friday, and clearly stated on company website.

PURPOSE AND OBJECTIVES

a. The purpose of this solicitation is to establish a supply source that will provide the contracted items for Prosthetics and Sensory Aids Services (PSAS) at the Department of Veterans Affairs Medical Centers (VAMCs). The objectives are to ensure availability and consistency of product for nationwide usage and to obtain volume-based, pricing.

b. The base contract period for hospital beds is one (1) year, with four (4) one-year option periods that may be exercised by the Government.

c. Contract Effective Date: The effective date of the contract shall be 45 calendar days (or sooner upon mutual agreement) after the date of award.

EXTENT OF OBLIGATION

a. Government Participants: The Contractor shall provide uninterrupted delivery of approved hospital beds as specified in the contract, directly to VA Medical Centers (VAMC) or Durable Medical Equipment (DME) provider throughout the United States including Alaska, Hawaii, and Puerto Rico at the prices awarded herein and under the terms and conditions set forth in the contract upon receipt of a delivery order/purchase order signed by a person with purchasing authority on behalf of a VAMC.

b. Delivery Requirements Delivery shall be made to any VA medical facility or DME within the fifty (50) United States and Puerto Rico.

Food and Drug Administration (FDA) and other Regulatory Agencies Recall At the time of the award of the contract resulting from this solicitation, the offeror(s) shall not have any outstanding actions from the FDA or other regulatory agencies or unresolved FDA warning letters on the manufacturing processes or quality control issues involving the products covered by this solicitation. VA will require proof from the vendors that the FDA issues have been resolved. A letter to the vendor from the regulatory agency will meet this requirement. Vendors must include the letters in volume V with their proposals.

INFORMATION SECURITY CONSIDERATIONS:

36C10G25R0011 The Certification and Accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required.

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B.5 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) COMPLIANCE

a) As a covered entity, the VA is required by law to obtain satisfactory assurance of a Business Associate that the Business Associate appropriately safeguards protected health information it receives or creates on behalf of the covered entity. Contractors and any Subcontractors must adhere to the provisions of Public Law 104-191, HIPAA to include the Administrative Simplification Provisions of the law and associated rules and regulations published by the Department of Health and Human Services (HHS). The Contractor shall comply with all HIPAA-related rules and regulations to include Electronic Transactions, the Standards for Privacy of Individually Identifiable Health Information, and the Security Standards. This includes both the Privacy and Security Rules published by HHS. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities. The covered entity component of the VA is the Veterans Health Administration (VHA). Business associates must follow VHA privacy policies and practices. All Contractors and business associates must receive privacy training annually. For Contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or Contractor furnished training that meets the requirements of HHS Standards for Privacy of Individually Identifiable Health information as determined by VHA. For Contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required.

b) Any violation of HIPAA will be reported to the CO, the COR, and the PM in writing within one (1) business day of the Contractor’s discovery of an occurrence. Included in the report will be a description of the occurrence, patient names (if known), location, date and time. A copy of any filed police report will be provided by the Contractor to the CO within one (1) business day of completion.

c) Security must be designed into the system to protect patient information as required by HIPAA. All external network connects to the remote server shall be via encrypted SSL connects, VPN software and hardware. The process and method in which the transmission or routing of VA image data shall be reviewed and approved in accordance with form VA 6500.6. All patient information remains the sole property of the United States government and shall not be used for any purpose other than those stipulated in this contract. The VAMCs shall act as primary custodian of the patient information (including both the image data and the report) for all purposes related to Government records retention requirements. Patient information, including images shall be retained by the Contractor only for the minimum period of time required to comply with any applicable laws, regulations, and the retention policies stated herein. Upon request, the Contractor shall provide the Strategic Acquisition Center (SAC) CO, assigned COR for the applicable facility, Information Security Officer (ISO), or Privacy Officer (PO) with access to information pertaining to the way the Contractor maintains NPOP/VAMC patient data and the steps taken on an ongoing basis to assure the privacy and security thereof. This includes information regarding computer network architecture, configuration of firewall(s), routers, and other pieces of networking equipment, information about installed security software, and audits of patches of known security vulnerabilities. All relevant security-related patches and anti-virus updates shall be installed with seven (7) days of initial release. Patient lists, no matter how developed, shall be treated as privileged information. Lists and names of patients shall not be disclosed or revealed in any way for any use outside the contract of this PWS. Contractor must meet all VA required security restrictions and Contractor representatives shall undergo all HIPAA/confidentiality related training to comply with V15 requirements.

d) Contractors are not to retain any copies of the corresponding testing services, clinical data, even unidentified data (i.e., data that has had patient information redacted).

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B.6 FACSIMILE (FAX) PRIVACY STATEMENT

Should the Contractor require the use of facsimile communication during the life of the contract, the VA requires the following statement on all fax cover sheets be included:

“This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.”

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B.7 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 within 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.

e) The Contractor or Subcontractor must notify the CO 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 CO must also be notified immediately by the Contractor or Subcontractor prior to an unfriendly termination.

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B.8 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) 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 SAC CO within 30 days of termination of the contract.

c) 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.

d) The Contractor/Subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the contract 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.

e) 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 for cause under FAR part 12.

f) If a VHA contract is terminated for cause, any 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.

g) 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.

h) 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.

i) 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.

j) 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 SAC CO for response.

k) For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require Certification & Accreditation (C&A) or a Memorandum of Understanding – Information Security Officer (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 assigned COR for each applicable facility.

36C10G25R0011

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B.9 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 assigned COR for the applicable facility 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, Contractor personnel, and its Subcontractors and their personnel 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.

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B.10 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. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

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

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

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

(2) Description of the event, including:

(a) Date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

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

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

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

d) Assessment of the potential harm to the affected individuals;

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

(2) 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.

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

(1) Notification;

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

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B.11 PRICE/COST SCHEDULE

ITEM INFORMATION

See Attachment 9 – Pricing Schedule Template

36C10G23R0011

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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…