36C24824Q1463-1.pdf

PAGE 1 OF 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C24824Q1463

Marie Smith 407-646-4011 08-28-2024

13:00 EDT

36C248

Department of Veterans Affairs

Network Contracting Office 8 (NCO 8)

Orlando VA Healthcare System

13800 Veterans Way

Orlando FL 32827

X 100 x

334510

1250 Employees

N/A

X

36C675

Department of Veterans Affairs

Orlando VA Healthcare System

Orlando Fl 32827

36C248

Department of Veterans Affairs

Network Contracting Office 8 (NCO 8)

Orlando VA Healthcare System

Orlando FL 32827

Department of Veterans Affairs

Financial Services Center

P.O. Box 149971

Austin TX 78714-9971

(877) 353-9791 (512) 460-5429

See CONTINUATION Page

This solicitation is Set Aside for VOSB.

See CONTINUATION Page

X

Table of Contents

SECTION A

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

COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 PRICE/COST SCHEDULE

ITEM INFORMATION

B.2 DELIVERY SCHEDULE

B.3 STATEMENT OF WORK

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.8 VAAR 852.219-74 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED VETERAN-

OWNED SMALL BUSINESSES (JAN 2023) (DEVIATION)

C.9 VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (JAN 2023)

(DEVIATION)

C.10 AAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB

2023)

C.11 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.12 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

ITEMS

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—

REPRESENTATION AND DISCLOSURES (DEC 2023)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

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

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.9 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

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

a. CONTRACTOR: (Company Name)

(Address)

(City-State-Zip)

POINT OF CONTACT:

PHONE NUMBER:

E-MAIL ADDRESS:

UEI#:

TAX ID (TIN) #:

b. GOVERNMENT: Marie E. Smith, Contracting Officer

(E): Marie.smith4@va.gov

Network Contracting Office 8 (NCO 8)

Orlando – Commodities & Services Team

13800 Veterans Way

Lakemont Bldg., Room 101

Orlando, FL 32827-7403

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

[[X] 52.232-33 Payment by Electronic Funds Transfer - System For Award Management (JUL 2013)

3. INVOICES/PAYMENT: Invoices shall be submitted in arrears in accordance with:

a. 852.232-72 Electronic Submission of Payment Requests (NOV 2012)

b. SUMITTED: Monthly in Arrears

c. In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with Tungsten Corporation e-Invoicing network, for submissions of all electronic invoices to

VA. Tungsten Network electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with Tungsten Network by submitting an email to Tungsten Network

VA.Registration@tungsten-network.com or calling 1-877-752-0900 option 2 for Enrollment.

d. Contractor shall submit an electronic invoice to the Veterans Affairs Financial Services Center (VAFSC) e-

Invoice through the website at https://portal.Tungsten-Network.com/Login.aspx after their itemized report has been reviewed and approved by the Contracting Officer’s Representative (COR). For questions regarding the submission of VA electronic invoices, Tungsten Network customer service may be contacted at 1-877-489-6135.

e. All invoices shall reference the vendor’s name and address, customer name, contract number, appropriate obligation/funding order number, description of services provided, quantity, unit price, and total invoice amount.

mailto:Marie.smith4@va.gov mailto:VA.Registration@tungsten-network.com https://portal.tungsten-network.com/Login.aspx

f. For questions regarding invoice receipt or payment, please call VAFSC directly at 1-877-353-9791 or email vafsccshd@va.gov

g. VA’s Electronic Invoice (e-Invoice) system uses a third-party contractor (Tungsten Network) for submission of electronic invoices. Go to this website to begin submitting electronic invoices, free of charge:

http://www.tungsten-network.com/customer-campaigns/veteransaffairs-us/

4. GOVERNMENT INVOICE ADDRESS: (See SF1449 Block 18):

a. All invoices from the contractor shall be submitted electronically in accordance with 852.232-72

ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012)

b. Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests.

c. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten Network e-Invoice, to transition vendors from paper to electronic invoice submission.

Please go to this website: http://www.tungsten-network.com/customer-campaigns/veterans-affairs-us/ to begin submitting electronic invoices, free of charge.

d. For assistance setting up e-Invoice, the below information is provided:

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

* Tungsten Network e-Invoice email: VA.Registration@ob10.com

<http://VA.Registration@ob10.com/>

* FSC e-Invoice Contact Information: 1-877-353-9791

* FSC e-invoice email: vafsccshd@va.gov <http://va.gov/>

OFFERORS MUST COMPLETE AND RETURN ALL INFORMATION DESIGNATED HEREIN PRIOR

TO THE TIME SPECIFIED IN BLOCK 8 OF SF 1449 IN ORDER TO BE CONSIDERED FOR AWARD.

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

AMENDMENT NO DATE

OFFER REQUIREMENTS & INSTRUCTIONS:

See Section E.1. 52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS (JAN 2017) and Section E.2

GENERAL INSTRUCTIONS TO OFFERORS.

EVALUATION/BASIS OF AWARD:

This is a commercial item acquisition that will be conducted under the authority of FAR 13.106-2– Comparative evaluation. See 52.212-2 Evaluation – Commercial Items for a description of the factors in addition to price that the

Government will use to evaluate offers. Prospective contractors must furnish the information listed herein with their quotes to ensure they receive full consideration.

SPECIAL NOTE

In order to maintain integrity of this solicitation and subsequent award date, all offerors are advised that any questions must be submitted in written form via e-mail to Marie.smith4@va.gov and shall be received no later than Tuesday, August 20, 2024 AT 12:00 PM EASTERN STANDARD TIME (EST).

http://www.tungsten-network.com/customer-campaigns/veterans-affairs-us/ http://www.tungsten-network.com/customer-campaigns/veterans-affairs-us/ mailto:VA.Registration@ob10.com http://ob10.com/ mailto:vafsccshd@va.gov http://va.gov/ mailto:Kurt.Kramer@va.gov

Quotes will be considered only from offerors who are regularly established in the business called for, who are financially responsible, and able to show evidence of their reliability, ability, experience, facilities and personnel, directly employed by them to render prompt and satisfactory service.

CONTRACT ADMINISTRATION

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitment or issue changes that will affect price, quantity or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in cost incurred thereof.

B.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVICE

S

Estimated

QUANTIT

Y

UNI

T UNIT PRICE

Estimated

AMOUNT

2,500.00 EA _________________

Disposable Sleep Device, IAW SOW

Contract Period: Base

POP Begin: 09-16-2024

POP End: 09-15-2025

Disposable Sleep Device, IAW SOW

Contract Period: Option 1

POP Begin: 09-16-2025

POP End: 09-15-2026

Disposable Sleep Device, IAW SOW

Contract Period: Option 2

POP Begin: 09-16-2026

POP End: 09-15-2027

Disposable Sleep Device, IAW SOW

Contract Period: Option 3

POP Begin: 09-16-2027

POP End: 09-15-2028

Disposable Sleep Device, IAW SOW

Contract Period: Option 4

POP Begin: 09-16-2028

POP End: 09-15-2029

Estimated GRAND

TOTAL

B.2 DELIVERY SCHEDULE

Deliver all devices to Orlando VA Healthcare System (OVAHCS), 13800 Veterans Way, Orlando FL

32827, Logistics services, MARK FOR: Sleep study clinic.

B.3 STATEMENT OF WORK

STATEMENT OF WORK (SOW)

DISPOSABLE SLEEP TESTING

A. General: This is a contract to provide disposable sleep study testing to the Orlando VA Healthcare

System (OVAHCS), 13800 Veterans Way, Orlando FL 32827.

1. Scope of Work: The Contractor shall provide all personnel, equipment, supplies, facilities, and all other items necessary to provide disposable sleep study devices and the reading reposts to the Orlando

VA Healthcare System, 13800 Veterans Way, Orlando Fl, 32827, as defined in this statement of work.

2. Background: The OVAHCS Sleep Clinic has a requirement for disposable sleep study testing that will supplement their in-clinic testing. The disposable testing will allow the clinic to also test, diagnose, and treat some obstructive sleep apnea patients without the need to have them enter the Lake Nona sleep lab.

These disposable tests will be delivered to the medical center and issued (mailed) to the veteran when needed.

3. Performance:

a. The government contemplates awarding a single Fixed-Price Indefinite Delivery type contract– with a 12-month base period and four 12-month option periods. The contractor shall not commence performance on the tasks in this SOW until the Contracting Officer (CO) has conducted a Kickoff meeting (Post award Orientation) or advised the contractor that a kickoff meeting is waived. Exercising of all options will be at the discretion of the government.

b. 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 with all other products of the project. Costs incurred by the contractor through the actions of parties other than CO shall be borne by the contractor, if not approved by the CO through a contract modification.

c. The Contractor agrees to attend any post award orientation convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5.

The contracting officer and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

4. Deliverables:

Contractor Responsibility:

a. The contractor shall provide sleep study tests to the OVAHCS Sleep Clinic as needed in accordance with the contract price cost schedule. The tests shall include Home Sleep Apnea

Testing (HSAT) Devices which can track sleep staging respiratory events and central sleep apnea.

The sleep study device shall be disposable/ non-recoverable, and the veteran shall discard the device after use.

The HSAT Direct package is compromised of the following:

• Home Sleep Apnea Testing device

• Wrist Device

• Finger Probe

• Chest Sensor

• Packing

• Battery

b. The contractor shall provide an authorized data reporting tool for the delivery of the test results no later than 3 days after the sleep test to the VA.

c. The contractor shall provide phone service to support the Veteran during use of the Home Sleep

Apnea Testing (HSAT) kit on the night of testing.

d. The contractor shall ensure acquired data from the home sleep apnea test is successfully uploaded via an acquisition software compatible with VA’s utilization of an authorized Health Systems

Integration Tool for the provider to review and interpretation of the acquired data from the testing.

e. If Contractor is informed by VA that acquired data (readings) from home sleep apnea test failed to upload, was invalid, or is not accessible by the VA, the contractor shall respond to the VA via email no later than 3 working days with the results, estimated timeline of resolution. If the information is not available, the test will need to be repeated. If this happens, the contractor is responsible for sending the VA a replacement device.

f. Provide a dedicated phone number to be identified as technical support for veteran during testing.

g. Replace defective devices with a replacement that will be shipped to the OVAHCS. Devices will be considered defective if:

1. Device fails to power-on with proper operation by the patient, and the failure cannot be resolved by Contractor’s technical support team.

2. Device displays an error code that cannot be resolved by the technical support team which prevents testing from occurring.

3. Any other malfunction of the device or components that occurs with proper operation by the patient that cannot be resolved by Contractor’s technical support team and prevents testing from occurring.

h. If Contractor’s technical support team is contacted by veteran during attempt to test and device is determined to be defective, the Contractor shall inform the VA via email of the reason or code contributing to the defective status and the estimated shipping date of replacement device. This shall be done by the Contractor no later than 5 working days from defective date.

i. If Contractor is informed by VA that veteran reported an issue directly to the VA foregoing utilization of Contractor’s technical support team, and device is determined to be defective, the

Contractor shall respond to the VA via email no later than 5 working days to provide estimated shipping date of replacement device or submit any inquiries required to facilitate replacement of device.

j. If device is found defective IAW paragraph g, the contractor shall ship the replacement device to the VA at their expense and will not charge the VA for the defective device. This device shall also be under warranty.

VA Responsibility:

a. Upon contract award, the VA shall provide the contractor with a list of contacts (email address) as required to support the contractor’s responsibility for reports.

b. The VA will contact the veteran to ensure their mailing address is correct and will mail each device to the veteran when prescribed by the provider.

c. The VA will give the veteran directions to contact technical support when they receive the device to set up the testing.

d. If VA determines device to be defective during initialization of the device before mailing, the VA will notify the Contractor via email of the reason or code contributing to the defective status of the device. This will be done by the VA no later than 3 working days from date of defectiveness.

e. If VA is contacted by veteran who reports an issue with testing or is having problems with the contractor’s technical support team, and device is confirmed to be defective, the VA will inform the contractor via email of defective status of the device. This will be done by the VA no later than 3 working days from date of knowledge or call from the veteran of the defectiveness.

5. Quality Control: The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective processes. The contractor’s quality control program is how he assures himself that his work complies with the requirement of this contract. This plan will be required with the contractor’s quote. When changes are made, the contractor shall submit change requests to the CO within

5 days of notification of changes.

6. Performance Hours:

a. Government normal duty hours are from 0800-1630, Monday through Friday, excluding Federal holidays. There are eleven (11) Federal Holidays as follows:

New Year’s Day January 1

Martin Luther King Day 3rd Monday in January

President’s Day 3rd Monday in February

Memorial Day Last Monday in May

Juneteenth June 19

Independence Day July 4

Labor Day 1st Monday in September

Columbus Day 2nd Monday in October

Veterans Day November 11

Thanksgiving Day Last Thursday in November

Christmas Day December 25

b. If a holiday falls on Sunday, the following Monday will be observed as the National Holiday.

When a holiday falls on a Saturday, the preceding Friday is observed as the National Holiday by the U.S. Government agencies. Also included would be any day specifically declared by the

President of the United States of America as a National Holiday.

7. Records Management Language:

a. Contractor shall comply with all applicable records management laws and regulations, as well as

National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR

Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

b. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of

44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

c. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for

Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law.

Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

d. OVAMC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of OVAMC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity.

Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to OVAMC. The agency must report promptly to NARA in accordance with 36 CFR 1230.

e. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government's behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to OVAHCS, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is

EXPRESSLY PROHIBITED unless in accordance with appropriate law.

f. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The

Contractor (and any sub-contractor) is required to abide by Government and OVAHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall not create or maintain any records containing any non-public OVAHCS information that are not specifically tied to or authorized by the contract.

h. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

i. The OVAHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which OVAHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

j. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take OVAHCS -provided records management training.

k. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

l. The Contractor shall incorporate the substance of this clause, its terms, and requirements including this paragraph, in all subcontracts under this contract, and require written subcontractor acknowledgment of same if a sub-contractor is used.

m. Violation by a subcontractor of any provision set forth in this clause will be attributed to the

Contractor.

8. Key Personnel: The contractor shall provide a point(s) of contact (Name(s), phone number(s) and email address(es)) for who shall be the representative(s) for this contract who the sleep clinic can email for all performance issues with the deliverables. The name of this person and an alternate who shall be designated in writing to the contracting officer no later than 5 working days after award or at the kick-off meeting, whichever comes first.

B.4 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for

Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance.

National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S.

defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the

Office of Operations, Security, and Preparedness.

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

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The

Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in

Rights in Data - General, FAR 52.227-14(d) (1).

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

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA

Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA

Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

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

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

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed

VA's minimum requirements. VA Configuration Guidelines are available upon request.

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

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by

Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a

Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information

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

Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on

Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

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

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

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for

Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information

Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

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

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

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

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

Act; and

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

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

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

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

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

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

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 5 days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe

Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the

Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 5 days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and

Technology.

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

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy

Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

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

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

PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization)

(C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government.

Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System

Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor.

The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

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

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media

Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media

(hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

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

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

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

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

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

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

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

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

6. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to…