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

36C25026Q0276 04-01-2026

Angela Higgins 615-225-4512 04-24-2026

4PM EDT

Department of Veterans Affairs Network Contracting Office (NCO) 10 260 E. University Avenue Cincinnati OH 45219

X 100

X

Y

541990

$19.5 Million

N/A

Department of Veteran Affairs John D Dingell VA Medical Center 4646 John R Street Detroit, Michigan 48201

Network Contracting Office (NCO) 10

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

Radiation Safety Officer and equipment testing services in accordance with the Statement of Work (SOW).

Please see the "Instructions to Offerors" for instructions to submit a complete quote package on page 53.

$0.00 See CONTINUATION Page

X 1

Angela Higgins Contracting Officer

36C25026Q0276

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE SCHEDULE

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 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.4 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.5 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.7 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.8 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (OCT 2025) (DEVIATION FEB 2025)

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)

E.2 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.3 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

E.4 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION

FEB 2025)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C250

Network Contracting Office (NCO) 10

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X]Monthly

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

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

1. Contract Title: Radiation Safety Officer

2. General Information:

This is a non-personnel services contract to provide Radiation Safety Officer (RSO) services at John D. Dingell VA Medical Center located in Detroit, MI. The Government shall not exercise any supervision or control over the contract service providers performing the service herein. Such contract service providers shall be accountable solely to the contractor, who in turn is responsible to the Government.

3. Background:

This is a non-personnel services contract to provide Radiation Safety Officer (RSO) services at John D. Dingell VA Medical Center located in Detroit, MI. The Government shall not exercise any supervision or control over the contract service providers performing the service herein. Such contract service providers shall be accountable solely to the contractor, who in turn is responsible to the Government.

4. Scope:

The Radiation Safety Program which is required for the John D Dingell VA Medical Center must have a Radiation Safety Officer (RSO) to oversee the safe use of radiation at the medical center as required by 10 CFR 35.24(b) (http://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-0024.html). The RSO must meet certain criteria to be named on the hospital’s radioactive material license. The criteria include experience in a similar position and/or having been named an RSO on another similar license (medical-use radioactive license). The purpose of this contract is to provide tasks as required of a RSO in administering a broad scope of the use of radioactive materials per:

The National Health Physics Program (NHPP) (http://www.patientcare.va.gov/NHPP.asp). The RSO must also be approved to be named on the permit by the NHPP.

This program provides regulatory oversight for the Nuclear Regulatory Commission master materials license issued to VHA to include permitting for use of materials, on-site inspections, and investigations of allegations, medical events, and incidents. The contractor shall comply with applicable Federal, State, and local laws, regulations, codes, technical manuals, and recommendations, and acceptable commercial practices in the delivery of required services.

5. Specific Tasks:

a. The RSO is responsible for managing the Radiation Protection Program

b. Identifying radiation protection problems

c. Initiating recommending, or providing corrective actions

d. Verifying implementation of corrective actions and stopping unsafe activities

6. Performance Monitoring (if applicable):

a. The contractor shall report to the Medical Facility Director and the Medical Center Safety Office. In the usual organizational arrangements, the Radiation Safety Officer completes day-to-day actions with oversight by the Radiation Safety Committee. Overall, the actions by the Radiation Safety Committee and Radiation Safety Officer must include, but not be limited to:

i. Providing oversight for the safe use of radioactive materials with a focus to ensure occupational and public doses are as low as reasonably achievable (ALARA) and a safety conscious work environment is achieved.

ii. Establishing committee membership to include the Radiation Safety Officer, a management representative, and a representative for each type of authorized use and a representative from Nursing Service.

iii. Holding meetings at intervals not to exceed 6 calendar months; and establishing a committee quorum of at least one-half of committee membership for meetings which must include the Radiation Safety Officer and management representative.

iv. Preparing records and reporting committee results as required by executive management and/or Title 10 Code of Federal Regulations (CFR), Part 35; and ensuring the records document executive management approvals for actions under 10 CFR 35 (e.g., 35.24 and 35.26).

v. Coordinating with other medical facility committees as needed and reporting results of committee meetings to executive management or other medical facility oversight committees.

vi. Attending the Laser Safety Committee (semi-annual), Health and Safety Committee (monthly), and the MRI committee (Quarterly).

b. The contractor shall complete and provide oversight for the radiation program through periodic reviews and audits, to include:

i. Annual radiation safety program review per 10 CFR 20.1101, to include locations of use.

ii. Reviews audits as needed based on the radioactive materials scope of use.

iii. Evaluation of results from audits, reviews and inspections to determine possible generic issues or trends. Identify root causes, specify corrective actions and actions to prevent recurrence, and determine if any results are applicable to other uses of radioactive materials.

iv. Distribution of results of audits, reviews and inspections to all work centers and availability to the staff working with or around radioactive materials.

v. Oversight and follow-up to resolve health and safety issues and radiation safety program deviations as needed.

vi. Reviewing, at least every 6 months, occupational and public doses.

vii. Reviewing, at least every 6 months, any identified health and safety issues or possible radiation safety program deviations from regulatory compliance or required practices.

viii. Conduct quarterly Nuclear Medicine Department audits.

ix. Reviewing and approving training and experience for prospective Radiation Safety Officers, authorized users and other staff requiring regulatory approval.

x. Reviewing and approving proposed changes to training, equipment, facilities and radiation safety procedures or practices.

xi. Providing training as required to fluoroscope users.

xii. Contractor shall conduct inspections and calibrations on all x-ray equipment that are made at least annually and after the equipment has been repaired or modified in any way that might affect output.

c. The contractor shall ensure that sealed source inventories are completed:

i. Quarterly, for sealed sources with either current activity greater than one millicurie or current activity greater than 1000 times the quantities in 10 CFR 20, Appendix C.

ii. Semiannually, for all other sealed sources except sources specifically exempted by 10 CFR 30.

iii. Shall ensure that sealed source records are maintained for transfer or disposition to document leak test results, if the sealed source was required by regulation or permit condition to have a leak test.

iv. Shall provide results if requested, for sealed source inventories and leak tests to NHPP.

d. The contractor shall provide oversight for security of radioactive materials by:

i. Compliance with regulations per 10 CFR 20.1801, 10 CFR 20.1802 and 10 CFR 37 (when issued).

ii. Prevention of adversary or unauthorized removal of radioactive materials.

iii. Compliance with the security guidelines in VHA Handbook 1200.06.

iv. Focusing on adequate security commensurate with possible risks of radioactive materials unauthorized use.

v. Classifying sealed sources, not in active use for their intended clinical or research purpose for a period of 24 months, as disused sources and evaluating the disused sources for disposal as expeditiously as possible.

vi. Using NRC documents (NUREG-1556 series) as guidance to prepare and submit requests for new, renewed, or amended permits.

vii. Restricting radiation safety program implementation to be consistent with the program codes (i.e., whether broad-scope or limited-scope medical or research uses) and permitting conditions approved for the permittee.

viii. Ensuring approvals for authorized users and locations of use (except as authorized per 10 CFR 35.14) are limited to broad-scope permittees.

e. The contractor shall ensure compliance with posting requirements per 10 CFR 19 and 10 CFR 21.6, as in the following:

i. VHA Radioactive Material Permit No. 21-04234-01 issued under VHA NRC License No. 03-23853-01VA authorizes the use of radioactive materials at this location. Contact Jeremy Mangum at jeremy.mangum@va.gov or (702) 355-6201 to examine the permit and supporting documents.

ii. VHA license, amendments, and supporting application are available for examination by contacting NHPP at 501-257-1571, or at mailing address NHPP (115HP/NLR), Bldg 101, Room 208, 2200 Fort Roots Drive, North Little Rock, AR 72114.

f. Providing information to workers at the various locations of use or work centers, especially satellite locations of use, on current radiation safety programs and regulatory issues, as needed, using NHPP Intranet Web site, periodic newsletters, and other information resources made available to permittees.

g. Perform annual physics evaluations using American College of Radiology (ACR) standards and phantoms on all equipment listed within each section as outlined in Appendix A. Provide certifications for each piece of equipment that can be displayed and presented during audits or inspections.

h. Ensure all x-ray producing equipment is inspected for safety operations, compliance with applicable FDA performance and safety standards and compliance with other accepted standards, including the Joint Commission, and standards established by the medical center for quality performance and quality control.

i. Perform annual evaluations and calibration and calibration accuracy tests of nuclear medicine equipment including scintillation cameras, thyroid update systems, probe/well counters, dose calibrators, and survey meters.

j. Shall work to ensure that any plan affecting the use of space or function adjacent to areas and within areas approved for radioactive material use, sources of ionizing radiation use, or ionizing radiation machine use is assessed to meet mailto:jeremy.mangum@va.gov regulatory requirements and referred to the Radiation Safety Committee for review and approval prior to any move or alteration of that space.

k. Shall provide structural shielding design reports for linear accelerators to NHP for approval prior to installation and shielding reports prior to first clinical use.

l. Manage waste disposal for all users of radioactivity

m. Prepare all license renewals and amendments

n. Provide the following additional services:

i. Instruction, upon request, of personnel as required by state, federal, and accreditation agencies if performed in conjunction with quarterly audits;

ii. A review of incidents involving licensed material with respect to cause and subsequent actions taken and prepare incident reports;

iii. Preparation of misadministration/medical event reports

iv. Be reachable in person or by telephone for emergency situations

v. Be available for inspections in person for planned inspections, by phone/internet for unannounced inspections.

7. Security Requirements:

The contractor employees shall not have access to VA sensitive or computer information and will not require routine access to VA Facilities. The contractor employees’ shall require intermittent access only and will be escorted by VA employees while at VA Facilities. No background investigation is required.

A flash badge shall be obtained from the facility HR office. The flash badge will be worn while the Contractor employee(s) is on-site and will be returned to the HR office, upon completion of that job.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information

(GFI):

N/A

9. Qualifications:

a. The Contractor shall be approved by the VA National Health Physics Program (NHHP) to act as the RSO for the John D Dingell VA Medical Center radioactive materials permit.

b. The Contractor shall meet qualifications in order to be able to be named on the materials permit at the John D Dingell VA Medical Center and be authorized users for all materials permitted by: 10 CFR 35.100, 10 CFR 35.200, 10 CFR

35.300 and Research. The RSO must be experienced with administering radioactive materials to patients and would have to be able to meet qualifications per 10 CFR Part 35.50 and 10 CFR Part 35.59.

c. The Contractor shall dress professionally at all times in no less than business casual and carry out all interactions with the utmost professionalism.

d. The Contractor shall be aware of other departments at the John D Dingell VA Medical Center.

e. The Contractor assigned to perform services covered by this contract shall be a United States Citizen.

f. The Contractor shall follow all local, state, and federal regulations involving oversight of the Radiation Safety Program at the John D Dingell VA Medical Center.

10. Period of Performance:

The Government anticipates awarding a firm-fixed-priced service contract. The period of performance shall be for a base year plus four (4) one-year option periods.

11. Place of Performance:

John D Dingell VA Medical Center 4646 John R Street Detroit, MI 48183

Pontiac CBOC – X ray Room 44200 Woodward Avenue, Suite 212 Pontiac, MI 48341

12. Hours of Operation:

The contractor shall provide oversight of the John D Dingell VA Medical Center Imaging department for the safe use of radioactive materials, between the hours of 7:00 AM through 4:30 PM, Monday through Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the performance of all tasks defined within this SOW when the Government facility is not closed for the above reasons. When hiring personnel, the contractor shall keep in mind that the stability and continuity of the workforce are essential. The RSO will be reachable both through telecommunications and the Internet during normal business hours of operation at the facility. The RSO will be available onsite within a reasonable amount of time for Emergencies as per regulatory policy, such as accidental Exposure to Radioactive Material and accidental spills.

B.3 PRICE SCHEDULE

ITEM

NUMBER

DESCRIPTION

OF SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

12.00 MO ____________ _________________

Radiation Safety Officer services in accordance with the

Statement of Work (SOW) Contract Period: Base POP Begin: 08-01-2026 POP End: 07-31-2027 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services PRODUCT/SERVICE CODE: R425 - Support - Professional: Engineering/Technical

1.00 YR ____________ _________________

Annual Compliance testing for equipment in accordance with the Statement of Work (SOW) Contract Period: Base POP Begin: 08-01-2026 POP End: 07-31-2027 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Statement of Work (SOW).

Contract Period: Option 1 POP Begin: 08-01-2027 POP End: 07-31-2028 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Annual Compliance testing for equipment listed in

Statement of Work (SOW).

Contract Period: Option 1 POP Begin: 08-01-2027 POP End: 07-31-2028 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Statement of Work (SOW) Contract Period: Option 2 POP Begin: 08-01-2028 POP End: 07-31-2029 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Annual compliance testing for equipment in accordance with the Statement of Work (SOW).

Contract Period: Option 2 POP Begin: 08-01-2028 POP End: 07-31-2029 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Statement of Work (SOW).

Contract Period: Option 3 POP Begin: 08-01-2029 POP End: 07-31-2030 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services with the Statement of Work (SOW).

Contract Period: Option 3 POP Begin: 08-01-2029 POP End: 07-31-2030 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Radiation Safety Officer Services in accordance with the

Statement of Work (SOW).

Contract Period: Option 4 POP Begin: 08-01-2030 POP End: 07-31-2031 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services with the Statement of Work (SOW).

Contract Period: Option 4 POP Begin: 08-01-2030 POP End: 07-31-2031 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

GRAND

TOTAL

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 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 30 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 copies and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

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

Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

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

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

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

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

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

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

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

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

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

6. SECURITY INCIDENT INVESTIGATION

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

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

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

Failure to cooperate may be deemed a material breach and grounds for contract termination.

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

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

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

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

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

(9) Assessment of the potential harm to the affected individuals;

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

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

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

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

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