36C24723Q0558.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

36C24723Q0558 04-26-2023

Terrence McMillan terrence.mcmillan@va.gov 05-02-2023

3:00 PM EDT

36C247 Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker GA 30084

X 100

X

325412

1250 Employees

N/A

X

See Delivery Address

36C247

Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker GA 30084

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

Emergency Prescription Service The Contractor shall provide outpatient pharmacy services emergency 10- day supply of medications for patients to be located within a 10-mile radius of each Community Based Outpatient Clinic (CBOCS)-Brunswick, Tifton, Perry, Milledgeville, Macon, Albany, Warner Robins AFB, and Carl Vinson VA Medical Center in the event of emergent medication not being readily available at Dublin VAMC and/or needed CMOP can send to patient.

Period of Performance:

Base Year July 1, 2023 - June 30, 2024 Option Year 1 July 1, 2024 - June 30, 2025 Option Year 2 July 1, 2025 - June 30, 2026 Option Year 3 July 1, 2026 - June 30, 2027 Option Year 4 July 1, 2027 - June 30, 2028

See CONTINUATION Page

X X

X 1

Earnest Ellison

36C24723Q0558

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 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

1. GENERAL:

2. PERIOD OF PERFORMANCE:

3. DAYS AND HOURS OF OPERATION:

3.1 CVVAMC & CBOC Locations:

5. PERFORMANCE REQUIREMENTS:

6. Security Requirements for Unclassified Information Technology Resources

1. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY

REQUIREMENTS

2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008)

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

3. VA INFORMATION CUSTODIAL LANGUAGE

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

6. SECURITY INCIDENT INVESTIGATION

7. LIQUIDATED DAMAGES FOR DATA BREACH

8. SECURITY CONTROLS COMPLIANCE TESTING

9. TRAINING

7. CONTRACT PERFORMANCE MONITORING:

8. INVOICES:

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (DEC 2022)

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.3 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.4 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.5 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR VERIFIED SERVICE-

DISABLED VETERAN-OWNED SMALL BUSINESSES (NOV 2022)

C.6 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING--

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (NOV 2022) .. 38

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 (MAR 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

BUSINESS ASSOCIATE AGREEMENT BETWEEN THE DEPARTMENT OF VETERANS

AFFAIRS VETERANS HEALTH ADMINISTRATION, , AND

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (MAR 2023)

52.212-2 EVALUATION—SIMPLIFIED ACQUISITION PROCEDURES

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.4 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C247

VISN 7 Network Contracting Office

LaVista Business Park - Bldg A

2008 Weems Road

Tucker GA 30084

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly in Arrears

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVIC

ES

QUANTIT

Y

UNI

T UNIT PRICE AMOUNT

12.00 MO ________________

Outpatient Prescription Services for Brunswick CBOC Contract Period: Base POP Begin: 07-01-2023 POP End: 06-30-2024

Outpatient Prescription Services for Tifton CBOC Contract Period: Base

Outpatient Prescription Services for Perry CBOC Contract Period: Base

Outpatient Prescription Services for Milledgeville CBOC Contract Period: Base

Outpatient Prescription Services for Macon CBOC Contract Period: Base

Outpatient Prescription Services for Albany CBOC Contract Period: Base

Outpatient Prescription Services for Warner Robins CBOC Contract Period: Base

Outpatient Prescription Services for Dublin VAMC Contract Period: Base

BASE YEAR TOTAL

Outpatient Prescription Services for Brunswick CBOC

Contract Period: Option 1 POP Begin: 07-01-2024 POP End: 06-30-2025

Outpatient Prescription Services for Tifton CBOC Contract Period: Option 1

Outpatient Prescription Services for Perry CBOC Contract Period: Option 1

Outpatient Prescription Services for Milledgeville CBOC Contract Period: Option 1

Outpatient Prescription Services for Macon CBOC Contract Period: Option 1

Outpatient Prescription Services for Albany CBOC Contract Period: Option 1

Outpatient Prescription Services for Warner Robins CBOC Contract Period: Option 1

Outpatient Prescription Services for Dublin VAMC Contract Period: Option 1

OPTION YEAR 1 TOTAL

Outpatient Prescription Services for Brunswick CBOC

Contract Period: Option 2 POP Begin: 07-01-2025 POP End: 06-30-2026

Outpatient Prescription Services for Tifton CBOC Contract Period: Option 2

Outpatient Prescription Services for Perry CBOC Contract Period: Option 2

Outpatient Prescription Services for Milledgeville CBOC Contract Period: Option 2

Outpatient Prescription Services for Macon CBOC Contract Period: Option 2

Outpatient Prescription Services for Albany CBOC Contract Period: Option 2

Outpatient Prescription Services for Warner Robins CBOC Contract Period: Option 2

Outpatient Prescription Services for Dublin VAMC Contract Period: Option 2

OPTION YEAR 2 TOTAL

Outpatient Prescription Services for Brunswick CBOC

Contract Period: Option 3 POP Begin: 07-01-2026 POP End: 06-30-2027

Outpatient Prescription Services for Tifton CBOC Contract Period: Option 3

Outpatient Prescription Services for Perry CBOC Contract Period: Option 3

Outpatient Prescription Services for Milledgeville CBOC Contract Period: Option 3

Outpatient Prescription Services for Macon CBOC Contract Period: Option 3

Outpatient Prescription Services for Albany CBOC Contract Period: Option 3

Outpatient Prescription Services for Warner Robins CBOC Contract Period: Option 3

Outpatient Prescription Services for Dublin VAMC Contract Period: Option 3

OPTION YEAR 3 TOTAL

Outpatient Prescription Services for Brunswick CBOC

Contract Period: Option 4 POP Begin: 07-01-2027 POP End: 06-30-2028

Outpatient Prescription Services for Tifton CBOC Contract Period: Option 4

Outpatient Prescription Services for Perry CBOC Contract Period: Option 4

Outpatient Prescription Services for Milledgeville CBOC Contract Period: Option 4

Outpatient Prescription Services for Macon CBOC Contract Period: Option 4

Outpatient Prescription Services for Albany CBOC Contract Period: Option 4

Outpatient Prescription Services for Warner Robins CBOC Contract Period: Option 4

Outpatient Prescription Services for Dublin VAMC Contract Period: Option 4

OPTION YEAR 4 TOTAL

GRAND TOTAL ________________

B.3 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

0001-

SHIP TO: VAMC Dublin 1826 Veterans BLVD Dublin, GA 31021

USA

ALL 7/1/2023-

6/30/2028

MARK

FOR:

Leslie Wilkinson (Pharmacy) (478)272-1210 X2911 leslie.wilkinson@va.gov

STATEMENT OF WORK

Emergency Prescription Service

Carl Vinson VA Medical Center Dublin, GA

1. GENERAL:

The Contractor shall provide outpatient pharmacy services for emergency 10- day supply of medications for patients to be located within a 10 mile radius of each Community Based Outpatient Clinic (CBOCS-Brunswick, Tifton, Perry, Milledgeville, Macon, Albany, Warner Robins AFB, and Dublin VAMC) Carl Vinson VA Medical Center, 1826 Veterans Blvd, Dublin, GA 31021 in the event of emergent medication not being readily available at Dublin VAMC and/or needed before CMOP can send to patient.

2. PERIOD OF PERFORMANCE:

One base year with the possibility of four (4) one-year option periods.

Base Year July 1, 2023 – June 30, 2024 1st Option Period July 1, 2024 – June 30, 2025 2nd Option Period July 1, 2025 – June 30, 2026 3rd Option Period July 1, 2026 – June 30, 2027 4th Option Period July 1, 2027 – June 30, 2028

3. DAYS AND HOURS OF OPERATION:

Monday – Friday, 8:00 a.m. to 9:00 p.m. Saturday & Sunday, 9:00 a.m. to 9:00 p.m.

3.1 CVVAMC & CBOC Locations:

Dublin VAMC 1826 Veterans Blvd. Dublin, GA 31021 Brunswick CBOC 93 Benchmark Way Brunswick, GA 31525 Tifton CBOC 1824 N. Ridge Avenue Tifton, GA 31794 Perry CBOC 2370 S Houston Lake Rd Kathleen, GA 31047 Milledgeville CBOC 2249 Vinson Hwy SE Milledgeville, GA 31061 Macon CBOC 5566 Thomaston Rd Macon, GA 31220 Albany CBOC 814 Radford Blvd Bldg 7000 Albany, GA 31701 WRAFB CBOC 655 7th St. Bldg 700 Warner Robins, GA 31098

4. SERVICE DESCRIPTION:

• Account Management

• Customer Care Team

• Network of local convenient pharmacies.

• Point-of Sale Automated Claims processing.

• Disaster Response Plan.

• Authorized Prescriber List.

• Authorized Pharmacy Formulary Drug List.

• Initial Fill Voucher.

• Prior Authorization Services.

• Non-VA Care program Support.

5. PERFORMANCE REQUIREMENTS:

a. These services shall include the dispensing of pharmaceuticals when clinic staff determine that they are emergent and in the best interest of patient care. Pharmacy staff will provide medications to beneficiaries in a timely and courteous manner

b. Only new prescriptions will be filled using the VA National Formulary. A new prescription is defined as a written or telephonic prescription for a drug product and strength that has not been previously dispensed to the beneficiary in the past 12 months. The VA National Formulary* is the only approved formulary to be used for this contract and only medications listed on the VA National Formulary are to be filled unless the prescription is accompanied by a Non-Formulary Consult signed by a VA Pharmacist. Non-Formulary requests can also be approved by the email or telephone contact with the clinic pharmacist. A repeat order for the same drug product within 12 months, even if transmitted as a new prescription order is not considered a new prescription. Exception may be made for second courses of the second courses of antibiotic therapy. (*The National VA Formulary can be found on the Internet at http://www.pbm.va.gov/PBM/NationalFormulary.asp.)

c. Refills will not be authorized. Unless otherwise pre-authorized, prescription fills will be limited to a maximum of a ten-day supply or fourteen days’ supply for antibiotics.

d. Prescriptions shall be filled within one hour of delivery to the pharmacy. The mailing and delivery of prescriptions are not authorized.

e. Only prescriptions from VA authorized practitioners shall be filled under this contract. Prescriptions will be written on a VA prescription form and hand carried by the beneficiary. Each prescription to be filled under this contract will be accompanied by a certification sheet from the CBOC. Prescriptions from non-VA authorized practitioners shall not be filled under the contract. Prescriptions that are non-emergent that the provider wrote for the patient to purchase at his/her own expense shall not be filled under the contract.

f. Prescriptions filled under this contract will be, to the extent permitted by law, the least expensive drug product the pharmacy has in stock and are not restricted by NDC number. Generic drugs will be dispensed whenever possible. A product is not considered a generic equivalent unless the strength, quantity, and dosage are the same as the brand name. The generic name must be displayed on all labels for all medications.

g. The authorized pharmacy(s) shall provide the date of filling, quantity provided (if other than the prescribed quantity), prescription number and name or initials of responsible pharmacist. Contractor shall perform quality assurance checks of all prescriptions prior to dispensing. Beneficiaries will be provided counseling and drug information, as requested.

h. A point of contact (POC) for this contract will be designated within 5 days of the contract award, and the Contracting Officer notified of the POC in writing. The name and address of the local servicing pharmacy(s) will be provided to the Contracting Officer within 10 days of contract award.

i. Contractor must assure all pharmacies utilized are registered with the Drug Enforcement Agency (DEA) and be able to dispense controlled substances Scheduled II, III, IV and V, meet DEA acceptable guidelines and be in good standing in the state of Georgia.

i. All information concerning VA beneficiaries shall be kept confidential and shall not be disclosed to any person, except as authorized in writing and according to all applicable laws. Representatives of the VA http://www.pbm.va.gov/PBM/NationalFormulary.asp are authorized to visit the premises of any pharmacy filling VA prescriptions under the contractor’s plan during business hours for the purpose of auditing and evaluation, which may include the inspection of clinical records.

j. All adverse drug events reported to the contractor’s pharmacies by beneficiaries of the VA shall be reported to the Carl Vinson VAMC (CVVAMC) at 478-272-1210, extension 72911. Adverse drugs events include dispensing errors, drug allergies and adverse drug reactions.

k. Pharmaceutical care provided to beneficiaries under this contract shall meet all standards applicable to

Medicaid recipients in the State where the services are provided, and standards set forth in the current Joint Commission accreditation manual for Ambulatory Care/Pharmaceutical Services.

l. The contractor submits invoices with 30 days of service to CVVAMC monthly for services rendered.

The VA will randomly audit all billings. All invoices will reference the following information:

• Contract Number

• Patient Name

• Patient's Social Security Number (Last Four)

• Prescription Number

• Date of Fill

• Quantity of fill

• Name of medication, generic or brand designation

• Any other information required by law

• Provider Name

• Contractor's charge

m. Contractor shall provide a listing of licensed pharmacies in Brunswick, Tifton, Perry, Milledgeville, Macon, Albany, Warner Robins, and Dublin, GA that will accept its plan. The VA will designate pharmacy/pharmacies the contractor shall utilize.

n. The contractor shall provide monthly excel reports providing the list of drugs dispensed by:

• Pharmacy

• Provider

• Patient

• Drug

(Monthly reports shall be provider to the COR.)

o. The mechanism/documentation used to ensure the VA sensitive information is protected is by VA PKI “partner” certificate to allow encrypted email exchange. Invoices, authorizations, and reports can then be sent via PKI encrypted email.

p. Contractor will provide a high level of quality service to both patients and providers. Communication with providers should be open and immediate in order to resolve professional issues. Patient satisfaction is paramount. Procedural issues should be immediately resolved with the designated Contracting Officers Technical Representative (COTR).

6. Security Requirements for Unclassified Information Technology Resources

VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE

NOTE: This clause will undergo official rule making by the Office of Acquisitions and Logistics. The below language will be submitted for public review through the Federal Register. The final wording of the clause may be changed from what is outlined below based on public review and comment. Once approved, the final language in the clause can be obtained from the Office of Acquisitions and Logistics Programs and Policy.

1. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY

REQUIREMENTS

839.201 Contract clause for Information and Information Technology Security:

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

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

2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008)

As prescribed in 839.201, insert the following clause:

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. The certification and accreditation (C&A) requirements do not apply, and the security accreditation package is not required.

Contractor will comply with VA Medical Center security badging for all onsite personnel during the course of this contract. All onsite maintenance personnel will be required to wear VA issued security badge.

Contractor will provide the names of all onsite maintenance personnel and Privacy Training certificate to the VA Medical Center COTR.

When the contractor’s service representative arrives on station, he/she will be required to sign a log sheet which will be placed at the actual equipment site (Pharmacy, Room C108-5).

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

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 COTR.

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 COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COTR 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.

(2) 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

(3) 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 10 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 vulnerability 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 COTR 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 COTR.

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 preapproved 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 COTR 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 $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification.

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

(3) Data breach analysis.

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

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

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

8. SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract.