36C26318Q0277-001.docx

36C26318Q0277

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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

437-18-2-029-0049

36C26318Q0277 02-09-2018 Scott Hendrix 651-293-3024 03-09-2018 1:00pm CST

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Scott Hendrix 316 Robert Street N.

St. Paul MN 55101 x

621511 $32.5 Million

X

N/A X

Department of Veterans Affairs Fargo VA Health Care System 2101 Elm Street N.

Fargo ND 58102-2498

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Scott Hendrix 316 Robert Street N.

St. Paul MN 55101

Y Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page Provide Thyroid Biopsy Testing Services.

See Statement of Work in Section B.3

See Schedule of Services in Section B.2

See Submittal Instructions Section E.2.

See CONTINUATION Page

One

Scott E. Hendrix Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

(Continuation from Standard Form 1449, block 18A.)

SYSTEM FOR AWARD MANAGEMENT (SAM) REGISTRATION IS REQUIRED TO BE ACCOMPLISHED BY THE CONTRACTOR BEFORE CONTRACT AWARD. https://www.sam.gov/portal/public/SAM (SEE FAR PART 12)

CAUTION - LATE Submissions, Modifications, and Withdrawals: See provision 52.212-1 “Instructions to Offerors – Commercial Items). All offers are subject to all terms and conditions of this solicitation.

1. CONTRACT ADMINISTRATION DATA

a. CONTRACT ADMINISTRATION: List below responsible party that may be contacted during the term of this contract for matters pertaining to the contract:

Contractor Name: __________________________________________

Title: __________________________________________

Address: __________________________________________

Telephone: __________________________________________

Facsimile: __________________________________________

E-mail: __________________________________________

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

[ ] 52.232-36, Payment by Third Party

3. BILLING FOR SERVICES:

3.1 Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted within 30 days of the end of each month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

1. Name and Address of Contractor

2. Contractor’s ID Number (Tax ID number)

3. Invoice Date and Invoice Number

4. Contract Number and Purchase/Task Order Number

5. Date of Service

6. Line Item Pricing

7. Total Price

3.2 Vendor Electronic Invoice Submission Methods: Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically per the accepted electronic data transmission methods below. Reference VAAR Clause 852.232-72: The contractor shall submit electronic payment requests through:

3.2.1 VA’s Electronic Invoice Presentment and Payment System (See Web site at http://www.fsc.va.gov/einvoice.asp); or,

3.2.2 A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org) includes additional information on EDI 810 and 811 formats.

3.2.3 The Contractor may contact Tungsten or FSC at the phone number or email address listed below with any questions about the e-invoicing program:

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

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

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

3.2.3.4 FSC e-invoice email: vafsccshd@va.gov

3.3 All payments shall be processed in accordance with the payments clause (FAR Clause 52.232-1).

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

5. SAFETY REQUIREMENTS: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer, or his/her designee may determine to be reasonably necessary to protect the lives and health of the occupants of the buildings. The Contracting Officer or his/her designee will notify the Contractor of any noncompliance with the forgoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his/her representative at the site of the work, shall be deemed sufficient for the purposes aforesaid. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default.

6. CONFORMITY TO REGULATIONS: The Contractor and his/her operators shall conform to all regulations, Federal, State, and local, governing the performance of contracted services.

7. TYPE OF CONTRACT: Resultant contract shall be an Indefinite Delivery / Indefinite Quantity (IDIQ) contract effective for the period stated in the Schedule of Services.

8 TERM OF CONTRACT: Resultant contract shall be effective for a base period of one year with four (4) twelve-month option periods as defined in the Schedule of Services.

9. AVAILABILITY OF FUNDS: The contract is subject to the availability of VA funds. The contractor shall perform no service after the end of the current exercised contract year until the Contracting Officer authorizes such services in writing.

10. POINT OF CONTACT: The Contractor shall provide a point of contact (POC) who shall be responsible for the performance of the work under this contract. The POC shall have full authority to act for the Contractor on all matters relating to the daily operation of this contract. The POC may be a contract health care provider performing under this contract. An alternate may be designated, but the Contractor shall identify, in writing, those times when the alternate shall act as the POC. The Contractor shall identify the POC and alternate in writing to the Contracting Officer’s Representative (COR) and Contracting Officer (CO). The Contractor shall give written notification to the COR and CO of the time when the alternate will act as the POC. The POC shall be available by telephone Monday through Friday, 8:00 AM through 4:30 PM, excluding Federal holidays.

11. INDEMNIFICATION: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

12. REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM: As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed $150,000, and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

Each Contractor whose contract award is estimated to exceed $150,000 requires a CPARS evaluation. A government Focal Point will register your contract within thirty days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations). Additional information regarding the evaluation process can be found at www.cpars.gov or if you have any questions, you may contact the Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690.

For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have sixty (60) days to submit any comments and re-assign the report to the CO.

Failure for the Contractor’s representative to respond to the evaluation within those sixty (60) days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

13. CITIZENSHIP RELATED REQUIREMENTS: The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals;

While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document (see Attachment 2 – Immigration and Nationality Act Certification).

14. ANNUAL OFFICE OF INSPECTOR GENERAL (OIG) STATEMENT: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contract providers (s) are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractors are and/or firm is not listed as of the date the offer/bid was signed.

15. SECURE FAX: VA Handbook 6500 requires the following statement on all fax cover sheets be included: “This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribute on, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.”

16. POST AWARD ORIENTATION: The Contracting Officer will schedule a post-award orientation conference for contract orientation purposes as required by IL 003A3-12-04.

B.2 SCHEDULE OF SERVICES

The contractor agrees to furnish all personnel, supplies, facility and equipment to provide services necessary to perform Thyroid Biopsy Testing services as outlined in the Statement of Work (SOW) for the Department of Veterans Affairs, Fargo VA Health Care System (FVAHCS), 2101 Elm Street N., Fargo, ND 58102-2498.

Contract type is a Fixed Price, Indefinite Delivery, Indefinite Quantity (IDIQ).

The guaranteed minimum contract quantity and maximum contract quantity including the base year and any option years exercised.

Minimum: $4,000.00 Maximum: $150,000.00

Place of Performance: Services shall be provided at contractor’s site.

BASE PERIOD – April 1, 2018 Through March 31, 2019

OPTION PERIOD ONE – April 1, 2019 Through March 31, 2020

OPTION PERIOD TWO – April 1, 2020 Through March 31, 2021

OPTION PERIOD THREE – April 1, 2021 Through March 31, 2022

OPTION PERIOD FOUR – April 1, 2022 Through March 31, 2023

TOTAL BASE AND ALL OPTION PERIODS: $___________________________

B.3 STATEMENT OF WORK

Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to act as our reference lab in the provision of gene expression classification services as a reference lab to the Fargo VA Health Care System described herein. Reference Laboratory Services include, but are not limited to: specimen preparation and storage; performance of analytical testing; reporting of analytical test results; and consultative services.

I. Specimen Preparation and Storage for Reference Testing Specimens

1. Contractor shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor’s requirements.

1. Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the Contractor for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the Contractor.

1. Contractor shall be responsible for storing specimens in such a manner to insure the integrity of the specimen.

1. Transportation Services for Reference Testing Specimens

1. Contractor shall provide transportation of primarily biomedical materials that include patient specimens Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained.

1. Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor’s laboratory. These supplies shall include, but may not be limited to:

1) Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory.

2) Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.

3) Test request forms, preprinted with the appropriate Shipping Section details and account information.

4) Test request forms for specialized testing (i.e. cytogenetics, tissue, etc.).

1. Specimen Testing

1. The Contractor shall provide testing using tissue extracted during a fine needle aspiration. Contractor is requested to provide genomic sequencing to determine the expression profile of the mRNA. This test must use the expression profile to determine benign or suspicious for malignancy resulting for the submitted tissue. The Contractor is requested to offer BRAF and RET/PTC mutation testing in addition to the genomic sequencing classification to help determine the extent of surgery.

1. Contractor shall make available the following test information:

1. Requisition form requirements

1. Specimen collection and preservation requirements

1. Test method employed (indicate if testing performed in duplicate) and interpretations

1. Test reference intervals adjusted for age, sex or race, when required

1. Test specific sensitivity, specificity and interferences, when required

1. Test critical values, if any

1. Policy for critical value notification

1. Report Turn-around time will be within 14 days from the date on which the Contractor receives the specimen

1. Testing shall be performed Monday-Saturday Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change.

1. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

1. The Contractor shall ensure the accurate and timely performance (defined in Section III.B.8) of laboratory testing services on the biomedical materials.

1. Reporting of Results

1. The results of testing shall be reported within the prescribed turnaround times provided by the Contractor as part of the test information (defined in Section III.B.8).

1. A report of laboratory testing results must be transmitted as a printed copy by telephone facsimile to a protected machine identified to the Contractor by the VA. Delivery by electronic mail i.e. MS Outlook, etc. is prohibited.

1. Each test report generated in hard copy form shall, at minimum, include the following information:

1. Patient's full name

1. Patient’s identification number, e.g. social security number (SSN)

1. Physician’s name (if supplied)

1. Submitting facility name

1. Submitting facility account number

1. Test(s) ordered

1. Date/time of specimen collection (when available)

1. Date/time test completed

1. Test result

1. Reference intervals (adjusted for age, sex or race, when appropriate)

1. Toxic and therapeutic ranges, if applicable

1. Flagged abnormal results

1. Reference laboratory accession number

1. Name and address of testing laboratory

1. Any other information the laboratory has that may indicate a questionable validity of test results.

1. Specimen inadequacy with documentation supporting its unsuitability for testing.

1. Customer Service

1. Contractor shall provide customer service that is accessible during Contractor’s business hours Monday-Friday 7:00am-5:00pm to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

1. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period:

1. Telephone Inquiries – Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government’s minimum time expectation for meeting this service.

1. Specimen Collection

1. Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call.

1. Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within ½ hour of the initial call.

1. Testing

1. Inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

1. Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call.

c. Technical Expertise

1. Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call.

1. Result interpretation inquiries shall be addressed within four business hours of initial call.

3) Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call.

d. Account follow-up

1. Information general in nature yet specific to the account, e.g. test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call.

1. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc.

1. The Government will place orders for specimen collection and transportation supplies by telephone or through written or electronic methods.

1. Consultative Services/Utilization Reports

1. Contractor shall provide consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

1. Contractor shall provide a statistical analysis of the Government facilities’ workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities on mechanisms to reduce their costs.

B.4 IT CONTRACT SECURITY

VA HANDBOOK 6500.6 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 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1568 , http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=832&FType=2 . 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 onsite 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 http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=429&FType=2 and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=475&FType=2 and VA Handbook 6500.1, Electronic Media Sanitization http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=416&FType=2 . 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 1605.05, Business Associate Agreements http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3027. 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 VA Directive 6508, Implementation Of Privacy Threshold Analysis And Privacy Impact Assessment http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=767&FType=2.

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, Risk Management Framework For VA Information Systems – Tier 3: VA Information Security Program http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=793&FType=2 and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=485&FType=2.

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 30 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 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 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, Assessment, Authorization, And Continuous Monitoring Of VA Information Systems http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=733&FType=2. 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, and Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

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