36C26121Q0757 RFQ_05AUG.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. 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 83

36C26121Q0757 08-06-2021

Michaela S. Brown 916-923-4527 08-13-2021

1200 PDT

612MCP

Department of Veterans Affairs Network Contracting Office (NCO) 21 5342 Dudley Blvd., Bldg. 209

McClellan CA 95652

X

541380

$16.5 Million

N/A

X

Department of Veterans Affairs VA Palo Alto Health Care System

3801 Miranda Avenue Palo Alto CA 94304

612MCP

Department of Veterans Affairs Network Contracting Office (NCO) 21

3230 Peacekeeper Way, Bldg. 209 McClellan CA 95652-1012

Department of Veterans Affairs FMS VA-9(101) Financial Services Center

PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

Contractor shall provide predictive Bartlett's Services for the VA Palo Alto Health Care System on an as-needed basis in accordance with the Performance Work Statement contained herein.

IDIQ Period of Performance: 09/01/2021 - 08/31/2026 Ordering Period One: 09/01/2021 - 08/31/2022

This solicitation will result in a Indefinite Delivery Indefinite Quantity (IDIQ) contract. Please refer to the price schedule for minimum and maximum contract value information.

This procurement is being done on a sole source basis. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered.

Please send questions to michaela.brown@va.gov.

See CONTINUATION Page

X X

Gary T. Basile Contracting Officer

36C26121Q0757

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 PERFORMANCE WORK STATEMENT

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

C.2 52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST (JUN 2020)

C.3 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION

SYSTEMS (JUN 2016)

C.4 52.216-18 ORDERING (AUG 2020)

C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.7 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.8 52.232-18 AVAILABILITY OF FUNDS (APR 1984)

C.9 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) 43

C.10 52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER—SYSTEM FOR

AWARD MANAGEMENT (OCT 2018)

C.11 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.12 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.13 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.14 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.15 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) ALTERNATE

II (FEB 2021)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY

REFERENCE (JAN 2008)

E.8 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.9 VAAR 852.223-70 INSTRUCTIONS TO OFFERORS—SUSTAINABLE ACQUISITION

PLAN (SEP 2019)

E.10 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (FEB 2021) (JUL 2020) (DEVIATION)

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 36C261 Gary T. Basile Department of Veterans Affairs Network Contracting Office (NCO) 21 5342 Dudley Blvd., Bldg. 209 McClellan CA 95652

c. ADMINISTRATION: Contract Specialist 36C261 Michaela S. Brown Department of Veterans Affairs Network Contracting Office (NCO) 21 5342 Dudley Blvd., Bldg. 209 McClellan CA 95652

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] Upon Government Acceptance on a Monthly Basis

4. GOVERNMENT INVOICE ADDRESS: Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/ Tungsten direct vendor support number is 877-489- 6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA-FSC.

This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA- FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. For additional information, please contact:

Tungsten Support

Phone: 1-877-489-6135

Website: http://www.tungsten-network.com/uk/en/

Department of Veterans Affairs Financial Service Center

Phone: 1-877-353-9791 Email: vafscched@va.gov

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

AMENDMENT NO DATE

mailto:vafscched@va.gov

B.2 PRICE/COST SCHEDULE

Contractor shall provide Predictive Bartlett’s Esophagus assay (PBEA) for eligible Veterans at contractor’s place of business. All testing services shall be provided in accordance with the specifications, terms and conditions contained herein.

The guaranteed minimum, award amount for this contract is $1,000.00. The maximum aggregate value of orders that can be placed under this contract is, $2,500,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 100.00 EA ________________ ________________

TissueCypher Barrett’s Esophagus Assay Contract Period: Ordering Period 1 POP Begin: 09-01-2021 POP End: 08-31-2022

1001 100.00 EA ________________ ________________

TissueCypher Barrett’s Esophagus Assay Contract Period: Ordering Period 2 POP Begin: 09-01-2022 POP End: 08-31-2023

2001 100.00 EA __________________ __________________

TissueCypher Barrett’s Esophagus Assay Contract Period: Ordering Period 3 POP Begin: 09-01-2023 POP End: 08-31-2024

3001 100.00 EA __________________ __________________

TissueCypher Barrett’s Esophagus Assay Contract Period: Ordering Period 4 POP Begin: 09-01-2024 POP End: 08-31-2025

4001 100.00 EA __________________ __________________

TissueCypher Barrett’s Esophagus Assay Contract Period: Ordering Period 5 POP Begin: 09-01-2025 POP End: 08-01-2026

GRAND TOTAL __________________

B.3 PERFORMANCE WORK STATEMENT

1. SCOPE OF WORK.

1.1 OVERVIEW

VAPAHCS has a new requirement for a predictive Bartlett’s Esophagus assay (PBEA) which will identify the probability that a patient will develop esophageal cancer over a 5-year period. The PBEA must be able to be performed on previously collected gastroesophageal biopsies that have either been processed to slides or are still in formalin-fixed, paraffin embedded (FFPE) tissue block form. The vendor will section these tissue blocks into a form factors as needed to conduct the PBEA. The PBEA results must accurately group patients into 3 cohorts – low, intermediate and high risk for developing esophageal cancer customized care plans based on a 1-10 scale.

1.2 WORK DETAILS

Specimen Collection and Delivery to Test Lab Vendor

1) Vendor will provide VAPA HCS with pre-paid shipping kits for next day delivery to the vendor’s testing facility

2) The shipping kits must maintain the integrity of the esophageal biopsies during transit, accounting for environmental factors such as ambient temperature as well as the normal jostling that the kit would encounter.

3) The vendor must provide shipping kits that will accommodate both the processed specimen slides and the FFPE tissue blocks

4) Within 1 business day of receipt of the specimen, Vendor will confirm the same using either secure fax or encrypted email.

1.3 Specimen Testing and Reporting

1) Vendor will prepare the specimen as needed to conduct the PBEA.

2) Vendor will provide the PBEA results to VAPA no later than 15 business days after receipt of the specimen. Reports are to be sent by either secure fax or encrypted email; information that must be included is detailed below.

3) Specimens that were used to conduct the PBEA will be stored at the vendor’s storage location in accordance with normal industry practices, regulatory agency requirements, and certifying authorities.

4) If the supplied specimen form was tissue block, the portion of the block not used in the PBEA process will be returned to the provider who initially ordered it at no cost to VAPA.

5) The return shipping kits must maintain the integrity of the tissue block during transit, accounting for environmental factors such as ambient temperature as well as the normal jostling that the kit would encounter.

1.4 Reporting of Results.

1) A report is defined as a printed final copy in duplicate of laboratory testing results. This report shall be received by remote terminal where applicable. Each test report shall at minimum indicate the following information:

a. Patient's name and/or identification code (Social Security number)

b. Physician's name

c. Medical record number (if supplied)

d. Date/time specimen received in Reference Lab

e. Test ordered

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

g. Date test completed

h. Test result

i. Testing laboratory specimen number

j. Name of testing laboratory (contractor and/or subcontractor)

k. Type of specimen

l. Any additional comments related to test provided by submitting labs.

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

n. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing.

2. LICENSING AND ACCREDITATION

1) Staff/Laboratory Licenses/Certifications

1.1 Laboratory License: The Contractor shall make sure the laboratory has all licenses, permits;

accreditation and certificates required by law and specifically maintain current certifications/accreditation through:

a) CAP (College of American Pathologists)

b) CLIA (Clinical Laboratory Improvement Act)

All medical facilities providing laboratory services under the contract must possess a valid state license and full accreditation from the JCAHO and the College of American Pathologists (CAP).

Contractor is to provide evidence of such accreditation to COR within 30 days of contract start date. Any recertification updates will be given to the COR within 30 days of receiving them.

1.2 Staff License: The Contractor shall make sure testing staff have current and valid professional state and or federal certifications. Technologists, medical technicians, and cytotechnologists shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology, be Clinical or Anatomic Pathology board certified and must possess a valid license to practice clinical reference laboratory services from a United States (U.S.)

jurisdiction The laboratory Director shall be a licensed American Board of Pathology certified pathologist.

1.3 Anatomic Pathology & Clinical Laboratories testing staff will work under the general direction of a qualified clinical or anatomic pathologist who specializes in the requested testing discipline and the supervisory technologist.

3. CONTRACTOR RESPONSIBILITIES

1) The Contractor shall not introduce new medical procedures and services for specimens provided by VAs without prior recommendation to, and approval of, the COTR, or authorized laboratory representative.

2) The Contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy.

The standard deviation and daily control records are to be available for review upon request by the Contracting Officer or contracting officer’s technical representative.

3) The Contractor shall perform repeat tests at no charge to the government if the results do not, in the government requesting physician's opinion, fit the clinical picture of the patient. When requesting these tests, the government requesting physician or representative will explain the conditions of the patient or any discrepancies observed. Repeat tests shall be the same test originally ordered.

4. MONTHLY TESTS SUMMARY

1) The Contractor shall provide to VAPA a cumulative (year-to-date) monthly report of all tests received during the month and for all outstanding results. The report shall identify the tests that were received to include accession number, patient’s name, Social Security Number, and specimen collection and test report dates required by accreditation agencies. The Contractor report shall indicate the requesting physician, tests, TAT for each test, corresponding cost per test and a STAT charge.

5. SERVICE

1) The contractor shall always provide telephone number(s) and contact person to be used by the VA facilities to make specimen problem inquiries and problem solving including weekends and holidays.

2) The contractor shall include names and telephone numbers of technical Directors and Pathologists available for consultation.

3) Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency.

4) Contractor shall assign a specific account representative

5) Contractor shall advise facility of any changes in methodology, procedure, delays in testing, and any new tests introduced.

6. GOVERNMENT RESPONSIBILITIES.

1) Specimen Preparation and Packaging:

a) VAPA will a test order and package laboratory specimens for overnight shipment according to the contractor's test ordering process. The contractor shall provide an adequate supply of test order forms, shipping kits, re-usable cooling packs and any other supplies, consumables required to ship specimens.

b) Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to the designated Contracting Office4r.

In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan;

increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

7. COR RESPONSIBILITIES.

1) The COR for this contract is: Daniel McLean daniel.mclean1@va.gov

2) The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

3) The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: enter data that may be collected.

4) The COR will maintain a record-keeping system of services by keeping and maintaining monthly a Running Balance database of services rendered and invoices paid. The COR will review this data on a regular basis when invoices are received and certify all invoices for payment. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

5) The COR will review and certify invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

mailto:daniel.mclean1@va.gov

8. CONTRACTOR PERSONNEL.

1) The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. Technologist, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology acceptable to the United States Surgeons General must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction; and shall have provided pathology services a minimum of 24 months within the past 36 months and pathology consultation services a minimum of 36 months within the past 48 months.

2) The Contractor shall provide evidence of reapplication to the VA COTR of any state license, CLIA certification, or clinical pathology certification 60 days before expiration license. The Contractor shall provide a copy of the renewed licenses/certificates to the VA COR before expiration.

3) The Contractor shall not employ any person who is an employee of the U.S. Government if employing that person would create a conflict of interest. The Contractor shall not employ any person who is an employee of the Federal Government, either military or civilian, unless such -person seeks and receives approval according to DOD 5500.7-R, the Joint Ethics Regulation (JER). This policy is available to the Contractor upon request.

9. PERFORMANCE STANDARDS QUALITY ASSUARANCE (QA) AND QUALITY

IMPROVEMENT (QI).

1) Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, timely reporting of test results, and maintaining required certifications. Methods of Surveillance: Periodic inspection and monitoring of customer comments/complaints. Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

2) Laboratory Manager Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The COR will assist with communication between CO and Contractor. The CO is final authority on validating complaints.

10. HOURS OF OPERATION.

1) Normal Hours of Operation. The Contractor shall perform the services required under this contract 24 hours per day, 7 days per week, 365 days per year. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA COTR.

2) This includes weekends and federal holidays.

11. JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS

(JCAHO).

1) All medical facilities providing laboratory services under the contract must possess a valid state license and full accreditation from the JCAHO and the College of American Pathologists (CAP). Offeror is to provide evidence of such accreditation.

12. MALPRACTICE LIABILITY INSURANCE.

1) Malpractice liability insurance shall be by a commercial insurance company in the business of providing the required insurance coverage. The Contractor shall provide a copy of the Medical Malpractice Insurance Certificate before award of the contract.

13. MALPRACTICE CLAIMS.

1) The Contractor shall notify the contracting officer in writing of any malpractice investigation or licensure or certification suspension which concerns the Contractor or any employees, within 24 hours of notification of an, investigation or suspension.

14. END OF CONTRACT PERFORMANCE.

1) At the end of the period of contract performance, the participating medical treatment facility (VAMC) will notify the Contractor of the quantity of unused supplies and arrange a pick-up time. All Contractor provided equipment shall be disconnected by the Contractor from the VAMC, upon contract expiration and removed within five working days.

15. BILLING.

1) Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than the 20th workday of the following 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:

a) Name and Address of Contractor

b) Invoice Date and Invoice Number

c) Purchase/Task Order Number

d) Date of Service

e) Total Price

2) Vendor Electronic Invoice Submission Methods

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

a) VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten Network, to transition vendors from paper to electronic invoice submission. Please go to this website: https://www.tungsten-network.com/customer-campaigns/veteransaffairs/to begin submitting electronic invoices, free of charge.

4) 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).

5) The Contract may contact FSC at the phone number or email address listed below with any questions about the e-invoicing program or OB10:

a) OB10 e-Invoice Setup Information: 1-877-489-6135

b) OB10 e-Invoice email: VA.Registration@ob10.com

c) FSC e-Invoice Contact Information: 1-877-353-9791

d) FSC e-invoice email: vafsccshd@va.gov

16. GENERAL SECURITY REQUIREMENTS

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.

1) ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a) A contractor/subcontrator 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 mailto:vafsccshd@va.gov 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.

2) 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.

3) 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:

i) Vendor must accept the system without the drive;

16.3.i.1. 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

16.3.i.2. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

16.3.i.3. 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;

16.3.i.4. 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

16.3.i.5. 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.

16.3.i.6. 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.

16.3.i.7. The ISO needs to maintain the documentation.

4) 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.

5) 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:

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

16.5.c.2. Description of the event, including:

16.5.c.3. date of occurrence;

16.5.c.4. data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

16.5.c.5. Number of individuals affected or potentially affected;

16.5.c.6. Names of individuals or groups affected or potentially affected;

16.5.c.7. 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;

16.5.c.8. Amount of time the data has been out of VA control;

16.5.c.9. The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

16.5.c.10. Known misuses of data containing sensitive personal information, if any;

16.5.c.11. Assessment of the potential harm to the affected individuals;

16.5.c.12. Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

16.5.c.13. 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:

16.5.d.1. Notification;

16.5.d.2. One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

16.5.d.3. Data breach analysis;

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

16.5.d.5. One year of identity theft insurance with $20,000.00 coverage at $0 deductible;

and

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

6) SECURITY CONTROLS COMPLIANCE TESTING

a) 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. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

7) TRAINING

a) All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

16.7.a.1. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

16.7.a.2. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

16.7.a.3. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

16.7.a.4. Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b) The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c) Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

B.4 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information…