36C26123Q0609_1.docx

36C26123Q0609

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

640-23-3-444-0012 36C26123Q0609 06-03-2023 Cindy Smith 808-539-1306 06-16-2023

10AM

Department of Veterans Affairs Network Contracting Office (NCO) 21 VA Pacific Islands Health Care System 711 Kapiolani Blvd Suite 200 Honolulu

HI

96813 X X 811210 $34 Million N/A X VA Palo Alto Health Care System 3801 Miranda Ave Palo Alto

CA

93703 Department of Veterans Affairs Network Contracting Office (NCO) 21 VA Pacific Islands Health Care System 711 Kapiolani Blvd Suite 200 Honolulu

HI

96813

Department of Veterans Affairs FMS VA-9(101) Financial Services Center PO Box 149971 Austin

TX

78714-9971 866-372-1141 vafscenterprisesupport@va See CONTINUATION Page The Contractor shall provide endoscope services for the VA Palo Alto Health Care System (VAPAHCS) in accordance with the Statement of Work (SOW).

All questions shall be directed in writing to Cindy Smith cindy.smith@va.gov by 6/09/2023.

See CONTINUATION Page Table of Contents

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 Rico Johnson Department of Veterans Affairs Network Contracting Office (NCO) 21 VA Pacific Islands Health Care System 711 Kapiolani Blvd Suite 200 Honolulu HI 96813

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

3. INVOICES: Invoices shall be submitted in arrears:

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

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ORTH SCOPE

Contract Period: Base POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance PRODUCT/SERVICE CODE: Q523 - Medical - Surgery

MANUFACTURER PART NUMBER (MPN): N/A

CYSTO SCOPE

POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

HYSTO SCOPE

POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

LAPAROSCOPIC-GENERAL

POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

LAPAROSCOPIC-GYNL

POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

THORASIC

POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

ENT

POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

VIDEO SERVICES

POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

ORTH SCOPE

Contract Period: Option 1 POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

CYSTO SCOPE

POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

HYSTO SCOPE

POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

LAPAROSCOPIC-GENERAL

POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

LAPAROSCOPIC-GYNL

POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

THORASIC

POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

ENT

POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

VIDEO SERVICES

POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

ORTH SCOPE

Contract Period: Option 2 POP Begin: 08-01-2025 POP End: 07-31-2026 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

CYSTO SCOPE

POP Begin: 08-01-2025 POP End: 07-31-2026 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

HYSTO SCOPE

POP Begin: 08-01-2025 POP End: 07-31-2026 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

LAPAROSCOPIC-GENERAL

POP Begin: 08-01-2025 POP End: 07-31-2026 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

LAPAROSCOPIC-GYNL

POP Begin: 08-01-2025 POP End: 07-31-2026 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

THORASIC

POP Begin: 08-01-2025 POP End: 07-31-2026 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

ENT

POP Begin: 08-01-2025 POP End: 07-31-2026 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

VIDEO SERVICES

POP Begin: 08-01-2025 POP End: 07-31-2026 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

ORTH SCOPE

Contract Period: Option 3 POP Begin: 08-01-2026 POP End: 07-31-2027 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

CYSTO SCOPE

POP Begin: 08-01-2026 POP End: 07-31-2027 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

HYSTO SCOPE

POP Begin: 08-01-2026 POP End: 07-31-2027 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

LAPAROSCOPIC-GENERAL

POP Begin: 08-01-2026 POP End: 07-31-2027 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

LAPAROSCOPIC-GYNL

POP Begin: 08-01-2026 POP End: 07-31-2027 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

THORASIC

POP Begin: 08-01-2026 POP End: 07-31-2027 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

ENT

POP Begin: 08-01-2026 POP End: 07-31-2027 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

VIDEO SERVICES

POP Begin: 08-01-2026 POP End: 07-31-2027 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

ORTH SCOPE

Contract Period: Option 4 POP Begin: 08-01-2027 POP End: 07-31-2028 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

CYSTO SCOPE

POP Begin: 08-01-2027 POP End: 07-31-2028 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

HYSTO SCOPE

POP Begin: 08-01-2027 POP End: 07-31-2028 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

LAPAROSCOPIC-GENERAL

POP Begin: 08-01-2027 POP End: 07-31-2028 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

LAPAROSCOPIC-GYNL

POP Begin: 08-01-2027 POP End: 07-31-2028 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

THORASIC

POP Begin: 08-01-2027 POP End: 07-31-2028 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

ENT

POP Begin: 08-01-2027 POP End: 07-31-2028 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

VIDEO SERVICES

POP Begin: 08-01-2027 POP End: 07-31-2028 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance

B.3 STATEMENT OF WORK (SOW)

Statement of Work Endoscopy Services VA Palo Alto Health Care System Section 1: General Information

1.1 General: This is a non-personal services contract to provide endoscopy services for the VA Palo Alto Health Care System (VAPAHCS). The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.2 Period of Performance:

3801 Miranda Ave Palo Alto, CA 93703

1.4 Hours of Operation: Contracting technicians must be available during operating room business hours of 7:00 a.m. to 7:00 p.m. weekdays to assist, troubleshoot and provide consultation on all rigid endoscopic video equipment on a case-by-case basis as needed. During weekends, contracted technicians will be on-call e.g. available via phone regarding pre, intra and post operative set utilization. The on-call Contracting technicians will be on-site within four (4) hours once the procedure has ended to clean surgical instrumentation.

1.5 Type of Contract: The government will award a Firm Fixed Price contract.

1.6 Invoicing: All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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

More information on the VA Financial Services Center is available at http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

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

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

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

· FSC e-invoice email: vafsccshd@va.gov Section 2: Definitions & Acronyms

2.1 Definitions:

Contractor. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

Subcontractor. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

Work Day. The number of hours per day the Contractor provides services in accordance with the contract.

Work Week. Monday through Friday, unless specified otherwise.

2.2 Acronyms:

Section 3: Government Furnished Property, Equipment, and Services

3.1 The VAPAHCS will furnish the Contractor with the following:

A. Office space B. Shelving units for instrumentation C. Cleaning area with brushes, pipe-cleaners, and syringes D. Peel pack, blue-wrap, and tip protector materials E. Autoclaves, Steris processors, and Sterrad processors F. Tapes, Indicators, and other related material Section 4: Contractor Furnished Items and Services

4.1 The Contractor shall provide all equipment, supplies, management, supervision, personnel, and transportation except as specified herein as government-furnished, necessary to assure that all services are in accordance with the contract and all applicable laws and regulations. The contractor shall ensure all work meets performance standards specified in this Statement of Work (SOW) and referenced documents.

Section 5: Specific Tasks

5.1 The Contractor shall provide all instruments (imaging and scopes) for Endoscopic surgery cases available for each procedure. All instruments shall remain the property of the Contractor.

5.2 The Contractor shall manage the upkeep of their instruments, which includes all cleaning, repair, sharpening, and replacement when necessary.

5.3 All work performed under this contract will be charged at the prices established in the Price Schedule.

5.4 The Contractor shall provide trained technicians to assist preoperatively with room setup, intra-operatively with verbal technical assistance with instruments and video equipment, and post-operatively with breakdown of equipment.

5.5 The Contractor shall furnish not to exceed three (3) qualified Endoscope Specialists and/or Manager to VAPAHCS to perform the following:

A. On-site personnel to assist during regular business hours from 7:00 a.m. to 7:00 p.m. Monday-Friday excluding Federal Holidays during all laparoscopic, arthroscopic, endoscopic, sinus/ENT, and urology procedures performed.

B. Standardization of instrumentation trays used in laparoscopic, arthroscopic, endoscopic sinus/ENT and urology procedures performed.

C. Purchase, maintain, repair, and replace instrumentation and specialty equipment, including video components, for use in laparoscopic, arthroscopic, endoscopic, sinus and urology procedures performed.

D. Troubleshoot video equipment (monitor, camera, light source, printer, Digital Capture Unit, etc.), light cords, rigid and semi-rigid scopes, and all related components for all laparoscopic, arthroscopic, endoscopic, sinus, and urology procedures.

5.6 The Contractor will purchase, maintain, repair, replace, and oversee total capital and video equipment for the use in all laparoscopic, arthroscopic, endoscopic, sinus/ENT, and urology procedures.

5.7 The Contractor shall supply pre-operative, intra-operative, and post-operative technical assistance to physicians, scrub personnel, as well as Operating Room (OR) Nurses to coordinate cost effective measures in all laparoscopic, arthroscopic, endoscopic, sinus, and urology procedures.

5.8 The Contractor personnel shall manage and oversee pre-operative sterilization and processing, intra-operative troubleshooting and maintenance, as well as post-operative cleaning and repair management of all video-towers, components, and systems used for laparoscopic, arthroscopic, endoscopic sinus and urology procedures.

5.9 The Contractor shall adhere to and follow all applicable Occupational Safety and Health Administration (OSHA), Joint Commission (JC), Association of Perioperative Registered Nurses (A.O.R.N.), and Health Insurance Portability and Accountability Act (HIPAA) protocols, standards, and policies mandated for all healthcare personnel that function either directly or indirectly with patient care within the Operating Room environment.

5.10 The Contractor shall conduct account surveys to collect data measuring the success of services provided, which are made available twice a year.

5.11 The contractor shall supply a copy of each and every invoice generated after all laparoscopic, arthroscopic, endoscopic sinus, and urology procedure performed for evaluation and/or necessary signatures.

5.12 HIPAA Compliance: Under HIPAA Privacy and Security Rules, the Contractor providing services under this contract is considered to be a "covered entity," and thus is not required to enter into a Business Associate Agreement with VA. However, the Contractor must observe Public Law 104-191 and all respective regulations implementing this law while providing services under this contract.

5.13 Equipment Requirements:

Video Camera Platform:

A native 4K video system that includes the capability to perform real-time endoscopic visualization and near-infrared fluorescence imaging with activation control of different SPY Modes from the camera head, including white light Overlay, ENV and Contrast.

A 4k camera that is indicated for use during minimally invasive surgery using native 4K endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging. The camera system must also include an Infrared Illumination System (IRIS), designed to transilluminate and visualize the ureters during laparoscopic surgery.

A hand-held camera imaging technology that allows surgeons the ability to visualize blood flow in vessels and related tissue perfusion during reconstructive and gastrointestinal procedures. This camera must have fluorescence assessment software to allow surgeons to further assess the intensity of the fluorescence signal through relative values and a color map mode.

Safelight Light Cord Technology:

Designed to reduce the risk of OR fires, the light cord technology must have the ability to automatically shut off the light source if the fiberoptic cable becomes disengaged from the scope.

Light Source:

Must include Technology that enables automatic light output adjustments to maintain consistent lighting. Auto-light technology maintains consistency through a camera algorithm, which determines optimal lighting levels.

Insufflator:

All-inclusive closed system with integrated heating, humidification, and smoke evacuation capabilities.

4k Monitors:

32 inch 4k OLED Surgical Displays with 1,000,000:1 contrast ratio with anti-reflective and anti-fingerprint coating

Wireless 4k:

Wireless transmission to 2 displays in both true 4k and 1080p signal.

Surgeon Profiles:

Completely customizable surgeon profiles inclusive of specific connected device settings for a consistent operating room environment with a simple selection of the surgeon’s profile by the nurse.

Device and Voice Control:

The Digital Capture must have the capability to control all connected surgical devices from the sterile field using the camera head, remote control, touch panel, and voice control. The platform must also provide digital image enhancement and automated smoke detection/evacuation technology to improve visualization.

Critical Device Statuses on Surgical Displays: Insufflator, light source, arthroscopy pump, shaver, and other devices are able to display power levels, statuses, and modes necessary to be monitored, directly on the surgical displays for continuous awareness of device performance.

Available Video Upgrades:

Next generation video platform upgrades will be provided as they are released over the course of the contract.

5.14 Personnel Qualifications

A. The Contractor personnel shall be trained through a minimum six-week intensive process where classroom and in-field training cover the following:

1) Anatomy, Physiology, and Medical Terminology

2) Surgical procedures and instrumentation (all specialty areas)

3) Cleaning, sterilization processes, and peel packing

4) Video systems management and troubleshooting

5) Operating room protocols, techniques, and standards B. The Contractor personnel shall have continuing education and clinical training on routine OR competencies and practical modules ensuring compliance where the following areas are covered:

1) Laparoscopy (Gastric surgery, Lap Chole, Lap Hernia, lap Colon etc.)

2) Arthroscopy (Knee, Shoulder, Wrist, Ankle, etc.)

3) Thoracoscopy (Pleural Effusion, Lobectomy, esophageal etc.)

4) Endoscopy Sinus (Rhinoplasty, Polypectomy, etc.)

5) Urology (TUR, Kidney and Bladder Examination, etc.)

6) Gynecological procedures (hysterectomy, tubal and ovary surgeries,

7) Hospital Video Systems

8) Sterilization Processing (Blue-Wrapping, Peel Packing, Tapes, Indicators, Parameters, Documentation, etc.)

C. The Contractor personnel must attend the Operating Rooms morning communication briefing (daily).

D. The Contractor personnel must be available during operating room business hours to assist, troubleshoot and provide consultation on all rigid and semi-rigid endoscopic video equipment on a case-by-case basis as needed.

E. The Contractor shall supply a copy of all related personnel documentation showing compliance with all immunizations, competencies, and governing body policies, protocols, and practices mandated for all personnel that function within the Operating Room environment.

F. Compliance and Business Integrity (CBI) Training:

1) Awareness Training: Contractor employees shall complete initial compliance awareness training within thirty (30) days of commencing work under this contract as well as complete annual compliance awareness refresher training. At the minimum, CBI awareness training will include the following topics:

a) The revenue cycle

b) Seven elements of an effective compliance program

c) Definition of high-risk areas

d) Definition of a compliance concerns and how to address a compliance concern.

2) This requirement can be fulfilled by completing the training module available via the following Internet site: http://www.visn21.va.gov/CBI.asp.

3) The Contractor personnel must submit proof of awareness training completed to the Contracting Officer's Representative (COR) for this contract. The COR will retain proof of training in accordance with applicable Records Control Schedule.

G. Remedial Training: When notified, contract employees shall complete remedial training and education to address any detected compliance exceptions.

B.4 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

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

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

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

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

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

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

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

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

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

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

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

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

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

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

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

g. The contractor/subcontractor agrees to:

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

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

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

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

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

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

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

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

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

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

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 3 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 10 days.

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

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

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

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

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

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

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

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

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

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

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

(2) VA's initial medical…