36C26321Q0782.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 66

36C26321Q0782 8/25/2021

JOSH IMDACHA 3193397017 09-08-2021

4pm CDT

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

X

339113

750 Employees

N/A

MULTIPLE LOCATIONS

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

SINGLE AWARD IDIQ FOR SURGICAL LIGHTS, EQUIPMENT BOOMS &

VIDEO INTEGRATION SYSTEM FOR VISN 23 VAHCS

SEE STATEMENT OF WORK FOR DETAILS

This solicitation is being conducted by the VISN 23

Contracting office for the VISN 23 VA Health Care System.

THIS IS A LPTA SOLICITATION

OFFERS MUST SATISFY 100% OF THE STATEMENT OF WORK. FAILURE

TO DEMONSTRATE THIS MAY RESULT IN THE OFFER BEING FOUND

UNACCEPTABLE

ALL QUESTIONS NEED TO BE SUBMITTED 72 HOURS BEFORE RFQ

CLOSE TO BE CONSIDERED.

EMAIL ALL QUESTIONS TO JOSHUA.IMDACHA@VA.GOV

SIGN SF1449 AND RETURN ALL PAGES WITH OFFER SUBMISSION

THIS IDIQ WILL HAVE A FIVE YEAR ORDERING PERDIOD

See CONTINUATION Page

X X

X 1

Harry.GramboIII@va.gov

36C26321Q0782

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 Statement Of Work

B.3 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 IT CONTRACT SECURITY

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

C.3 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) 27

C.8 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.9 VAAR 852.212-71 GRAY MARKET ITEMS (APR 2020)

C.10 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.11 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE

(JUL 2018)

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

C.13 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020)

(DEVIATION)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUL 2021)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.212-2 EVALUATION—COMMERCIAL ITEMS (JAN 1999)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

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

E.7 52.216-1 TYPE OF CONTRACT (APR 1984)

E.8 52.233-2 SERVICE OF PROTEST (SEP 2006)

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 36C636

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

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 ACCEPTANCE AFTER INSTALLATION

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.

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 Statement of Work A. Project Title

VISN 23 Surgical Lights, Booms, Video Integration Equipment IDIQ Procurement FY21

B. Background

VA Midwest Healthcare Network (VISN 23) requires new surgical lighting, ceiling-mounted equipment management booms for increased maneuverability and efficiency, and a Video Integration System solution to replace existing aging equipment experiencing performance issues and replacement part shortage.

Surgical lights illuminate the surgical site for optimal visualization of small, low-contrast objects at varying depths in incisions and body cavities. Surgical lights reduce shadows, minimize color distortion, and operate for extended periods of time without radiating excessive heat, which could cause discomfort or dry tissues at the surgical site.

Facility booms are used to organize utility services and devices, such as surgical video equipment, electrosurgical units, etc. Facility booms allow the clinical staff more freedom of movement around the patient and reduce clutter by removing potential tripping hazards, such as electrical cables and cords.

Video integration controls the way surgeons and clinicians view information in the operating rooms.

allows easy access and visibility to surgical video. Through video integration, a multitude of imaging systems and devices can me managed centrally to display surgical images more precisely while making workflow more efficient and achieving more flexibility in the operating room. Video integration in the operating room allows clinicians to share surgical video from and to anywhere. Video sources can be selected via a user interface and displayed on different surgical displays in the operating room, i.e. for remote specialists for consultation, or classrooms for students for teaching applications.

C. Scope

VA Midwest Healthcare Network (VISN 23) seeks a multiple year Indefinite Delivery Indefinite Quantity (IDIQ) contract to replace Surgical Lights, Booms and Video Integration equipment. Fargo, St. Cloud and Iowa City equipment and installation services will be purchased initially in FY21. Central Iowa and Black Hills sites at VISN 23 will be able to place a task order at a future time.

All solutions must be compatible with existing infrastructure at sites as depicted in the Site Floor Plans in Attachment A (for example ceiling supports and med gasses) so no additional construction would be needed except for installation services. The exception to this is Central Iowa who currently does not have ceiling mounted booms and will require construction. Construction for Central Iowa will be a separate procurement and not included in this requirement. Please still include equipment and installation services for Central Iowa and additionally please include with your official bid what infrastructure changes will be needed to support your equipment at Central Iowa.

The project includes a site walkthrough, design services, equipment acquisition, delivery, installation, setup, implementation and project management services, clinical and technical training, education, and training documents at each site.

Contractor shall provide solution based on Floor Plans for each site in Appendix A and Salient Characteristics for each site in Appendix B of this SOW.

D. Security Requirements

The contractor shall comply with all VHA security protocols, procedures and requirements of the VA’s Office of Information Technology including the following:

a) The contractor shall complete and return separate 6550 forms with accurate information for the equipment and software. Additionally, the contractor shall provide each product’s MSD2 and a diagram of data flow for each product.

b) The software shall be approved in the Office of Information Technology’s Technical Resource Manual (TRM) or the contractor shall be willing to gain approval in TRM.

c) The contractor shall minimize the number of staff members needing access to the VHA’s network. Please indicate the number needed. These individuals shall return completed forms within 10 days of receipt from the VA.

d) The equipment shall be FIPS 140-2 compliant. The contractor will identify the certificate number for FIPS compliance.

e) All Microsoft products used in the technology are actively supported by Microsoft.

f) Individual user accounts available that facilitate assigned access only. Two factor authentications are preferred.

E. Optional Site Visit

Contractor has the option to do a site walkthrough at a time convenient to the government during the solicitation period at contractor’s expense. Floor plans will be provided to the contractor so the site visit is not necessary but can be done at contractor’s request.

F. Implementation/Project Management Services

The contractor shall provide implementation services as part of the equipment purchase. Implementation Services shall include, but are not limited to, a project manager, a detailed project timeline (Gantt Chart) with defined roles and responsibilities (including contractor provided and VA resources), on-site installation coordination of all equipment, software and accessories, and schedule for Go-Live.

a) VISN 23 has designated technical and clinical points of contact for each facility that shall be provided upon award. The contractor shall work with these individuals to implement the technology.

b) Within 4 weeks of the placement of an order, the contractor shall provide a generic project management plan including the activities required in support of the upgrade and clearly delineating the party responsible for accomplishing each activity.

c) Within 5 weeks of the placement of an order, the contractor shall hold a kickoff meeting with the designated technical and clinical points of contact for each facility. The project management plan and communications plan shall be reviewed at the kickoff meeting. Discussion about site order and schedule for implementation will begin at the kick-off meeting.

d) The project manager shall hold periodic project meetings as needed with the facility points of contact.

e) The project manager shall hold monthly meetings with the VISN Surgery Executive and Chief Biomedical Engineer to report progress, challenges, and lessons learned for all facilities.

f) The surgery operation is one of the busiest in the medical centers and downtime has major impact on patient care. The contractor shall collaborate with site points of contact to minimize down time related to this implementation, including accommodating site requests for after-hours work. The dates resulting from this collaboration will be recorded in the project plan for each facility.

g) All activity associated with this statement of work will be completed within one year of the award date.

h) When the implementation is complete at each facility, the contractor shall present an acceptance letter to the POC Biomedical Engineer for signature. The POC Biomedical Engineer will have a period of 2 weeks to return that acceptance letter with signature or to identify the reasons the acceptance letter cannot be signed.

G. Period of Performance

The IDIQ shall have a five year ordering period with a period of performance dependent on what is specified in the orders that are placed. Installation work shall be performed after hours Monday through Friday 4pm-6am and weekends at VA facilities. Training shall be performed during normal business hours Monday through Friday at VA facilities.

H. Place of Performance

Unless otherwise noted, the contractor shall deliver the equipment at the VA facilities listed below. Floor plans for each site are listed in Appendix A.

Facility Address Fargo VA 2101 Elm Street N, Fargo, ND 58102 St. Cloud VA 4801 Veterans Drive, St. Cloud, MN 56303 Iowa City VA 601 Highway 6 W, Iowa City, IA 52246 Black Hills-Fort Meade

VA

113 Comanche Rd, FORT MEADE, SD 57741

Central Iowa VA 3600 30th Street, Des Moines, IA 50310

I. Delivery Requirements

The contractor shall coordinate delivery and installation with the POC and on-site Point of Contacts (POCs) listed below. The contractor shall verify delivery date and time with the on-site POC at least three (3) business days prior to scheduled delivery.

*CONTACTS WILL BE PROVIDED AT AWARD*

Facility Clinical POC Technical POC

VISN 23 VA

Fargo VA St. Cloud VA Iowa City VA Black Hills-Fort Meade VA

Central Iowa VA

J. Installation Requirements

The contractor shall de-install existing equipment and dispose of the equipment to an off-site location.

The contractor shall provide a project manager onsite available during equipment de-installation and installation. All on-site installation services shall be contractor-provided by technical staff (not sales reps) fully trained to service and install equipment products, parts, and accessories. De-installation and installation shall occur after hours from 4pm-6am Monday through Friday and weekends.

Contractor shall install all equipment, pull necessary cabling and medical gas tubing and certify all medical gases.

Contractor shall have only one (1) room down at a time per department. Contractor shall provide dust mats, install infection control plastic barrier around work area inside Operating Room (OR)/department and create plastic barrier in corridor if necessary, for proper removal of waste. Contractor shall provide appropriate attire to be in OR, for example, Bunny Suit, shoe covers, hats, beard covers, face masks, etc.

All waste will be removed the contractor. Contractor shall work with onsite staff to limit interference with all clinical activities.

K. Disinfecting Instructions

The contractor shall provide training instructions, procedures, and documentation necessary to properly and safely disinfect the equipment and accessories.

L. Electrical/Power Requirements

The components shall use existing electrical services of VA facilities and operate with a line of power of 120 Volts AC and current draw less than 20 Amps.

M. Licensing

Contractor shall provide all third-party license.

N. Materials Requirement

Materials provided shall be new equipment, parts, and accessories. The contractor shall deliver materials to the job site in OEM's (Original Equipment Manufacturer) original unopened containers, clearly labeled with the OEM's name, equipment model and serial identification numbers, Purchase Order (PO) number and site Technical POC. The contractor is responsible for inventorying materials prior to delivery to MVAHCS to check for accuracy in quantity and part number. The contractor shall tag the bill of materials by area/room for ease of installation. Site POC’s may reject items that do not conform to this requirement.

O. Surface Requirements

The contractor is responsible for repairing, painting and patching any damage to the ceiling, walls, floors and other surfaces.

P. Disposal of Waste and Job Site Clean Up

The contractor shall provide, maintain, and dispose of all material waste and packaging associated with the delivery of the specified items and/or waste generated during the installation services. Contractor will be responsible for moving waste materials daily from job site(s) to a contractor-provided waste container, and then off site.

Q. Warranty

The contractor shall provide a minimum one-year warranty from date of commissioning. The manufacturer’s factory-trained field service personnel shall perform installation and maintenance during the warranty period. The warranty period shall not begin until after VA authorized personnel have accepted the products delivery, installation, and functionality. In addition, contractor shall indicate availability and cost of extended parts warranty options.

R. Invoicing and Pricing

Detailed invoices will be submitted in arrears by the contractor. Invoices must include purchase order (PO) number, PO line item number, site location and POC, contract number, period of service covered/dates, and cost at a minimum. Pricing shall be competitive market value and reasonable.

S. Service and Operator Manuals

The contractor shall provide the following documentation for the proposed system:

a) Ten electronic copies of the Operators Manual and ongoing web-based access.

b) Two electronic copies and ongoing web-based access of complete technical service manuals including troubleshooting guides, necessary diagnostic software and equipment, schematic diagrams, and parts lists.

c) Two copies of any DVD training (and/or access to web-based training).

d) Ongoing access to training materials for future staff, online or DVD.

T. On-Site Training

The contractor prior to, at the time of and post installation shall provide on-site staff education at the VA facilities. A System Technology and Services education professional shall administer the training.

Education curriculum must include the following:

a) Operations and set-up

b) User maintenance

c) Repair in house

d) Safety

e) User troubleshooting tips

The contractor providing the system will be responsible for staff/user clinical and technical training as described below:

a) Contractor shall provide training during normal business hours for each site as listed in the table below. Contractor shall verify each sites availability prior to scheduling the training.

Facility Training days/hours

Fargo Monday-Friday, 7am-3pm

St. Cloud Monday-Friday, 6:30am - 4pm

Iowa City Monday-Friday, 7am – 4pm

Black Hills-Fort Meade Monday-Friday, 7am-4:30pm

Central Iowa Monday-Friday, 7am-3:30pm

b) Contractor shall provide a minimum or 40 hours of clinical training for each site.

c) Contractor shall provide on-site Biomed training for the minimum number Biomed Technicians listed below for each site:

i. Fargo, 4

ii. St. Cloud, 3

iii. Iowa City, 2

iv. Black Hills-Fort Meade, 3

v. Central Iowa, 6

d) Contractor shall provide off-site Biomed school training to a minimum of 2 Biomedical Technicians per site.

U. Inspection and Acceptance

The contractor shall conduct a joint inspection with the on-site POCs upon completion of the project. In the event deficiencies are identified, the contractor shall provide the date when the identified deficiencies will be addressed if not addressed on the date of installation. The contractor shall conduct a joint inspection with the on-site POCs after addressing all deficiencies. All deficiencies identified in the joint inspections shall be fixed by the contractor prior to government acceptance of the item. Any disputes shall be resolved by the Contracting Officer.

APPENDIX A –Site Floor Plan/Room Layout

The contractor shall review the floor plans/room layout for each site. The contractor will be responsible to review and confirm exact placement with VA site POC’s prior to starting on-site installation services.

-See Attachment A

APPENDIX B –Salient Characteristics

-See Attachment B

B.3 PRICE/COST SCHEDULE

The Department of Veterans Affairs has set the maximum value for this IDIQ at $8,000,000.00 for the lifetime of this contract. The total of all orders placed against this IDIQ will not exceed this maximum value of $8,000,000.00

The guaranteed minimum value of this contract is set at $722,000.00. All quantities are estimates. The VA is only obligated to the extent of the guaranteed minimum value.

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

ESTIMATED

QUANTITIES UNIT UNIT PRICE AMOUNT

56.00 EA __________________ __________________

SURGICAL LIGHTS

42.00 EA __________________ __________________

EQUIPMENT BOOMS

17.00 EA __________________ __________________

ANESTHESIA BOOMS

27.00 EA __________________ __________________

VIDEO INTEGRATION SYSTEM

56.00 EA __________________ __________________

INSTALLATION FOR SURGICAL LIGHTS

59.00 EA __________________ __________________

INSTALLATION FOR BOOMS

27.00 EA __________________ __________________

INSTALLATION FOR VIDEO INTEGRATION SYSTEM

120.00 HR __________________ __________________

ON SITE TRAINING

GRAND TOTAL __________________

SECTION C - CONTRACT CLAUSES

C.1 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

may be an evaluation factor.

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements.

Absent an agreement to use or disclose protected health information, there is no business associate relationship.

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

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

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations:

(i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

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

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

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

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

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

g. The contractor/subcontractor agrees to:

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

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

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

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

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

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

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

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

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

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

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

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 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 device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

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

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

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

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools.

Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

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

6. SECURITY INCIDENT INVESTIGATION

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

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

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach.

Notifications need to be made in accordance with the executed business associate agreement.

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

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

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

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

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

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

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

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

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

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

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

d. Based on the determinations of the independent risk…