36C24125Q0419.docx

SUBJECT*

Medivators Subscription and Setup Intent to Sole Source to SB OEM_Proprietary and Exclusive

GENERAL INFORMATION

SET-ASIDE

VAMC Providence

830 Chalkstone Avenue

Providence RI

CONTACT INFORMATION

VA CENTRAL WESTERN MASSACHUSETTS HCS

421 North Main Street Leeds MA 01053-9764

POINT OF CONTACT*

Contract Specialist Sean Genereux Sean.Genereux@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Presolicitation Notice Presolicitation Notice Intent to Sole Source SB OEM _Proprietary and Exclusive

Presolicitation Notice

Presolicitation Notice Presolicitation Notice

DESCRIPTION

Page 1 of

Presolicitation Notice

Page 1 of Pre-Solicitation Notice under $25K sole-sourced firm-fixed price to the OEM.

Pre-Solicitation Notice.

VHA Network Contracting Office 1 New England (NCO1) intends to solicit a SB Sole-Source Firm-Fixed priced to Steris Corp. (OEM) for the goods/services described below.

OEM: Steris Corp (SB)

5960, HEISLEY ROAD,

MENTOR, OH 44060 USA

UEI: UGGQJGGH6846

A Sole Source Letter has been provided by the SB OEM describing the proprietary nature of Medivator software upgrade with Connect Assure Subscription establishing this product as being peculiar to Steris Corporation, the SB OEM. The letter states that only the OEM is authorized distribute this product domestically. Per [OEM], no other vendors in any class, aside from the OEM are authorized to distribute this product as a distributor or a reseller in the US.

The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901. This statute is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(1).

The intent is to procure these services on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 513210. The most current Business Size Rating for this NAICS is $47M.

NCO1 intends to obtain the following: MediVators Adv and Adv + Win10 Upgrade and Connectivity Set Up, CAT Annual Subscription enables data export from one AER, Drying Cabinet or related device, ConnectAssure Data Services to Centralize Scope and User Data for Endo Equipment, and ConnectAssure Technology Endo Management Utility Software – Annual Subscription from the Small Business source listed above.

PURPOSE:

The purpose of this procurement is for software licenses, software installation and staff training for the networking and integration of the three Steris MediVator Advantage Plus endoscope reprocessing systems with the CensiTrac surgical instrument and asset management system at the Providence VA.

MediVator Adv and ADV+ Upgrades The following three MediVator Advantage Plus Endoscope Reprocessors will be networked and integrated with CensiTrac. These three pieces of equipment are already on-site and in use at the Providence VA:

· EE 77347: MediVator Advantage Plus ADVPT-3007

· EE 77346: MediVator Advantage Plus ADVPT-3007

· EE 76451: MediVator Advantage Plus ADV-1007

SCOPE: The Contractor shall provide all software, licensing, and subscriptions necessary to connect and integrate the MediVator ADV + System with CensiTrac workflow management. This includes the software upgrade and the ConnectAssure subscription.

MediVator:

The Contractor shall provide a fully functional system that meets the following characteristics:

Vendor (MediVator) will provide:

· MediVator Advantage+ Windows 10 Upgrade and Connectivity Set Up (Qty 3)

· ConnectAssure annual subscription (Qty 3)

· Enables data export to CensiTrac and includes technical support, software maintenance and security updates as required.

· ConnectAssure Data Services to Centralize Scope and User Data for Endo Equipment (Qty 3)

· Enables scope and sterile processing data sharing across the three MediVator units.

· ConnectAssure Technology Endo Management Utility Software annual subscription

· A software utility to sync users and scopes (Qty 1)

AREAS TO BE SERVICED:

Providence VA Medical Center 830 Chalkstone Ave Providence, RI 02908

The items are exclusively available from the SB OEM no solicitation will be posted to Contracting Opportunities SAM.gov. This procurement is subject to prohibitions in the VA Acquisition Regulation (VAAR), including 852.212-71 Gray Market Items and 852.212-72 Gray Market and Counterfeit Items.

Interested persons may contact the Contracting Officer/Contract Specialist via email at: deidra.thomas@va.gov regarding this procurement. The determination of the acquisition strategy based on responses to this notice is within the discretion of the Contracting Officer.

Capable parties may identify their interests and authorization to respond to this requirement by 04/30/25 at 13:00 PM (EDT).

A determination by the Government not to compete this proposed award upon response to this notice is solely within the discretion of the Contracting Officer.

STATEMENT OF WORK

SCOPE OF WORK: The Contractor shall provide all software, licensing, and subscriptions necessary to connect and integrate the MediVator ADV + System with CensiTrac workflow management. This includes the software upgrade and the ConnectAssure subscription.

1. EQUIPMENT

a. There is no physical equipment associated with this order. It is for software licenses, software installation and staff training for the networking and integration of the three Steris MediVator Advantage Plus endoscope reprocessing systems with the CensiTrac surgical instrument and asset management system at the Providence VA. VAMC Providence has standardized to MediVator ADV+ System.

b. The following three MediVator Advantage Plus Endoscope reprocessors will be networked and integrated with CensiTrac. These three pieces of equipment are already on-site and in use at the Providence VA:

i. EE 77347: MediVator Advantage Plus ADVPT-3007

ii. EE 77346: MediVator Advantage Plus ADVPT-3007

iii. EE 76451: MediVator Advantage Plus ADV-1007

2. SALIENT CHARACTERISTICS

The Contractor shall provide a fully functional system that meets the following characteristics:

Salient Characteristics Steris (MediVator) will provide:

· MediVator Advantage+ Windows 10 Upgrade and Connectivity Set Up (Qty 3)

· ConnectAssure annual subscription (Qty 3)

· Enables data export to CensiTrac and includes technical support, software maintenance and security updates as required.

· ConnectAssure Data Services to Centralize Scope and User Data for Endo Equipment (Qty 3)

· Enables scope and sterile processing data sharing across the three MediVator units.

· ConnectAssure Technology Endo Management Utility Software annual subscription

· A software utility to sync users and scopes (Qty 1)

2. AREAS TO BE SERVICED

Department of Veterans Affairs Providence VA Medical Center 830 Chalkstone Ave Providence, RI 02908

3. INSTALLATION

a) The Contractor shall provide all labor, materials, tools, equipment etc. to prepare for and complete the installation of the equipment in the space determined by the Government.

b) Project implementation meetings, if necessary, shall be coordinated with the COR.

c) Installation and implementation dates are to be coordinated in advance with the Contractor and the COR.

d) All employees of the Contractor and subcontractors shall comply with VA security management program and obtain the permission of the VA police, be identified by project and employer, and restricted from unauthorized access.

e) All installation personnel shall be trained by the manufacturer on how to properly install the equipment. Resumes and certifications shall be submitted for review upon request by the Government.

f) All installation personnel shall be trained by the manufacturer on safe and proper Personal Protective Equipment (PPE) usage and general infection control regulations and requirements relevant to the work outlined in the Scope of Work.

3. INSTALLATION

g) The Contractor shall communicate to the Government the estimated downtime required to complete full installation and testing. If the Contractor is unable to install the equipment to its normal operational state within 24 hours, the Contractor shall compensate the Government for the downtime by extending the warranty service in a period equivalent to the downtime of the equipment.

h) The Contractor shall be responsible for the safe removal and disposal of all trade-in equipment as applicable.

i.) The Contractor shall be responsible for the safe removal and disposal of all packing materials and related waste generated during installation.

4. TRAINING

The Contractor shall provide a comprehensive onsite training program for the operating clinicians. This training program shall include at the minimum the following sessions: (i) Technical Training, (ii) Operational Training, (iii) Administrative Training, and (iv) Hardware and Software Troubleshooting. Training shall occur onsite during normal business hours, 7:00am-3:30pm, Monday through Friday. Competency assessments shall be provided with the training. Onsite training is to be scheduled in advance with the Providence VA Medical Center through the COR.

The Contractor shall provide onsite general overview technical training for Clinical Engineering personnel as requested. Training shall include a technical overview of the mechanics, electronics, and general operations of the system. Training shall cover detailed instruction regarding the preventative maintenance, troubleshooting, and general maintenance of the equipment.

5. INSPECTION AND ACCEPTANCE

a) The Contractor shall conduct a joint inspection with the COR upon delivery of equipment.

b) Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s).

c) The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer.

6. WARRANTY

a) The contractor shall provide a one-year manufacturer’s warranty on all parts and labor.

b) The warranty shall include all travel and shipping costs associated with any warranty repair.

7. TASK FREQUENCY AND INSTRUCTIONS

The work set forth in the Scope of Work shall be completed in a single visit, be it a single day or multiple days as required for appropriate completion. All work is to be scheduled in advance with the COR. Equipment delivery shall not precede installation by more than 20 days. Installation and implementation must be immediately followed by clinical user training including “go live” support. Implementation and integration with VistA CPRS shall not exceed 90 days from date of award.

8. SPECIAL WORK REQUIREMENTS

The Contractor shall comply with any and all Infection Control Risk Assessment requirements deemed appropriate by the Providence VA Medical Center during all portions of the work set forth in the Scope of Work.

The Contractor must comply with security, privacy, and safety issues in accordance to VA standards, policies, and directives set forth at all times while providing the work outlined in the Scope of Work.

9. PROPERTY DAMAGE

The contractor shall take all necessary precautions to prevent damage to any government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (e.g. trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the government, upon approval of the Contracting Officer.

10. ATTACHMENTS: None.

11. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS

The contractor's employees shall wear visible identification at all times while on the premises of the VA property. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VA. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

12. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD

The contractor shall comply with the Federal OSHA Blood borne Pathogens Standard. The contractor shall:

13. INFORMATION SECURITY LANGUAGE

14. Records Management Language for Statement of Work (SOW):

The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract:

Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

The Government Agency owns the rights to all data/records produced as part of this contract.

The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID:______ 36C241-25-AP-1611________________

1. Contracting Activity: Department of Veterans Affairs, VISN 1 Providence VAMC 830 Chalkstone Ave, Providence RI 02908.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Steris MediVator Adv + Win10 Upgrade/Connectivity Set-up, ConnectAssure Data Services and Data Export, ConnectAssure Technology Endo Management Utility Software:

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

VAMC Providence has standardized to the MediVator Plus Advantage endoscope sanitization system. VAMC Providence requires a MediVator Advantage Plus/Windows 10 software upgrade and Connect Assure Technology (CAT) subscription service from Steris that will allow the three MediVator Advantage Plus units on-site and in use at VAMC Providence to be placed on the VA network and export data. To provide integration with CensiTrac, a sterile processing surgical instrument and asset workflow management system. The software upgrade, the Connect Assure subscription, and the ultimate integration with the CensiTrac workflow management system will allow sharing of endoscope reprocessing data across the (3) MediVator Advantage Plus units, affording automated documentation of endoscope reprocessing through CensiTrac.

Networking and data export of these MediVator units cannot be enabled unless they are upgraded to the latest operating system/software version and the subscription services offered by Steris/MediVator are purchased. Steris is the SB (Small Business OEM (Original Equipment Manufacturer) for the required software upgrade and for the CAT subscription. The software and the CAT subscription are proprietary, exclusive, and peculiar to Steris. No other vendor can provide a software upgrade or subscription to enable these services.

Although, there are (2) SB distributors who can sell the service packages, all software downloads and subscriptions are proprietary to and flow directly from the SB OEM, Steris. The SBs would add no value to the product and cannot license nor provide the product directly, which would create a passthrough relationship. The recommendation is for a direct source, single source from the SB OEM.

4. Description of market research conducted and results or statement why it was not conducted: Market Research was conducted in the traditional manner by excluding mandatory sources, by researching available mandatory National Contracts and by researching non-mandatory GSA FSS Schedule contracts.

i. Ability One: Ability One is mandatory and takes precedence over VFCP (Veterans First Contracting Program): Ability One is not capable for this requirement. They do not supply the requested equipment.

ii. VAAR 810.001-70 Compliance with VFCP (Veterans First Contracting Program): A VetBiz search was conducted using NAICS 513210 and the Keywords: MediVator, to locate potentially capable VIP-Verified suppliers. There is one (1) potentially capable SDVOSB vendor authorized to distribute the MediVator mainframe. The download of the required software and the CAT subscription flow direct from the SB OEM. The SDVOSB would take no possession of the downloads nor the required CAT subscription; they are not authorized due to data rights remaining exclusive to the OEM. Distribution would be pass-through for the software upgrade/CAT subscription.

4. Description of market research conducted and results or statement why it was not conducted (cont’d):

iv. VAAR 813.003-70(c) VFCP, Rule of Two, and Fair & Reasonable Offers: The Rule of Two (2), 38 USC 8127(d) cannot be met. There is no expectation to receive at least two There is only one (1) OEM-Authorized SDVOSB distributor; that distributor is restricted to the MediVator Advantage Plus mainframe, alone.

v. FAR 8.002-Mandatory Sources: There are no mandatory contracts indicated in the Market Research.

vi. FAR 19.202: PREFERENCE FOR SMALL BUSINESS: SBA DSBS Search produced zero results for SBs using the NAICS 513210 and Keywords:

ConnectAssure. two of the SB vendors listed are authorized to distribute for Steris. There are (2) known SB distributors for the MediVator mainframe. These SBs were identified via individual SBA DSBS profiles; they are not authorized for the software upgrade nor the CAT subscription.

Nonmanufacturer Rule (NMR) Findings: No NMR waiver exists for NAICS code 513210. No SDVOSB set-aside can be applied per VAAR 819.7003(d). The SBA NMR Exception, FAR 19.502-2(a) could generally be applied for a SB set-aside. There are (2) SB distributors that can distribute MediVator commodities. The SB OEM has provided a sole source letter indicating that the software, software and all data rights, licensing, and upgrades, and the CAT subscription are proprietary, exclusive, and unique to the SB OEM.

Recommendation: The requirement is to procure MediVator Advantage Plus Software Upgrade with Connect Assure Technology, to establish a seamless interface/integration with the CensiTrac Workflow Management System already in place at VAMC Providence, will fall below SAT. There is no NMR waiver for NAICS Code 513210. An SDVOSB Set-aside could not be applied. Although the SBA NMR Exception would allow for application of a Straight SB Set-aside, there are no SB distributors authorized to download the MediVator software upgrade, nor to service the software annually. The required CAT (ConnectAssure Technology) subscription, renewable annually to maintain the MediVator/CensiTrac integration, is downloaded direct from the SB OEM. There are no mandatory contracts capable of performing the requirements.

The LB OEM has provided a sole source letter indicating that the MediVator software upgrade, and all licensing/data rights and the Connect Assure Technology (CAT) subscription required to maintain the annual software upgrades, servicing, and integration are peculiar to the SB OEM, Steris Corporation. The

SB OEM is unique in its capability to provide the required MediVator software download and CAT subscription, to the Government. Market research indicates that there is only one (1) authorized and capable vendor that can provide the contract requirements. This procurement should be a sole source firm fixed priced contract IAW FAR 13.106-1(b)(1).

Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Deidra Thomas Date Contracting Officer VAMC White River Junction VT, NC01 RPOE

Revision: 01 Effective Date: 11/15/2024 Page 3 of 3 Acquisition ID# 36C241-25-AP-1611Acquisition ID# image1.emf image2.emf

Appendix C 6500 ISO Info 6-2022.pdf

MARCH 12, 2010 VA HANDBOOK 6500.6

APPENDIX C

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VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

d. Custom software development and outsourced operations must be located in the U.S.

to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where 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.

VA HANDBOOK 6500.6 MARCH 12, 2010

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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.

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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

C-4 payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

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

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

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

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

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R.

Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy

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

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

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration.

Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

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

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

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

g. The contractor/subcontractor agrees to:

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

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

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

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

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

SOR.

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

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

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

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

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

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

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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 COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

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

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

d. The contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA’s POA&M management process. The contractor/subcontractor must use VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may

C-8 affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

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

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

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

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

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

(2) VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

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

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(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 COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

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

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

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

C-10 compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

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