36C25223Q0577 RFQ.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* Mobile CT Trailer - Danville

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 53214-1476

SOLICITATION NUMBER* 36C25223Q0577

RESPONSE DATE/TIME/ZONE 05-15-2023 1700 EASTERN TIME, NEW YORK, USA

ARCHIVE 15 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE SDVOSBC

PRODUCT SERVICE CODE* 6525

NAICS CODE* 532120

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Great Lakes Acquisition Center (GLAC)

115 S 84th Street, Suite 101

Milwaukee WI 53214-1476

POINT OF CONTACT*

Contracting Officer

Stacy Massey

Stacy.Massey@va.gov

PLACE OF PERFORMANCE

ADDRESS

Department of Veterans Affairs

VA Illiana Health Care System

1900 E. Main Street

Danville IL

POSTAL CODE 61832-5198

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov

URL DESCRIPTION Homepage

AGENCY CONTACT’S EMAIL ADDRESS Stacy.Massey@va.gov

EMAIL DESCRIPTION Procurement Point of Contact

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in

Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and

Solicitation for Commercial Items,” as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-08 (effective 10/28/2022).

This solicitation is set-aside for Service-Disabled Veteran-Owned Small Businesses.

The associated North American Industrial Classification System (NAICS) code for this procurement is

532120, Truck, Utility Trailer, and RV (recreational Vehicle) Rental and Leasing with a small business size standard of $38.5M. The FSC/PSC is 6525, Imaging Equipment and Supplies: Medical, Dental, Veterinary.

Requirement

The VA Illiana Health Care System located at 1900 E. Main Street, Danville, IL 61832-5198 is seeking to lease a Mobile Computed Axial Tomography (CT) scanner trailer to provide better access for patients in remote locations. The estimated period of performance will be for the length of 3 months, Jul 2023 through Sep 2023 with the option to extend the contract for 1 additional month if needed. An exact timeline will be provided to the awardee.

The Government intends to award a firm fixed-price purchase order. The awarded purchase order will include FAR Clause 52.217-9, Option to Extend the Term of the Contract.

All interested contractors shall provide quotations for the following:

Estimated Period of Performance 07/01/2023 through 09/30/2023

Line

Item

Description Qty Unit of

Measure

Unit Price Total Price

0001 Mobile CT Scanner Monthly Rental Fee 3 MO

0002 Delivery and Set Up Fee 1 EA

0003 Decommissioning and Removal Fee 1 EA

0004 Cold Weather Package (if not standard) 1 EA

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

1. OVERVIEW

Currently, Medical Imaging has one (1) CT scanner and is at end-of-life and needs replacing. Illiana

Healthcare System cannot successfully operate without the scanner; therefore, a temporary mobile CT scanner is needed. The timeframe will be three (3) months for removal, construction, and installation.

Contractor will provide all equipment (including mobile trailer/unit), supplies, and tools necessary to

Effective Date: 02/01/2022 perform Mobile Computed Axial Tomography (CT) scan services at the Illiana Healthcare System VA

Medical Center (VAMC) located at 1900 E. Main Street, Danville IL, 61832

2. SUPPLIES, MEDICINES/PHARMACEUTICALS, & WASTE

Danville VAMC (Medical Imaging) staff shall procure, receive, dispense, administer, and safeguard all supplies and medicines/pharmaceuticals required in the performance of the services defined herein.

3. CONTRACTOR FURNISHED EQUIPMENT

a. General: Contractor shall provide all necessary equipment to perform on-site CT scans as specified herein. Contractor furnished equipment shall include, but not be limited to, a fully equipped mobile trailer/unit where scans will be performed on contractor furnished and maintained CT scanner. Contractor shall provide at least a 64-slice, full body CT scanner system that can perform a wide range of scans such as, but not limited to: Neuro, Ortho, Body, and

Angiographic Imaging to include a CT Power Injector. All imaging equipment must be FDA approved. As further defined in 52.212-1, Instructions to Offerors, Contractor shall submit the equipment specifications on which it will be performing CT scans, including manufacturer name, equipment model number and any other pertinent data. The entire offering of a CT Mobile Trailer service shall meet all local, state, federal, industry, Joint Commission, NEC, NFPA, VA, OSHA, and other regulatory standards internal or external for which the VA is currently accountable.

Contractor will provide up 1 week of Applications Training.

b. Mobile Trailer: Contractor furnished mobile CT trailer/unit will be placed at a location designated by the Contracting Officer Representative (COR) on-site at the Danville VAMC and be prepared for use regardless of outside environmental conditions. The mobile trailer/unit shall be capable of housing the CT scanner unit and associated equipment (to include CT Power Injector) as well as meet all criteria below.

1) Mobile CT trailer/unit must be handicapped accessible and interface to an enclosed access ramp in order to provide both security of VA and Contractor property and to provide a barrier to outside weather conditions. Trailer must have a lift that will act as a platform that will connect the mobile trailer to the permanent structure.

2) Mobile CT trailer/unit must be capable of maintaining a temperature that ensures proper operation of the scanner without frequent calibration and provides for patient comfort.

3) Mobile CT trailer/unit must have space sufficient for conducting CPR and cardiac code if

4) needed.

5) Mobile CT trailer/unit must contain an outlet connection capable of transmitting data and voice through a Government provided category five (5) cable. NOTE: The Government will provide the connection required for the transmission of images, data and voice.

6) Mobile CT trailer/unit must be able to connect to VISTA Imaging/AGFA PAC Network

(or designated PACs system at the Danville VAMC) and to transmit all images to VISTA

Imaging/PAC to include compatibility with Digital Imaging and Communications in

Medicine (DICOM) 3 imaging standards. NOTE: PACS interface contact person shall be provided to the successful Contractor during the post-award orientation.

7) Digital Imaging and Communications in Medicine (DICOM) network connection to existing AFGA IMPAX version 6.5.5.3.0.2.0 or any updated version or designated PACs system.

8) Mobile CT trailer/unit must be equipped with CD-R burning capabilities as a backup to network transfer of data.

9) Mobile CT trailer/unit must have an intercom system between the control room and scanning room.

c. CT Scanner Requirements: Contractor shall make, at its own expense, any necessary modifications to its equipment to ensure compatibility with the VA furnished services defined herein and to ensure Contractor furnished equipment meets or exceeds all criteria below.

1) The CT scanner consistently produces quality images.

2) The CT scanner must be capable of acquiring 2-dimensional and/or 3-dimensional CT images or true 3-dimensional images.

3) The CT scanner must contain a multi-slice (at least 64) detector and be capable of acquiring the transmission images within one breath hold.

4) The CT scanner must be capable of acquiring data for anatomic localization and attenuation correction.

5) The CT scanner system must include attenuation correction algorithm(s) designed to use -

i. non-contrast enhanced CT data.

ii. CT data with intravenous contrast enhancement.

iii. CT data with oral contrast enhancement with positive contrast (iodinated contrast).

iv. CT data with oral contrast enhancement with negative contrast (water).

6) A CT computer review station with dual monitors that has processing performance and memory capacity to achieve real-time interactive navigation without compromising the native resolution of CT images (spatial resolution and dynamic range). The review stations shall also have software tools that are capable of providing three orthogonal planes of the CT images alone.

7) CT scanner of the following types/brands are STRONGLY encouraged: Siemens, (this is due to the fact that VA employees will be operating the equipment and have experience with these platforms).

4. GOVERNMENT FURNISHED EQUIIPMENT, FACILITIES, & UTILITIES

a. Contractor shall contact the Administrative Officer and Supervisor of CT to make the necessary arrangements for a site visit at the actual location where the mobile trailer/unit will be located so that precise measurements can be taken by the Contractor to ensure compatibility of the location designated. Any additional costs as a result of the Contractor’s failure to confirm the above shall be the responsibility of the Contractor.

b. Contractor shall be held responsible for any damages, which may be done to the VA property during hookup and/or removal of equipment at the site.

c. Proper installation/staging of the Contractor’s furnished equipment including the mobile trailer/unit must be completed in accordance with industry standards, all OSHA regulations and applicable manufacturer’s recommendations. The above must be completed prior to commencement of services. Dates and time for completion of the above shall be mutually agreed upon between the VA and the Contractor.

d. Danville VAMC will provide the utilities and services necessary for operation of the mobile CT trailer/ unit as specified below.

1) Water – water is not needed.

2) Electricity – Contractor and local Facilities Management will coordinate hook-up.

3) Steam – N/A

4) Sewage – N/A

5) Natural Gas N/A

6) Telephone Line(s) * - VA will provide.

7) Data Port – VA will provide.

8) Housekeeping ** - VA will provide.

9) Covered breezeway or walkway – the designated location is covered.

* Telephone will be used to facilitate the movement of patients to and from the unit. Telephone calls placed and received shall be restricted to the appropriate free dialing areas and long distance without charge to the VAMC.

** The VA shall be held responsible for areas within the hospital facility prior to entrance of the mobile trailer/unit. The Contractor shall be responsible for all housekeeping duties and responsibilities within the trailer/unit itself.

e. Access to the electrical and data connections are external to the mobile pad structure via key lock box.

f. Access to the mobile pad structure, supply cabinet and mobile pad garage door are external to the mobile pad structure via same key lock box as referenced above.

5. EQUIPMENT MAINTENANCE/REPAIRS

a. Contractor must possess all licenses, permits, accreditation and certificates as required by law to provide Mobile CT Trailer. Contractor shall maintain all equipment utilized in the performance of this contract in good working order at all times. This includes, but is not limited to the following:

1) Contractor shall perform all preventive maintenance, emergency and general repairs, safety, cleaning, and upkeep of all Contractor furnished equipment. Contractor personnel shall perform preventive maintenance/repairs on the CT mobile unit and all associated equipment in accordance with manufacturer’s recommendations.

i. If the equipment should fail during normal working hours, contractor is responsible for obtaining emergency repairs to be performed on-site by qualified service engineer.

2) Danville VAMC (Medical Imaging) staff shall perform overall housekeeping of the unit including but not limited to removal and proper disposal of all debris on a daily basis or as often as necessary to maintain a sanitized and neat environment.

3) Contractor shall be responsible for all Contractor furnished equipment while on VA premises. The VA is not liable for any loss or damage to the Contractor’s property, including the mobile trailer/unit, which may be vandalized or otherwise damaged, while on-site. Contractor shall maintain property insurance on all equipment throughout the duration of the contract and the Contractor shall provide proof of insurance as required herein.

b. Mobile CT Trailer Vehicle Operator: Typical tasks to be performed by the Mobile CT

Trailer/Unit Vehicle Operator under this contract include, but are not limited to, those identified below.

1) Maintain applicable licenses necessary to operate and drive the mobile vehicle in which the CT scanner unit is housed.

2) Operate vehicle on Government property in accordance with applicable facility, state and local statutory and regulatory requirements.

3) Park vehicle at Danville VAMC designated location and assist with proper placement and securing of handicap access accessory equipment, as required.

4) Assist with proper hookup of any necessary interfaces for proper operation of CT and other related equipment, as required.

5) Ensure mobile trailer’s/vehicle’s various internal systems – e.g., any heating/air conditioning; refrigeration; etc. – are operating properly for CT equipment functionality and protection, as well as for patient comfort.

6) Monitor fuel, oil, vehicle fluids, temperatures, sensors and gauges, etc. to ensure optimum vehicle operation.

7) Post Radiation hazardous signs around the mobile unit when at destination.

8) Cover electrical power cables under metal cover if it crosses pedestrian pathways/sidewalks, as required.

6. SPECIAL CONTRACT REQUIREMENTS

a. The services specified herein may be changed by written modification to this contract. The

Contracting Officer will prepare the modification (reference FAR clause 52.212-4(c), Changes) and, prior to becoming effective, shall be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized, and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

b. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor’s employee(s). Contractor personnel are not subject to the supervision and control of a Government officer or employee. Rather contractor personnel perform their duties in accordance with the

Statement of Work. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare provider(s) who furnish services under this contract is/are subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance.

c. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

d. Contractor is required to maintain medical liability insurance for the duration of this contract.

Medical liability insurance must cover the provider(s) for services in all states where services are rendered by the provider.

e. The services to be performed by the contractor will be performed in accordance with VA policies, procedures, regulations, and the medical staff bylaws of the VA facility (copies and/or links will be provided upon request). In all cases, dignity of the patient shall be given the highest regard and the precepts of the American Hospital Association’s “Bill of Rights for Patients” shall be observed.

f. Contractor shall provide the required services listed herein throughout the contract period. Other necessary personnel for the operation of the services contracted for at the VA will be provided by the contractor at levels mutually agreed upon which are compatible with the safety of the patient and personnel and with quality medical care programming.

g. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.

7. TERM OF CONTRACT

This contract period of performance is estimated for Jul 2023 through Sep 2023 and any option periods if exercised.

8. JOINT COMMISSION STANDARDS

Joint Commission accreditation, although not required, is preferred. The contractor shall perform the required work in compliance with Joint Commission Standards. A copy of these standards may be obtained from Joint Commission, One Renaissance Blvd., Oakbrook Terrace, IL 60181.

9. DESIGNATION OF CONTRACTING OFFICER REPRESENTATIVE

The name and contact information for the Contracting Officer’s Representative (COR) designated to represent the Contracting Officer (CO) will be provided upon contract award. The COR will furnish technical guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. The extent and limitations of this designation will be provided in the COR Delegation Memo.

10. CONTRACT PERFORMANCE MONITORING

a. Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. Contracting Officer's Representative (COR) will be responsible for verifying contract compliance. COR will designate appropriate Government personnel to monitor services through one or a combination of the following mechanisms:

b. Departments being served will monitor contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the

Contracting Officer.

c. Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks and document with the using service to ensure records monitoring.

The Government will pay only for services actually provided, and in strict accordance with the

Price Schedule. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

d. Chief of Staff's office reviews monitoring data.

e. The using service, upon request and through the COR, shall provide a written statement to the

Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted 14 days prior to expiration of contract or annually.

11. PAYMENT

The Government agrees to reimburse the contractor for services performed, paid monthly, in arrears, upon receipt of a properly prepared invoice submitted by the contractor. Payments made by the Government under this contract shall constitute the total cost of services provided by the contractor. The contractor hereby agrees that in no event, shall contractor bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against the beneficiary, the beneficiary’s family, private insurer, Medicare or any other entity acting on the beneficiary’s behalf, for services provided pursuant to this contract. Billings rendered by the contractor to the Government for services furnished to a VA beneficiary under the terms of this contract shall be billings in full. This provision shall survive the termination or ending of the contract.

12. PROPOSED LOCATION OF MOBILE CT TRAILER

Behind building 98 on the Danville VAMC Campus. Vendor Site visits for CT Trailer placement are strongly encouraged.

13. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

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 onsite inspections of contractor and subcontractor

IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of

VA by a contractor/subcontractor must be done in accordance with National Archives and

Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and

Information Management and its Handbook 6300.1 Records Management Procedures, applicable

VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable

Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

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

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

Federal Acquisition Regulation (FAR) part 12.

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

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

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

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

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

(i) in response to a qualifying order of a court of competent jurisdiction, or

(ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or

Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

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

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 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

(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.

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

Assistant Secretary for Office of Information and Technology.

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

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-

VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment

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

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally

Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the

PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and

Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor’s systems in accordance with VA

Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program

Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the

ISO for entry into VA’s POA&M management process. The contractor/subcontractor must use

VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities.

Security deficiencies must be corrected within the timeframes approved by the government.

Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the

C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook

6500.3. This may require reviewing and updating all of the documentation (PIA, System Security

Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

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

f. VA prohibits the installation and use of personally owned or contractor/subcontractor owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal

(host-based or enclave based) firewall that is configured with a VA approved configuration.

Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-

VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook

6500.1, Electronic Media Sanitization upon:

(i) completion or termination of the contract or

(ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

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

(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. 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 preapproved 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 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. 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 analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least

3 relevant credit bureau reports;

(3) Data breach analysis;

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

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

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

8. SECURITY CONTROLS COMPLIANCE TESTING

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

9. TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and

VA information systems shall complete the following before being granted access to VA information and its systems:

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

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any…