CareFusion Alaris Infusion Pumps Intent to Sole Source Notice.pdf

NOTICE OF INTENT TO AWARD SOLE SOURCE: IAW FAR 5.101 this notice is to advise the public that the Department of Veterans Affairs (VA) Regional Procurement Office East (RPOE), Network Contracting Office 4 (NCO 4) intends to award a sole source firm fixed price contract pursuant to FAR 12.102 with CareFusion Solutions located at 3750 Torrey View Ct. San Diego, CA 92130 for a base year with four (4) options years.

The Pittsburgh VA Medical Center requires preventative maintenance and repair services for the CareFusion Alaris Infusion Pump System.

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES; however, any firm responsible that believes it can meet the requirement may give written notification and capability statements prior to the response due date and time. Vendors shall indicate if they are the direct supplier or service provider of the items and/or authorized reseller/distributor. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to fulfil the requirement and must include relevant corporate experience along with the applicable contract number, total contract dollar amount, contract period of performance, details of the relevant supply, and customer point of contact with corresponding telephone number and email address.

Responses must include the following information:

1. Company Name

2. SAM UEI Number

3. Company’s Address

4. Point of Contact Information (title, phone number and email address)

5. Business Size.

Response received will be evaluated; however, a determination by the Government not to compete the proposed procurement based on responses to this notice is solely within the discretion of the Government. The information provided will not be returned.

The North American Industry Classification System (NAICS) code for this procurement is 811210 Electronic and Precision Equipment Repair and Maintenance and the size standard is $34 Million.

Responses are due by 10:00 am (EST) on November 26, 2025. This will be the only notice regarding the Government's intent to solicit and award a contract to a single source to meet this requirement. Any responses received will only be considered to determine the marketplace for future procurements. The Government will not pay for information submitted. Inquiries will only be accepted via email to matthew.wright6@va.gov. Responses are due by 10:00 am (EST) on November 26, 2025.

mailto:matthew.wright6@va.gov

STATEMENT OF WORK

I. GENERAL GUIDANCE – Software Management

(a) Service Agreement: The VA Pittsburgh Healthcare System is requesting to establish a service contract for software management services and for the Alaris System used throughout the medical center sites. The facilities are located at:

VA Pittsburgh Healthcare System University Drive Campus 1 University Drive, Pittsburgh, PA 15240

VA Hospital H J Heinz Campus 1010 Delafield Rd, Pittsburgh, PA 15215

VA Monroeville Clinic 421 Mall Cir Dr, Monroeville, PA 15146

(b) Scope of Work: The Contractor shall supply all labor, travel, materials, equipment, tools, supervision, and all incidentals required to complete software management services of the equipment identified in Section II, in accordance with Manufacturer’s recommendations, Joint Commission standards, design specifications, and the specifications, terms, and conditions of this contract.

(c) Background: This contract is issued to ensure the continuous reliability of the Alaris System and ancillary equipment identified in the Statement of Work.

The equipment is critical for continuous patient care throughout the VA Medical Center and the reliable and accurate operation of the equipment always is considered critical to the health of patients.

1. EQUIPMENT TO BE SERVICED

All CareFusion Alaris infusion pumps at the VA Pittsburgh Health Care System are to be serviced in accordance with the specifications, terms and conditions of this contract.

2. SERVICES TO BE PROVIDED

The contractor shall provide software management services on the Alaris system:

1. 24 hours a day, 7-days a week, Technical Telephone Support

2. Guardrails Suite MX Software enhancements

3. On-site technical touch to update embedded software

4. Webcast refresher training for Guardrails Editor

5. Access to Pharmacy Consultants via phone/email

6. Access to Clinical Infusion Data Consultants (formerly, CQI

Consultants) via phone/email

7. Monthly web-based refresher training for infusion data

8. Tuition for two attendees for the data workshops

9. Remote installation of server system patches

10. Server updates

11. Monitoring of Alaris Systems Manager

12. Clinical on-site RN clinical support on the use of the Alaris System

13. Quarterly infusion alerts data reports with remote analyst review

II. GENERAL GUIDANCE – Preventative Maintenance

a. Preventative maintenance of CareFusion Alaris infusion pumps and modules

b. Scope of Work: The services will include the following:

i. Onsite preventative maintenance (PM) and calibration for a total of

1,225 devices.

1. Quantity 665-Carefusion 8100 pump modules Quantity 420-Carefusion 8015

PCU’s

Quantity 57-Carefusion 8120 PCA pump modules

Quantity 60-Carefusion 8300 pump modules

Quantity 23-Carefusion 8110 syringe pump module

2. PM must be performed according to the original equipment manufacturers (OEM) requirements per the service manuals.

3. Vendor will complete PM’s on as many devices that are surrendered to the team within a straight 2-week period (total of 9 business days).

4. Devices are located or will be re-located to VA Pittsburgh’s main campus (1 University Dr. C, Pittsburgh, PA 15240).

a. Space will be provided with tables and chairs for contractor to work at. WIFI will not be available.

5. Contractor will wipe pumps with PDI wipe if unit must be returned to patient floor to swap out a unit that has not been

PM’d yet. If devices are not required to swap out, they will be returned to sterile processing to be cleaned after PM.

a. VA Pittsburgh will provide PDI wipes and gloves for contractor.

b. All pumps brought to contractor for PM’s will be cleaned prior to hand-off.

ii. VA will provide PM stickers that the contractor shall complete and place on each piece of equipment once the PM is completed.

iii. PM inspections shall be documented to ensure compliance with manufacturers’ guidelines.

1. Vendor will provide a report after devices are completed which includes but not limited to serial number, PM pass/fail status, testing information and parts required for repairs.

iv. VA Pittsburgh will perform repairs on equipment failing PM with their stock of parts that commonly fail. If additional parts are required to repair the devices, contractor will assist VA Pittsburgh with acquiring all parts required to repair deficiencies. Contractor may charge additional for required repair parts that are not available in house. If additional parts are required, contractor must have contracting officer’s approval to add the parts via a modification to the contract before continuing with request.

v. Contractor will supply all testing equipment required to complete PMs and extension cords, as required, to power testing equipment.

III. GENERAL REQUIREMENTS

a. Contractor will provide on-site support by a trained field technician, Monday- Friday, excluding federal holidays. Contractor can work between hours of 7am- 6pm, as required, to complete the work in 9 days.

b. Contractor shall notify Biomedical Engineering and the Police service when they arrive on site. Contractor will schedule all preventative maintenance with Biomedical Engineering. All PM work must be completed between

January 1- February 15 of each year and will be scheduled based on

Biomed’s availability.

(a) Service Manuals/Tools/Equipment

a. The VA shall not provide tools, test equipment, service manuals, or service diagnostic software to the contractor. Contractor shall obtain, have on file, and make available to its FSE all operational and technical documentation (such as operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract. The location and listing of the service manuals, by name and/or the manuals themselves shall be provided to the Contracting Officer (CO) upon request.

b. The Contractor shall provide the Technical point of contact (POC) in the Biomed Engineering department copies of all documentation that pertains to any hardware, software, or firmware upgrade or repair.

c. Copies of the latest version(s) of all documentation and licensing agreements, which shall include operation, service, and diagnostic software. The Technical POC shall have access to the same operation, service, diagnostic software, and documentation as the OEM's FSE.

Contractor shall provide to the Technical POC OEM Service Bulletins for the equipment covered under this contract. All documentation and service bulletins, etc. shall be provided within 30 days of award in either hard copy or electronic format. Any future service bulletins generated during the contract period shall be provided to the Technical POC within 30 days of receipt in either hard copy or electronic format.

(b) Services Not Covered by Contract

CO authorization for any work outside the scope of this contract must be received prior to performance of work or payment will not be authorized.

(c) Removal of Equipment

Approval from the CO must be obtained before removing any equipment from the VA Medical Facility. No transportation charges will be allowed for either the repairperson or equipment to or from the Contractors facility.

The Contractor will be responsible for all damage or loss of equipment. A loaner of the same type and functionality of the equipment removed, if required, shall be furnished, installed, and made fully operational by the contractor without additional cost.

III. CONDITION OF EQUIPMENT

All equipment is currently fully operational per required standards. The Contractor has been provided an opportunity to visit the VA Medical Centers, examine the equipment, and note in writing to the CO any condition which may affect the Contractors performance of this contract, except for any conditions so noted the Contractor accepts responsibility for the equipment described in Section II in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract.

IV. DEFINITIONS/ACRONYMS

• CO – Contracting Officer, Network Contracting Office (NCO) 4.

• ESR - Engineering Service Report - Documentation provided by the vendor of the services rendered for each incidence of work performance under the terms and conditions of the contract.

• FSE - Field Service Engineer - A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAPHS premises.

• NFPA - National Fire Protection Association.

• OEM – Original Equipment Manufacturer.

• OSHA – Occupational Safety and Health Administration.

• PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

• POC – Technical Point of Contact

• Unscheduled repairs – emergency services required to restore equipment to working condition outside normal hours of coverage.

• UL – Underwriter’s Laboratories

V. Conformance Standards

Contractor shall ensure that the equipment functions in conformance with the latest published edition of the applicable standards; including but not limited to Joint Commission, NFPA-99, UL, OSHA, VA, CDRH, etc. and the “Manufacturer's Performance standards/ specifications” as used when the equipment was originally procured and that any upgrades/updates will meet the stated standards/specifications.

VI. Hours of Coverage

a. The contractor will provide all required services within the normal business hours (8:00 AM to 5:00 PM (EST) M-F).

b. All services shall be performed during these normal hours of coverage unless one of the following conditions exists:

i. The contractor wishes to furnish services at a time that is outside of the normal hours of coverage, at no additional cost to the Government, the contractor submits a request to the POC prior to the proposed start of the work, and the request is approved in writing by the POC before work is begun.

ii. The POC directs that the services be furnished at a time that is outside the normal hours of coverage and the additional cost is recommended by the POC and authorized by the CO.

c. The contractor shall provide coverage 24 hours/day, 7 days/week and all holidays.

d. Work performed outside the normal hours of coverage must be preapproved by the CO, POC. The Contractor will provide a written estimate of the charges prior to approval of the work.

e. Work performed outside the normal hours of coverage at the request of FSE/contractor shall be considered service performed during normal hours of coverage.

f. There will be no additional charge for time spent waiting at the site during or after the normal hours of coverage for delivery of parts.

Note: Hardware/software update/upgrade installations shall be scheduled and performed during normal hours of coverage at no additional charge to the government.

VII. FEDERAL HOLIDAYS OBSERVED BY THE VA MEDICAL CENTER

New Year’s Day, Martin Luther King, Jr. Day, President’s Day (Washington’s birthday), Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated by the President of the United States.

VIII. DOCUMENTATION/REPORTS

No later than seven (7) business days after the conclusion of any maintenance or repair the Contractor will provide to the POC a signed detailed service/inspection report listing all devices, all repairs for each device, parts used to maintain or repair the devices, and operating efficiency of the devices. The service/inspection report shall contain, at a minimum, the following information:

(a) Date and time of the technician’s arrival on station.

(b) Type, model, and serial number(s) of all equipment on which maintenance was performed.

(c) Total time spent performing maintenance (exclusive of any travel time).

(d) Detailed narrative description of work performed.

(e) Complete list of parts replaced.

(f) Comments as to the cause of the malfunction when applicable

(g) Date and time the repair/preventive maintenance was completed

IX. SECURITY REQUIREMENTS

Upon arrival at the VA Medical Center, all Contractor personnel shall be required to report to the VA Medical Center Police for a temporary ID and then to the POC for check-in. This check-in process is mandatory. When the service is completed, the personnel shall be required to check out with the POC or Biomedical Engineering Shop Supervisor. The contractor's field service employee shall always wear visible identification while on the premises of the VA Medical Center.

X. Competency of Contractor Personnel

a. The Contractor must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

b. “Fully Qualified" is based upon training and experience in the field. For training, the FSE(s) must have successfully completed a formal OEM Certified (or equivalent) training program for all equipment to be maintained and all equipment to be utilized in the performance of the contract. For field experience, the FSE(s) must have a minimum of two years of experience in the installation, calibration, maintenance and repair of the specific equipment identified in Section II.

c. All work shall be performed by "Fully Qualified" competent FSEs. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs. The CO may authenticate the training requirements by request training certificates or credentials from the Contractor at any time for any personnel who are providing services. The CO and/or the POC specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on equipment.

d. If subcontractor(s) are used, they must meet the same competency standards as Contractor personnel.

XI. EXPOSURE TO BLOOD BORNE OR INFECTIOUS MATERIAL

There is a potential for exposure to blood borne or other infectious material with equipment throughout the medical centers. All maintenance persons must use the “Universal Precautions” (i.e. decontamination of medical equipment, wearing protective gloves, aprons, and goggles) during cleaning and maintenance/repair procedures.

XII. TEST EQUIPMENT

The Contractor shall provide the POC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor in the performance of this contract. Test equipment calibration shall be traceable to a national standard.

XIII. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS

a. Contractor’s personnel shall always wear visible identification while on the premises of the VA. Identification shall include, as a minimum, the employee’s name, position, and the contractor’s trade name.

b. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from VA Police Service. VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions.

c. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not local district, state, or municipal court.

d. Smoking is prohibited inside all VA buildings.

e. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state or municipal court.

XIV. IT SECURITY REQUIREMENTS

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 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 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 follow 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 during performance of 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 enough 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 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 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 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 10 days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 10 days.

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

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

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine 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 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 the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host- based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon:

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

6500.1 requirements. This must be completed within 30 days of termination of the contract.

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

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

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

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

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

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

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

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

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

c. annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until the training and documents are complete.

d. This contract is for Manufacturer-Trained technicians/educators to service CareFusion/Alaris Infusion Pumps, and to assist VAPHS employees with optimizing their use. See SOW attached to e-mail message with this document.

e. Does the equipment store PII/PHI? No

f. Will the contractor have access to PII/PHI? No

g. Could the contractor have incidental contact with PII/PHI? No

h. Is the equipment connected to the network? Yes

i. Will the contractor come on-site? Yes

j. Will the contractor have remote access (CAG)? No

k. Will the contractor need access to sensitive areas, i.e. data center, data closets, etc.? No

l. ISSO/PO Comments: The POC is responsible for ensuring that all Contractors comply with physical security policies. A compliant ID badge must always be worn by Contractors while on VA premises.

m. Contractor may not have access to the VA network or any VA sensitive information under this contract.

n. Contractor owned computer equipment including laptops are not permitted to be connected to the VA network.