Attachement B- PWS.pdf

B.3 PERFORMANCE WORK STATEMENT

PREVENTIVE MAINTENANCE AND REPAIR SERVICES FOR

STRYKER STRETCHERS AND JOERNS ELECTRICAL BEDS

1.0 Introduction - This is a non-personal services contract to provide “Preventive Maintenance and Repair for Stryker beds” at VA Caribbean Healthcare System (VACHS)”. The government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the contractor who, in turn is responsible to the government. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform the required service at VACHS as defined in this Performance Work Statement (PWS), section five (5.00) except for those items specified as Government-furnished property and services. The contractor shall perform to the standards of this PWS.

2.0 Mission - The Facilities Management Service (FMS) provide, operate and maintain a "state of the art" facility service program in support of our Veterans Health Care System;

carry out a program of education and development of personnel involved in the health care environment, promote environmental research and development of technologies in support of health care and provide these services in a cost effective, compassionate, humanitarian and ethical manner.

3.0 Scope- The Contractor shall perform these requirements in accordance with this PWS, local, state, and federal laws and regulations, and Veteran Affairs (VA) regulations. In the event of conflict between regulatory guidance, the most stringent requirement shall apply. The contract is to provide the appropriate intrusion detection system, monitoring, preventive maintenance, repairs and guard response.

4.0 General Requirements: This section describes the general requirements for this effort.

The following sub-sections provide details of various considerations on this effort.

4.1 Non personal services - The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services or give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contracting Officer (CO) immediately.

4.2 Type of contract - The Government will award a firm-fixed price contract.

4.3 Period of performance - The period of performance for this effort will be a base year of 12 months and four (4) option periods of twelve (12) months each. Each option will be exercised at the government’s discretion. In addition, the resulting contract will have an additional option to extend the services for up to six (6) months at the government’s discretion. The proposed schedule is as follows:

4.3.1 Base Year – December 1st, 2023 (Or date of award if later) – November 30, 2024

4.3.2 Option Number 1 – December 1st, 2024 – November 30, 2024

4.3.3 Option Number 2 – December 1st, 2025 – November 30, 2025

4.3.4 Option Number 3 - December 1st, 2026 – November 30, 2026

4.3.5 Option Number 4 - December 1st, 2027 – November 30, 2027

4.4 Location - The services under this PWS shall be performed at VA Caribbean

Health Care System (VACHS) facilities.

4.5 Recognized Government Holidays. The Contractor is not required to work on the legal public holidays listed below. Holidays occurring on weekends will be observed as directed by the published United States Office of Personnel Management (OPM) calendar.

New Year’s: Day 1 January Martin Luther King Jr. Birthday: 3rd Monday in January Washington’s Birthday: 3rd Monday in February Memorial Day: Last Monday in May Juneteenth: 19 June Independence Day: 4th of July Labor Day: 1st Monday in September Columbus Day: 2nd Monday in October Veterans Day: 11th of November Thanksgiving Day: 4th Thursday in November Christmas Day: 25 December

Or any other specifically declared by the President of the United States to be a National Holiday.

4.6 Business Relations - The contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The contractor shall manage the timeliness, completeness, and quality of problem identification. The contractor shall provide corrective action plans, submittals, timely identification of issues, and effective management of subcontractors, if any. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel. Within the bounds of acquisition policy, the VACHS intends to work to find solutions that will be beneficial to both the Government and its Contractors.

4.7 Contract Administration and Management

4.7.1 Post Award Conference / Performance Evaluation Meeting - Post

Award Conference / Performance Evaluation Meetings. The Contractor may be required to attend a post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation (FAR) Subpart

42.5. This meeting may be conducted virtually. Written minutes of such meetings will be recorded by the Contractor and signed by the Program/Project Manager and the CO and/or Point of Contact (POC) and distributed within five (5) workdays after the meeting.

4.7.2 Performance/Progress Meetings will be held as necessary. There may be occasions when subsequent meetings will be called by either party to reconfirm mutual understandings and/or address deficiencies in the Quality Control (QC) system or procedures which may require corrective action by the Contractor. The Contractor Representative shall meet with the POC and/or CO as required. A mutual effort will be made to resolve all problems identified. The Contractor Representative and the POC shall sign the written minutes of these meetings.

4.7.3 Contract Administration Notwithstanding the contractor’s responsibility for total management during the performance of this contract, the administration of the contract requires maximum coordination between the government and the contractor.

4.7.4 Contractor Employees - The contractor shall accomplish the assigned work by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The contractor shall match personnel skills to the work specified herein. The contractor shall ensure the labor categories/occupation code as defined by the Department of Labor are aligned to those tasks delineated in this PWS. The contractor shall comply with the minimum rates established in the applicable wage determination for this service. The Contractor shall provide the necessary resources and infrastructure to manage, perform, and administer the contract.

4.7.5 Contractor Identification - All contract personnel shall be identified as a Contractor (i.e., badge, company logo, or uniform). All contract personnel are required to identify themselves such that they avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all correspondence (documents, emails etc.) or reports produced by the Contractor are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

4.7.6 The services specified in the Sections entitled Schedule of Supplies/Services and Special Contract Requirements may be changed by written modification to this contract. The VA Contracting Officer will prepare the modification.

5.0 Performance Requirements The following section specifies the Performance Objectives and Performance Elements for the contract.

5.1 Vendor requirements

5.1.1 The contractor shall provide all inspections and maintenance services in accordance with manufacturer's service manual instructions and procedures.

5.1.2 The contractor shall conduct a thorough inspection of equipment’s to detect defective components capable of adversely affecting it performance.

5.1.3 The contractor shall replace parts found defective during inspections.

5.1.4 Replacement parts shall be included. The inventory of parts to be maintained.

5.1.5 The contractor maintenance services shall include cleaning, calibration, and adjustment of components to maintain equipment within manufacturer's specifications, level of performance and accuracy.

5.1.6 The contractor shall conduct operational tests after each corrective and preventive maintenance service to assure level of performance is within specifications.

5.1.7 Contractor shall conduct risk assessment to assign appropriate

Preventive Maintenance (PM) frequency and will perform PM guidelines as established by the manufacturer service per system per year in accordance with manufacturer's recommendations and procedures, Emergency Care Research Institute (ECRI) and the American Hospital Association (AHA). If updates to manufacturer's requirements and/or recommendations occur, contractor must assure compliance with these requirements. All protocols used will comply with The Joint Commission (TJC) and AHA requirement.

5.1.8 Contractor shall perform complete repairs to re-establish proper operation of medical devices. If the unit is damaged beyond repair, parts are no longer available, or the unit is obsolete; the corresponding corrective maintenance may not complete staff will provide all the necessary documentation to the hospital.

5.1.9 Contractor shall provide and install any enhancement intended to update system software or correct errors and deficiencies.

5.1.10 Contractor shall supply all labor, parts, test instruments, tools, equipment, hardware, provided by Stryker/Joerns; required to perform all corrective maintenance required.

5.1.11 Contractor shall perform on-site visits to perform preventive maintenance activities as determined by the PM schedule and will respond with on-site visits to service calls within 24 hours if phone or technical support cannot resolve the problem.

5.1.12 On-site service will be offered between 7AM and end by 3PM, except when a change in hours is requested by the VACHS. If service is to be continued after 3PM, prior notification needs to be done to the Contracting Officer Representative (COR) or his/her designee.

5.1.13 Contractor must possess any service license keys in order to properly install the parts, configure and test them for proper performance after the corrective maintenance.

5.1.14 Contractor's service personnel shall report to the Biomedical Supervisor or his designee when reporting on-site for corrective maintenance.

5.2 Service Reports

5.2.1 A copy of each service report with a checklist of all tasks performed will be provided to the Biomedical Supervisor or his designee after each service call.

5.2.2 Replacement equipment must follow manufacturer specifications; to avoid jeopardizing the warranty or any malfunction in the equipment Perform maintenance services in accordance to manufacturer’s service manual instructions and procedures.

5.2.3 Provide emergency response plan in case of natural disaster or other fortuitous event, Act of God. The plan must guarantee the inventory, vehicle, equipment, and personnel necessary for hauling of products and services.

5.2.4 An operational and status report shall be issued after each preventive maintenance service and after each quarterly inspection with the Customer acknowledgement.

5.2.5 Contractor shall submit a Service Report to the COR or his/her designee every time maintenance, part replacement, or repairs are done. This report shall include date, the name of the employee(s) performing the work, the title of the employee(s), the time in an out, a brief description of what was done, a list of parts used, and hours of labor expended. The Service report must be in a format acceptable to the COR or designee.

5.2.6 A monthly activity report will be provided to the COR within three (3) business days after the completion of the month. This report shall include all alarm activities (test, activation. response, malfunction, down time) during the previous month with date and time of each activity, action taken, name of employee performing the action, name and badge of VA Police and local authorities taking the report when applicable.

5.3 Safety Requirements

5.3.1 The contractor shall take all safety precautions and safety measurement necessary to protect the lives and health of occupants of the building.

5.3.2 The Contractor is responsible to identify, provide and maintain all personal protective equipment (PPE) required to perform the duties outlined in the contract.

5.4 Personnel’s Competency

5.4.1 The contractor shall comply with requirements of TJC. To comply with TJC requirements the contractor shall provide written confirmation that employees are competent to perform the task as described in the statement of work assigned on this contract. This written confirmation shall specify in which areas each contract employees are competent.

5.4.2 A written confirmation/certification is required from the Contractor such as:

5.4.2.1 "This is to certify that Mr./Mrs./Ms. _____________ meets all the qualification requirements for the position of _____________, is properly trained (credentials, if applicable) and competent to perform the tasks as described in the statement of work and that we maintain employee records updated with the following: Health annual certificates, Good Conduct Certificate from the Puerto Rico Police Department, educational documents, job descriptions, evaluation methods and qualification standards”

5.4.3 If subcontractors are used, the CO must approve them. The Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

5.5 Quality Assurance Surveillance Plan

5.5.1 Upon contract award and prior to the issuance of the Notice to Proceed; the COR, with the assistance of the CO will establish a complete Quality Assurance Surveillance Plan (QASP) to ensure that the requirements of this contract are being met by the Contractor.

6.0 Equipment Information

6.1 Five (5) Years Services will be provided to:

6.1.1 Twenty-five (25) stretchers Model 1125000000E

6.1.2 Nine (9) stretchers Model 1125000030

6.1.3 Six (6) stretcher Model 1115 primer big wheel

6.1.4 Twenty (20) Electric beds Model U700

6.1.5 One hundred ten (110) Electric beds Model ECS

6.1.6 Fourteen (14) Electric beds Model Spirit

7.0 Influenza Vaccination

7.1 All contract employees shall comply with VHA Directive 1192.01, Seasonal Influenza Vaccination Program for VHA Healthcare Personnel. This policy applies to all individuals who, during the influenza season, work in VHA locations or who come into contact with VA patients or other Health Care Personnel (HCP) as part of their duties.

7.2 Masking requirements for unvaccinated HCP: HCP who do not receive influenza vaccination due to medical or religious exemptions must designate this at the VA Employee Health Unit on the HCP Influenza VA Form 10-9050 and wear a face mask while in any VHA location, including both clinical and non-clinical areas.

In addition, HCP are required to wear a face mask during performance of their assigned duties and responsibilities. The face mask shall be worn throughout the influenza season, or until the individual HCP receives a flu vaccination and completes the required VA Form 10-9050.

8.0 VAINFORMATION ANDINFORMATION SYSTEMSECURITY/PRIVACY

LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

8.1 GENERAL

8.1.1 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.

8.2 ACCESS TOVAINFORMATION ANDVAINFORMATIONSYSTEM

8.2.1 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.

8.2.2 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.

8.2.3 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.

8.2.4 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.

8.2.5 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.

8.3 VAINFORMATION CUSTODIAL LANGUAGE

8.3.1 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).

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

8.3.3 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.

8.3.4 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.

8.3.5 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.

8.3.6 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.

8.3.7 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.

8.3.8 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.

8.3.9 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.

8.3.10 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.

8.3.11 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. 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.

8.4 INFORMATION SYSTEM DESIGN ANDDEVELOPMENT

8.4.1 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.

8.4.2 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.

8.4.3 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.

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

8.4.5 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.

8.4.6 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. The contractor/subcontractor agrees to:

8.4.6.1 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:

8.4.6.1.1 The Systems of Records (SOR); and

8.4.6.1.2 The design, development, or operation work that

the contractor/subcontractor is to perform;

8.4.6.2 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 onindividuals that is subject to the Privacy Act; and 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.

8.4.7 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, contractor /subcontractor is considered to be an employee of the agency.

8.4.7.1 “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.

8.4.7.2 “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.

8.4.7.3 “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.

8.4.8 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.

8.4.9 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.

8.4.10 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 Fixed within ____ days.

8.4.11 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.

8.5 INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR

USE

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

8.5.2 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.

8.5.3 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.

8.5.4 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.

8.5.5 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.

8.5.6 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.

8.5.7 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.

8.5.8 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:

8.5.8.1 Vendor must accept the system without the drive;

8.5.8.2 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;

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

8.5.8.4 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.

8.5.8.4.1 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

8.5.8.4.2 Any fixed hard drive on the device must be non-

destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies /methods /tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

8.5.8.4.3 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.

8.6 SECURITY INCIDENT INVESTIGATION

8.6.1 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.

8.6.2 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.

8.6.3 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.

8.6.4 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.

8.7 LIQUIDATED DAMAGES FORDATABREACH

8.7.1 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.

8.7.2 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.

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

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

8.7.3.2 Description of the event, including:

8.7.3.2.1 date of occurrence.

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

8.7.3.2.3 Number of individuals affected or potentially

affected;

8.7.3.2.4 Names of individuals or groups affected or

potentially affected;

8.7.3.2.5 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;

8.7.3.2.6 Amount of time the data has been out of VA

control;

8.7.3.2.7 The likelihood that the sensitive personal

information will or has been compromised (made accessible to and usable by unauthorized persons);

8.7.3.2.8 Known misuses of data containing sensitive

personal information, if any;

8.7.3.2.9 Assessment of the potential harm to the affected

individuals;

8.7.3.2.10 Data breach analysis as outlined in 6500.2

Handbook, Management of Security and Privacy Incidents, as appropriate; and

8.7.3.2.11 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.

8.7.3.3 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:

8.7.3.3.1 Notification;

8.7.3.3.2 One year of credit monitoring services consisting

of automatic daily monitoring of at least 3 relevant credit bureau reports;

8.7.3.3.3 Data breach analysis;

8.7.3.3.4 Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution.

8.7.3.3.5 One year of identity theft insurance with

$20,000.00 coverage at $0 deductible; and

8.7.3.3.6 Necessary legal expenses the subjects may incur to

repair falsified or damaged credit records, histories, or financial affairs.

8.8 SECURITY CONTROLS COMPLIANCE TESTING

8.8.1 On aperiodic 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-day’s 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.

8.9 TRAINING

8.9.1 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:

8.9.1.1 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;

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

8.9.1.3 Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

8.9.1.4 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.]

8.9.2 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.

8.9.3 Failure to complete the mandatory annual training and sign the Rules of Behavior 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 such time as the training and documents are complete.

B.3 PERFORMANCE WORK STATEMENT