Attachment F Sample ORDER PWS FINAL 0002-1.docx

PERFORMANCE WORK STATEMENT

Biomedical Engineering Technical Support Services Sample Task Order - OEHRM

VHA HEALTHCARE TECHNOLOGY MANAGEMENT

NETWORKED MEDICAL DEVICE DATABASE 2.0 GUIDEBOOK

VERSION 1

XXXX XX,, 2018

Contents

1. Scope of Work The purpose of this contract is to provide technical and professional support to Biomedical Engineering departments at Department of Veterans Affairs (VA) medical centers, outpatient clinics, VISN offices, and the HTM Program Office to accomplish professional Biomedical Engineering services in support of the Electronic Health Record Modernization (EHRM)/Cerner deployment. The Cerner electronic health record (EHR) will be replacing VA’s existing EHR system and bring an increased ability to integrate medical devices and interface clinical systems for a more seamless diagnosis and care documentation process. There are many competing priorities for Biomedical Engineering staff in today’s environment, and the support services shall provide interim Biomedical Engineering services to successfully prepare for and deploy the Cerner EHR, as well as, integrate/interface medical devices and clinical systems to the Cerner EHR. When Contractor support services are required by a VA medical facility, a local VISN or facility VA Contracting Officer Representative (L-COR) will be designated to monitor and provide oversight to the contractors at that facility. This task order will support all VA medical centers and outpatient clinics in in VISNs 10, 12, 23, 15, 17, 19, 21, and 22.

These services are non-personal. Contractor personnel are to serve in a support role; final decisions regarding VA business will always be made by Government personnel. Contractor personnel are not subject to the supervision and control of a Government officer or employee in accordance with (IAW) FAR 37.104(a) (1) (ii). Rather, contractor personnel perform their duties IAW specific tasks outlined in the PWS. Supervisory functions such as hiring, directing, counseling, and firing of contractor personnel are not performed by the Government. Contractor personnel shall at no time allow an employer-employee relationship to develop with VA organizations or their staff. VA organizations will refrain from any activities that create the appearance of such a relationship. Contractor personnel who furnish services under this contract are subject to Government technical oversight of the services provided. The Government retains the right to reject nonconforming services.

Contractors shall not perform inherently governmental functions including: decision-making, supervision of Government employees, supervision of other contractors on other contracts, and activities that create the appearance of performing such functions.

2. Performance Schedule The anticipated period of performance of this task order (TO) is September 1, 2021 – September 30, 2022.

3. Place of Performance This TO supports all VA medical centers and outpatient clinics in in VISNs 10, 12, 23, 15, 17, 19, 21, and 22 where professional Biomedical Engineering services are needed in support of OEHRM/Cerner deployment. Attachment A: List of Facilities identifies all main facilities where work may be performed as part of this contract. The Contractor can determine how to service the outpatient clinics associated with main facilities. The Government retains the right to add or subtract facilities as needed, and this will be done via a modification to the base IDIQ contract.

4. Contract type This will be a labor hour type TO.

NOTE: Normal working hours will be between 7:00 AM to 5:00 PM, Monday through Friday, excluding federal holidays, although there may be some working hours flexibility. Occasional overtime may be needed and will be billed at the agreed upon rate.

5. Travel Some tasks may require travel. This travel must be pre-approved by the L-COR and will be reimbursed in accordance with Federal Travel Regulations (FTR) and Federal Acquisition Regulations (FAR) 31.205-46. Each Contractor invoice shall include copies of all receipts that support the travel costs claimed in the invoice. Local travel within a 50-mile radius from the duty location noted in the task order, is considered the cost of doing business and will not be reimbursed. Travel performed for personal convenience and daily travel to and from work at the Contractor’s facility will not be reimbursed. General and Administrative (G&A) fees will not be reimbursed.

6. Scheduling and Status Reports The Contractor shall provide an availability calendar 60 (sixty) days in the future indicating the number of qualified personnel available each week through the course of the year to aid in scheduling activities. The Contractor shall conduct weekly status report meetings with the L- COR detailing, at a minimum, the previous week’s achievements, work planned for the current week, identified risks and recommendations to mitigate risk, staffing plans and forecasts. Additionally, a monthly progress report shall be provided that details the previous month’s achievements, rolls up the information in the weekly status reports, and provides a financial analysis of contract expenditures for the month (and year-to-date), burn rates, and includes variance analyses compared to baseline and estimated plans.

7. List of Equipment All medical equipment listed in Attachment B: List of Types of Medical Equipment will be included within the scope of this contract. Medical equipment covered under the manufacturer’s warranty or covered under a service contract with another vendor are excluded from this contract, and this equipment varies per site. Upon request from the Contractor, the L-COR will provide the list of medical equipment excluded from the contract for a specific site/VISN due to warranty or service contract coverage. The Government retains the right to add or subtract equipment as needed, and this will be done via a modification to the task order.

8. Services Overview At a high level, the tasks within the requirement include professional services for the technology assessment and implementation of medical devices and clinical systems and healthcare consulting in support of the EHRM/Cerner deployment. The Contractor support services shall provide interim Biomedical Engineering services to successfully prepare for and deploy the Cerner EHR, as well as, integrate/interface medical devices and clinical systems to the Cerner EHR. These activities would be required during any of the following project phases: the Current State Review (CSR), Integration Validation, Post Integration Validation (including issue resolution), Go-Live, and Post Go-Live.

The core functions in support of the Cerner EHR deployment initiative are described in Table 2: Core Biomedical Engineering Functions and in further detail Section 8.1 Professional Services.

Technology Assessment

TECHNOLOGY ASSESSMENT (PRE-PURCHASE)

This work is performed following local approval and stated intent to acquire a medical device/system and extends through issuance of purchase order/contract. Includes all work performed related to supporting technology assessment and requirements definition prior to new equipment purchase order or contract award.

· Support of Market Research: what features and functions are currently available; who are the manufacturer/suppliers; what are important design considerations; what the integration considerations are; cost considerations, support of IGCE formulation, etc.

· Support of Requirements Definition: assistance determining “must have” and “desired” features/functions and level of technology; systems engineering design; support of writing technical specifications and RFP development

· Support of usability testing and human factors design; assessing ease of use

SPACE AND UTILITIES CERTIFICATION

Space & utilities assessment and certification of availability or identification of needed space and utilities. Includes scoping and/or preliminary design of site prep construction associated with pre-purchase activities.

SECURITY RISK ASSESSMENT

All work performed prior to new equipment purchase order or contract award related to Pre- Procurement Risk Assessment for information security (e.g., Directive 6550, MDS2, etc.), data protection, and privacy. Includes assessment work regarding networked medical devices such as bandwidth and connectivity requirements for local area, wide area and wireless networks.

Technology Implementation

SITE PREP SUPPORT

Work pertaining to site preparation support and space planning activities for the implementation of new equipment. This work generally follows issuance of purchase order/contract award for new medical equipment/systems and extends through the installation phase into initial clinical use. Includes site preparation planning, design, coordination, and execution, including collaboration with architects, engineers, equipment vendors, construction contractors, and clinical departments.

PRE-IMPLEMENTATION SECURITY

Work associated with Information Security and Network Attached Medical Equipment Pre-Implementation Checklist (e.g., VA Directive 6550) and implementation of new equipment on medical Virtual Local Area Network (VLAN) with appropriate network isolation and protection. Includes design and configuration of Access Control Lists (ACLs). This work is performed following issuance of purchase order or contract award for new equipment and generally extends through first clinical use and system optimization.

INSTALLATION

Installation work associated with implementation of new equipment/systems. Assembly and installation of new equipment items includes hardware and software installation. Includes systems integration and connectivity testing.

INCOMING INSPECTION

Initial inspections and acceptance inspections to validate specifications and performance levels of new equipment, including owned, rental, loaner, and demo equipment. Includes safety inspection prior to first clinical use. This includes functional testing, user acceptance testing, and formal acceptance actions (per contract). Includes design and assignment of operations and maintenance strategy, developing O&M plan and maintenance standard operating procedures. Establishing inventory record(s) and assigning maintenance schedule(s) for new equipment.

Healthcare Consulting

Table 2: Core Biomedical Engineering Functions

8.1. Professional Services

Professional services include any work related to supporting medical equipment or Biomedical Engineering department operations. Contractor services to support OEHRM deployments focus primarily on technology assessment, implementation, configuration management and healthcare consulting services. Services breakdown will vary per location and contractor skill level. Contractor-provided professional services in support of the Cerner HER deployment initiative shall include, but are not limited to the following:

Technology Assessment:

· Information Gathering – collect requested technical and clinical details related to local interface/device integrated systems to include providing system inventories, confirming and working with local POCs for each system (Informatics, Biomed, etc.), and participating in gap analyses for the systems.

· Specification Development – Support defining and validating the requirements, compliance, features, and functions for medical equipment and clinical systems through extensive stakeholder interaction, technical subject matter expertise, and market research.

· Technical Analysis - Perform technical market analysis of medical equipment and clinical systems, considering clinical capabilities, technical performance, supportability, device integration, design and architecture, desired features, human factors design, ease of use, cost, and other factors.

· Risk Assessment - Perform risk assessments of medical equipment and clinical systems in collaboration with clinical stakeholders, patient safety personnel, and with IT for human factors design, reliability, information security, data protection, and connectivity requirements. Submit information required for Enterprise Risk Assessments (ERAs).

Technology Implementation:

· Project Management - Overall project management. Project management, coordination, and system configuration design with clinicians and vendors to implement new equipment/clinical systems. Includes preparation, participation, and leadership of meetings, conference calls, and communications. Includes creation, development, and upkeep of project documentation. This work is generally performed following issuance of purchase order or contract award for new equipment/systems and extends through first clinical use and transitions to operational sustainment.

· Site Readiness - Collaborate with architects, engineers, equipment vendors, construction contractors, clinical services, IT, and others to ensure proper medical equipment and clinical systems siting, safety compliance, physical and remote connectivity, security documentation, and code compliance in preparation for major medical equipment and clinical system installations.

· Preparation and Coordination – Coordinate with the Network POC for connectivity and testing; coordinate devices, hubs, cabinets or desktop installation needs to ensure availability/readiness; and coordinate with vendors to ensure connectivity requirements for interfaces and device integrated systems are met. Work with Cerner team and local SMEs to prepare local systems for testing, integration, and cut-over events. Work with Cerner team in coordinating local interface/device integrated systems resources for both cutover planning and go live support, including preparing events such as cutover planning events and production validation, as well as during cutover to production.

· Installation and Inspection - Ensure equipment and systems are inspected and approved for implementation by validating specifications, performance levels, and electrical code compliance; performing functional testing, user acceptance testing, formal acceptance actions (per contract), and work associated with documentation; designing the equipment lifecycle strategies; developing preventative and corrective maintenance plan and standard operating procedures; facilitating proper user training; evaluating needs for system access and ensuring that the need to perform a task, permission levels, and competency requirements are met; ensuring proper nomenclature categorization; and assigning maintenance schedule(s) for new equipment and systems.

· Systems Design and Integration - Address and evaluate multiple parameters to ensure that separate medical equipment and clinical systems work as complete, integrated systems (when necessary). Facilitate with Cerner-medical device integration parameter testing efforts, medical device configurations and Cerner Connectivity Engine (CCE) configurations required for BMDI solutions.

· System Testing – Work with local resources to install applications or devices to testing devices when needed and participate in testing interfaces/device integrated system, both scheduled and ad hoc. Work with local and national teams for test scenario review and provide feedback when requested, troubleshoot issues and log service records for EHRM support if needed, and coordinate testing resources when troubleshooting issues.

· Technical Training and Support - Provide or facilitate education and applications training for Biomedical Engineering staff and facilitate operator training around operating and maintaining medical equipment and clinical systems. Provide helpdesk and troubleshooting support for medical equipment and/or clinical systems.

Configuration Management:

· Configuration - Arrange and document clinical system specifications, components, connectivity, and operating system and software versions; track and control changes; and validate and maintain consistency and completeness of the clinical system.

Healthcare Consulting:

· Equipment and Systems Planning – Support assessing medical equipment and clinical systems portfolios, identify equipment approaching the end of its useful life, identify legacy systems, identify emerging or innovative technology/systems, support developing medical equipment and clinical systems strategic plans.

8.2 Remote Support

Remote Biomedical Engineering support is a valuable, feasible and timely alternative to onsite work in order to fulfill healthcare technology management needs. The Contractor may be required to perform many professional services remotely, with the exception of implementations, and technical training and support, which typically require a physical presence onsite with colleagues and technology.

8.3 Test Equipment

The Contractor shall provide their own general test equipment to perform services covered under this contract, to include an electrical safety analyzer, gas flow analyzer, test lung simulator, defibrillator analyzer, pulse oximeter/ noninvasive blood pressure simulator analyzer, electrosurgical analyzer, external pacemaker analyzer, vital signs / patient ECG Simulator, bladder scanner phantom, x-ray test device, and network cable tester. Any specialized test equipment owned by the VA can be used by the contractor with approval from the L-COR. The Contractor shall notify the L-COR if any specialty test equipment is needed that is not available in-house, and if deemed necessary by the L-COR, the VA will procure the test equipment. The test equipment owned by the Contractor shall be on a calibration cycle, and the calibration of test equipment shall be traceable and in conformance with the test equipment OEM standards. A copy of current test equipment calibration certificates used by the Contractor shall be provided by the Contractor at the beginning of the period of performance and at any time upon the request of the L-COR or Contracting Officer. All test equipment used for services rendered as part of this contract shall be annotated on the VA’s work order/assessment of equipment including the certification expiration date for the test equipment. Work completed by the Contractor using test equipment with expired calibration certificates will not be accepted.

8.4 Parts and Service

The contractor will not be asked to work on medical equipment covered under the manufacturer’s warranty or covered under a service contract with another vendor. If parts or medical equipment manufacturer services are needed for any work on medical equipment or accessories rendered as part of this contract, then the Contractor shall notify the L- COR of the exact parts or medical equipment manufacturer services they require to complete the contracted work. The L-COR will confirm this need, process the procurement of any parts or medical equipment manufacturer services related to the work covered in this contract, and will provide those parts or services to the Contractor for work completion as per the contract.. NOTE: If services are required from the medical equipment manufacturer (OEM), or If the contractor runs into an issue with a device that requires work from the medical equipment OEM of the medical device, then the Contractor shall inform the L-COR who will confirm the need and procure those additional services from the OEM for needed to complete the repair/maintenance on that device.

9. Work Order Process Work Orders may be issued, within the scope of this TO, by the base IDIQ COR or the L-COR to provide further information and details regarding specific in-scope, nascent, or normal repair services required. The method for which work orders will be initiated and tracked will be determined by the CO and followed by each applicable facility, but some examples include email, conference calls which will be followed up by email to document the call, contractor-provided portal, or VA Computerized Maintenance Management System (CMMS). When a work order is initiated the contractor shall submit the estimated number of hours and labor mix required along with the schedule to complete the work defined in the work order. Prior to starting work the L-COR must approve the estimated hours. Work orders covered under this task order will be processed by VA and the Contractor using the following steps:

· Initiation – The L-COR will initiate the work order and send it to the Contractor through the CO determined and facility-determined method based on description above. During this initiation, the L-COR will provide any necessary documentation for the Contractor to both estimate and complete the work (e.g. Planned Maintenance (PM) procedures, issue descriptions, points-of-contact, etc.). For the initiation of PM work orders, the L-COR will notify the Contractor by the end of the month prior that Contractor support is required for PM services in the following month, so the Contractor has sufficient time to complete the scheduled maintenance in the month due.

NOTE: PM work orders differ from normal repair or professional service work orders because they provide scheduled maintenance services on equipment at defined intervals (annual, semi-annual, quarterly, monthly, etc.). PM work is known in advance, and as such, the Government will notify the contractor in advance so they have adequate time to complete the required service during the month the maintenance is due.

· Confirmation – The Contractor shall confirm receipt of the work order and provide the estimate within 1 business day.

· Scheduling – Once the estimate is approved, the Contractor shall work with the L- COR or Biomedical Engineering point-of-contact to schedule the work as soon as possible, taking into consideration the level of responsiveness needed, the type of medical equipment involved, and the resources that are available.

· Completion of Work – The Contractor shall notify the L-COR or Biomedical Engineering point-of-contact prior to commencing service during normal operating hours. While on-site for maintenance, the Contractor shall be equipped with the appropriate test equipment based on the maintenance and repair required. At this time, the COR can request to see a copy of the test equipment calibration certificates to verify they are not expired. If during the accomplishment of the work order, the Contractor needs parts or medical equipment manufacturer services to be procured, the Contractor shall notify the L-COR or Biomedical Engineering point-of-contact and the COR will confirm the need and provide the parts or medical equipment manufacturer services required to complete the work order. The Contractor shall be required to have a VA Contractor PIV card, and the Contractor shall be allowed to accomplish the work unescorted in VA facilities.

NOTE: On some medical equipment, manufacturer services are required as repairs may require the manufacturers factory training or have special access to the device. In these situations, the Contractor shall inform the L-COR of this need, and once confirmed, the L-COR will procure those services from the manufacturer.

· Close-Out – Once the work has been completed, the Contractor will provide a field service report to the L-COR or Biomedical Engineering point-of-contact which details the work completed. The Contractor shall also include in the field service report, the name of the person performing the work, the hours spent on the work order, the equipment ID#, and the equipment location. All test equipment used for services rendered on a work order shall be annotated on the field service report, including the certification expiration date for the test equipment. The Contractor shall provide the date the work was completed in the field service report, allowing the L-COR or Biomedical Engineering point-of-contact can review, examine, determine acceptance, and close out the work order with the appropriate date.

10. Physical Demands Work assignments will involve bench and on-site repairs requiring sitting, standing, walking, lifting, climbing, bending, and working in cramped and awkward positions. Contractor personnel shall be able to frequently handle objects weighing up to 40 pounds and occasionally objects weighing more than 40 pounds.

11. Work Environment Work will be completed in the Biomedical Engineering department and patient care areas. Work will primarily be done inside well-lighted, heated, and ventilated areas, although access to some equipment may be more cramped and poorly lit. Contractor personnel may be exposed to tremendously high electrical voltages and currents, and may sustain cuts, bruises or burns caused by electric shock, hot components, and ionizing radiation x-rays. They may also be exposed to patient bodily fluids when working in patient care areas. Please note that the contractor shall provide their staff with Personal Protective Equipment (PPE) as VA is not liable for any injuries caused by a contractor staff’s non-protection.

12. Policies, Safety and Infection Control The Contractor shall follow all relevant hospital and department-level policies and standard operating procedures (SOP’s) during performance of services under this contract. Upon request from the Contractor, the L-COR will provide copies of any relevant hospital and department-level polices and SOP’s that the Contractor shall follow.

During the performance of services in this contract, the Contractor shall be required to follow local safety and infection control processes. These safety and infection control process can include, but are not limited to the following: ladder safety, laser safety, personal protective equipment, lock-out/tag-out, hazardous material disposal, infection control risk assessment (ICRA), and permitting.

13. Contractor Personnel

13.1. Basic Qualifications

The Contractor personnel shall meet one of the following basic qualifications, regardless of role in the services provided under this contract:

· Experience within a medical center and Biomedical Engineering department

OR

· Experience working in or with the Veterans Health Administration (VHA)

OR

· Understanding of VISN, VA medical center, and Biomedical Engineering department operations

13.2. Role-Specific Qualifications

In addition to the basic qualifications, the Contractor personnel shall meet the following role-specific qualifications based on the core functions and services each will be providing under this contract.

a. Biomedical Technician / Equipment Support Specialist – General (Level I, II, III)

· A two-year associate degree or higher in an applied science or equivalent military training.

· Demonstrated competency to perform operational verification procedures, planned maintenance, and repair service on various medical equipment.

· Understanding of regulatory agencies’ requirements, industry regulatory requirements and International Standard Organization standards.

· Familiarity with the setup and application of test equipment.

· Ability to read, analyze, and interpret technical literature, schematics, and drawings.

· Level I Experience - A minimum of one year of hospital or healthcare experience performing medical equipment maintenance.

· Level II Experience - A minimum of three years of hospital or healthcare experience performing medical equipment maintenance.

· Level III Experience - A minimum of five years of hospital or healthcare experience performing medical equipment maintenance.

b. Biomedical Technician / Equipment Support Specialist – Information Systems (e.g. MUSE, ICU-CIS, PACS, etc.)

· A two-year associate degree or higher in an applied science or equivalent military training.

· A minimum of three years of hospital or healthcare experience performing medical equipment maintenance, with a minimum of one-year specialized experience in medical information systems and networking.

· Current and advanced knowledge of computer virus protection software, available software patches and upgrades, information security tools, electronics, computers and network theory.

· Demonstrated competency in utilizing and maintaining computer and server based medical equipment, medical record databases, and proprietary and generic software; experience with TCP/IP, HL7, networking, network security and DICOM standards; experience maintaining, interfacing and troubleshooting networked medical equipment to include VLAN configuration, IP addressing, sub-netting, and network security; ability to interpret, identify and apply network engineering principles and practices; and ability to distinguish networking problems from non-networking problems.

· Understanding of regulatory agencies’ requirements, industry regulatory requirements and International Standard Organization standards.

· Familiarity with the setup and application of network test equipment and tools.

· Ability to read, analyze, and interpret technical literature, schematics, and drawings.

c. Biomedical Technician / Equipment Support Specialist – Medical Imaging Systems (e.g. CT, MRI, X-Ray, Linear Accelerator, etc.)

· A two-year associate degree or higher in an applied science or equivalent military training. Certification as a Certified Radiology Equipment Specialist (CRES) is highly desired, but not required.

· A minimum of three years of hospital or healthcare experience performing medical equipment maintenance, with a minimum of one-year specialized experience with medical imaging equipment.

· Comprehensive knowledge of imaging techniques, technologies, radiological practices and procedures.

· Demonstrated competency in maintaining medical imaging systems; ability to resolve highly complex breakdowns that have an immediate risk to patient safety; ability to maintain and troubleshoot networked medical imaging equipment to include VLAN configuration, IP addressing, sub-netting, and network security, and build, configure, repair and install workstations and servers in imaging and non-imaging environments; ability to utilize and maintain computer and server based medical equipment, medical record databases, and proprietary and generic software; experience with TCP/IP, HL7, networking, and DICOM standards.

· Understanding of regulatory agencies’ requirements, industry regulatory requirements and International Standard Organization standards.

· Skill in using advanced radiological test equipment such as radiation dosimeters, calibration phantoms, high voltage testing devices, KV and MA meters and monitor calibration devices.

· Ability to read, analyze, and interpret technical literature, schematics, and drawings.

d. Biomedical Engineer / Clinical Engineer

· A Bachelor’s degree or higher in Engineering or Certification as a Clinical Engineer (CCE).

· A minimum of three years of hospital or healthcare experience maintaining medical equipment or managing a hospital medical equipment program.

· Demonstrated knowledge of concepts related to computer based medical systems, networking protocols, and information security as it applies to medical technology within VHA.

· Demonstrated competency in the ability to conduct a medical equipment management program that is compliant with applicable healthcare standards and regulatory agencies; ability to develop a curriculum for a continuing education program that address the safe and effective use of medical technology; ability to manage a recall and safety alert program for medical devices, including medical device hazard investigations, to assure compliance with patient safety goals, SMDA, and TJC requirements; ability to conduct capital asset and infrastructure planning for medical equipment spanning initial concept, installation, and effective implementation of complex medical equipment; ability to function as the subject matter expert in the field of biomedical engineering, directly supporting specialized clinical technology, including service, system administration, training, quality assurance, and life-cycle management; ability to effectively advise clinical and administrative staff on medical technology, including existing and emerging technology, which addresses viability, long-term suitability, compatibility, and/or safety; to apply project management principles to deployment of medical equipment and health information technologies.

· Demonstrated skill in in communicating and working collaboratively with key stakeholders, including technical and professional staff at various levels of the organization.

· Understanding of regulatory agencies’ requirements, industry regulatory requirements and International Standard Organization standards.

e. Project Manager

· Bachelor’s degree or higher and certification in project management (e.g. Project Management Professional (PMP).

· A minimum of two years of hospital or healthcare experience planning, managing and controlling projects.

· Demonstrated competency in planning, managing and controlling projects throughout their lifecycle; writing or reviewing project management documentation (including project charters, project management plan, Business Reference Model (BRM); problem solving; and risk mitigation and management.

· Demonstrated mastery and skill in applying the theory, concepts, practices, and techniques consistent with the project management principles outlined in the Project Management Institute's (PMI) Project Management Body of Knowledge (PMBOK).

· Demonstrated skill in in communicating and working collaboratively with key stakeholders, including technical and professional staff at various levels of the organization.

· Understanding of regulatory agencies’ requirements, industry regulatory requirements and International Standard Organization standards.

13.3. Evidence

The Contractor shall furnish qualified personnel as required by contract specifications to accomplish services required under this contract. The Contractor shall have evidence of training, certifications, experience, and other qualifications for their personnel performing work under the contract. Evidence shall include a list of the types of medical equipment on which contracted personnel have experience performing planned and corrective maintenance. If the Contractor proposes to add or replace personnel to perform contract services, the Contractor shall submit the required evidence of training certification, experience, and other qualifications to the L-COR. At no time shall the Contractor utilize additional or replacement personnel to perform contract services who do not meet the qualifications under the terms and conditions of this contract or have not been approved by the L-COR.

13.4. Acceptance

Contractor personnel shall not be considered Government employees for any purpose. The VA reserves the right to restrict any Contractor personnel from performing services under this contract who do not meet the required qualifications for the services they are required to perform, and who violate Federal regulations or are identified as a potential threat to the security, safety, health and/or operational mission of VA and its Veteran population. The restriction of such Contractor personnel shall not relieve the Contractor from performing all the required services, in accordance with all terms, conditions, and schedules contained herein.

14. Badging and Security Contractor personnel working under this contract shall be fingerprinted and have a background verification completed by the VSC Personnel Security Office for issuance of a VA Contractor PIV badge, prior to commencement of work (NOTE: A temporary ID badge may be provided prior to final verification and issuance of the PIV badge). The contractor PIV badge request shall be initiated through the COR for the base IDIQ contract or the L-COR.

Contractor personnel working under this contract shall obtain a VHA government email account prior to commencement of work.

Contractor personnel working under this contract shall obtain VA GFE (Government Furnished Equipment) within 120 days of the commencement of work under this contract.

Contractor personnel providing networked medical system management services under this contract shall apply and be granted elevated privileges through ePAS within 150 days of the commencement of work under this contract.

All Contractor personnel working under this contract, requiring on-site access, shall wear visible identification while on the premises of a VA facility. The Contractor shall park in the appropriate designated parking areas. Information on parking is available from the applicable VA Police Section or the L-COR. The VA facility will not validate or make reimbursement for any parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, are subject to search. Violations of VA regulations will result in citations answerable in the United States (Federal) District court, not a local district, state, or municipal court.

15. Contractor Performance Schedule and Surveillance Contractor performance will be monitored by the L- COR with respect to the estimated schedule provided by the contractor in response to specific work orders after approval by the Government. Completed assignments will be reviewed and discussed with the L-COR. Incomplete or pending work orders and other assigned tasks will be reviewed during the weekly status meetings to ensure work is being completed in accordance with task order requirements.

The Government will evaluate the Contractor’s performance under this contract using the method of surveillance specified in Table 3: Quality Assurance Surveillance Plan. All surveillance observations will be recorded by the Government through the L-COR. When an observation indicates defective performance, the L-COR will provide the Contractor with a copy of the record of the observation.

Table 3: Quality Assurance Surveillance Plan

16. Information Security/Privacy for Inclusion into Contracts

16.1 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.

16.2 ACCESS to VA INFORMATION AND VA INFORMATION SYSTEMS

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

1. 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 shall 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.

Contract personnel who require access to national security programs shall 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 shall be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

Custom software development and outsourced operations shall 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 shall 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.

The contractor or subcontractor shall 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 shall be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

16.3 VA INFORMATION CUSTODIAL LANGUAGE

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).

VA information shall 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 shall 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.

Prior to termination or completion of this contract, contractor/subcontractor shall not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by VA. Any data destruction done on behalf of VA by a contractor/subcontractor shall 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 shall be sent to the VA Contracting Officer within 30 days of termination of the contract.

The contractor/subcontractor shall 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.

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 shall be appropriately destroyed.

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.

If a VA 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.

The contractor/subcontractor shall 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.

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.

Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor shall 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 shall refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

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 shall complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

16.4 INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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.