PWS BETPSS_Initial Task Order_0003_FINAL.docx

B.3 PERFORMANCE WORK STATEMENT (PWS)

1. Introduction

Veterans Health Administration (VHA) Office of Healthcare Technology Management (HTM) develops and guides the comprehensive management of healthcare technologies to ensure safe, available, and innovative medical technology used to deliver exceptional health care for Veterans. HTM’s vision is to be an efficient, innovative and customer-oriented Center of Excellence that continually enhances VHA’s ability to deliver world class health care for our nation’s Veterans through exceptional management of healthcare technology as well as position VHA as the national leader in healthcare technology management. HTM/Biomedical Engineering at the medical facilities and VISNs direct the medical equipment management program and support clinical care through providing preventive and corrective maintenance, healthcare consulting, and professional services for the technology assessment, implementation and sustainment of medical equipment and clinical systems.

1. Scope of Work

The purpose of this Task Order is to provide technical and professional support to the VHA Office of HTM to accomplish networked medical system and cybersecurity-related corrective and planned maintenance, professional Biomedical Engineering services, and project management work. Task Order resources shall accomplish routine operational tasks for networked medical system management and cybersecurity management nationally for VHA HTM. There are many competing priorities for Biomedical Engineering staff in today’s environment, and the support services shall provide interim Biomedical Engineering services remotely while full-time positions are recruited and hired to fill permanent roles in VHA HTM Program Office, as needed. A local VA Contracting Officer Representative (L‑COR) will be designated to monitor the contractor’s performance and provide technical insight to the Contracting Officer in accordance with the COR delegation.

The work under this Task Order may involve the contractor accessing or handling Protected Health Information (PHI), the successful contractor may be required to execute a Business Associate Agreement (BAA). Once the contract or Task Order is awarded, the COR or designated VA staff will contact the VHA Privacy Office BAA Issues Team (VHABAAIssues@va.gov) to ensure the appropriate BAA is prepared and implemented. The Contractor’s role is limited to informing the Contracting Officer if PHI will be involved.

These services are non-personal. Task Order personnel shall serve in a support role and do not make final decisions, approvals, or determinations on behalf of the Government. Task Order personnel are not subject to the supervision and control of a Government officer or employee in accordance with (IAW) FAR 37.201-2. Rather, Task Order personnel shall perform their duties IAW specific tasks outlined in the PWS. Supervisory functions such as hiring, directing, counseling, and firing of Task Order personnel are not performed by the Government. Task Order 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. Task Order personnel who furnish services under this Task Order personnel are subject to Government technical oversight of the services provided. The Government retains the right to reject nonconforming services.

Task Order personnel shall not perform inherently governmental functions including decision-making, supervision of Government employees, supervision of other Task Order personnel on other Task Orders, and activities that create the appearance of performing such functions.

1. Task Order Type

Labor Hour

1. Period of Performance

The anticipated period of performance of this task order (TO) is July 20, 2026 – July 19, 2027 September 20, 2026 – September 19, 2027.

Task Order Options:

Option Year 1: period of performance July 20, 2027 – July 19, 2028. August 03, 2027 – August 03, 2028 Option Year 2: period of performance July 20, 2028 – July 19, 2029. August 03, 2028 – August 03, 2029

1. Place of Performance

The work under this Task Order will be done remotely from any US location with secure internet connection.

1. Hours of Performance

Normal working hours will range between 8:00 AM to 4:30 PM ET, Monday through Friday, excluding federal holidays, although there may be some working-hours flexibility. Task Order hours will be monitored by the L-COR and verified prior to billing and payment.

1. Travel

No travel is expected under this Task Order. 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. If travel is not specifically authorized in writing by the L-COR in the applicable task order, it shall not be authorized as a separate billable expense.

1. Scheduling and Availability Reports

The Contractor shall designate a Key Personnel for the entire Task Order as well as for each task order to address Task Order/task order needs. The Contractor shall provide an availability calendar sixty (60) days out indicating the number of qualified personnel available each week through the course of the year to aid in scheduling activities.

Deliverable: Availability calendar (due sixty (60) days after IDIQ Contract award)

7.1 Kick-Off Meeting:

The contractor shall participate in Technical Kick-Off Meeting within ten calendar days after Task Order award. The technical kick-off meeting shall occur in conjunction with the post award conference. The contractor shall present, for review and approval by the Government, the details of the intended approach, work plan, and projected schedule for this effort. The contractor shall provide an agenda at least five calendar days prior to the meeting, and document meeting minutes within three calendar days after the meeting. The contractor shall invite the Contracting Officer (CO), L-COR, Contract Specialist (CS), and the HTM/Biomedical Engineering’s operations staff.

Deliverable: Kickoff Meeting Agenda (five calendar days prior to the meeting) and Kick off Meeting Minutes (three calendar days after the kickoff meeting).

7.2 Monthly Status Reports:

The Contractor shall conduct monthly status report meetings with the facility-L-COR detailing, at a minimum, the previous month’s achievements, work planned for the current month, identified risks and recommendations to mitigate risk, staffing plans and forecasts, and a financial analysis of Task Order expenditures for the month (and year-to-date), including variance analysis compared to baseline and forecasted plans. Contractor monthly reports shall be submitted by first business day of each month.

Deliverable: Monthly Status Report (shall be submitted by first business day of each month to the L-COR by email)

END OF DELEVERABLES

1. List of Equipment

All medical equipment listed in Attachment B: List of Types of Medical Equipment are included within the scope of this Task Order for networking and cyber security purposes. Medical equipment covered under the manufacturer’s warranty or covered under a service Task Order with another vendor is excluded from this Task Order. The Government retains the right to add or subtract equipment as needed, and this will be done via a modification to the Task Order.

1. Services Overview

The tasks within the requirement include planned maintenance; corrective maintenance; and professional services for the technology assessment, implementation, and sustainment of networked medical devices and clinical systems, as well as healthcare consulting/internal operation support regarding medical equipment management and cybersecurity management. The core functions are described in more detail as listed in Table 2: Core Biomedical Engineering Functions.

Technology Assessment

TECHNOLOGY ASSESSMENT (PRE-PURCHASE)

This work is ordered and performed when local medical center leadership have a stated intent to acquire a medical device/system and extends through issuance of purchase order/Task Order for a recommended device/system. Technology Assessments include all work performed related to technology assessment and requirements definition prior to new equipment purchase order or Task Order 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 Contractor support for market research, requirements definition, and usability testing shall be limited to technical analysis and recommendations. Final decisions, approvals, and determinations shall be made by Government personnel.

SECURITY RISK ASSESSMENT

All work performed prior to new equipment purchase order or Task Order 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

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 (ACL). This work is performed following issuance of purchase order or Task Order 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 include hardware and software installation. Includes systems integration and connectivity testing.

Technology Sustainment - Safety

MEDICAL DEVICE SECURITY INCIDENT

Medical device security incident investigation, corrective action, and reporting/documentation. Includes responses to incidents such as malware intrusions, unauthorized/unsuccessful group policy pushes, and unauthorized/unexplained ACL change.

DE-INSTALLATION/ DECOMMISSIONING

Physical de-installation of a medical device/system. Decommissioning activities include sanitization of stored sensitive information as appropriate (e.g., physical destruction), reviewing maintenance history for completeness, assisting logistics with condition coding, removing from maintenance schedule, and other associated turn-in activities (abiding with Decommissioning standard operating procedures).

Technology Sustainment - Planned Maintenance

PLANNED MAINTENANCE

Routine support and planned maintenance of medical devices and medical systems (includes medical servers and other computer-based systems), including hardware, software, or communications networks. Typically performed according to defined procedures and on a scheduled basis, to minimize a device or system’s risk of failure and/or to ensure continued operation, safety, and data security. Include monthly patching and vulnerability management.

Technology Sustainment - Corrective Maintenance

SOFTWARE REPAIR

Work performed to repair/restore medical device software or systems to clinical operation after a failure via software related actions including reloads, re-imaging, and other corrective actions. Includes problem identification and resolution of medical systems servers that is primarily software related (may include incidental troubleshooting and correction of hardware routines, reloading hardware, or connectivity assessment that is incidental to the software resolution).

MEDICAL SYSTEMS CONNECTIVITY

Determination of cause and correction of a reported operational problem(s) with a network-connected medical device or system determined to be related to network, interoperability protocol, or other connectivity-based infrastructure. Includes troubleshooting and correcting reported problems associated with Virtual Local Area Network (VLANs), ACLs/Firewalls, network port security, telecommunications, patch cable problems, Health Level 7 (HL7)/ Digital Imaging and Communications in Medicine (DICOM) outages, etc. Includes activities related to system connectivity or system wide related interoperability and interconnectivity issues.

Technology Sustainment

UPGRADES

Enhancement and upgrades for added functionality, greater reliability, and improved patient safety, including hardware and software improvement. Includes any significant reconfiguration of existing medical device/systems.

EDUCATION PROVIDED- CLINICAL USER

Providing training on the operation of medical equipment and technology systems. Includes training on operator-level maintenance and system administration. Includes time spent facilitating training with clinical educators, vendors, and other 3rd parties. Includes general training provided regarding medical equipment management, HTM services, equipment safety, new employee orientation, nurse staff meetings, etc., and mentoring of non-Biomedical Engineering personnel.

MEDICAL APPLICATION SUPPORT

Time spent on medical application changes. Work includes but not limited to adding/removing users, configuration changes, system application administration, regular medical device application software patching, clock resets, rebooting PCs, and interoperability verification.

Healthcare Consulting

Internal Operations

Table 2: Core Biomedical Engineering Functions

9. Planned Maintenance (PM)

Planned maintenance refers to a procedure ensuring proper medical equipment operation and calibration. This procedure includes inspection of the medical equipment for mechanical defects, cleaning of interior fans and filters, performance verification of operator controls and adjustments, calibration verification per original equipment manufacturers’ (OEM) specifications, inspection for ground integrity and current leakage, and documentation of all results. The Contractor shall have the appropriate level of training or OEM certification to perform PM services, and they shall not perform PM services on medical equipment that they are not fully trained or certified on. The Contractor shall submit training certificates to the COR when required for the equipment being maintained. The OEM’s specifications shall be used as the source document for all planned maintenance (unless otherwise instructed by the L-COR).

The Contractor shall ensure planned maintenance services support the VA facilities in preparation for The Joint Commission and other regulatory inspection surveys. 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. The Contractor shall ensure all scheduled PM services are completed by the due date set in the VA Computerized Maintenance Management System (CMMS). If at the due date, the Contractor still cannot complete the PM, all efforts to complete the PM shall be documented on a field service report and the information provided to the L-COR. Contractor planned maintenance services shall include, but are not limited to the following:

· Performance verification

· Electrical safety inspection and testing

· Monthly patching and vulnerability management

· Routinely scheduled service per OEM specifications

· Ensuring all equipment is maintained and repairing it to OEM standards if needed

· Documentation of all planned maintenance services upon completion or no later than the fifth (5th) business day of the subsequent month

9. Corrective Maintenance

Medical equipment repairs shall be facilitated by the Contractor to ensure equipment availability, to provide an optimum level of equipment performance, and to extend the useful life of the equipment. The Contractor shall have the appropriate level of training or OEM certification to perform corrective maintenance services, and they shall not perform corrective maintenance services on medical equipment that they are not fully trained or certified on. The Contractor shall submit training certificates to the COR when required for the equipment being repaired. When repairs are required to correct equipment malfunctions, the Contractor shall use industry accepted repair practices and maintain high standards of equipment performance and safety to complete corrective maintenance services in a timely manner. All efforts shall be made to meet an average corrective maintenance turn-around time of 7 calendar days from the initiation of a work order from the VA to the completion of the work order by the Contractor. The Contractor corrective maintenance services shall include, but are not limited to the following:

· Performance analysis

· Troubleshooting and problem identification

· Decision-making regarding problem correction in the most pertinent, timely, and cost-effective manner

· Completing the repair

· Documentation of all corrective maintenance services upon completion or within one (1) day of job completion.

9. Professional Services

Professional services include any work related to supporting medical equipment or Biomedical Engineering department operations that is not planned or corrective maintenance. The Contractor shall provide professional services in the areas of technology assessment, implementation, and sustainment of medical devices and clinical systems; healthcare consulting; and internal operation support. Contractor services for Office of Electronic Health Record Modernization (OEHRM) deployments focus primarily on technology assessment, implementation, configuration management and healthcare consulting services. Contractor services for operational support of a VA medical center or VISN could include any of the services listed. Services breakdown will vary per location and Contractor skill level. Contractor-provided professional services shall include, but are not limited to the following:

· 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 Task Order award for new equipment/systems and extends through first clinical use and transitions to operational sustainment.

· 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.

· 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). Review and assess medical device boundary controls with OIT and assign medical devices to the correct boundaries. Submit and track POAMs for medical system that is not able to comply with current controls.

· 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/Oracle-medical device integration parameter testing efforts, medical device configurations and Cerner Connectivity Engine (CCE) configurations required for Biomedical Device Integration (BMDI) solutions or Lab Management Device Integration (LMDI) solutions.

· 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.

· 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.

· Safety Alerts, Recalls, and Incident Management - Manage, lead, and document activities associated with medical equipment and clinical systems safety, recalls, and incident investigations to prevent harm to patients, including proactive risk assessments, evidence preservation, data capture and analyses, root cause identification, corrective action development, solutions implementation, and disaster recovery. Set, monitor, and/or remediate clinical system alerts and failures, including performing remote monitoring and recovery.

· Cybersecurity Risk Management - Directly support and monitor medical equipment and clinical system cybersecurity compliance, including: ensuring proper medical network security operations, conducting planned and proactive updates of devices and systems, providing quality assurance on medical system compatibility, ensuring equipment inspections and calibrations do not degrade medical equipment performance, performing security incident investigation and corrective action, and testing device communication and system reporting to validate the expected level of integration and interoperability exists.

· Hardware and Software Upgrades - Proactively upgrade hardware and software to optimize patient safety and clinical efficacy through technology refresh cycles.

· Regulatory Compliance - Ensure compliance with VA and regulatory standards pertaining to network medical equipment and clinical systems including those from VHA's Office of Healthcare Technology Management (HTM), Joint Commission (JC), National Fire Protection Association (NFPA), Food and Drug Administration (FDA), Office of Inspector General (OIG), and other applicable federal, state, and local regulatory bodies.

· Data Analytics Support – Perform ad-hoc analytical Structured Query Language (SQL) queries, develop PowerBI reports, and develop SQL Server Reporting Services (SSRS) reports to support data analytics and data reporting for Biomedical Engineering operations. Support ASP.NET MVC web development, troubleshoot analytics applications, and provide bug fixes to reports and web applications to assist national Biomedical Engineering data analytics initiatives. Support in this area requires proficiencies in Microsoft PowerBI, Microsoft SQL Server Reporting Services (SSRS), ASP.NET MVC framework, and Web App Development and could require proficiencies in, C#, T-SQL, HTML and JavaScript, ETL Development using Microsoft SQL Server Data Tools (SSDT), and Internet Information Services (IIS).

9. Remote Support

Remote Biomedical Engineering support is a valuable, feasible and timely alternative to onsite work in order to fulfill healthcare technology management needs. All services and tasks for planned maintenance; corrective maintenance; and professional services under this task order can be performed remotely, and no onsite work is anticipated.

9. Test Equipment

While none anticipated, the Contractor shall provide their own general test equipment to perform services covered under this Task Order. 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 COR.. All test equipment used for services rendered as part of this Task Order will be annotated by the L-COR on the VA’s work order including the certification expiration date for the test equipment. Work completed by the Task Orderor using test equipment with expired calibration certificates will not be accepted.

9. Parts and Service

The Contractor shall 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 vendor services are needed for any work on medical equipment or accessories rendered as part of this Task Order, then the Contractor shall notify the L-COR of the exact parts or services that they require to complete the ordered work. The L-COR will process the procurement of any parts or vendor services related to the work covered in this Task Order and will provide those parts or services to the Contractor for work completion as per the Task Order. NOTE: If services are required from the medical equipment 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 needed to complete the repair/maintenance on that device.

1. Work Order Process

The method for which work orders will be initiated and tracked within the VA HTM Nuvolo system with exceptions to this method to be determined by the L-COR. Relevant work orders covered under this Task Order will be processed by the VA and the Contractor using the following steps:

· Initiation – The L-COR will initiate the work order to the Contractor through the L-COR determined and facility-determined method. During this initiation, the L-COR will provide any necessary documentation for the Contractor to 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.

· Confirmation – The Task Orderor shall confirm receipt of the work order within 1 business day.

· Scheduling – The Task Orderor 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 contracted. At that time the L-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 required parts or vendor services to be procured, the Contractor shall notify the L-COR or Biomedical Engineering point-of-contact who will provide the parts or vendor services required for the Contractor to complete the contracted work. The Contractor shall have a VA Contractor PIV card, and will be allowed to accomplish the work unescorted when in VA facilities.

· Close-Out – Once the work has been completed, the Contractor shall provide a field service report to the L-COR or Biomedical Engineering point-of-contact detailing the planned maintenance steps completed and the PM status or the cause of the equipment malfunction and corrective action that was taken. The Task Orderor 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 on the field service report, so that the L-COR or Biomedical Engineering point-of-contact can review, examine, determine acceptance, and close the work order with the appropriate date.

1. Physical Demands

Work assignments will involve general computer/desk work. There are no physical capability requirements related to this work.

1. Work Environment

There are no work environment considerations for this Task Order.

1. Policies, Safety and Infection Control

The Contractor shall follow all relevant VHA Office of HTM and overarching VHA policies and standard operating procedures (SOP’s) during performance of services under this Task Order. Upon request from the Contractor, the L-COR will provide copies of any relevant polices and SOP’s that the Contractor shall follow.

1. Contractor Key Personnel

14. Basic Qualifications

The Contractor personnel shall meet the minimum following qualifications.

· Experience within a Biomedical Engineering department in a medical center

OR

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

14. Role-Specific Qualifications

In addition to the basic qualifications, the Contractor personnel identified below are considered key personnel and shall meet the following role-specific qualifications based on the core functions and services each will be providing under this Task Order. A Biomedical Technician / Equipment Support Specialist – Information Systems OR a Biomedical Engineer / Clinical Engineer with experience supporting networked medical systems is required.

1. Biomedical Technician / Equipment Support Specialist – Information Systems (e.g., MUSE, Intensive Care Unit Clinical Information System (ICU-CIS), Picture Archiving and Communication System (PACS), etc.)

0. Education Requirement:

0. Associates or higher degree in the biomedical technology or biomedical engineering field; OR

0. Associates or higher degree in electronics, a field of information technology, or engineering (other than biomedical engineering) AND 1 year of creditable experience; OR

0. Completion of the Department of Defense (DOD) biomedical equipment technician training program; OR

0. Completion of a DOD training program in repair and maintenance of electronic systems or information technology AND 1 year of creditable experience; OR

0. Completion of a biomedical engineering technician or Healthcare Technology Management (HTM) certificate program that included an internship or apprenticeship; OR

0. Completion of biomedical engineering technician or HTM certificate program that did not include an internship AND 1 year of creditable experience; OR

0. Hold or having ever held certification as a Certified Biomedical Equipment Technician (CBET), Certified Radiology Equipment Specialist (CRES), Certified Laboratory Equipment Specialist (CLES), or Certified Healthcare Technology Manager (CHTM). Continuous maintenance of certification is not required throughout Task Order.

0. 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.

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

0. 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 Digital Imaging and Communications in Medicine (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.

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

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

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

OR

1. Biomedical Engineer / Clinical Engineer

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

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

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

1. 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, Safe Medical Device Act (SMDA), and JC 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.

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

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

14. Evidence

The Contractor shall furnish qualified personnel as required by Task Order specifications to accomplish services required under this Task Order. The Contractor shall have evidence of training, certifications, experience, and other qualifications that is listed on their resume for their personnel performing work under the Task Order. NOTE: There may be additional specific education or experience requirements at the task order level. 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 Task Order services, the Contractor shall submit the required evidence of training certification, experience, and other qualifications to the COR or L-COR at the task order level. 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 Task Order or have not been approved by the COR or L-COR at the task order level to provide support. Evidence can be subject to validation by the L-COR.

14. Staffing Plan

Contractor shall provide resumes of proposed Task Order personnel. Selection of Task Order personnel to VA sites must be approved by designated VHA personnel before arrival and onboarding of credentials.

Contractor shall provide minimal notice of 72 hours to designated L-CORs of personnel removal or swap out/exchange for government to reassign work associated with contracted individuals.

Earliest billing of Task Order services can occur after creation of an active VA email and some method to access VA email (Virtual Desktop/Remote Access, etc). Exemptions can be applied through the L-COR, if needed, depending on the situation presented (e.g., contractor personnel working with a temporary ID while PIV is being processed).

Contractor shall assist Task Order personnel with navigating VHA onboarding process.

14. 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 Task Order 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.

1. Badging and Security

Contractor personnel working under this Task Order are required to be fingerprinted and have 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 must be initiated through the COR for this IDIQ contract or the L-COR for a specific TO.

Contractor personnel working under this Task Order are required to obtain a VHA government email account prior to commencement of work.

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

Contractor personnel providing networked medical system management services under this Task Order shall apply and be granted elevated privileges through Electronic Permission Access System (ePAS) within 150 days of the commencement of work under this Task Order.

All Contractor personnel working under this Task Order, requiring on-site access, shall always 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 L-COR. The VA facility will not invalidate or make reimbursement for any parking violations of the Contractor under any conditions. Smoking is prohibited inside any building 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.

1. Contractor Performance

Contractor performance will be monitored by the L-COR. Completed assignments will be reviewed and discussed with the L-COR. Incomplete or pending work orders, planned maintenance assignments, and other assigned tasks will be reviewed during 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 Task Order using the method of surveillance specified in Table 3: Quality Assurance Surveillance Plan. All surveillance observations will be recorded by the Government through 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

1. Information Security/Privacy for Inclusion into Task Orders

17.1 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.

17.2 Access to VA Information and VA Information Systems

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.

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.

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.

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.

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.

17.3 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 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.

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.

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.