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

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 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 corrective and planned maintenance, professional Biomedical Engineering services, and project management work. Contract resources may be required to accomplish routine operational tasks (e.g. maintenance, patient safety recall investigation), as well as unexpected or time-limited tasks (e.g. COVID-19 pandemic support, operational readiness services for Office of Electronic Health Record Modernization (OEHRM)/Cerner deployment). There are many competing priorities for Biomedical Engineering staff in today’s environment, and the support services shall provide interim Biomedical Engineering services either onsite or remotely while full-time positions are recruited and hired to fill permanent roles in Biomedical Engineering departments, as needed. 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.

Successful offeror(s) may have to execute a Business Associate Agreement (BAA). Once a contract requiring a BAA is awarded, please contact the VHA Privacy Office BAA Issues team at VHABAAIssues@va.gov to assist in implementing the appropriate BAA.

These services are non-personal. Contractor personnel shall serve in a support role and do not make final decisions, approvals, or determinations on behalf of the Government. Contractor personnel are not subject to the supervision and control of a Government officer or employee in accordance with (IAW) FAR 37.201-2. Rather, Contractor personnel shall 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.

1. Period of Performance

The anticipated period of performance of this task order (TO) is September 20, 2021 – September 19, 2022.

1. Place of Performance

This is a nationwide contract to include Continental United States (CONUS) and Puerto Rico for all VA medical centers and outpatient clinics where Biomedical Engineering currently provides support. 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 modification to the contract.

1. Hours of Performance

Normal working hours will range between 7:00 AM to 5:00 PM, Monday through Friday, excluding federal holidays, although there may be some working-hours flexibility. This will be further defined in each task order. Occasional overtime may be needed and will be billed at the agreed rate. Contractor hours will be monitored by the L-COR and verified prior to billing and payment.

1. Travel

Some tasks may require travel; authorized travel will be identified at the task order level. This travel must be pre-approved by the Local Contracting Officer’s Representative (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. 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 contract as well as for each task order to address contract/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 contract 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 contract 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 contract. Medical equipment covered under the manufacturer’s warranty or covered under a service contract with another vendor is excluded from this contract. The Government retains the right to add or subtract equipment as needed, and this will be done via a modification to the contract.

1. Services Overview

At a high level, the tasks within the requirement include planned maintenance; corrective maintenance; and professional services for the technology assessment, implementation, and sustainment of medical devices and clinical systems, as well as healthcare consulting/internal operation support regarding medical equipment 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/contract 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 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 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.

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. For example, drafting the scope or preliminary design of a space to prepare it for medical equipment to be installed.

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 (ACL). 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 include 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 Operations & Maintenance (O&M) plan and maintenance standard operating procedures. Establishing inventory record(s) and assigning maintenance schedule(s) for new equipment.

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. Includes tasks such as adjusting, calibrating, lubricating, cleaning, and replacing parts. Includes electrical safety inspection and testing. Includes testing the resiliency of medical systems infrastructure and fault tolerance testing. Includes visual inspection. Includes overhauls that are extensive replacing or rebuilding of system components (separate from upgrades).

Technology Sustainment - Corrective Maintenance

GENERAL REPAIR

Work performed on equipment to restore to clinical operation. Generally, hardware related. Restore physical integrity, safety, and/or performance of a device/system after a failure. This work typically includes troubleshooting and determination of the actions to complete the necessary repair(s); researching and determining necessary replacement parts; routine purchasing procedures; receipt of parts; completion of repair; and any intra-facility travel associated with pickup or return of equipment. Includes problem identification and resolution of medical systems servers that is primarily hardware related (may include incidental running of software routines, reloading software, or connectivity assessment that is incidental to the hardware resolution).

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, network port security, telecommunications, patch cable problems, Health Level 7 (HL7) 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.

FABRICATION/ MODIFICATION

Work performed to design/create new equipment, assemblies, or apparatuses. Modification that alters a device/system to improve performance, reliability, or safety, or to add new functionality.

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

8. 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

· 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

8. 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

· Performance and electrical safety testing

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

8. 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 contract 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).

· 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.

· 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 Biomedical Device Integration (BMDI) 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 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), 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).

8. Remote Support

Remote Biomedical Engineering support is a valuable, feasible and timely alternative to onsite work in order to fulfill healthcare technology management needs. Planned and corrective maintenance inherently cannot be performed remotely. However, the Contractor may be required to perform professional services remotely, except for hardware and software upgrades, implementations, and technical training and support, which require onsite attendance.

8. 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, COR or Contracting Officer. All test equipment used for services rendered as part of this contract 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 Contractor using test equipment with expired calibration certificates will not be accepted.

8. 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 contract, then the Contractor shall notify the L-COR of the exact parts or services that they require to complete the contracted work. The L-COR will process the procurement of any parts or vendor 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 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 will be determined by the L-COR and followed by each applicable facility, but some acceptable examples include email, conference calls, Contractor-provided portal, or VA Computerized Maintenance Management System (CMMS). Relevant work orders covered under this contract 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 Contractor shall confirm receipt of the work order within 1 business day.

· Scheduling – 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 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 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 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 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.

1. Work Environment

Work will be completed in the Biomedical Engineering department and patient care areas. Work will primarily be done inside well-lit, 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. Contractor personnel working near radiological equipment shall comply with VA radiation safety procedures. They may also be exposed to patient bodily fluids when working in patient care areas. Contractor personnel shall follow all applicable infection control protocols, including use of PPE, hand hygiene, and exposure reporting procedures, in accordance with VA facility policies. 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. Contractor personnel shall be familiar with VA facility emergency procedures including reporting incidents.

1. 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 follow local safety and infection control processes. These safety and infection control processes 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.

1. Contractor Key Personnel

13. 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

13. 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 contract.

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

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 contract.

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

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

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

0. Familiarity of networking principles and language (e.g., Access Control List (ACL), Transmission Control Protocol/ Internet Protocol (TCP/IP), and Virtual Local Area Networks (VLAN))

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

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

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

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

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.)

1. 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 contract.

1. 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.

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

1. 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.

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

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

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

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

2. 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 contract.

2. 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.

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

2. 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 and interfaces 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,…