Biomedical Engineering Technical Support Services_SOW.docx

STATEMENT OF WORK (SOW)

FOR

SUPPORT SERVICES

BIOMEDICAL ENGINEERING TECHNICAL SUPPORT SERVICES

NIH Clinical Center Biomedical Engineers contracting provide essential services to keep the Clinical Center (NIH Hospital) accredited: 1) for human care by The Joint Commission (TJC) 2) for laboratories performing testing on specimens from human beings or animals by The College of American Pathologists (CAP) 3) for blood bank safety to patients, donors, regulatory agencies by the Association for the Advancement of Blood and Bio-therapies (AABB).

The NIH Clinical Center requires contractor support to provide specialized Biomedical Engineering Technical Support Services necessary to sustain the Medical Equipment Program and ensure the safe, reliable, and compliant operation of medical and research equipment used throughout the Clinical Center. These services are essential to maintaining the availability and performance of complex biomedical instrumentation that supports patient care, clinical operations, and biomedical research. The position is essential for working with the Department of Clinical Research Informatics (DCRI) and the NIH Center for Information Technology (CIT) to conduct IT security reviews and meet compliance with HHS Cybersecurity standards. The Biomedical Engineer works with DCRI and CIT to review medical systems that connect to the NIH IT Network to ensure required security protocols are implemented and device function is not impeded. This includes providing an information technology (IT) maintenance strategy for life support and life critical equipment used in patient care.

This Biomedical Engineer contracting is needed for medical equipment selection and procurement that is appropriate for the scope of services provided by the Clinical Center and meets the needs of health care personnel, patients, and the IRB-approved study design methodology. The position facilitates translational clinical research by ongoing integration of current health care technology into patient care and performs surveillance activities by monitoring and responding to recalls, alerts and failures of medical equipment and meet reporting requirements for the FDA Safe Medical Devices Act. The contractor shall provide technical expertise for preventive maintenance, calibration, inspection, repair, installation, systems integration, engineering evaluation, and lifecycle management of medical equipment, as well as support the design, testing, and modification of specialized research instrumentation. Contractor support also includes maintaining required technical documentation, assisting with equipment acceptance testing, providing technical consultation and user training, and recommending equipment improvements to enhance reliability and operational efficiency. The biomedical engineer contracting is required to provide preventative maintenance and calibration records to sponsors of NIH protocols.

SCOPE

Under this task order, the contractor shall independently provide biomedical engineering technical support services to satisfy the operational objectives of the NIH Clinical Center Materials Management & Environmental Services Department (MMESD). Services shall support the Medical Equipment Program through inspection, preventive maintenance, repair, calibration, installation, modification, testing, documentation, and technical consultation for clinical and research medical equipment. The contractor shall furnish all personnel necessary to perform these services while remaining independent from Government supervision in accordance with FAR Parts 7.5 and 37.1.

ORGANIZATION

National Institutes of Health Clinical Center Materials Management & Environmental Services Department (MMESD) Biomedical Engineering Section

TASKS/SERVICES

The contractor shall:

· Perform preventive maintenance, inspection, calibration, safety testing, troubleshooting, repair, and functional verification of biomedical and research equipment.

· Support patient monitoring systems, telemetry, defibrillators, ventilators, dialysis equipment, laboratory instrumentation, nurse call systems, and other clinical devices.

· Analyze and resolve malfunctions involving analog, digital, electromechanical, and microprocessor-controlled medical equipment.

· Install, configure, relocate, integrate, and commission new medical equipment and verify compliance with manufacturer specifications and applicable safety standards.

· Develop conceptual designs, engineering sketches, wiring diagrams, and technical specifications for custom biomedical research instrumentation.

· Assist Government scientists and clinicians with evaluation, modification, and optimization of research instrumentation.

· Perform acceptance inspections and operational testing of newly acquired medical equipment.

· Maintain complete electronic work orders, maintenance records, calibration records, equipment histories, and engineering documentation.

· Prepare technical reports, recommendations, and engineering documentation supporting equipment lifecycle management.

· Provide user training and technical guidance regarding operation and safe use of medical equipment.

· Recommend replacement parts, inventory levels, equipment upgrades, and technology improvements.

· Coordinate with Government personnel and manufacturer representatives to resolve technical issues while providing recommendations only; all Government decisions remain inherently governmental.

DELIVERABLES

Upon request, the contractor shall provide documentation including:

· Preventive maintenance and repair records

· Calibration and electrical safety test documentation

· Acceptance testing reports

· Engineering drawings and design packages

· Technical evaluations and equipment recommendations

· Prototype test reports and modification documentation

· Training materials and attendance records

· Monthly activity summaries and equipment performance metrics

· Complete electronic work order documentation

CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED

· Bachelor’s degree in electrical, mechanical, biomedical, mathematical, physical engineering sciences from a college with ABET accreditation

· Minimum three years of biomedical equipment maintenance experience in a healthcare or research environment.

· Knowledge of medical equipment safety standards and biomedical test equipment.

· Strong analytical, organizational, oral, and written communication skills.

· Ability to lift up to 50 pounds and safely move medical equipment using carts or dollies.

PLACE OF PERFORMANCE

NIH Clinical Center, Bethesda, Maryland.

OPERATIONAL HOURS

Up to 40 hours per week, Monday through Friday, excluding Federal holidays, unless otherwise authorized.

SAFETY ISSUES

Work is performed in clinical, laboratory, shop, and office environments. Contractor personnel shall comply with infection control, radiation, electrical, and other applicable safety requirements and wear required PPE.

GOVERNMENT-FURNISHED EQUIPMENT

Government will provide workspace, computer, telephone, access to work order systems, and Government-owned test equipment as required.

SECURITY CLEARANCE

Work is Unclassified. Contractor personnel shall comply with all NIH security, privacy, and information protection requirements.

NON-PERSONAL SERVICES STATEMENT

Contractor personnel shall be supervised solely by contractor management. Contractor employees shall not perform inherently governmental functions, obligate Government funds, supervise Federal employees, establish Government policy, or serve in positions that create an employer-employee relationship with the Government.