STATEMENT-OF-WORK-vital signs monitor and software21-010513.docx

Statement of Work Vital Signs Monitors and Software Development

Statement of Work: Vital Signs Monitors and Software Development for the Center for Interventional Oncology 05/26/2021

TABLE OF CONTENTS

1.0 INTRODUCTION/OVERVIEW

The objective of this project is to develop a contactless vital sign monitor that reduces staff contact time required for vital sign acquisition by minimizing patient–clinician contact. The contactless sensor is mounted underneath a bed to continuously monitor vital signs (heart rate, respiration rate, and blood pressure) and motion activities (entry/exit of bed, movement, and posture changes).

1.1 BACKGROUND

The ability to assess patients remotely via wireless tools in an informal non-hospital setting has never been more relevant to public health as it is today in the midst of the COVID-19 pandemic. Such technology might also simultaneously address the risk induced by two well-documented patient outcomes with potential for increased morbidity and mortality: 1) patient falls through early detection of signal patterns that are able to predict those falls based upon deep learning models of a patient or person’s sleep patterns; and 2) pressure ulcers by monitoring prolonged lack of mobility using seismic motion sensors. As we struggle to define exit strategies for shelter in place, there is an opportunity for sensors linked to smartphones and personal technologies to better assess heart rate, respiratory rate, other vital signs and physiology readouts in a person under surveillance who might be asymptomatic and SARS-CoV-2 positive, or on home quarantine for disease symptoms not yet necessitating hospitalization, with its inherent transmission risks.

During a COVID-19 outbreak, it is possible for hospitals and point of care infrastructure to become severely overburdened. Temporary hospitals are often set up to treat the overflow of patients in hard-hit areas, but the problem of understaffing remains, as well as the risk presented to healthcare workers responsible for the immediate and regular assessment of patients, which often requires a face to face encounter, as well as use of PPE. Monitoring vital signs requires close patient contact during its setup and adjustment, therefore placing medical professionals at potential risk of contracting COVID-19.

The Clinical Center, Interventional Radiology Department and Center for Interventional Oncology in partnership with the National Cancer Institute and National Heart Lung and Blood Institute develops novel technologies for handling COVID patients.

This device and software are investigational tools for preclinical trials.

1.2 SCOPE

Requirements for the incumbent include development of a vital signs monitor and software.

1.3 OBJECTIVES

1. Develop prototypes for preclinical studies for vital signs monitoring using noncontact sensors.

· Prototype vital signs monitor QTY 10

· The sensor is completely contactless. Once installed on a bed, it will not need to be touched by staff or patient. Vital sign measurement will start as soon as the patient gets on the bed. This will drastically reduce the risk of cross-contamination.

· The sensor will continuously monitor vital signs, including HR (Heart Rate), RR (Respiratory Rate), and BP (Blood Pressure), and patient activity, including entry/exit of bed, time-on-bed, time-out-of-bed, number and duration of bed exits, bed restlessness, movements, and posture changes.

2. A software prototype that will:

· The vital sign data collected by the sensor can be displayed on a smart device outside the patient’s room or to a remote data center. This will reduce the amount of contact needed between staff and patient and will be particularly useful for isolation room/infection control room configurations and home quarantine.

· Because the sensor can detect bed exits, it can be configured to send alerts if a contagious patient leaves bed unattended.

· As the sensor detects patient activity, it can be used to prevent pressure ulcers by determining when patients need to reposition, either by themselves or with staff assistance.

2.0 REQUIREMENTS

2.1 TASKS:

12 Month Period of Performance 12 Month deadline 3 and 6 month Progress report

2.2 DELIVERABLES

Expected 12 months following award:

Data on prototype testing and any user information should accompany the prototypes. Dr. Brad Wood or his designee will evaluate all prototypes and approve them. At time of first testing, the Vendor will be on site.

2.3 SCHEDULE

Period of performance: 12 months request a warranty for repair or replacement of any component originally developed or installed by the vendor for 12 months after the system is delivered.

Place of performance: vendors lab and NIH Clinical Center 1N314 preclinical lab Milestones: Develop prototypes as described above

2.4 ASSUMPTIONS

• Effort: Development of these prototypes requires expert level understanding of sensing techniques for physiological monitoring. Must have experience developing and manufacturing prototype for preclinical applications. This may include using 3-D printing. Must have experience with computer software development and a knowledge of biosignal processing software commercially available.

• Schedule: 12-month schedule, with progress reports at 3 and 6 months. On site evaluation of prototypes

• Resources: A PhD in computer engineering and an assistant.

• Budget: The estimated cost of the project $ 86,000

3.0 GOVERNMENT FURNISHED PROPERTY

The vendor for this project will not receive Government owned property.

4.0 SECURITY REQUIREMENTS

The contactor staff must follow all security rules and regulations to gain access to the NIH campus including but not limited to:

1) Required to show one (1) form of identification (a government-issued photo ID-driver's license, passport, green card, etc.) and to state the purpose of their visit

2) Federal law prohibits the following items on Federal property: firearms, explosives, archery equipment, dangerous weapons, knives with blades over 2½ inches, alcoholic beverages and open containers of alcohol.

3) Vendor owned or rented vehicle must go through the Gateway Vehicle Inspection Station (Building 66A), and the vendor must obtain a visitor badge

4) Vendor must contact a Wood Lab staff member for access to the IRL

Award

Hardware: prototypes delivered Software delivered