6515--Brand Name or Equal to QUALISYS - Markerless Motion Capture System. Unrestricted

STATEMENT OF WORK INTRODUCTION: The Department of Veterans Affairs, Veterans Health Administration (VHA), Corporal Michael J. Crescenz VA Medical Center, (CMCVAMC), CREATE Motion Center (Cartilage Regeneration Using Advanced Technologies To Enable Motion) located at 3900 Woodland Avenue, Philadelphia, PA 19104, has a Brand Name or Equal to requirement for a Markerless Motion Capture System that will facilitate patient diagnosis, treatment, and health outcomes of those experiencing arthritis, joint injuries, and other joint related disorders. The CReATE Motion Center is a newly funded research center focusing on developing new clinical therapies to treat patients who have the aforementioned conditions. In particular, knee osteoarthritis is a prevalent condition in the veteran population, and it is estimated that 33% of the veterans across the country endure the condition which causes limited mobility, pain, and is the number 1 reason leading to knee replacement surgery. Cartilage damage and progressive osteoarthritis exist along a spectrum, and our new CReATE Motion Center is focused on addressing this spectrum of disease through development of novel technologies and clinical interventions. The overall goal is to preserve cartilage and joint motion in veterans with early-stage disease, and to repair/replace cartilage and restore motion in late-stage disease. The Markerless Motion Capture System will aid our research team in testing the impact of novel therapies on motion in our study participants with arthritis, and aid in prognosis development, specialized care delivery, and motion restoration. BACKGROUND: Markerless Motion Capture is a newer technology that uses advanced video cameras, motion sensors, and 3D computer imaging to identify and capture human joints and limbs while monitoring movement. The cameras will be mounted 4 10 feet above the ground and be secured by wall mounts. The technology has advanced our ability to capture intricate motion details as the need for precise motion analysis will help healthcare providers offer tailored care for patients experiencing knee pain, mobility issues, and cartilage loss. Markerless Motion Capture is a newer alternative to measure the impact of joint disease on mobility and joint motion. Commonly used imaging modalities (i.e., x-rays, MRIs) measure joint damage, but do not tell the entire story. Specifically, these imaging modalities are limited in their ability to measure the impact of joint damage on the patient,as they rely on conventional methods of diagnosing joint and cartilage disorders which do not identify and address the specific problems that the patient is experiencing. Markerless Motion Capture will allow the research team to use a precision-medicine approach to tailor unique patient care delivery to outcomes patients care about (mobility), instead of using a one-size fits all model for patient diagnosis and treatment. Witnessing patients move in real-time while in the motion capture area will enhance our abilities to pinpoint the problem, evaluate pain and walking motion, measure clinically-relevant outcomes, and repair movement dysfunction. Importantly, using the technology will help providers and researchers track rehabilitation progress and evaluate the progression of knee disorders (and other disorders that hinder movement). While the patient is walking/moving in the capture area, multiple cameras will detect their movement and acceleration using 3D technology. The cameras will capture and transmit motion data to the computer for which scientific data and calculations will be produced and used for data analysis that will facilitate the understanding of physical health, how effective treatments are, and ultimately inform treatment plans. INFORMATION SECURITY INFORMATION: The Markerless Motion Capture System (Mocap) operates using its own computer that will run independent of the VA network. The captured data is streamed to the Mocap computer which will be setup in the CMCVAMC s Physical Therapy gymnasium (Building 1 A239). The cameras connect directly to the Mocap computer so that data can be secured properly. The computer having access to the internet would be ideal, but it is not critical for the system to function. The data is then processed via software that turns the digital videos into a series of 3D positions corresponding to specific body parts (i.e. joints). The data is streamed to the Mocap computer where patient data will be analyzed. We plan to transfer the de-identified data captured from the Mocap system using VA Box or TRM approved flash drives as the primary plan. Since our research studies are occurring at the Medical Center, data will not leave the facility, and will be transferred to our Research R Drive as soon as data leaves the Mocap computer. There are no currently active research studies using this technology inhouse, but we plan to submit studies to the Institutional Review Board upon installation of the system. More specific information security information will be found in the IRB Application (Section 11) for any projects that will use the Mocap system. PRIVACY/HIPAA INFORMATION: The primary use of the system is going to be for VA patients with knee osteoarthritis enrolled in IRB-approved research studies. The capture view is governed by the location of the cameras and their lenses. Data will be collected from a series of digital video cameras. These processed data files will be linked to the participant identifier which will be de-identified (i.e., Subject 01). There will be no HIPAA identifiers used while conducting our studies. We will keep the file linking the subject code with the participant s PHI on the VA network, in particular, the Research R Drive where only those involved with the study will have access. More specific privacy information will be found in the IRB Application (Section 11) for any projects that will use the Mocap System. DELIVERY SCHEDULE: Delivery of required services and deliverables shall be coordinated between the Contractor and the COR. Delivery Instructions: Deliver to the CMCVAMC warehouse Department. 3900 Woodland Ave Philadelphia PA 19104. Deliver material to job in manufacturers original sealed container with brand name marked thereon or maintain coverings in place and in good repair. PO# must be on the outside of the shipping box for easy identification. Delivery Days are Monday through Friday during normal business hours which are defined as 7:30am to 3:00pm. National Holidays are excluded. Any delivery service performed for emergency orders may be delivered other than normal business work hours and must be approved. The Contractor is not required to provide delivery services on the following National Holidays, nor shall the Contractor be paid for these Holidays and any other declared national holiday by the President. HOLIDAY New Year s Day Martin Luther King s Birthday President s Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Other special requirements or situations: If for any reason the scheduled time for a deliverable cannot be met, the contractor is required to formally explain (include the original deliverable due date) in writing to the COR (Contracting Officer Representative) and CO (Contracting Officer) the justification for late delivery. The formal document shall include a firm commitment of when the work shall be completed. This notice to the COR and CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response in accordance with the FAR. INSTALLATION/TRAINING Training and installation is requested, and this will take place at the Medical Center, with staff, on consecutive days. Installation and training is as quoted on Page 2 of the sales quotation WARRANTY Vendor provides a warranty to protect its customers from defects in product workmanship or production materials. The warranty covers all products manufactured by the vendor. The vendor warrants that the equipment purchased will be from defects in material and/or workmanship under normal operating conditions for a period of 24 months from the date of shipment. For warranty accessories the vendor is an approved reseler lof the devices as listed within this quotation. All device orignals manufacturer s warranty is passed through to the customer as offered by the device manufacture. Additional support, service and extended warranties can be purchased directly frm the device provider CUSTOMER SUPPORT The contract covers technical support by e-mail or telephone, downloads of QTM software upgrades, support on issues with all vendor hardware and upgrades on firmware. Vendor undertaking does not include any installation or implementation services in connection with supply of patches, upgrades/new release or any other services or cost, related to installation procedures or use of hardware or software. Additional documentation is available on contracts. CHANGES TO STATEMENT OF WORK Any changes to this SON shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of contractor s staff, sub-contractors, and all other parties other than the CO shall be the responsibility of the contractor. Smoking All VA Philadelphia property is smoke-free. Contractor personnel will comply with VA Philadelphia smoking policies. Violations will result in a warning and possible citation. COVID-19: Upon entering CMCVAMC, per CDC and federal regulations, all personnel must wear the required PPE while on-site; at a minimum this includes a cloth mask. PPE will not be provided by CMCVAMC. All individuals are required to enter through the main entrance for temperature screening. If Contractor s temperature exceeds the designated threshold, they will be asked to leave. In the event of an FSE being forced to vacate the premises, they shall notify the necessary Biomedical Engineering staff and provide a contact for a replacement.