SON.docx

Statement of Need VA Pittsburgh Healthcare System-University Drive University Dr C Pittsburgh, PA 15240 Synchrony Dysphagia Solutions

1. Background

1.1. The VA Pittsburgh Healthcare System (VAPHS) requires two (2) Synchrony Dysphagia Solutions units with accessories noted below for the Surgical Speech Pathology Department. Two (2) deliveries will be needed, one (1) at the University Drive campus and one (1) at the H. John Heinz III campus. These units are needed for dysphagia treatment of patients targeting improvement of the muscles used for swallowing utilizing non-invasive surface electromyography (sEMG) which has been shown to facilitate faster learning and skill acquisition. Successful dysphagia treatment intervention will significantly improve patient quality of life.

2. Requirement

2.1. Salient characteristics

2.1.1. Visualizes swallowing activity using virtual reality sEMG feedback.

2.1.2. Provides visual and auditory feedback for Speech Language Pathologists and patients to facilitate swallow behavioral changes.

2.1.3. Utilizes patterned electrical neuromuscular stimulation (PENS) to enhance patient neuromuscular control.

2.1.4. Captures objective data for real-time assessment of treatment effectiveness.

2.1.5. Provides swallowing data and interactive exercise activities are displayed on a color monitor using specialized computer software

2.1.6. Omnistim FX2 Portable

2.1.6.1. 2 channels of programmable stimulation with PENS and Transcutaneous Electrical Nerve Stimulation (TENS) programs

2.1.7. OMNIsEMG surface electromyography (sEMG) biofeedback system

2.1.7.1. Virtual reality augmented biofeedback rehabilitation unit

2.1.7.2. Facilitate relaxation of tense or hypertonic muscles

2.1.7.3. Discriminate among different types of muscle activity

2.1.7.4. Differentiate effects of posture or other variables on muscle activity

2.1.7.5. Learn new behaviors

2.1.7.6. Learn unfamiliar behaviors

2.1.7.7. Learn behaviors difficult to conceptualize or identify under normal circumstance

2.2. Responsibilities

2.2.1. All equipment will be new and not refurbished.

2.2.2. Vendor to provide on-site device set-up and clinical training in the location and at time(s) designated by VA Pittsburgh COR representative.

2.2.3. Vendor representative to inspect equipment for condition, functionality and supporting hardware.

2.3. Technical Specifications

2.3.1. OMNIsEMG Transmitter/Sensor

2.3.1.1. Geometry

2.3.1.1.1. Variable

2.3.1.2. Electrodes

2.3.1.2.1. Standard sensing electrode with clip connection

2.3.1.3. Battery

2.3.1.3.1. Rechargeable lithium ion

2.3.1.4. Dimensions

2.3.1.4.1. 17mm x 36mm x 8mm

2.3.1.5. Weight

2.3.1.5.1. <9g battery included

2.3.1.6. Frequency

2.3.1.6.1. ISM band 2.4GHz (standard IEEE802.15.4)

2.3.1.7. Input Impedance

2.3.1.7.1. >10G Ohms

2.3.1.8. CMMR

2.3.1.8.1. >110db @ 50-60Hz

2.3.1.9. Resolution

2.3.1.9.1. 16bit

2.3.1.10. Acquisition frequency

2.3.1.10.1. Up to 4KHz

2.3.1.11. Sensitivity

2.3.1.11.1. 1µV

2.3.2. OMNIsEMG Receiver/Dongle

2.3.2.1. Dimensions

2.3.2.1.1. 152mm x 82mm x 22mm

2.3.2.2. Weight

2.3.2.2.1. 240g

2.3.3. OMNIsEMG

2.3.3.1. Ambient conditions for operation

2.3.3.1.1. -20 ºC to +45 ºC

2.3.3.1.2. 50 to 80% Rh, non-condensing

2.3.3.2. Ambient conditions for storage or transportation

2.3.3.2.1. 0 ºC to +40 ºC

2.3.3.2.2. 50 to 80% Rh, non-condensing

2.3.3.3. Altitude

2.3.3.3.1. 0 to 2000M

2.3.3.4. Autonomy

2.3.3.4.1. Up to 24 hours with rechargeable battery

2.3.4. Table

3. Delivery Location

3.1. One (1) unit to be delivered to University Drive campus and one (1) unit to be delivered to H. John Heinz III campus to the following addresses:

3.1.1. University Drive campus address

Attn: Scott Deluisio 2A118 Pittsburgh VA Medical Center-University Drive University Drive C Building 1 Pittsburgh, PA 15240

3.1.2. H. John Heinz III campus address

Attn: Audiology and Speech-Language Pathology VA Pittsburgh Healthcare System H. John Heinz III campus, Building 71, Room 1C158 1010 Delafield Road Pittsburgh, PA 15215

3.1.3. Delivery should be coordinated with the COR of the contract prior to shipping of any equipment

3.2. The Contractor must comply and provide all necessary information to VAPHS. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government.

3.3. Normal business hours for acceptance of deliveries are 8:00am-15:30pm, Monday thru Friday excluding Federal Holidays. Deliveries must be coordinated in advance with COR once a ship date is established. The COR, Biomedical Engineering and/or Logistics Representative shall be the only VA entity signing for freight received on this requirement. The VA-issued purchase order number must be included in the packing slip. All items included in the requirement shall be shipped and delivered to site at same time. If deliveries must be broken into several shipments due to size, this must be coordinated in advance with the COR. Failure the coordinate shipment with COR, may result in failure to deliver on site and cause re-scheduling of delivery/freight at no charge to the government. The packing slip must include the VA-issued purchase order number

4. Training

4.1. Any training scheduled should be coordinated with the COR and VA staff.

5. Additional Charges

5.1. There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts or installation. There will be no additional charges for time spent assembling the bladder scanners. There will be no additional charges for any time spent on-site provided training to either clinical or technical staff. There will be no additional charges with the waste management protocol listed in section 8.

6. Packaging Waste management

6.1. Contractor shall remove packaging materials and all shipping debris from site and dispose of at appropriate recycling facilities. Contractor shall collect and separate for disposal all paper, plastic, polystyrene, corrugated cardboard, packaging material in appropriate bins for recycling on site if available. Contract shall fold metal and plastic banding, flatten and place in designated areas for trash.

7. Influenza Vaccination

7.1. VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical, and administrative, paid, and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VAPHS.

7.2. Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

7.3. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

7.3.1. Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination.

7.3.2. Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine.

7.3.3. The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer’s Representative (COR) that all contract staff performing services at VA facilities follows VHA Directive 1192.

8. HIPAA Training Certificates

8.1. If Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the COR listed in the awarded contract.

9. Tobacco

9.1. All VA Pittsburgh property is tobacco free. Contractor personnel will comply with VA Pittsburgh tobacco and smoking policies. Violations will result in a warning and possible citation.

10. COVID-19 Related Policies

10.1. Upon entering VAPHS, 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 VAPHS.

10.2. 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.

11. Vendor Credentialing

11.1. Vendor access to the VAPHS is by appointment only and requires credentialing through our vendor credentialing partner, Symplr at https://vcsdatabase.com/login Symplr registration is at cost to the vendor only and VAPHS is not responsible for this.

11.2. All vendors are required to check-in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (HJH) and obtain a day badge, which will include date, time, and location of approved appointment. Company badge with photo ID is also required to be worn while onsite at any of the VAPHS sites. Vendors are only permitted to visit the location identified on their Symplr generated badge and must exit the facility promptly, checking out via their smart phone once the scheduled appointment has ended.