36C24421Q0471 – Sources Sought – 6515–646-21-2-233-0124 | Storz OR1 NEO IP TAVR Suite Equipment Upgrade

Mar 19, 2021 | Sources Sought

Purpose and Objectives: The intent of this Sources Sought Notice #36C24421Q0471 is to identify any Small Businesses, mainly any SDVOSB/VOSB vendors who are capable of providing a Storz OR1 NEO IP TAVR Suite as listed in the attached Statement of Need. In addition, we are also seeking any Small Business manufacturers that have the capability of providing this system as well. Responses to this Sources Sought Notice should demonstrate the firm’s ability, capability, and responsibility to provide the principal components of supplies listed in the attached document. Responses should include the following information: Business name, address, Point of Contact, Service-Disabled Veteran Owned Small Business info. All information is to be submitted via e-mail at Louellen.Butler@va.gov. Information provided will not be returned. All responses shall be in the English Language. Responses are due by 01:00 PM (EST) on Wednesday, March 24, 2021. No submissions will be accepted after this date and time. Questions can be submitted electronically to at Louellen.Butler@va.gov. This is a Sources Sought Notice and submissions will be used for informational and planning purposes only. This notice does not constitute a formal Request for Quote (RFQ), nor is the government obligated to issue an RFQ. In addition, the Government does not intend to pay for any information provided under this notice. The Government is not obligated to notify respondents of the results of this survey.  

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STATEMENT OF WORK

VA Pittsburgh Healthcare System (VAPHS)

SCOPE OF WORK AND GENERAL SPECIFICATIONS FOR OR1 integration solution.

Background
VAPHS is upgrading Operating Room 11 to a new Hybrid suite and requires an upgrade to the current Karl Storz OR1 integration system. Karl Storz is the current vendor and OR1 is the current platform for all equipment integration.

Project Scope
Replacement of existing NEO Essential Integration System in VAMC Pittsburgh OR11 with NEO IP Integration System to integrate with Siemens Artis Hybrid system. The system includes StreamConnect Live Streaming node for connection to the StreamConnect content management system. The rack mounted NEO IP hardware will be installed in the existing data closet.

Specifications

NEO IP rack mounted OR Integration solution capable of routing SD, HD,
3D, and 4K signals.
IP network switch for custom configuration of up to 48 inputs/outputs
21.5 desk mounted Touch panel control of video/image routing and image
capture.
Display kit to connect Medical 4k Display 1
Display kit to connect Medical 4k Display 2
Display kit to connect existing 55″ Wall Displays
DVI kit to connect Siemens Artis -3 signal inputs/ 3 outputs
HDMI Computer input for PACS or Hospital provided PC
Aux 2n1 HDMI and Display Port 4k plate1
Aux 4n1 DVI, VGA, S-video and Composite plates
DVI computer input for ECG Hemo, Carto, and IVUS
Wireless microphone for video recording audio.
Ceiling mounted speakers for operating and control room
Encoders/ decoders for live streaming
Live streaming node for use with StreamConnect
1 Year Complete Warranty for all wall plates and cable kits to image/video
sources and displays

Training

Hands-On Training: The Project Manager will lead Hands-On Training sessions, using a hard copy tutorial that will reinforce the lessons learned during e-learning.
On The Job Training: The company support team will be available to support system usage during cases as well.
E-Learning: An on-line modular course that provides component and technology overviews, real world simulations and knowledge based testing. E-learning helps ensure that the OR team is ready to use all systems and equipment the day the surgical suite opens.
Assessment: Advanced administrative tools provided by the E-Learning course allows for easy tracking of progress and results for the group learning.
Training: The local team will be trained on the usage, technical aspects and first line of defense protocol.
Certification: Each team member who has successfully completed the training E-Learning course will receive a certificate of completion.

Technical training must be provided to Biomedical Engineering Staff
Contractor will provide (2) copies of user manual and (2) copies of service manual to the Biomedical Engineering department. VAPHS will follow guidance outlined in these manuals.
The unit must have onboard training showing proper use of the product.

Maintenance
The system must require no annual preventative maintenance according to the manufacturers specifications.

Warranty
The system must have at minimum a 1-year warranty

Assembly
The dedicated service technicians and Project Managers will be available on-site for the entire installation process.

Safety Data Sheet (SDS)
Contractor shall provide three (3) copies of each Safety Data Sheet for every product, chemical, etc. used on this project. SDS sheets shall be provided for any material on the same day those materials arrive on VA property. At no time shall the contractor have, or permit subcontractors to have, materials on station without SDS sheets. All instructions for use shall be followed. Products will not be used until SDS’s are submitted to the COR.

The contractor shall maintain a current, green in color, loose-leaf notebook on the job site at all times, which is readily available for viewing by the COR or VA Safety Officer.

Delivery Coordination

Normal business hours for acceptance of deliveries are 8:00am-3:30pm, 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

Additional Charges

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 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.

Packaging Waste management

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.

Estimates

In the quotes, vendors will indicate whether their solution has MET, NOT MET or MET WITH QUALIFICATIONS for each line item in this document (MET WITH QUALIFICATIONS will require a detailed listing of non-compliance). In addition, vendors will complete the Instructions to Offertory s (ITO) and respond in detail to each question. Vendors are required to respond to each item individually in both documents. Include the specification/question number and text in your response document to facilitate review.

Influenza Vaccination
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.

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.

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:

– 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.

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

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 is in compliance with VHA Directive 1192.

Tuberculosis Prevention

Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer.  Tests shall be current within the past year.

TUBERCULOSIS TESTING:  Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel.  A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results.  The PPD test shall be repeated annually.
RUBELLA TESTING:  Contractor shall provide proof of immunization for all contract personnel for measles, mumps, rubella or a rubella titer of 1.8 or greater.  If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the COR.
Please provide a signed memo stating that:
(number of assigned Key Personnel) assigned to VA Contract #___________ have tested negative for tuberculosis within the past 365 days.
(number of assigned Key Personnel) assigned to VA Contract #___________ have been immunized for measles, mumps, rubella or a rubella titer of 1.8 or greater.

HIPAA Training Certificates
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.
Tobacco
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.
Vendor credentialing:
Vendor access to the VA Pittsburgh Healthcare System is generally by appointment only and requires credentialing through our vendor credentialing partner, Symplr at https://www.symplr.com/. Symplr registration is at cost to the vendor.

All vendors are required to check in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (Heinz) and obtain a day badge which will include date, time, and location of approved appointment. Company badge with photo ID is also always required to be worn while onsite. Vendors are only permitted to visit the location identified on their badge and must exit the facility promptly, checking out via their smart phone, once appointment has ended.  
 
COVID-19 Related Policies
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.
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 Surgery Service staff and provide a contact for a replacement.
VAPHS is requesting vendor onsite activity be limited to patient care and mission critical purposes. The facility is recommending a negative COVID-19 viral test not more than 72 hours prior to presenting onsite for vendors who are required to be onsite. Exceptions include emergency service/repair vendors, urgent/emergent case OR /procedure reps, other urgent/emergent need vendors serving the facility who have not been tested within 72 hours. Negative test on day one is recommended each week for vendors reporting onsite daily to support mission critical functions. Vendors reporting previous positive COVID test with clearance by medical professional are not required to undergo testing.

Delivery Location:

VA Pittsburgh Healthcare System
University Drive C
Building 1
Pittsburgh, PA 15240-1001

Prior to delivery, Contracting Officer Representative and/or Business Manager shall receive shipping information from Contractor and forward to Logistics and Biomed using the emails listed above.

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.

Emailed response to Louellen.Butler@va.gov and received no later than 01:00 P.M. EST on Wednesday, March 24, 2021.
Point of Contact
Any questions or concerns regarding this solicitation should be submitted in writing to the Contracting Officer, via email to Louellen.Butler@va.gov.
End of Doc

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