SOLICITATION NOTICE
65 -- FDA Approved Robotic-Assisted Navigational Bronchoscopy AMENDED
- Notice Date
- 6/30/2021 9:33:33 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 245-NETWORK CONTRACT OFFICE 5 (36C245) LINTHICUM MD 21090 USA
- ZIP Code
- 21090
- Solicitation Number
- 36C24521Q0591
- Response Due
- 7/7/2021 9:00:00 AM
- Archive Date
- 07/22/2021
- Point of Contact
- brina.bolden@va.gov, Brina Bolden, Phone: 410-637-1511
- E-Mail Address
-
brina.bolden@va.gov
(brina.bolden@va.gov)
- Awardee
- null
- Description
- Robotic Surgical Platform for Bronchoscopy Procedures GENERAL INFORMATION: Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24521Q0591 Department of Veterans Affairs Maryland VAMHCS 10 North Greene Street Baltimore, MD 21201 DESCRIPTION/BACKGROUND: The Cardiothoracic Surgery Section and the Pulmonology Service have received approval to begin utilizing robotic surgery equipment to perform both therapeutic and diagnostic procedures as clinically indicated. As a result, the Medical Center is in need of a robotic surgery system that is FDA approved for use for both therapeutic and diagnostic bronchoscopy. The system is needed for advanced visualization of difficult to navigate airways and better precision biopsy. SCOPE OF WORK: The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to setup and configure FDA-approved robotic system approved for bronchoscopy procedures. Training to all clinicians who will be utilizing the system will also be provided. Contractor shall be responsible for proper disposal of all packing material and other unwanted items as a result of the installation. Delivery day/ time shall be coordinated in advance with the Medical Center. Installation and training day/ time shall also be coordinated in advance. The Robotic Surgical system must: Be FDA approved Allow for diagnostic and therapeutic bronchoscopy procedures, using both rigid and flexible endoscopes Must provide continuous vision with a dedicated camera and working channel Utilize single-use sheaths and scopes to decrease infection control risks Quote must include all carts, towers, controllers, sensors, generators, mounts, patches and tubing to be fully operational. Include minimum one-year warranty with extended warranty options 1. EQUIPMENT: The contractor shall provide all tools and equipment necessary to properly and safely perform the services set forth within this statement of work. This shall include, but is not limited, to all Personal Protective Equipment (PPE) which may be required for the work to be completed in a safe manner. 2. AREAS TO BE SERVICED: Baltimore VAMC 10 North Greene Street Baltimore, MD 20201 3. TASK FREQUENCY AND INSTRUCTIONS: This will be a single visit, be it a single day or multiple days, at the facility for a period sufficient to complete the work set forth in the scope of work. This visit is to be scheduled in advance with the BaltimoreVAMC s Biomedical Engineering department. Contractor shall check in with Biomedical Engineering prior to visitng the worksite. Service report shall be provided within 5 business days of work completion. Contractor shall submit all removable media to be used on a VA system to Biomedical Engineering for scanning with anti-virus software prior to use on the system. In the case of equipment turn-in, exchange, repair or replacement hard drives used by the VA shall be removed from the equipment and remain in possession of VA this includes loaned or rented equipment. 4. SPECIAL WORK REQUIREMENTS: None. PROPERTY DAMAGE: The contractor shall take all necessary precautions to prevent damage to any government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (i.e., trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the government, upon approval of the Contracting Officer. 6. ATTACHMENTS: None. 7. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS: The contractor's employees shall wear visible identification at all times while on the premises of the VA property. It is the responsibility of the contractor to park in the appropriate desig nated park ing areas. Information on parking is available from the VA Police-Security Service. The VA will not invalidate or make reimbursement for parking viola tions of the con tractor under any con ditions. Smoking is prohibited inside any buildings at the VA. Cellular phones and two way radios are not to be used within six feet of any medical equipment. Posses sion of weapons is prohibited. Enclosed containers, including tool kits, shall be sub ject to search. Violations of VA regulations may result in a citation answer able in the United States (Federal) Dis trict Court, not a local district state, or municipal court. Vendor shall comply with all COVID-19 precautions in place. To be eligible for award of a contract, vendor must be actively registered in the SAM database (http://www.sam.gov). Vendor is also required to complete representations and certifications found in the provision at 52.212-3, Offeror Representations and Certifications - - Commercial Items. Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24521Q0591. Questions regarding this solicitation must be made in writing to the Contract Specialist, Brina Bolden at brina.bolden@va.gov, and must include the solicitation number 36C24521Q0591 on the subject line or the cover sheet. NO TELEPHONE REQUESTS OR INQUIRIES WILL BE ACCEPTED. Submissions for all RFI questions must be received by 12:00 PM, Friday, July 2, 2021. B.2 PRICE/COST SCHEDULE ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 0.00 __________________ __________________ The Robotic Surgical for Bronchoscopy Procedures MUST BE: 1. Be FDA approved 2. Allow for diagnostic and therapeutic bronchoscopy procedures, using both rigid and flexible endoscopes 3. Utilize single-use sheaths and scopes to decrease infection control risks 4. Quote must include all carts, towers, controllers, sensors, generators, mounts, patches and tubing to be fully operational 5. Include minimum one-year warranty with extended warranty options 0002 0.00 __________________ __________________ Delivery and Installation GRAND TOTAL __________________ B.3 DELIVERY SCHEDULE ITEM NUMBER QUANTITY DELIVERY DATE 0001 0.00 0002 0.00
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/5708581a4414427590182db44cc10786/view)
- Place of Performance
- Address: Department of Veterans Affairs VAMC 10 N Greene St, Baltimore 21201
- Zip Code: 21201
- Zip Code: 21201
- Record
- SN06048149-F 20210702/210630230118 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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