SPECIAL NOTICE
W -- Monarch Robotic Bronchoscopy Platform Lease
- Notice Date
- 12/9/2021 7:35:10 AM
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 246-NETWORK CONTRACTING OFFICE 6 (36C246) HAMPTON VA 23667 USA
- ZIP Code
- 23667
- Solicitation Number
- 36C24622P0351
- Archive Date
- 12/14/2021
- Point of Contact
- John P Harmsen, Contract Specialist, Phone: 757-315-3978
- E-Mail Address
-
john.harmsen@va.gov
(john.harmsen@va.gov)
- Awardee
- null
- Description
- Sole Source Justification PM Part 813.5 SAP for Certain Commercial Items Page 1 of 9 Original Date: 08/30/17 Revision 03 Date: 02/11/2021 DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: 36C246-22-AP-1020 Contracting Activity: Department of Veterans Affairs, VISN 06, Western North Carolin VA Healthcare System, Charles George VA Medical Center 637-22-1-109-0288 $336,079.95 Nature and/or Description of the Action Being Processed: This acquisition is a new requirement for the lease of the Monarch Robotic Bronchoscopy System. The contract type will be Firm-Fixed Price, Indefinite Delivery Indefinite Quantity contract. Description of Supplies/Services Required to Meet the Agency s Needs: Robotic System for Rigid and Flexible Therapeutic and Diagnostic Bronchoscopy, with Continuous Vision (FDA-Approved) Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below: ( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Monarch Robotic System for Rigid and Flexible Therapeutic and Diagnostic Bronchoscopy, with Continuous Vision (FDA-Approved) is the only unit that does both therapeutic and diagnostic bronchoscopy. The Monach Bronchoscopy system allows for high accuracy navigation to a lung lesion and has the ability to stay securely in place for biopsies and treatment modalities . This unit will achieve a higher yield in biopsies (up to 97% from current rate of 60-70%). This will decrease the amount of second procedures and associated complications. Also this unit allows for ablation of tumors via the Navigation System s working channel, where Auris Health is currently the sole proprietor in the USA. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: There are two advanced Bronchoscopy systems: one is from Auris Health called Monarch and the competitor is from Intuitive call Ion. Both are similar in technology, but the Monarch is the only one that has ablation technology in their portfolio and offer a lease. Ion does not perform all the required tasks plus it would have to be purchased. The sales support team at Auris Health and Intuitive were contacted. Auris Health currently holds contracts at several VAMCs including Charleston SC, Pittsburgh, PA, and Washington DC and can provide ablation technology as part of the need for the system requirements. Intuitive was rejected as a possible source because it s ION system cannot provide ablation technology and limits acquisition methods and strategies to outright purchase without the option to lease the system, components, and periphials. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: When I compared the purchase history against the cost of the lease with considering the expense of the lease would be used to reduce the cost of the Monarch if VAMC Asheville decided to purchase the unit. The lease price is fair and reasonable. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A Vendor Information Pages (VIP) search of North American Industry Classification System (NAICS) code 339112 bronchoscopy didn t reveal any Service Disabled Veteran Owned Small Businesses (SDVOSB) or Veteran Owned Small Business (VOSB) that are authorized by the manufacturer to distribute this system and provide these items/services. Therefore, in accordance with VAAR Class Deviation 810.001-70, the Rule of Two can not be applied. There are two advanced Bronchoscopy systems currently on the open market: one is manufactured by Auris Health called Monarch and the competitor is from Intuitive called Ion. Both are similar in technology, but only Auris Health has ablation technology in their portfolio and offer a lease. Auris Health is the OEM of the Monarch System manufactured. Any Other Facts Supporting the Use of Other than Full and Open Competition: Lung cancer is the leading cause of cancer deaths worldwide. More patients die every year from lung cancer than from prostate, breast, and colon cancer combined. The majority of patients diagnosed with lung cancer do not survive, largely,in part, because the disease has often progressed to a more advanced stage at the time of diagnosis. Nodule location and size combined with technology limitations have made early-stage diagnosis of lung cancer challenging. With the ability for early detection of nodule location and size of the Monarch platform, and the reduced rate of pneumothoraxes requiring inpatient hospital stays after percutaneous biopsies, it is imperative to bring this capability into the medical center as soon as feasible. Due to the outright purchase cost requiring the acquisition to follow the lengthy Capital Investment Board (CIB) process, the CGVAMC seeks to lease the system for a base plus two option year contract with the intent to purchase the system once approval and funding has been approved. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Auris Health Inc A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Due to the proprietary, patent, and copywrite nature and costs associated with the equipment and support functions it requires, it is unlikely competition would be expanded in a reasonable period of time. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. Eric Apple December 7, 2021 Business Acquisitions Manager Charles George VA Medical Center Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: n Contracting Officer: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. John Harmsen Contracting Officer NCO 6 One Level Above the Contracting Officer: I certify the justification meets requirements for other than full and open competition. Jerry Mann Branch Chief Supply Team 3 NCO 6
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/fce1efb1f0354005a2733e0edc9e924f/view)
- Record
- SN06194610-F 20211211/211210201441 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |