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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 22, 2018 FBO #5963
DOCUMENT

65 -- Houston VA Equip: Iovera Health System Handpiece VA256-18-AP-5065 - Attachment

Notice Date

3/20/2018
 

Notice Type

Attachment
 

NAICS

541714 — Research and Development in Biotechnology (except Nanobiotechnology)
 

Contracting Office

Department of Veterans Affairs;Southeast Louisiana Veterans HCS;1555 Poydras Street;New Orleans LA 70112
 

ZIP Code

70112
 

Solicitation Number

36C25618Q9255
 

Archive Date

5/19/2018
 

Point of Contact

Winston P. Graber Jr.
 

E-Mail Address

n.graber@va.gov<br
 

Small Business Set-Aside

N/A
 

Description

Department of Veterans Affairs Memorandum Special Notice This is not a request for proposal or a request for quote. There is no solicitation documentation available Under F.A.R Part 6.302-1. This is a notice of intent; The Houston Veterans Health Care System intends to negotiate a sole source firm fixed price contract with Myoscience located at 46400 Fremont Blvd., Fremont CA., 94538. which is the sole source provider of Iovera Health system handpiece and accessories. The statutory authority for the sole source procurement is 41 U.S.C.253(b)(c). Oral communications are not acceptable in response to this notice. Interested parties may identify their interest and capability to respond to this requirement no later than Mar. 28, 2018, @ 10:00 PM CST. Responses must be in writing and must provide clear and concise documentation, indicating an offerors ability to meet the required services. Responses will be emailed to winston.graber@va.gov. Emails are not to be in the excess of 5MB. Prospective offerors shall complete electronic annual representations and certification at http://orca.bpn.gov, shall be registered in the Central Contractor Registration (CCR) database at http://www.ccr.gov prior to award of a contract. STATEMENT OF WORK/DESCRIPTION OF WORK GENERAL INTENTION Contractor shall furnish all labor, materials, parts, equipment, tools, transportation, and supervision to provide, install at the Michael E DeBakey VA Medical Center, 2002 Holcombe Blvd, Houston, Texas 77030. The Contractor shall provide all necessary training to the designated VA employees on how to use the installed equipment/products after the installation and setup were complete. All equipment shall be brand new, and all work shall be done in a first-class manner. The contract price shall be firm-fixed, all-inclusive not limited to specified products/equipment, installation, setup/configuration, and training on how to use the installed products/equipment. CONTRACT REQUIREMENTS MEDVAMC would like to acquire Purchase 4 each Iovera ° health system handpiece* and accessories 1-year warranty, 4 each Iovera ° 307 Smart Tips, 5-Pack 3 x 6.99mm and 4 each Iovera ° Cartidges*, 10-pack. These items are intended for use by the Anesthesiology Care Line Regional Anesthesia Team to perform cryotherapy nerve blocks for patients scheduled for knee replacement surgery. Item # Description/Part Number* Qty 1 iovera ° health system handpiece* and accessories 1-year warranty qty. 4 2 iovera ° 307 Smart Tips, 5-Pack 3 x 6.99mm qty. 4 3 iovera ° Cartidges*, 10-pack qty. 4 Specifications iovera ° system Compact and cordless, the iovera ° system is operated with single push-button control to deliver a precise, minimally invasive treatment. Handpiece mass: 250g (.55 lbs.) Charging dock mass: 225g (.50 lbs.) IPX0: no protection against ingress of fluids Type of Refrigerant Used: Nitrous Oxide (N2O) Power Requirements: Input 100-240 VAC 50/60 HZ, 0.35 0.2 A Internal Battery (not serviceable): 3.7V 3100mAh Indications for Use (FDA): The Myoscience iovera ° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The iovera ° system is not indicated for treatment of central nervous system tissue. Safety Information: Temporary site-specific reactions include bruising (ecchymosis), swelling (edema), inflammation and/or redness (erythema), pain and/or tenderness (including headache), and altered sensation (localized dysesthesia). JUSTIFICATION FOR SINGLE SOURCE AWARDS IAW FAR 13.106-1 (OVER MICRO-PURCHASE THRESHOLD($3K) BUT NOT EXCEEDING THE SAT ($150K)) IAW FAR13.104, COs must promote competition to the maximum extent practicable to obtain supplies and services from the source whose offer is the most advantageous to the Government, considering the administrative cost of the purchase. When competition is not practicable, IAW FAR13.106-1(b), COs solicit from a single source for purchases not exceeding the simplified acquisition threshold. COs may solicit from one source if the CO determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). IAW FAR13.106-3(b)(3),COs are required to include additional statements explaining the absence of competition (see 13.106-1 for brand name purchases) if only one source is solicited and the acquisition does not exceed the simplified acquisition threshold (does not apply to an acquisition of utility services available from only one source) or supporting the award decision if other than price-related factors were considered in selecting the supplier. This template when completed can be used to document single source awards IAW FAR13.106-3(b)(3). Note: Statements such as "only known source" or "only source which can meet the required delivery date" are inadequate to support a sole source purchase. PURCHASE REQUEST OR REQUISITION NUMBER: 580-18-2-167-0057 1A. PROJECT/TASK NUMBER None 1B. ESTIMATED AMOUNT: 24,598.00 2. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE: Anesthesiology Care Line would like to purchase 4 each Iovera ° health system handpiece* and accessories 1-year warranty, 4 each Iovera ° 307 Smart Tips, 5-Pack 3 x 6.99mm and 4 each Iovera ° Cartidges*, 10-pack. These items are intended for use by the Anesthesiology Care Line Regional Anesthesia Team to perform cryotherapy nerve blocks for patients scheduled for knee replacement surgery. 3. UNIQUE CHARACTERISTICS THAT LIMIT AVAILABILITY TO ONLY ONE SOURCE, WITH THE REASON NO OTHER SUPPLIES OR SERVICES CAN BE USED: The Iovera ° health system is the only known device on the market capable of delivering a controlled dosage of liquid nitrous oxide by use of the Smart Tip to a specific targeted nerve. 4. REASON THAT SUGGESTED SOURCE IS THE ONLY SOURCE, WHICH CAN PROVIDE THE SUPPLIES OR SERVICES: The Iovera health system is the only nerve block device on the market capable of performing cryotherapy nerve blocks. There is only one supplier on the market for the Iovera ° health system handpiece* and accessories. The supplier is ( Myoscience ) 5. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND RESULTS OR STATEMENT WHY IT WAS NOT CONDUCTED: Actions taken to conduct market research, information obtained. a. Name, title, organization, and contact information of the individual(s) conducting market research: Lance D. Peet, Administrative Officer Anesthesiology Care Line and Dr. Edmund Ho, Deputy Executive Anesthesiology Care Line. Michael E. DeBakey VAMC, Houston, TX Tele: 713-791-1414 ext. 26410 b. Date(s) market research conducted: October 2016 to Present c. Companies/organizations contacted as part of our market research (including names, titles, and contact information): GSA Advantage, Internet, Vendor demonstrations, d. Technique(s) used to conduct market research (e.g., review of product catalogs, database queries, NASA SEWP Manufacturer Look-Up): review of product catalogs, GSA Advantage, Vendor Demonstrations e. Conclusion No, there are no products available to meet the needs on open market and no GSA is not an option with the supplied vendors. The monitors are on DAPA Contract SP0200-07-H-0034 but not on any other contract. 6. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Signature: ______________________________ Date: 3-19-2018 Name: Winston P. Graber Jr. Title: Contracting Officer Facility: Houston VA Medical Center (580)
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/NOrVAMC/VAMCCO80220/36C25618Q9255/listing.html)
 

Document(s)

Attachment
 

File Name: 36C25618Q9255 36C25618Q9255.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4164316&FileName=36C25618Q9255-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4164316&FileName=36C25618Q9255-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04860653-W 20180322/180320231304-24cb10ea10f9b813d07f24c013e897d4 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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