65-- Cypass Micro Stents

Chapter VI: Other Than Full and Open Competition (OFOC) SOP Attachment 4: Single Source Justification for SAP under $150K OFOC SOP Revision 05 Original Date: 03/22/11 Revision 05 Date: 05/02/2016 Page of 2 JUSTIFICATION FOR SINGLE SOURCE AWARDS IAW FAR 13.106-1 (OVER MICRO-PURCHASE THRESHOLD($3.5K) 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. 1. ACQUISITION PLAN ACTION ID: VA250-17-AP-7719 1A. PROJECT/TASK Number: Not Applicable 1B. ESTIMATED AMOUNT: $32,030.00 2. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE: This acquisition is to purchase 4 boxes containing five (5) Cypass Micro Stents per box (MPN): 8065754003. The requested item is used during Glaucoma Surgery and is implanted into the patient s eye. Delivery is required on or before April 24, 2017. 3. UNIQUE CHARACTERISTICS THAT LIMIT AVAILABILITY TO ONLY ONE SOURCE, WITH THE REASON NO OTHER SUPPLIES OR SERVICES CAN BE USED: With the FDA approval of the iStent®, Micro-Invasive Glaucoma Surgery (MIGS) became a preferred approach to glaucoma management for many eye care professionals and their patients with mild-to-moderate glaucoma. Performed at the time of cataract surgery, iStent® has proven to be effective in decreasing IOP, with an excellent safety profile, few complications, and fast recovery time. iStent® reduces the patients need for medications. Other benefits associated with this innovative treatment include: Minimally traumatic to delicate eye tissue Effectively lowers IOP Excellent safety profile Rapid recovery time The iStent is proprietary to Alcon Laboratories, Inc. and is currently the manufacturer and sole distributor of the product. It has been determined by the clinical team to be the best product to treat the Veteran patient s medical condition and functional limitations. Substituting an implant with other than that specifically prescribed is detrimental to the treatment of the Veteran patient. 4. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND RESULTS OR STATEMENT WHY IT WAS NOT CONDUCTED: Market Research was conducted based on the medical determination described within this single source justification and there are no SDVOSB/VOSB located under the NAICS Code 339113 that are authorized to distribute or sell this product. The time constraints associated with this emergent / special procurement did not allow for extensive market research. However, the market will continue to be monitored in the item is required in the future. 5. 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. Note: COs are required to make a determination of price reasonableness IAW FAR 13.106-3. See the Commercial Supply and Service SOP for Price Reasonableness templates. Michele R. Bartelt Digitally signed by Michele R. Bartelt 949984 DN: dc=gov, dc=va, o=internal, ou=people, 0.9.2342.19200300.100.1.1=michele.bartelt@va. Signature: 949984 gov, cn=Michele R. Bartelt 949984 Date: April 20, 2017 Date: 2017.04.20 16:46:24 -04'00' Name:Michele R. Bartelt Title: Contracting Officer NCO: 10