LIMITED SOURCES JUSTIFICATION ORDER >$150,000 FAR PART 8.405-6 This acquisition is conducted under the authority of the Multiple Award Schedule Program. The material or service listed in par. 3 below is sole source, therefore, consideration of the number of contractors required by FAR Subpart 8.4 - Federal Supply Schedules, is precluded for the reasons indicated below. Restricted to the following source: Provide original manufacturer's name for material or contractor's name for service. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.) Manufacturer/Contractor: BioFire Diagnostics, LLC Manufacturer/Contractor POC & phone number: Ron Rohrer, Phone
+1 (555) 000-0000 Mfgr/Contractor Address: 390 Wakara Way, Salt Lake City, UT Dealer/Rep Address/Ph Number: Chris Foley, 390 Wakara Way, Salt Lake City, UT Phone
+1 (555) 000-0000 1 The requested material or service represents the minimum requirements of the Government. (1) AGENCY AND CONTRACTING ACTIVITY: Department of Veterans Affairs 940 Belmont Street________________ Brockton, MA 02301______________ VISN: 1 (2) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED: The Government owns seven (7) Film Array Testing Systems and currently pay FSS pricing for supplies and service maintenance with individual delivery orders per medical center, occasionally as an emergency requirement. BioFire Diagnostics, LLC currently holds a VA National Acquisition Center Contract Award V797D-30085, This request is per FAR 8.405-6 An FSS BPA for a base year + 4 annual option years is needed to receive discounted rates off FSS pricing for VISN 1 Network Consolidated Laboratory. The agreement would cover equipment maintenance (both emergency and Preventative Maintenance), Test Panel Kits for the BioFire Diagnostics Film Array PCR Testing System, and training for government personnel on-site once per year (at each site in VISN 1), as needed. (3) (a) A DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY'S NEED: 1. Film Array Respiratory Disease Panel Kit 2. Film Array Blood Culture Identification Panel Kit 3. Annual Service for Preventative Maintenance 4. Other testing kits should be added under this agreement to allow the Government to utilize other testing needs that may arise, due to direct patient care needs. a. 510K Meningitis/Encephalitis Panel, Launch Estimated September 2015 b.BioThreat-E, Emergency Use Authorization Ebola Test) c. Respiratory Panel__________________________ d. BCID Panel ________________________________ e. GI Panel (b) ESTIMATED DOLLAR VALUE: $3,554,786.65 based on current testing needs. The maximum BPA limit is $5,000,000 to cover additional testing for all sites and additional equipment purchased over the five year period. (c) REQUIRED DELIVERY DATE: August 19, 2015 (4) IDENTIFICATION OF THE JUSTIFICATION RATIONALE (SEE FAR 8.405-6), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. 1 Specific characteristics of the material or service that limit the availability to a sole source The FilmArray® System offers the only test kits FDA approved that can be used on the FilmArray® System. The FilmArray® System was chosen because it provides a comprehensive panel of results for both the Respiratory Disease and the Blood Culture Identification panels with less than 2 minutes of tech hands-on time and an automated protocol delivering results within one hour. Only the BioFire Diagnostics Film Array test kits can be used because they are vendor specific. There are no other commercially available kits that are FDA approved for testing on the Film Array. 1 These are "direct replacements" parts/components for existing equipment. The Government owns seven (7) FilmArray® Systems and actively use them for patient care. BioFire Diagnostics, LLC has a current FSS contract V797D-30085 under FSC Group 65, Part VII, Section B, Invitro Diagnostics, Reagents, Test Kits and Test Sets. The VA is mandated to utilized this Schedule. 1 The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system. BioFire Diagnostics is the only firm capable of providing the supplies and services described in Section III above. They are the only vendor that has the expertise, knowledge and parts to service these automated analyzers. The Government owns seven (7) FilmArray® Systems and actively use them for patient care. (5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.4 TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: Market research was done prior to purchasing the FilmArray PCR Testing System and that is how it was determined that the FilmArray is the only FDA approved moderately complex PCR Virus testing analyzer available. Only one source was identified upon surveying the market place and confirms our assumption regarding the capability of the industry to meet our needs. BioFire Diagnostics is the sole supplier for the FDA approved test kits that can be utilized on this testing system. No other suppliers offer FDA approved test kits that are compatible. No other vendor can provide an extended service warranty for these analyzers. (6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED: Market Research was conducted on FSS, under 65VII, Section B, SIN 555-6. There are 11 vendors on this Schedule, but no-other vendor can provide the supplies, maintenance or training on the FilmArray® System. A sources sought notice was posted on www.FBO.gov from 2/24/2015 - 3/3/2015 with no responses from other vendors. BioFire Diagnostics, LLC currently holds a VA National Acquisition Center Contract Award V797D-30085, This request is per FAR 8.405-6. (7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: The Department of Veterans Affairs mandated the use of Schedule 65VII and this procurement is Following agency policy. Contract V797D-30085 - Contract Period: 02/15/2013 - 02/14/2018 (8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE: Each year the BPA will be reviewed in accordance with FAR 8.405-3 (e) before the next option year is exercised. A sources sought notice was posted on FEDBIZOPPS on Feb 24, 2015 and no other vendors responded with interest or capable of fulfilling the agency's needs.
