6550--Agilent--Omnis-IHC Stainer

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT OFOC SOP Revision 08 Page 1 of 9 Original Date: 03/22/11 Revision 08 Date: 04/18/2018 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C250-20-AP-1675 Contracting Activity: Department of Veterans Affairs, VISN 10, VA Ann Arbor Healthcare System, 506-20-3-1030-0037 Nature and/or Description of the Action Being Processed: New requirement for a Firm-Fixed Price IDIQ for one (1) base year Cost Per Test (CPT) contract with two (2) additional contract option years to provide immunohistochemical patient specimen testing. Description of Supplies/Services Required to Meet the Agency s Needs: The Contractor shall provide one (1) automated immunohistochemical (IHC) staining system that performs the staining of human tissue to target specific proteins. The instrument, ancillary equipment, quality controls, slides, disposables, consumables, antibodies, reagents, supplies, shipping and handling costs associated with receipt of reagents, technical manual, service manual, operator training, hardware and software, preventative and repair maintenance agreement, and operator training in the operation of and performance of preventive maintenance on the automated IHC system must be provided to VA Ann Arbor Healthcare System. Estimated Value Including Options: $524,920.00 Estimated Period of Performance: _5/18/20 TO 5/17/23 Statutory Authority Permitting Other than Full and Open Competition ( x ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Dako Omnis is currently leased by VAAAHS, and onsite. The equipment is only two years old. The original contract was for base plus four option years, but we reached the ceiling of the award after two years and this caused the need for the new contract. The leased equipment has shelf life of 5 years, so we are requesting three more years of contract on same equipment to save time and money invested on this equipment. Service has invested two years of verification and validation work in the Dako Omnis system. This includes countless work hours from both the professional and technical components. Work hours of Pathologists and techs translate into a sizable financial investment from Pathology and Laboratory Medicine Service. The reagents, supplies, consumables/disposables, calibrators, standards, and controls used are unique to the Dako-omnis analyzer currently leased by the VA. If another vendor s reagents and supplies are used with this analyzer, the results would be incorrect. The Dako Omnis uses polymer-based detection system. This system is preferred over Avidin-biotin-enzyme or Streptavidin -enzyme systems as the polymer-based system stains with greater specificity and sensitivity with fewer protocol steps. This results in time efficient microscopic examination time by the pathologist as slides are cleaner and crisp. The polymer-based stain can be completed in three to four hours in some cases while the Avidin-biotin and Streptavidin systems traditionally take 9 hours to complete. This time savings results in more rapid final diagnosis and better care for our Veterans. DAKO Omnis is truly a load and walk away instrument which allows for more efficient use of technical time. The established specificity of the Dako Omnis polymer-based staining system allows for a considerable cost savings as the necessity of running a negative reagent and negative tissue control slides is not required for each patient or antibody being tested. The savings is represented in reagent saved, antibody save, Pathologist time saved reading the negative control slides and technical/material costs producing the negative controls. College of American Pathologist (CAP) laboratory accreditation mandates that a negative reagent control slide be stained on each patient for each antibody tested (ANP. 22570). CAP also mandates the necessity to assess the specificity of each antibody by a negative tissue control slide, which must show no staining of tissues known to lack the antigen. Once again, the polymer-based detection system consistently maintains specificity to the extent that the negative tissue control slide is not necessary. Pathology and Laboratory Medicine Service has realized a cost savings of thousands of dollars as we continue to provide our pathologists with the highest quality Immunohistochemistry slides and most importantly, provide expeditious and excellent care for our veterans. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Intent to sole source was posted to Contract Opportunities with no responses. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Pricing is considered fair and reasonable in comparison to the last two delivery orders for the same equipment: PO 506-C80173, 5/18/2018 5/17/2019, $138,804.00 and PO 506-C90202, 5/18/2019 5/17/2020, $168,000.00. The current contract is an estimate of $169,920 for the base year, $175,000 for option year 1 and $180,000 for option year 2. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: VIP was queried under NAICS 325413 and 31 results were found. A keyword search of immunohistochemical along with the NAICS code resulted in 0 concerns. An intent to sole source was posted to Contract Opportunities and no responses were received. The manufacturer was contacted and they confirmed they have no small business distributors for this type of contract. Any Other Facts Supporting the Use of Other than Full and Open Competition: None. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Agilent Technologies, Inc., 6392 Via Real, Carpinteria, CA 93013-2921. 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: Once this order is complete and the equipment is ready to be replaced, a new requisition will be competed.