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Leica Bond-Max Reagents, Antibodies, Detection Kits, and Consumables 36C250-23-AP-5039 Effective Date: 02/01/2022 Page 1 of 9 DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED ... Leica Bond-Max Reagents, Antibodies, Detection Kits, and Consumables 36C250-23-AP-5039 Effective Date: 02/01/2022 Page 1 of 9 DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: 36C250-23-AP-5039 Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10, in support of VISN 10, John D. Dingell VA Medical Center located at 4646 John R Street, Detroit, MI 48201 2237: 553-24-1-058-0003 Nature and/or Description of the Action Being Processed: This is a request for other than full and open competition for a sole source procurement to obtain various specialized reagents, antibodies, detection kits, and consumables to be used with the lab-owned Leica Bond-Max immunohistochemistry (IHC) automated histology stainer in the John D. Dingell VA Medical Center Histology Department in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. A sole source procurement is being conducted for these products and services. The action will be awarded as a new open market, firm-fixed price, single award, 5-year ordering period Indefinite Delivery Indefinite Quantity (IDIQ) contract. The 5-year period of performance is anticipated to be August 1, 2024 through July 31, 2029. The previous BPA (36C25022A0002) expired on September 30, 2023. Due to time constraints and the need to obtain a Made in America waiver, a new procurement vehicle beginning on October 1, 2023 was not possible.The estimated value of the proposed action is $622,986.47 for five (5) years. The estimated value of the first year is $117,342.35. Description of Supplies/Services Required to Meet the Agency s Needs: The procurement will provide specialized Leica Biosystems (doing business as Leica Microsystems, hereinafter Leica ), products to the Pathology and Laboratory Medicine Service. Leica is the sole manufacturer of these proprietary reagents, detection kits, and supplies compatible with the Bond-Max instrument, and the preferred source for the antibodies used in the Bond-Max instrument. These products are critical to the support of VA patient care. 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): All manufacturers (e.g., Leica, Ventana, BioCare, & Dako) of Immunohistochemistry (IHC) instrumentation, antibodies, detection kits, reagents, and consumables are proprietary oriented. Detection kits, reagents, and consumables are validated to their specific instrumentation. We can use non-Leica antibodies in the instrument, but we need to purchase open containers from Leica to put the antibody in so that the instrument can use them. However, Leica, like all the other manufacturers, will not provide technical support for using third party antibodies on their platform. Conversely, third party antibody vendors will not provide technical support using these antibodies on another vendor s platform. Furthermore, any potential use of third-party antibodies are deemed Laboratory Developed Tests and require user validation per our accreditation agency (e.g., The Joint Commission (JC)) and the College of American Pathologist (CAP) before being placed in clinical service, which would require additional costs and man-hours. Depending on the cost of antibodies (we currently provide 40), which if a third-party vendor charged us $300 per antibody, would be about $12,000. The detection kits and other consumables (retrieval solution, bond wash, bond dewax) need to be purchased by Leica because those are the only products that will work on the instrument. If we had to validate those third-party antibodies, we would use about 9 detections kits and 5 bottles of each solution which would cost approximately $32,000. Manpower would be about 4 months for validation and in that time frame we would not be able to do any testing and would have to send tests to an outside testing facility any patient tissues which cost about $100 per slide. We run about 300 slides per month, for a cost of approximately $30,000 per month. The total cost to perform antibody validation for the four months would be approximately $164,000. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government s requirements. There is no competition anticipated for this acquisition. Government Scientific Source, Inc. (GSS) is Leica s small business distributor to the Federal Government, and can provide many of the required supplies either through their GSA contract GS-07F-5934R or their ECAT contract SPE2DE19D0004. However, searches on GSA and ECAT revealed that five of the required items were not available on GSA and twenty-one items were not available on ECAT. Additionally, GSS s GSA and ECAT pricing was significantly higher on many items compared to pricing from Leica in the open market, due to the fact that Leica offers significant discounted pricing based on minimum order quantities. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer will ensure that the anticipated cost to the Government will be fair and reasonable. The Contracting Officer will make a fair and reasonable price determination based on a comparison of proposed pricing to historical prices from Leica for reagents, antibodies, detection kits, and consumables. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Search of SBA VetCert using NAICS 334516 resulted in 213 potential SDVOSB/VOSB s. Search of SBA DSBS using the same NAICS and keyword Polymer Refine Red Detection Kit resulted in zero small business concerns. Search of GSA Advantage for Leica Bond-Max products returned one result, a Bond-Max Processing Module available from Government Scientific Source, Inc. Leica representative stated that Government Scientific Source, Inc. (GSS) is their small business distributor to the Federal Government and many of the reagents and consumables are available on GSS s GSA contract. A sources sought notice (36C25024Q0468) was published on SAM.gov from March 26, 2024, through April 10, 2024, seeking sources capable of providing U.S. manufactured reagents, antibodies, detection kits, and consumables certified for use in a Leica Bond-Max IHC stainer. Two vendor responses were received, ASAP Cargo Van Service, LLC (small business), and Government Scientific Source (small business). ASAP Cargo Van Service gave no information concerning their capability to provide the required products. Also, their primary NAICS associated with their SAM.gov entity information did not include 334516. This vendor only appears to be engaged in courier and delivery services. Government Scientific Source stated they are the sole source, small business authorized distributor for LEICA and carry the items on their GSA contract GS-07F-5934R. However, searches on GSA by specific part numbers indicate they can provide most, but not all, of the required products on their GSA contract (but not manufactured in the U.S.). The contracting officer reviewed GSA and ECAT pricing from Government Scientific Source and noted that pricing appeared to be considerably higher than pricing which could be obtained through Leica in the open market, with many items appearing 2-2.5 times higher. The previous BPA (36C25022A0002) was awarded to Leica Biosystems on a sole source basis, and ended on September 30, 2023. There are no other existing VA or other Government agency contracts from which to source the required products. Leica Biosystems is the only vendor capable of providing all the required reagents, kits, and consumables. The Buy American statute applies to this acquisition. The majority of the reagents, antibodies, kits, and consumables are manufactured in Great Britain with the remaining manufactured in either Australia, Canada, the United States, or China. As such, a Buy American waiver will need to be obtained. Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no other supporting facts. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Leica Microsystems (dba Leica Biosystems) 10 Parkway North, Suite 300 Deerfield, IL 60015 Government Scientific Source, Inc. 12355 Sunrise Valley Drive, Suite 400 Reston, VA 20191 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: The proposed contract action is for a period of five years. After the five years, the market will be surveyed to determine if there are other sources that could lead to a competitive procurement.