Roche Equipment Supplies

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C246-19-AP-5299

Contracting Activity: Department of Veterans Affairs, VISN 6, Asheville, NC, Durham, NC, and Hampton VA Veterans Affairs Medical Centers.

Nature and/or Description of the Action Being Processed: Asheville, NC, Durham, NC, and Hampton VA Veterans Affairs Medical Centers require a new firm-fixed price Indefinite Delivery Contract for the supply of reagents, wash solution, buffers, slides, disposables, and any consumable part necessary for staining and testing on Roche/Ventana equipment.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for the supply of reagents, wash solution, buffers, slides, disposables, and any consumable part necessary for staining and testing on Roche/Ventana equipment 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.

Description of Supplies/Services Required to Meet the Agency s Needs: The vendor will provide each participating facility that owns Roche/Ventana Equipment with Food and Drug Administration (FDA) approved, reagents, wash solution, buffers, slides, disposables, and any consumable part necessary for staining and testing. This contract shall have one base year and four option years. The estimated value of this contract is REDACTED (including options). The period of performance for this contract will be 10/01/2019-09/30/2024.

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;

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The manufacturer of the facility owned equipment provided a letter stating that Roche Diagnostics Corporation (RDC) hereby confirms that the Roche Tissue Diagnostics (RTD) products are proprietary to Roche Diagnostics Corporation (RDC) and only available for purchase in the United States directly from RDC. The RTD product portfolio is not available through any Veteran Owned Small Business (VOSB) distributor or any other distributor, regardless of size.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought notice (36C24619Q1118) was posted on FBO from 08/30/2019 to 09/04/2019. Responses were received from:

Roche Diagnostics Corporation (Large): The manufacturer of the facility owned equipment. The response included a letter stating that Roche Diagnostics Corporation (RDC) hereby confirms that the Roche Tissue Diagnostics (RTD) products are proprietary to Roche Diagnostics Corporation (RDC) and only available for purchase in the United States directly from RDC. The RTD product portfolio is not available through any Veteran Owned Small Business (VOSB) distributor or any other distributor, regardless of size. ; and

AvKARE (SDVOSB): This firm thanked the VA for considering their company, but stated at this time we are unable to supply the requested items."

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The VA has worked with Roche Diagnostics Corp. for many years. The Salisbury VAMC currently has a contract for these items under contract # 36C24619D0030 for one base year and three option years, awarded on 10/25/2018, with a total contract value of $660,000. The CO will use historical pricing, that has already been deemed fair and reasonable, to negotiate the best pricing for the government. If deemed necessary, the CO with request other than certified cost or pricing data to perform a price analysis.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research sources include VIP, GSA eBuy, FPDS, FBO, sources sought notices, Google searches, past contracts, and conversations with industry professionals. VIP was searched utilizing NAICS code 325413 and keyword reagents. The following six vendors were found; Access International LLC (SDVOSB), AvKARE, Inc. (SDVOSB), D'S Ventures,LLC. (SDVOSB), Maness Veteran Medical, LLC (SDVOSB), SJ Medsav Solutions LLC (SDVOSB), and TEVET LLC (SDVOSB). A search in GSA eLibrary showed that Roche Diagnostics Corporation has GSA contracts V797P-5279B, GS-07F-0446V, and V797P-7347A. After searching through its price list, it was determined that the required supplies are not available on either of Roche s GSA schedules. See section 6 of this document for the results of the sources sought notice.

Any Other Facts Supporting the Use of Other than Full and Open Competition: The manufacturer has provided a sole source letter certifying the proprietary nature of the required products. (see attachment).

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Roche Diagnostics Corporation.

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 VA will continue performing market research through the use of sources sought notices to survey the market and determine the availability of additional suppliers. Awarded contract 36C24620D0028 to ROCHE DIAGNOSTICS CORPORATION;9115 HAGUE RD;INDIANAPOLIS;IN;46256 for 1,557,468.88 on 2019-10-03.