Roche SSJ_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C241-24-AP-1814

1. Contracting Activity: Department of Veterans Affairs, Regional Procurement Office East, Network

Contracting Officer 1 (New England) on behalf of VISN 1 Network Consolidated Laboratory (NCL).

2. Nature and/or Description of the Action Being Processed: This procurement is 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. This is a new 5-year BPA requirement with Roche Diagnostic Corporation with a POP: 5/17/24- 5/16/2029.

An open market FAR 13 Blanket Purchase Agreement (BPA) is being requested with Roche Diagnostic Corporation for stains, kits and consumables required for staining specimens on the automated in the Pathology Labs in VISN 1. These sole source products are specific for the that are used in Pathology Labs in West Roxbury VA and White River Junction VA. They are specially formulated, bar coded and packaged to be used exclusively on the Ventana staining systems. No other vendor has product that is ready to go off the shelf for these staining systems.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

he cartridges that hold the stain dispense this stain evenly over the slide holding the patient tissue. These dispensers are prefilled with reagents that are optimized for the Ventana instrumentation.

It is this barcoding that allows for the to update the volumes remaining in the cartridges and prevent the waste of costly stain. This specific barcoding also allows for reagent to be removed from one stainer and then run on a different stainer while maintaining accurate volume tracking.

The reagents supplied utilize self-contained, prediluted and prepackaged antibodies that are optimized to react with patient tissue and provide staining that is consistent from day to day. It is this prepackaging and the quality of their reagents and antibodies that allow for the interaction with the patient tissue that is on the slide to consistently stain the patient sample. This staining and color reaction that allows the Pathologist to interpret a patient’s disease state and help dictate the appropriate treatment by the clinician. There are numerous reagents and antibodies that are utilized in diagnosing patient cancer. Often times it is combinations of these reactions that are needed to confirm a disease state. The SOW lists the various stains and reagents needed for this procurement.

These have been in place for several years and to replace them to accommodate a different manufacturer’s stain would be cost prohibitive.

The reagents and consumables from Roche Diagnostic Corporation and are required for the Laboratory Departments at VISN1 VAMC locations. They will be used with the Roche – Ventana Systems for testing of reagents. VISN 1 owns the Equipment. The Period of Performance

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(POP) is expected to begin on 05/17/2024 and will end 5/16/2029. The estimated value of this action over the proposed 5-year period is

4. 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

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Roche Diagnostics is the manufacturer of the automated Ventana Staining Systems present already in the West Roxbury and White River Junction Pathology Labs in VISN 1. The requested products are sole source with Roche and are compatible with these systems. VISN 1 sites will be on one BPA to secure the best pricing available as well as provide a guarantee of supply for these products so that service to our Veterans will not be interrupted. This automation will also reduce the amount of Tech time needed to keep the patient care flowing without compromising patient safety. The use of any other vendors manual stains would require time to validate and optimize results which is both time and cost prohibitive for the VISN1 sites. Pathologists need to be able to read patient slides quickly and accurately in order to make a diagnosis without compromising patient safety.

Roche is the only vendor that can supply the needs of these sites. Their reagents are prepackaged, provide uniform and high-quality staining, and have a proven reliability of results. These reagents are sequenced and barcoded to correlate with the computer software of each system. Roche is the only vendor that can provide these ready to go reagents.

These have been in place for several years and to replace them to accommodate a different manufacturer’s stain would be cost prohibitive. The owned equipment alone is worth over . These are highly specialized staining systems for Pathology specimens. Accordingly, Roche is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition.

Disposal of the current instrumentation and replacing it with an entirely new testing platform would come as a significant cost, not to mention all the reagents and consumables that need to be purchased to support the new testing platform. Continued use of the current instrumentation far outweighs replacing it with a suitable substitute.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

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Sources Sought Synopsis: A notice of intent to sole source was posted on Federal Business Opportunities (FBO) on 2/2/24 under RFQ 36C24124Q0279 – Roche Diagnostic Corporation.

Zero responses were received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be considered fair and reasonable. This will be determined by comparing historical data from a previously awarded BPA action for the same items. See BPA 36C2419A0012 for details (POP: 5/17/19 – 5/16/24).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Market Research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting a Notice of Intent to Sole Source. The Vendor information Pages (VIPS), GSA Schedules, Federal Procurement Data Systems (FPDS), Small Business Dynamic Search (SBA) and CSST Medical Catalogs were all reviewed to identify potential sources. All actions have concluded that Roche Diagnostic Corporation is the only vendor to be cost effective because VISN1 locations own the Ventana Equipment. The products are solely offered by Roche and their manufactured products are proprietary.

Roche Diagnostic Corporation:

FPDS:

National Acquisition Center MedSurg Catalog: Market Research was conducted on the National Acquisition Center (CCST) and there were no findings for Ventana products.

Small Business Dynamic Search: A search was conducted under NAICS 325413 and there were over 648 profiles matching this particular NAICS. However, these vendors cannot sell Ventana products as they are proprietary to Roche Diagnostic Corporation.

Vendor Information Pages: Market Research was conducted on the VetBiz website to identify SDVOSB and VOSB sources. No sources were identified capable of satisfying this requirement.

GSA: Market Research was also conducted on GSA Advantage to identify potential sources capable of supplying the requested items. Findings did conclude that there were no available sources to supply the reagents and consumables.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

of Sources that Expressed, in Writing, an Interest in the Acquisition: None