FINAL FAR 13.5 JOFOC - Roche Immunohistochemical Stainers (Signed)_Redacted.pdf

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 5 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C249-20-AP-2284

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Network Contracting Office 9 (NCO), 1639 Medical Center Parkway, Suite 400, Murfreesboro, TN 37129.

Purchase Request number: 621-21-1-037-0002.

2. Nature and/or Description of the Action Being Processed:

This is a procurement for a reagent rental agreement, in accordance 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. The requirement will result in a Firm Fixed-Price Indefinite Delivery Indefinite Quantity (IDIQ) contract with an overall estimated value of $2,403,690.00.

3. Description of Supplies/Services :

The estimated ordering periods and value of the proposed action is:

Ordering Period 1: Oct 1, 2020 through Sep 30, 2021 / $480,738.00 Ordering Period 2: Oct 1, 2021 through Sep 30, 2022 / $480,738.00 Ordering Period 3: Oct 1, 2022 through Sep 30, 2023 / $480,738.00 Ordering Period 4: Oct 1, 2023 through Sep 30, 2024 / $480,738.00 Ordering Period 5: Oct 1, 2024 through Sep 30, 2025 / $480,738.00

Total Estimated Value $2,403,690.00

This acquisition is for the rental of two Roche-VENTANA BenchMark ULTRA (FS) Immunohistochemical Stainers (IHC Stainers) and one Benchmark Special Stainer for the Histology section of the Pathology and Laboratory Medicine Service (PLMS) at the James H. Quillen VA Medical Center (VAMC) at 809 Lamont Street, Mountain Home, TN 37684. The acquisition includes all reagents, related stains, antibodies, consumables, and associated services, including quarterly decontamination services. The required items and services are necessary to produce quality stained slides, which are evaluated by pathologist and assist in the diagnosis of patients. The equipment currently utilized is near obsolete and will no longer receive maintenance support beginning January 2021. The only vendor capable of fulfilling the requirement in its entirety is Roche Diagnostics Corporation (Roche), a large business and manufacturer of the required equipment. The establishment of a new multiple year IDIQ contract with Roche is essential veterans.

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.

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 5

Revision 02 Date: 08/04/2020

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 C Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The PLMS at the James H. Quillen VAMC currently uses the Roche Ventana Ultra IHC Stainer and the Roche Ventana Ultra Nexus special Stainer and has rigorously validated its capability real time for approximately nine years. While both strainers offer unprecedented workflow control, which enables the lab to manage urgent requests without delay to in process slides, the Ultra Nexus special Stainer is at the end of its lifecycle and will not receive further maintenance support. This acquisition includes the procurement of the Roche BenchMark Special Stainer to replace the Ultra Nexus.

The Roche IHC and Special Stainer platforms offer the ability to add/remove slides without stopping the workflow. -ten slide system, which is non-continuous loading, that must complete the staining process before it can be utilized for another stain or multiple stains, which causes delays in patient tissue turn-around time and eventual diagnosis. Reagents can also be added or removed from the Roche system without impacting workflow, as the system contains individual drawers. There is no need to batch runs and operators have continuous access to the system, thus preventing delays in patient tissue staining and subsequent diagnosis. The Special Stainer requirement calls for the ability to utilize unique barcodes in determining when specific stains are required and the capability to utilize barcode kits, which have to be heated to different temperatures before stains are considered valid. Roche BenchMark provides bar coded antibodies, reagents, bulks, special stain kits that must be registered into the system to perform tests for both staining platforms, which eliminates accidental use of expired reagents or mislabeling of reagents with manual entry. The c Stainer does not fulfill the current Special Stainer requirement, as it utilizes Radio Frequency Identification to drive the staining process, not unique barcodes, and lacks the capability to heat solutions for staining, though it does provide heat specifically for the purpose of melting wax from slides during routine staining. The Roche staining platform is the only staining system that meets the current requirement in its entirety. The Roche system has been proven all around superior to competitive brands and offers a capability the Histology lab cannot do without.

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

A Sources Sought Notice under solicitation number 36C24920Q0365 was posted to Beta SAM on 08/06/2020 and closed on 08/13/2020. The notice, utilizing North American Industry Classification System (NAICS) 325413 In-Vitro Diagnostic Substance Manufacturing and Product Service Code (PSC) 6550 In-Vitro Diagnostic Substances, Reagents, Test Kits and Sets, detailed the need for the rental of

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 5

Revision 02 Date: 08/04/2020 two Automated IHC Stainers, one Automated Special Stainer, all reagents, related stains, antibodies, consumables, decontamination of automated stainers (quarterly or per manufacturers recommendation) and related services. Upon the closing of the notice, two source submissions were received, one from Roche Diagnostics Corporation and one from Leica Microsystems, Inc., Biosystems Division.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Many recent examples of historical negotiated pricing between Roche and the government have been identified in BetaSAM and FPDS. By leveraging this, which was established through direct awards to Roche Diagnostics Corporation, along with Federal Supply Schedule contract pricing, the government can anticipate receiving pricing reflective of true market value, which is likely be determine fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

A search was made for Service Disabled Veteran Owned Small Businesses (SDVOSB) capable of fulfilling the requirement through the Vendor Information Pages at ttps://www.vip.vetbiz.va.gov/, using NAICS 325413 In-Vitro Diagnostic Substance Manufacturing, which resulted in zero available SDVOSB/VOSB vendors. An additional inquiry of the Dynamic Small Business Search portal was made, revealing one Small business. International Diagnostic Equipment, LLC of Temecula, CA, indicates on their SBA profile that they distribute Roche brand analytical laboratory equipment. After reviewing the SBA NAICS class waiver listing, no waiver has been issued for 325413 In-Vitro Diagnostic Substance Manufacturing, and since Roche is a large business, the non-manufacturing rule has not been met, thus International Diagnostic Equipment, LLC is not capable of fulfilling the requirement.

Further, a search of General Services Administration (GSA) the National Acquisition Center revealed the existence of various VA NAC FSS contracts awarded to Roche Diagnostics Corporation. The required reagents, test kits, and test sets are found on schedule 65VII on VA NAC FSS contract V797P-5279B, which will be leveraged to obtain the fair and reasonable pricing. See the Market Research Report for details.

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

The PLMS currently stocks a large volume of testing supplies procured specifically for use with currently available Roche equipment. Stainers from another manufacturer will not accommodate the use of the current supplies, which will cause a significant duplication of cost to procure new materials and supplies. Additionally, laboratory personnel working in the Histology section will require retraining on a new system, which will require waste valuable resources and cause a delay in the care of patients.