P03 FAR 13.5 JA OVER SAT (FS) 1r2.pdf

PM Part 813.5 SAP for Certain Commercial Items Original Date: 08/30/17

Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C249-21-AP-2198

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Veterans Integrated Service Networks (VISN) 09, Robley Rex VA Medical Center, 800 Zorn Avenue, Louisville, Kentucky 40206. Purchase Request Number: 603-22-1-068-0003.

2. Nature and/or Description of the Action Being Processed: This procurement is for reagents, 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. The establishment of a new multiple year Indefinite

Delivery Indefinite Quantity (IDIQ) contract with Roche is essential for providing continual support of this critical capability for the care The requirement will result in a Firm

Fixed-Price IDIQ contract with an overall estimated value of $815,294.66.

3.

periods and value of the proposed action is:

: The estimated ordering

Ordering Period 1: October 1, 2021 through September 30, 2022 / $153,564.54

Ordering Period 2: October 1, 2022 through September 30, 2023 / $158,171.40

Ordering Period 3: October 1, 2023 through September 30, 2024 / $162,916.33

Ordering Period 4: October 1, 2024 through September 30, 2025 / $167,804.15

Ordering Period 5: October 1, 2025 through September 30, 2026 / $172,838.24

Total Estimated Value: $815,294.66

This acquisition is for reagents to be used with the Ventana BenchMark ULTRA

Immunohistochemical (IHC) Stainer and BenchMark Special Stainer for the Histology section of the

Pathology and Laboratory Medicine Service (PLMS) at the Robley Rex VA Medical Center (VAMC).

The required items are necessary to produce quality stained slides, which are evaluated by

Pathologists and assist in the diagnosis of patients.

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

Description of Supplies/

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

The PLMS at the Robley Rex VA Medical Center currently uses the Ventana BenchMark ULTRA (IHC)

Stainer and BenchMark Special Stainer and has rigorously validated Roche reagent capability real time for approximately seven years. Both stainers offer unprecedented workflow control, which enables the laboratory to manage urgent requests without delay to process slides.

The Ventana BenchMark ULTRA (IHC) Stainer and BenchMark Special Stainer platforms offer the ability to add/remove slides and reagents without stopping the 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 calls for the ability to utilize unique barcodes in determining when specific stains are required and the capability to utilize barcode kits, which must be heated to different temperatures before stains are considered valid. Roche BenchMark provides bar coded antibodies, reagents, bulks, and 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 Roche staining platform is the only staining system that meets the current requirement in its entirety.

Reagents from a different manufacturer would require the purchase of compatible Stainer equipment, which would cause a significant duplication of cost to the Government. Additionally, laboratory personnel working in the Histology section would require retraining on a new system, causing a delay in the care of patients. The only vendor capable of fulfilling the requirement is

Roche Diagnostics Corporation (Roche), a large business and manufacturer of the reagents.

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

An Intent to Sole Source Notice under solicitation number 36C24921Q0371 was posted to BetaSAM at https://beta.sam.gov/ through the Electronic Contract Management System (eCMS) on

06/10/2021 and closed on 07/10/2021. 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 reagents compatible with Ventana BenchMark ULTRA (IHC) Stainer and BenchMark Special Stainer. Upon the closing of the notice, there were no responses submitted for consideration.

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

Reasonable:

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Many recent examples of historically 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 for similar items, the government can anticipate receiving pricing reflective of true market value, which is likely to be determined 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 https://www.vetbiz.va.gov/vip, using NAICS 325413 In-Vitro Diagnostic Substance Manufacturing and key words Ventana Ultra

BenchMark Reagents, which resulted in seven potential SDVOSB/VOSB vendors. These results will not be used at this time. The Nonmanufacturer Rule (NMR) does not apply to this acquisition.

There are no authorized distributors which eliminates the possibility of purchasing the product from a veteran owned small business or nonmanufacturer from any demographic.

An additional inquiry of the Dynamic Small Business Search (DSBS) Portal was made, revealing one small business. International Diagnostic Equipment, LLC. of Temecula, CA, indicated on their SBA profile that they distribute Roche brand analytical laboratory equipment. According to the manufacturer they cannot provide reagents due to the temperature control requirements established by the Food and Drug Administration (FDA).

A search conducted in eCMS revealed the following past purchases:

1. Reagents for Ventana BenchMark ULTRA (IHC) Stainer last purchased on 10/01/2020 using purchase order 603C10059 and 36C24921P0040 from Roche Diagnostic Corporation at

$195,000.00 (Period of Performance 10/01/2020 09/30/2021).

2. A BenchMark Special Stainer was purchased on 06/11/2021 using purchase order 603A19024 and 36C24921F0365 from Roche Diagnostics Corporation at $84,617.52.

A review of General Services Administration (GSA) eLibrary and the VA National Acquisition Center (NAC)

Contract Catalogue resulted in the identification of at least two VA NAC Federal Supply Schedule (FSS) contracts awarded to Roche Diagnostics Corporation for in-vitro diagnostic equipment, reagents, and analyzers and 0 additional distributors/contract holders of Roche manufactured products. An additional search of GSA schedule 65VII, Category 555-5 Histology/Cytology, revealed multiple large and small business contract holders for various diagnostic equipment, reagents, test kits and related supplies.

Reagents for the Ventana BenchMark ULTRA (IHC) Stainer and BenchMark Special Stainer are not available on either of the two FSS contracts referenced above.

A search conducted on Federal Procurement Data System-Next Generation (FPDS-NG) at https://fpds.gov/fpdsng_cms/index.php/en/ using key words Ventana Ultra Benchmark Reagents returned only purchases from a large business, Roche Diagnostics Corporation.

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

Roche Diagnostics Corporation, manufacturer of the reagents, provided a proprietary letter stating they are the sole source of the requirement. The reagents are subject to FDA approval and regulation. Roche has an obligation to ensure all consumable products are properly temperature http://www.vetbiz.va.gov/vip

Revision 03 Date: 02/11/2021 controlled throughout the entire shipping and storage process in route to a customer. Failure to comply with these regulations could create potential safety issues. Because of potential patient safety issues and other factors, Roche has made the business decision to only sell these products directly to the end-users.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Company POC Business Size Capability

Roche Diagnostics Corp.

9115 Hague Road

Indianapolis, IN 46250

Chris Hoff Mgr. Government Contracts

Chris.hoff@Roche.com 317-746-8092

Large Meets

Requirement

11. 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

Department of Veterans Affairs will continue to seek vendors capable of providing these supplies in future procurements. However, at the present time, based on available market research, there are no other vendors that are fully capable of providing the required supplies other than Roche

Diagnostics Corporation.

mailto:Chris.hoff@Roche.com

MONICA E.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are ace rate and complete to the best of my knowledge and belief.

Latha Parthasarathy, Ph.D., MB HTL Date Histology/Cytology Supervisor Robley Rex VA Medical Center

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

ROBERT KELLNER Digitally signed by ROBERT KELLNER

Date: 2021.07.23 08:15:38 -05'00'

Robert M. Kellner Date

Contracting Officer Network Contracting Office 9

Branch Chief (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Digitally signed by MONICA E.

THOMPSON 110287

THOMPSON 110287 Date: 2021.07.23 09:05:57 -05'00'

Monica Thompson Date Branch Chief, Supply East Network Contracting Office 9

c. Division Chief (Recommendation): I certify the justification meets requirements for other than full and open competition.

ROBERT KELLNER

Robert M. Kellner Division Chief Network Contracting Office 9

Digitally signed by ROBERT KELLNER

Date: 2021.07.23 08:15:56 -05'00'

Date

d. Director of Contracting (Concurrence): I Concur / Non-Concur that the justification meets requirements for other than full and open competition.

Digitally signed by Tara L. Petersen 3529852

Date: 2021.07.28 16:38:11 -05'00'

Tara L. Petersen Director of Contracting

Network Contracting Office 9

Date

e. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

TERRY Digitally signed by TERRY

SPITZMILLER

SPITZMILLER Date: 2021.08.03 08:53:19 -05'00'

Terry L. Spitzmiller Executive Director Regional Procurement Office Central (VHA)

Revision 03 Date: 02/11/2021

Date

Tara L. Petersen 3529852

08/03/202