P03 - LSJ - OVER_SAT Ventana Slide Stainer .pdf

36C244-24-AP-2043

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C244-24-AP-2043

PR/2237: 595-24-2-480-0123

(1) Contracting Activity: Department of Veterans Affairs, VISN 04, Lebanon VA Medical Center (LVAMC), 1700

South Lincoln Avenue, Lebanon, PA 17042

(2). Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). The LVAMC Laboratory requires; Benchmark special Stainer, DP200 Scanner, Vantage Workflow Solution (Navify Pathology Lab Advantage Workflow), Ventana Connect (Navify Pathology Lab Hub Middleware), all accessories to include assembly, installation, training and preventative maintenance and support on equipment and software.

Order against: FSS Contract Number: GS-07F-0446V

Name of Proposed Contractor: Roche Diagnostics

Street Address: 9115 Hague Rd

City, State, Zip: Indianapolis, IN, 46256

Phone: 445-231-7524

(3) Description of Supplies or Services:

https://www.acquisition.gov/far/part-8#FAR_8_405_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

Roche Diagnostic’s DP200 slide scanner is approved by the FDA for primary reads/diagnosis. The quality of slides scanned by the scanner is second to none in the market. In addition, way the slide scanner operates prevents slides from breaking, unlike its competitors. In addition, the vantage workf low system is the only application currently on the market that communicates seamlessly with VISTA and it’s Cerner-ready when the VA brings Cerner on board. The DP200, Vantage connect, Vantage workflow and The BenchMark Special Stainer will all work together to ensure coherent and smooth workflow. All the systems can be integrated and connected to work harmoniously. Roche Diagnostics is the sole manufacturer and distributor of the Ventana system. Additionally, the service of this system must be performed by Roche

Diagnostics trained service engineers, or the warranty for this instrument is rendered null and void.

0001 Benchmark Special Stainer - #6657389001, (includes PM)

50,000.00

$ 50,000.00

0002 DP200 Scanner - #8303924001, (includes PM)

65,000.00

$ 65,000.00

0003 VANTAGE Software Core License - #9963235001

98,000.00 $ 98,000.00

0004 VENTANA Connect / Navify Pathology - #9923101001

8,720.00 $ 8,720.00

Total for Base Year (04-26-2024 - 04/25/2025) $ 221,720.00

1001 Benchmark Special Stainer PM 1 Year $8,340.53 $ 8,340.53

1002 DP200 Scanner PM 1 Year $7,800.80 $ 7,800.80

1003 VANTAGE Software License renewal 1 Year $11,700.00 $ 11,700.00

1004 VENTANA Connect subscription 1 Year $1,570.00 $ 1,570.00

Total for Option Year 1 (04-26-2025 - 04/25/2026) $ 29,411.33

2001 Benchmark Special Stainer PM 1 Year $8,340.53 $ 8,340.53

2002 DP200 Scanner PM 1 Year $7,800.80 $ 7,800.80

2003 VANTAGE Software License renewal 1 Year $11,700.00 $ 11,700.00

2004 VENTANA Connect subscription 1 Year $1,570.00 $ 1,570.00

Total for Option Year 2 (04/26/2026 - 04/25/2027) $ 29,411.33

3001 Benchmark Special Stainer PM 1 Year $8,340.53 $ 8,340.53

3002 DP200 Scanner PM 1 Year $7,800.80 $ 7,800.80

3003 VANTAGE Software License renewal 1 Year $11,700.00 $ 11,700.00

3004 VENTANA Connect subscription 1 Year $1,570.00 $ 1,570.00

Total for Option Year 3 (04/26/2027 - 04/25/2028) $ 29,411.33

4001 Benchmark Special Stainer PM 1 Year $8,340.53 $ 8,340.53

4002 DP200 Scanner PM 1 Year $7,800.80 $ 7,800.80

4003 VANTAGE Software License renewal 1 Year $11,700.00 $ 11,700.00

4004 VENTANA Connect subscription 1 Year $1,570.00 $ 1,570.00

Total for Option Year 4 (04/26/2028 - 04/25/2029) $ 29,411.33

The estimated value of the proposed action is $339,365.32.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

The proprietary nature of the technology contained within the instrument requires that only Roche Diagnostics perform certain maintenance and service procedures. The operator’s manual describes the routine maintenance activities that should be performed by end-users. All other activities must be performed by Roche Diagnostics trained service engineers.

It’s Industry-leading technology combines individual slide heating, vortex mixing, and liquid coverslip to ensure high-quality staining on every slide, every time. Automated baking, deparaffinization, and staining, combined with ready-to-use reagent kits limits exposure to, and handling of, hazardous chemicals, creating a safer work environment. In addition, the option for flexible and customizable staining protocols allows assays to be optimized to suit pathologist’s preference.

DP200 Scanner for digital pathology. This model is approved by the FDA for primary diagnosis and manufactured by Roche Diagnostics.

https://www.acquisition.gov/far/part-8#FAR_8_405_6

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

Services offered on the schedule are set at a fixed price for performance of a specific task (technology contained within the instrument). GSA has already determined the prices of supplies and fixed-price services, under the scheduled contracts to be fair and reasonable.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Researched Historical Contracts, Web Searches, collected specifications and brochures, GSA Search, VIP Search, Verified SAM Registrations and FPDS Search. Contacted the manufacturer Roche Diagnostics and obtained an informal quote. Roche also provided a sole source letter stating that Roche is the sole manufacturer and distributor of their equipment.

(7) Any Other Facts Supporting the Justification: This acquisition will provide our veterans will improve and better care. Clinicians will be able to rely on the lab for state of the arts diagnostic care around the clock. In addition, the productivity of the lab will increase more than double fold. Roche is the sole manufacturer and distributor of their equipment.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

For future requirements, additional market research will be completed to see if market conditions and/or agency needs have changed.

(9) 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 accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Frank Wornyo Supervisor Histotechnologist

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Debra Willard NCO 4, Contracting Officer https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

William C. Schlobohm

NCO 4, Branch Chief – Services 5