P03 Limiting Sources Justification_OVER_SAT signed pr.pdf

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C24E-23-AP-0058

(1) Contracting Activity:

Veteran Health Administration (VHA) Regional Procurement Office-East R&D 323 North Shore Drive, Suite 500 Pittsburgh, PA 15212

Requesting Facility:

Atlanta GA VA Medical Center Research Services 1670 Clairmont Rd Decatur, GA 30033

2237 Number: 508-23-1-2000-0008

(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).

Aperio GT 450 Next Generation Scanner is a Large Capacity Whole Slide Digital Pathology Scanner to Advance Precision Medicine. This is a new requirement for the Atlanta GA VA Medical Center, Research Office.

Order against: FSS Contract Number: GS-07F-5934R

Name of Proposed Contractor: Government Scientific Source, Inc.

Street Address: 12351 Sunrise Valley Drive

City, State, Zip: Reston, VA 20191

Phone: (800) 248-8030

(3) Description of Supplies or Services:

The estimated value of the proposed action is $320,851.00

This request is for a Leica Aperio GT 450 Scanner with an Admin MGR Server and Admin MGR- SAM SW to be utilized by the Research Service Line. This equipment is a high quality, high-

36C24E-23-AP-0058

capacity slide scanner for use at the Atlanta VA Healthcare System (AVAHS). The slide scanner allows for rapid slide digitization of routine pathology. The slide scanner will help stand up a digital data repository of pathology images that will serve as a research resource for computational pathology and Artificial Intelligence (AI) based projects. The Leica Aperio GT 450 Scanner with an Admin MGR Server and Admin MGR-SAM SW will serve as a shared resource for many VA investigators. The other components enable scans to be stored, viewed, and shared on a non-VA network.

LEICA - 23GT450 Aperio GT 450 Next Generation Scanner, Each 1, $301,595.00 LEICA - 23GT450SAM Aperio GT450 Scanner Admin MGR Server, Each 1, $10,718.00 LEICA - 23GT450SAMSW Aperio GT 450 Scanner Admin MGR SAM SW, Each 1, $8,538.00 The delivery period is 45 to 60 days after award.

(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)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

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 GT-450 whole slide scanner is a high-throughput instrument that, when deployed in the Atlanta VAHCS, will allow for efficient scanning and digitization of tissue slides from VA and non-VA subjects. It has a capacity of 450 slides and can digitize each slide with a 40x objective at a rate of 63 seconds per slide. Since it has an automated carousel configuration, it can be loaded and left unattended. Data is then stored on an attached server which can be configured to be accessible on the VA network. The viewing station is used to confirm the slides were scanned appropriately and to enable discussion by the research team using it. The slide scanner will allow for the creation of a digital data repository within the Atlanta VA that in turn will serve as a research resource for computational pathology and AI related projects. This could significantly help boost AI in medicine research for positive health impact of VA patients. The Atlanta VA is required to work with other VA stations to aggregate data collected on other Leica GT 450s and promote cross-VA research.

The Atlanta VA is creating data repositories of 5000 subjects for lung and prostate cancer which will include whole slide images. This data will be shared within the VA to develop new AI and Computer Vision tools. Use of this scanner is paramount to accomplishing this goal and will support the research productivity in Atlanta.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright, or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

This project seeks to align a network of duplicate scanners initially at the Atlanta, Boston, Cleveland, Los Angeles, Philadelphia, and Seattle VA stations to digitize pathology slides. Atlanta is the only location that does not have this piece of equipment. The slide scanner will also allow for new VA-specific projects in head and neck, colorectal, breast, brain, and skin cancer where the research group has active CVML research.

(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:

The CO will compare the pricing for this order to other orders purchased by other VA Healthcare Systems. Competition was conducted by the Greater Los Angeles VA and the same scanner purchased on 09/24/21 under 36C24E21P0185, PO 691D10030 from Government Scientific Source, Inc, (SB). On 4/1/2020, Cleveland VA purchased the same Leica GT450 with accessories and a 3-year service agreement for $414,900; under contract 36C24E20P0093 PO# 541-D02005 from Inspirate, Inc, (SB).

This product is being purchased off GSA Federal Supply Schedule GS-07F-5934R, where pricing has been determined fair and reasonable. The CO will ask the vendor for additional discounts.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

A search was conducted in the VA’s VIP database using NAICS code 339113, FSC code 6640, and keyword: Scanner, which resulted in no SDVOSB’s or VOSB available to meet this requirement. A search was also conducted in the Small Business Administration Dynamic Small Business Search (SBA DSBS) using keywords Leica and Scanner, which resulted in no small businesses available for this requirement. A sources sought was posted on 12/21/2022 under 36C24E23QQ0038 with the listed salient characteristics and one response from Government Scientific Sources, Inc (GSS) was received, and they included a letter from Leica showing they are an authorized distributer. FBO in SAM.Gov was searched for LEICA Aperio GT 450 Next Generation Scanner, which turned up no results. Product literature and vendor website information was searched, and only Leica was identified as having the GT 450 Next Generation Scanner. The recommendation is to sole source this requirement to Government Scientific Solutions, Inc. (GSS), a small business.

(7) Any Other Facts Supporting the Justification:

To cultivate large, clinically relevant data sets to avoid bias and increase clinical utility, we must reduce scanner variability. To this end, this project seeks to align a network of duplicate scanners initially at the Boston, Cleveland, Los Angeles, Philadelphia, and Seattle VA stations to digitize pathology slides.

(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:

The research office will always conduct market research on all future purchases to search for the most advanced technology and determine best value to the Government.

(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. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

SIGNATURE DATE

NAME TITLE SERVICE LINE/SECTION

FACILITY

01/05/2023

Reginald Harden Purchasing Agent Research

Atlanta VA Medical Center

REGINALD HARDEN Digitally signed by REGINALD HARDEN Date: 2023.01.05 16:32:41 -05'00'

(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.

SIGNATURE DATE

Contracting Officer, Regional Procurement Office-East R&D

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.

SIGNATURE DATE

ANN MARIE

STEWART

Digitally signed by ANN MARIE

STEWART

Date: 2023.01.05 16:58:31 -05'00'