36C261-24-AP-5278-FY24-706 JOFOC NCO21 Oncotype GPS DX Testing_HCA.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C261-24-AP-5278 FY25 JOFOC Tracker Log# FY25-NCO21-178

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C261-24-AP-5278

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 21, located at 3237 Peacekeeper Way, Bldg 200, Ste 204, McClellan, CA 95652, in support of VISN 21 VA Health Care System at 10535 Hospital Way, Mather, CA 95655. PR: 612-25-1-111-0010

(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 proposed contract action is for a new task order for Oncotype DX Genomic Prostate Score (GPS) testing. The task order will include a base period plus four, one-year option periods. The total estimated period of performance is 01/01/25 – 09/30/29

Order against: FSS Contract Number: V797D-70066

Name of Proposed Contractor: MDXHealth, Inc.

Street Address: 15279 Alton Parkway Ste 100

City, State, Zip: Irvine, CA 92618

Phone: 949-812-6979

(3) Description of Supplies or Services:

The estimated value of the proposed action is $1,132,231.26

The use of the Oncotype DX testing is a recommendation by the National Comprehensive Cancer Network (NCCN). These tests aid in determining the next step to take in the treatment and prognosis of patients diagnosed with prostate cancer.

The Oncotype DX GPS prostate cancer testing applies advanced genomic science to reveal the unique biology of a patient’s tumor to optimize cancer treatment decisions. By providing answers to key questions about the aggressiveness of and appropriate treatment for early-stage cancer, the practice-changing tests help physicians and patients select the right treatment at the right time in each individual case. In this way, Oncotype DX GPS testing helps patients and their physicians to optimize their cancer care and outcomes, enabling many patients to avoid unnecessary procedures and therapies, and saving the healthcare system billions of dollars in unnecessary costs.

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(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;

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.

(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:

As detailed in the market research results below, MDXHealth is the only company capable of providing the required prostate cancer testing services. Utilizing the GSA schedule provides a more streamlined and efficient acquisition strategy, which includes pre-negotiated rates; thus, a task order saves time and tax-payer dollars in establishing a much-needed service for our Veterans.

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

The contracting officer conducted market research from 08/28/24 – 09/25/24 with the following results:

A search through the SBA’s VetCert portal under NAICS 621511 resulted in 322 SDVOSB and VOSBs. In order to determine if any of these companies were capable and interested in providing the required services, further market research was conducted.

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Searches through mandatory sources, AbilityOne and UNICOR, reveal that neither source can be utilized for this procurement. The contracting officer searched through existing contract vehicles provided through the Strategic Acquisition Center, the Western States Network Consortium, VA Enterprise, and other VISN wide contracting departments. There are no existing contract vehicles that can be utilized for this procurement.

Searches through the General Services Administration (GSA) Advantage website revealed Schedule Category 621 II – Medical Laboratory Testing and Analysis Services. Under this schedule is category 621-213 Pharmacogenetics/Pharmacogenomics with the following five vendors listed: Ethos Holdings Corp., Exact Sciences Corporation, Laboratory Corporation of America, MDXHealth Inc., and Quest Diagnostics Inc.

A search on the Small Business Administration (SBA) Dynamic Small Business Search tool under the applicable NAICS and keyword “prostate cancer” revealed only one company: MDXHealth Inc.

In order to determine if there are two or more SDVOSBs or VOSBs interested and capable to provide the required testing service and to determine the acquisition strategy for this procurement, a Sources Sought Notice was posted to GSA eBUY and Contracting Opportunities on 09/16/24. A drafted copy of the Performance Work Statement (PWS) was included with both postings. The notice requested that any potential companies provide a capabilities statement that specifically addressed how they could provide prostate cancer testing services as instructed in the PWS. Responses were due on 09/23/24.

Only one vendor submitted a response to GSA eBUY Sources Sought Notice RFQ1726814:

MDXHealth Inc (Small Business). The company submitted a capabilities statement and provided all the relevant information as requested in the notice. The vendor has an active SAM.gov registration and is registered with the SBA as a Small Business under NAICS 621511, which is the NAICS applicable to the requirement.

Two vendors submitted a response to Contracting Opportunities Sources Sought Notice 36C26124Q1064: BHPE LLC (SDVOSB) and Trackster Global LLC (WOSB). BHPE LLC responded to the notice by sending an email with no capabilities statement attached. The email offered market research services and did not address the actual cancer testing services that are needed. The company did not follow the instructions in the Sources Sought Notice to submit a capabilities statement that specifically addressed how they could provide prostate cancer testing services as instructed in the PWS. As such, BHPE LLC is not considered technically capable to perform the cancer testing services.

Trackster Global LLC submitted a capabilities statement; however, the capabilities statement gave general statements about Radio Frequency Identification Systems and tracking services for goods. The email from the vendor offered tracking services and did not address the required

VHAPG Part 808.405-6 Limiting Sources Page 4 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C261-24-AP-5278 FY25 JOFOC Tracker Log# FY25-NCO21-178 prostate cancer testing services. The company did not follow the instructions in the Sources Sought Notice to submit a capabilities statement that specifically addressed how they could provide prostate cancer testing services as instructed in the PWS. As such, the vendor is not considered technically capable to perform the required services.

The contracting officer notes that Trackster Global LLC also submitted a capabilities statement for Solomon Security Systems (WOSB). This company is in a joint-venture with Trackster Global LLC, has an active SAM.gov registration, and is registered with the SBA as a WOSB. However, the capabilities statement provides general information about cyber secure supply chain network technologies and tracking services for goods. The company did not follow the instructions in the Sources Sought Notice to submit a capabilities statement that specifically addressed how they could provide prostate cancer testing services as instructed in the PWS. As such, the company is not considered technically capable to provide the required cancer testing services.

(7) Any Other Facts Supporting the Justification: There are no other facts to support this justification.

(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 Government will continue to conduct market research to determine if any new companies can provide the required prostate cancer testing services.

(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.

SIGNATURE DATE

NAME TITLE SERVICE LINE/SECTION

FACILITY

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(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.

Krystal Zoufaly DATE Contracting Officer Network Contracting Office 21

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.

Nicholas Kluch DATE Director of Contracting Network Contracting Office 21

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Curtis M. Jordan Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)