LSJ Genomic Health final signed.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 6 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C259-20-AP-3341 JOFOC Tracking Number: 2020-08-04T17:10:46

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 19, 6162 South Willow Drive, Suite 300, Greenwood Village, CO 80111

Organizational Activities: PURCHASE REQUEST (2237):

VA Eastern Colorado Health Care System, 1700 N Wheeling St. , TBD – Funding memo provided Aurora, CO 80045

VA Eastern Oklahoma Health Care System, 1011 TBD – Funding memo provided Honor Heights Dr., Muskogee, OK 74401

VA Western Colorado Health Care System, 2121 North Ave, TBD – Funding memo provided Grand Junction, CO 81501

Oklahoma City VA Health Care System, 921 NE 13th St, TBD – Funding memo provided Oklahoma City, OK 73104

VA Salt Lake City Health Care System, 500 Foothill Blvd, 660-21-1-098-0002 Salt Lake City, UT 84148

(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 Department of Veterans Affairs requires specialized genetic oncology testing for the above listed VISN 19 stations. This will be a sole source, single award BPA. This award will be a firm fixed-price BPA funded by yearly task order by each VA facility. The period of performance will be October 1, 2020 through September 30, 2021, followed by four (4) one-year options.

Order against: FSS Contract Number: V797D-70053

Name of Proposed Contractor: Genomic Health

Street Address: 301 Penobscot Drive

City, State, Zip: Redwood City, CA 94063

Phone: 813-951-1112 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

VHAPM Part 808.405-6 Limiting Sources Page 2 of 6

(3) Description of Supplies or Services:

The estimated value of the proposed action is $919,774.30 for 5 years. The estimated value of the base year is $170,000.00.

The procurement will provide specialized oncology genetic testing service to the Pathology and

Laboratory Medicine Services for Oncotype Cancer testing on previously negative prostate biopsy specimens from men who are considered at risk for prostate cancer. This service is critical to the support of the prognosis and treatment of VA patients regarding prostate, breast, or colon cancer through the identification of specific genetic markers. This supports the mission of the VA to provide timely, accurate and appropriate pathology services in support of patient care. These tests are only available from

Genomic Health. The tests to be covered under this BPA are:

Oncotype DX Breast Recurrence Score Assay (81519) - $3,453.96 per test Oncotype DX Breast DCIS Score Assay (0045U) - $3,873.00 per test Oncotype DX Colon Recurrence Score Assay (81525) - $3,116.00 per test Oncotype DX Genomic Prostate Score Assay (0047U) - $3,192.93 per test Oncotype DX AR-V7 Nucleus Detect (81479) - $3,395.00 per test

The requirement will contain a one-year base period, followed by four (4) one-year options.

Base Year – October 1, 2020 – September 30, 2021

Option Year 1 - October 1, 2021 – September 30, 2022

Option Year 2 - October 1, 2022 – September 30, 2023

Option Year 3 - October 1, 2023 – September 30, 2024

Option Year 4 - October 1, 2024 – September 30, 2025

(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 required Oncotype genetic tests are proprietary to Genomic Health.

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.

VHAPM Part 808.405-6 Limiting Sources Page 3 of 6

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

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

Oncotype DX Breast Recurrence Score Assay is a proprietary test using mRNA, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as Recurrence Score® result. There are currently no other tests on the market that provide the results this Oncotype test does. This test is proprietary to Genomic Health in both its analyzer/supplies as well as its testing methodology and algorithms.

Oncotype DX Breast DCIS Score Assay is a proprietary test using real-time RT-PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as Recurrence Score result. There are currently no other tests on the market that provide the results this Oncotype test does. This test is proprietary to Genomic Health in both its analyzer/supplies as well as its testing methodology and algorithms.

Oncotype DX Colon Recurrence Score Assay is a proprietary test using mRNA, gene expression profiling by real-time RT- PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a Recurrence Score result. There are currently no other tests on the market that provide the results this Oncotype test does. This test is proprietary to Genomic Health in both its analyzer/supplies as well as its testing methodology and algorithms.

Oncotype DX Genomic Prostate Score Assay is a proprietary test using mRNA, gene expression profiling by real-time RT-PCR of 17 genes (12 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a risk score.

There are currently no other tests on the market that provide the results this Oncotype test does. This test is proprietary to Genomic Health in both its analyzer/supplies as well as its testing methodology and algorithms.

Oncotype DX AR-V7 Nucleus Detect is a proprietary test using mRNA, gene expression profiling by real-time RT-PCR of individual patient specific genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a risk score. There are currently no other tests on the market that provide the results this Oncotype test does. This test is proprietary to Genomic Health in both its analyzer/supplies as well as its testing methodology and algorithms.

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.

VHAPM Part 808.405-6 Limiting Sources Page 4 of 6

Revision 02 Eff Date: 02/21/2020

(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:

This requirement is for tests that are both necessary for patient care but are also proprietary to Genomic Health. There are currently no alternatives to using Genomic Health because they are the only ones who can provide the required tests. Tests from any other vendor would not fully meet the requirement, which would lead to increased risk to patient care. The best value to the Government is to award to Genomic Health under a limited source justification as the tests they offer have been in place within VISN 19 facilities for the past 5 years and are proprietary to Genomic Health. There are no other tests currently on the market that will fulfill the requirement. The pricing for each required test is listed in the contractor’s FSS schedule and has previously been determined by GSA to be Fair and Reasonable.

Additional discounts based on volume will be requested.

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

Sources Sought notice 36C25920Q0482 was posted to FBO on 06/24/20 and closed on 07/10/20. It received no responses other than confirmation from Genomic Health. In addition, a search in VetBiz was conducted using NAICS code 621511, the states of Wyoming, Colorado, Utah, and Oklahoma along with the key words “Cancer Testing”. It yielded 15 SDVOSB/VOSB vendors. Phone calls and/or emails to 8 of them either got no response or the vendor verified they could not provide the Oncotype tests necessary for this requirement. The other 7 were not testing labs and appeared to be consulting type vendors that would act as a pass through to testing labs.

(7) Any Other Facts Supporting the Justification:

Genomic Health provided a letter explaining the proprietary nature of the required tests. There are no other authorized vendors for these tests at this time. The specific genetic markers regarding these oncology tests are offered only through the Genomic Health proprietary tests.

(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:

All future requirements for specialized genetic oncology testing will be competed to the greatest extent practicable, including the consideration of the Veterans First program as well as all other possible small business set-asides. The market will be evaluated to determine if the Genomic Health Oncotype tests are still the best fit for the requirement, as well as if additional vendors offer the same types of tests.

VHAPM Part 808.405-6 Limiting Sources Page 5 of 6

Revision 02 Eff Date: 02/21/2020

(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

Tania Urenda Medical Technologist Path / Lab

NAME TITLE SERVICE LINE/SECTION

Rocky Mountain Regional VA Medical Center

FACILITY

(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.

_____ _______08/10/20_______________________

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

Ian Boettcher – Contracting Officer NCO 19__________________________

NAME AND TITLE FACILITY/NCO/PCO

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

Danny O. Freeman Director of Contracting, NCO 19 https://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx https://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx VHAV19FreemD Typewritten Text 09/03/2020

VHAPM Part 808.405-6 Limiting Sources Page 6 of 6

Revision 02 Eff Date: 02/21/2020

HIGHER LEVEL APPROVAL (Required for orders over $700,000):

c. VHA RPO HCA Review and Approval (over $700,000 to $68 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 DATE Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)