Limiting Sources Justification Oncotype Testing.pdf

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

36C246-24-AP-0994

Effective Date: 02/01/2022 Page 1 of 3

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C246-24-AP-0994

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 06, located at 100 Emancipation Dr., Hampton, VA 23667 in support of Durham VA Medical Center.

(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). A firm fixed price purchase order for a period of five years, during which the Durham pathology and laboratory service is expected to collect and ship forty samples to Exact Sciences for oncotype DX testing. The standard of care test for predicting the prognosis of breast cancer, oncotype, is utilized in treatment planning.

Order against: FSS Contract Number: V797D-70053

Name of Proposed Contractor: Exact Sciences Corporation

Street Address: 5505 Endeavor Lane

City, State, Zip: Madison, WI 53719

Phone: 866-662-6897

(3) Description of Supplies or Services:

The contractor shall provide all labor, supervision, transportation, and supplies necessary to execute Oncotype DX Breast. This includes contractor provided materials necessary to collect, preserve, and package specimens destined to contractor laboratory; transportation of specimens from the Durham VAMC to the contractor laboratory; diagnostics testing; reporting of test results; and consultative services. The tests must cover breast recurrence score. The required services will help physicians formulate treatment plans that are specific to a patient’s individual needs, therefore optimizing patient treatment. Based on historical tests volumes, approximately 41 tests are required annually.

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

36C246-24-AP-0994

Effective Date: 02/01/2022 Page 2 of 3

(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 requested Oncotype tests are advanced and highly specialized in that they use mRNA, real-time RT-PCR of 21 genes (for breast) to process and report the specific tumor’s recurrence score, which details the composition of an individual’s specific tumor. These customizable results inform providers of the likelihood that cancer will return, how likely the cancer is to spread, and insight into how much added benefit will likely be received from chemotherapy over surgery alone. This information drives discussions with patients and helps physicians formulate treatment plans that are specific to a patient’s individual needs, therefore optimizing patient care. Genomic Health, a wholly owned subsidiary of Exact Sciences Corporation, is the exclusive laboratory provider for these tests. Therefore, these services can only be procured through Exact Sciences Corporation.

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: These items are available under an existing VA Federal Supply Schedule. Services offered on the schedule are listed as fixed price and have already been determined to be fair and reasonable. Additionally, https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6

36C246-24-AP-0994

Effective Date: 02/01/2022 Page 3 of 3 the facility doesn’t have the resources nor capability to perform the testing in house at the level of quality that is needed. Furthermore, the Oncotype DX testing are the most comprehensive tests known available and have been a standard of care at numerous VA medical centers for years. Based on this information, the anticipated award represents the best value to the Government.

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

Mandatory Services Resources: Services not available through AbilityOne.

Veterans First Contracting: No Service-Disabled Veteran Owned Small Businesses (SDVOSB) or Veteran Owned Small Businesses (VOSB) were found qualified under NAICS 621511 after a review of the populated companies’ capability statements. Additionally, federal procurement history was searched through FPDS.gov and found no history of SDVOSB or VOSB awards for Oncotype Testing. The rule of two was not met on this acquisition.

Use of Non-Mandatory Sources: Searched GSA eLibrary for the requirements brand and found one vendor listed, Exact Sciences Corporation, GSA contract V797D-70053 who has the rights and is the proprietor of the Oncotype DX Breast Test technology that is being required.

(7) Any Other Facts Supporting the Justification: These tests go beyond traditional genetic cancer screening tests that assess hereditary risk for cancer. These advanced and highly specialized tests report the tumor’s recurrence score, which details the composition of a patient’s specific tumor. The information provided from these tests have been instrumental in helping formulate treatment plans that are specific to a patient’s individual needs.

(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 Durham VAMC will continue to monitor the market for advances in cancer research and treatment that will provide the best possible patient care.

(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.