A.02.04_Limited_Sources_Justification_KO_Signed.docx

Control Number: 16-RHCO-C-228 Limited Sources Justification or Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold (Simplified Acquisition Threshold is $150K)

1. Contracting Activity: This requirement is for Evan Army Community Hospital. The contracting activity is Regional Health Contracting Office-Central, Fort Carson Health Contracting Cell, Fort Carson, CO.

2. Description of Action:

3. Description of Supplies/Services: Vendor will provide the Afirma Thyroid Gene Expression Classifier (GEC) test to the Department of Pathology, Evans Army Community Hospital, Fort Carson, Colorado. The amount of the estimated total value is $64,000.01.

4. Authority Cited:

|X| (a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

|_| (b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

|_| (c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

|_| (d) FAR 8.405-6(a)(1)(i)(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; OR

|_| (e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures. (1 October 2015)

5. Reason for Authority Cited: The Afirma Gene Expression Classifier (GEC) test is a proprietary diagnostic test developed by Veracyte, Inc. for the preoperative identification of benign thyroid nodules whose cytology is indeterminate. Testing is offered through a sole source, Clinical Laboratory Improvement Amendments (CLIA) certified reference laboratory. The Afirma GEC test is protected by a patent portfolio covering the test method (RNA extraction, amplification, etc.) and test algorithm that correlated a thyroid biopsy gene expression signature with a benign tumor histopathology. The US Patent and Trade Office has recognized as valid and issued to Veracyte, Inc. patent claim numbers US 8,541,170 and US 8,669,057. Market Research indicated that no other tests actually test for the thyroid gene expression.

6. Actions to Increase Competition: Efforts to provide full and open competition will include, posting a sources sought announcement on Fed Biz Ops and conducting thorough market research to seek other vendors who can provide similar testing.

7. Market Survey: A review of a variety of VA FSS and an on-line review of the market place indicate that the Thyroid Gene Expression Classifier (GEC) tests are only available through one source. Many of the competitors found in both the open market and VA FSS schedules do not provide the test. Since the Thyroid Gene Expression Classifier (GEC) test is owned by Veracyte, Inc. it is determined that a sole source award to Veracycte, would be most advantageous to the Government. A Federal Business Opportunities (FBO) sources sought post was done on 5 APR 16 and closed 11 APR 16, stating the government’s intent to award a contract for the Thyroid Gene Expression Classifier (GEC) test. No responses were received. Since the Afirma Thyroid Gene Expression Classifier (GEC) test is by Veracyte, Inc. the price the Government expects to pay is $64,000.00.

8. Procurement History:

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this mini-J&A are accurate and complete to the best of my knowledge and belief.

Submitted By:

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

(1 October 2015) image1.png image2.emf image3.emf