Attachment 36C25921Q0337 Sole Source Justification_FAR13.5_JA_OVER_SAT Sirtex.pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 3 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

2021-02-25T14:28:37 Acquisition Plan Action ID: 36C259-21-AP-1663

1. Contracting Activity: Organizational Activity:

Department of Veterans Affairs Oklahoma City Veterans Network Contracting Office 19 (NCO 19) Affairs Medical Center 6162 South Willow Drive, Suite 300 921 NW 13th St.

Greenwood Village, CO 80111 Oklahoma City, OK 73104

2. Nature and/or Description of the Action Being Processed:

The Nuclear Medicine Service is a vital clinical service within the Oklahoma City Veterans Affairs Medical Center to provide care for veterans. Y-90 sir-spheres micropsheres consist of biocompatible microspheres containing the radioactive isotope yttrium-90. This permanent implant is indicated for the treatment of patients with unresectable metastiatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy. A firm-fixed-price contract is requested to cover a one year time period from 4/1/21 to 3/31/22.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The quantities shown below are estimates for this facilities requirments. The Oklahoma City Veterans Affairs Medical Center Nuclear Medicine Service is requesting doses and ancillary supplies.The requested 16 doses will treat 16 patients. Y-90 Sir-Sphere micorspheres therapy consists of 1 dose to be delivered to the patient via arterial catheter by Interventional Radiology. Each item is ordered by phone by Nuclear Medicine approximately one week prior to patient treatment – dates and times of the therapy are spectifc to each individual patient and treating physician. This items are required to be purchased directly from Sirtex Medical Inc.

1 SIR-Y001 Y-90 SIR-Spheres 16 ea

2 SIR-10200 SIROS D-Vial Prep Set 2 ea

3 SIR-10300 SIROS Delivery Set 2 ea

4 SIR-10100 Delivery Dome 1 ea

5 SIR-S001 Syringe Shield 1 ea

4. Statutory Authority Permitting Restricted Competition:

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 3

Revision 03 Date: 02/11/2021

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or

Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority):

Y-90 SIR-Spheres Microspheres consist of biocompatible microspheres containing yttrium-90, a high energy, pure beta emitting isotope. SIR-Spheres microspheres are a permanent implant for the treatment of unresectable metastatic liver tumors. The SIR- Spheres are the only FDA approved Y-90 product on the market. Y-90 SIR- Spheres Microspheres are only manufactured by Sirtex Medical, Inc.; and it can only be ordered directly from Sirtex Medical, Inc. as there are no authorized distributors.

The Oklahoma City VA Medical Center needs to purchase Y-90 Sir-Spheres for therapy in selected patients who meet the requirements (non-resectable liver tumors from primary colorectal cancer). This is a patient specific purchase –and a time sensitive purchase (as it is a radioactive material).

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Intent to Sole Source Notice will be posted on Contracts Opportunities, BETA.SAM.gov, allowing for an opportunity for sources to respond if their companies offer products that may have the capability of meeting the VA’s requirement.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Prices will be determined fair and reasonable through review of www.fpds.gov regarding orders placed by other facilities and comparing those prices to assure the same or lower prices are offered to the VA.

8. Description of the Market Research Conducted and the Results, or a Statement of the

Reasons Market Research Was Not Conducted: A search on FPDS-NG was completed and results showed awards only to Sirtex Medical, Inc. for this product. Sirtex Medical, Inc., a small business, was contacted and it was confirmed by email (see copy in the briefcase) http://www.fpds.gov/

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 3

Revision 03 Date: 02/11/2021 that the product is manufactured by Sirtex, Medical, Inc.; and it can only be ordered directly from Sirtex Medical, Inc. as there are no authorized distributors.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Sirtex

Medical, Inc., 303 Unicorn Park Drive, Woburn, MA 01801.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any

Barriers to Competition before Making subsequent acquisitions for the supplies or services required: New developments regarding nuclear medicine will be evaluated for consideration for future requirements.

12. 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 and belief.

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

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