Final Approved J_A - PETNET Radiopharmaceuticals_Redacted.pdf

OFOC SOP Revision 09 Page 1 of 5 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C249-20-AP-0757

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration (VHA), Network Contracting Office 9 (NCO), 1639 Medical Center Parkway, Suite 400, Murfreesboro, TN 37129. Purchase Request number: 626-21-1-165-0002.

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

The Tennessee Valley Healthcare System (TVHS) requires daily compounding and delivery of calibrated Positron Emission Tomography (PET) radiopharmaceuticals, including Fluorodeoxyglucose (FDG), Nitrogen-13 Ammonia Imaging Protocol (N-13), Florbetapir (Amyvid), Sodium Fluoride (NaF), and Fluciclovine F18 (Axumin), in order for imaging studies to be performed on patients. This requirement will result in a Firm Fixed-Price Indefinite Delivery Indefinite Quantity (IDIQ).

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement will establish an IDIQ contract in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically, FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303 2.

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

The estimated value of the proposed action is: Ordering Period One: $375,000.00 Ordering Period Two: $375,000.00 Ordering Period Three: $382,500.00 Ordering Period Four: $382,500.00 Ordering Period Five: $382,500.00

TOTAL: $1,897,500.00

This acquisition is for the delivery of calibrated unit doses of PET radiopharmaceuticals to the Nuclear Medicine Department at the Nashville Veterans Affairs Medical Center (VAMC) campus at 1310 24th Avenue South, Nashville, TN 37212 and the Alvin C. York campus at 3400 Lebanon Pike, Murfreesboro, TN 37129. An estimated minimum of 1140 doses of FDG, 80 doses of N-13, and 25 doses of Axumin will be required annually. The acquisition also includes the removal of all radioactive waste generated, to include all syringes and vials, in accordance with Occupational Safety and Health Administration (OSHA) guidelines, Department of transportation (DOT) regulations, Board of Pharmacy regulations pertinent to radiopharmaceuticals, and the Nuclear

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Regulatory Commission (NRC). The establishment of a new multiple year IDIQ contract is essential for providing continual support of this critical capability for the care of this nation’s veterans. The period of performance for the IDIQ will be 10/01/2020 through 09/30/2025.

4. Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

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

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

PETNET Solutions, Inc. is a major manufacturer of F-18 FDG, F-18 NaF, and N-13 Ammonia, and the first company to sign a manufacturing and distribution agreement with top pharmaceutical corporations such as Eli Lilly, for the production of Amyvid, and Blue Earth Diagnostics, for the production of Axumin. The PETNET radiopharmacy operates the largest PET network with over 40 cyclotron equipped manufacturing and distribution centers in the United States. The isotopes required to fulfill this acquisition have abbreviated half-life and decay quickly, therefore a local contractor with a cyclotron is paramount. N-13 ammonia has half-life of 10 minutes, so the production facility must be within minutes from the VA campuses. PETNET manufactures isotope material from a facility at Vanderbilt University and is the only vendor that satisfies not only the critical proximity requirement but is able to fulfill requirements across the entire range of radiopharmacy materials. As the principal supplier of PET tracers in Middle Tennessee, PETNET’s close proximity permits short notice ordering of additionally needed doses for timely care of patients. A facility with additional travel time would lead to insufficient doses being delivered to the facility. Inadequate doses would either be denied at the facility or have an adverse impact image quality and outcomes at the facility.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A Sources Sought Notice under solicitation number 36C24920Q0086 was posted to Beta SAM on 02/04/2020 and closed on 02/11/2020. The notice, utilizing North American Industry Classification System (NAICS) 325412 Pharmaceutical Preparation Manufacturing and Product

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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:

The Department of Veterans Affairs will continue to seek vendors capable of providing radiopharmacy isotope material in future procurements. However, at the present time, based on available market research, there are no other vendors capable of providing the required supplies other than PETNET Solutions, Inc.