JA Over SAT Axumin Final_52721 Signed_Redacted.pdf

36C244-21-AP-3131

PM Part 813.5 SAP for Certain Commercial Items Page 4 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C244-21-AP-3131

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Corporal Michael J. Crescenz VA

Medical Center, 3900 Woodland Avenue, Philadelphia, PA 19104. Purchase Request Number 642- 21-3-029-0107

2. Description of the Action Being Processed:

This is a Brand Name requirement for Axumin (fluciclovine F 18 Injection). This must be ordered through a company that is licensed by the Nuclear Regulatory Commission that provides the radiopharmaceutical and calibration sources required. This radiopharmaceutical drug is required for an imaging procedure for prostate cancer that will be offered to Veterans at the Philadelphia VA Medical Center. The calibration sources are required for equipment quality and control testing.

Axumin injection is designated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment(s).

Item Number Description Quantity Price Per Unit

0001 Axumin (fluciclovine F 18 Injection) 168

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

Axumin is to be delivered directly to the Diagnostic Imaging section of Nuclear Medicine (secured receiving areas), room 3A101B, Philadelphia Veterans Administration Medical Center. Only the Nuclear Medicine department’s authorized staff at the CMCVAMC, will place orders when needed for next day delivery. There may be orders placed during other than normal working hours, to be delivered within 1 hour for in an emergency situation. The vendor must be able to fulfill this requirement. All items delivered to the Nuclear Medicine department as specified above.

CMCVAMC will require credit statements (itemized returned doses) and monthly invoices.

Electronic daily dose tracking systems should be available for the Medical Center’s use in certifying and tracking per patient doses delivered.

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4. Statutory Authority Permitting Restricted Competition:

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 per 41 USC §3304(a)(1) as implemented by FAR 6.302-1(c) Brand Name.

( ) 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):

This Brand Name radiopharmaceutical drug is required for an imaging procedure to treat prostate cancer. PetNet Solutions Inc. (Large Business) a subsidiary of Siemens Healthineers company and Trillamed, LLC. Service Disabled Veteran Owned Small Business (SDVOSB) has been verified as the only authorized reseller by PetNet Solutions Inc. to assit in their government supply chain distribution. Trillamed currently provides Axumin to over 20 VA Medical Centers.

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

This Brand Name solicitation will be posted Unrestricted to allow both PetNet Solutions Inc. (Large) and Trillmed LLC (SDVOSB) to provide quotes.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

This Brand Name requirement will be competed in the Open Market. Fair & Reasonableness will be determined by competition. After responses are received, a comparison will be done of the responsible responses. At that time, the Contracting Officer will determine price fair & reasonableness.

In the case of a Brand Name justification under 6.302-1(c), the justification shall be posted with the solicitation (see 5.102(a)(6)).

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 to Brand Name on this procurement via FAR 13.106-1(b)(2).

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8. Description of the Market Research Conducted and the Results:

Market Research was conducted utilizing search engines on the Vendor Information Pages, National Acquisition Center, General Service Administration and System for Award Management websites.

PetNet Solutions (Large) and Trillamed, LLC (SDVOSB) are the only authorized distributors of Axumin and there are no additional authorized distributors.

Trillamed LLC. has an active Center for Veteran Enterprise (CVE) certification.

None of the additional searches or market research history have identified any other capable and responsible sources for the delivery of Axumin.

There is no class waiver to the Non-Manufacturing Rule under North American Classification Code 325412, and no additional small businesses distributors for Axumin.

Therefore, based on the market research and the non-manufacture rule this requirement will be solicited as unrestricted to include PetNet Solution, Inc. (Large) and Trillamed LLC. (SDVOSB)

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: PetNet Solution Inc.

and Trillamed, LLC.

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:

Market research will be ongoing, Axumin is not offered as a generic drug at this time. The purchase order will be awarded for one year due to the volatility manufacture pricing.

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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.

Date

Program Analyst Corporal Michael J. Crescenz VA Medical Center

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

a. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Andrew Taylor Contracting Officer NCO4, Commodities 2

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.

Branch Chief NCO4, Commodities 2

PM Part 813.5 SAP for Certain Commercial Items

PM Part 813.5 SAP for Certain Commercial Items Page 4 of Original Date: 08/30/17 Revision 03 Date: 02/11/2021

Division Chief, Division 2, NCO4

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Executive Director, RPO East