Justification Radiopharma_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans Affairs, VISN 7, Network Contracting Office (NCO) 07.

In support of the Department of Veterans Affairs, Birmingham VA Medical Center, Nuclear Medicine Service, 700 South 19th Street, Birmingham, Alabama 35233. Purchase request number

2. Nature and/or Description of the Action Being Processed: This procurement is for a new base plus four option years firm-fixed price contract for Miscellaneous Radiopharmaceuticals 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. The award will be a single, open market contract using other than full and open competition.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Contractor shall provide all labor, compounding, supervision, and transportation necessary to provide daily delivery, including one-hour emergency orders, of the radiopharmaceuticals listed in Table 1 below. All deliveries must be received by the delivery date requested and in the quantities and dosage specified at the time the order is placed.

Table 1 – List of Radiopharmaceuticals and quantities (annual estimates).

Item # Product (Unit Doses) Quantity (Estimated)

1 I 131 Iodine Diagnostic 20 2 99m Tc Sulfur Colloid Filtered 20 3 99m Tc Sulfur Colloid Egg Sandwich 50 4 I131 Therapy capsule 1-6mCi 20 5 Tc99m WBC Set-up 5 6 Ceretec WBC Study 5 7 (Mag-3) Tc-99m Mertiatide ERPF Standard 60 8 (Mag-3) Tc-99m Mertiatide UD 60 9 I123 MIBG Dose 2

10 I123 Cap (price for 100 uCi) 10 11 I-131 USP NaI TX Cap 10 12 NaF Dose 100 13 FDG Dose 800 14 FDG Source 20 15 Sestamibi 2100 16 Ceretec Brain Study (Exametazime) Unit dose 1

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17 MAA Unit Dose 80 18 MDP Unit Dose 250 19 DTPA Aerosol (Pentetate) Unit Dose 40 20 PYP Unit Dose 20 21 PYP Vial 5 22 Mebrofenin Unit Dose 70 23 Tc-99m Na Tc04 UDuCI 30 24 Tc-99m NA multidose Per mL 100 25 Tc -99m NaTc04 UD mCi 120 26 In-111 DTPA Vials 1 27 Sulfur Colloid Unit Dose 10 28 Lymphoseek Dose - (Brand Specific) 15 29 Tc-99m Succimer UD (DMSA) 5 30 Ga-67 Gallium Citrate UD per mL 50 31 TL-201 Thallous Chloride Unit dose 30 32 I 123 Cap (price for 200 uCi) 10

The estimated value of the proposed action is for one base year and four, one-year option periods.

Period of Performance Total Base 1/1/2023 - 12/30/2023 Option 1 1/1/2024 - 12/30/2024 Option 2 1/1/2025 - 12/30/2025 Option 3 1/1/2026 - 12/30/2026 Option 4 1/1/2027 - 12/30/2027

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

( ) 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): VA Physicians prescribe the items

Effective Date: 02/01/2022 Page 3 of 5 listed in Table 1 for specific characteristics in patient care. The product Lymphoseek is required for lymphatic studies due to its unique mechanism of binding therefore, no alternate product will suffice. Lymphoseek is proprietary to, and can only be provided by, Cardinal Health. Accordingly, Cardinal Health is the only firm capable of providing all of the the supplies described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted in the Vendor Information Pages (VIP), Small Business Administration’s Dynamic Small Business Search (DSBS), GSA’s eLibrary, and the Federal Procurement Data System to identify all potential sources for this procurement. A sources sought notice was published on Contract Opportunities from 9/16/2022 – 9/23/2022 encouraging interested and capable vendors to respond to the notice. Three large businesses responded to the sources sought notice and as a result, solicitation 36C24723Q0064 was issued unrestricted on Contract Opportunities from 10/24/2022 to 10/31/2022. Only two vendors (large) submitted quotes to the solicitation. However, one of the vendors did not submit pricing for all items.

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

Reasonable: The Contracting Officer anticipates that the cost will be considered fair and reasonable based on a comparison of prices proposed for this requirement to the facility’s current contract 36C24722P0959 (7/1/2022 - 12/31/2022), the IGCE, and prices submitted in response to the previous solicitation.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As described in Section 6 above, market research was conducted in accordance with FAR Part 10 in the Vendor Information Pages (VIP), Small Business Administration’s Dynamic Small Business Search (DSBS), GSA’s eLibrary, and the Federal Procurement Data System to identify all potential sources for this procurement. Research showed numerous vendors offering various radiopharmaceuticals but the products were different than those specified under this requirement. A sources sought notice was published on Contract Opportunities from 9/16/2022 – 9/23/2022 encouraging interested and capable vendors to respond to the notice. Three large businesses responded to the sources sought and as a result, solicitation 36C24723Q0064 was issued unrestricted on Contract Opportunities from 10/24/2022 to 10/31/2022. Two large businesses submitted quotes for the solicitation. However, only Cardinal submitted pricing for all items.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The Nuclear

Medicine department provides continuous care with a variety of Nuclear Medicine imaging test and the radiopharmaceuticals in accordance with prescribed physicians requests. This requirement includes Lymphoseek, a product prescribed by VA physicians for certain lymphatic studies due its unique mechanism of binding. Therefore, no alternatives may be used when Lymphoseek is ordered.

Lymphoseek is proprietary to, and can only be provided by Cardinal. Additionally, due to short lifespan of the active materials, there is a small window to prepare, deliver, and use the material before it is no longer effective. As a result, the facility requires a single firm-fixed price contract be awarded to one contractor who can provide all items on an as needed basis, including the 1-hour emergency orders.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Three large business responded to the sources sought notice. However, response to the previous solicitation shows only one vendor can provide all requested items.

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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.

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.