P03 JNA - Radiopharmaceuticals.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: __________________

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C246-24-AP-5901 \

1. Contracting Activity:

Department of Veterans Affairs, Network Contracting Office 06, located at 100 Emancipation Drive Hampton, VA 23667, in support of the Salem VA Medical Center at 1970 Roanoke Blvd, Salem , VA 24153.

Purchase Request #: 658-25-1-046-0001.

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

The proposed acquisition is for firm fixed price order for radiopharmaceuticals for VAMC

Salem via other than full and open competition citing Only One Awardee Capable FAR 6.302-1 The products are supplied by more than one supplier, the delivery is not possible due to the distance of delivery for other vendors. The products are time sensitive once mixed the life cycle is critical. The radioactive labeled cells and material leukocyte must be returned VAMC Salem within 1 hour of the labeling process. The c closest vendor approximately five miles away, is Blue Ridge Isotopes at 1630 Midland Rd, Salem, VA is the only vendor that can perform to the standard of the statement of work. The next closest vendor being approximately 225 miles away.

FAR13.5 Simplified Procedures for Certain Commercial Items:

This procurement is for 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.

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

The proposed acquisition is to provide radiopharmaceutical Isotopes for the Salem VA Medical Center Radiology department for nuclear medicine imaging and procedures.

This acquisition is for a single year contract to be awarded on 10-01-2014 The schedule of items includes single dose containers and multi-dose vials of multiple radiopharmaceuticals. The estimated value for the single year contract is $326,035.52.

This estimate is based on historical use data.

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

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Acquisition ID#: __________________

(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;

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

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

The unique qualification of Blue Ridge Isotopes is location. No other vendor can meet the delivery time necessary to supply the product needed by the government for daily use, the time frame for emergency delivery is much shorter. The short delivery time is justified and consistent in the market place based on the shelf life of the medication.

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

Sources Sought #36C24624Q0015 was posted on Contract Opportunities from 08-30- 2024 to 09-09-2024 to verify if another pharmaceutical company held an interest in opening a branch in the local area to meet the requested delivery terms. No vendor/vendors were found that could fulfill the needs of the government.

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

Fair and reasonable price will be determined by comparison to historical costs paid throughout NCO6 for identical line items by comparing line by line price comparison to the price quoted by the vendor. The Contracting Officer anticipates cost will be fair and reasonable based on FAR 13.106-3(a)(2)(ii).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

A sources sought was posted to Contract Opportunities from 08-30-2024 to 09-09-2024 receiving 4 responses from one SDVOSB (BHPE), upon completion of a review of their SAM and CRA reports the CO did not feel that they would not be able to fulfil the unique radiopharmaceutical requirements of this request. Two Small Businesses (Blue Ridge Isotopes), located in Salem VA, (Telix Pharmaceuticals US Inc), located in Fishersm IN and one large (PETNET Solutions) who stated on their response that they may not be qualified for all listed radiopharmaceuticals products listed on the sources sought. Due to the short

VHAPG Part 806.3 OFOC Page 3 of 4

Acquisition ID#: __________________ life span of the radiopharmaceutical isotopes, further research was conducted to look at the physical location of each of the vendor who responded to the Source Sought to see if they could meet the 1-hour delivery time requirement. Of the four on Blue Ridge Isotopes was found to be able to meet this requirement. Bases on the market research above CO does not anticipate on receiving a quote from any other vendor than Blue Ridge Isotopesthe can make a deliver within the required sensitive time frame. The CO believes that it is in the best interest of the government to award this requirement directly to Blue Ridge Isotopes IAW FAR 6.302-1 to satisfy the program need date.

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

Sources sought 36C24624Q0015 received four responses:

BHPE, LLC (SDVOSB), 901S Spring LN, Blanchaerd , OK 73010 .

BlueRidge Isotopes Inc. (Small Business), 1630 Midland Rd, Salem VA, 24513.

Telix Pharmaceuticals US Inc. (Small Business), 11700 Exit 5 PKWY, Fishers IN, 46037.

PETNET Solutions, Inc. (Large Business), 810 Innovation Dr. Knoxville, TN 37932.

10. 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:

At this time, there are no actions that may be taken to overcome any barriers to competition. The Contracting Officer will continue to monitor the market for new vendors.

11. 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.

Emily Cyrus Date Administrative Officer Salem VAMC

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

EMILY CYRUS Digitally signed by EMILY CYRUS Date: 2024.09.24 10:27:35 -04'00'

VHAPG Part 806.3 OFOC Page 4 of 4

Acquisition ID#: __________________

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

James Risbon Date Contract Specialist

NCO 6

James Mann Date Branch Chief, Supply/Service 1

NOC 6

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.

Keeshia Newman Date Division 1

NOC 6

JAMES

RISBON

Digitally signed by JAMES

RISBON

Date: 2024.09.24 10:44:44 -04'00'

JERRY MANN Digitally signed by JERRY MANN Date: 2024.09.24 11:02:41 -04'00'

KEESHIA

NEWMA

N

Digitally signed by KEESHIA

NEWMAN

Date: 2024.09.24 14:59:30 -04'00'