Final Justification and Approval - Photopheresis Requirement (Signed)__Redacted.pdf

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 4 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C249-20-AP-3082

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Network Contracting Office 9 (NCO), 1639 Medical Center Parkway, Suite 400, Murfreesboro, TN 37129. Purchase Request number: 626-21-1-200-0003

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

The Tennessee Valley Health System (TVHS) Nashville Medical Center requires Therakos Cellex sterile photopheresis procedural kits to provide photopheresis blood treatments to veterans.

Photopheresis is an FDA-approved apheresis procedure used to treat cutaneous T-cell lymphoma, graft-vs-host disease and transplant organ rejection. The Nashville Medical Center is the only medical center in the Veterans Affairs Healthcare System providing this procedure and has done so since 1988.

During the procedure, whole blood is removed from the patient and centrifuged. Then, the white blood cell, fraction spiked with methoxypsoralen, is exposed to an ultraviolet A (UVA) light source before being returned to the patient. The procedure is completed using a closed loop sterile kit that includes sterile IV tubing, centrifuge bowl and a clear acrylic photoactivation plate. Each treatment requires a sterile kit, which and is disposed after each procedure. The government is seeking a Firm Fixed-Price Purchase Order for the required Photopheresis kits and associated supplies.

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: $617,726.00

This acquisition is for the purchase of Therakos Cellex photopheresis procedural kits to perform photopheresis on veterans who require the procedure for treatment. The Veterans Affairs Tennessee Valley Health System Nashville Medical Center is the only medical center in the Veterans Affairs Healthcare System providing this procedure and has provided the immune modulating blood procedure to veterans from across the country. The Therakos Cellex sterile photopheresis procedural kits are the only kits available to work in the FDA-approved Therakos Cellex photopheresis device. The establishment of a purchase order is essential for continued photopheresis treatments for veterans. Only Therakos, Inc., a Division of Mallinckrodt Pharmaceuticals manufactures the kits necessary to continue this vital procedure for the veterans we serve. The photopheresis procedure is a crucial treatment modality for veterans with cutaneous T-cell lymphomas, a form of Non-Hodgkin lymphoma, and graft-vs-host disease, a complication of hematopoietic cell transplant used to treat aggressive leukemias and lymphomas.

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 4

4. Statutory Authority Permitting Restricted Competition:

Therakos, Inc., a Division of Mallinckrodt Pharmaceuticals is the only manufacturer and distributor of the Therakos Cellex sterile photopheresis procedural kits necessary to continue to provide photopheresis. Therefore, there is only one responsible source and no other supplies or services will satisfy our agency’s requirements per FAR 6.302-1.

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

FAR13.5 Simplified Procedures for Certain Commercial Items: This requirement meets the criteria for using simplified procedures under FAR 13.5 Simplified Procedures for Certain Commercial Items, as it is exclusively for the procurement of commercial supplies, exceeds the simplified threshold, but does not exceed $7M.

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Therakos, Inc., a Division of Mallinckrodt Pharmaceuticals is the original manufacturer and distributor of the Therakos Cellex photopheresis device and Therakos Cellex sterile photopheresis procedural kits. They are the only one responsible source.

Tennessee Valley Health System Nashville Medical Center is the only medical center in the Veterans Affairs Healthcare System providing this highly specialized procedure. The photopheresis procedure is a crucial treatment modality for veterans with cutaneous T-cell lymphomas, a form of Non- Hodgkin lymphoma, and graft-vs-host disease, a complication of hematopoietic cell transplant used to treat aggressive leukemias and lymphomas. Veterans from around the country have been and continue to be treated with photopheresis at Tennessee Valley Health System Nashville Medical Center.

The advantages of photopheresis over other treatment modalities include the lack of side effects, lack of interference with co-morbid conditions and, most importantly, its immune modulating or enhancing effects to treat immune mediated disease.

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 36C24920Q0364 was posted to Beta SAM on 08/06/2020 and closed on 08/12/2020. None of the source submissions demonstrated the capability to meet the requirement in its entirety other than Therakos, Inc., a Division of Mallinckrodt

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 4

Pharmaceuticals.

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

Based on market research and historical pricing established with the previous acquisition of the exact same items under 36C24920P0008, the anticipated costs to the government for the fulfillment of this requirement are expected to be fair and reasonable.

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

Market Research was initiated with the search for Service Disabled veteran-Owned Small Businesses and Veteran-Owned Small Businesses through the Vendor Information Pages at https://www.vip.vetbiz.va.gov/, using search term “Photopheresis”, which resulted in zero available SDVOSB/VOSB vendors. Research continued with a search of GSA eLibrary and VA National Acquisition Center database using the manufacturer’s business mname and product name and other terms, which resulted in zero vendors. See Market Research report for details.

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

According to the Therakos, Inc. the required Therakos Cellex sterile photopheresis procedural kits are proprietary to Therakos, Inc. There are no authorized vendors or distributors for these products except Therakos, Inc., the original equipment manufacturer (OEM).

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

None, other than the manufacturer.

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 these supplies in future procurements. However, at the present time, based on available market research, there are no vendors capable of providing the required supplies other than Therakos, Inc.

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

8/13/20

PM Part 813.5 SAP for Certain Commercial Items Page 4 of 4

Revision 02 Date: 08/04/2020

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

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 $700K): I certify the justification meets requirements for other than full and open competition.