Brand Name Only J_A for Tucson Surgical Tools.pdf

OFOC SOP Revision 11 Page 1 of 4 Original Date: 03/22/11 Revision 11 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: 36C258-21-AP-1142

1. Contracting Activity:

Department of Veterans Affairs

VISN 22

Southern Arizona VA Medical Center Contracting Agency: NCO22-G 2237: 678-21-3-071-0086

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

The Southern Arizona VA Medical Center needs to replace their antiquated Medtronic MR8 drill system. This system is comprised of both Electric and Pneumatic powered, rotary cutting handpieces, attachments, surgical dissecting tools, and accessories designed to remove soft and hard tissue, bone, and biomaterials during various surgical procedures. The surgical dissecting tools are provided sterile and are single use, while the rest of the system components are provided non-sterile and are reusable. The Midas Rex MR8 ClearView Tools, which are currently in use at the Medical Center, are designed to interface with Midas Rex MR8. The Medtronic MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Cranial and Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

Drill System motor to support bone and tissue removal during surgical procedures. Additionally, the MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

• Lumbar Microdiscectomy

• Lumbar Stenosis Decompression

• Posterior Lumbar Interbody Fusion (PLIF)

• Transforaminal Lumbar Interbody Fusion (TLIF)

• Anterior Lumbar Interbody Fusion (ALIF)

• Direct Lateral Interbody Fusion (DLIF)

This action will be awarded as a new contract. The Government anticipates awarding a firm-fixed price contract to a single vendor.

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

The Southern Arizona VA Medical Center needs to procure 6 (EA) Medtronic Midas Rex MR8 electric high speed drill systems to replace current equipment that is approaching end-of-life and will

OFOC SOP Revision 11 Page 2 of 4

Revision 11 Date: 02/11/2021 eventually be out of warranty and no lnger available for the required periodic maintenance. The Medical Center is fast approaching losing this vital capability needed to provide first class medical care to our Veterans. The estimated delivery of this equipment is 30 days ARO.

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;

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 Medical Center is requesting a brand name only acquisition of the Medtronic Midas Rex MR8 electric high-speed drill system. The Medtronic MR8 system will repace the antiquated Midas Rex Legand EHS currently in use at the Medical Center. The current system is nearing end-of-life and this requirement will ensure that there is no loss a care for our Veterans. This is highly specialized equipment used for the incision/cutting, removal drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Cranial and Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Artroscopic, Spinal, Sternotomy, and General Surgical procedures.

Replacing this system with an alternative would require surgeons to train on and become familiar with a new type of surgical equipment. The power console infrastructure would need to be replaced if an alternative system were to be installed. The sterilization equipment and processes would need to be updated. Choosing an alternative system would cause unacceptable delays in the critical care provided to our Veterans. Substantial duplication of costs to the Government would be incurred if an alternative system is selected. The removal and replacement of the current system would be cost prohibitive. Accordingly, Medtronic USA, Inc. is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost, and also experiencing unacceptable delay in fulfilling its requirements that could not be expected to be recovered through competition.

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

Market research has shown that there are four SDVOSB concerns who are authorized via a teaming agreement with Medtronic to sell/distribute these items. This requirement will be solicited on the open market, unrestricted. The Government anticipates two or more offers from SDVOSB concerns, and any other small business concern authorized to provide these items.

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

Reasonable: Because competition is expected to be brisk, the Government has a reasonable expectation that a fair and reasonable price will be provided via competition.

OFOC SOP Revision 11 Page 3 of 4

Revision 11 Date: 02/11/2021

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

Market research was conducted by the Contract Specialist and the Medical Center. Interviews were conducted with knowledgeable members of both Government and Industry. Because of unacceptable delay and unreasonable costs involved with removing and repacing the Medtronic system currently in place, and the medical center personnel’s compatibility with the current system, the SAVAMC is requesting a brand name specific acquisition Midas Rex MR8 Drill System.

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

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

Academy Medical Affirmative Solutions Marathon Medical Veterans Healthcare Supply Solutions

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:

No actions are planned. The costs of removing and repacing the infrastructure involved with an alternative brand will outweigh the benefits of competition.

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.

Anna Malone Program Specialist / COR Tucson VA Medical Center

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

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.

Abdalia Smith Branch Chief / Contracting Officer

NCO22-G

Anna M. Malone 292577

Digitally signed by Anna M.

Malone 292577 Date: 2021.08.07 08:03:42 -07'00'

Abdalia R.

Smith 690283

Digitally signed by Abdalia R. Smith 690283 Date: 2021.08.08 09:27:14 -07'00'

OFOC SOP Revision 11 Page 4 of 4

Revision 11 Date: 02/11/2021

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.

Chief

NCO22-G

Lori A. Faber 1550168

Digitally signed by Lori A. Faber 1550168 Date: 2021.08.09 15:38:39 -07'00'