Att 1-Brand Name Justification- OKC Stryker CORE Systems with TPX and Acc.pdf

Justification Tracking Number: 2023 08 30T14:19:03

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Brand Name Justification Template >SAT $7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: AP#

1. Contracting Activity: Organizational Activity:

Department of Veterans Affairs Department of Veterans Affairs Network Contracting Office 19 (NCO 19) Oklahoma City VA Health Care System 6162 South Willow Drive, Suite 300 921 N.E. 13th Street Greenwood Village, CO 80111 Oklahoma City, OK 73104

2237#:

2. Nature and/or Description of the Action Being Processed: This Brand Name procurement is for a new firm fixed price Stryker CORE Systems with TPX and Accessories for the Oklahoma City VA Health Care System (OKC). The estimate total is .

3. Description of Supplies/Services Required to Meet the Agency’s Needs: OKC requires the purchase of five (5) Stryker CORE systems, with eight (8) TPX power tool attachment and accessories sets, and three (3) Elite cutting attachments, which are complete systems for various orthopedic, dental, ENT, neuro and endoscopic applications and procedures.

The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to orthopedic, dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

The TPX attachments are intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drill is intended for use in cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to Dental, ENT (ear, nose and throat), Neuro, Orthopedics, Spine and Endoscopic applications. It is also usable in the placement or cutting of screws, metals, wires, pins, and other fixation devices.

The Elite and Heavy Duty Attachments are intended to be used with the Stryker Consolidated Operating Room Equipment (CORETM) console and electric and pneumatic motors. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone and bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otorhinolaryngology; Craniofacial and Maxillofacial; Dental; and Endoscopic applications. The specific applications include Craniotomy/Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach

Attachment 1: Request for Brand Name Justification Template >SAT $7.5M under FAR13.5

Effective Date: 02/01/2022 Page 2 of 4

(EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, segmenting, splitting, fragmenting, extracting, removing, drilling, and reaming. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, deburring, smoothing or shaping of metal, and removing/rounding sharp edges.

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): Stryker is the only company available that offers such a highly specialized comprehensive operating room system compatible with the Stryker system already in use at the OKC facility. Stryker solely owns all proprietary rights in and to the CORE, TPX, and Elite systems. Stryker is also the sole source manufacturer of the CORE system and all its associated instrumentation. Stryker sell this equipment in conjunction with

, both SDVOSBs, in the United States.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted to identify Stryker authorized distributors able to full this requirement. were both identified as potential distributors able to fulfil the requirement. Since the manufacturer is a large business and no waiver exists, the Non Manufacturer Rule cannot be met on a set aside. Therefore, recommendation is to solicit this Brand Name requirement on an unrestricted basis to allow the SDVOSBs the opportunity to quote the requirement.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: It is anticipated that a fair and reasonable price determination will be found with the pricing received on quotes due to this requirement planned to be competitive to the manufacturer and authorized distributors. A determination of fair and reasonable pricing will also be prepared prior to award of the subsequent contract.

Attachment 1: Request for Brand Name Justification Template >SAT $7.5M under FAR13.5

Effective Date: 02/01/2022 Page 3 of 4

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 using GSS, FSS, ECAT, VetBiz, GSA Advantage, and communications to potential vendors. Three vendors were identified:

Stryker (Large Business Manufacturer), , and (SDVOSB).

These companies are able to provide the comprehensive operating room systems, with all of its many components, attachments, and instruments, as listed in paragraph 3 of this document.

Verified via VIP database that and are verified SDVOSBs.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The CORE system exists within the OKC in their operating rooms. The OKC surgeons have been trained using this equipment and familiarity with the equipment will enable them to provide the necessary patient care without gap in training/patient care. The equipment is needed for immediate patient care.

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

a.

b.

c. Stryker

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: This requirement is recommending competition to fulfill the requirement. Future requirement will continue to consider additional small businesses for 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.

Date

Oklahoma City VA Health Care System

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.

Date

Contracting Officer Network Contracting Office (NCO) 19

Attachment 1: Request for Brand Name Justification Template >SAT $7.5M under FAR13.5

Effective Date: 02/01/2022 Page 4 of 4

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.

Date

Branch Chief, Supply 1 Network Contracting Office (NCO) 19