S02 - ATTACHMENT 5 - P03 - SIGNED - HTHC POWER TOOLS STRYKER INSTRUMENTS FOR MARTINSBURG VAMC - 05-09-2023.pdf

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

U.S. DEPARTMENT OF VETERANS AFFAIRS

JUSTIFICATION UNDER SIMPLIFIED PROCEDURES

FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C245-23-AP-0774

1. Contracting Activity:

U.S. Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Regional Procurement Office East (RPOE), VA Capitol Health Care Network (VISN 5), Network Contracting Office 5 (NCO 5), Station 613 Martinsburg Veterans Affairs Medical Center (VAMC) is fully responsible for Justification and Approval for order above the Simplified Acquisition Threshold (SAT).

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

The proposed action is for the purchase of Stryker TPX and F1 Small bone power system. The powertools being procured need to be compatibale with the stryker core 2 console part number 5400-052-000.

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

The Martinsburg VA Medical Center has a requirement for Stryker “Brand Name Only” Request is for 3 sets of TPX Micro Drill, oscillating saw, sagittal saw, reciprocating saw to include universal driver, cable, handswitch pin collet, ¼” drill with key, 5/32” drill with key, small drill microdrill, Hudson.modified trinkle drill, reamer, Hudson/modified trinkle reamer, to include small bone solid container.

Request is for 7 sets of F1 Micro drill, oscillating saw, sagittal saw, reciprocating saw, U-Driver, F1 small AO chuck, F1 T-latch, F1 5/32” chuck, 5/32” key, F1 wire collet and perforated container.Request is for 2 universal charger, 14 pencil batteries and 14 pistol batteries. Order will be processed upon receipt of Purchase Order

4. Statutory Authority Permitting Other than Full and Open 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 restrictin competition on this procurement. Competions is restricted on this procurement for the reason below:

( x ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

( ) (2) Unusual and Compelling Urgency ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

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( ) (4) International Agreement ( ) (5) Authorized or Required by Statute ( ) (6) National Security ( ) (7) 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):

Only One Responsible Source (FAR 6.302-1) - Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; The Stryker TPX and F1 are part of a interoperable system that is proprietary to the Stryker. Stryker TPX and F1 provides unique differentiating features, essential to the facility, that cannot be found or duplicated in any other product on the market. VA Martinsburg has existing Stryker powered surgical systems and components which are compatible with the requested system and will reduce the need to purchase redundant equipment.

Accordingly, Stryker is the only brand name capable of providing the supplies described in Section 3 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.

Items requested are compatible with equipment/console already in use. No other equipment is compatible with the stryker core 2 console which is only made by stryker.

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

Stryker is the only brand name capable of providing the supplies described in Section 3 above.

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

Fair and Reasonable:

Contracting Officer antipates that this requirement wil receive multiple offers, and therefore, fair and reasonable pricing will be determined based on competition.The evaluation will be Price Alone since the customer’s requirement is specifically defined and no other set of characteristics is acceptable, such as when an exact replacement is required, then the award basis should be Price Alone. The Contracting Officer and customer will continue to work in a collaborative effort to ensure appropriate steps will be taken to ensure the final contract price will be in the best interest and most advantageous for the Government

8. Description of the Market Research Conducted and the Results, or a

Statement of the Reasons Market Research Was Not Conducted:

Market research is always conducted in a collaborative effort with requesting service/Contracting Officer’s Representative (COR) to ensure a mutual https://www.acquisition.gov/far/part-6#FAR_6_302_1

Effective Date: 02/01/2022 Page 3 of 4 understanding to identify agency requirements. Market research for this procurement was conducted in accordance with (IAW) FAR part 10, which describes the policies and procedures that govern the market research process.

Contract Specialist sent an email to Ms. Kendal Enmark, Stryker Orthopaedic Instruments-Baltimore North to provide an official letter on your company letter head that you are the manufacturer of the requested items. Ms. Dena Rennaker Brand Manager for Stryker stating that “Stryker Instruments is the sole manufacturer of the TPX Capital Product”.

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

Micro Power has been used at government facilities for several years with outstanding results, continues improvement, superior product performance, and outstanding local support. The hospital medical staff is experienced and trained in these types of surgical equipment, which will enable the staff to grasp new and upgraded Stryker equipment more quickly to provide additional cost savings both in equipment and down time for high skilled medical teams compared to training on unfamiliar products. This facility has reiterated their support of the Stryker product equipment being awarded to provide full optimization of product features and functionality.

Post-sale, Stryker’s solution offers a single point of contact to increase efficiencies in procedural time, equipment life and performance, and staff’s ability to perform their duties. Accountability in one Vendor that delivers exceptional results that will help surgical teams provide the best in patient care.

Stryker manufactures its own products in the US. This allows control over regulatory, upgrade, and obsolescence processes for their equipment.

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

No other sources have expressed interest due to the uniqueness of this type of equipment.

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:

Future competition will require other medical equipment manufactueres to develop a more robust product than what is currently offered.

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.

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

JAMES B REGAN

James B. Regan Chief of Surgery Martinsburg 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.

Mohsin Abbas Contract Specialist, NCO 5

Anna Forsythe Contracting Office, NCO 5

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.

Phillip Duba Contracting Office, Branch Chief, NCO 5 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx