FAR 13.5 Sole Source Justification - Stryker Drills-1_Redacted.pdf

Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 6

REVISION: 01

Acquisition ID#: 36C245-25-AP-2451

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C245-25-AP-2451

1. Contracting Activity: Department of Veterans Affairs, VISN 05, 688 Washington DC VA Medical

Center, 50 Irving Street NW, Washington, DC 20422. 2237 funding number: 688-25-3-995-0009

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

The proposed action is for the award of a contract on a sole source basis for purchase of Stryker TPX drills, accessories, and CORE 2 power supplies. These items are available on FSS contract 36F79724D0118.

The Stryker TPX is a versatile, corded small bone power tool system designed to enhance surgical procedures through its design and customizable features. It offers a range of specialized handpieces, such as reciprocating saws, sagittal saws, micro drills, universal drivers, and wire drivers to accommodate various small bone procedures. The current Stryker RemB drills at the Washington DC VAMC are rapidly deteriorating and decreasing the facility�s number of available drills for surgery.

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

The estimated value of the proposed action is $351,597.10.

The Operating Room (OR) and Sterile Processing System (SPS) departments at the Washington DC VA Medical Center require:

QTY 10 7400-099-000 TPX UNIVERSAL DRIVER which includes:

QTY 10 4100-062-000 WIRE COLLET

QTY 10 7400-037-000 TPX RECIP SAW

QTY 10 7400-034-000 TPX SAGITTAL SAW

QTY 10 7400-015-000 TPX MICRO DRILL

QTY 20 7400-009-000 TPX HANDSWITCH

QTY 10 4100-132-000 5/32IN inch Drill with Key

QTY 10 4100-131-000 1/4" DRILL WITH KEY

Effective Date: 11/15/24 Page 2 of 6

Acquisition ID#: 36C245-25-AP-2451

QTY 20 7400-004-000 TPX CABLE

QTY 10 4100-125-000 Pin Collet (2.0-3.2mm)

QTY 2 5400-052-000 US CORE 2

6400-454-000 Small Bone Sterilization Case

The requirement includes all parts, materials, labor, software/licenses, travel, and training to complete the full installation of the TPX drills. The system shall be compatible with the existing RemB drill components to be reused at the facility.

The system shall allow for the personalization by different surgeons to tailor the sensitivity/etc. to their preference/style. The system shall contain the safety feature of an audible alert for the successful connection of the different components. The equipment shall be able to be reprocessed, to include submersion, and withstand those processes on a repetitive basis without deterioration or complications.

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:

( ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

(X) 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):

These remaining items are essential equipment that are needed at once to compete surgery kits.

The Washington DC VAMC has been using deteriorating drills for months while waiting for the updated TPX drills procurement to get approved and justified. The original surgical kits are beyond their useful life and are no longer serviceable. Many of the existing drills at the DC VAMC are no longer useable, causing potential patient safety risks and delays in surgical care. Healthcare deliveries are being delayed, cancelled, and rescheduled because the surgical kits are not complete.

The mission of the surgical/operating room department is in jeopardy if they are not able to perform surgeries on veterans. This has created an urgent and compelling need that would cause damage to the Government and its mission to Veteran care if not fulfilled.

Effective Date: 11/15/24 Page 3 of 6

Acquisition ID#: 36C245-25-AP-2451

Only the brand name product of Stryker, TPX, has been determined to meet all the requirements of the Government.

The Washington DC VAMC has existing Stryker RemB powered surgical drills and components which are compatible with the requested TPX system and will reduce the need to purchase additional equipment. In addition, the RemB drills are deteriorating, and Stryker no longer provides service support as of 12/31/2024. Purchasing TPX drills will allow the DC VAMC to continue to use the current drill attachments while having a more technologically advanced and durable handpiece. In addition, the DC VAMC has already purchased some TPX drills components that cannot function or be used without the remaining items on this contract.

Only the brand name product of Stryker, TPX, has been determined to meet all the requirements of the Government.

The Washington DC VAMC has existing Stryker RemB powered surgical drills and components which are compatible with the requested TPX system and will reduce the need to purchase additional equipment. In addition, the RemB drills are deteriorating, and Stryker no longer provides service support as of 12/31/2024. Purchasing TPX drills will allow the DC VAMC to continue to use the current drill attachments while having a more technologically advanced and durable handpiece

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

A sources sought synopsis was issued and five vendor stated interest to the solicitation.

An unrestricted was placed out for competition on GSA. Beacon Point Associates was the lowest price technically acceptable quoter.

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

Reasonable:

The price is considered Fair and Reasonable as compared to the IGCE and through competition.

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 to ensure that any SDVOSBs or other small businesses were considered in this procurement action, and to investigate if other similar products could fulfill this requirement. Sam.gov, medpdb, and GSA were reviewed to determine if any other suppliers could provide the TPX drill product for the Washington DC VAMC. No SDVOSBs or small businesses offer this product. Stryker has an FSS contract (36F79724D0118) with the government that includes these products.

The contracting officer placed a sources sought (S.S.) on SAM.gov and GSA. The GSA S.S. had one company respond to the request. Trillamed (SDVOSB) stated that they could meet the requirement and provided a letter of authorization for Stryker products. Trillamed stated that all the items were

Effective Date: 11/15/24 Page 4 of 6

Acquisition ID#: 36C245-25-AP-2451 on their schedule; but the program and the contracting officer could not find all of the items. The contracting officer wrote the company, and they were getting their Federal Supply Schedule (F.S.S.)

updated and would let me know when they are on the schedule; furthermore, Trillamed stated that some of the items could be purchased on the MSPV Contract 36C24122A0058(BPA).

The contracting officer (CO) brought this information to the program�s attention during the CO�s market research and the program was able to buy some of the items on Deliver Order: 688-A55553.

Most of the items were on back order through the MSPV contract and they were cancelled. The program requested that I send back the 2237 again to order the items. That is when the contracting officer sent out the S.S.

Beacon Point Associates (SDVOSB), BHPE LLC (SDVOSB), Big Mouth Productions, and Bright Labs Diagnostics responded to the SAM.gov S.S. The contracting officer had the program review the responses to the S.S. These are the responses from the program:

�Big Mouth Productions� Response from karwanna1@gmail.com:

Cannot meet our requirement. No information was provided in their email �FW: [EXTERNAL] Re:

Contracting Opportunities.� They did not provide useable information. No website was given.

Cannot verify that they are an authorized Stryker distributor.

Bright Labs Diagnostics:

Cannot meet our requirement. No information was provided on the part numbers we requested.

Cannot verify that they are an authorized Stryker distributor. Their website is blocked by the VA so I can�t even go on it.

BHPE LLC:

Likely cannot meet our requirement. Their email said they are working on requested Information and will share it soon. I do not think they will meet our requirement. Their website does not provide any useful information for this requirement. Cannot verify that they are an authorized Stryker distributor.

Beacon Point:

Likely can meet our requirement. No document provided that shows they have our specific part numbers requested. Their FSS does not have our part numbers on it. They did provide an authorized Stryker distributor letter. They provided a list of all their federal contracts. This is a certified

SDVOSB.�

The contracting officer confirmed that Stryker, Large business, has a F.S.S. contract, 36F79724D0118, all the remaining items are on the F.S.S. except one, the Small Bone Sterilization Case which Stryker offers on the open market. Request for the open market items through the SBAR system is under way.

The contracting officer has two choices, open market or GSA both will be placed out unrestricted RFQ�s because the VA rule of two and FAR 19.5 rule of two cannot be met. This will be a follow-on contract from the MSPV Contract order, for standardization of stock within the hospital, and surgeons� understanding and familiarity with the tools that are needed. The RFQ will go out as a brand name only for Stryker equipment on a Limited Source on GSA.

Effective Date: 11/15/24 Page 5 of 6

Acquisition ID#: 36C245-25-AP-2451

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

Stryker bone drills products have been used at the Washington DC VAMC and other VHA facilities for several years with superior product performance and local support.

Washington DC VAMC clinical staff is already experienced and trained on Stryker bone drills, which will enable staff to grasp the new and upgraded Stryker equipment more quickly.

This will provide additional cost savings in equipment down time for highly skilled medical teams for training on unfamiliar products. Washington DC VAMC already possesses two (2) Stryker CORE 2 Consoles. Two other VISN 5 facilities (the Martinsburg VA Medical Center and the VA Maryland Health Care System) have procured and utilized the Stryker surgical tools and consoles, which provide additional confidence in the equipment, opportunities for sharing resources, technical support collaboration, standard reprocessing policies/procedures, and the ability to better consult across sites on cases and techniques.

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

Beacon Point Associates, LLC and Stryker, Inc.

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 agency will continue to evaluate its needs and conduct market research for future procurements to determine whether other systems can sufficiently meet the VA/VISN 5�s need.

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.