Redacted Limiting-Competition-under-SAT.pdf

Maintenance on Medtronic Stealth Station S8

CUI Control No: 24-RHCO-C-154

Version – February 2017 CUI

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: Fort Cavazos Health Contracting Branch, (CavHCB), Fort Cavazos, Texas, 76544-4752.

2. Description of Action:

Nature: ☒ New Requirement ☐ Follow-on Requirement

Contract Vehicle: ☒ Purchase Request Number PR 0012089281

Pricing/Contract Type: ☒ Fixed

Funds: ☒ Other Funds: __DHP_X____ FY: ____FY24___

Name of Proposed Contractor(s) and Address:

Medtronic, USA 6743 Southpoint Drive N Jacksonville, Florida, 32216-6218 ATTN: Natasha Cano-Marin, 904-279-3224

Brand Name Buy: ☐ Yes ☒ No

3. Description of Services or Supplies:

The Carl R. Darnall Army Medical Center (CRDAMC), Fort Cavazos, Texas 76544-4752 has a need to provide scheduled and unscheduled repair, maintenance and calibration for one (1) Government-owned Medtronic Stealth Station S8. This medical equipment is used during spine surgery and is manufactured by Medtronics. The Medical Maintenance department of CRDAMC, does not have the capability of maintaining the equipment as it is proprietary to the manufacturer. The manufacturer, Medtronic USA has the certified engineers authorized to perform the required maintenance. CRDAMC currently owns one (1) Medtronic Stealth Station S8.

The NAICS listed on the company’s Reps and Certs is 811210, “Electronic and Precision Equipment Repair and Maintenance.”. The PSC code used will be J065, “Maint/repair/rebuild Of Equipment- Medical, Dental, and Veterinary Equipment and Supplies”

The approximate total value for this award is $20,825.00 for the base and the total with all options will be $104,125.00. Should the potential six-month extension be exercised under FAR § 52.217-8, the total contract amount would be $10,412.50. The contract will include FAR § 52.217-8 and 52.217-9.

Base Period: 1 October 2024 to 30 September 2025 Value: $20,825.00 Option Period 1 1 October 2025 to 30 September 2026 Value: $20,825.00 Option Period 2 1 October 2026 to 30 September 2027 Value: $20,825.00 Option Period 3 1 October 2027 to 30 September 2028 Value: $20,825.00 Option Period 4 1 October 2028 to 30 September 2029 Value: $20,825.00 FAR Clause 52.217-8 option: 1 October 2029 to 31 March 2030 Value: $10,412.50 Total: $114,537.50

There is no escalation in option year pricing between the base, option year 1, option year 2, option year 3 nor option year 4.

4. Authority:

☒ FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited:

The Carl R. Darnall Army Medical Center (CRDAMC), Fort Cavazos, Texas 76544-4752 has a need to provide scheduled and unscheduled repair, maintenance and calibration for one (1) Government-owned Medtronic Stealth Station S8. This medical equipment is used during spine surgery and is manufactured by Medtronics. The Medical Maintenance department of CRDAMC, does not have the capability of maintaining the equipment as it is proprietary to the manufacturer. The manufacturer, Medtronic USA has the certified engineers authorized to perform the required maintenance. CRDAMC currently owns one (1) Medtronic Stealth Station S8.

The company provided a sole source letter. The letter confirmed Medtronic is the sole manufacturer and distributor of the Stealth Station S8 and “Medtronic will not assume responsibility or liability for any claims, costs, and expenses resulting from the use of systems, devices, or instruments for which unauthorized service or maintenance was performed, non- OEM (Original Equipment Manufacturer) parts have been used, or third-party operation of the system was performed.” The sole source letter is posted to PCF.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 ☐ do not apply due to the $ threshold, ☒ apply and will be followed, or ☐ do not apply due to an exception at 5.202_____________.

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A)

☒ Action is NOT a brand name restriction and is under $250K, no posting required.

☐ Action is a brand name restriction, under $25K, no posting required.

☐ Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

7. Market Research: Market research was conducted to determine the extent of competition available. The contract specialist conducted a dynamic small business search (DSBS) at http://dsbs.sba.gov/dsbs/search/dsp_dsbs with the NAICS code “811210” and keyword “surgery”. There were six small businesses. A further search with the keyword “spine” showed no results. Another search with the NAICS code “811210” and keyword “spine” showed no small business results.

Additionally, an SBA QMS was conducted using the NAICS “811210” and the keywords “surgery”. The results also showed several ‘self-certifications’ but no ‘Government certified’ small businesses in any category. The manufacturer, Medtronic, USA, was searched in the SBA website and not found. Medtronic, USA is not a small business.

The market research results reveal there is not two or more small businesses that can fill this requirement. Results from this search did not identify two or more small businesses that could supply this software update.

A sources sought was posted for five days. There were no results on the Interested Vendors list, nor were there any email responses to the sources sought. There will be a continued future need for the required scheduled and unscheduled repair, maintenance and calibration for one (1) Government-owned Medtronic Stealth Station S8. Medtronics, USA the manufacturer of the http://dsbs.sba.gov/dsbs/search/dsp_dsbs device, would offer the best value to the Government in providing the maintenance services required.

The contract specialist conducted the market research on 10 April 2024. After conducting the market research, the contracting officer determined the recommended source and the company used in accordance with FAR § 13.106-1(b)(1), for purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization, is the only small business. There are no small or large businesses that can perform the software updates for the one (1) Government-owned Medtronic Stealth Station S8.

The Contracting Officer will make a determination that the award price for the contract is fair and reasonable. Due to the lack of companies which can provide the services this action should not competitively solicited. IAW FAR § 13.106-1(b)(1)(i); only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization). The Contracting Officer has recommended this be procured as a sole source award to Medtronic, USA.

8. Other Facts:

Procurement History: The contract specialist found several old contracts and two recent and relevant contracts. W81K00-21-P-0136 was for Medtronic maintenance for a similar device for surgical imaging for $18,381.25 annual maintenance per device and W81K02-22-P-0074 was the same similar equipment for $19,750.00 annual maintenance per device.

Method of procurement: N/A.

Description of requirements: N/A

9. Technical/Requirements Certification: I certify 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.

Typed Name: Mark A. Gonzales, CW3 Title: Chief of Healthcare Technology Management Signature: XXXXXXXXXXXXXXXXXXXXXXXXX

XXXXXXXXXXXXXXXXXXXXXXXXXX

10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon price analysis and historical prices paid.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government.

Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name: TIMOTHY T. HOERZ Title: Contracting Officer Signature: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

Controlled by: Army Controlled By: ODASA(P) CUI Category(ies): General Procurement and Acquisition Distribution/Dissemination Control: FED ONLY POC: Clarence C Cude, Jr., 254-553-8440

KO Reviewed and Approved 11 Apr 2024, Timothy T. Hoerz