JA 25-0002 - Other than Full Open - Stryker - Final_Fully-signed.pdf

CUI//SP-PROCURE//DL ONLY

J&A No. 25-0002

V1.4, 26 September 2024

JUSTIFICATION AND APPROVAL (J&A)

FOR USE OF OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity.

Contracting Office: Marine Corps Installations – West (MCIW), Regional Contracting Office (RCO) – Camp Pendleton (CPEN), CA

Requiring Activity: Fire and Emergency Services (F&ES) Departments located at Marine Corps Base

(MCB) Camp Pendleton (CPEN), Marine Corps Logistics Base (MCLB) Barstow, Marine Corps Air Ground Combat Center (MCAGCC) 29 Palms, and Marine Corps Air Station (MCAS) Miramar.

2. Description of the Action Being Approved.

This Justification and Approval (J&A) supports a proposed sole source award for on-site original equipment manufacturer (OEM) inspection, testing, maintenance, and recertification of Stryker brand emergency services equipment in support of Fire and Emergency Services (F&ES) departments aboard MCB CPEN, MCAS Miramar, MCLB Barstow, and MCAGCC 29 Palms.

A. Proposed Contractor: Stryker Sales, LLC B. Estimated Contract Value: $479,361.00 C. Contract Type: Firm-Fixed Price (FFP) D. Period of Performance: (1) Base year, plus four (4) one-year option periods E. Statutory Authority for Other than Full and Open Competition: 10 U.S.C. 3204(a)(1) F. FAR Implementation: FAR 13.501(a) G. Acquisition Procedures: This acquisition will utilize Simplified Acquisition Procedures under FAR Subpart

13.5, as authorized by 41 U.S.C. 1901 for the acquisition of commercial products and commercial services.

3. Description of the Supplies/Services.

The United States Marine Corps (USMC) F&ES, through a policy letter, requires Marine Corps fire departments to utilize the Center for Public Safety Excellence and the Commission on Fire Accreditation International model to assess and align the department’s operations. This model emphasizes regular inspections, testing, preventive maintenance, and emergency repairs for all fire apparatus and equipment, including the annual maintenance and certifications of the Stryker brand equipment. Historically, these services have been contracted out.

Required services:

The Contractor shall provide for the annual inspection, testing, diagnostics, maintenance, and calibration services of Stryker brand emergency medical services (EMS) equipment to include: Power Pro series ambulance cots, Power Load series ambulance cot fasteners, Lucas devices, and Stair Chairs owned by the

Controlled by: DON, USMC, I&L HCA Controlled by: Fire and Emergency Services of MCI- West Area of Responsibility CUI Category(ies): PROCURE Limited Dissemination Control: DL ONLY POC: Brian Cato (brian.cato@usmc.mil, 858-307-1956);

Christopher Hubmer (christopher.hubmer@usmc.mil, 760-763-2701); Ryan Tworek (ryan.tworek@usmc.mil, 760-577-6099); Marcelino Ryan (marcelino.ryan@usmc.mil, 760-830-7770)

F&ES Departments aboard MCB CPEN, MCLB Barstow, MCAGCC 29 Palms, and MCAS Miramar. These annual services are mandated by manufacturer specifications and published National Fire Protection Association (NFPA) in consolidated “NFPA 1910: Standard for the Inspection, Maintenance, Refurbishment, Testing, and Retirement of In-Service Emergency Vehicles and Marine Firefighting Vessels, Chapter 17 – Inspection and Maintenance of Patient Compartment.”

This maintenance ensures device reliability, extends the life of the equipment, and helps prevent costly repairs. These services are also required in order to maintain regulatory compliance, which cannot be deferred or interrupted without creating liability concerns and compromising equipment reliability during emergency situations. Specifically, NFPA 1910 mandates specific inspection and maintenance procedures that only Stryker-trained and certified technicians can perform effectively and safely. Failure to adhere to these standards could result in equipment malfunction during critical emergency situations, potentially leading to serious harm or death.

The allocation of the equipment is broken down by location in Table 1.

Table 1

Styker Power Pro series Cots*

MCB CPEN* 7

MCLB Barstow 3 MCAS Miramar 3

MCAGCC 29 Palms*** 3 Styker Power Load Cot Fasteners

MCB CPEN 6

MCLB Barstow 2 MCAS Miramar 3

MCAGCC 29 Palms 1 Stryker Lucas Devices*

MCB CPEN* 15

MCLB Barstow 5

MCAS Miramar** 2 MCAGCC 29 Palms 0

Stryker Stair Chair**

MCB CPEN* 5

MCLB Barstow 0 MCAS Miramar 3

MCAGCC 29 Palms 3

* MCB CPEN has 1 Power Pro, 1 Lucas Device, and 1 Stair Chair on order, all of which are included in the provided quantities but will not be serviced in the Base Year.

** MCAS Miramar has 2 Lucas Devices on-order which are included in the provided quantities but will not be serviced in the Base Year.

*** MCAGCC 29 Palms has 1 Power Pro Cot that will not be due for service during the Base Year.

Table 2: Estimated Dollar Value

Base Yr. 1 Opt. Yr. 1 Opt. Yr. 2 Opt. Yr. 3 Opt. Yr. 4 6-month

Ext. Grand Total Contract

Value $90,025.00

$97,334.00 $97,334.00 $97,334.00

$97,334.00

$48,667.00 $ 528,028.00

Funding O&M MC O&M MC O&M MC O&M MC O&M MC O&M MC

The period of performance will be as follows:

Base Year: 3 September 2025 – 2 September 2026 Option Year One (1): 3 September 2026 – 2 September 2027 Option Year Two (2): 3 September 2027 – 2 September 2028 Option Year Three (3): 3 September 2028 – 2 September 2029 Option Year Four (4): 3 September 2029 – 2 September 2030 6-Month Extension: 3 September 2030 – 2 March 2031

4. Statutory Authority Permitting Other Than Full and Open Competition.

The statutory authority for this J&A is 10 U.S.C. 3204(a)(1), Only one responsible source and no other supplies or services will satisfy agency requirements.

FAR Subpart 13.5 procedures are being utilized for this acquisition in accordance with 41 U.S.C. 1901.

5. Rationale Justifying Use of Cited Statutory Authority.

The use of 10 U.S.C. 3204(a)(1) is absolutely essential due to the agency’s unique and non-negotiable requirement for OEM-authorized inspection, maintenance, and recalibration of the covered equipment. The safety of both USMC personnel and the patients they serve depend directly on the proper functioning of this life-saving equipment, and only Stryker can guarantee that level of performance. Stryker Sales, LLC (Stryker), as the OEM, has formally certified that it is the sole entity authorized to perform these services, and is the exclusive distributor of critical, proprietary, and often patented parts for the covered equipment. The use of these OEM parts is not merely a preference, but a mandatory requirement for maintaining the equipment's integrity and ensuring regulatory compliance.

As discussed in more details below, Stryker has not authorized any third-party vendors to perform these specific services. While Stryker could theoretically act as a subcontractor to another vendor, such an arrangement would introduce unnecessary layers of bureaucracy, communication delays, and significantly increased costs to the Government. Furthermore, it would completely negate any potential benefits of using a different prime contractor, as the actual work would still be performed by Stryker. In essence, the USMC would be paying a middleman for no added value, while simultaneously increasing the risk of errors and delays.

Considering the foregoing, the OEM is the only source capable of performing the required services to the standards necessary for ensuring patient safety and operational readiness. Any deviation from direct engagement with Stryker would represent an unacceptable risk to both personnel and equipment and would be a fiscally irresponsible use of taxpayer dollars.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

Market research revealed Stryker Sales, LLC (Stryker), as the OEM of the Stryker EMS gurneys, Lucas devices, Stair Chairs, and EMS Power Loads, and holds proprietary rights, including patents, copyrights, and trade secrets, regarding the design, functionality, and internal workings of the equipment. These rights extend to the specific diagnostic software, calibration tools, proprietary algorithms, and detailed technical knowledge required to perform comprehensive annual inspections, testing, diagnostics, maintenance, and calibration services. A prior sole-source contract between Stryker and the Department of Veterans Affairs (VA) (contract #36C24125P0540) further confirmed Stryker as the only source capable of providing these services.

Stryker has not authorized any third-party vendors to perform these specific services, maintaining strict control over the service process to guarantee that all equipment is maintained to the highest standards of performance and safety, ensure regulatory compliance, and protect device integrity and warranty.

Specifically, Stryker utilizes specialized, proprietary software for the Lucas Devices, that is not publicly available and only licensed to Stryker ProCare-trained technicians. Stryker also possesses unique calibration tools and access to proprietary calibration data. Comprehensive technical documentation, including service manuals and engineering specifications, is proprietary to Stryker and provided only to authorized service personnel who receive specialized training.

Therefore, no additional market research was conducted. For the reasons discussed above, and because attempting to reverse-engineer or circumvent these protections could compromise equipment safety and efficacy, it is not possible for another company to satisfy the Government’s needs as the required services are only available through Stryker’s ProCare service.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer has determined that the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable.

8. Actions to Remove Barriers to Future Competition.

Given the agency's ongoing requirement for Stryker brand EMS equipment, and the OEM's exclusive control over necessary parts, diagnostic tools, and specialized training, MCIW RCO has no plans at this time to compete future contracts for the types of supplies/services covered by this document. If another potential source emerges, MCIW RCO will assess whether competition for future requirements is feasible.

CERTIFICATIONS AND APPROVAL

TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein are complete and accurate to the best of my knowledge and belief.

Signature Name (Printed) Phone No. Date

LEGAL SUFFICIENCY REVIEW

I have determined that this Justification is legally sufficient.

CONTRACTING OFFICER CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief.

COMPETITION ADVOCATE APPROVAL

Upon the basis of the above justification, I hereby approve as Competition Advocate, the solicitation of the proposed procurement(s) described herein using brand name or equal descriptions or proprietary specifications and standards.