Deter-One Source Available - Zoll Monitors KO Signed.pdf

CUI//SP-PROCURE//DL ONLY

Determination that Only One Source is Reasonably Available (Including Brand Name) – FAR Part 13 Acquisitions under the SAT

V 1.6 (20 December 2023)

MEMORANDUM TO THE FILE

Subj: DETERMINATION THAT ONLY ONE SOURCE IS REASONABLY

AVAILABLE FOR A FAR PART 13 ACQUISITION UNDER THE SIMPLIFIED

ACQUISITION THRESHOLD

I. BACKGROUND:

1. FAR 13.106-1(b)(1)(i) states for purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).

2. As required by FAR 13.106-3(b)(3)(i), this memorandum explains the absence of competition for this acquisition, as only one source will be solicited for this requirement (or for a portion of the requirement) and the requirement (or portion of the requirement to be sole-sourced) is not expected to exceed the simplified acquisition threshold.

II. DESCRIPTION OF ITEM OR SERVICE:

This requirement is for the annual inspection, testing, diagnostics, maintenance, and calibration services of twenty-five (25) Zoll brand X-Series Monitors/Defibrillators owned by the Fire and Emergency Services Departments aboard Marine Corps Base Camp Pendleton, Marine Corps Logistics Base Barstow, Marine Corps Air Ground Combat Center 29 Palms, and Marine Corps Air Station Miramar.

MCP Camp Pendleton Item SN#

Zoll Monitor X-Series AR14J010449 Zoll Monitor X-Series AR19H042498 Zoll Monitor X-Series AR19H042499 Zoll Monitor X-Series AR19H042500 Zoll Monitor X-Series AR20G049479 Zoll Monitor X-Series AR20G049480 Zoll Monitor X-Series AR20G049484 Zoll Monitor X-Series AR20G049485 Zoll Monitor X-Series AR25A089058 Zoll Monitor X-Series AR25C090355

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, Determination that Only One Source is Reasonably Available (Including Brand Name) – FAR Part 13 Acquisitions under the SAT

MCLB Barstow Zoll Monitor X-Series AR13H005275 Zoll Monitor X-Series AR13H005283 Zoll Monitor X-Series AR13H005421 Zoll Monitor X-Series AR13H005451 Zoll Monitor X-Series AR13H005452

MCAGCC 29 Palms Zoll Monitor X-Series AR13H005431 Zoll Monitor X-Series AR13H005455 Zoll Monitor X-Series AR14G009056 Zoll Monitor X-Series AR20J052152 Zoll Monitor X-Series AR20B045925

MCAS Miramar Zoll Monitor X-Series AR16E019660 Zoll Monitor X-Series AR16I021192 Zoll Monitor X-Series AR20I051346 Zoll Monitor X-Series AR20F048950 Zoll Monitor X-Series AR20J051531

These annual services are mandated by the National Fire Protection Association (NFPA) and manufacturer specifications. This maintenance ensures device reliability, extends the life of the equipment, and helps prevent costly repairs. These compliance requirements cannot be deferred or interrupted without creating liability concerns and compromising equipment reliability during emergency situations.

III. THE DETERMINATION FOR USE OF OTHER THAN FULL AND OPEN

COMPETITION IS BASED ON THE FOLLOWING (select all that apply):

A. ___ ONLY ONE RESPONSIBLE SOURCE (select all that apply):

1. X RESTRICTIVE RIGHTS. The source has established proprietary rights, limited rights in data, patent rights, copyrights or secret processes in the item or service required.

Zoll Medical Corporation, as the Original Equipment Manufacturer (OEM) of the X-Series Monitor/Defibrillators, holds proprietary rights, including but not limited to patents, copyrights, and trade secrets, regarding the design, functionality, and internal workings of the X-Series. These rights extend to the specific diagnostic software, calibration tools, and detailed technical knowledge required to perform comprehensive annual inspections, testing, diagnostics, maintenance, and calibration services. This includes access to proprietary algorithms and data necessary to ensure the device operates within validated performance specifications.

The restrictive rights held by Zoll make these services available from only one source because only Zoll possesses the complete and unrestricted access to the intellectual property necessary to properly assess, maintain, and calibrate the X-

Determination that Only One Source is Reasonably Available (Including Brand Name) – FAR Part 13 Acquisitions under the SAT

Series defibrillators to OEM standards. Specifically, performing these services requires:

• Proprietary Diagnostic Software: Zoll utilizes specialized, proprietary software that is not publicly available and only licensed to Zoll-trained technicians. This software is essential for in-depth diagnostics and calibration adjustments.

• Calibration Tools and Data: Zoll possesses unique calibration tools and access to proprietary calibration data specific to the X-Series. Using non- OEM tools or data could compromise the accuracy and reliability of the defibrillator.

• Technical Documentation and Training: Comprehensive technical documentation, including service manuals and engineering specifications, is proprietary to Zoll and provided only to authorized service personnel.

Zoll-trained technicians receive specialized training on the X-Series architecture and specific maintenance procedures.

Another company could not satisfy the Government's need because they would lack the legal right to access and utilize Zoll's proprietary intellectual property.

Attempting to reverse-engineer or circumvent these protections would be illegal and could lead to inaccurate diagnoses, improper maintenance, and potentially compromise the safety and efficacy of the defibrillators, ultimately putting patients at risk. Furthermore, using non-OEM parts or services would likely void the manufacturer's warranty and increase the risk of device malfunction.

2. X EXCLUSIVE LICENSING AGREEMENTS. These services are only available from the Original Equipment Manufacturer (OEM).

The Original Equipment Manufacturer (OEM) for the X-Series Monitor/Defibrillators is Zoll Medical Corporation. The annual inspection, testing, diagnostics, maintenance, and calibration services are only available from Zoll because Zoll has not authorized any third-party vendors to perform these specific services. This exclusivity is maintained to ensure quality control, maintain device integrity, adhere to regulatory requirements, and minimize the risk to patient safety. Circumstances surrounding why the item or service is only available from the OEM:

• Quality Control and Patient Safety: Zoll maintains strict control over the service process to guarantee that all X-Series defibrillators are maintained to the highest standards of performance and safety. This ensures consistent and reliable operation, which is critical in life-saving situations.

• Regulatory Compliance: Defibrillators are highly regulated medical devices. Zoll, as the OEM, is responsible for ensuring that the X-Series meets all applicable regulatory requirements and performance standards.

Allowing unauthorized third parties to perform maintenance could jeopardize regulatory compliance.

• Device Integrity and Warranty: Using non-OEM parts or services can compromise the integrity of the device and potentially void the manufacturer's warranty. Zoll's exclusive service agreement protects the Government's investment and ensures the longevity of the X-Series defibrillators.

Determination that Only One Source is Reasonably Available (Including Brand Name) – FAR Part 13 Acquisitions under the SAT

• Liability: Zoll assumes liability for the proper functioning of the device when services are performed by their trained and authorized technicians.

Utilizing a third party would introduce potential liability issues and could compromise patient safety.

• Risk Assessment and Mitigation: A comprehensive risk assessment reveals significant potential hazards associated with using non-OEM service providers. These hazards include:

a) Compromised Device Performance: Inadequate training, lack of access to proprietary diagnostic tools, and use of non-OEM parts can lead to inaccurate diagnoses, improper calibration, and reduced device performance, potentially resulting in ineffective treatment during critical cardiac events.

b) Increased Device Failure Rate: Improper maintenance can accelerate device degradation and increase the likelihood of unexpected failures, jeopardizing patient safety and requiring costly emergency repairs.

c) Legal and Regulatory Risks: Failure to comply with regulatory requirements due to improper maintenance can expose the organization to legal liabilities and penalties.

d) Patient Safety Risks: The ultimate risk is that a malfunctioning or improperly maintained defibrillator will fail to deliver the necessary therapy, leading to adverse patient outcomes, including death.

By limiting service to Zoll, the OEM, we mitigate these risks by ensuring that all maintenance is performed by qualified technicians using validated procedures and OEM-approved parts, thereby maintaining the highest level of device performance and patient safety.

3. ___ OTHER REASONS.

B. ___ BRAND NAME

Item required must be a brand name, product, or feature of a product, particular to one manufacturer.

C. ___URGENT AND COMPELLING. The supplies or services are of such unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals. Urgent requirements are supplies or services that will result in a work stoppage or are mission critical and the routine processing time would result in injury to the Government. The determination that the procurement for the above item/service is an urgent and compelling requirement is based on the following:

1. Date on which the requirement was first identified:

2. Required delivery date/period of performance:

3. Explanation of why delivery/commencement of services by the date mentioned above is required:

Determination that Only One Source is Reasonably Available (Including Brand Name) – FAR Part 13 Acquisitions under the SAT

CUI//SP-PROCURE//DL ONLY

V 1.6 (20 December 2023)

V. CERTIFICATIONS:

A. Technical / Requirements Certification: I certify that the facts and representation under my cognizance which are included in this justification are complete and accurate to the best of my knowledge and belief.

Signature Name (Printed) Date

Signature Name (Printed) Date

Signature Name (Printed) Date

Signature Name (Printed) Date

B. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature Name (Printed) Date