J and A Biomed PDF.pdf

USE OF OTHER THAN FULL AND OPEN COMPETITION FOR AN

ACQUISITION UNDER THE SIMPLIFIED ACQUISITION THRESHOLD

5/9/2022

NMCP/MMD-Biomedical Engineering

I. BACKGROUND:

The service or material listed on N0018322RCMR108 for competition is precluded for the reasons indicated below on this justification for other than full and open competition, in accordance with:

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 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 is not expected to exceed the simplified acquisition threshold)

II. DESCRIPTION OF ITEM OR SERVICE:

Manufacturer Details:

Provide original manufacturer’s name (if a sole source manufacturer distributes via dealers, include dealer information as well).

Name: MEDTRONIC

POC: CATHEY L. MASSEY

Phone Number: 720-890-3370 E-mail: cathey.l.massey@medtronic.com

Manufacturer’s Dealer/Rep Details (if applicable):

Name:

POC:

Phone Number: E-mail:

PROVIDE A DESCRIPTION OF THE ITEM OR SERVICE REQUIRED:

Estimated Cost: $143055.00 RDD/POP: 06/01/2022 - 07/30/2023 Description:

MAINTENANCE/ REPAIR FOR THE RADIOGRAPHIC/FLUOROSCOPIC UNIT, MOBILE. ECN:129396

S/N: C1348 AND STEALTH STATION S7

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

BASED ON THE FOLLOWING (select all that apply):

☒ ONLY ONE RESPONSIBLE SOURCE (example: OEM technical representative) ☐ LIMITED SOURCE (example: multiple OEM authorized technical representatives) ☐ BRAND NAME SOLE SOURCE (example: OEM replacement part) ☐ BRAND NAME LIMITED SOURCE (example: multiple OEM authorized part distributors) ☐ UNUSUAL AND COMPELLING URGENCY (example: Urgent Requirement, work stoppage, mission critical)

SECTION A:

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

☒ EXCLUSIVE LICENSING AGREEMENTS. The item or service is only available from the Original Equipment Manufacturer (OEM), or there is only one authorized distributor or technical representative for the OEM.

☒ FORM, FIT AND FUNCTION. The required items are direct replacement parts/components for existing equipment and must be compatible in terms of form, fit and function with existing equipment/ configurations.

Provide the following information:

1. Make and Model Number:

2. Explanation of how direct replacement parts/components must be compatible with existing equipment (i.e. reagents & analyzers, electrical system of medical equipment, etc.):

MEDTRONIC is the sole manufacturer and maintenance provider of the O-ARM in use at NMCP and only available through MEDTRONIC.

There are no other sources with certified MEDTRONIC authorized field service technicians due to proprietary software and copyrights. MEDTRONIC is the only certified company to perform services on the MEDTRONIC O-Arm. The maintenance required to maintain safe optimal operation of the MEDTRONIC O-Arm can only be provided by MEDTRONIC authorized field service technicians. The maintenance services and software updates are only available through the OEM MEDTRONIC.

If other than MEDTRONIC certified field service technicians provide maintenance, software upgrades and or repairs resulting in analyzer failure NMCP will incur additional costs to return equipment to OEM Standards.

MEDTRONIC O-Arm Preventive Maintenance requires calibration and maintenance using proprietary and copyrighted software. The software is only available through MEDTRONIC authorized field service representatives authorized to access the System software and are licensed to perform software updates and maintenance. The calibration software is proprietary property and copyrighted by MEDTRONIC. Due to the proprietary rights and copyrights of software producing copies is prohibited by law without a license from or authorization from MEDTRONIC.

☒ UNIQUE FEATURES. Similar products lack features that are necessary to meet the Government's minimum needs (i.e. Beckman WA-96 Plus analyzer vs. Becton Phoenix M50 analyzer). Provide the following information:

☒ OTHER REASONS. Other reason not identified above.

SECTION B:

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

SECTION C:

☐ UNUSUAL AND COMPELLING URGENCY.

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:

If the equipment is not kept up to date with all manufacturer recommendations which is a result form Non OEM technicians performing service. This puts Naval Medical Center Portsmouth Joint Commission Accreditation at risk.

A violation finding by the Joint Commission could endanger Naval Medical Center Portsmouth patient care and safety accreditation.

The maintenance procedures used by MEDTRONIC ensures that the analyzers are kept up to date with the latest software and maintenance for optimal safe operation during use for patient diagnosis.

The MEDTRONIC O-Arm must be maintained per MEDTRONIC recommendations for maintenance and software upgrades accordingly. The software features and capabilities of the MEDTRONIC O-Arm are exclusive only to the OEM MEDTRONIC. The maintenance service provided by MEDTRONIC is required for safe and optimal operation of the MEDTRONIC O-Arm and only the OEM MEDTRONIC can minimally meet the Government's needs.

All software updates and parts provided must be direct replacement parts I components of MEDTRONIC O-Arm. All required OEM replacement parts and software updates are only available through MEDTRONIC. If other than direct replacement parts and or software are installed it endangers the operation of the MEDTRONIC O-Arm.

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:

4. If appropriate, include any additional pertinent information.

IV. CERTIFICATIONS/APPROVALS:

Section 1: Department Representative / Technical Reviewer complete the following:

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:

Print Name Adam J. Figueroa

Phone Number: 757-953-5336 E-mail: adam.j.figueroa3.mil@mail.mil Date: 5/9/2022

Section 2: Contracting Officer (KO) complete the following:

Requirements Certification: I certify that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

KO Signature:

KO Print Name

Phone Number: E-mail:

Date: Click here to enter a date.

☐ The anticipated cost to the Government will be fair and reasonable.

757-953-4038 melissa.peregrino-white.civ@mail.mil x