Justification for NON-Competitive Procurement (JNCP) Template_Signed_KO_Redacted.pdf

1 Template March 2019

JUSTIFICATION FOR NON-COMPETITIVE PROCUREMENT (JNCP)

FOR ACTIONS < SIMPLIFIED ACQUISITION THRESHOLD (SAT)

PR:

Department: DCSS RADIOLOGY ONCOLOGY (BASA01)

1) Agency, Contracting Activity and Purpose: Naval Medical Center San Diego, Radiology Oncology Division, Radiology Department, DCSS, Justification for Other than Full and Open Competition.

2) Description of the Supply or Service being procured, its intended use and anticipated/estimated value

a. Describe the product or service: (provide make, model, product serial number/part number—include a spreadsheet if necessary).

One-year full-service maintenance agreement (SMA) on Varian Medical Systems linear accelerator, SN

H140971, ECN 117385, POP 24MAY2024-23MAY2025.

b. What is its intended use or purpose?

Provide one-year full parts, service and computer support on Varian Medical Systems linear accelerator, SN H140971, ECN 117385.

c. What is the total estimated cost of this/these products or services (include any option periods, required delivery date/period of performance if applicable)?

Annual cost estimate is , period of performance 24MAY2024-23MAY2025.

3) Possible Authority for Non-Competitive Procurement

a. Sole/Limited Source Procurement ((Sole Source: Only one source exists with no known distributors of the required product or service. Only One Responsible/Capable Source IAW either FAR 8.405-6(a), FAR 13.106-1(b) or FAR 16.505(b)(2)).

b. Brand Name Requirement ((Brand Name: Only one manufacturer with multiple distributors (this justification covers only the portion of the acquisition which is brand name). Item Peculiar to One Manufacturer with multiple distributors/resellers/vendors IAW FAR 8.405-6(b), FAR 13.106-1(b) or FAR 16.505(a)(4)).

4) Reason for Non-Competitive Procurement

An urgent and compelling need exists, and following the procedures would result in unacceptable delay

Unique or highly specialized requirement/Only one source reasonable available Exclusive Licensing Agreements Logical Follow-on to previously competed work The material or service must be compatible in all aspects (form, fit, and function) with existing systems presently installed (identify systems and why other products are not compatible) Patent, copyright, or proprietary data limits competition (identify specifics and corresponding level

2 Template March 2019 of Government rights – if any) Direct replacement parts/components for existing equipment and similar parts/components will not meet Government requirements End to End Engineering (For example, Command X supports engineering and/or development efforts for Program of Records and supplies are required from OEM.)

Testing (For example, Command X supports laboratory testing that must replicate shipboard/command environment without deviation.)

Software (Either license and maintenance renewals with compatibility and proprietary coding and data warranty requirements.)

5) Provide rationale and justification regarding the above selection.

1. The Varian Medical Systems treatment hardware, computers and software and all associated treatment accessories were designed and installed by Varian Medical Systems. All pertinent hardware, data, software, and drawings required to maintain the equipment are proprietary to Varian Medical Systems This equipment is marketed and under patent by Varian Medical Systems. All replacement parts, software, and upgrades must be 100% compatible with the existing proprietary equipment. Any change in software support could potentially cause treatment delivery errors that would lead to serious injury or death. Only Varian technicians have the proper training and authorization to service Varian equipment. Any unauthorized modification of the Varian hardware or software could result in a potential misadministration of radiation therapy dose which would lead to a TJC sentinel event and serious injury or death of a patient.

2. The software and components of the radiation therapy systems is under constant improvement by the manufacturer. Critical patches, software updates and component updates as required are essential to the continued operation of the systems. These updates and improvements are all proprietary and can only be provided by Varian Medical Systems.

6) Describe the Market Research conducted.

1. Varian Medical Systems was contacted, and a Market Survey (2033-432212) dated 12OCT2023 obtained for a service maintenance agreement for unit SN H140971, ECN 117385, with one year Period of Performance 24MAY2024-23MAY2025. Annual cost estimate is , which is comparable with the current Varian Medical Systems 2-year SMA annual contract price of (HT9410-22-O- 0003) for unit SN H140971. The estimated SMA annual cost of is approximately 7% of the currently system purchase price, excluding inflation, ( , Contract V797P-6996(a), delivery order SP0200-04-FQC82, issued 2004AUG26) which is consistent with or below the cost of other Radiology service maintenance agreements covering hardware, software, and unlimited helpline support (typically 10% or less of equipment market value).

2. Varian Medical Systems was contacted and provided on 17NOV2023 a letter detailing their service support capabilities in San Diego, including number of qualified support personnel, training and qualification of personnel, proprietary spare parts supply chain, and software.

3. Internet search was performed on 04DEC2023 using both “Bing” and "Google" search engines for search topics of “Varian Trilogy Accelerator Service Coverage” and “Varian Trilogy Software Updates.” Only Varian Medical Systems was identified as a service provider. Since the Varian linear accelerator hardware and software is propriety to Varian Medical Systems, this internet search results are logical.

3 Template March 2019

7) Any other information of facts supporting the justification to limit competition not described elsewhere on this form (i.e. international agreement). NA

8) Provide a statement of actions that will be taken to remove or overcome any barriers to competition prior to any future procurements for this Supply or Service.

The equipment/systems in operation were procured under a competitive bid; only the service/maintenance is being purchased in a non-competitive environment. The use of proprietary hardware and software makes it unlikely that a third-party vendor could maintain the system as required by FDA 510K certification or in compliance with DHA RMF Cybersecurity conditions incorporated with the SMA contract. In the future, other vendor services will be evaluated as they are made available.

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Technical Cognizance Department Head or Above

Print Name / Signature Title Code Date Jonathan Bear, M.D., CDR MC USN Vice Chairman, Department of Radiology Office:

FOR COMPLETION and SIGNATURE BY CONTRACTING OFFICE:

Contracting Officer Certification:

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

Contracting Officer Print Name / Signature Title Code Date