NMRC JAA_BD_FY26_FACSymphony_KO Signed.pdf

NMRC

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

Standard Document Number: N3239825PR00141

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Command (NMRC), Silver Spring, MD, on behalf of the Navy to meet Naval Medical Research and Development mission.

2. Nature and/or description of the action.

The proposed action is for the preventive maintenance and repairs/service of the Becton Dickinson (BD) flow cytometry system, FACSymphony A1 System – 2 components with computer workstation, located in the WRAIR/NMRC Agile Vaccines and Therapeutics Department (AVAT) Casares’ Laboratory, Building 503, Room 3W16, Silver Spring, MD. The Government intends on awarding a Firm Fixed Price contract for one base year plus 4 option years. The proposed source is a Becton Dickinson and Company: BD Biosciences (or Becton Dickinson Biosciences). USBDB Service Contract Admin (BD), 155 North McCarthy Boulevard, Milpitas, CA 95035 with a BD payment remittance address of: East Coast Lockbox, BD, PO Box 28983, New York, NY 10087-8983.

3. Description of Supplies or Services:

The Naval Medical Research Command AVAT Department has a critical need to maintain their highly technical BD FACSymphony A1 system (SN R664892000042, ECN 111454), including attached computer workstation (ECN 111455) and the FACS Flow Supply System (SN 349277N0530, ECN 111454) collectively referred to herein as the FACSymphony to remain fully operational with minimal downtime throughout the one-year base period of performance that initiates immediately upon current PM and repair service contract expiration plus an additional 4 option years to support full operational function throughout the instrument. The system is critical to acquiring and analyzing ongoing NMRC nonclinical and clinical/IND supporting study data across disease models and must be maintained to full OEM and routinely calibrated (2PM/year) plus additional and unlimited repair services as needed to meet our mission. Navy Operation and Maintenance Fiscal Year 2025/2026 funds (MIDRP Proposal #s MI240107 & MI240016) in the amount of $ XX,XXX.XX base year will be used to maintain these systems at full operation within manufacturer specifications (each $XX,XXX option year may utilize different funds).

Minimum Requirements:

The BD Biosciences BD FACSymphony A1™ (SN# R604892000042) with one BD computer workstation and with one FACSFlow Supply System (detailed above), Department of Defense owned equipment, as listed on the DD Form1155 “Order for Supplies or Services”, requires two on-site routine periodic inspections and preventive maintenance services during a 12 month period (2 PM/year, 1 year service contract minimum), normal working hour coverage or 48-hour emergency on-site service, and ongoing, unlimited, on-site visits and associated repairs throughout the period of performance (POP) by specially trained field service engineers that use the manufacturer’s unique certified parts (to OEM specifications; no refurbished parts), specialized hardware replacements as needed and software updates to maintain these critical instruments at full operation and within the manufacturer’s tight operational specifications;

deviation from which results in corrupted/inaccurate data or data interpretation. Only manufacturer-certified (BD) parts (to OEM specifications; no refurbished parts) may be used in maintenance and repairs. Software should remain the manufacturer installed software with manufacturer revisions released during the POP provided installed, minimally, at each PM to keep current with the manufacturer’s software system to ensure the equipment is running at its most efficient and software bugs are fixed as rapidly as possible. Additionally, use of these machines requires unlimited and prompt technical telephone support to resolve problems and, where the problem cannot be resolved over the phone, quickly dispatch FSE to resolve problems (48 hour or less response time). The proper maintenance of this machine is necessary for ongoing operations. Proper service and maintenance require service engineers trained and BD-certified in the proper care and maintenance of each specific unit. Additionally, unlimited and rapid service of mechanical or software failures on these units (emergency on-site service, 48 hrs.) are required to ensure there is no wasted experiments, given many experiments analyzed on these units cannot be repeated, are evaluating unreplaceable human or animal study samples, and must be analyzed within a narrow window of time. Emergency on-site service response time must be guaranteed. Field Service technicians must meet DoD requirements for base access pre-vetting (Real ID Driver’s License, and PII required for pre-vetting) in addition to having the required field service skills and certifications described above. Equipment PM and repairs service coverage must, critically, include all labor, travel expenses and manufacturer-certified parts (excluding consumable items) and the following:

• two (2) onsite Preventive Maintenance Inspections to be performed during a twelve-month period, to include all installed lasers and preventive maintenance performed 2 times per year during the following months: January 12, 2026, +/- 2 weeks and July 14, 2026 +/- 2 weeks.

• Two (2) Preventive Maintenance Kits provided.

• Software Revisions that are released during the POP and any ‘catch-up’ software updates needed to install those POP software releases.

• Unlimited service visits during the POP, Monday through Friday, excluding holidays.

• 48 hour guaranteed response to a request for emergency on-site service (Monday through

Friday, excluding holidays).

• Unlimited telephone support for instruments, reagents and applications provided at no additional charge.

• Covered equipment will be maintained to meet the original equipment manufacturers

(OEM’s) specifications

• Coverage shall include all systems, subsystems, components, and assemblies that were part of the original system purchased. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. It is acceptable if workstation printers are not covered.

• Maintenance engineers are trained, equipped, and capable of calibrating, maintaining, and repairing the specific BD equipment named, such that these units meet BD manufacturer specifications for safe and reliable operation.

• Service engineers are certified in, have several years’ experience in, or are considered by the manufacturing company as highly proficient in the repairs and maintenance on the designated models.

• Service provides proper care and maintenance schedules sufficient to maintain the instruments in good working order thereby to ensure that our instrument system is always functional. Thereby, planned experiments can be conducted, and repairs do not compromise critical experiments.

• All material required in the performance of the contract shall be furnished by the Contractor. The Contractor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the contractor service technicians and as required for the completion of the services in accordance with this contract.

• Service plan covers all shipper, freight, postage, and storage costs both to/from as needed for all parts not on hand with the Field Service Engineer/Technician (FSE) and PM kits sent in advance of service.

• The Contractor shall have ready access to unique and/or high mortality replacement parts.

All parts supplied shall be made at the OEM’s facility or meet OEM specifications and be compatible with the existing system.

• Vendor will replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

• Vendor will use only new or warranted replacement parts where the quality is equal to or better than the OEM’s original part. Any defective replacement parts will be repaired or replaced. When discrepancies occur, or part quality is in question, the Government will make the final determination on whether a replacement part is of appropriate (equal or better) quality.

• Vendor/supplier will, if client deems needed, provide a quote for separate PO for repair service needed on weekends and holidays.

• Equipment Modification Upgrades:

o The Contractor shall only incorporate OEM specified modifications, alterations and upgrades. Approval shall be obtained from the Medical Maintenance prior to the Contractor installation of any modification, alteration, or upgrades.

o The Contractor shall perform all OEM field modifications and safety inspections without charge to the government.

o The Contractor shall maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these field modifications in accordance with the time schedule set forth by the OEM.

o The Government shall not alter the system without prior notification to the contractor.

o Software upgrade shall be provided by the contractor at no additional cost to the

Government. Installation of upgrades will be left to the discretion of the Government The requested service contract will ensure that the required high performance quantitative and multi-parameter analysis of samples is available and functioning for all the laboratory needs (both human and animal studies) critical to our department’s mission while mitigating any data loss.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1) and FAR 6.302-1 sole source (including brand name) acquisitions OR FAR 13.106-1(b)(1) soliciting from a single source.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The BD FACSymphony flow cytometry system is manufactured by BD Biosciences (BD). BD (Becton Dickinson and Company, BD Biosciences, or BD), USBDB Service Contract Admin, the proposed vendor for the requested services, is the sole manufacturer (all) of new FACSymphony flow cytometer and OEM parts. This requirement is for preventive maintenance and repair service of our FACSymphony system for one base year plus 4 option years. The vendor/manufacturer spends considerable time training and certifying personnel in the building, maintenance, and improvements to this machine, which ensures optimal performance to their customers. The vendor has the unique capability of engineering fixes and providing up-to-date machine and software improvements based on manufacturing improvements to these models.

We have not been able to identify another vendor that can provide this type of unit-specific improvements, maintenance, and certified maintenance engineers. BD is uniquely capable to maintain, service, and troubleshoot the units they manufacture. They are the only vendor we identified with manufacturer certified and trained service engineers specifically certified in each unit. Service engineers are also trained in FACSymphony-specific troubleshooting and prompt repairs to customer-specific equipment configurations. Additionally, other potential vendors do not provide unlimited service visits for the specified units in addition to using only manufacturer-certified parts and may not be able to meet the required response times and are not able to provide certified BD trained field service engineers; without which key instrument nuances may not be properly accounted for in repairs. BD has successfully kept our FACSymphony equipment (under warranty service and a subsequent service contract), and our other BD instrument systems (FACSCalibur, LSR II, LSRFortessa) under BD service contracts, fully operational, thereby having a proven track record. Additionally, select services are under GSA Contract #FSS GS-07F-195DA reflected in the BD quote.

This unit is very sensitive and complex machine (with multiple lasers and multi-parameter analysis systems) requiring manufacturer (BD) certified unit-specific engineers. Lesser trained or less reliable services could result in irreparable loss of clinical samples, key clinical data, misinterpretation of data collected with faulty parts, force repeated experiments with lesser quality samples or result in costly or irreparable equipment damage or total equipment failure, all at great cost to the Government should repairs not be swift or done correctly. Properly maintained equipment is critical to completing the NMRC AVAT Department mission.

BD Biosciences are expert in the development, manufacture, and maintenance of this flow cytometry unit. They have considerable effort and expertise into proper care of their machines, at considerable cost and time. BD Biosciences, the FACSymphony System manufacturer, distributor, and maintenance and repairs provider, does not certify third party organizations to perform service on its instrumentation in the United States and the only supplier that can supply spare or replacement parts unique to BD™ flow cytometry system [provided:

NIH_SoleSource_Form letter-NOELLE.pdf]. BD is not a small business and was asked 5/31/2024 if they have authorized small business resellers or service providers for this requirement to which no additional response was received.

Taken together, BD is uniquely qualified and the only capable source to provide the required services meeting our key minimum requirements (see #3 above).

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed in the April 2025 – May 2025 timeframe, the results of which are in paragraph 8. This requirement will be posted to NECO and/or FedBizOpps in accordance with FAR 5.202.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price (unit discount and GSA CONTRACT #FSS GS-07F-195DA plus a 10% multiunit discount for not GSA contract items) will reflect a discount from BD’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

Market research was conducted by technical experts in the April/May 2025 timeframe by Noelle Patterson. This research consisted of contacting colleagues with similar instruments if they identified or utilized a non-BD vendor for their service contracts, reviews of previous procurements for these types of instrument/equipment preventive maintenance and repair services, quote requests to the manufacturer who is currently providing PM and repair service on this unit, surveys for potential small business suppliers [government wide (GSA: small business, SBA, and GSA Advantage!) using the general keyword “FACSymphony” with, in GSAAdvantage!, an advanced search with small business categories selected under the Services (the target search area) to elicit all potential suppliers in our results. Additional government wide searches were performed in FPDS-NG ezSearch with keywords “BD FACSymphony service” and GSA Advantage! using keyword “FACSymphony”. buyGSAgov, GSA, Interagency Contract Directory (ICD), and Federal Strategic Sourcing Initiative (FSSI) searches were not performed as prior years returned no relevant hits or are not relevant. Finally, a search was conducted using keyword “FACSymphony” through the government wide procurement instruments, AbilityOne and UNICOR, and no alternate source was identified. A review of the AbilityOne, FSSI, UNICOR sites in April/May 2024 revealed they do not provide biomedical/scientific research instrument preventive maintenance and repair services.

Government wide searches returned no results or no relevant hits on GSA Small Business Home, SBA, and GSA Advantage! FPDS-NG results returned 23 contract action results – all of where were with Becton Dickinson and Company which includes BD Biosciences and is the covered equipment manufacturer of this requirement. BD is also the current provider and was contacted at Service_PO@bd.com, cc: Chris Ruggiero who is our BD representative, 5/1/2025 for an estimate. BD Biosciences provided an estimate on 5/6/2025.

Open market survey through search engines Google, DuckDuckGo, and Ecosia using keywords “FACSymphony preventive maintenance and repairs” of open market contractors was done. BD Biosciences, the instrument manufacturer and our current FACSymphony warranty service supplier, was abundantly cited. Most searches brought up BD services or service brochures, other BD instruments, BD FACSymphony or other BD instrument models user guide/user manual (rather than a supplier of required services), other government RFPs/bids/contracts (highergov, SAM, USFCR) for BD FACSymphony A3, A5, FACSVia, or LSRFortessa X-30 models PM/repair service– which are not the covered equipment A1 model. Hits for PM/repair service of non-flow cytometry equipment were reviewed and found irrelevant (Pediatric Research Alliance, Roy Carver Biotechnology Center, CMMS or other PM software hits). We found a USFCR FACSymphony Sources Sought solicitation notice by the USDA ARS that matched our requirement with an archive date of 08/29/2024. I emailed the point of contact, Jennifer Peterson, on 5/5/2025, requesting which suppliers were found able to meet the minimum requirements. Jennifer replied 5/7/2025 stating “Unfortunately, it did not provide any sources”.

Other hits could not be explored further because sites were restricted or not accessible/URL not found or required subscription to access (instantmarket, web search engine-sponsored hits) or referenced irrelevant services (Building maintenance). Several hits for the specific BD FACSymphony A1 model covered in this requirement were present – all for BD Biosciences, who is the equipment manufacturer, current supplier for the required services.

No alternate supplier was identified in the government wide or open market surveys.

We have spoken to our DoD colleagues with this or similar BD flow cytometry unit(s) and there are no other preferred vendors for the required services that meet our minimum requirements.

We requested an estimate from BD Biosciences 5/1/2025 and an estimate was provided a quote for this requirement (Quotation 440084983, dated 5/5/2025). As of this writing no other suppliers able to meet the government requirements have been identified. Only BD is the manufacturer and provider of service for BD™ flow cytometry systems. Additionally, BD has indicated they do not certify third party organizations to perform service on its flow cytometry systems in the United States and are the only provider that can supply the required instrument software revisions and preventive maintenance requirements (4/13/2020 letter from Carol Acosta, included in Market Research file: Market Research_BD_FACSymphony_FY26_rfs.pdf, bookmark BD Sole Source Letter 2020, NIH_SoleSource_Form letter-NOELLE.pdf). BD is not a small business and was asked if they have authorized small business resellers or service providers for this requirement to which no additional response was received. Taken together, BD Biosciences is the only supplier identified that provided a quote meeting the minimum requirements, BD remains the only vendor providing any of the required equipment service(s) under GSA contract (#FSS GS-07F-195DA), and therefore, BD remains the sole vendor able to meet our minimum requirements at this time.

mailto:Service_PO@bd.com

We continue to look for new vendors offering comparable services by conducting web searches, contacting our colleagues with similar equipment, and inquiring at scientific meeting associated vendor shows to identify other potential providers and evaluate for capability to meet the minimum requirements.

Consequently, the Government’s technical experts determined that BD Biosciences (Becton Dickinson and Company, BD Biosciences) is the only source that can meet the Government’s requirements. The results of the market research are attached (Market Research_BD_FACSymphony_FY26_rfs.pdf, a bookmarked file for ease of use).

9. Other facts supporting the use of other than full and open competition.

The requirement for BD flow cytometry instrument model FACSymphony A1 with computer workstation and FACS Flow Supply system preventive maintenance and repairs/service was first acquired by AVAT under N3239824P0333, $17,108.28 after the original instrument system purchase and warranty via BD Biosciences contract N3239823F0311, totaling $139,178.00 which includes 1 preventive maintenance service in the 1-year warranty included in purchase cost. The instrument (all components) must be serviced by the manufacturer or a manufacturer certified technician that uses manufacturer direct parts. BD Biosciences are expert in the development, manufacture, and maintenance of this flow cytometry units. They have considerable effort and expertise into proper care of their machines, at considerable cost and time; we have not been able to identify a high-quality cost-effective alternative. The total amount invested in BD Biosciences FACSymphony A1 flow cytometry PM/repairs since FY24 is $17,108.28; a preventive maintenance and repair service contract is cost effective at this time relative to FY25 equipment replacement cost estimated at $147,654.

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

For the reasons set forth in Paragraph 5, (contracting activity) has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, NMRC will assess whether competition for future requirements is feasible.

12. Point of Contact.

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification is, Deborah M. Sharpe, who may be reached at (301) 319-6471.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

SUNDARAM.APPAVU.KA

LYANA.1513194621

Digitally signed by

SUNDARAM.APPAVU.KALYANA.1513194621

Date: 2025.05.29 16:46:00 -04'00'

Name Appavu K. Sundaram, Ph.D. Phone 301-319-7199 Date Title Head, AVAT Department

Requirements Cognizance

Name Phone Date Title Department/Command

CONTRACTING OFFICER CERTIFICATION

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

SHARPE.DEBORAH.

M.1232127429

Digitally signed by

SHARPE.DEBORAH.M.1232127429

Date: 2025.07.27 14:16:56 -04'00'

Deborah M. Sharpe Phone Date Contracting Officer

Phone Date Contracting Officer