NMRC JAA_BD FY24_20240422_EV_rev.1.pdf

NMRC

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

Standard Document Number/PR: N3239824 PR00125 PR#1301157321

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 a Becton Dickinson (BD) flow cytometry instrument, LSRFortessa, located in NMRC Agile Vaccines and Therapeutics (AVAT) Department (previously the NMRC Malaria Department), Flow Cytometry Core Laboratory. The Government intends on awarding a Firm Fixed Price contract. The proposed source is BD Biosciences, 2350 Qume Drive, San Jose, CA 95131.

3. Description of Supplies or Services:

The Naval Medical Research Command, NMRC Agile Vaccines and Therapeutics (AVAT) Department (previously the NMRC Malaria Department), has a critical need to maintain their BD LSRFortessa (SN H64780000028) instrument, including the sapphire, red, green, violet, and UV lasers (SN NO-SERIAL-8258 through NO-SERIAL-8262) and the high throughput sampler (SN U30100198) collectively referred to herein as the LSRFortessa to remain fully operational with minimal downtime the 1 year period of performance (POP). Navy Operation and Maintenance Funds will be used to maintain this instrument at full operation within manufacturer specifications.

The BD Biosciences LSRFortessa (with 5 lasers, blue, red, green, violet, and UV and a High Throughput Sampler system) flow cytometer requires two preventive maintenance inspections (2PM/year) during the year. Additionally, the use of this instrument requires occasional technical telephone support, technician in house visits and specialized hardware and software. 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. 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 this unit (emergency on-site service, 48 hrs.) are required to ensure there are no wasted experiments, given the majority of experiments analyzed on these units cannot be repeated, are evaluating irreplaceable clinical trial samples, and must be analyzed within a narrow window of time. HTS equipment must be included in the work scope and include 1PM and emergency replacement of the HTS unit(s) within 2 working days. Only manufacturer-certified (BD) parts may be used in maintenance and repairs. The requested service contracts 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 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 LSRFortessa flow cytometry instrument was manufactured by BD Biosciences (BD). BD the proposed vendor for the requested services, is the sole manufacturer and supplier of the LSRFortessa flow cytometer. The vendor/manufacturer spends considerable time training and certifying personnel in the building, maintenance, and improvements to these instruments, which ensures optimal performance to their customers. The vendor has the unique capability of engineering fixes and providing up-to-date instrument improvements based on manufacturing improvements to these models. No other vendor can provide this type of instrument-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 with manufacturer certified and trained service engineers specifically certified in each unit.

Service engineers are also trained in servicing custom units such as our LSRFortessa in addition to having direct access to technical engineers that created the custom unit making troubleshooting and repairs prompt and within custom equipment specifications. Additionally, other vendors do not provide unlimited service visits for the specified units in addition to using only manufacturer-certified parts. Other vendors, while claiming to be trained, were not able to provide certified BD training; without which key instrument nuances may not be properly accounted for in repairs. BD has successfully, for the duration of our owning the equipment, kept our equipment working under prior service contracts, thereby having a proven track record. Additionally, select services are under GSA Contract (GS-07F-0195DA).

Other flow cytometry vendors/maintenance were not readily available. These instruments are very sensitive and complex (with multiple lasers, and multi-parameter analysis systems) requiring instrument-specific engineers certified by the manufacturer- BD Biosciences. Lesser trained or less reliable services could result in irreparable loss of clinical samples, key clinical data, misinterpretation of data collected with faulty parts, or force repeated experiments with lesser quality samples or in total, all at great cost to the government should repairs not be swift or done correctly.

BD Biosciences are expert in the development, manufacture, and maintenance of these flow cytometry units. They have considerable effort and expertise into proper care of their machines, at considerable cost and time. Properly maintained equipment is critical to completing the mission. Therefore, 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, 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 will reflect GSA pricing, where applicable and a 10% discount from the BD Biosciences’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 in April 2024 by Jessica Bolton. This research consisted of reviews of previous procurements for these types of instrument/equipment preventive maintenance and repair services and a market survey through search engines Google, AOL and Yahoo, using keywords “BD LSRFortessa preventive maintenance” or “BD LSRFortessa service contract” of open market contractors and Federal Supply Schedule contractors. Most searches brought up BD instruments for sale, BD service brochures and manuals and other government bids/contracts. Market research was unable to find any other vendor that provides preventative service and repairs for the BD LSRFortessa.

We have spoken to other owners of these units at DoD facilities, and there are no other preferred vendors providing these services that we are aware of. At this time, BD remains the sole vendor proven to meet our minimum requirements effectively and efficiently. BD remains the only vendor providing any of the required equipment service(s) under GSA contract (GS-24F-2044D / FSS GS-07F-0195DA). Our findings are summarized below.

BD’s quote and terms (Quotation: 440077300) regarding the proposed SOW was reviewed and found to meet all the minimum requirements. BD Biosciences has serviced our flow cytometer instruments successfully since FY06 and currently hold our present contract. BD Biosciences has consistently provided the required services to our minimum requirements and maintained these key instruments fully operational within the contract guidelines. We continue to receive reliable service, quick responses to any issues encountered and receive BD LSRFortessa specific manufacturer approved software upgrades and manufacturer-recommended parts and repairs.

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.

As of 2024, no new hits for equipment maintenance services have been found.

Finally, we checked the Government-wide database of contracts and other procurement instruments and were not able to identify an alternate source. BD is the sole manufacturer and reseller of new units.

Consequently, the Government’s technical experts determined that BD is the only source that can meet the Government’s requirements.

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

The requirement for BD flow cytometry instrument preventive maintenance and repairs/service was competed full and open based on the minimum salient characteristics in 2006. The contract was awarded to BD Biosciences through contract N32398-06-F-0006, totaling $27,036.67 after warranty of the current LSR system expired. BD flow cytometry service contracts have been renewed with BD Biosciences with sole sources after market research was conducted and BD remained the sole supplier able to meet the minimum requirements as follows (prefix N32398-): 10/1/07-9/30/08 08-F-0002, and 10/1/08-9/30/09

09-F-0101, 10/1/09-9/30/10 10-P-1902, 10/1/10 – 9/30/11 11-F-0301, 10/1/11 – 9/30/12 12-F-0200, 10/1/12 – 9/30/13 13-F-0301. 10/1/13 – 9/30/14 14-F-0302, Note: NMRC traded in the BD LSR II for the BD LSRFortessa Jan 2014 and 10/1/14 – 9/30/15 15-F-0200, 10/1/2015-9/30/2016 16-P-0202, 10/1/2016-9/30/2017 17-F-0301, 10/1/2017-9/30/2018 18-F-0300, 10/1/20-09/30/21 20-F-0330, 09/06/21-09/05/22 21-F-0003, 09/27/22-09/26/23 22P0322, 09/27/23-09/26/24 23P0351. The instruments 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 these 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 and cost-effective alternative. The total amount invested in BD Biosciences flow cytometry PM/repairs since FY2006 is $569,000.00.

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. Any sources expressing interest in response to the synopsis will receive consideration.

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, usn.detrick.nmrc.mbx.mmd-contracts@health.mil mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil

Date: 2024.04.22 15:36:11 -04'00'

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

VILLASANTE.EILEEN.DIANE.1025935701 Digitally signed by VILLASANTE.EILEEN.DIANE.1025935701

Name: Eileen Franke Villasante, PhD Phone: 301-319-2076 Date

Title: Department Head, AVAT Department/Command: DIDD/NMRC

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.

Deborah M. Sharpe Phone Date Contracting Officer

Phone Date Contracting Officer

301-319-6471 6-13-2024