NMRC JAA_1301168548_Redacted.pdf

NMRC

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

Standard Document Number: PR#1301168548

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 ABI 7500 FAST

Real Time PCR system (RT-PCR system) and the Quantstudio 5, 0.1 mL Block RT-PCR system

(Quantstudio 5) located in the NMRC Agile Vaccines and Therapeutics (AVAT) Department

Laboratories 3W30 (may be moved to 3W22 or 3W10 in June 2024) and 3W16, respectively, Silver Spring, MD. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Life Technologies Corporation, 5781 Van Allen Way, Carlsbad, CA 92088.

3. Description of Supplies or Services:

The Naval Medical Research Command AVAT Department has a critical need to maintain their

7500 FAST (ABI 7500, SN 275010858, ECN 007256) and Quantstudio 5, 0.1 mL Block system with laptop (Quantstudio 5, SN 272511152, ECN 106151) Real Time PCR Systems (RT-PCR systems), collectively referred to herein as the RT-PCR systems, to remain fully operational with minimal downtime throughout the one-year period of performance. Navy Operation and

Maintenance Fiscal Year 2023 funds in the amount of $12,282.76 will be used to maintain these systems at full operation within manufacturer specifications.

The NMRC AVAT Department must perform molecular biology assays in human emerging infectious diseases and malaria immunotherapeutic trials and drug/immunotherapeutic development studies in animal model systems, especially the human-immune-system humanized

DRAGA mice, the ILSDA assay for clinical correlates of protection, and other critical research in order to meet its mission: to conduct research, development, testing and evaluation of vaccines and therapeutics to prevent and treat infectious diseases to maintain effective global operational capability by maximizing warfighter readiness and performance. Several critical samples are being tested for susceptibility to emerging and other infectious diseases and to assess clinical outcomes, as well as to assess various infectious disease and immunotherapeutic agent-induced bioactivity. The equipment proposed for a service contract here is critical to this mission.

To carry out this work, continuously efficient and high-quality preventive maintenance and repair service of the RT-PCR systems, ABI 7500 and Quantstudio 5 [LIFE TECHNOLOGIES

CORPORATION, a merge of Applied Biosystems and Invitrogen, part of Thermo Fisher

Scientific since 2014] instruments, is required. The units detect, in a high-throughput quantitative manner, specific genetic sequences that allows early detection of malaria parasite/ infectious disease load in humanized mice, animal models and human clinical trials as well as to explore infectious disease/immunology/functional assay correlates. The equipment is an essential part of analyses for emerging and infectious disease research and AVAT immunoprophylactic antigen discovery and preclinical (IND-supporting) research studies able to verify/identify unique sequences. It is our mission to develop effective immunotherapeutics for infectious diseases. The data generated via these instruments provides comprehensive analysis of the DRAG and DRAGA mice generated by Dr. Casares for NMRC and collaborator use, and the infectious diseases preclinical and clinical studies crucial to the mission. A service contract to ensure that these systems remain fully operational, in good working order, and routinely calibrated within operational specifications permits us to generate the required data with confidence, without loss of critical irreplaceable clinical/humanized animal model samples, and know that the data are scientifically reliable and can be used to make the critical scientific decisions essential to achieving the programmatic goals and the NMRC mission. Therefore, an equipment service contract including one on-site preventive maintenance inspection and ongoing repairs by specially trained field service engineers that use the manufacturer’s unique certified parts to maintain these critical instruments at full operation and within the manufacturer’s tight operational specifications to maintain these RT-PCR (ABI 7500 FAST and Quantstudio 5) equipment in optimal working condition is required; deviation from which results in corrupted or inaccurate data/data interpretation.

As such, the minimum requirements are to:

• Provide a one-year service contract with on-site (NMRC, Silver Spring, MD, USA) rapid response and reasonable repair times by a manufacturer trained and certified service engineer with instrument-specific training and field experience on the specified equipment covered under the contract.

• Provide one on-site Preventive Maintenance/Planned Maintenance (1PM) per RT-PCR system as scheduled and on-site rapid response (a priority 4-hr phone response when dispatched to a service and onsite service and repairs within 2 business days of a client’s service call request).

• Utilize the Spectral Dye Calibration or suitable for each system during the PM -

Performed during the planned maintenance visit. Calibration involves analysis of signal strength from standard pure dyes to adjust software for correct data output for the Real

Time PCR Instrument. Service and costs include: Dyes, Certification documentation, Certificate of Calibration, all consumables required for each calibration service.

• Maintain the units according to manufacturer OEM specifications; keeping the unit fully functional and safe operation status.

• Provide Diagnostic Software Services fully vetted and approved by the manufacturer.

• Service Engineers will utilize the instrument(s)’ manufacturer diagnostic software and service tools, that incorporate the latest technical developments, repair procedures, software application updated and planned maintenance procedures, for preventive maintenance and service repairs. The Service Engineers will utilize instrument manufacturer-certified and tested calibration tools for all calibration services provided under the contract.

• Covered Replacement Parts - All parts are OEM/factory-certified and guaranteed to optimize instruments performance and reliability. All parts are manufactured by Life

Technologies (ABI and LT are part of ThermoFisher (TF), the instrument factory manufacturer) or LT's direct vendors. Must use only new or warranted replacement parts

(used or reconditioned parts). Replacement parts are only to be used as a last resort.

Refurbished/reconditioned parts not certified by the factory manufacturer (LT/TF) will not be used.

• Cover the Computer and Computer Hardware. Maintain the computer and provide needed software updates. Provide 100% coverage on all computer components sold with each covered RT-PCR systems or provided under manufacturer (LT) service contracts.

All components will match the computer manufacturer and field engineer will carry full complement of business class spares for use during PM and onsite repairs. Computer repair coverage to include software updates (bug fixes and patches) and reinstallation and reimaging of the software and transfer of client data free of charge.

Software/Hardware fixes may require pre-authorization by the NMRC Information

Technology Department.

• Service Engineers performing the equipment services will be RT-PCR system-specific

Manufacturer/Factory-certified and trained. Service Engineers performing work under this contract must be fully trained and up-to-date on all relevant manufacturer (LT) training required to service the covered instrument(s); training must be renewed every two years. No Service Staff/Engineers will be sent to service the covered instrument(s) until all training is complete and up-to-date.

• Full client access to instrument and application technical support. Support services shall provide the highest level of expertise for troubleshooting the covered instrument as issues arise and speed call resolution. Remote diagnostic services for the specific covered instrument must be available as part of the instrument coverage.

• All Parts, Labor & Travel Fees included - All parts, labor and travel fees are included for repair and planned maintenance.

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.

Failure to maintain this instrument in good working order would compromise scientific research, and result in substantial wastage of resources and personnel time and effort, and jeopardize programmatic goals.

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 ABI 7500 FAST and Quantstudio 5 are rapid RT-PCR state-of-the art machines in quantitative RT-PCR. The AVAT Department uses this instrument to analyze disease specific targets, immune system or disease-relevant sequences, and experimentally-induced controlled infections, using samples from animal and human tissues processed as needed for RT-PCR.

LIFE TECHNOLOGIES CORPORATION (which is a Thermo Fisher Scientific brand and includes Applied Biosystems Inc.) is the sole manufacturer of the 7500 FAST and Quantstudio 5 instruments. They also maintain the software upgrades and the diagnostic software utilized in the

PM and service repairs considered a minimum requirement. LT ensures that all Field Engineers are fully factory/manufacturer trained, utilize manufacturer diagnostic software, and utilize manufacturer-certified and tested calibration tools for all calibration services provided under the contract. LIFE TECHNOLOGIES CORPORATION is able to meet all the minimum requirements (see #3). LIFE TECHNOLOGIES (original equipment manufacturer) has certified that Life Technologies, a part of Thermo Fisher Scientific, is the only organization that provides services related for maintenance and repair of the covered equipment to the specified criteria

(Sole Source Q_40709039.pdf) and states “Thermo Fisher Scientific is the sole manufacturer of the instruments listed … and has not issued a letter of assurance nor provided a manufacturer’s training certification to any third party (or its employees, subcontractors, or agents) for the servicing of its manufactured instruments” (Thermo Fisher Scientific Services Advantage

Letter.pdf). To our knowledge, comparable, perhaps identical, service suitable to these units by appropriately certified engineer is available through GSA/FSS contractors, but there may be limits to number of vendors that supply estimates for their Life Technologies direct services. A service contract to ensure that these machines are always functional and in good working order, ensuring data generated by the machine is reliable and can be used to make critical scientific decisions is essential to achieving the programmatic goals and mission of NMRC. The maintenance service purchased from this company for these systems, to date, yielded prompt and reliable service.

Additional unique capabilities are that Thermo Fisher Scientific maintains intellectual property rights to its data collections software and service tools software, both of which are essential to the RT-PCR systems’ operation. The company has devoted years of expertise and fund for the development of their equipment and services. It would not be cost-effective for the Government to develop a competitive package. Therefore, Life Technologies Corporation is a uniquely qualified and 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 SAM.gov 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 a 25% discount from Life Technologies Corporation/

ThermoFisher 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 Noelle Patterson, technical expert, in the April/May 2024 timeframe for the now aligned ABI 7500 FAST and Quantstudio 5, 0.1 mL Block RT-PCR instrument systems’ one year on-site preventive maintenance and repair services contract. Both instruments require an AB Assurance plan or comparable. This research consisted of reviews of previous procurements for these RT-PCR systems preventive maintenance and repair services

(see below) and a market survey through search engines of open market contractors and Federal

Supply Schedule contractors. Search engines utilized include Google, DuckDuckGo, and government wide websites. The Google search conducted utilized keywords “Quantstudio 5”

AND “7500 FAST” AND “preventive maintenance and repair service”. While there were several irrelevant hits (testing services, unrelated brands of RT-PCR service unique to their brand, instrument sales, software services/systems, etc.), we identified four (4) potential suppliers for which we requested estimates. Therefore, no further open market search engines were used for this requirement as we exceeded 3 estimate requests. Our search verified 1.

Thermo Fisher/Life Technologies, our current supplier, as a supplier for this requirement

(estimate requested 4/05/2024 via email to Anita Werbelow, cc: service.sales@LifeTech.com, estimate 40709039 provided for $12,282.76) and yielded these potential alternate suppliers: 2.

DCM Bioservices (estimate requested 04/05/2024 via email to Jeff Griffin, cc:

service@dcmbio.com, declined to estimate), 3. Franklin Young International, Inc., known to provide items through GSA Advantage!/GS contract (estimate requested 04/05/2024 via email to dave@franklinyoung.com and Ron@franklinyoung.com, agreed to provide an estimate via

Aaron Ramirez, 04/09/2024 but no estimate was provided as of 05/17/2024), 4. Diamond

Diagnostics was initially contacted via their website diamonddiagnostics.com/services/lab-equipment-repair on 04/05/2024 for an estimate, their representative, Jim Merrill reached out via phone (1-508-429-0450) 04/11/2024, and an estimate requested via email to include the full estimate request with minimum requirements was sent to jmerrill@diamonddiagnostics.com the same day (revised estimate, Ref: 105046, provided for $10,460.00 plus a one-time $12.00 processing fee with calibrators/kits essential to perform the required services of unspecified amounts as additional costs, $10,472.00plus). We requested references (both references, Paul

Martin, Platinum Diagnostic Services, and Francia Pierre, Previse, responded but only Francia provided direct feedback via email 05/17/2024) and direct responses to key minimum requirements (provided by Jim Merrill 05/01/2024 via email) to further evaluate if Diamond

Diagnostics is able to meet our minimum requirements. Results of these efforts indicated that

Diamond Diagnostics does not include all the required consumables/calibration dyes (requiring additional and unknown costs to effect the PM service; open market search estimates at approximately $1,400 each, 2-3 kits required, a minimum of $2,800 additional costs not included in the contract/estimate provided); though provides warranted replacement parts, does not mailto:service.sales@LifeTech.com mailto:service@dcmbio.com mailto:dave@franklinyoung.com mailto:Ron@franklinyoung.com mailto:jmerrill@diamonddiagnostics.com guarantee use of OEM/factory-certified replacement parts; new or recondition validated parts are of unknown validation relative to OEM; Service Engineers are not the Manufacturer/Factory-certified and trained, though do hold Diamond Diagnostics internal certifications which are constantly updated; does not include application technical support in their estimated service plan.

References confirmed that for Diamond Diagnostics services consumers have to purchase the

PM reagents and consumables separately, one reference experienced issues with one service technician, and experienced misunderstanding in what was required for a successful PM. Taken together, Diamond Diagnostics estimated service does not appear to be more cost effective given the additional required costs and currently does not meet the minimum requirements.

We looked for small business(es) that could meet the government minimum requirements. We searched the government wide databases/search engines 1. GSAAdvantage! using keywords either “7500 FAST” or “Quantstudio 5” in combination with, initially, just the “Small Business” socio-economic category and then broadening to include most socio-economic categories (Small

Business, Women Owned Small Business, SBA-certified Small Disadvantaged Business, SBA-certified HUB Zone Firm, and others) and 2. FDPS ezSearch using keywords “Quantstudio 5” and “preventive maintenance and repairs” and “small business” and/then using keywords “7500

FAST” and “preventive maintenance and repairs” and “small business”. We also searched for suitable small business(es) for this requirement in an open market search, via DuckDuckGo, using keywords, one string, “Quantstudio 5” and “700 FAST” and “preventive maintenance and repairs” and “small business”. We did not identify a small business meeting the minimum requirements. Results are included in Market Research_QS5 7500_FY24_rfs2.pdf.

Additionally, we reached out to Life Technologies’ Anita Werbelow via email 5/24/2024 asking if Life Technologies Corporation / Thermo Fisher Scientific is a small business and/or works with a small business(es) to provide the same/comparable services and, if yes to the latter, to provide the company name and POC information. Anita returned my call 5/30/24 and said they do work with Franklin and Young International, Inc. but was not sure if this requirement was one of the covered services. We had reached out to Franklin Young International, Inc. on 04/05/2024

(see vendor “3” above) but, as of this writing, we have not received an estimate for this requirement.

We conducted government wide searches. FPDS-NG ezSearch done using keywords

“Quantstudio 5” AND “7500 FAST” yielded four hits for Life Technologies, the current supplier and estimate already requested, but did not identify any alternate suppliers. A more refined search in FPDS-NG ezSearch using the keyword string “Quantstudio 5” AND “7500 FAST”

AND “preventive maintenance and repairs” returned “No Results found”. GSA Advantage!

Searches for “Quantstudio 5” and “7500 FAST” were conducted separately (to maximize hits) in their services category employing, where enabled, the sub-search “Scientific & Medical” for search refinement. No exact matches were returned. Review of the federal procurement sites

AbilityOne, FSSI, and UNICOR confirmed their services do not include scientific/medical equipment preventive maintenance and repair services and therefore, did not lead to alternate suppliers. Finally, a search was conducted using keywords “Quantstudio” alone then

“7500FAST” alone (keywords with spaces returned bad request) through the government wide database, Interagency Contract Directory which did not identify an alternate supplier. Thermo

Fisher/Life Technologies Corporation and Diamond Diagnostics were the only two suppliers providing an estimate for this requirement. Life Technologies Corporation’s estimate for this procurement is cost effective. Life Technologies Corporation estimate and terms (Quotation:

40709039 revised 04/08/2024, noting a POP change might be required depending on contract processing times) was reviewed and found to meet all the minimum requirements. Additionally, Life Technologies proven track record (see prior market research summary below) providing the required services to each unit since warranty expiration demonstrates they are capable and a trusted supplier for this requirement. Therefore, Life Technologies is considered the most cost-effective supplier meeting this government requirement.

We have spoken to our DoD colleagues with these/similar units for this April/May 2024 market research and there are no other preferred vendors for the required services that meet our minimum requirements other than described above.

Prior market research for each the ABI 7500 FAST and the Quantstudio 5 RT-PCR systems preventive maintenance and repair services, done separately in FY21 & FY22, as POPs did not previously align, then combined into a single contract for FY23, were reviewed and are summarized here:

Prior Market Research Summary:

Briefly, the ABI 7500 FAST, FY21: The market research for a one year on-site preventive maintenance and repair service contract to cover the ABI 7500 revealed several hits for Thermo

Fisher Scientific/Applied Biosystems/Life Technologies (all the same source). Other hits citing the ABI 7500 were not alternate suppliers, but rather, suppliers selling new/used instruments. A potential vendor, SeqMe, looked promising, but, review of their website confirmed they are an international company serving the Czech Republic and not the US. As we require on-site service we did not pursue this company for an estimate. We contacted, Femto Scientific given their website confirmed they provide ABI 7500 calibration, preventive maintenance, and repair services in our area, but were not certain they were able to meet the Field Service Engineer manufacturer certified and trained government minimum requirements or have access to the required manufacturer certified/warrantied parts required given the Thermo Fisher sole source statement. Femto Scientific did not provide an estimate. Several irrelevant hits for software or preventive maintenance management software and advice were not pursued. No other alternate suppliers were identified. Therefore, the commercial market survey identified two potential sources and only one source, Life Technologies/Thermo Fisher, provided an estimate and met the government requirements. FY22: Jessica Bolton conducted market research for the same requirement reviewed previous procurements, a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include

Google, AOL, and Yahoo, for “ABI 7500 preventive maintenance contract” or “ABI 7500 service contact”. Finally, a search was conducted through the government wide databases:

AbilityOne, UNICOR, GAO, GSA and Interagency Contract Directory using the following search words: “ABI 7500 service contract”, "ABI 7500" and "preventive maintenance". We also contacted the instrument manufacturer and our prior years’ ABI 7500 preventive maintenance and repair service provider, Life Technologies Corporation (part of Thermo Fisher Scientific) who provided an estimate. Life Technologies Corporation estimate and terms was reviewed and found to meet all the minimum requirements. Taken together, Thermo Fisher/Life Technologies

Corporation was the only supplier identified and found to meet the minimum requirements for prior ABI-7500 one year on-site preventive maintenance and repair services contract award.

Briefly, the Quantstudio 5, 0.1 mL Block RT-PCR instrument one year on-site preventive maintenance and repair services after original warranty, market research initiated in the April

2020 timeframe by Soumya Shashikumar and Noelle Patterson and the May 2021 market research by Noelle Patterson indicated Life Technologies Corporation was the sole supplier of a

Quantstudio 5 preventive maintenance and repair service contract and the AB Assurance plan was selected as meeting our minimum requirements. This research consisted of reviews of previous procurements for the Quantstudio 5 RT-PCR system preventive maintenance and repair services and a market survey through search engines of open market contractors and Federal

Supply Schedule contractors. Search engines in general (Google, Bing, Yahoo), identified irrelevant hits which either did not provide the Quantstudio 5 services required or linked to technical information not relevant to this requirement. The market research did reveal several hits for Thermo Fisher Scientific/Life Technologies (all the same source) and many other hits were not alternate suppliers, but rather, Quantstudio (various models) instrument manuals, technical information, or instrument sales/distributors. Google identified contract notices or calls for similar services that did not lead to identifying an alternate supplier. A potential hit with unitylabservices, when investigated, proved to be provision of a ThermoFisher (LifeTech) service contract so an estimate was not requested as it was considered duplicative. Therefore, the commercial market survey identified only one source that met the government requirements.

Finally, a search was conducted through the government wide databases: GSA, GAO, and

Interagency Contract Directory. We were successful in both instances obtaining an estimate from Life Technologies Corporation for those procurements. The April/May 2022 market research, utilizing open market Google, Bing, Yahoo search engines for “Quantstudio 5” AND

“preventive maintenance and repair service” verified Thermo Fisher/Life Technologies, the current supplier, but did not identify an alternate supplier. Irrelevant hits included software services/systems, US Government RFPs (including ours from last year). Government wide databases: GSA, GAO, and Interagency Contract Directory for “Quantstudio 5 preventive maintenance and repair service”, “Quantstudio 5” AND “preventive maintenance and repair service”, or shortened to “Quantstudio 5” to obtain results as database required, and federal procurement databases using the same full or shortened keywords with/without “Scientific &

Medical” where search refinement was required also did not identify an alternate supplier.

Similarly, government procurement instruments/websites (April/May 2022), Ability One, GSA

Advantage, and UNICOR did not identify an alternate supplier. The remainder of the government wide databases searches revealed the system (FSSI) did not offer biomedical equipment preventive maintenance and repair services or returned no results (GSA Interagency

Contract Directory).

Therefore, no alternate suppliers were identified in the government wide databases searched

Taken together, Thermo Fisher/Life Technologies Corporation was the only supplier identified that met the minimum requirements for prior Quantstudio 5 one year on-site preventive maintenance and repair services contract award.

We combined our RT-PCR systems (ABI 7500 FAST and Quantstudio 5) preventive maintenance and repair coverage to increase contracting efficiency and align POPs in FY23/24.

Market research was conducted by Noelle Patterson, technical expert, in the April/May 2023 for the now aligned ABI 7500 FAST and Quantstudio 5, 0.1 mL Block RT-PCR instrument systems’ one year on-site preventive maintenance and repair services contract. Research consisted of reviews of previous procurements for these RT-PCR systems preventive maintenance and repair services and a market survey using the Google search engine and government wide and government procurement websites. These verified that Thermo Fisher/Life Technologies

(estimate provided) remains a supplier for this requirement and yielded potential alternate suppliers:

Femto Scientific (no estimate provided), Government Scientific Source (declined to estimate), LabSquad, (declined to estimate), Agilent (no estimate received), and. Franklin Young

International,Inc., (GS contract, estimate provided, highest cost). While there were several irrelevant hits (testing services, unrelated brands of RT-PCR service unique to their brand, instrument sales, software services/systems, etc.), we identified six (6) potential suppliers for which we requested estimates.

Therefore, no further open market search engines were used for this requirement. GSA

Advantage! Searches confirmed Fisher Scientific/Thermo Fisher (our current supplier) as a supplier. Review of the federal procurement sites AbilityOne, FSSI, and UNICOR confirmed their services do not include scientific/medical equipment preventive maintenance and repair services. Finally, a search was conducted using keywords “Quantstudio 5” alone then “ABI

7500 FAST” alone through the government wide databases: GSA, GAO, and Interagency

Contract Directory which did not identify an alternate supplier. In summary, two estimates were obtained, Thermo Fisher/Life Technologies Corporation and Franklin Young International. Life

Technologies Corporation’s estimate for this procurement was the most cost effective and found to meet all the minimum requirements. Additionally, Life Technologies’ proven track record providing the required services to each unit since warranty expiration demonstrates they are capable and a trusted supplier for this requirement. Therefore, Life Technologies was considered the most cost-effective supplier meeting this government requirement.

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 and evaluate alternate vendors capability to meet the minimum requirements. Our recent search identified two suppliers that met the government’s requirements and provided an estimate: Life Technologies Corporation and Diamond Diagnostics. Diamond

Diagnostics did not meet all minimum requirements and did not include consumables costs which, when accounted for, total costs slightly exceed the estimated Life Technologies estimate.

Therefore, at this time, Life Technologies Corporation remains the vendor able to meet our minimum requirements at a price that is most cost effective.

Life Technologies Corporation (a part of Thermo Fisher Scientific that includes Applied

Biosystems (ABI)) is the sole manufacturer of Quantstudio 5 systems and legacy access to the

ABI 7500 FAST and thus ideally suited to provide preventive maintenance and repair services for these RT-PCR systems. Consequently, the Government’s technical experts determined that

Life Technologies Corporation is the most cost-effective source that can meet all the

Government’s requirements. The results of the market research are attached [Market

Research_QS5 7500_FY24_rfs2.pdf].

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

The NMRC AVAT’s ABI-7500 has been protected under Life Technologies Corporation since

FY09 [N3239821P0027 (9/20/2021 - 9/19/2022)] after warranty expired. Prior contracts: Life

Technologies/ Thermo Fisher, formerly ABI: N3239820P0037 (9/9/2020 - 9/8/2021), N3239819P0049 (9/9/2019 - 9/8/2020), N32398-18-P0205 (10/1/17-9/30/18), N32398-17-P-

0207 (10/1/16-9/30/17), N32398-16-P-0309 (10/1/15-10/1/16), N32398-15-P-0209 (10/1/14 –

9/30/15) N32398-14-P-0201 (10/1/13 – 9/30/14), N32398-13-P-0318 (10/1/12 – 9/30/13), N00168-12-P-5815 (11/21/11 – 9/30/12). N00168-10-P-1905 (10/1/09 – 9/30/10; 10/1/10 –

9/30/11; 10/1/11 – 9/30/12), N00168-09-F-2924: FY09, APPLERA CORP, for ABI].

Quantstudio 5 RT-PCR system has been protected under Fisher Scientific Company

(ThermoFisher, Life Technologies- same company) warranty through 9/19/2020 then preventive maintenance and repair services in FY20/21, FY21/22, FY22/23 [N3239820P0208, POP

9/20/2020 – 9/19/2021, $3,907.53; N3239821P0024, POP 9/20/2021 – 9/19/2022, $4,484.97;

N3239822P0325, 9/20/22 - 9/19/2023, $4,709/97]. The ABI 7500 FAST and Quantstudio 5 RT-

PCR systems were then both protected under Life Technologies Corporation in FY23/24

[N3239824P0300, 10/19/2023 – 10/18/2024. The requirement for preventive maintenance (1PM) and repairs/service of these two RT-PCR systems is required to be in effect between 09/19/2024 to utilize available funds and no later than 10/19/2024, without lapse, after current contract end.

Life Technologies Corporation has maintained both units through warranty/extended warranty as part of Thermo Fisher Scientific (manufacturer) or its predecessors. We are requesting this requirement to ensure this highly technical instrument remains fully operational during its critical use in our emerging and other infectious diseases research to continue PM/repairs as needed to extend the lifespan of the ABI 7500 FAST and Quantstudio 5 at full operational capacity within manufacturer specifications. The company has devoted years of expertise and funds for the development of their equipment and services. It would not be cost-effective for the Government to develop a competitive package. The total amount invested in LIFE TECHNOLOGIES

CORPORATION for the ABI 7500 FAST, Real Time PCR System (qRT-PCR/TaqMan) instrument PM/repairs since FY2013 is approximately $36,299 (~$4800/year) and approximately

$57,000 over its lifespan for an instrument initially costing ~$15,000. The total amount invested in LIFE TECHNOLOGIES CORPORATION for the Quantstudio 5, 0.1 mL block, Real Time

PCR System (qRT-PCR/TaqMan) instrument PM/repairs since FY2019 is $8,392.50 for an instrument initially costing $41,400. Combined total for both instruments’ repair services over their life span, to include through FY24, is approximately $30,543. We are not funded to replace these equipment systems and expect, with continued PM/repair services, the unit will continue to operate optimally.

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.

ELDINA.1460586964 4

CARTER.SHAMA Digitally signed by

I.M.1624726649 Date: 2024.06.08 17:59:23 -04'00'

CARTER.SHAMAI.M.1624726649

(301) 319-7182 6/10/2024

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, Shamai Carter, who may be reached at (301) 319-

7182.

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

JOHNSON.YULIYA.S DJOigHitaNllSyOsNig.YneUdLIbYyA.SELDINA.146058696

Date: 2024.06.06 14:07:23 -04'00'

301-319-9047 6/6/2024

Name: Yuliya S. Johnson, PhD. Phone Date

Title: Civilian Head, AVAT Department Department/Command: AVAT, 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.

Contracting Officer Phone Date