ERP PR 1301254258_JNA_Redacted.pdf

NMRC

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

Standard Document Number/PR#: PR#1301254258

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 onsite preventive maintenance and repairs/service of two

Autoimmun Diagnostika (AID) specialized plate reader systems (2 iSpot instruments) located in the NMRC AVAT (formerly Malaria) Department Clinical Immunology Laboratory. The

Government intends on awarding a Firm Fixed Price contract. The proposed source is

Autoimmun Diagnostika GMBH (AID, AID GmbH), Ebinger Str. 4. D-72479 Strassberg.

Germany.

3. Description of Supplies or Services:

The Naval Medical Research Command (NMRC) Agile Vaccine and Therapeutics Department

(AVAT/IDD; formerly Malaria) has a critical need to maintain their AID specialized (iSpot) plate reader instruments, AID iSpot Reader ELRIFL07 (SN: ELRIFL071203148) and AID iSpot reader ELR08IFL (Reader- ELR08IFL1609253, Computer- GB00DD2) which each include a computer, monitor and printer (collectively referred to herein as the iSpot readers), at full operation with minimal downtime throughout the one year period of performance (POP). Units are critical to acquiring and analyzing ongoing clinical study data and must be maintained consistent with GLPs and GCPs to meet our mission. Navy Operation and Maintenance Fiscal

Year 2025 funds in the amount of $ 17,340.00 will be used to maintain these systems at full operation within manufacturer specifications.

The AID iSpot readers require periodic inspections and preventive maintenance (1PM/year) during the contract year 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.

The NMRC AVAT Department must perform molecular, cellular, immunology, and parasite assays in evaluating candidate infectious disease(s) vaccines in both preclinical and clinical research studies. These studies are ongoing, and critical to daily activities. To carry out this work in accordance with GLP and GCP (good laboratory practices and good clinical practices), these iSpot reader systems must be continuously operational, be maintained at state-of-the-art conditions, and routinely calibrated and serviced. Therefore, the minimum requirements are:

• Vendor that offers a minimum of 1-year routine service contract with appropriate on-site or vendor/supplier-site preventive maintenance (1 PM/year) and repairs (initially on-site or, if necessary, at manufacturer’s site thereafter) to ensure the units are functioning properly and will be repaired promptly.

• Must offer service contract options for AID iSpot instruments no longer under warranty.

• Maintenance engineers are trained, equipped, and capable of calibrating, maintaining, and repairing the specific AID equipment named in the contract, such that these units meet

AID 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 contract-designated models.

• Service contract must provide proper care and maintenance schedules sufficient to maintain the instruments in good working order thereby to ensure that our iSpot Readers are always functional. Thereby, planned experiments can be conducted, and repairs do not compromise critical experiments.

• Service plan must be able to accommodate supporting clinical trial requirements. This unit is used to generate Clinical Immunogenicity data in support of the NMRC AVAT

Department to include preclinical (rodents, rabbits, and NHP studies) and Clinical Trials research (to GLP/GCP). As such, the equipment maintenance must adhere to those required by clinical practices and/or by clinical research auditors. The vendor must be willing to provide the necessary certifications. PM service must be scheduled around clinical trials testing.

• Service contract must include: on-site PM (minimum 1/yr each covered instrument) and on-site repairs as needed, system check/repair at manufacturer’s site if issue cannot be repaired/resolved on-site; provide manufacturer certified replacement parts (excepting camera and computer is okay); manufacturer-issued/authorized and instrument-specific software upgrades; technical support via telephone/email/eSupport; all shipping costs included; client staff training (half day minimum), replacement bulbs, and master lot plate(s) included. Vendor responsible for all shipper, freight, postage, and storage costs both to and from manufacturer site.

• Must be committed to prompt telephone support to resolve problems and, where the problem cannot be resolved over the phone, quickly initiate (within 24 hours) a servicing plan to resolve problems.

• Repairs requiring repair at the manufacturer’s site require the Vendor/Service Engineer to keep the End-User informed of repair progress and estimated instrument return date.

• Able to coordinate required PM for each iSpot reader to be during the same site visit.

Where manufacturer-site repairs required, Vendor must coordinate, without damage or issues, the covered equipment to/from manufacturer/vendor-site to include any return-to-site installation/QC maintenance checks for all off-site services required during the POP.

Meeting these minimum requirements should prevent the need to repeat experiments due to broken equipment, avoiding substantial wastage of resources, personnel time and effort, loss of irreplaceable samples without obtaining the required mission-critical data, and the risk of jeopardizing programmatic goals. Additionally, repeating failed experiments due to machine error/disrepair may not be possible for clinical trials where additional samples may not be available. 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 AID iSpot readers were manufactured by Advanced Imaging Devices (AID) [or Autoimmun

Diagnostika GmbH, AID]. Autoimmun Diagnostika GmbH (AID), the proposed vendor for the requested services, is the sole manufacturer and repair/service vendor of the AID iSpot readers.

AID is the current manufacturer and a distributor of the named equipment. Therefore, AID

(Autoimmun Diagnostika GmbH) is uniquely capable of meeting manufacturer specifications on the instruments, and have trained service and maintenance engineers capable of calibration, repairs, and maintenance of these units to manufacturer specifications. As the manufacturer, they are also most likely to have required parts in stock and are committed to keeping their equipment functioning at state-of-the-art levels. As the sole manufacturer and sole U.S.

distributor of the iSpot Reader system, they provide the warranty service; and as such are uniquely capable of meeting warranty and PM service needs after the warranty period. AID field technicians are trained on all AID instruments so the same service team can service both iSpot instrument systems- thereby are able to provide PM service of both units during the same visit

(minimizing down time to the laboratory operations). Their PP-5 Service plan meets the minimum requirements.

The company providing the service 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.

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 as a Special Notice.

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.

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 immunospot instrument technical experts (versed in multiple instrument models) for each annual renewal since FY2007, to include the iSpot instruments starting with FY13, and most recently, in April/May 2025 by Harini Ganeshan. 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, DuckDuckGo, and Ecosia using keywords “AID iSpot” + “service” of open market contractors.

Government wide/Federal Supply Schedule contractors market survey utilized keywords “iSpot”, given required keyword brevity which unfortunately pulled out the irrelevant results too. These searches identified several AID iSpot instrument distributors of used units or informational materials and manuals. Overall, our market research verified that only AID offered service contracts/preventive maintenance and repair services for the covered instruments meeting minimum requirements. AID has also provided sole source justification letter that they are the sole provider of service and products and that they do not supply parts to other resellers or vendors in the US.

Additionally, we reviewed the FY24 contract market research package.

Market research has previously included Ms. Glenna Banania’s 2007 contract market research for other vendors offering a manufacturer-approved service contract on the AID ELISpot system

(taken off service contract Sept 2021) within the US. The FY07 AID US manufacturer/ distributor, CELL TECHNOLOGY, INC., has not offered AID EliSpot Reader Service Contracts since FY07, nor are any other US Vendors authorized to provide such service. Market research in May/June 2008, June 2009 and May-July 2011, and FY12 confirmed AID was the sole AID instrument PM and repair service supplier. In FY13, an iSpot Reader System was added to our laboratory assets. Market research for a supplier providing service for both AID ELISpot and iSpot Reader systems was conducted by internet Google search and we remained unable to identify an alternate service provider capable of meeting the minimum requirement of both capability and preventive maintenance (PM) visit servicing of the covered equipment systems.

Again, in July 2014, we found that all other vendors either offered other scientific services or, where they offered an equipment service contract only provided service to their own equipment.

July 2015 market research identified potential competitors: resolving IMAGES, Australia; Volt

Tecnologia, Argentina; and Alpha-Omega Diagnostics, Netherlands. All distribute AID instruments, but do not all offer on-site service in the US. Where on-site service appeared an option, we sent an estimate request. Resolving IMAGES on-site service was provided in partnership with AID, and they did not provide a direct estimate. Subsequent FY16-FY22 searches yielded similar results. This year’s market research confirmed ResolvingIMAGES on-site service is provided in partnership with AID, and they did not provide a direct estimate. Taken together, our AID spot reader instrument service contract searches reaffirmed that AID remains the sole provider able to meet the minimum requirements. Subsequent years market research by Jessica

Bolton and/or Noelle Patterson, with input from Harini Ganeshan, confirmed in FY19, FY20, FY21 and FY22, that AID remained the sole provider able to meet our minimum requirements.

FY22 Potential alternate suppliers: Volt Tecnologia, Medical Expo, Silo Tips, Premedical Labs, and Oxford Biosystems proved not to be alternate suppliers. We also encountered access denied websites/links and attempted workarounds yielded no valuable information. Harini Ganeshan conducted new market research for this requirement in April 2024 and April 2025. Searches yielded similar results. Hits were generally for AID instruments through new/refurbished equipment distributors, were irrelevant services, or referenced AID, Autoimmun Diagnostika

GmbH (AID ELISpot and iSpot Reader Systems manufacturer and the current selected supplier) outdated service brochures, AID instrument manuals, or AID instrument price lists. We also encountered access denied websites/links and attempted workarounds yielded no valuable information. Autoimmun Diagnostika (AID) was identified as a current AID iSpot PM and repair service contract supplier, which is the current supplier of the required services. We requested an AID estimate from Martin Schuster 3/31/25 and received their estimate on April 07, 2025.To date, we still have not successfully identified an alternate provider for AID iSpot Reader

Service contracts executed in the United States that meets the minimum requirements. The iSpot equipment has been properly maintained under a service contract with AID (Autoimmun

Diagnostika GmbH) in FY13, FY14, FY15, FY16, FY17, FY18, FY19 (a second, newly purchased iSpot was added), FY20, FY21, and FY22; as no other service alternatives for this equipment have been identified. We were not able to identify another service provider that offered the equivalent Gold, PP-5 (preferred), or even a PP-2 Service Contract on the listed equipment outside of AID (Autoimmun Diagnostika GmbH) based on discussions with colleagues and internet searches for alternate service companies. Therefore, the sole U.S.-based vendor for providing maintenance and repair service contracts on the AID iSpot Reader System is AID (Autoimmun Diagnostika GmbH) and submit with this package their estimate.

Finally, we checked the Government-wide database of contracts and other procurement instruments (FPDS, www.fpds.gov; GSA, gsa.gov; GSA Advantage; Interagency Contract

Directory, https://www.contractdirectory.gov/contractdirectory/; Federal Strategic Sourcing

Initiative (FSSI). We were not able to identify an alternate source or any issues with AID, the selected provider. AID is the sole manufacturer of the AID iSpot readers and sole provider of equipment service contracts for the required instruments. Consequently, the Government’s technical experts determined that AID is the only source that can meet the Government’s requirements. The results of the market research are attached.

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.

http://www.fpds.gov/ http://www.contractdirectory.gov/contractdirectory/%3B

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

The requirement for iSpot readers preventive maintenance and repairs/service was researched as described above; no other vendor is able to meet the minimum salient characteristics as cost effectively as AID since Cell Technology, Inc. discontinued servicing these instruments (AID

ELISpot Reader, at the time). AID provides service contracts on our AID iSpot Reader Systems and is the sole vendor for the AID iSpot Reader Service Contract in the U.S.A. The iSpot

Reader System, installed in May 2012, was on partial service contract to cover its preventive maintenance (FY13, N32398-13-P-0205) as required in our Clinical Immunology Lab (3W40), per GLP and Clinical Lab Maintenance Requirements. The iSpot warranty expired in FY2013.

FY14, N32398-14-P-0203. FY15, N32398-15-P-0312 covered both ELISpot and iSpot reader units and continued in FY16, N32398-16-P-0302; FY17, N32398-17-P-0300; FY18, N3239818P0310 demonstrating AID is a capable and effective supplier of the required services.

We added a second iSpot reader, off warranty in FY19, N3239819P0016 that covered all three

NMRC Malaria AID instruments which was renewed in FY20, N3239820P0036. We renewed

PM and repair service coverage of just the iSpot reader systems in FY21, N3239821P0025 and

FY22, N3239822P0317. AID has provided prompt, thorough, and effective preventive maintenance and service of the AID ELISpot and iSpot readers throughout their warranty and contracts with NMRC keeping the systems calibrated, fully operational, and prolonging the lifespan of these mission critical instruments. The company providing the service has devoted years of expertise and funds for the development of their equipment and services; we have not been able to identify a high-quality cost-effective alternative. The total amount invested in AID iSpot PM/repairs since FY2013 is $71,170.00 elongating the equipment lifespan for units costing

$45,000 + 12% inflation each (estimated 2 unit replacement cost of $100,800) to replace.

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

9955.

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.KALYAN Digitally signed by

SUNDARAM.APPAVU.KALYANA.1513194621

A.1513194621 Date: 2025.05.30 20:26:40 -04'00'

Name Appavu K. Sundaram, PhD Title

Department/Command

Requirements Cognizance

Phone 301-319-7199 Date

Name

Title Department/Command

Phone Date

CONTRACTING OFFICER CERTIFICATION

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

(301) 319-9955 9/3/2025

Shamai Carter Contracting Officer

Phone Date