A02 JA 22-02-1113 FPDS 24MAR22_Redacted.pdf

CUI//SP-SSEL

Control Number: JA-22-02-1113

CUI/SP-SSEL

(See FAR 2.101 and 3.104-4)

(SEP 2021)

Justification Review Document For Sole Source - FAR Part 13.501*

(*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: The U.S. Army Medical Material Development Activity’s (USAMMDA) Warfighter Deployed Medical Systems Project Management Office (WDMS PMO) has a requirement to identify and procure up to 480 medical Food & Drug Administration (FDA) 510(k)-cleared commercial, Field Portable Dental System (FPDS) for use in Army Deployed Medical Roles of Care 1 and 2. The FPDS is a compact and lightweight dental unit used by operational dental providers to complete dental procedures ranging from simple surgical extractions to permanent restorations in austere environments.

Authority: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount: $7,213,500.00

Prepared by:

Typed Name: Herbert (Caj) Keen DSN: (301) 619-1011

Title: Contract Specialist Date: 3 March 2022

E-mail: herbert.e.keen.civ@mail.mil

Contracting Officer:

Typed Name: Rebecca Foster DSN: (301) 619-1356

Date Reviewed: 8 March 2022

E-Mail: rebecca.d.foster4.civ@mail.mil

Technical Representative:

Typed Name: Adam Hayes DSN: 301-693-9590

Title: Assistant Product Manager, Modernization Date Reviewed: 9 March 2022

E-Mail: Adam.k.hayes.civ@mail.mil

FPDS

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4)

Requirements Representative:

Typed Name: Erica Smith DSN: 301-619-6241

Title: Product Manager, Modernization, WDMS Date Reviewed: 9 March 2022

E-Mail: Erica.k.smith5.civ@mail.mil

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel

Typed Name: Roger S. Higgs DSN: 343-2727

Signature: _ _____ ______ Date: ______________________

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD.

2. Description of Action: U.S. Army Medical Material Development Activity (USAMMDA) Warfighter Deployed Medical Systems Project Management Office (WDMS PMO), Fort Detrick, MD, requests a new Blanket Purchase Agreement (BPA) with Aseptico, Inc., 8333 216th St. SE, Woodinville, WA 98072. This BPA will utilize Defense Health Program (DHP), 6.7 Operational Systems Development funds and 6.7 Other Procurement Army (OPA) funds. Funding in the amount of $84,000.00 has been provided for the initial call order utilizing PR# 0011750572.

3. Description of Supplies/Services: A minimum of six (6) to a maximum of 480 Field Portable Dental Systems, Aseptico Model, AEU-14CF, Emergency Field Dental Units will be procured via this contract.

Period of Performance: 1 July 2022 – 30 June 2027

Total Value: $7,213,500.00

4. Authority Cited: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5. Reason for Authority Cited:

The property or services needed by the agency are available from only one responsible source.

The U.S. Army Medical Material Development Activity (USAMMDA)/Medical Modernization, WDMS PMO, has a requirement to identify and procure a medical Food & Drug Administration (FDA) 510(k)-cleared commercial, Field Portable Dental System (FPDS) for use in Army Deployed Medical Roles of Care (ROC) 1 and 2. The FPDS is a compact and lightweight dental unit used by operational dental providers in austere environments to complete dental procedures, from simple surgical extractions to permanent restorations. ROC 2 primarily utilizes the FPDS, but when requested, must forward deploy to provide dental treatment to support ROC 1 operations for human and veterinary treatment. The legacy product has come to the end of its useful life. The

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4)

Government can no longer procure the device from the commercial market and the manufacturer offers limited product support for the system. USAMMDA’s market research report identifies the Commercial Off The Shelf (COTS) Field Portable Dental Systems as a potential to replace the legacy product. Acquiring COTS products will meet capability shortfalls and provide a significant opportunity to Army dentistry to realize capabilities with predictable and lower costs, shorter fielding schedules, and reduced technical risk, while maintaining the highest standard of care consistent with current dental practices.

6. Efforts to Obtain Competition: A Request for Information (RFI) was published on 15 December 2021 with a due date of 5 January 2022. The Government received one

(1) response from Aseptico, Inc. A Notice of Intent (NOI) was published on 15 February 2022 with a due date of 2 March 2022, with no responses received. This is a sole source action, and effective competition is not practicable, as indicated from the results of the published NOI.

7. Actions to Increase Competition: USAMMDA and USAMRAA will take appropriate action to increase competition to the maximum extent practicable (based on results of market research) in the event subsequent requirements are identified.

8. Market Research: From September to October 2021, USAMMDA employed MilTech to support the market research effort to identify the specific niche dental capabilities the system required. This in-depth market research ensured identification of any appropriate COTS systems to support the Government’s requirement. MilTech has supported the transition of new technology to the U.S. Government since 2004 and performed over 150 technology acceleration and transition projects for every military service, including joint and special operations commands. During this effort, MilTech reviewed published sources such as manufacturer websites, product manuals, keyword searches, medical equipment and supply directories. Researchers evaluated the products against the USAMMDA-provided Essential Characteristics (ECs) and Additional Performance Parameters (APPs). For information not listed publicly, researchers contacted manufacturers via phone and email to confirm product availability and features.

Market research reviewed the commercial market for a small, compact, portable, and lightweight FPDS. The new product met the threshold standard of ten (10) ECs specified by USAMMDA. There were also four (4) APPs considered desired features of a new FPDS, but not required characteristics. The system had to be able to withstand extreme storage and operating conditions to achieve maintainability and sustainability

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4) by military and civilian biomedical maintenance technicians using existing military supply channels.

The initial search identified ten (10) companies that offered 15 portable dental systems. Some companies offered more than one (1) system. A second search yielded an additional two (2) systems from previously identified companies. In total, market research identified ten (10) companies and 17 products for further analysis. Refining the list of potential products, researchers consulted with USAMMDA and utilized publicly available sources to analyze the systems and manufacturers. A total of 12 portable dental systems, all commercially available, produced by four (4) manufacturers were evaluated against the approved Essential Characteristics (EC) and Addition Performance Parameters (APP). Only one, Aseptico’s Emergency Field Dental Unit (AEU-14CF), met all ten (10) ECs at the Threshold level or higher. Ten (10) products met seven (7) or fewer ECs. Of the 12 Field Portable Dental Systems evaluated, the Aseptico, Emergency Field Dental Unit (model AEU-14CF) was the only system that met all the Essential Characteristics, with ten (10) met at the Threshold or Objective level. This technology also met all four (4) of the Additional Performance Parameters.

Based on the above factors, Aseptico, Inc. is the only vendor that can supply the required FPDS that meets the Army’s requirements. The loss of the FPDS capability will affect the opportunity for treatment and possible return to fight. This capability must be maintained to support the National Defense strategy for MDO: Multi-domain formations (Enhanced Medical Support) and Maximize Human Potential [TRADOC Pamphlet 525- 3-1, 6 December 2018].

9. Interested Sources: As shown in the market research, RFI and the lack of responses received to the NOI, only one interested source can provide the required FPDS to meet the needs of the Government.

10. Other Facts:

a. Operational History: Two separate end users provided historical operational data on the performance of the Aseptico, Emergency Field Dental Unit (model AEU- 14CF). LTC Joseph Ivory and LTC Larry Munk, both Army operational dentists, identified that the unit stated above performed and filled all requirements necessary over four separate combat deployments in support of Operation Enduring Freedom. This data is outlined in separate memorandums for record and was provided to the Project Manager. Based on the successful operational history of the system it is advantageous that the Government take advantage of this COTS capability.

b. Other facts. None.

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4)

(SEP 2021)

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Signature: _____Date: __________

Typed Name: Adam Hayes Title: Technical Representative

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Signature: _ __Date: __________

Typed Name: Erica Smith Title: Project Manager

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4)

14. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

This determination will be made using price analysis based on a comparison of the proposed price to the Independent Government Cost Estimate (IGCE) and other similar requirements awarded by the Government within the past year. In accordance with FAR 15.403(a), certified cost and pricing data is not required as the items being acquired are considered commercial.

Signature: _____Date: __________

Typed Name: Rebecca D. Foster Title: Contracting Officer

15. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature: _ ___Date: __________

Typed Name: Rebecca D. Foster Title: Contracting Officer

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4)

Approval

Based on the foregoing justification, I hereby approve the procurement of Field Portable Dental System (FPDS) for use in Army Deployed Medical Roles of Care 1 and 2 for the estimated amount of $7,213,500.00 on an other than full and open competition basis pursuant to the authority of Only One Responsible Source [10 U.S.C. 2304(c) (1), FAR 6.302-1.], subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: _ Date: _______________

Typed Name: Christopher E. Sherman Title: Command Advocate for Competition

USAMRAA