JA Sole Source Chemistry Analyzers Reagents Redacted.pdf

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

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I. Contracting Activity.

The Contracting Activity is 60th Contracting Squadron, Travis Air Force Base, CA, 94533.

II. Nature and/or description of the action being processed.

The proposed action is for a sole source, firm-fixed-price new Purchase Order with Siemens Medical Solutions Diagnostics. This acquisition is for Chemistry Lab Analyzers and Reagents, in accordance with the Statement of Work (SOW). The Government projects award for August 31, 2021, with a start date of September 1, 2021.

III. Description of supplies/services required to meet agency needs.

The 60th Medical Group (60 MDG) at Travis Air Force Base has a requirement for a complete Core Laboratory solution for Chemistry Laboratory Analyzers and Reagents located at the David Grant Medical Center (DGMC), Travis AFB, CA.

The Period of Performance (PoP) is 01 September 2021 - 31 October 2021.

This 2 month PoP provides 60 MDG continuous lab testing capability while the current contractor (Siemens Medical Solutions Diagnostics) phases-out and the new contractor (Abbott Laboratories) phases-in.

The IGCE is The appropriation is FY21 O&M Funds

The requirement includes the following CLINS:

CLIN Item Quantity 0001 Chemistry Analyzer Tests 153,400 0002 Urinalysis Analyzer Tests 5,000 0003 Coagulation Analyzer Tests 5,100 0004 COVID Tests 500

This requirement allows the vendor, Siemens Medical Solutions Diagnostics, to continue to provide support and allow the new vendor, Abbott Laboratories, the opportunity for the delivery of new equipment, installation, and validation of analyzers.

IV. Statutory authority permitting other than full and open competition.

AFFARS 5313.501- 10 U.S.C. 2302b, Implementation of Simplified Acquisition Procedures (41 U.S.C. 1901)

V. Demonstration that the contractor's unique qualifications or nature of the acquisition requires the use of the authority cited above (applicability of authority).

Siemens Medical Solutions Diagnostics has the current Chemistry Analyzer contract FA442716P0047, which fully expires 31 August with no possible further extension. The extensive chemistry, immunology-chemistry, coagulation, and urinalysis automation line is vital to the 60 MDG Diagnostics and Therapeutics Laboratory's ability to process thousands of specimens on a daily basis. The current contract includes all management, materials and reagents, and consumable parts to keep the equipment in working order and enables the laboratory team to continuously run specimens and receive timely test results.

A new contract Chemistry Analyzer FA442721F0046 was awarded to Abbott Laboratories on 17 August 2021. This contract award was subject to unforeseeable delays, as it was protested earlier in the year. In order to maintain continued operation of the 60 MDG Lab's testing capabilities, Siemens Medical Solutions Diagnostics contract FA442716P0047 was extended under FAR 52.217-8 during the protest period. By the time the protest was resolved and FA442721F0046 was awarded to Abbott Laboratories, FA442716P0047 had been extended to its maximum potential length, Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

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In order to maintain continued operation of the 60 MDG Lab's testing capabilities, a phase-out and phase-in period is necessary while a new contractor's Chemistry Analyzer is installed and configured for use. The delivery, installation, and configuration process normally takes 30-60 days to complete. Siemens' Chemistry Analyzer is already in place, certified, connected to the Air Force network, and fully operational. Since it takes 30-60 days to deliver, install, calibrate, and test a different system, there is no other vendor that can provide continuous operation for the Lab's testing capabilities while Abbott Laboratories phases in. Siemens Medical Solutions Diagnostics is the only vendor that can provide continuous Chemistry testing operation during the phase-in period.

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

No solicitation was made for this contracting action under the circumstances. Siemens Medical Solutions Diagnostics' Chemistry Analyzer is the only equipment that 60 MDG can use, as it is already installed, certified, and operational. There is no other equipment that can be delivered, installed, and certified to meet 60 MDG's needs given the time constraints discussed in block V above. Therefore a sources sought was not issued.

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

The Contracting Officer will make a determination that the proposed price is fair and reasonable using:

1) The pricing technique at FAR 15.404-1(b)(2)(ii), comparison of proposed prices to historical prices paid for the same or similar items, i.e. 60 MDG's expiring and new Chemistry Analyzer contracts (FA442716P0047 and FA442721F0046).

2) FAR 15.404-1(b)(2)(v), comparison with independent government cost estimates.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

Market research was not conducted, as it has been determined that any new vendor's Chemistry Analyzer equipment would need to be delivered, installed, configured to the Air Force network, and tested. This process takes 30-60 days, by which time the newly awarded FA442721F0046 contractor's (Abbott Laboratories) equipment will already be operational. Hence, Siemens Medical Solutions Diagnostics' Chemistry Analyzer is the only equipment that provides 60 MDG continuous capabilities, as it is already installed, certified, and operational.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

None at this time.

X. List of any sources that expressed, in writing, an interest in the acquisition.

None at this time.

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required.

The Government does not anticipate this procurement to be Single Source in the future. Any future re-procurements of the equipment will include sufficient transition time between the old and new piece of equipment, so there will be no need for future single source awards.

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XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.

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Contracting without providing for full and open competition shall not be justified on the basis of lack of advance planning by the requiring activity or concerns related to the amount of funds available (e.g., funds will expire) (10 U.S.C. 2304(f)(4)).

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

(FAR 6.303-2(b)(6))

Describe all efforts taken (or to be to be taken) to ensure that offers are solicited from as many potential sources as practicable under the circumstances. Although Market Research is covered in Section VIII, the information in Section VI should correlate with the Market Research described in Section VI. The following issues should be addressed in this paragraph:

Sources Sought Synopsis (used as part of market research). If a sources sought synopsis was issued, state the date the synopsis was issued and a brief description of its content. If any responses were received, describe in detail the results of the screening process and the rationale for determining the unacceptability of any synopsis respondents. Reference FAR 13.105, Synopsis and Posting Requirements.

Other Actions. In this paragraph, discuss any other actions taken or planned to facilitate competition for this acquisition. The discussion should include actions tried or considered even if the actions were unsuccessful. If the efforts were unsuccessful, so state and describe why.

Qualifying Country Sources. If qualifying country sources have expressed interest, but are to be excluded, provide supporting rationale.

VII. Determination by the Contracting Officer that the anticipated cost to the government will be fair and reasonable. (FAR 6.303-2(b)(7))

Include a statement by the contracting officer that the anticipated cost will be considered fair and reasonable and provide the basis for this determination. The steps that will be taken to ensure the final contract price will be fair and reasonable are also described here. Describe the extent of cost or price analysis anticipated including the requirements for certified cost or pricing data, technical evaluations, and audits.

VIII. Description of the market research conducted and the results, or explain why market research was not conducted. (FAR 6.303-2(b)(8))

Generally, some form of market research should be conducted. Discuss any market research conducted pursuant to FAR Part 10 and describe results of that research. Market research is any effort undertaken to determine if sources capable of satisfying the agency's requirements exist and to determine if commercial items or non-developmental items are either available or can be modified so that they will satisfy the agency's needs. Market research should be focused not only on identifying alternate sources, but also on alternate equipment or substitutes that might fulfill the Government needs with only minor modification.

Regardless of the approach used, the results should provide a high level of confidence that no other qualified sources exist.

When other exceptions from the requirement to obtain full and open competition are relied upon, the market research might be limited to an examination of the acquisition history and experience with the marketplace under previous acquisitions for the same or similar items.

If no market research was conducted, so state and provide the rationale.

IX. Any other facts supporting the use of Other Than Full and Open Competition. (FAR 6.303-2(b)(9)(i))

Provide any other facts supporting the use of other than full and open competition, including an explanation of why technical data packages, specifications, engineering descriptions, statements of work, statements of objectives, or purchase descriptions suitable for full and open competition have not been developed, are not being developed, are not being used, or are not available.

X. List of sources, if any, that expressed interest in the acquisition. (FAR 6.303-2(b)(10))

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If a sources sought synopsis was done and all interested sources are included in Section VI, it is acceptable to state, “See Section VI above.”

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required. (FAR 6.303-2(b)(11))

Describe any actions taken or to be taken to foster competition for future acquisitions of the supplies or services being acquired.

Describe potential actions that could be taken to remove the barriers to competition that have been identified in the justification and include a milestone schedule, where available, for accomplishing these actions. For example, if a follow-on competitive acquisition is planned, so state and provide the planned award date, or state that the Government will attempt to acquire rights in technical data and computer software sufficient to compete follow-on acquisitions as a priced option in the contract action that is the subject of this Justification, or (if applicable) state how the Government intends to challenge nonconforming markings on technical data and computer software delivered to it under previous contracts so those markings can be removed in order that the technical data and computer software may be used in support of a follow-on competitive acquisition, or describe plans to qualify additional sources.

Address efforts to ensure competition for future spare parts and maintenance in support of systems or equipment covered by the justification, even when these acquisitions will be accomplished by other organizations. Include a discussion on available breakout data.

If no actions are planned, so state and provide reasons. If approval is sought for more than one year, explain why a sole source effort is required for the planned time duration.

For a non-competitive follow-on acquisition to a previous award for the same supply or service supported by a Justification citing the same authority, include a discussion of the actions planned to overcome barriers to competition established in the previous justification, the status of those actions, and the results of those actions. The approval authority shall determine whether the planned actions were completed. If the planned actions were not completed, the justification for the follow-on acquisition shall be approved by the approval authority one-level above the approval authority for the previous justification (see FAR 13.501(a)(2)). If the previous justification was approved by the Senior Procurement Executive (SPE), the approval remains at the SPE level.

[DFARS 213.501(a) and DFARS PGI 206.304(a)(S-70)(ii)]

XII. Certification by the Contracting Officer. (FAR 6.303-2(b)(12))

As evidenced by his/her signature, the contracting officer has determined this document to be both accurate and complete to the best of his/her knowledge and belief.

XIII. Certification by the technical/requirements personnel. (FAR 6.303-2(c))

As evidenced by their signatures, the technical and/or requirements personnel have certified that any supporting data contained herein, which is their responsibility, is both accurate and complete.