A.02 Sole Source Justification and Approval under FAR 13.501_ 24 RHCO-A-378 - KOSigned (002).pdf

Control Number: 24-RHCO-A-378

PAN#: PANHCA-24-P-0000 007947

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(Source Selection information - See FAR 2.101 and 3.104-4)

AUG 2022

Sole Source Justification and Approval under FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office-East (MRCO-E), Fort Belvoir Health Contracting Branch, 9275 Doerr Road, Building 1221, Fort Belvoir, VA 22060

2. Description of Action: This is a new firm-fixed price requirement for Allergen Extract Biological products, diluents, diagnostic testing antigens and ancillary supply items in support of the United States Army Centralized Allergen Extract Laboratory (USACAEL), Kimbrough Ambulatory Care Center (KACC), Fort Meade, MD. Defense Health Program (DHP) Appropriations will be used to fund the resultant contract.

3. Description of Supplies/Services: This requirement is for the procurement from Greer Laboratories, Inc., of Allergen Extract Biological products, diluents, diagnostic testing antigens and ancillary supply items in support of the United States Army Centralized Allergen Extract Laboratory (USACAEL), Kimbrough Ambulatory Care Center (KACC), Fort Meade, MD. The contractor shall provide all requested items listed above.

The Government will purchase supplies for a six-month period beginning on 27 September 2024 through 27 March 2025 with no option periods. The estimated value of the requirement is $981,232.07. FAR 52.217-8, “Option to Extend Services” will not be included in the resultant contract because this is a supply requirement.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the “Simplified Procedures for Certain Commercial Items.”

5. Reason for Authority Cited: The Allergen Extract Biological supplies needed are the only FDA approved Allergen Extract diagnostic testing antigens that adheres to USACAEL’s prescribed standards of care. The safe and effective delivery of Allergen Extract vaccine diagnostic testing and treatment materials is critical to the accomplishment of USACAEL’s mission. USACAEL’s supplies are currently at a critical level which can have significant impacts on their ability to provide care and life-saving treatments to service members and their families. The Government can only use Food and Drug Administration (FDA) approved allergen extract supplies because, allergen extract biologicals are not interchangeable. Greer Laboratories, Inc., as an FDA approved manufacturer of these allergens has extensive experience, knowledge, required resources, background, and expertise to fulfill the necessary mission requirements of USACAEL in a timely and cost-effective manner. As described below, Greer is the only source that can provide the needed supplies in a timely manner.

Controlled by: USAHCA Controlled by: MRCO-E CUI Category: SP-PROCURE Limited Dissemination Control: FEDCON

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(Source Selection information - See FAR 2.101 and 3.104-4)

POC: Sara M. Fetterolf (571) 515-8249

Potency differences from one extract to another may result in severe adverse reactions to include anaphylaxis and death. Manufacturer package inserts, which are approved by the Food and Drug Administration (FDA), establish a standard of care that warrants the use of quality and effective allergen extract products for the prevention of severe and adverse consequences to the allergy patient. A copy of the FDA license is in folder A.03.

6. Efforts to Obtain Competition: A long-term requirement was solicited on the System for Award Management website (sam.gov) on 28 July 2024 as a competitive 100% Small Business Set-Aside. Only one vendor, Greer Laboratories, Inc responded. Greer Laboratories, Inc.’s proposal, provided, most, but not all, of the required reagents for which the Government solicited. Therefore, the Government could not award the contract to Greer.

7. Actions to Increase Competition: There are currently no practical alternatives available to increase competition for this requirement.

a. Effective competition. There is no effective competition expected for this requirement.

This will be a sole source contract to Greer Laboratories, Inc. in order to allow the Contracting Activity to resolicit and award a new long-term contract.

b. Subcontracting competition. In accordance with FAR 19.702(b) (1) a subcontracting plan is not required from small business concerns.

8. Market Research: Market Research was conducted in accordance with FAR Part 10.

Market research for previous procurements of the same products illustrate that several vendors have some of the requested capability. Only one vendor, however, Greer Laboratories, Inc. can provide all the requested items and supplies. Although some vendors indicate an ability to provide some of the supplies, only the recommended vendor, Greer Laboratories, Inc. can support the entire requirement. These allergenics are regulated by the Center for Biologics Evaluation and Research (CBER) and must be provided from an FDA approved manufacturer. Due to these requirements, Greer Laboratories, Inc. is the only contractor currently able to supply the total list of items required by this contract. The KO Market Research will be placed in PCF folder A.02. A search of the Dynamic Small Business using the NAICS 325412 resulted in the following:

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(Source Selection information - See FAR 2.101 and 3.104-4)

Economic Group Number of Firms Found

Service-Disabled Veteran 155

Currently SDB Certified 535

Currently HUBZone Certified 28

Currently 8(a) Certified 39

Woman or Women Owned 16

Veteran 194

9. Interested Sources: To date, no other sources have expressed an interest in this requirement, in writing or otherwise.

10. Other Facts:

a. Procurement history.

(1) W81K0423D0004, 1 March 2023 – 28 February 2027, Unrestricted

W91YTZ22C0021, 1 October 2022 – 31 March 2023, Sole Source, 100% Small Business Set-Aside W91YTZ-17-D-0007, 1 September 2017 – 31 August 2022, Competitive, 100% Small Business Set-Aside

W91YTZ-12-D-0022, 1 September 2012 – 31 August 2017, Competitive, 100% Small Business Set-Aside

(2) The competitive status of these actions. Three of the previous contracts were solicited competitively as 100% Small Business set-asides and one was a sole source as identified above.

(3) Authority previously cited if less than full and open competition was used. FAR 13.501

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. Contracts W81K0423D0004, W91YTZ-17-D-0007 and W91YTZ-12-D-0022 were competed. Contract W91YTZ22C0021was issued as a sole source bridge due to receipt of several protests on the long-term contract W81K0423D0004.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. N/A

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(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. N/A

b. Other facts. Greer Laboratories, Inc. was the incumbent contractor performing on W81K0423D0004, the predecessor contract to this effort. The requirements of W81K0423D0004 substantially mirror the requirements sought in this Sole Source Justification. Although Greer’s performance was acceptable, in or around February 2024, the Government inadvertently failed to exercise the option for the first option year and the contract lapsed.

The requirement was issued as a competitive 100% Small Business set-aside on 28 July 2024. On 05 September 2024, the date proposals were due, the Government received only one proposal, from Greer Laboratories. In evaluating Greer’s proposal, the Government noted several issues. Of key concern was the fact that the vendor acknowledged that, of the 203 products, it could not provide 23 food products and two tree allergen products required in the RFP. Because the Government solicited this requirement on an “all or none” basis, the Government had to rate Greer as Unacceptable. In light of the urgent need to obtain these products, the Government decided to pursue a short-term requirement on a sole source basis to allow time to resolicit and award a long-term contract on a competitive basis. Because Greer was the only Offeror on the recent competitive solicitation, and demonstrated in its proposal that it could provide the vast majority of the Government’s needs, the Government determined that Greer is the sole source to meet the current requirement.

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: Susan E. Kosisky Title:

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.

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Typed Name: Susan E. Kosisky Title: Chief, Microbiologist__________

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. The basis for this determination will be price analysis in accordance with FAR 15.404-1(b). Certified cost or pricing data is not required per FAR 5.403-1(b)(3) because the item and/or service being acquired are considered commercial.

Typed Name: Sara M. Fetterolf Title: Contracting Officer

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

Typed Name: Sara M. Fetterolf Title: Contracting Officer

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Approval

Based on the foregoing justification, I hereby approve the procurement of Allergen Extract Biological products, diluents, diagnostic testing antigens and ancillary supply items with an estimated total price of $981,232.07 for a six-month period of performance on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501 and provided that the supplies and equipment herein described have otherwise been authorized for acquisition. FAR 52.217-8, Option to Extend Services will not be included in this requirement as this is a supply requirement.

Signature: ________________________________ Date: ________________________

Typed Name: Kerry A. Alvarenga Title: Command Advocate for Competition