B06 J-A Brand Name_Redacted.pdf

Only or 9% of the overall contract value are for the brand name or equal items. These Brand Name or Equal items will be purchased on the T&M CLINs for Equipment, Reagents and Supplies. The list of brand-name items purchased annually is outlined in Technical Exhibit 6 of the PWS (there are 114 different items). 22 of the 114 items are for brand name Qiagen, AW2, iSEQ, Kingfisher, MagMax, MagPix, Microamp, CTR and QIAAMP products. The value of these Brand Name or Equal items comprise approximately per year of the NTE value of the T&M CLIN. Attachment 1 to this Justification and Approval (J&A) shows the brand-name items.

4. AUTHORITY CITED: This action is authorized under provisions of 10 U.S.C.

2304(c)(1) as implemented by Federal Acquisition Regulation (FAR) 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements (Brand Name). Only or 9% of the overall contract value are for the brand-name or equal items.

5. REASON FOR AUTHORITY CITED: The Brand Name or Equal items listed in

Attachment 1 are necessary to ensure that biological testing of foreign or unidentified substances are successfully carried out in order to mitigate potential threat/harm on the Pentagon Reservation. Alternatives will not work because these items are crucial for the extraction of the DNA for Polymerase Chain Reaction (PCR). Lab protocols have been validated using these specific brands with associated reagents. Certain instruments are also required due to the validation of the method solely performed on this instrument.

Using instruments not identified in Attachment 1 would require a full method validation of side by side analysis of hundreds of samples to ensure statistical equality. The Lab is accredited to ISO 17025:2017 Standard for Testing Laboratories which requires full validation of critical reagents and test platforms and strict adherence to SOPs.

If the J&A is not approved, the impact to the mission would result in substantial duplication of costs since another brand would require a full-method validation, which would entail running side-by-side testing for a minimum of 60 samples for each matrix/agent. Special studies take months to years to complete. A special study is required to validate the different items, and the cost to the agency is estimated to be

(per reagent/kit change) to or more (per equipment change);

this includes special study labor (study planning, execution, data analysis, etc.), equipment and supplies. Additionally, if the Lab used a non-validated instrument or critical reagent/supply item in the interim, they could not ensure results under their accreditation, and it would affect their ability to provide mission-essential daily results to PFPA to ensure the safety of Pentagon occupants. The switch to another brand could result in degraded performance since another brand may not offer the same level of detection of the agent. As a result, the Lab would not be in compliance with their ISO accreditation and would lose certification. Without confidence in results, the laboratory could shut down, and/or be unable to provide critical daily results that ensure Pentagon Reservation facilities and mail are free of biological threats. The duplication of cost, comprised of additional staffing, materials, data analysis, and anything else required to successfully make the transition to other items, to the agency would be between $3 to $5 million in order to validate non-brand-name items.

6. EFFORTS TO OBTAIN COMPETITION: The solicitation for CBRN Laboratory Services will be posted on an unrestricted basis for Full and Open Competition via System for Award Management (SAM) at https://sam.gov under Contract Opportunities.

A presolicitation notice was posted via https://sam.gov under solicitation number HQ003422R0085 on 3/18/2022.

7. FAIR AND REASONABLE COST DETERMINATION: I hereby determine that the anticipated price for this contract action will be fair and reasonable. The techniques identified at FAR 15.404-1(b) will be used to ensure award will be at fair and reasonable prices. Certified Cost and Pricing Data will not be obtained.

8. MARKET RESEARCH: The market research conducted indicated that this is a commercial procurement suitable for large businesses who carry out biological testing with the necessary ISO accreditation and laboratory capability within the indicated location.

9. OTHER FACTS: The procurement of these brand name or equal supplies, equipment and equipment maintenance have been historically made under subcontracting opportunities to small businesses. Additionally, the brand-name items listed may be sourced from several different scientific reagent companies (e.g. VWR, Fisher Scientific and Sigma are all companies that stock multiple brands of scientific reagents including the ones listed).

10. INTERESTED SOURCES: One large business, MRI Global, the incumbent on the current CBRN Laboratory Services contract HQ003417C0087, responded to the Sources Sought Notice that was posted via https://sam.gov on 12/16/2021. It is anticipated that there are other large businesses who may be capable of proposing on this requirement.

To date, no other sources have expressed an interest in writing. The notices required by FAR 5.201 shall be published and any proposals received shall be considered.

11. ACTIONS TO INCREASE COMPETITION: The solicitation will be competed at

SAM.

12. Is this acquisition for a non-competitive follow-on acquisition previously awarded on a non-competitive basis?

Yes. A copy of the previous justification is attached. The actions to remove any barriers to competition cited on the previous justification were were not completed

No. The original acquisition was conducted on a competitive basis.

Not Applicable. This is a new requirement.