JA Limited Source Justification FAR Part 8 (APR 2021)_Redacted.pdf

CUI//SP-SSEL

Control Number: 21-RHCO-C-438

APR 2021

Justification Review Document for Limited Source Justification

Under FAR Part 8

Program/Equipment: Sofia Reagent FLU and RSV (Respiratory Syncytial Virus) Test Kits

Authority: Title III of the Federal Property and Administrative Services Act of 1949 (41U.S.C. 251, et. Seq) and Title 40 U.S.C 501, Services for Executive Agencies, as implemented by FAR 8.405-6.

Amount:

Prepared by:

Typed Name:

Contract Specialist Date: 26 July 2021 Email:

Contracting Officer:

Typed Name: Date Reviewed: 27 July 2021 E-Mail:

Technical Representative:

Typed Name: Date Reviewed: 27 July 2021 Title:

E-Mail:

Requirements Representative:

Typed Name: Date Reviewed: 27 July 2021 Title:

E-Mail:

Controlled by: USAHCA Controlled by: RHCO-C CUI Category (ies): SSEL

Limited Dissemination Control: FED ONLY

POC:

Limited Source Justification

1. Contracting Activity: Region Health Contracting Office-Central

2. Description of Action: FDA approved Microbiology Sofia Reagent FLU and RSV (Respiratory Syncytial Virus) Test Kits.

3. Description of Supplies/Services: The Department of Pathology, Microbiology Section at Carl R. Darnall Army Medical Center (CRDAMC), Fort Hood, Texas requests FDA approved Sofia Reagent FLU and RSV (Respiratory Syncytial Virus) Test Kits to enable the detection of seasonal illness in patient specimens.

4. Authority Cited: Title III of the Federal Property and Administrative Services Act of 1949 (41U.S.C. 251, et. Seq) and Title 40 U.S.C 501, Services for Executive Agencies, as implemented by FAR 8.405-6 and substantiated by the following:

FAR 8.405-6(a)(1)(i)(B):Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

5. Reason for Authority Cited: The Department of Pathology, Microbiology section has a need for the flu reagents that are compatible with the Government owned Sofia analyzer. The requested reagents are compatible with the Government owned analyzer and are produced by Fisher Healthcare, LLC. Currently there are no other U.S. Food and Drug Administration (FDA) approved Sofia Reagent FLU and RSV (Respiratory Syncytial Virus) Test Kits reagents that can be utilized on the Sofia Analyzer. Currently Fisher Healthcare, LLC is the only manufacturer that meets the Government’s requirements. The reagents have been determined by the Microbiologist to meet the medical, health, and wellness of the patients of the Microbiology laboratory. Fisher Scientific is the exclusive authorized distributor/dealer for the requested reagents. The requested item, as needed by patient physicians and has been determined to meet the medical, health, and lifestyle needs of the patients, to include active duty, beneficiaries and retirees to provide quality health care for the CRDAMC community in the most proficient manner possible.

Meeting the flu detection mission is not only CRDAMC’s mission, this mission also supports the U.S. Department of Defense (DoD) Global Respiratory Pathogen Surveillance Program. The DoD Global Respiratory Pathogen Surveillance Program monitors influenza and provides the Centers for Disease Control (CDC) and FDA with data to facilitate the creation of the flu vaccine each season. Unlike chemicals that can be bought in bulk and stored for several years, these particular kits comes with very limited expiration dates and short shelf life. Having this item on a contract benefits the Department of Pathology, Microbiology section in order to maintain a consistent and reliable testing service for the MTF.

https://www.facebook.com/FDA/?fref=mentions&__xts__%5B0%5D=68.ARAXXEW-yQ5W-6u8nMQv9K3if3N3PlY5wAxbS5ienqopEl27yfsLFJdvy1SE8r_K5NfT5v0t8nlNdlRz3eEpKk56AANgQjOiIko0IzhuanXeZsln37M7QekwxgBcwAyvj26KjxXgvE9afv8CwbVdMhykR6E60FJkfswyV58UphM6WFH0Vo4CxZWBAyPQ_XP8kHbUWe9J0qHqQAda_wEOvts12fjJM72_rKYzN11SvSzsAXKal5BH-xwP8zpQExdTDeBbsWLEufghXdNtBBMKjWOj2M1G6mIBTRCFKx_3gjlQypvWeuw&__tn__=K-R https://www.facebook.com/FDA/?fref=mentions&__xts__%5B0%5D=68.ARAXXEW-yQ5W-6u8nMQv9K3if3N3PlY5wAxbS5ienqopEl27yfsLFJdvy1SE8r_K5NfT5v0t8nlNdlRz3eEpKk56AANgQjOiIko0IzhuanXeZsln37M7QekwxgBcwAyvj26KjxXgvE9afv8CwbVdMhykR6E60FJkfswyV58UphM6WFH0Vo4CxZWBAyPQ_XP8kHbUWe9J0qHqQAda_wEOvts12fjJM72_rKYzN11SvSzsAXKal5BH-xwP8zpQExdTDeBbsWLEufghXdNtBBMKjWOj2M1G6mIBTRCFKx_3gjlQypvWeuw&__tn__=K-R https://www.facebook.com/DeptofDefense/?fref=mentions&__xts__%5B0%5D=68.ARAXXEW-yQ5W-6u8nMQv9K3if3N3PlY5wAxbS5ienqopEl27yfsLFJdvy1SE8r_K5NfT5v0t8nlNdlRz3eEpKk56AANgQjOiIko0IzhuanXeZsln37M7QekwxgBcwAyvj26KjxXgvE9afv8CwbVdMhykR6E60FJkfswyV58UphM6WFH0Vo4CxZWBAyPQ_XP8kHbUWe9J0qHqQAda_wEOvts12fjJM72_rKYzN11SvSzsAXKal5BH-xwP8zpQExdTDeBbsWLEufghXdNtBBMKjWOj2M1G6mIBTRCFKx_3gjlQypvWeuw&__tn__=K-R https://www.facebook.com/CDC/?fref=mentions&__xts__%5B0%5D=68.ARAXXEW-yQ5W-6u8nMQv9K3if3N3PlY5wAxbS5ienqopEl27yfsLFJdvy1SE8r_K5NfT5v0t8nlNdlRz3eEpKk56AANgQjOiIko0IzhuanXeZsln37M7QekwxgBcwAyvj26KjxXgvE9afv8CwbVdMhykR6E60FJkfswyV58UphM6WFH0Vo4CxZWBAyPQ_XP8kHbUWe9J0qHqQAda_wEOvts12fjJM72_rKYzN11SvSzsAXKal5BH-xwP8zpQExdTDeBbsWLEufghXdNtBBMKjWOj2M1G6mIBTRCFKx_3gjlQypvWeuw&__tn__=K-R https://www.facebook.com/FDA/?fref=mentions&__xts__%5B0%5D=68.ARAXXEW-yQ5W-6u8nMQv9K3if3N3PlY5wAxbS5ienqopEl27yfsLFJdvy1SE8r_K5NfT5v0t8nlNdlRz3eEpKk56AANgQjOiIko0IzhuanXeZsln37M7QekwxgBcwAyvj26KjxXgvE9afv8CwbVdMhykR6E60FJkfswyV58UphM6WFH0Vo4CxZWBAyPQ_XP8kHbUWe9J0qHqQAda_wEOvts12fjJM72_rKYzN11SvSzsAXKal5BH-xwP8zpQExdTDeBbsWLEufghXdNtBBMKjWOj2M1G6mIBTRCFKx_3gjlQypvWeuw&__tn__=K-R https://www.facebook.com/hashtag/flu?__eep__=6&source=feed_text&epa=HASHTAG&__xts__%5B0%5D=68.ARAXXEW-yQ5W-6u8nMQv9K3if3N3PlY5wAxbS5ienqopEl27yfsLFJdvy1SE8r_K5NfT5v0t8nlNdlRz3eEpKk56AANgQjOiIko0IzhuanXeZsln37M7QekwxgBcwAyvj26KjxXgvE9afv8CwbVdMhykR6E60FJkfswyV58UphM6WFH0Vo4CxZWBAyPQ_XP8kHbUWe9J0qHqQAda_wEOvts12fjJM72_rKYzN11SvSzsAXKal5BH-xwP8zpQExdTDeBbsWLEufghXdNtBBMKjWOj2M1G6mIBTRCFKx_3gjlQypvWeuw&__tn__=%2ANK-R

Describe the reason for authority cited:

FAR 8.405-6(a)(1)(i)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

6. Efforts to Obtain Competition: Market Research that was conducted revealed that there is currently one business concern that will be able to provide these services. A Sources Sought Notice was posted on https://beta.SAM.gov from 26 May 2021 through 31 May 2021 with no responses to the Sources Sought other than the preferred vendor.

None other than Fisher Scientific Company LLC expressed interest in this requirement and no responses were received from any other interested parties when the sources sought notice was posted. The contract specialist conducted research on Defense Logistics Agency, Medical Master Catalog and ECAT the similar items were found however per the Medical Director of Microbiology at CRDAMC “the flu detection mission is not only CRDAMC’s mission but it is also to support the DoD Global Respiratory Pathogen Surveillance Program. Unlike chemicals that can be bought in bulk and stored for several years, this item comes with very limited expiration dates which makes it very hard to prepare for testing and any “unexpected funding freezes”.

a. Effective competition. To date, no other sources have written to express an interest in this requirement. Based on market research, acquisition history, and the results of the Sources Sought Notice, competition is not anticipated for this requirement. The Government will continue to assess the market for new entrants.

b. Subcontracting competition. As per FAR 19.705-2, if a subcontracting possibility exist, the contractor will be required to submit a subcontracting plan.

7. Actions to Increase Competition: For future actions, the Government will reassess the market for available vendors, including but not limited to, issuing a Sources Sought Notice to determine market availability for brand name, or equal requirements. A Special Notice of Intent for the proposed limited source award will be posted on the Government Point of Entry at https://www.beta.SAM.gov for which any responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency for future requirements. CRDAMC in conjunction with MEDCOM will continue to evaluate the capabilities of other vendor's services and products in order to provide items that are of the best value to the Government. The Government will continue to seek new resources that will satisfy these requirements through continued market research, requests for Statements of Capability, and telephonic inquiries. Further, this office will continue to monitor the market for any new participants within the Federal Supply Schedule (FSS) and the open market that may be able to fulfill the Government’s needs.

8. Market Research: A sources sought was posted from 26 May 31 through 31 May 31 on GSA E-Buy https://wbuy-gsa.gov and beta.SAM https://beta.SAM.gov with one https://beta.sam.gov/ https://www.beta.sam.gov/ https://wbuy-gsa.gov/ https://beta.sam.gov/ vendor Fisher Scientific Company, LLC responding. The Federal Supply Schedule Multiple Award Schedule “Scientific Management and Solutions – Laboratory Equipment, Category 334516 Analytical Instruments; Includes analytical equipment for laboratory use, such as testing equipment, etc.” has 107 contractors listed in this category, with 75 small business contractor. The contract specialist did a drill down with the word “Flu” and located one small business that had “Flu” in their pricelist however the company does not sell Flu Test Kits and the “Flu” stands for Fluorescent Well Preparation Rack. Market Research that was conducted revealed that there is currently only one business concern that will be able to provide these products. The contract specialist located no contractors on the schedule that currently have FDA approved Sofia Reagent FLU and RSV (Respiratory Syncytial Virus) Test Kits that can be utilized on the Government owned Sofia Analyzer on this Federal Supply Schedule other than Fisher Scientific Company, LLC. Databases such as the SBA’s Dynamic Small Business Search (DSBS) were reviewed to identify small business vendors, determine potential set-asides. The DSBS search revealed no vendors capable of providing the test kits required by the government. There were no responses to the sources sought other than the requested vendor, Fisher Scientific Company, LLC.

9. Other Facts:

a. Procurement history.

W81K0016F0041, (PoP: 01 October 2016 – 30 September 2017), Full and Open, One offer, Fisher Scientific LLC, Firm-Fixed-Price.

W81K0017F0052, (PoP: 01 October 2017 – 30 September 2019), Full and Open, One offer Fisher Scientific LLC, Firm-Fixed-Price.

W81K0019F0327, (PoP: 01 October 2019 – 30 September 2020), Sole Source Procurement, Firm-Fixed-Price. FAR 8.405-6(a)(1)(i)(B) W81K0020F0144, (PoP: 01 October 2020 – 30 September 2021), Sole Source Procurement. Firm-Fixed-Price FAR 8.405-6(a)(1)(i)(B)

(4) W81K0020F0144 Control No: 21-RHCO-C-38

Paragraph #7 Market research showed that Fisher Healthcare is the only manufacturer of providing the required reagents that meets CRDAMC’s requirements. Due to this unique requirement this action was not solicited. However, in the future this requirement will be solicited on www.beta.SAM.gov to seek maximum competition.

(5) The two actions that were competed W81K0016F0041 and W81K0017F0052 had only one vendor, Fisher Scientific LLC that responded to both of the solicitations and that vendor has been able and continues to meet the Government’s need.

10. Technical Certification:

http://www.beta.sam.gov/

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:

Title:

11. 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:

Title:

12. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

I hereby determine that the order represents the best value to the Government in accordance with FAR 8.405-6(c)(2)(v). Additionally, I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: Price Analysis IGCE Signature:

Signature:

Date:

Typed Name:

Title: Contracting Officer

13. Contracting Officer Certification:

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

Signature:

Date:

Approval

Based on the foregoing justification, I hereby approve limiting sources in the acquisition of Sofia Reagent FLU and RSV (Respiratory Syncytial Virus) Test Kits for a proposed base and two options for $558,450.00 pursuant to the authority of authority of Title 40 U.S.C 501 as implemented by FAR 8.405-6, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature:

Date:

Reviewed and Approved By: KO, 27Jul2021