JA_Hologic_PAN0027471_v11.30 Redacted.pdf

Control Number: 21-RHCO-A-188

RFQ/RFP #: W91YTZ21Q0021

For Official Use Only (See FAR 2.101 and 3.104-4)

(25 February 2016)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office –Atlantic, Dalecarlia Health Contracting Branch, 6000 MacArthur Blvd. Bethesda, MD 20816.

2. Description of Action: Blanchfield Army Community Hospital (BACH), Department of Pathology requests a new Firm-Fixed Price (FFP) contract using Army Operations and Maintenance Appropriations funds for supplies and reagents for the Hologic Panther Fusion Analyzer (Cat. # 303095 Panther System). They currently have the equipment in place at BACH but require supplies and reagents to meet the burgeoning requirement to test personnel for Coronavirus 2019 (COVID-19).

3. Description of Supplies/Services: The requirement is for the purchase of supplies and reagents for COVID-19 testing that must be used on the Hologic Panther Fusion Analyzer at Blanchfield Army Community Hospital (BACH). The period of performance will be a 12 month base period and one 12 month option year. The estimated value of the contract for the base and option period is

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501 (a)(1)(ii), sole source (including brand name) and unusual and compelling urgency under the authority of the simplified procedures for certain commercial services.

5. Reason for Authority Cited: There is no space in our lab for an additional COVID analyzer. We presently have a supply contract through September 2023 for a Hologic Panther analyzer and reagents under contract W91YTZ-18-P-0363 for Sexually Transmitted Disease (STD) testing. Contract W91YTZ-18-P-0363 was awarded on 21 September 2018 to Gen-Probe, Incorporated. Gen-Probe is owned by Hologic. It is the intent of this procurement to utilize the existing analyzer to perform COVID-19 testing.

Hologic is the Original Equipment Manufacturer (OEM) of the Panther Fusion Analyzer.

In addition, the vendor submitted a proprietary letter dated September 22, 2020 stating that Hologic is the sole source of the instrument system, assay kits and associated kits and reagents requested. The firmware in the Panther Fusion analyzer system is necessary for running the Panther Fusion assays and is unique to Hologic. Hologic is the sole source of this firmware. Hologic does not sell through dealers or distributors in the U.S. All sales are made directly to end users. Additionally, there are U.S. patents covering the instrument system and associated assay kits, reagents, and consumables on the company’s website at https://www.hologic.com/IP. BACH needs additional supplies to use the existing Hologic Panther for COVID-19 testing. In the past, the Hologic Panther was used exclusively for sexually transmitted diseases, but now there is an increasingly high demand for COVID-19 testing, so much so that the existing contract cannot be modified because it is beyond the scope of the original contract.

Blanchfield Army Community Hospital best course of action is to use the existing

For Official Use Only (See FAR 2.101 and 3.104-4)

(25 February 2016)

Control Number: 21-RHCO-A-188

RFG/RFP #: W91YTZ21Q0021

Reagent and Testing Supplies

Hologic Panther for COVID-19 testing due to the throughput of 1100 COVID tests per day on this analyzer. If BACH cannot perform the required tests, patients will have to be sent out to other medical facilities. This would be very costly to the government, but even worse, would result in delayed diagnoses of COVID-19, continued pandemic spread, and inability to mobilize troops for training or warfighting.

6. Efforts to Obtain Competition: A presolicitation notice was posted to the Government Point of Entry (GPE), beta.SAM.gov for a similar Hologic Panther supply acquisition (under Solicitation # W91YTZ21Q0007) on October 8, 2020 and no responses were received.

a. Effective competition. There is no effective competition expected for this requirement. This will be a sole source requirement to Hologic due to the nature of the requirement and their Sole Source Justification Letter provided to the Government.

b. Subcontracting competition. No subcontracting opportunities exist.

7. Actions to Increase Competition: There are no practical alternatives available to increase competition for this requirement since the items are proprietary and Hologic analyzers use the proprietary reagents needed to operate the analyzers. Sole source is necessary to ensure that COVID-19 testing is available and that there is no break in service for the patients seen at facilities supported by the BACH laboratory.

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

Internet searches show that Hologic is the only company that can provide the required reagents that must be used on the Hologic Panther Fusion Analyzer already used by BACH. A search on Small Businesses Quick Market Search was performed using NAICS code 325413 (In-Vitro Diagnostic Substance Manufacturing) and key words “Panther Fusion”. There were no small businesses that met the search criteria. A search on GSA eLibrary was also performed, no small businesses were found when searching for Panther/Fusion equipment suppliers.

9. Interested Sources: Gen-Probe Inc. is the only interested source. To date, no other sources have written to express an interest. Notices required by FAR 5.201 shall be published, and any proposals received shall be considered.

10. Other Facts:

a. Procurement history. Reasonable efforts to retrieve the following items from computer records, contract files, competition advocate office files or other sources are expected:

(25 February 2016)

Control Number: 21-RHCO-A-188

(1) Contract numbers and dates of the last several contracts for these same requirements. None

(2) The competitive status of these actions. N/A

(3) Authority previously cited if less than full and open competition was used. N/A

(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. N/A

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. None

(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. Acquisition data availability. Statement of Work (SOW) have been posted with solicitations. It is anticipated that Hologic Inc. will be the only company that can supply the required reagents because the reagents must be used on the Hologic Panther Fusion Analyzers that are currently being used at BACH.

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.

(25 February 2016)

Control Number: 21-RHCO-A-188

BAXTER.BARRY.LEE. Digitally signed by

JR.1103177975

BAXTER.BARRY.LEE.JR.1103177975

Date: 2020.12.03 08:06:05 ‐06'00'

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.

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 based on price analysis in accordance with FAR 15.404- 1(b)(2)(ii), comparison of the proposed prices to historical prices paid, whether by the Government or other than the Government, for the same or similar services. An updated independent government estimate has been prepared based on market research and historical prices and supports this price fair and reasonable determination. Commercial items are being acquired, therefore cost or pricing data is not required per FAR 15.403- 1(b) (3).

Signature: Date:

Typed Name: Barry Baxter Title: Contracting Officer

14. Contracting Officer Certification:

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

BAXTER.BARRY.LE Digitally signed by

BAXTER.BARRY.LEE.JR.1103177975

Signature: E.JR.1103177975 Date: 2020.12.03 08:06:39 ‐06'00' Date:

Typed Name: Barry Baxter Title: Contracting Officer

(25 February 2016)

Control Number: 21-RHCO-A-188

ESMOND LIZA Digitally signed by

J.1016102195

ESMOND.LIZA.J.1016102195

Date: 2020.12.03 12:57:00

‐06'00'

Approval

Based on the foregoing justification, I hereby approve the procurement of (Consultation and clinical services to include diagnostic testing unavailable at Blanchfield Army Community Hospital, totaling $1,967,860.00.) 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, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: Date:

Typed Name: Liza J. Esmond Title: Command Advocate for Competition