JA Sole Source FAR Part 13.5 Analyer and Reagents_Redacted.pdf

CUI//SP-PROCURE

Control Number: 21-RHCO-C-542 Cepheid GeneXpert XVI Analyzer and Reagents CRDAMC Fort Hood, Texas

CUI//SP-PROCURE APR 2021

Sole Source Justification and Approval Review Document Under FAR 13.501*

(*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: The Department of Pathology, Microbiology Department Carl R.

Darnall Army Medical Center (CRDAMC), Fort Hood, Texas 76544 requests approval to issue a new contract on a sole-source basis to Cepheid for the services of a Cepheid GeneXpert XVI molecular analyzer and Food and Drug Administration (FDA) approved in-vitro diagnostic (IVD) reagents to test for GBS, S. Aureus and MRSA, C.Difficile/Epi, Flu, Strep A, and Flu/RSV in the medical center. A firm-fixed-price contract is contemplated. Fiscal year 2022 Defense Health Program funds are not available for obligation for the base period

Authority: The statutory authority permitting other than full and open competition is 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.

Amount: The total estimated contract amount with all options is (PoP: 01 October 2021 – 30 September 2022 and 4 Option Years 1 October 2022 through 30 September 2026). With the possible six month extension of per 52.217-8, “Option to Extend Services for a potential total dollar amount of

Prepared by:

Typed Name:

Title: Contract Specialist

Date: 19 August 2021 E-mail:

Contracting Officer:

Typed Name:

Date Reviewed: 19 August 2021 E-Mail: t

Controlled by: USAHCA Controlled by: RHCO-C CUI Category (ies): General Procurement and Acquisitions Limited Dissemination Control: FEDCON

POC:

CUI//SP- PROCURE APR 2021

Technical Representative:

Title:

Date Reviewed: 19 August 2021

Requirements Representative:

Title:

Date Reviewed: 19 August 2021

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel:

Signature:

Date:

Command Advocate for Competition Typed Name:

Signature:

Date:

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: REGIONAL HEALTH CONTRACTING OFFICE-C

2. Description of Action: New contract action, firm fixed price, Defense Health Program funds, Army

3. Description of Supplies/Services: The requested services of a Cepheid GeneXpert XVI analyzer and reagents to test for GBS, S. Aureus and MRSA, C.Difficile/Epi, Flu, Strep A, and Flu/RSV in the Department of Pathology, Microbiology Department at CRDAMC. The requested molecular analyzer supports the entire Government requested testing menu. The contract will also cover all maintenance of the analyzer, analyzer trouble shooting, replacement, and software support for the analyzer. The total estimated contract amount with all options is (PoP: 01 October 2021 – 30 September 2022 and 4 Option Years 1 October 2022 through 30 September 2026).

With the possible six month extension of per 52.217-8, “Option to Extend Services for a potential total dollar amount of

4. Authority Cited: FAR 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 Government has a current need in the Department of Pathology, Department of Microbiology in order to provide a diverse array of tests (i.e., assays and stains) that is required in order to accommodate the potential variety of patients to include active duty, retirees and civilians. Current market research to include a sources sought notice, has not revealed any other vendors than Cepheid that could provide all of the FDA approved tests that the Government requires. Failure to award a contract to Cepheid would result in a lapse in testing, further resulting in potential mission failure in providing health care services to the military treatment facility and the broad beneficiary population. Cepheid is the only responsible source and no other vendor is capable of meeting the Government’s need. Cepheid’s GBS, S. Aureus and MRSA, C.Difficile/Epi, Flu, Strep A, and Flu/RSV is approved by the FDA and are compatible with the requested analyzer. There are resellers on the market that provide Cepheid products and reagents but the resellers are not authorized manufacturers or distributors, and they do not have the capability to provide maintenance, troubleshoot, provide any needed replacement equipment, or provide software support.

Currently Cepheid has the proprietary rights of the firmware that is necessary to run the GeneXpert system molecular analyzer and is unique to Cepheid.

Purchasing the analyzer and FDA reagents from a vendor other than Cepheid would result in the Government duplicating costs that is not expected to be recovered through competition. The Department of Pathology would have two different vendor’s products at CRDAMC in order to fulfill the Government’s requirement. Although there are other vendors that are able to provide Molecular testing analyzers and testing systems, however only reagents authorized by the device manufacturer can be used with the vendor’s molecular analyzer. Using one vendor’s reagents with another vendor’s analyzers and systems will infringe on a vendor’s intellectual property and warranty rights. Therefore, CRDAMC will have to purchase Cepheid analyzers and testing systems to support their reagents and purchase additional analyzers and testing systems from another vendor to support the reagents they are capable of providing.

This will create a considerable duplication of cost to the Government. Currently it is in the best interest of the Government to purchase the requested products from Cepheid, as they are the only vendor capable of meeting the Government’s requirement.

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 20 May 2021 through

25 May 2021 with no responses to the Sources Sought other than the preferred vendor.

None other than Cepheid expressed interest in this requirement and no responses were received from any other interested parties when the sources sought notice was posted.

a. Effective Competition. Based on market research that was conducted 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. It is anticipated that only one vendor is capable of meeting this particular requirement due to the ability to provide all six FDA approved tests to be used on the Cepheid molecular analyzer.

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

7. Actions to Increase Competition: 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. Due to the specific needs for the supplies for the health and welfare of the patients this action was not solicited. The Government will continue to seek new resources that will satisfy these requirements through continued market research, request for Statements of Capability, and telephonic inquiries. When the current product becomes obsolete, or when equivalent products that meets the requested Government specifications becomes available, every effort shall be made to utilize the equivalent product. Regional Health Contracting Office – Central will continue to evaluate the capabilities of other vendor’s products and re-procure the products that provides the best value to the Government. CRDAMC in conjunction with MEDCOM will continue to evaluate the capabilities of other vendor's products and re-procure the system equipment that provides 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. This justification shall be made available on the Government Point of Entry https://sam.gov/content/home after award.

8. Market Research: This requirement is to procure the services of a Cepheid GeneXpert XVI analyzer and reagents. A sources sought notice was posted with the minimum requirements to https://beta.SAM.gov from 20 May 2021 through 25 May 2021. There were no responses to the sources sought other than the requested vendor, Cepheid. An SBA Dynamic small business search and Quick Market search was conducted using key words “MRSA Reagents” and NAICS code “334516” that resulted in no small businesses found. The contract specialist conducted research on the FDA website for companies that provide the tests that are being requested. Currently only one source is capable of providing the specialized equipment and supplies required at the level of quality required because the reagents and tests are unique and highly specialized. Cepheid provides for the services of a Cepheid GeneXpert XVI analyzer and reagents to test for GBS, S. Aureus and MRSA, C.Difficile/Epi, Flu, Strep A, and Flu/RSV. Cepheid has provided a sole source letter stating that they are the sole https://sam.gov/content/home manufacturer of the GeneXpert® systems and the reagent test cartridges used on this analyzer. Based on this information, the Contracting Officer has determined this is a sole source requirement. “Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization)”.

Internet searches determined that McKesson Corporation and Henry Schein do resell used Cepheid analyzers and reagents however they are currently not authorized to provide for any Cepheid maintenance or Cepheid software support.

Internet searches were conducted on the FDA website that found companies that could possibly provide the tests that are being requested. However after completing the research it was noted that the following companies could not provide all of the FDA approved reagents.

Abbott Laboratories could provide the C.Difficile and Flu tests.

Becton Dickinson could provide for the GBS test.

BD Diagnostics could provide for the C.Difficile, GBS and MRSA.

Roche Diagnostics could provide for the C.Difficile, Flu and MRSA.

Quidel could provide for the C.Difficile, GBS and MRSA.

Therefore it was determined that Cepheid is the only vendor that can provide all six FDA approved tests to be conducted on the Cepheid molecular analyzer.

9. Interested Sources: To date, no other sources have written to express an interest in this requirement. As stated in paragraph 6 above, the notices required by FAR 5.201 have been published, and there are none that could provide the entirety of the Government’s requested requirement at this current time.

10. Other Facts: The following facts support the use of other than full and open competition:

a. Procurement history. N/A This is a new requirement.

b. Other facts. The end user is in the process of submitting a Capital Equipment packet in order to secure the analyzer.

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.

Typed Name:

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.

Signature:

Typed Name:

Title:

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. A price analysis will be conducted to compare the proposed prices to competitive contracts within RHCO-C for the same or similar requirements.

Certified cost or pricing data is not required, in accordance with FAR 15.403-1(b)(3).

Signature:

Date:

Typed Name: Title: Contracting Officer

14. Contracting Officer Certification:

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

Signature:

Typed Name: Title: Contracting Officer

Approval

Based on the foregoing justification, I hereby approve the procurement of the requested services of a Cepheid GeneXpert XVI molecular analyzer and Food and Drug Administration (FDA) approved in-vitro diagnostic (IVD) reagents to test for GBS, S.

Aureus and MRSA, C.Difficile/Epi, Flu, Strep A, and Flu/RSV Carl R. Darnall Army Medical Center, Fort Hood, Texas. The total estimated contract amount with all options is (PoP: 01 October 2021 – 30 September 2022 and 4 Option Years 1 October 2022 through 30 September 2026). With the possible six month extension of per 52.217-8, “Option to Extend Services for a potential total dollar amount of 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.

Typed Name: Title: Command Advocate for Competition