JA Redacted.pdf

CUI//SP-PROCURE

Control No: 22-RHCO-C-134 Contractor: GenProbe/Hologic Program/Equipment: Microbiology Section/ Analyzer and Testing Reagents

APR 2021

CUI//SP PROCURE

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 at Carl R.

Darnall Army Medical Center (CRDAMC) request approval to issue a new contract on a sole-source basis for Molecular Diagnostic Testing Analyzers for FDA approved test kits of Neisseria Gonorrhoeae (GC), Chlamydia trachomatis (CT), Aptima HPV, HPV 16, 18/45 Genotyping, Bacterial Vaginitis, Vaginal Trichomonas and Yeast FDA approved Testing for Carl R. Darnall Army Medical Center, Fort Hood, TX. The Government is requesting an analyzer and the vendor is required to cover all maintenance of the analyzer to include parts, labor and software if applicable.

A firm-fixed-price contract is contemplated. Fiscal year 2023 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 $2,883,300.00 (Pop: 01 October 2022 – 30 September 2023 and 4 Option Years ending 30 September 2027).

With the possible six month extension of $288,300.00 per 52.217-8, “Option to Extend Services for a potential total dollar amount of $3,171,300.00.

Prepared by:

Date:

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

Limited Dissemination Control: FEDCON

POC:

I

Contractor: GenProbe/Hologic Program/Equipment: Microbiology Section/ Analyzer and Testing Reagents

APR 2021

CUI//SP PROCURE

Technical Representative:

Title: Medical Technologist, Microbiology Section Supervisor Date Reviewed:

Requirements Representative:

Title: Medical Technologist, Microbiology Section Supervisor Date Reviewed:

Reviews

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

Signature:

Command Advocate for Competition: Typed Name:

0'

Contractor: GenProbe/Hologic Program/Equipment: Microbiology Section/ Analyzer and Testing Reagents

CUI//SP PROCURE

APR 2021

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office-C, Fort Hood, TX

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

3. Description of Supplies/Services: The requested services for a Molecular Diagnostic Testing Analyzers for FDA approved test kits of Neisseria Gonorrhoeae (GC), Chlamydia trachomatis (CT), Aptima HPV, HPV 16, 18/45 Genotyping, Bacterial Vaginitis, Vaginal Trichomonas and Yeast FDA approved Testing for Carl R. Darnall Army Medical Center, Fort Hood, TX. The Government is requesting an analyzer and the vendor is required to cover all maintenance of the analyzer to include parts, labor and software if applicable.

For Actions with Options*:

Base Period: 1 Oct 2022 to 30 Sep 2023 Value: $576,600.00 Option Period 1: 1 Oct 2023 to 30 Sep 2024 Value: $576,600.00 Option Period 2: 1 Oct 2024 to 30 Sep 2025 Value: $576,600.00 Option Period 3: 1 Oct 2025 to 30 Sep 2026 Value: $576,600.00 Option Period 4: 1 Oct 2026 to 30 Sep 2027 Value: $576,600.00 Total: $2,883,000.00

FAR Clause 52.217-8 option: 1 Oct 2027 to 31 Mar 2028 Value: $288,300.00 Total: $3,171,300.00

4. Authority Cited: FAR 13.5, 10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited: The Government has a current need in the Department of Pathology Department of Microbiology for a Molecular diagnostic analyzers, service and reagents/consumables for various viral assays 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 revealed that no other vendor can provide required analyzer and all of the FDA approved tests kits that the Government requires. Industry has indicated that a 30 to 60 day validation correlation process is required. This is necessary to deliver, install, validate and correlate the system prior to becoming fully operational. The Panther Analyzer attachment is necessary to ensure the continuity of operations of essential patient testing currently being performed by the Department of Microbiology at Carl R. Danall Army Medical Center, Fort Hood, Texas. This is especially critical given the Panther Analyzer is supporting CRDAMC mission with the current COVID-19 Pandemic and is the only platform at CRDAMC that has the ability to test over 300 patient samples per shift.

Additionally, with the RMF requirement, and if the potential new vendor does not have a current Authority to Operate (ATO), the timeframe needed is substantially longer. In order to continue providing for molecular diagnostic analyzers and reagents/consumables for various viral assays, which is critical to the Department of Defense mission of providing access to patient care. GenProbe/Hologic is the only company that possesses the ability to immediately support this requirement. Gen- Probe/Hologic, Inc. is the incumbent contractor and they have performed satisfactorily.

The requested Molecular diagnostic testing analyzer and testing kits are unique and specialized equipment that has the ability to test over 300 patients per shift, A Sources Sought was posted to Beta.Sam.gov on January 24, 2022 for eight (8) days with only one (1) vendor GenProbe/Hologic responding to the sources sought. GenProbe/Hologic is the manufacturer and sole authorized distributor of the molecular diagnostic analyzer that provide FDA approved test kits of Neisseria Gonorrhoeae (GC), Chlamydia trachomatis (CT), Aptima HPV, HPV 16, 18/45 Genotyping, Bacterial Vaginitis, Vaginal Trichomonas and Yeast FDA approved Testing.

6. Efforts to Obtain Competition: Sources Sought was posted to Beta.Sam.gov on January 24, 2022 until January 31, 2022 for 8 days. No Interested parties responded to the Sources Sought other than the GenProbe/Hologic, the sole provider of the Panther analyzer. Market Research that was conducted revealed that there is currently one business concern that will be able to provide these services.

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 unique molecular test analyzer with the FDA approved tests kits.

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: Any future requirements shall, also try to be procured through full and open competition on the Government Point of Entry. CRDAMC 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, request for Statements of Capability and telephonic inquiries. The government will monitor industry for diversified molecular diagnostic testing analyzer and test kits in order to overcome barriers to competition.

8. Market Research: Market research was conducted using the current contract W81K00-20-P-0322 that indicates that same components were purchased on contract. A Sources Sought was posted Beta.Sam.gov on January 24, 2022 for eight days with one

(1) response from GenProbe/Hologic. GenProbe/Hologic, who is the sole source manufacture and distributor of this analyzer and test kits. GenProbe is owned by Hologic.

Based on the findings, only one vendor will be able to satisfy the government’s requirement.

In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a request for information or sources sought was posted to Bet.Sam.gov on January 24, 2022 for eight (8) days and the results were one (1) potential vendor. GenProbe/Hologic who is the manufacture of the required type Analyzer and Test Kits responded to the sources sought.

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:

(1) W81K-20-P-0322, Total Dollar Value was $ 1,153,200.00 (01 Oct 2020 – 30 Sep 2022)

(2) The competitive status of these actions. Sole Source

(3) Authority previously cited if less than full and open competition was used: FAR Part 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

(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.

Contents of Paragraph 7, - Any future requirements shall, also try to be procured through full and open competition on the Government Point of Entry. CRDAMC 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, request for Statements of Capability and telephonic inquiries. The government will monitor industry for diversified molecular diagnostic testing analyzer and test kits in order to overcome barriers to competition.

Contractor: GenProbe/Hologic Program/Equipment: Microbiology Section/ Analyzer and Testing Reagents

CUI//SP PROCURE

APR 2021

Explanation of results – Sources sought was posted to the Government Point of Entry, with only GenProbe/Hologic being the only vendor who responded to the sources sought. There has been a search to evaluate other vendor’s products for the needed capabilities, and seek new resources that will satisfy the requirement with no success in finding another vendor that can provide the needed capabilities to fulfill the requirement as required by the government.

(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.

Contract – W81K00-15-P-0956, full and open competition, There were two (2) offerors, Roche and GenProbe/Hologic. Contract was awarded to GenProbe/Hologic. GenProbe/Hologic who is the sole source manufacture and distributor of the required type of analyzer and test kits needed by the government.

Based on the findings, GenProbe/Hologic is the only vendor to be able to satisfy the government’s requirement.

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

(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. N/A

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: Medical Technologist, Microbiology Section Supervisor Signature:

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.

Typed Name: Date:

Title: Medical Technologist, Microbiology Section Supervisor Signature:

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost or price 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).

Typed Name:

Title: Contracting Officer Signature:

14. Contracting Officer Certification:

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

Typed Name:

Title: Contracting Officer Signature:

Approval

Based on the foregoing justification, I hereby approve the procurement for the Hologic Panther analyzer system to include the FDA approve test kits. The estimated contract amount of $2,883,300.00 (Pop: 01 October 2022 – 30 September 2023 and 4 Option Years ending 30 September 2027). With the possible six month extension per 52.217-8, “Option to Extend Services for a potential total dollar amount of $3,171,300.00 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..

Command Advocate for Competition Signature:

Reviewed and Approved by KO, 9Feb2022