Justification and Approval ---Hologic Panther ---KO Signed-- 6122023 (7)_Redacted.pdf

23-RHCO-C-242

Contractor: Hologic, Inc.

Program/Equipment: Hologic Panther Instruments

Controlled by: USAHCA Controlled by: MRCO-W CUI Category: PROCURE

LDC: FED ONLY

CUI//CP-PROCURE

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: The Department of Pathology and Area Laboratory Services (DPALS) seeks to establish a cost-per-test arrangement to perform testing for SARS- CoV-2, Flu A/B, Bacterial Vaginosis, Candida Vaginitis, Chlamydia Trachomatis, Mycoplasma Genitalium, Neisseria Gonorrhea, Trichomonas Vaginalis in support of the Brooke Army Medical Center located at the JBSA - Fort Sam Houston, Texas

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Amount: $649,371.50

Prepared by:

Contract Specialist

DSN: 389-8525

Date: 23 January 2023

Email:

Contracting Officer:

Contracting Officer

DSN: 539-8655

Date: 23 January 2023

Technical:

OIC, Molecular

DSN: 429-3168

Date: 23 January 2023

Department of Pathology and Area Laboratory Services Brooke Army Medical Center Email:

Requirements: DSN: 429-3168 Chief, Microbiology Date: 23 January 2023 Department of Pathology and Area Laboratory Services Brooke Army Medical Center

Reviews: I have reviewed this justification and find it adequate to support a sole source contract action.

Program Manager:

Typed Name:

Laboratory Manager Department of Pathology and Area Laboratory Services Brooke Army Medical Center

DSN: 429-1817

Signature: Digitally signed by

23607 Date: 2023.04.13 11:17:29 -05'00' 1236074672

Program/Equipment: Hologic Panther Instruments

Controlled by: USAHCA Controlled by: MRCO-W

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole

Source Justification and Approval

1. Contracting Activity: Joint Base San Antonio Health Contracting Branch (JBSA HCB), Medical Readiness Contracting Office, West– Central (MRCO-W), US Army Health Contracting Activity, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas.

2. Description of Action: The Brooke Army Medical Center Department of Pathology and Area Laboratory Services requests a firm-fixed-price (utilizing a cost-per-test arrangement) contract with Hologic, Inc. The Government projects award by May 2023, with a start date of 1 October 2023, contingent upon the availability of FY24 Defense Health Program funds. An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

3. Description of Supplies/Services: This requirement is a follow-on to the current contract W81K00-18-P-0637 with Hologic, Inc. (Hologic) expiring 30 September 2023.

This contract is currently in place to provide instrumentation, consumables, and warranty for Bacterial Vaginosis, Candida Vaginitis, Chlamydia Trachomatis, Mycoplasma Genitalium, Neisseria Gonorrhea, Trichomonas Vaginalis molecular testing platform and compatible testing supplies for the Microbiology laboratory at the Brooke Army Medical Center (BAMC) Department of Pathology and Area Laboratory Services Core Laboratory at Fort Sam Houston, Texas.

For this requirement, BAMC will move to a cost-per-test (CPT) arrangement, wherein the contractor retains ownership of the equipment, and the cost of the lease is embedded in the reagents. See paragraph 6 below for details on how actions to increase competition for this new requirement were executed. The CPT agreement will include new molecular testing equipment, reagents, consumables, maintenance support and instrument warranties to support bacterial vaginosis, candida vaginitis (CV), Trichomonas vaginalis (TV), Chlamydia trachomatis (CT), Neisseria gonorrhea (GC), and Mycoplasma genitalium (MG) clinical testing.

During the ongoing global pandemic of SARS-CoV-2, BAMC has been utilizing task order W81K00-22-F-0127 from the Panther Fusion centralized contract W81K04-21- D-0010 with Hologic, Inc. to purchase reagents and consumables for SARS-CoV-2 and Flu A/B test. The centralized Contract W81K04-21-D-0010 only provide supplies compatible with Hologic Panther instrument. The Hologic Panther instrument is currently the primary instrument to perform high throughput SARS-CoV-2 and Flu A/B testing. BAMC is required to utilize the centralized Contract W81K04-21-D-0010 with Hologic, Inc. through 02 May 2025. The centralized contract will provide the SARS- CoV-2 & Flu A/B reagents, and this new requirement will provide the instrumentation to run the testing for the reagents/supplies received from the centralized contract at

Program/Equipment: Hologic Panther Instruments

Controlled by: USAHCA Controlled by: MRCO-W no additional cost to the Government. All testing will be performed in-house at BAMC.

The below table identifies all of the estimated quantities for the base period and option year; estimated pricing remains consistent for the option period.

Table 1 – Base Year – 01 October 2023 – 30 September 2024

Line Items Test Reagents Quantity Average Unit Price Price Per Year

0001 CV 2,200

0002 TV 2,200

0003 CT 35,000

0004 GC 4,000

0005 MG 2,200

Total Price

Table 2 - Option Year 1 – 01 October 2024 – 02 May 2025 Line Items Test Reagents Quantity Average Unit Price Price Per Year

0001 CV 1,284

0002 TV 1,284

0003 CT 20,416

0004 GC 2,334

0005 MG 1,284

Total Price

NOTE: As a supply contract, FAR 52.217-8 is not available for use.

Amount: $649,371.50 Base Period (1 October 2023 – 30 September 2024):

Option 1 (1 October 2024 – 30 May 2025):

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority exceeding the simplified acquisition threshold for simplified procedures for certain commercial items.

5. Reason for Authority Cited: Hologic, Inc. is the sole source provider of the Panther System. The Aptima SARS-CoV-2 and Flu A/B Assay has been validated for use only with the Panther System. The firmware in the Panther System is necessary for running the Aptima SARS-CoV-2 and Flu A/B Assay and is unique to Hologic, Inc.

Hologic is the sole source of this firmware. Hologic does not resell through any dealers or distributors in the United States. A sole source letter was submitted by Hologic, Inc on 24 February 2023.

The follow-on procurement to the current contract W81K00-18-P-0637 with Hologic, Inc.

must be considered a sole source requirement to fulfill the requirement of SARS-CoV-2 and Flu A/B testing until 02 May 2025 on Contract W81K04-21-D-0010. The reagents and supplies on the HRCO centralized contract W81K04-21-D-0010 provide supplies, which are only compatible with Hologic Panther instrument. This contract, through

Program/Equipment: Hologic Panther Instruments

Controlled by: USAHCA Controlled by: MRCO-W

LDC:

HRCO, provides no instruments and cannot be modified to include any non-covid requirements and instruments.

Although there are other companies that meet the qualifications for fulfilling the contract requirements to support bacterial vaginosis, candida vaginitis (CV), Trichomonas vaginalis (TV), Chlamydia trachomatis (CT), Neisseria gonorrhea (GC), and Mycoplasma genitalium (MG) clinical testing, only Hologic, Inc. Panther System is FDA approved to run the Aptima SARS-CoV-2 and Flu A/B Assay. There are no other alternatives to Hologic, Inc. that would not result in mission failure; other reagents that are not compatible to the Panther System Equipment can be used but would cause a significant delay in obtaining test results. Therefore, Hologic, Inc. is the proposed contractor with the unique qualifications for fulfilling the contract requirements.

6. Efforts to Obtain Competition: This contract is anticipated to be awarded with a base and one option year in order to align with the existing Hologic contract. At such time the two contracts expire, the government will consolidate them and open the requirement for competition. No further effort for competition will occur on this the current action. The Contracting Officer shall publish the notices required by FAR 5.201.

A Sources Sought Notice was posted for 30 days; upon finalization of this Justification and Approval document, a notice of intent to sole source will be posted to the GPE, with the final J&A to be published within 14 days of contract award.

7. Actions to Increase Competition: Should BAMC continue to have a need for this testing beyond the conclusion of FY25, a sources sought notice will be posted to the GPE to continue to foster competition and ensure fair and reasonable pricing for any future effort.

8. Market Research: Prior to the posting of the sources sought notices, market research was conducted by DPALS personnel in conjunction with the contracting personnel to determine the likelihood of other laboratory testing companies to compete this requirement. The methods used included internet searches, review of the College of American Pathologists, an accrediting authority for medical clinical laboratory. This outreach occurred in November and December 2022. As discussed above, there were no other contractors identified that could meet the entirety of BAMC’s requirement and can provide instrumentation that will be compatible with Hologic’s Aptima SARS-CoV-2 and Flu A/B Assays on Contract W81K04-21-D-0010 and that are FDA approved.

A Sources Sought Notice was posted to https://sam.gov, the official Government Point of Entry, on 7 September 2022 with a response due date of 7 October 2022 to find interested sources (small and other-than-small) that could provide equipment/instruments and reagents to conduct the COVID-19, Flu A/B, Trichomonas vaginalis testing, Chlamydia trachomatis and Neisseria gonorrhoeae (CT/GC) testing.

Responses were received from three (3) companies: Hologic’s, Inc (other-than-small business), Engaged Healthcare Solutions (small business) and Roche Diagnostics Corporation (other-than-small business).

Program/Equipment: Hologic Panther Instruments

Controlled by: USAHCA Controlled by: MRCO-W CUI Category: PROCURE

POC:

1) Hologic, Inc. - The capability statement received from Hologic Inc., meets all the requirements of the Sources Sought Notice issued on 7 September 2022. Hologic’s system is FDA approved and compatible to run the Hologic Aptima SARS-CoV-2 and Flu A/B Assays which DPALS is mandated to purchase through 02 May 2025.

These two test can only be run utilizing the Hologic Panther or Hologic Panther Fusion systems and the laboratory is in urgent need of an FDA approved system to run these to tests. In conclusion, Hologic meets all requirements for this FY24 action.

2) Engaged Healthcare Solutions - The technical team reviewed the capability statement received from the Engaged Healthcare Solutions Company and was unable to determine if the company was able to meet any of the requirements listed in the Sources Sought Notice. The Company did not provide any information addressing each of the requirements listed on the Sources Sought Notice issued on 7 September 2022. The Engage Healthcare Solution Company is not FDA approved or compatible to run the Hologic Aptima SARS-CoV-2 and Flu A/B Assays. These two tests can only be run using the Hologic Panther or Hologic Panther Fusion systems as indicated in their respective product insert. Due to the existing Contract W81K00-21-D-0010 for the Hologic Aptima, SARS-CoV-2 and Flu A/B Assays the laboratory is in need of an FDA approved system that is compatible with the reagents to run the tests.

3) Roche Diagnostics Corporation - The technical team reviewed the capability statement received from Roche Diagnostics Corporation on 6 October 2022. Roche meets the requirements of the Sources Sought Notice. However, Roche Diagnostic COBAS 6800 is not FDA approved or compatible to run the Hologic Aptima SARS- CoV-2 and Flu A/B Assays. These two tests can only be run using the Hologic Panther or Hologic Panther Fusion systems as indicated in their respective product insert. Due to an existing Contract W81K00-21-D-0010 for the Hologic Aptima SARS-CoV-2 and Flu A/B Assay, the laboratory is in need of an FDA approved system that is compatible with the reagents to run the tests.

9. Interested Sources: There were two other contractors listed above, Engaged Healthcare Solutions and Roche Diagnostics Corporation that responded to the sources sought notice but were not FDA approved and their instrumentation were not compatible to run the Hologic Aptima SARS-CoV-2 and Flu A/B Assays on the centralized Contract W81K04-21-D-0010. As discussed above, Hologic, Inc. is the only vendor that can provide the reagents that are FDA approved;

developed for laboratory use and can provide the instrumentation that is compatible with the Hologic Aptima SARS-CoV-2 and Flu A/B Assays.

10. Other Facts:

Program/Equipment: Hologic Panther Instruments

Controlled by: USAHCA Controlled by: MRCO-W

a. Procurement History:

(1) Contract W81K00-18-P-0637 was issued with a base period of 01 October 2018 – 30 September 2019 plus Four (4) twelve-month option periods through 30 September 2023.

(2) This action was solicited on a full and open basis.

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

(4) If a justification was prepared to support the procurement made beforethis one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results – N/A.

(5) The solicitation for the current contract solicited on a full and open basis yielded only one offeror, Hologic, Inc.

(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 andwhether there have been any significant changes. –N/A.

b. Hologic, Inc. does not have any known distributors or other authorized vendors that could provide the required instrumentation compatible with the Hologic Aptima SARS-CoV-2 and Flu A/B Assays.

(End of page)

Program/Equipment: Hologic Panther Instruments

Controlled by: USAHCA Controlled by: MRCO-W CUI Category: PROCURE

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: Date: 30 January 2023 Title: OIC, Molecular Signature:

Digitally signed by

Department of Pathology and Area Laboratory Services, Brooke Army Medical Center

.151356 151356530 5301

Date: 2023.04.13 11:10:19 -05'00'

12. Requirements Certification: I certify that the supporting data under mycognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: Date: 30 January 2023 Title: Chief, Microbiology Signature:

Department of Pathology and Area

Brooke Army Medical Center 6619 Date: 2023.04.13 11:20:09 -05'00'

Program/Equipment: Hologic Panther Instruments

Controlled by: USAHCA Controlled by: MRCO-W CUI Category: PROCURE

LDC: FED ONLY

POC:

210 -539-8525

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 based on the Independent Government estimate and previous prices paid. As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Typed Name: Date:

Title: Contracting Officer Signature:

. 1381612640

Digitally signed by

Date: 2023.04.13 12:31:40 -05'00'

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Date: Title: Contracting Officer Signature:

Program/Equipment: Hologic Panther Instruments

Controlled by: USAHCA Controlled by: MRCO-W CUI Category: PROCURE

Approval

Based on the foregoing justification, I hereby approve the procurement of Hologic, Inc.

reagents under a cost-per-test arrangement for Brooke Army Medical Center on a sole source basis, in the amount of $649,371.50 pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Date:

Approval Authority Signature: