JandA Gen-Probe COVID-19_Redacted.pdf

Control No: 21-RHCO-C-162

Gen-Probe, Inc.

Instrument/Service/Reagent/Consumables for Various Viruses

Version –March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: Modification to existing bridge contract with Gen-Probe, Incorporated for a Molecular Diagnostic PCR identification and sensitivity system which is already in place (installed December 2018).

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5.01(a)(1)(ii), sole source, Gen-Probe, Inc., under the authority of the simplified procedures for certain commercial items.

Amount: Total increase is . The total obligated amount for this purchase order is increased to

Prepared by: DSN: ( Date: 17 November 2020

Contracting Officer: DSN:

Technical: DSN: (

Requirements: DSN: (

Instrument/Service/Reagent/Consumables for Various Viruses

Version – March 2017 FOR OFFICIAL USE ONLY

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole

Source Justification and Approval

1. Contracting Activity: Regional Health Contracting Office-Central

2. Description of Action: The Department of Pathology requests approval for firm fixed-price modification to existing contract with Gen-Probe, Inc., for a molecular diagnostic PCR identification and sensitivity system analyzers with service and reagents/ consumables for COVID-19 viral assay for Evans Army Community Hospital, Colorado Springs, Colorado. The period of performance is date of award to 30 September 2021 utilizing fiscal year 2021, DHP Operations and Maintenance funds will be used:

X 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: Evans Army Community Hospital (EACH) requires a Molecular Diagnostic PCR identification and sensitivity system, reagents, and consumables in order to execute COVID-19 testing for deploying units and symptomatic patients on the order of the Secretary of Defense and the Chief of Staff of the Army.

a. The Contractor shall provide one Molecular Diagnostic PCR identification and sensitivity system and reagents/consumables for COVID-19 assays on a cost-per-test arrangement. These reagents and supplies are necessary to ensure the continuity of operations of essential patient testing currently being performed by the Department of Pathology, Evans Army Community Hospital, Colorado Springs, CO.

b. Gen-Probe, Inc., shall provide the testing system, which includes at a minimum, analyzer and peripherals to include: Uninterruptable Power Sources (UPS), instrument specific computers, Central Processing Units (CPU’s), printers, barcode scanners, terminals, monitors, etc. Testing system shall be delivered and installed at Evans Army Community Hospital, (EACH), Colorado Springs, CO.

Period of Performance: Date of Award to 30 September 2021. Total Value:

0 (increase) for a total contract amount of

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5:

Unusual and compelling urgency

Exclusive licensing agreements

Industrial mobilization

X Other: Federal Acquisition Regulation 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: Current contract W81K00-20-P-0277 provides for

Instrument/Service/Reagent/Consumables for Various Viruses

Version – March 2017 FOR OFFICIAL USE ONLY

Molecular diagnostic analyzers, service and reagents/consumables for various viral assays, which expires 30 September 2021. An option year package for the renewal will follow, subject to the availability of Fiscal Year 2022 funds. 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. Additionally, with the RMF requirement, and if the potential new vendor does not have a current ATO, the timeframe needed is substantially longer. In order to continue providing for molecular diagnostic analyzers and reagents/consumables for various STD and COVID- 19 assays, that are critical to the Department of Defense mission of providing access to patient care, a modification to the current contract is required. Gen-Probe, Inc., is the only company that possesses the ability to immediately support the continuation of this requirement, because they are the incumbent and the required analyzer is currently in use.

6. Efforts to Obtain Competition: Contract W81K00-20-P-0277 was awarded to Gen- Probe, Inc., with a period of performance of 1 October 2020 to 30 September 2021. It is not feasible to compete the requirement at this time because the directives from the Secretary of Defense and Secretary of the Army to test all deploying and training units for COVID-19 as soon as possible. Upon approval of this justification, contract W81K00- 20-P-0277 will be modified to accommodate the COVID-19 testing.

7. Actions to Increase Competition: When the current analyzer reaches end of life, the customer will research other competitive solutions to meet the Government’s need for fairness of competition.

8. Market Research: Based on market research, there are other vendors capable of providing molecular diagnostic analyzers, service and reagents/consumables for various viral assays testing under a cost-per-test arrangement, but there are none who have a single platform to provide multiple types of testing. Additionally, due to the extreme time constraint to re-solicit the requirement, evaluating and awarding the new contract, along with the aforementioned delivery/install/validation process, it is not possible for another vendor to fully and immediately support this effort and meet the requirements of this modified contract.

9. Interested Sources: Not applicable

10. Other Facts:

a. Procurement History

(1) Contract numbers and dates of the last several contracts for these same requirements. W81K00-20-P-0277, period of performance: 1 October 2020 to 30 September 2021 W81K00-20-P-0078, period of performance: 1 April 2020 to 30 September 2020, W81K00-19-P-0392, period of performance: 1 October 2019 to 31 March 2020, W891K00-18-P-0661, period of performance: 1 October 2018 to 30 September 2019, one year base.

Instrument/Service/Reagent/Consumables for Various Viruses

Version – March 2017 FOR OFFICIAL USE ONLY

(2) The competitive status of these actions. Contracts W81K00-20-P-0277, W81K00- 20-P-0078 and W81K00-19-P-0392 were awarded as sole source bridge requirements to Gen-Probe, Inc. Contract W81K00-18-P-0661 was competed as a full and open requirement and awarded to Gen-Probe, Inc.

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

W81K00-20-P-0277: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

(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. W81K00-20-P-0277: previous solicitations indicate that adequate competition exists. Prior procurements referenced market research that indicated there were are businesses that provided singular testing, but none of them provided multiple testing on one platform.

(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 W81K00-18-P-0661 was competed as a full and open requirement and awarded to Gen-Probe, Inc. Bridge contracts were awarded to Gen-Probe, Inc., because the customer could not develop a complete requirement due to time constraints without adversely affecting patient care.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g, several consecutive, urgent buys. Not applicable.

(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. W81K00-20-P-0277 was awarded as a sole source contract to prevent a break in service of patient care due to the time constraints customer faced in preparing package.

b. Class J&A: This Class J&A will cover all future actions for these items/services (as appropriate). Each action will be supported by a memorandum for record stating the action is within the scope of the class J&A in each contract file. Not applicable

(End of page)

Instrument/Service/Reagent/Consumables for Various Viruses

Version – March 2017 FOR OFFICIAL USE ONLY

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: 20NOV2020

Title: 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: 20NOV2020

Title: Signature:

Instrument/Service/Reagent/Consumables for Various Viruses

Version – March 2017 FOR OFFICIAL USE ONLY

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.

This determination will be made using the following: X price analysis cost analysis

☒ IGCE audit: other:

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

Title:

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

Typed Name: