JA Panther Fusion signed by SPE 12 Apr 2021_Redacted.pdf

CUI

Control Number: 21-HRCO-256

Contractor: Gen/Probe Program/Equipment: MEDCOM HQ

CUI

(See FAR 2.101 and 3.104-4)

Justification Review Document For Other than Full and Open Competition

Program/Equipment: Panther Fusion SARS-CoV-2 Assays COVID-19 Test Kits for

MEDCOM HQ

Authority: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 – Only one responsible source and no other supplies or services will satisfy agency requirements.

Amount:

Prepared by:

Typed Name: DSN:

Title: Contracting Specialist Date: March 23, 2021

E-mail:

Contracting Officer:

Typed Name: DSN:

Date Reviewed: March 23, 2021 E-Mail:

Technical Representative:

Typed Name: DSN:

Title: Program Manager Date Reviewed: March 23, 2021

Email:

Requirements Representative:

Typed Name: DSN:

Title: Program Manager Date Reviewed: March 23, 2021 Controlled by: Army Controlled by: USAHCA CUI Category: General Procurement and Acquisition Distribution/Limited Dissemination Control:

FEDCON

POC:

CUI

(See FAR 2.101 and 3.104-4)

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

Program Manager:

Signatu Date: March 23, 2021

Typed Name: DSN: _

Legal Counsel

Signatu Date: March 23, 2021

Typed Name: DSN:

Command Advocate for Competition:

Signatu Date: March 23, 2021

Typed Name: DSN: _

Senior Contracting Official:

Signatur Date: March 23, 2021

Typed Name:

U.S. Army DSN

CUI

(See FAR 2.101 and 3.104-4)

Justification Review Document

For Other than Full and Open Competition

1. Contracting Activity: U.S. Army Health Contracting Activity (USAHCA), Health Readiness Contracting Office (HRCO), 2199 Storage Street, Building 4197, Suite 68, Joint Base San Antonio (JBSA) Fort Sam Houston, Texas 78234-5074.

2. Description of Action: U.S. Army Medical Command (MEDCOM), U.S. Army Health Contracting Activity (USAHCA), requests a sole source Indefinite Delivery Indefinite Quantity contract with one-three year ordering period with Firm Fixed Price (FFP) Delivery Orders. Gen-Probe Incorporated, 250 Campus Dr., Marlborough, MA 01752- 3020, CAGE Code 0BDV3. The Government projects award for April 2021 and fiscal year 2021, funds Defense Health will be used.

This action is a follow-on to contract W81K04-20-D-0007. That contract was competed under authority 10. U.S.C. 2304(c) (2) as implemented by FAR 6.302-2, Unusual and Compelling Urgency. Paragraph, “Actions to Increase Competition” of the previous justification, stated: Gen-Probe, Inc. is a subsidiary of Hologic, Inc. To date, Hologic has not granted any other third parties with a license to sell or service any of its products. In light of the licensing restrictions and the emergency nature of the requirement no other actions will be taken to increase competition at this time. Those actions were not accomplished due to letter dated February 11, 2021 stating “Hologic does not sell through dealers or distributors in the U.S. All sales are made directly to end users. U.S. patents covering the instrument system and associated assay kits, reagents, and consumables can be found at https://ww.hologic.com/IP.

3. Description of Supplies/Services: The MEDCOM is acquiring Panther Fusion SARS-CoV-2 assays, Aptima SARS-CoV-2 assays, Multiplex test kits and associated reagents and consumables in order to conduct COVID-19 testing on the Hologic Panther Fusion systems. The Panther Fusion SARS-CoV-2 test kits are qualitative tests for the detection of nucleic acid from SARS-CoV-2 isolated and purified from NP, nasal, mid-turbinate and OP swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria, and from individuals without symptoms or other reasons to suspect COVID-19 infection. The Panther Fusion and Panther Systems are integrated nucleic acid testing systems that fully automate all steps necessary to perform various Panther Fusion and Panther assays from sample processing through amplification, detection, and data reduction.

(a)The Panther Fusion SARS-CoV-2 testing capability on the Panther Fusion System primarily consists of Panther Fusion SARS-CoV-2 PPR Mix; Open Access Cartridges, RNA/DNA ENZ; and additional vendor specific reagents and consumables required to perform the SARS-CoV-2 test. Aptima SARS-CoV-2 testing capability on the Panther

(See FAR 2.101 and 3.104-4) and Panther Fusion primarily consists of Aptima SARS-CoV-2 assay kit, Solid Cap Specimen Lysis Tubes, and additional vendor specific reagents and consumables required to perform the SARS-CoV-2 test. The multiplex test kit is currently under production and capable of simultaneous detection of both influenza A & B and COVID- 19.

(b) Period of Performance: April 20, 2021 – April 19, 2024. One-three year ordering period.

Total Value:

Ordering Year One:

Ordering Year Two:

Ordering Year Three:

4. Authority Cited: 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: (a) As described at FAR 6.302-1(a)(2), when the supplies or services required by the agency are available only from one responsible source, or for DoD, NASA and the Coast Guard, from only one or a limited number of responsible sources, and no other types of supplies or services will satisfy agency requirements, full and open competition need not be provided for. Gen-Probe, Inc. is a subsidiary of Hologic, Inc. To date, Hologic has not granted any other third parties with a license to sell or service any of its products. In light of the licensing restrictions and the continued need of the requirement no other actions will be taken to increase competition at this time.

(b) On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there was a public health emergency, and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). In vitro diagnostic products (IVD’s) are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Regulated under 21 CFR Part 809 of the Food, Drug, and Cosmetic Act; test instruments are generally inextricably linked to test reagents as specified within the FDA approval and emergency use authorization documents. For FDA-cleared or approved test systems, when a laboratory modifies or deviates from the approved procedure, then it is regulated as a Laboratory Developed Test (LDT) and must establish test system performance specifications IAW 42 CFR 493.1252(b)(2)(i)-(vii).

Pursuant to Section 564(b)(1)(C) of Federal Food, Drug, and Cosmetic Act, the Secretary of the Department of Health and Human Services (HHS) has determined that there is a public health emergency and circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19. Use is limited to the EUA Letter of Authorization and Conditions of Authorization and deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials are not permitted. Rapid detection of COVID-19 cases in the United States requires wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness.

(c)There are multiple issues impacting this requirement including a lack of robust historical data, an increase in mission requirements due to exodus and other new Service testing requirements, multiple waves of significant infections, onset of flu season, identification of new SARS-CoV-2 variants, and changes in available testing technologies since the pandemic began.

(d) When the original JA was written in April 2020 the impact of COVID-19 was unknown and it was an evolving crisis. Therefore the independent government cost estimate was based on an immediate and critical need with minimal data, no historical reference, and a short term mission and expected impact. The lack of information and no historical data put the military departments at a disadvantage and as such, the estimated usage fell short significantly. The only known “similar” reference was the influenza season historical data. A three year average was 237,021 annual cases and 33,000 tests per month from October to May 2020. Since the beginning of the pandemic the Army has conducted over 1M tests with requirements doubling within 6 months resulting in a request to increase the current contract ceiling from to on November 24, 2020.

(e) While daily cases have been trending downward DoD's Tier testing requirements have remained consistently high. Potential new screening testing requirements for travel (e.g., DoD OCONUS travel policy) could further increase the demand for testing.

Increased incidences of infection with COVID-19 variants (e.g., UK, South African and Brazil) in conjunction with relaxation of COVID restrictions (e.g,. mask mandate) within some states could result in a resurgence in cases and another wave resulting in an increase demand for testing. The SecDef’s tiered testing of asymptomatic Service Members and the subsequent Force Health Protection Supplements, such as FHP 11 and 13 requires that the Army support the other Services’ readiness missions. These are all unknown requirements that have significantly impacted the usage of this contract, and are often identified with minimal notification and lead time. Currently, Army conducts 57% of all DoD testing, and as of February 5, 2021 has performed over 127,000 tests in support of the Air Force and Navy.

(f) Changes in testing technology and the onset of influenza season have also impacted this requirement. In recent months there has been considerable advancement in the development and authorization of multiplex tests by the Food and Drug Administration (FDA) under EUA. These multiplex tests allow for the simultaneous detection of multiple pathogens to include COVID-19 and flu A & B. Use of this test represents a significant advancement saving time and money to the government by rapidly identifying whether a patient has the flu versus COVID-19. This is critical to ensuring beneficiaries receive the correct diagnosis, treatment, and isolation (if appropriate) as quickly as possible in order to decrease transmission of the virus and outbreaks and resultant impacts to readiness and force health protection.

(g) It is critical to use Tecan pipette tips, or Hologic authorized tips. Due to the global shortage Hologic has identified four alternate pipette tips that have demonstrated acceptable performance in preliminary testing, however those tips have not been fully validated by the vendor nor amended into the FDA EUA. Additionally, Hologic’s technical bulletin issues several usage warnings for these alternative tips including use of the non-validated pipette tips that may interfere with assay performance, result in process control failures, invalidation of test results, and sampling errors.

(h) In reference to paragraph 3 above, the Government finds it necessary to acquire testing kits and related consumables in order to provide for current levels of COVID-19 testing, and support future levels, because even though cases are on the down swing, the testing of DoD personnel has remained consistently high. Given this, it is critical to use Tecan pipette tips, or other Hologic authorized tips, as they are a required component of Hologic’s SARS-CoV-2 test system, in order to support Army’s COVID-19 test requirements.

(i) Although the FDA has authorized multiple molecular testing systems for COVID-19 under emergency use Hologic is currently the only commercial vendor with the required COVID-19 testing systems with both sufficient high throughput testing and supply capacity to support the Army’s COVID-19 testing numbers. Another rate limiting factor is limited space and infrastructure support within the MTF clinical laboratories to support the needs of similar high throughput COVID-19 systems. For example the Panther Fusion system weighs 1,265 lbs while the comparable Roche testing system weighs 3,200 lbs which limits where the system can be installed. MEDCOM procured 16 Hologic testing system located in United States, Asia and Europe in support of COVID- 19 at a cost of approximately ( per system). Replacing these systems with comparable COVID-19 Roche testing systems would result in a loss of the initial investment of but also cost MEDCOM an estimated additional ( a piece) to procure the new testing systems. Sustainment of test kits will still be limited to the testing system and vendor as specified within the EUA documents. Additionally, test kit production capacity of commercial vendors with comparable testing systems are insufficient to support Army requirements. Based upon current market research Walter Reed has indicated that Roche can only supply 14,000 test kits a week. Currently, Army is being supplied 33,000 kits. The Hologic Panther and Panther Fusion systems possess a current Authority To Operate (ATO) under the Risk Management Framework (RMF) to connect to DoD networks and have established interfaces to DoD’s Electronic Health Record (e.g., MHS Genesis). Other testing systems would potentially require (RMF) approval and interface development which could take up to six months to obtain approval resulting in delays and additional costs adversely impacting readiness and more importantly patient care.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered.

Request for Information was posted on February 16 - March 5, 2021 and Notice of Intent was posted February 20 – March 5, 2021 were posted on betasam.gov however, there have been no responses from vendors.

(a) Effective Competition: Because this is a sole source action, effective competition is not applicable.

(b) Subcontracting Competition: Subcontracting competition will not be achieved by Hologic as there are no opportunities.

7. Actions to Increase Competition: Gen-Probe, Inc. is a subsidiary of Hologic, Inc.

To date, Hologic has not granted any other third parties with a license to sell or service any of its products. Contracting Officer and Program Manager will continually monitor the market for alternative emergency use authorized or FDA approved sources.

The contracting officer will begin the acquisition process to competitively source the testing capabilities including the systems for future requirements. Providing the other FDA approved sources the time to achieve RMF approval to place their system on the DoD Network. A cost benefit analysis will be conducted to determine what is more advantageous to the government.

8. Market Research: Since the onset of COVID-19, the Government has continually conducted market research to determine if any other vendors can provide the items or if there are suitable substitutions by posting Request for Information and synopsis on betasam.gov. However, to this date, there have been no responses from vendors.

Gen-Probe Inc. is the only vendor that can provide proprietary services and consumables for the Panther and Panther Fusion Systems, due to the fact that its parent company, Hologic, has not licensed the right to sell or maintain its products to any other company. In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.301-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a request for information was posted to

Betasam.gov on February 8, 2021 for 15 days and the results were that zero contractors could supply Panther Fusion test kits.

9. Interested Sources: To date, no other sources have written to express interest in the acquisition. The existing Panther and Panther Fusion Systems are manufactured by GenProbe/Hologic and are currently being used at multiple Army Military Treatment Facilities. The Panther and Panther Fusion Systems are the only authorized systems for SARS-CoV-2 RT-PCR, Aptima and Multiplex testing. See Paragraph 6 for the synopsis information.

10. Other Facts:

Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements. W81K04-20-D-0007 awarded on April 20, 2020.

(2) The competitive status of the sections. Awarded as Sole Source to GenProbe Incorporated under FAR 6.302-2, Unusual and Compelling, Urgency.

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

10 U.S.C. 2304(c) (2) as implemented by FAR 6.302-2, Unusual and Compelling, Urgency.

(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. The Panther Fusion SARS-CoV-2 Testing capability on the Panther Fusion primarily consists of Panther fusion SARS-CoV-2 PPR Mix; Open Access Cartridges, RNA/DNA ENZ; and additional vendor specific reagents and consumables authorized by the FDA under EUA to perform the SARS-CoV-2 test. Gen- Probe, Inc. is a subsidiary of Hologic, Inc. To date, Hologic has not granted any other third parties with a license to sell or service any of its products. In light of the FDA’s EUA requirements, licensing restrictions and the emergency nature of the requirement no other actions will be taken to increase competition at this time.

(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. To date there have been 59,779 Army affiliated cases reported within the Disease Reporting System Internet (DRSi). As the number of cases continues to rise across the DoD the health risks to Active Duty Service Members and healthcare beneficiaries continues to grow with significant implications for operational readiness and Force Health Protection.

(a) Diagnostic testing continues to remain a critical component of the Army’s COVID-19 response as it facilitates the identification of those infected regardless of whether they have symptoms or not allowing for rapid contact tracing, self-isolation or quarantine in an effort to contain and limit transmission of the virus. To date over 142,674,966 tests have been performed within the US with 1,528,335 of those being performed by the Department of Defense. Under the Army’s COVID-19 laboratory expansion plan the Army rapidly expanded its COVID-19 testing capability and capacity throughout its MTFs providing the majority of DoD’s initial diagnostic testing capability. To date the Army continues to conduct the majority of the COVID-19 testing within DoD performing 57% of total tests performed.

(b) Expansion and sustainment of COVID-19 testing capability for SARS-CoV-2 remains a high priority for DoD Senior Leaders. In order to fully support the DoD’s critical national capabilities, Operational and Deployed Forces and ongoing patient care missions, as defined by the SecDef within the tier testing requirements, the DoD requires the capability to perform approximately 195,000 tests a month. A large percentage of the Army’s testing is performed on high throughput Panther Fusion and Panther systems capable of performing approximately 1,005 tests per day per system.

Currently, there are 11 Panther Fusion systems in place at two Army research labs and eight Medical Centers. Additionally, there are seven Panther systems in place at four Army MEDDACs. In order to meet the Army’s and DoD’s current and projected diagnostic, screening and surveillance testing requirements these systems require a sustained, steady supply of test kits, reagents and consumables.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive urgent buys. Due to the imminent threat of the COVID-19 Pandemic the award of this contract was originally made to Gen-Probe as a sole source in accordance with attachments SS DIAG Panther Fusion and FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

(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. The Panther Fusion SARS-CoV-2 Testing capability on the Panther Fusion primarily consists of Panther fusion SARS-CoV-2 PPR Mix; Open Access Cartridges, RNA/DNA ENZ; and additional vendor specific reagents and consumables authorized by the FDA under EUA to perform the SARS-CoV-2 test. Gen- Probe, Inc. is a subsidiary of Hologic, Inc. To date, Hologic has not granted any other third parties with a license to sell or service any of its products. In light of the FDA’s EUA requirements, licensing restrictions and the emergency nature of the requirement no other actions will be taken to increase competition at this time.

11. Technical Certification:

CUI

(See FAR 2.101 and 3.104-4)

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: ___Date: March 23, 2021

Typed Name: Title: Program Manager

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: _____Date: March 23, 2021

Typed Name: Title Program Manager

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.

This determination will be made using the price analysis and independent government cost estimate.

As a part of this basis, certified cost or pricing data will not be required and the following exception applies (FAR 15.403) a commercial item is being acquired.

Signature: ___Date: March 23, 2021

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: _____Date: March 23, 2021

Typed Name: Title: Contracting Officer