A02_EFOJ_COVID-19 Mobile Labs_FINAL_Redacted.pdf

Control Number: JA 20 Edg 352

(Mobile Medical Laboratory Solutions for COVID 19 National Emergency Response)

For Official Use Only (See FAR 2.101 and 3.104 4)

(March 2020)

FAR Part 16 Exception to Fair Opportunity Justification Under Multiple Award Indefinite Delivery Contracts

For Actions Exceeding the Simplified Acquisition Threshold (SAT) Urgent and Compelling for COVID-19

1. Contracting Activity: U.S. Army Contracting Command (ACC) Aberdeen Proving Ground (APG), Edgewood Contracting Division, APG, MD 21010-5424

2. Description of Action: The proposed effort is for a new Joint Enterprise Research, Development, Acquisition and ProductionProcurement (JE-RDAP) (Base Contract Number:

W911QY-18-D-0115) Delivery Order (DO) Number: W911SR-20-F-0054. The type of DO will be Firm Fixed Price (FFP). The type of funds to be used are 2019 Army Procurement. This documents verbal approval granted on 24 April 2020 by the Advocate for Competition to award the aforementioned task order prior to approval of the justification because preparation and approval prior to award of the order would unreasonably delay the acquisition.

3. Description of Supplies/Services: “Procurement of Mobile Medical Laboratory Solutions (mobile labs) for COVID-19 National Emergency Response”. The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) must continue to fulfill its mission to protect personnel during the COVID-19 pandemic. The JPEO- CBRND proposes to contract with MRIGlobal, to procure mobile labs in support of testing military personnel for COVID-19.

– The ICGE was independently developed by Government personnel, based upon JE-RDAP labor rates, DTS travel regulations and given the urgency of the effort, upon limited market research information. The Performance Work Statement (PWS) was in rough draft at the time the initial IGCE was created, as requirements were finalized, the IGCE was updated to reflect changes to the PWS.

4. Authority Cited: 10 U.S.C. 2304c(b)(1) as implemented by FAR 16.505(b)(2)(i)(A) – The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays

5. Reason for Authority Cited:

The President of the United States made an emergency determination under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the "Stafford Act") in response to the COVID-19 pandemic on 13 March 2020.

JPEO-CBRND has a public responsibility to comply with the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) guidance to prevent further

For Official Use Only (See FAR 2.101 and 3.104 4)

(March 2020) spread of COVID-19. They are also required to comply with Department of Defense (DoD) and U.S. Army Europe guidance to implement plans to ensure compliance with directed force health protection measures throughout the area of operations in order to prevent an outbreak of COVID- 19 within U.S. personnel (service members, civilians, contractors, and dependents) or confine it to as small a population as possible. In order to comply and put protective measures in place, JPEO-CBRND has an urgent need for Mobile Labs. These mobile labs are required to protect the public from the spread of (or isolate people infected with) COVID-19. These mobile labs are specifically designed to maximize COVID-19 sample collection and screening, while ensuring greater testing accuracy, and are urgently required in support of the testing effort to determine whether individuals have COVID-19 and in order to protect the public from the spread of (or isolate people infected with) COVID-19.

Every day that passes confirmed COVID-19 cases spike and the death toll increases. It is imperative that these mobile labs are obtained as quickly as possible to protect public health. The U.S. Government cannot apply standard procurement times to an acquisition of this urgent nature. Even the short time-lines of 30-60 days to award could result in hundreds of thousands more being infected and thousands more dying.

In accordance with FAR 16.505(b)(2)(i)(A), the need for these supplies is so urgent that providing a fair opportunity would result in unacceptable delays. The spread of the COVID-19 virus presents high risk of immediate harm to government personnel and dependents from lack of COVID-19 testing facilities at designated Army installations where testing is immediately needed, or needed in the very near term.

Army Training and Doctrine Command (TRADOC) installations have identified they do not have the capacity to process a high throughput of samples collected for COVID-19 screening and diagnostics. Current medical treatment facilities have reached their maximum throughput capacity. Most installations facilities are able to process ~240 tests a day in a 24 hr. time period.

Due to the COVID-19 outbreak, sampling demands have increased from ~240 to ~816 samples in a 24 hr. time period. Facilities are unable to increase their sampling capacity, significantly increasing the risk of COVID-19 exposure on installations, especially at TRADOC installations where to 400 - 1200 new recruits and cadets are processed daily. Currently sampling capacities have reached their maximum. A temporary solution to increase the sampling capacity are mobile labs.

The required items must be provided at the requested quantities of three within an eight-week timeline, with the first mobile lab available in 14 days. MRIGlobal has built mobile labs to operate up to biological safety level 3 (BSL-3) regulations, as a point of reference only and vendor credibility, and are able to begin delivery of the required BSL-2 mobile labs in less than 2 weeks with complete delivery in 7 weeks. All other mobile labs options researched require 6-8 weeks to build and begin delivery of these capabilities. For COVID-19 samples, these mobile labs only are required to operate at BSL-2 level. The addition of these mobile labs at Army TRADOC installations will increase sample processing by 600 samples a day. Current medical

For Official Use Only (See FAR 2.101 and 3.104 4)

(March 2020) treatment facilities are still required to process normal medical, clinical and pathological samples collected for every day medical care in addition to COVID-19 samples. The COVID-19 outbreak has significantly stressed the Army TRADOC installation medical treatment facilities (MTFs). Without the delivery of these mobile labs, patient samples will not be processed in adequate time to make a diagnosis thus significantly increasing the risk of exposure to the installation population. Due to the ease of transmission of COVID-19, not being able to identify infected individuals will decrease the effectiveness of Army service members; therefore, increasing the risk to national security.

To support the US Army’s ability to protect personnel during the current crisis, Dr. Bruce Jette, Assistant Secretary of the Army for Acquisition, Logistics and Technology (ASA (ALT)) tasked the JPEO- CBRND in early April 2020 with immediately procuring three mobile labs to enhance sample processing and testing throughput, at designated points of need, for Army Service Members, Civilians, Contractors, and dependents.

6. Efforts to Obtain Competition: As indicated by the Market Research results, the Government identified limited potential sources to meet the minimum performance requirements of a mobile capability inclusive of two Biological Safety Cabinets (BSC), a HVAC System, laboratory benches, drawers, cabinets, electrical and power supply to support the processing of COVID-19 samples collected from patients up to a Biological Safety Level (BSL-2) operation.

Additionally, the urgency of the need required a vendor to be able to deliver NLT than early May. After assessing the availability of mobile laboratories across DoD, and finding no suitable options, the market research team scoured the internet using the above criteria and found three Industry developers for this type of product. After emailing and calling Battelle Memorial Institute (BMI) and GermFree, the market research team had follow up discussions with Other Government Agency (OGA) teams from the Army Public Health Command (PHC) and Defense Intelligence Agency (DIA). The team learned that existing mobile labs could not be leveraged to support the JPEO-CBRND efforts from either OGA team. However, the OGA team provided the JPEO-CBRND team a point-of-contact at MRIGlobal because this company was the builder for their current mobile labs. The team then also reached out to MRIGlobal and requested a ROM, information sheet, and delivery timeframe. No information was provided from BMI to present to leadership for consideration. MRIGlobal was the only vendor that met all of the performance requirements and urgent delivery schedule.

7. Actions to Increase Competition: The mobile labs will satisfy the immediate need for increased COVID-19 sample collection and analysis. Additional units, if needed, will be procured under a separate contract action via full and open competition.

8. Market Research: Market research was conducted from 6 April 2020 through 21 April 2020 by the requiring activity JPEO-CBRND’s Joint Program Manager (JPM) CBRN Sensors team.

Market research was limited due to the urgent nature of this urgent procurement and the lack of requirements package and historical data for this requirement.

For Official Use Only (See FAR 2.101 and 3.104 4)

(March 2020)

After a survey of the mobile medical laboratory market place and existing government mobile labs (that were unsuitable for COVID-19 testing), three companies were contacted: Battelle Memorial Institute (BMI)(JE-RDAP contract holder), Germfree, and MRIGlobal (JE-REDAP contract holder). Of the three companies contacted, BMI did not provide a response and Germfree indicated they could supply the mobile lab but not within the required delivery timeline. Germfree was also unable to meet the technical staffing requirements. Existing Government assests were not available and/or did not meet the performance requirements or could not be obtained within the required schedule of eight-weeks, with the first mobile lab available in 14 days. The potential production timelines were forecasted out to an eight-week timeline. From the results of this market survey, only one known vendor, MRIGlobal, would be able to fulfill the Government’s minimum requirements.

The JPEO-CBRND vetted those companies against the standards required by the DOD and the quantities required. The factors used to determine manufacturer viability of meeting the requirement of the COVID-19 Mobile Labs were: (1) 21 CFR 820, GMP General Controls Status compliance; (2) FDA Compliance; (3) Site Compliance (FDA and ISO 10993-1:2018 compliant); (3) Cost; and (4) Delivery schedule. The JPEO-CBRND also researched the ability to build and integrate the labs by the Government, leveraging the Advanced Design and Manufacturing (ADM) Division of CCDC-CBC, but could not meet the delivery schedule requirements. Only MRIGlobal could satisfy the requirements in terms of technical requirements and schedule. None of the other entities could provide the mobile labs and technical expertise for mobile operation and processing of COVID-19 samples within the required timeline. The level of technical expertise required to execute this task has to be specific to the operations, processing, and laboratory setup for the Athena lab. Due to the sample demand increase expected to process through the labs (>600 samples a day), the technical staff operating under these conditions needed to be familiar with delivery, setup and samples processing to begin operations at each site on day one. The expedited turnaround time reduced the sufficient amount of time required to train and familiarize additional staff on the mobile processing and operations of the Athena Lab. To meet the expedited turn-on time for labs to begin operations, it was determined that the level of expertise required could only be supplied by MRI Global.

Based on the substantial market research, the US Army guidance determined to only purchase the following: (3) Mobile Labs along with an option to procure technical services.

MRIGlobal is a contract holder under the JE-RDAP MA IDIQ and the Mobile Labs are within scope of the base contract; therefore a decision was made to utilize JE-RDAP as a vehicle under which to award this action.

In December of 2019 an outbreak of COVID-19 was reported in Wuhan City, Hubei Province, China. The World Health Organization (WHO) states COVID-19 is the infectious disease caused by the most recently discovered coronavirus. They also state in humans, several coronaviruses are known to cause respiratory infections, ranging from the common cold to more severe diseases, such as COVID-19. The WHO states:

For Official Use Only (See FAR 2.101 and 3.104 4)

(March 2020)

“Around 1 out of every 6 people who gets COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high blood pressure, heart problems or diabetes, are more likely to develop serious illness. People with fever, cough and difficulty breathing should seek medical attention.”

The WHO declared the global COVID-19 outbreak a pandemic on 11 March 2020, stating it is a “public health crisis”. The following is information from the WHO website. The WHO is recommending all countries activate and scale up their emergency response mechanisms utilizing a four-pronged approach. First, prepare and be ready. In other words, prepare your people and your health facilities. Second, detect, prevent, and treat. Utilize surveillance to find, isolate, test and treat every case in order to break the chain of transmission. Third, reduce and suppress.

Reduce transmission by finding and isolating as many cases as possible and quarantining their closes contacts. Protect health facilities, old age homes, and other vital areas. They recommend testing all suspected cases. Fourth, innovate and improve. Find new ways to prevent infection, save lives, and minimize impact. Utilize personal protective equipment. Utilize the WHO training programs, technical guidance, studies, protocols, and preparedness and response plans.

The procurement of the mobile laboratory will improve readiness of military forces by increasing the capacity of detection of positive carriers of the virus. This will ultimately reduce transmission and protect the forces against the further spread of COVID-19. By procuring the Mobile Medical Laboratory Solutions for the COVID-19 National Emergency Response, the Army is utilizing all four prongs mentioned above by preparing for unforeseen outbreaks requiring BSL-2 level of detection capability, thus suppressing further outbreak using innovation by mobilizing clinical diagnostic capability to the point of need.

On January 31, 2020, the United States Department of Health and Human Services Secretary Alex M. Azar II declared a public health emergency (PHE) for the United States to aid the nation’s health care community in responding to COVID-19. On 13 March 2020, the President of the United States of America declared COVID-19 an emergency IAW 42 U.S.C. 5122 (the Robert T. Stafford Disaster Relief and Emergency Assistance Act) which allows for Special Emergency Procurement Authority IAW 41 U.S.C.1903. On 18 March 2020, the President invoked his authority IAW the Defense Production Act. The Act allows the President, where necessary to promote the national defense, may require acceptance and performance of contracts orders by any person he finds to be capable of performing them.

9. Interested Sources: As shown in the market research, interest is limited as many Offerors cannot provide the required quantities of the supply within the required timeframes to meet the needs of the Government in order to protect public health.

Three JE-RDAP vendors were contacted to see if they had the mobile labs available, but only MRIGlobal was able to fulfill the Government’s urgent requirement. These supplies cannot be obtained online from other vendors because they would not arrive fast enough to meet the Government’s delivery requirements.