SSJ Opera Phenix Redacted.pdf

Control No:

Program/Equipment: High Content Screening System

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FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity: US Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD, 21702.

2. Description of Action: US Army Research Institute of Infectious Diseases (USAMRIID) requests a Firm-Fixed-Price (FFP) contract for a Brand Name Opera Phenix Plus High Content Screening system. The Government projects award for March 2021 and fiscal year 2021, funds will be used.

Preventative Maintenance costs (constructed in the subsequent contract as 12 month option periods) will be funded with current year (at the time of option exercise) 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).

(Insert approval authority title) approved an acquisition plan in accordance with DFARS 207.103(d)(i)(B) on (insert date).

The required acquisition plan in accordance with DFARS 207.103(d)(i)(B) is currently awaiting (insert approval authority title) approval.

3. Description of Supplies/Services: The Molecular Biology Division (MBD) of USAMRIID has a requirement for a High Content Screening System. The system consists of a High Throughput Automated Microscope, Air and Water Objectives, Instrument Software, Instrument Installation, User Training, Instrument Warranty and Preventative Maintenance (PM).

The Government’s Minimum Essential Characteristics (MECs) are outlined below:

1. Allows the combined use of 375 nanometers (nm) and the 425nm excitation lasers or the 405nm laser. The 375/425 laser combination is especially suited for Cyan Fluorescent Protein/Yellow Fluorescent Protein (CFP/YFP) Fluorescence Resonance Energy Transfer (FRET) applications.

2. Can be equipped with up to three (3) PerkinElmer proprietary high numerical aperture (NA) automated water immersion objectives of different magnifications (=20x, NA 1.0; 40x, NA 1.1.; 63x, NA 1.15).

3. Automatically corrects for objective offsets using a quasiperiodic grid when used with optional PreciScan automated prescan/rescan routine.

4. The high content screening system is required to be compatible with (able to export the captured images automatically as part of an image acquisition protocol) the current USAMRIID owned image analysis system (PerkinElmer Columbus Image Storage and Analysis System).

5. The high content screening system is required to be compatible with the operating system (both for data transfer and utilization of the existing image analysis protocols) to allow USAMRIID to transfer the existing data archive to the new system and to allow new imaging analysis protocols to be applied to existing imaging data to mine additional features from the achieved data. The current operating system is

For Official Use Only

PerkinElmer Operetta CLS High-Content Analysis System utilizing PerkinElmer Harmony High Content Analysis Software.

6. The high content screening system is required to able to export its own analysis protocols (including 3 voxel-based protocols) into the PerkinElmer Columbus Image Storage and Analysis Software for larger scale analysis.

Required Delivery Date for High Content Screening System: 26 March 2021.

Value:

Option Period 1 (PM and Extended Warranty): 26 March 2022 to 25 March 2023, Value:

Option Period 2 (PM and Extended Warranty): 26 March 2023 to 25 March 2024, Value:

Option Period 3 (PM and Extended Warranty): 26 March 2024 to 25 March 2025, Value:

Option Periods Total:

Total Value of System with PM and Extended Warranty Options-

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

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization Other: Only sources with brand names can provide the required brand name

Opera Phenix Plus System and Extended Warranty and Preventative Maintenance.

5. Reason for Authority Cited:

(a) The proposed acquisition is required to be competed as a sole source (brand name) because the PerkinElmer Opera Phenix Plus High Content Screening System is the only high content screening system available on the market that satisfies the Minimum Essential Characteristics (MECs) that are required to meet the Government’s requirement.

The Therapeutic Discovery Branch (TDB) of the USAMRIID MBD currently has two (2) PerkinElmer Opera High Content Screening Systems that were purchased over 10 years ago (2007-model 3024 and 2010). The system from 2007 has exceeded its serviceable life expectancy and is soon to be decommissioned because the parts required to service the PerkinElmer Opera 3024 High Content Screening System are no longer manufactured by the Original Equipment Manufacturer (OEM) and no OEM supported third party components are available in the marketplace. The 2010 system is estimated to be serviceable until March of 2022. The subject requirement is looking to replace the unit being decommissioned, while maintaining compatibility with the current USAMRIID data achieve of imaging data.

For Official Use Only

The Government’s MECs are provided in Section 3 of the subject Justification and Approval. The first three MECs are essential physical characteristics of the high content screening system that are required for the Government to carry out the required research. The second three MECs pertain to compatibility with the current USAMRIID data achieve containing 200 Terabytes (TBs) of imaging data.

The ability of the high content screening system to be compatible with (able to export the captured images automatically) the current image analysis system (PerkinElmer Columbus Image Storage and Analysis System) is essential to allow for the image analysis of newly produced images [MEC 4]. The PerkinElmer Columbus Image Storage and Analysis System, is the sole image analysis system utilized by the department for these functions. Market research determined that the PerkinElmer Opera Phenix Plus High Content Screening System is the sole high content screening system that is compatible with the current image analysis system (PerkinElmer Columbus Image Storage and Analysis System).

The ability of the new high content screening system to be compatible with the operating system of the current high content screening system is required to allow for the transfer of the current USAMRIID data archive containing 200 Terabytes (TB) of imaging data and to allow for the utilization of the existing image analysis protocols (PerkinElmer Operetta system) to allow USAMRIID to transfer existing data to the new system.

Additionally, it will allow new imaging analysis protocols to be applied to existing imaging data to mine additional features from achieved data [MEC 5]. The decommissioning of the PerkinElmer Opera 3024 High Content Screening System (purchased in 2007) requires that the existing data archive be migrated to the new high content screening system. Transfer of this data (stored solely via the database function of the current operating system) is the sole way to ensure the ongoing integrity of the data and is only achievable if the operating system of the new high content screening system is compatible with the current system. Second, the operating system of the new high content screening system is required to be compatible with the operating system of the current high content screening system to allow for new imaging analysis protocols to be applied to existing imaging data to mine additional features from achieved data. Without compatibility between the new and old operating system, 200 TB of imaging data generated through 12 years of biodefense pathogens research could be lost or not compatible with data acquired in the future. If new data is not recorded and stored in a format that is compatible with (and thus comparable to) newly generated data, the data in the archive is essentially the same as lost. The loss of 12 years of biodefense pathogen defense data would be a momentous setback in the fight against diseases such as COVID-19 and would cost millions of dollars and years of time to replace.

Furthermore, there is a large lost potential from the inability to apply new imaging analysis protocols to existing imaging data. Market research did not locate any high content screening system other than the PerkinElmer Opera Phenix Plus High Content Screening System (operating system: PerkinElmer Operetta CLS High-Content Analysis System utilizing PerkinElmer Harmony High Content Analysis Software) that is compatible with the current operating system.

The ability of the new high content screening system to be able to export its own analysis protocols (including 3 voxel-based protocols) into the PerkinElmer Columbus Image

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The TDB evaluated all platforms located during market research (listed above in Table 2), in order to evaluate the competitive landscape for phenotypic screening instruments;

As explained above, compatibility with the current HCI system is the sole way that USAMRIID can guarantee the future usability of the stored data because other High Content Screening Systems do not collect data in a manner that is backward compatible or compatible with past data collected for data collected is in a format that is not accessible to other HCI systems and this means that past data would not be comparable with data recorded going forward.

Only the PerkinElmer Opera Phenix system allows for the 375/425 laser combination to allow for the FRET applications required by USAMRIID. None of the other systems have the similar laser combination, which will result in different measurements than currently used by USAMRIID in their research.

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0627 was awarded to PerkinElmer Health Sciences, Inc. in the amount of . The current Opera High Content Imaging System Workstation consists of an Opera QEHS High Sensitivity Content Imager; Operetta High Content Screen Development Imager, upgrades to the Columbus Image Server and Janus Plate Preparation Robotic System.

(2) W81XWH-10-P-0627 was competed as a brand name or equal requirement on FedBizOpps (FBO). The solicitation, W81XWH-10-T-0493 was posted to FBO on 30 August 2010 with a closing date of 06 September 2010. Only one (1) quote was received, which was from PerkinElmer Health Sciences, Inc. prior to the closing date of the solicitation.

(3) As this was prior to the requirement for a Justification Document for Brand Name or Equal requirements, a justification was not prepared to support the procurement of the supplies.

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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.

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.

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: 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.

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

For Official Use Only

Approval Based on the foregoing justification, I hereby approve the procurement of Brand Name High Content Imaging System on a brand name source basis 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.