SATPC0039775 Tab 06 BNJ..pdf

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i-STAT Chemistry Analyzer
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80NSSC25914885Q
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This document is a NASA Shared Services Center Recommendation and Determination to Solicit from One Source or Brand Name, specifically a Brand Name Justification for the i-STAT 1 Portable Blood Analysis System from Abbott. The document justifies sole sourcing the i-STAT 1 device for a Venous Flow Study, highlighting its unique capabilities for point-of-care blood testing on the International Space Station (ISS). NASA requires this specific device because it can measure Hematocrit using only 2-3 drops of whole blood, eliminates the need for ambient blood return from the ISS, and is already certified for use in space, making alternative devices impractical due to insufficient time for certification and launch.

The recommended procurement has an estimated period of performance through August 2025, with the total estimated cost redacted in the document. The justification emphasizes that no other device in the market offers comparable capabilities, and using an alternative would require extensive flight certification testing and launch to the ISS, which is not feasible given the current study schedule. The data generated by the i-STAT 1 is critical for research aimed at characterizing thrombus risk and identifying potential countermeasures for space missions.

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Page 1 V2.0 3-15-2017

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

NASA SHARED SERVICES CENTER

RECOMMENDATION AND DETERMINATION TO SOLICIT FROM ONE SOURCE

OR BRAND NAME

PICK ONE

Sole Source:

☐I recommend that NASA, NASA Shared Services Center negotiate with Vendor Name only for Enter Supply or Service to be procured. The total estimated cost of this effort is Dollar Amount and the estimated period of performance or lead-time for delivery is August 2025.

OR

Brand Name Justification:

☒I recommend that NASA, NASA Shared Services Center negotiate with only with vendors who can provide the subject from Abbott for i-STAT 1 Portable Blood Analysis System. The total estimated cost of this effort is and the estimated period of performance or lead-time for delivery is August 2025.

This recommendation is for the acquisition of supplies or services determined to be reasonably available from only one source/only one manufacture. Competition is impractical for the following reasons (please answer the questions below):

1. What are the reasons for soliciting only the suggested source/suggested brand name? Please provide the unique characteristics of the items or services along with the supporting rationale and the market research performed to substantiate your reason for the suggested source/brand name.

The i-STAT 1 is a portable blood analyzer that operates together with i-STAT test cartridges to create a point-of-care testing platform that provides reliable laboratory results in minutes. The i-STAT Chem8+ and CG8+ cartridges both have capability to measure Hematocrit, which is a necessary measure for the Venous Flow Study. The i-STAT 1 device and procedure are user friendly and require only 2-3 drops of whole blood. Using the i-STAT 1 for Hematocrit measures will eliminate the need for ambient blood return from the International Space Station (ISS) for processing. Utilizing this point-of-care platform will allow for increase data collection and overall testing efficiency for crew and operations team. Finally, the iSTAT 1 is already available for use on the ISS and using an alternative device for ground testing would require a new device be certified to fly to the ISS to support inflight data collection. Given the current schedule for this study there is insufficient lead time to procure, test, approve, and launch a new device to meet our study needs. Thus, the same device must be purchased for testing on the ground.

2. What is the impact to the government if another vendor/brand is used? Include any dollar, schedule, or compatibility impacts if possible.

No other device is market available with same capabilities as the i-STAT 1. If a new device were identified that could be verified to produced comparable data, that device would need to go through flight certification testing and launch to the ISS prior to planned operations, which is not feasible. The data generated by this device is critical for implementing our research aimed at characterizing thrombus risk and identifying viable countermeasures.

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