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Attachment H - Down Selection Evaluation Criteria
The ultrasound system will be evaluated and down selected based on the following evaluation criteria:
For down select purposes, system attributes that are weighted as “high” are more important than system attributes weighted as “medium” and “low,” during environmental and operational testing. Additionally, systems attributes that meet the objective will be evaluated “higher,” in comparison to system attributes only meeting the threshold. Price and overall usability will also be considered. Down selection will be based on a comprehensive review and assessment against the evaluation factors below.
Evaluation Factors:
Environmental testing Operational Assessment/Usability Pricing Reasonableness
· Environmental Testing The Ultrasound Field Portable (USFP) system will undergo environmental testing. The system will be rated according to the data received and how the system performed in each attribute below.
· Operational Assessment/Usability
· The Operational Assessment will contain scenarios in a simulated operational environment where military end-users will use the USFP system and then will provide feedback. The system will be rated according to the information received in the feedback and how the system performed according to the below attributes during the Operational Assessment.
· Overall usability of the entire USFP system (including accessories) will be considered and rated, which may include other attributes in the MIL-STD-810. “Usability” is defined as the effectiveness, efficiency, ease of use and user satisfaction while an end-user interacts with the USFP system in a simulated operational environment.
· Price Reasonableness
· Price reasonableness of the 3,500 USFP systems (Deliverable 12). For a price to be reasonable, it must, in its nature and amount, represent a price to the Government that a prudent person would pay in the conduct of competitive business. Normally, price reasonableness is established through price analysis.
Ratings
| Ratings for Environmental Testing attributes |
| Description |
| EXCEPTIONAL |
| The USFP system attributes performed well under military environmental conditions, received no concerns from testing AND MEETS one or more OBJECTIVE attributes. Risk of unsuccessful performance is very low. |
| GOOD |
| The USFP system attributes performed well under military environmental conditions and received no concerns from testing. Risk of unsuccessful performance is very low. |
| ACCEPTABLE |
| The USFP system attributes performed well under military environmental conditions and received some minor concerns from testing AND meets the threshold. Risk of unsuccessful performance is low. |
| UNACCEPTABLE |
| The USFP system attributes received one or more notable concern(s) from testing. USFP systems is not acceptable. |
| Ratings for Operational Assessment/ Usability |
| Description |
| EXCEPTIONAL |
| The USFP system attributes performed well during operational assessment and received no concerns from military test users. Risk of unsuccessful performance is very low. |
| GOOD |
| The USFP system attributes performed well during operational assessment and received some minor concerns from military test users. Risk of unsuccessful performance is low. |
| ACCEPTABLE |
| The USFP system attributes received one or more notable concern(s) from military test users. There is risk of unsuccessful performance. |
| UNACCEPTABLE |
| The USFP system was unable to perform the operational assessment and/or the end user was unable to use the system. USFP system is not acceptable and/or has critical failures. |
| Ratings for Price reasonableness |
| Description |
| ACCEPTABLE |
| Pricing for the USFP system (including logistical support and all associated accessories) is fair, reasonable, and is competitively priced. The written price narrative reflects sound, rational judgment in deriving and applying historical data and pricing methodologies. |
| UNACCEPTABLE |
| Pricing for the USFP system (including logistical support and all associated accessories) is not fair, reasonable, and/or competitively priced. The written price narrative does not reflect sound, rational judgment in deriving and applying historical data and pricing methodologies. |
| Attribute: |
| Evaluation Weight: |
| Threshold: |
| Objective: |
| U.S. FDA Clearance |
| High |
| Shall have U.S. FDA Clearance |
| Shall have U.S. FDA Clearance |
| Focused Assessment with Sonography for Trauma (FAST) Capable |
| High |
| Shall be FDA Cleared for use in the abdomen and capable of performing FAST exams |
| Shall be FDA Cleared for use in the abdomen and capable of performing FAST exams |
| Extended Focused Assessment with Sonography for Trauma (e-FAST) Capable |
| High |
| Shall be FDA Cleared for us e in the abdomen and for cardiac use, and capable of performing eFAST exams |
| Shall be FDA Cleared for us e in the abdomen and for cardiac use, and capable of performing eFAST exams |
| Musculoskeletal (MSK) Capable |
| High |
| Shall be FDA Cleared for musculoskeletal use and capable of performing MSK/MSKI exams |
| Shall be FDA Cleared for musculoskeletal use and capable of performing MSK/MSKI exams |
| Reliability |
| Medium |
| The USFP system should have a 95% probability of completing 24 total run time hours within a 3-day timespan without a System Abort (SA), which equates to 468 hours Mean Time Between System Abort (MTBSA). |
| The USFP system should have a 95% probability of completing 24 total run time hours within a 3-day timespan without a System Abort (SA), which equates to 468 hours Mean Time Between System Abort (MTBSA). |
| Power Source Duration |
| Low |
| The power source should last for two hours at the highest setting |
| The power source should last for five hours or more at the highest setting |
| Power Source - |
| low |
| Should have a rechargeable power source |
| Should have a rechargeable and interchangeable power source |
| Weight |
| Low |
| The complete USFP system (screen & transducer(s)) should not weight more than three pounds |
| The complete USFP system (screen & transducer(s)) should not weight more than 0.5 pounds |
| Size |
| Low |
| The complete USFP system (screen & transducer(s)) should be a cube of no more than 280 cubic inches |
| The complete USFP system (screen & transducer(s)) should be a cube of no more than 160 cubic inches |
| High Temperature |
| Low |
| The fully functional USFP system should be operational at all settings at 49°C |
| The fully functional USFP system should be operational at all settings at 60°C |
| Low Temperature |
| Low |
| The fully functional USFP system should be operational at all settings at -1°C |
| The fully functional USFP system should be operational at all settings at -26°C |
| Transducer(s) |
| Low |
| The USFP system should have transducers to perform FAST, eFAST and MSK exams |
| The USFP system should have one transducer to perform FAST, eFAST and MSK exams (can have multiple heads on transducer) |
| Storage |
| Low |
| The USFP system should have at least 8 GB of storage space |
| The USFP system should have at least 16 GB of storage space |
(End of Down Selection Evaluation Criteria)
Defense Health Agency