Attachment B - Objectives to Performance Attributes Crosswalk (22 Apr 2024).xlsx
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- HT9425-24-R-0005
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Defense Health Agency
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This document appears to be an Attachment B - Objectives to Performance Attributes Crosswalk related to a federal contract opportunity.
The document provides a detailed crosswalk between the performance objectives and specific performance attributes for a Rapid Donor Screening (RDS) technology that the Department of Defense (DoD) is seeking to develop. Key details include the required technology readiness levels (TRL) and manufacturing readiness levels (MRL) for the RDS at different stages of the development process, as well as specific performance thresholds for attributes such as assay time, system weight and size, power requirements, shock/vibration resistance, storage stability, and regulatory approvals. The RDS technology must use a whole blood sample, provide results in 20 minutes or less, and ultimately support screening blood from donors in conflict zones. The document references several related military standards and specifications that the technology must comply with.
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Attachment B Attachment B - Objectives to Performance Attributes Crosswalk
| Objective to Performance Attribute Cross-walk | ||||||||
| Performance Threshold (minimum) | At Award | By end of Objective 1 | By end of Objective 2 | By end of Objective 3 | By end of Objective 4 | Final | ||
| Threshold | Threshold | Threshold | Threshold | Threshold | Reference | Notes | ||
| Multiplex Design | TRL 3 | TRL 5 | TRL 7 | TRL 8 | TRL 9 | TRL 9 | https://www.gao.gov/products/gao-20-48g | Click on "full report" and then download full report (149 pages total). Scroll to Table 7 on page 115 of the report or click select Table 7 from the "Table of Contents." |
| Sample Type | Whole blood | Whole blood | Whole blood | Whole blood | Whole blood | Whole blood | ||
| Assay Time | No more than 30 minutes | No more than 20 minutes | TRL 7 | TRL 8 | TRL 9 | TRL 9 | ||
| System Weight | Less than 1 lb but no greater than 15 lb. | TRL 6 | TRL 8 | TRL 9 | TRL 9 | |||
| System Cube (L x W x H) | Less than 1 cu. Ft but no greater than 2 cu. Ft. | TRL 6 | TRL 8 | TRL 9 | TRL 9 | |||
| Power (Battery) | Operates on rechargeable battery power OR no power required | Operates on rechargeable battery power OR no power required | Operates on rechargeable battery power OR no power required | Operates on rechargeable battery power OR no power required | http://everyspec.com/MIL-PRF/MIL-PRF-030000-79999/MIL-PRF-32383_35531/ | |||
| Joint Enroute Care Equipment Test Standard | ||||||||
| http://everyspec.com/USN/NAVSEA/NAVSEA_S9310-AQ-SAF-010_4137/ | ||||||||
| Power (Portable Generator) | Operates on generators operating at 50/60 Hz OR no power required | Operates on generators operating at 50/60 Hz OR no power required | Operates on generators operating at 50/60 Hz OR no power required | Operates on generators operating at 50/60 Hz OR no power required | http://everyspec.com/MIL-STD/MIL-STD-1300-1399/MIL_STD_1332B_476/ | Select the orange download file icon to obtain the latest regulation. The entire file is applicable. | ||
| Sensitivity to Shock & Vibration | Shock and vibration mitigation measures stabilize RDS performance OR no impact of shock and vibration | Shock and vibration mitigation measures stabilize RDS performance OR no impact of shock and vibration | Shock and vibration mitigation measures stabilize RDS performance OR no impact of shock and vibration | Shock and vibration mitigation measures stabilize RDS performance OR no impact of shock and vibration | http://everyspec.com/MIL-STD/MIL-STD-0800-0899/MIL-STD-810H_55998/ | Select the orange download file icon to obtain the latest regulation. Shock resistance guidance is detailed in Method 516.8 and begins on page 548, while vibration guidance is detailed in Method 514.8 and begins on page 333. | ||
| Storage Stability | TRL 6 | TRL 8 | TRL 9 | TRL 9 | See Attachment D - Technology Readiness Level (TRL) | |||
| Operational Storage Stability | TRL 6 | TRL 8 | TRL 9 | TRL 9 | See Attachment D - Technology Readiness Level (TRL) | |||
| Software | Software assessment for DoD use initiated OR no software required | Authorized for DoD use OR no software required | Authorized for DoD use OR no software required | Authorized for DoD use OR no software required | https://www.esd.whs.mil/Directives/issuances/dodi/ | Scroll down to " DoDI 8510.01." The entire document is applicable. | ||
| Department of Defense Instruction (DoDi) 8510.01 | ||||||||
| Regulatory Approvals | TRL 8 / FDA cleared/approved | CLIA Waived | TRL 9 | |||||
| Commercial Manufacturing | MRL 4 | MRL 6 | MRL 7 to 8 | MRL 9 | MRL 10 | https://www.gao.gov/products/gao-20-48g | Click on "full report" and then download full report (149 pages total). Scroll to Table 13 on page 122 of the report or select Table 13 from the "Table of Contents." |
https://www.gao.gov/products/gao-20-48ghttp://everyspec.com/MIL-STD/MIL-STD-0800-0899/MIL-STD-810H_55998/https://www.gao.gov/products/gao-20-48ghttp://everyspec.com/USN/NAVSEA/NAVSEA_S9310-AQ-SAF-010_4137/http://everyspec.com/MIL-PRF/MIL-PRF-030000-79999/MIL-PRF-32383_35531/http://everyspec.com/MIL-STD/MIL-STD-1300-1399/MIL_STD_1332B_476/https://www.esd.whs.mil/Directives/issuances/dodi/https://www.wpafb.af.mil/Portals/60/documents/stf-matrix/AFD-160512-024.pdf?ver=2016-09-22-072647-890
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