Attachment B - Objectives to Performance Attributes Crosswalk (10 May 2024).xlsx
XLSX spreadsheet 13 KB Posted
- Solicitation number
- HT9425-24-R-0005
- Issued by
-
Defense Health Agency
About this file
This document is an Attachment B - Objectives to Performance Attributes Crosswalk that outlines the technology requirements and performance thresholds for a Rapid Donor Screening (RDS) system being developed under Solicitation Number HT9425-24-R-0005.
The key objectives and performance attributes include: achieving a Technology Readiness Level (TRL) of 9 by the end of the contract for the multiplex design, using whole blood samples, providing results in 20 minutes or less, having a system weight no greater than 15 lbs and size no greater than 2 cubic feet, operating on rechargeable battery power or no power, demonstrating shock and vibration resistance, and meeting storage and operational stability requirements. The system must also be authorized for Department of Defense use, obtain FDA clearance/approval with a CLIA Waived classification, and reach a Manufacturing Readiness Level (MRL) of 10 by the end of the contract. The solicitation is being issued by the Defense Health Agency to develop an RDS technology to support screening blood from donors in conflict zones.
View the file
Other files
Show all 13
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
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 (Inclusive of carry case(s)) | No greater than 15 lb. | TRL 6 | TRL 8 | TRL 9 | TRL 9 | |||
| System Size (L x W x H) (Inclusive of carry case(s)) | 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/ | |||
| https://www.wpafb.af.mil/Portals/60/documents/stf-matrix/AFD-160512-024.pdf?ver=2016-09-22-072647-890 | ||||||||
| 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
File details come from the government source that posted it. Updated .