HT942626RE023 Questions and Answers.xlsx
XLSX spreadsheet 20 KB Posted
- Attached to
- Vector-borne Disease Agent Surveillance Research & Development in External Proficiency Testing
- Solicitation number
- HT942626RE023
- Issued by
- Not on record
About this file
This is a Questions and Answers document for solicitation HT942626RE023, which addresses contractor inquiries regarding the development of external proficiency testing procedures for vector-borne disease surveillance in arthropod samples.
The solicitation seeks to develop procedures for creating third-party proficiency tests that validate laboratory capability to detect pathogens in arthropod samples without using infectious materials themselves. Key technical requirements clarified through the Q&A include: the 60 samples referenced represent the total quantity for the entire period of performance rather than monthly deliveries; mosquito samples will be prepared and preserved in AVL solution and shipped via expedited services (FedEx) with costs covered by the Theater Preventive Medicine Flight; the contractor is responsible for managing logistics, shipping, and handling; contractors may propose qualified suppliers for synthetic nucleic acids and reagents with source selection at contractor discretion; and the validation process must meet ISO/IEC 17043 standards, though ISO/IEC 17043 accreditation is not required at submission. The government does not mandate a specific analytical platform, though RT-PCR is commonly used across units, and has indicated willingness to provide specific genomic regions of interest upon contract award if needed. This is a new requirement stemming from historical contract FA527022D0004 (IDIQ) F2H4A14184A001 (Task Order), which identified the need for safer proficiency testing procedures that eliminate reliance on live pathogenic cultures.
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Other files
| File | Type | Posted |
|---|---|---|
| Combined Synopsis Solicitation - HT942626RE0230002.pdf | ||
| Combined Synopsis Solicitation - HT942626RE0230001.pdf | ||
| Solicitation Amendment HT942626RE0230001 SF 30.pdf | ||
| Combined Synopsis Solicitation - HT942626RE023.pdf | ||
| Attachment 2 - PWS.docx | DOCX document | |
| Attachment 1 - QASP.docx | DOCX document |
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Text version
Sheet1
| Solicitation # | HT942626RE023 |
| Solicitation Title: | Vector-borne Disease Agent Surveillance Research & Development in External Proficiency Testing |
Senior Administrative Assistance Support Services
| Question # | PAGE AND PARAGRAPH | OFFEROR’S QUESTIONS | GOVERNMENT’S RESPONSE |
| 1 | Attachment 2 PWS, page 12, paragraph 6 | There is no quantity definition in reference to the 60 samples. Is this the total sample number per period of performance? Or are 60 samples delivered monthly? | Total sample number for the period of performance for testing if the proficiency test. The goal is to determine if the proficiency test is accurate within an arthropod sample. |
| 2 | Attachment 2 PWS, page 12, all paragraphs | How will the samples be delivered? Is this time to deliver to offeror included? | Sent via an expedited shipping (such as FedEx). |
| 3 | Attachment 2 PWS, page 12, all paragraphs | Who is responsible for paying for the shipping and logistics costs? | Shipping is paid for by the Theater Preventive Medicine Flight. |
| 4 | Attachment 2 PWS, page 12, paragraph 2 | There are no shipping conditions (temperature, packaging, biosafety level), is the government expecting the offeror to manage logistics, shipping, and handling for the 60 samples? | Yes |
| 5 | Attachment 2 PWS, page 12, paragraph 2 | How will the mosquitoes be prepared and preserved for shipping? | Mosquitoes will be macerated in AVL solution. |
| 6 | Attachment 2 PWS, page 12 and 13, paragraph 7 and 1 accordingly | Are there any custom and / or documentation requirements for shipping and who is responsible for this? | Customs depends on the location in which the samples are received. All appropriate conditions will be met. |
| 7 | Attachment 2 PWS, page 12, paragraph 2, 4 | What are the source requirements for the synthetic nucleic acids or reagents for replicability? | That is up to the contractor |
| 8 | Attachment 2 PWS, page 12, paragraph 2, 4 | What are the quality standards for the materials? | That is the purpose of the this contract to determine the highest applicable standards for a third party proficiency test. |
| 9 | Attachment 2 PWS, page 12, paragraph 2, 4 | Can we propose a qualified supplier? Or does the government have a supplier for the reagents? | Yes |
| 10 | Is the US Government interested in a validated analyte that encompasses the entire Dengue genome or are there specific regions of interest that should be targeted? | The Government is interested in validating the process of creating a third party proficiency test will measure the capability of a laboratory to accurately detect a pathogen in an arthropod sample without using the pathogen itself. Dengue can be used as a model | |
| 10a. | If there are specific regions of interest, will the US Government provide the specific regions upon contract award? | Yes | |
| 11 | Does the US Government have a preferred analytical platform that the validation should be performed on? | No | |
| 12 | Are the proposed vendors required to be an ISO/IEC 17043 accredited proficiency testing provider at the time of submission to be considered competitive and an eligible performer in the Request For Quote (RFQ)? | No, but the process of creating the PT test will need to meet the ISO/IEC 17043 standards | |
| 13 | Does the US Government plan to give preferential status to submissions that only utilize equipment that DHA currently has access to? | No, but most units use some form of RT-PCR | |
| 14 | Is there any incumbent/recompete or this is a brand-new project? If yes, could you please provide us with their award number or even if the customer bought similar services in the past. | This is a new requirement. This requirement is associated with historical contract FA527022D0004 (IDIQ) F2H4A14184A001(Task Order). The outcome of the task order found that external proficiency testing for arthropods required additional procedures to ensure safety and eliminate the sue of live culture pathogens to spike proficiency tests. Thus, the new requirement to develop procedures to produce external proficiency testing that do not use infectious materials. |
File details come from the government source that posted it. Updated .