Attachment C Laboratory Validation Information.docx
DOCX document 39 KB Posted
- Solicitation number
- BD-21-1039-EHS01-EHS01-63565
- Issued by
- Suffolk County, Massachusetts
About this file
This document is the Attachment C Laboratory Validation Information for a Request for Responses (RFR) issued by the Massachusetts Executive Office of Health and Human Services (EOHHS) to procure vendors to provide K-12 COVID-19 testing services, including pooled and individual diagnostic testing, to authorized schools and other designated programs.
The RFR requires bidders to submit this attachment for each laboratory and FDA EUA or EUA-pending pooled test they propose to use, providing details such as the lab name, test name, EUA status, extraction/PCR platform, collection type, age range, observer qualifications, maximum pool size, pooling type, and sample type. If a proposed pooled test does not have an EUA, bidders must complete a separate Attachment D - Laboratory Validation Application. The RFR has a State Local Contract Opportunity ID of 66ab59b824b406932d028355 and is open to qualified vendors.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| Attachment D Laboratory Validation Application.docx | DOCX document | |
| CommonwealthTermsAndConditions~7.pdf | ||
| StandardContractForm_Instructions~1.pdf | ||
| Contractor Authorized Signatory Listing~1.docx | DOCX document | |
| WTO Notice K-12 COVID-19 Testing Services RFR.docx | DOCX document | |
| Prompt Payment Discount Form~2.doc | DOC document | |
| Appendix B to DMCA Final Enterprise Standards_20191209.pdf | ||
| StandardContractForm~1.docx | DOCX document | |
| sdp-plan-form-1-commitment~5.docx | DOCX document | |
| Responses to Questions 070621.docx | DOCX document | |
| EFT_FORM~19.pdf | ||
| Attachment B Cost Response Instructions Worksheet.docx | DOCX document | |
| RFR for the K-12 COVID-19 Testing Services Program.docx | DOCX document | |
| newmass w9 2.pdf | ||
| Appendix B of Attachment A- Model DMCA.docx | DOCX document | |
| Attachment A Model Contract~4.docx | DOCX document |
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Text version
ATTACHMENT C
LABORATORY VALIDATION INFORMATION
INSTRUCTIONS:
Submission of Laboratory Validation Information:
1. Each item must be addressed specifically by entering information in the available space. Where specified, Bidder must complete each row by either checking the appropriate box and/or inserting information in the box available for text. If an item does not apply, the response must indicate "N/A" or “Not applicable” or any other appropriate explanation.
1. The Bidder must submit this Attachment C for each laboratory and EUA or EUA-pending pooled test it proposes to use for the K-12 COVID-19 Testing program. For example, if the Bidder proposes to use two separate laboratories, it must complete and submit this attachment separately for each such laboratory. Similarly, if the Bidder proposes two pooled test types, it must complete and submit this attachment separately for pooled test type, even if both pooled tests are processed at the same laboratory.
1. If the pooled test proposed by the Bidder does not have an EUA or does not have an EUA application pending, it must complete Attachment D – Laboratory Validation Application. Bidder should not complete Attachment C if an EUA is not available through the FDA for the pooled test being proposed.
1. The Attachment must be submitted with the following naming convention, “Attachment C – [bidder]_[lab name]_[test name].docx” 1.
LABORATORY VALIDATION INFORMATION
Please complete the table below for each FDA EUA or EUA-pending pooled test you propose to offer:
| Question |
| Answer |
| Lab Name |
| Free text response |
| Test Name |
| Free text response |
| FDA EUA pooling approval status |
| ☐ Pending |
· Insert application submission date:
☐ Approved
· Insert approval date:
| Extraction/PCR platform (instrumentation used with test) |
| Free text response |
Collection Type (check all that apply) ☐ Observed ☐ Unobserved ☐ At-home ☐ Other (please indicate below):
| Age Range for Collection Type |
| Free text response or “Not Specified” |
| Observer Qualifications, if necessary |
| Free text response or N/A |
| Maximum Pool Size |
| Insert number |
Pooling Type (check all that apply) ☐ Media or sample pooling ☐ Swab pooling ☐ Other (please described below)
Sample Type (check all that apply) ☐ Saliva ☐ Anterior Nasal (A/N) ☐ Other (please indicate below):
| Sample Collection Device |
| Free text; examples include: dry swab/dry tube; media/saline in tube; saliva collection device; etc. |
Attachment C: Laboratory Validation Information 1 K-12 COVID-19 Testing Services Program RFR
File details come from the government source that posted it. Updated .