Att B - Task Deliverables Table.xlsx
XLSX spreadsheet 22 KB Posted
- Solicitation number
- 75D301-22-R-72117
About this file
This document outlines requirements for two task areas of a federal contract opportunity with the Centers for Disease Control and Prevention. Task Area 1 involves COVID-19 IgG and IgM ELISA testing of approximately 33,800 blood samples every four weeks over an 11-month base period, with deliverables including specimen testing, draft and final data and progress reports, specimen shipping, and monthly invoicing and status updates. Task Area 2 involves reflexive COVID-19 microneutralization assay testing of an estimated 200 specimens identified as seropositive from Task Area 1 each four week period, with similar deliverables. The pre-solicitation notice indicates the agency's intent to issue a solicitation for these services to achieve seroprevalence data across 50 states, Washington D.C. and Puerto Rico, with an anticipated 11-month fixed price contract and optional 12-month extension. The agency will utilize full and open competition procedures and select awardees using a best value tradeoff methodology prioritizing technical merit and past performance over price.
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Other files
| File | Type | Posted |
|---|---|---|
| Att A - Offeror Capabilities and Specimens.xlsx | XLSX spreadsheet | |
| Draft Performance Work Statement - Mass Serology.docx | DOCX document |
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Sheet1
| Task Deliverables | Frequency | Brief Description | Critical Elements | |
| Task Area 1: Request for COVID-19 IgG and IgM ELISA Testing | ||||
| 1.2 | Specimen Testing | begins within 48 hours of task area 1.1 and continuous thereafter | CDC anticipates a testing rate of 33,800 samples with two assays (assay A- anti-S quantitative; assay B; anti-N qualitative) every four weeks, possibly spread among multiple offerors. | Testing will include CLIA-approved and/or EUA-approved ELISA, COVID-19 IgG and IgM serological assays. Tests (with specific test names) will be selected from offeror(s) proposals during the task order award. The required sample matrix and sample volume should be specified for each offered test name. |
If the Offeror(s) cannot perform reflexive testing or was not awarded Task 2, the offeror(s) will need to be able to ship any CDC-selected seropositive specimens to CDC-designated facilities for reflexive testing described under task area 2. A subset of seronegative specimens may also be selected for reflexive testing
1.3 Draft Data Report and Review Meeting 1 and 2-3 weeks post award Offeror(s) will provide a sample draft data report electronically to the CDC Project Officer one week post award and schedule a meeting for review two to three weeks post award. Data reports will include a 1-2 page cover letter stating a summary of findings, the CDC contract number, the tests run (with specific test names that are traceable to the task order test protocols offered), the total number of specimens tested, the total number of seropositive specimens identified, any items of note such as trends, corrective actions, or other anomalies, and be signed by the laboratory signatory.
Data reports will include a locked Excel file, an unlocked Excel file, and a .CSV file type.
The data reports will include at a minimum: the test run date, the test name, any lab comments of note, test result(s), the units of measurement, test limits of detection, the remaining sample volume available for reflexive testing, and a column indicating seropositivity. Based on availability of metadata, the report will also include at a sample level: Patient age (years), Gender, Race and ethnicity (if available), Classification of insurance used for payment (if available: e.g., private, military, Medicaid, Medicare, self-pay), Geographic location (residence zip code), Provider 5-digit zip code if residence not available, ICD10 diagnosis associated with the original laboratory test, Results (including collection date) of any previous COVID-19 testing or COVID-19 antibody testing (including assay type) on the same patient, Specimen collection date, Information on if the specimen came from an outpatient or inpatient facility (if available), Unique patient identifier to allow for deduplication of sample results from the same patient within the same round of testing.
| 1.4 | Data Reporting | within 2 weeks after every 8 week testing period | Offeror(s) will provide a data report electronically to the CDC Project Officer for every four week testing period post award. |
| 1.6 | Specimen Shipping (if applicable) | As needed | If needed, offeror(s) must be able to ship specimens to other CDC-designated facilities in the United States. |
CDC anticipates approximately 1,000 specimens for reflexive testing. If the residual specimens selected under task area 1.1 exceeds an offeror's specimen eight-week testing capacity under task area 1.2, the offeror will ship the CDC selected residual specimens to another testing facility designated by CDC.
Additionally, offeror(s) with any COVID-19 seropositive specimens identified from task area 1.2 and selected by CDC for reflexive testing in task area 2.1 must be able to ship those samples to a CDC designated facility for reflexive testing, if different than the facility where specimens were tested under task area 1.2. A small subset of seronegative specimens may also be selected for reflexive testing
1.7 Draft Final Report and Review Meeting once four weeks prior to end of performance period Offeror(s) will submit a sample draft of the final report for the task order four weeks prior to the end of the award performance period to the CDC Project Officer The final report will include at a minimum: a summary of work performed (total number of specimens analyzed, total number of specimens seropositive, and those totals broken out by each two-week surveillance period).
The report appendices of the report should include at a minimum: each data report, shipping manifests (if applicable), test protocols, meeting agendas, and invoices.
1.8 Final Report once after all testing has been completed and no later than four weeks after the testing period has concluded Offeror(s) will submit a final report for the task order at the end of the award performance period to the CDC Project Officer
A four week lead time beyond the period of testing will be allowed for final report submission so that data collected at the end of the testing period can be incorporated in the final report.
| N/A | Invoicing | monthly | Offeror(s) will invoice their work under this contract monthly by submitting their invoices electronically to the CDC at fmoapinv@cdc.gov and copying the CDC Project Officer | Note: If offeror(s) are performing work under multiple task areas during one month, they may combine multiple task areas in one invoice as long as the work performed is distinguishable between task areas. |
| N/A | Status Updates and Meetings | upon award, monthly, and upon request | Offeror(s) will update CDC regularly and respond to inquiries as requested. | Offeror(s) will be responsive to CDC requests for status updates and questions, especially given the importance of this work in addressing a public health emergency. |
Offeror(s) will include the CDC contract number in the body of all emails, reports, and meeting agendas for future tracking purposes.
| Task Area 2: Request for Reflexive COVID-19 Microneutralization Assay Testing | ||||
| 2.1 | Reflexive Specimen Testing | begins with first data collection period | CDC estimates approximately 200 specimens for every four seek testing period requiring microneutralization testing, possibly spread among multiple offerors. | This testing will include microneutralization assays for seropositive specimens identified in task area 1.1. Tests (with specific test names) will be selected from offeror(s) proposals during the task order award. The required sample matrix and sample volume should be specified for each offered test name. |
| 2.2 | Draft Data Report | 1 and 2-3 weeks after reflexive testing begins | Offeror(s) will provide a sample draft data report electronically to the CDC Project Officer one week post award and schedule a meeting for review two to three weeks post award. | Data reports will include a 1-2 page cover letter stating a summary of findings, the CDC contract number, the tests run (with specific test names that are traceable to the task order test protocols offered), the total number of specimens tested, the total number of seropositive specimens identified, any items of note such as trends, corrective actions, or other anomalies, and be signed by the laboratory signatory. |
Data reports will include a locked Excel file, an unlocked Excel file, and a .CSV file type.
In addition to the specimen information included in Attachment A, the data reports will include at a minimum: the test run date, the test name, any lab comments of note, test result(s), the units of measurement, test limits of detection, the remaining sample volume available for reflexive testing, and a column indicating seropositivity.
| 2.3 | Data Reporting | after every 8 week testing period | Offeror(s) will provide a data report electronically to the CDC Project Officer for every two weeks of testing post award. | |
| 2.4 | Draft Final Report and Review Meeting | once four weeks prior to end of performance period | Offeror(s) will submit a sample draft of the final report for the task order four weeks prior to the end of the award performance period to the CDC Project Officer | The final report will include at a minimum: a summary of work performed (total number of specimens analyzed, total number of specimens seropositive, and those totals broken out by each two-week surveillance period). |
The report appendices of the report should include at a minimum: each data report, shipping manifests (if applicable), test protocols, meeting agendas, and invoices.
2.5 Final Report once after all testing has been completed and no later than four weeks after the testing period has concluded Offeror(s) will submit a final report for the task order at the end of the award performance period to the CDC Project Officer
A four week lead time beyond the period of testing will be allowed for final report submission so that data collected at the end of the testing period can be incorporated in the final report.
| N/A | Invoicing | monthly | Offeror(s) will invoice their work under this contract monthly by submitting their invoices electronically to the CDC at fmoapinv@cdc.gov and copying the CDC Project Officer | Note: If offeror(s) are performing work under multiple task areas during one month, they may combine multiple task areas in one invoice as long as the work performed is distinguishable between task areas. |
| N/A | Status Updates and Meetings | upon award, monthly, and upon request | Offeror(s) will update CDC regularly and respond to inquiries as requested. | Offeror(s) will be responsive to CDC requests for status updates and questions, especially given the importance of this work in addressing a public health emergency. |
Offeror(s) will include the CDC contract number in the body of all emails, reports, and meeting agendas for future tracking purposes.
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