B3 - RFP 75D30125R00073 - NHANES General Chemistry Laboratory Testing 2025-2030 - QA.xlsx
XLSX spreadsheet 14 KB Posted
- Solicitation number
- 75D30125R00073
About this file
This is a Questions and Answers document for RFP 75D30125R00073, which seeks laboratory testing services for the National Health and Nutrition Examination Survey (NHANES) program. The Q&A clarifies that the contractor must use FDA-approved testing methods, maintain CLIA certification, and perform testing within the United States. Weekly sample shipments will come from 5 examination centers, with approximately 85 general chemistry panel samples, 85 total cholesterol/HDL samples, 100 hsCRP samples, and 100 urinary albumin/creatinine samples expected.
Key operational details include: CDC will cover sample shipment costs and provide data upload templates; data must be transmitted through CDC-approved secure sites; contractors should account for inflation in option year pricing; delays must be reported to the COR immediately; and no changes to the Statement of Work are anticipated. The acquisition strategy is Best Value Trade-Off, with technical/management approach and past performance being key evaluation factors. The complete solicitation includes five attachments, and any amendments will be posted on SAM.gov.
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Sheet1
| 75D30125R00073 – NHANES General Chemistry Laboratory Testing RFP Q&A | |
| Question | Government Response |
| Are there any anticipated changes or additions to the tests listed in the Statement of Work during the contract period? | No changes to the SOW are inticipated at this time. |
| What is the expected frequency and size of sample shipments during peak testing periods, beyond the stated average? | The shipments will come from 5 different exam centers located throughout the United States on a weekly basis and will be fairly consistent throughout the weeks. We anticipate a total of approximately 85 general chemistry panel samples and approximately 85 total cholesterol/HDL samples each week. We also anticiapte approximately 100 samples for hsCRP and 100 samples for urinary albumin/creatinine. These estimates are subject to change depending on response rates to the survey. |
| Are specific FDA-approved or cleared methods and instruments required for all assays, or are equivalent alternatives acceptable? | We require FDA-approved/cleared methods for all the testing. |
| Can you confirm if validation studies for new methods are included in the base year or will be addressed through task orders later? | Method validation studies may be included in both the base year and in subsequent task orders |
| What level of detail is required in subcontractor agreements for compliance with the contract (e.g., certifications, security protocols)? | All requirement listed in the SOW are required for subcontractors, must be CLIA-certified lab, FDA-approved testing methods, be enrolled in proficiency testing, etc. |
| Are there any restrictions or preferences for subcontractors located outside the U.S.? | It depends on what the subcontractor will contribute to the overall requirement. If laboratory-based work, it should be within the United States with that laboratory performing the testing covered by CLIA and have current CLIA certification. |
| Will CDC provide specific software or templates for electronic data transmission, or is the contractor expected to develop these systems independently? | The CDC or NHANES Data Collection contractor will provide templates for uploading data. |
| Are there specific encryption or cybersecurity requirements for transmitting anonymized sample data to the CDC? | NHANES data will be uploaded to secure sites that are approved by CDC. |
| For the Price Proposal Volume, how should offerors account for inflation or changes in cost structure over the five-year term? | Each proposal should generally account for variables such as inflation in the Option Years portion of your proposal. |
| Are there penalties for missed deadlines in quarterly reporting, or is there flexibility if delays occur due to sample shipment issues? | If there are delays in sample shipments, the COR must be notified immediately so the laboratory is not penalized. |
| Will the CDC cover costs associated with sample shipment logistics (e.g., shipping materials, transportation), or should these be included in our pricing? | CDC covers sample shipment costs to the laboratory. |
| What contingency plans are expected if sample shipments are delayed or compromised during transit? | Any sample issues should be reported to the COR upon receipt. Recollection of the samples will not occur and samples must be coded appropriately. |
| Will preference be given to laboratories with prior NHANES or federal testing experience? | All proposals will be evaluated in the same manner where we first look at the technical/management approach and then past performance. |
| Will preference be given to laboratories with prior NHANES or federal testing experience? | Same question as line #28. |
| How will CDC evaluate proposals that offer enhanced services, such as faster turnaround times or additional quality assurance measures? | The acquisition strategy is a Best Value Trade-Off solicitation. See Attachment 3 - Section M - Evaluation Basis for Award. |
| Are there additional attachments or instructions, beyond those provided, that need to be reviewed for proposal preparation? | No. The RFP with five (5) attachments are part of the complete solicitation. |
| If amendments to the solicitation are issued, how will those updates be communicated to offerors? | Amended portions of the solicitation - if applicable - will be posted via the soliciation on SAM.gov. |
| Could you clarify if this solicitation is looking for a company who can provide such instrumentation to bid FSS Pricing through a CPRR program including 8x5 service and consumables or are you looking for an Atlanta Area laboratory to provide you testing results required by this solicitation. Our instruments are used by CLIA approved labs all over the world, but CLIA certification is awarded at the lab level, not through the diagnostic vendor providing laboratory equipment. | This RFP is seeking a laboratory to perform the testing listed in the SOW. |
| Regarding a current CLIA certificate, would be possible to submit our subcontractor’s certificate as we don't have one? We would like to know if these requirements should reflect on the prime contractor, or the subcontractor? | The CLIA certificate should be submitted for the laboratory that will be performing the testing listed in the SOW. |
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