Questions and Answers.pdf

RFQ: W9114F26QA010

Questions and Answers (Q&A)

Question 1:

On page 2 of the file "Solicitation_-_W9114F26QA010", it states: “Questions about the Request for Quote (RFQ) are due no later than (NLT) seven (7) calendar days after the solicitation issue date identified in block 6 of the front page (SF1449) at 15:00 Central European Time (CET)” Since no date is indicated in block 6 of the front page (SF1449), we kindly request clarification on the deadline for submitting any questions regarding this procedure.

Answer 1:

The solicitation has been issued and publicized on 06 November 2025.

Question 2:

In section 1.1 of Exhibit A, it states: "The Contractor shall provide one (1) automated clinical chemistry analyzer and reagents in support of the chemistry mission at Vicenza Army Health Clinic in Vicenza, Italy". However, in section 2.1 of the same document, it is requested that: "The analyzer shall have a single point of specimen entry for the routine analysis of all required chemistry and immunoassay tests". Considering that the tests listed in Exhibit B are all clinical chemistry tests, we kindly ask for confirmation that a clinical chemistry analyzer is the instrument to be offered.

Answer 2:

Yes, the analyzer to be provided shall be one (1) automated clinical chemistry analyzer with a single point of specimen entry capable of running the tests specified in Exhibit B - Blood Chemistry Estimated Annual Workloads.

Question 3:

The Legal Manufacturer of the analyzer holds the Authority to Operate (ATO) Certificate and can provide, from the outset, the information related to the EMASS ID, decision date, and assessment termination date. For security reasons, we kindly request authorization to transmit this information with proper encryption in place through a DOD SAFE link in the event of a Tender Award.

Answer 3:

It is sufficient to submit the EMASS ID, which can be submitted through email.

Question 4:

On page 7 of Exhibit A, section 4.1.3, it is stated: “The Contractor shall provide off-site training in English for one person from each clinic for each delivery order, if available”.

We kindly request authorization to offer multiple training sessions in English on-site, at your facility, instead.

Answer 4:

Paragraph 4.1.3 of Exhibit A - Contract Requirement, has been changed to read as follows: “The Contractor shall provide off-site or on-site training in English for one person from each clinic for each delivery order, if available.”

Question 5:

On page 4 of Exhibit A, section 3.4, it is stated: “To account for expected fluctuations in workload, the Contractor shall provide a ‘sliding scale’ schedule of reagent cost per test.

This schedule shall provide a listing of all available analytes with the cost per reportable patient result for a given workload. As workload increases, the cost per reportable patient result should decrease. The workload will be based on the total number of patient reportable results.” Since it would be difficult to provide sliding-scale prices decreasing with the annual number of tests for all items in the catalog without having at least an indication of the possible annual consumption, we kindly request authorization to indicate sliding-scale prices only for the tests listed in Exhibit B, for which an annual requirement is specified. For all other possible tests, we would provide a single price.

Sliding-scale pricing will, in any case, be supplied at the time of implementation of new tests, should there be any interest on your part.

Answer 5:

Paragraph 3.4 of Exhibit A - Contract Requirement, has been changed to read as follows: “Reserved”

Question 6:

On page 31 of file Solicitation_-_W9114F26QA010, it states “Price each Contract Line Item Number (CLIN)”. Does this correspond to the SKU (Stock Keeping Unit)?

Answer 6:

There are only two CLINS listed in the solicitation (CLIN 0001 and 0002). The first one is for the two-month phase-in period for the analyzer setup, and the second one is for the Cost Per Reportable Result (CPRR) for the Estimated Workload provided in Exhibit B.

Question 7:

We request confirmation that only documents with a highlighted signature field are to be signed.

Answer 7:

The solicitation (SF1449) and each amendment (SF30) need to be signed. Ensure to also fill in the name and title of the signer and the date signed.

Question 8:

With reference to the Contract Requirement Document – Reagent Requirements, paragraph 3.7, we request that the phrase “undetermined time” be interpreted in accordance with the product Instructions for Use (IFU). Specifically, “undetermined time” should be understood as the maximum stability period of the reagent pack and under the specified storage conditions.

Answer 8:

This is a correct interpretation.

Question 9:

Regarding the Contract Requirement Document for Vicenza Army Health Clinic in Vicenza, Italy – Reagent Requirements, paragraph 2.5, and specifically the requirement:

"The bilirubin assay must have a range suitable for analyzing neonate specimens and must provide for measuring total bilirubin, direct bilirubin, indirect bilirubin, and neonatal bilirubin" While the assays, based on their stated intended use in the Instructions for Use (IFU), do not explicitly include the application of total and direct bilirubin in the neonatal setting, it is understood that the laboratory has the option to perform an internal validation of the assay for this specific use. This approach is consistent with practices adopted by other users.

Answer 9:

This is acceptable if the neonatal results, which are surveyed separately than adult parameters, fall within the limits of proficiency testing as determined by the College of American Pathologists (CAP).

(End of “Questions and Answers”)