W9114F26QA0100002 - RFQ Amendment .pdf

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.

If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

Previous edition unusable STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

Continuation of Supplies or Services and Prices/Costs

The following CLIN(s) / SLIN(s) / ELIN(s) were modified:

INFORMATION FROM TO CHANGED

BY

Description

Cost Per Reportable Result (CPRR), Chemistry Analyzer

The Contractor shall provide testing capabilities for the U.S.

Army Health Clinic- Vicenza (USAHC-V) to include a hematology analyzer system with maintenance and repair, and the necessary reagents, supplies, and consumables in accordance with the Contract Requirements.

Cost Per Reportable Result (CPRR), Chemistry Analyzer

The Contractor shall provide testing capabilities for the U.S.

Army Health Clinic- Vicenza (USAHC-V) to include a chemistry analyzer system with maintenance and repair, and the necessary reagents, supplies, and consumables in accordance with the Contract Requirements.

Continuation of Description

Miscellaneous text in this section has been modified to:

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:

W9114F26QA0100002

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.

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")

MEDICAL READINESS CONTR OFC EUROPE, CMR 402

APO, AE 09180-0402

UNITED STATES

HENNING FALK MAYER-GOLDSTEIN, EMAIL: HENNINGFALK.MAYER-GOLDSTEIN.LN@HEALTH.MIL TELEPHONE: 011-49-6371-9464-6789 AdminBy:

SCD: PAS:

a. Correct the contradictory information in the description of line-item 0002 by replacing the word "hematology" with the word "chemistry".

b. Provide additional answers to questions received from industry.