Amendment 0002-W81K0025QA091-.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

A. The purpose of this Amendment is as follows:Block 14 (Description of Amendment/Modification):

1) Extend the Questions due date to 25 July 2025 at 10AM Mountain.

2) Extend the Solicitation closing date from 31 July 2025 to 13 August 2025 10AM Mountain.

3) post Questions and Answers received to RFQ W81K00-25-Q-A091:

1) Q. Can the government provide the CAD file of the laboratory space?

A. Yes, please see attached.

2) Q. Can the government provide one week's worth of data via an LIS data pull?

A. Yes, please see attached. Please keep in mind that this week of data might not truly reflect seasonal or other variables that affect the rate of testing.

3) Q. Can the government provide the current configuration?

A. No

4) Q. Will there be a site visit to observe current workflow?

A. No site visit.

5) Q. There is reference to SOW, however, there is no reference to any requirements for Analyzers, is this an oversight or intentional?

a. As this is full and open competition, we would need a complete SOW to respond with questions.

i. Please post the updated document and extend time for the questions to next week.

A. Please refer to attachment 1- SOW paragraph 1.0 GENERAL INFORMATION.

A. See response #2.

6) Q. Last, requesting longer than 5 business days to respond if again full and open competition, as it is limited it time to respond, is that due to the preference to remain with the incumbent or some other driver to limit the industries time to respond?

a. We request a two -week extension to allow for full and open competition.

A. See response # 2 above, that formally extends the Solicitation closing date from 31 July 2025 at 10:

00AM (Mountain) to 13 August 2025 at 10AM (Mountain).

7. Q. Regarding the required menu, we are requesting that the option of Troponin T or Troponin I be included. Troponin T is currently source limiting to a single vendor, your incumbent. The utilization of Troponin I has been found to have higher specificity for cardiac tissue and may provide quicker results in emergent situations.

A. The lab prefers Troponin T or a similar FDA approved high sensitivity troponin.

8) Q. Is there a clinical need for Troponin T as opposed to Troponin I that was listed in the Sources Sought?

A. See response #10

9) Q. Prostate Specific AG was stated in the Sources Sought but, in the RFP, an additional test was added, Prostate Specific AG F. Can you please clarify and confirm that only PSA is needed?

A. Prostate Specific Ag F was added because we test for both total and free PSA which is provided in the attachment for response #3.

10) Q. Is the facility moderately or highly complex?

A. Highly complex

W81K0025QA0910002

11) Q. Could we kindly request a current floor plan, ideally a CAD drawing with a .dwg extension?

A. See response #2

Solicitation/Contract Form Continuation

The following changes have been made:

INFORMATION FROM TO

Response Due Date 31 Jul 2025 13 Aug 2025

List of Contract Documents, Exhibits, or Attachments

The attachments table has changed from:

Identifier Document Name Document Description Reference Identifier

Date Line Item Page Numbers

Document Type

Provided Under Separate Cover

Att.2- DHA MDE Cybersecurity-RMF Contracting Requirements

Supporting Technical Documentation 17 Jan 2024 Attachment No

Att.3-DHA Cybersecurity- Service Maintenance Agreement Contracting Requirements

Supporting Technical Documentation 16 Jan 2024 Attachment No

Att. 1- Chemistry SOW Immunoassay

_W81K0025QA091-

Statement of Work 15 Jul 2025 33 Attachment No

To:

Identifier Document Name Document Description Reference Identifier

Date Line Item Page Numbers

Document Type

Provided Under Separate Cover

Att.2- DHA MDE Cybersecurity-RMF Contracting Requirements

Supporting Technical Documentation 17 Jan 2024 Attachment No

Att.3-DHA Cybersecurity- Service Maintenance Agreement Contracting Requirements

Supporting Technical Documentation 16 Jan 2024 Attachment No

Att. 1- Chemistry SOW Immunoassay

_W81K0025QA091-

Statement of Work 15 Jul 2025 33 Attachment No

0005 CADBLD~1 Supporting Technical Documentation 18 Jul 2025 1 Attachment No

LIS Workload Data Pull July 6-12 2025

Supporting Technical Documentation 18 Jul 2025 1 Attachment No

The following contract documents were added:

CADBLD~1

LIS Workload Data Pull July 6-12 2025

The following contract documents Page Counts were changed:

DOCUMENT PAGE COUNTS

DOCUMENT NAME FROM TO

CADBLD~1 1

LIS Workload Data Pull July 6-12 2025 none 1

Miscellaneous text in this section has been modified to:

Reference Attachments:

1- Statement of Work (SOW)

2- Defense Health Agency (DHA) Contracting Requirements for Medical Device and Equipment (MDE) Cybersecurity/Risk Management Framework (RMF)

3- Defense Health Agency (DHA) Cybersecurity-Service Maintenance Agreement Contracting Requirements

Amendment 0002- Adds the following attachments:

4- CAD file

5- LIS Workload Data pull for one week- Excel sheet

MEDICAL READINESS CONTR OFFICE WEST, 3160 MCINDOE BLDG1103

JBSA FT SAM HOUSTON, TX 78234-4504

UNITED STATES

FABIOLA PALMA-TRUJILLO, EMAIL: FABIOLA.PALMA-TRUJILLO.CIV@HEALTH.MIL TELEPHONE: 202-813-9294 AdminBy:

SCD: PAS: