B.08 Attachment 1-1 Amendment W801K0425QA014.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

The purpose of this amendment is to:Block 14 (Description of Amendment/Modification):

-Provide responses to vendor questions received during the solicitation period; and -Extend the solicitation closing date to allow vendors adequate time to review the updated requirements and modify their proposals accordingly.

All other terms and conditions of the original solicitation remain unchanged unless specifically modified herein. Vendors who have already submitted proposals are encouraged to review this amendment and submit revised proposals if necessary.

****All proposals must acknowledge receipt of this amendment. Failure to acknowledge receipt of this amendment may result in rejection of the proposal. Acknowledgment may be made by signing and returning a copy of this amendment, by including a signed copy with the proposal, or by letter or telegram which includes a reference to the solicitation number and amendment number.

Q: Do we include antibodies in the cost per test unit price column of your file?

A: Yes

Q: What is your antibody menu and the associated volume for each antibody on an annual basis?

A: 94 different antibodies. Volumes fluctuate based on pathologists' requests.

Q: Pricing worksheet and solicitation document reference "kit" volumes. In order to provide market accurate pricing and a financially competitive offer can the government provide specific slide volumes for the base and option years?

A: Slide volume is an estimated 12,000 slides per year.

Q: 2.9 Clarify definition of "upgrade" and "update." I.e. software patches and OS updates.

A: Any updates and or component upgrades to maintain the instruments functionality and to keep up with current available technology.

Q: Both Cost Per Test (CPT) and Cost Per Reportable (CPRR) is used. Please clarify if this is a CPT or CPRR solicitation?

A: CPT

Q: 5.4 in the section "method for optimization studies and verification within 10 days." Does this section stipulate that the vendor, within 10 days, needs to affectively turn over the instrument to lab staff to begin reagent validation?

A: Yes

Q: Do you have a preference in the systems being built in the USA?

A: Yes, please refer to the Buy American Act for specific details.

Q: In order to provide an accurate quote, will Womack allow a site visit?

A: No

Q: Can Womack please provide lab drawings?

A: No, please see SOW section 2.4 for details.

Q: What are the instrument reliability expectations?

A: Per SOW

Q: Can Womack also provide send out testing menu and volume?

A: 94 different antibodies. Volumes fluctuate based on pathologists' requests.

W81K0425QA0140001

Q: Can Womack provide current inhouse testing menu and volume?

A: 94 different antibodies. Volumes fluctuate based on pathologists' requests.

Q: Do either of these categories include companion diagnostic/FDA approved assays?

A: Some FDA approved assays.

Q: Can you please define method validation?

A: Validation will be performed for each antibody with protocols established by CLSI and or CAP.

Q: What are the expectations for LIS connectivity to be included with the analyzer?

A: The instrumentation will not interface initially with the hospital system, however, it must be able to interface if need be at a future date.

Solicitation/Contract Form Continuation

The following changes have been made:

INFORMATION FROM TO

Response Due Date 06 Aug 2025 08 Aug 2025

W81K0425QA0140001

HEALTH READINESS CONTRACTING OFFICE, 2199 STORAGE ST BLDG 4197 STE 68

JBSA FT SAM HOUSTON, TX 78234-5074

UNITED STATES

VICTORIA MANIGAULT, EMAIL: VICTORIA.G.MANIGAULT.CIV@HEALTH.MIL TELEPHONE: 910-252-9883 AdminBy:

SCD: PAS: