36C25026Q0724 0001_1.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

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:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(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 is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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.

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

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

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

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

08-03-2026

36C250 Department of Veterans Affairs Network Contracting Office 10 Suite 210 3140 Governors Place Blvd Kettering OH 45409-1337

36C250 Department of Veterans Affairs Network Contracting Office 10 Suite 210 3140 Governors Place Blvd Kettering OH 45409-1337 To all Offerors/Bidders

36C25026Q0724

X

See vendor questions and government answers for RFQ 36C25026Q0724 for Radioactive Isotopes for the VA Ann Arbor Healthcare System and the Toledo CBOC.

All RFQ responses shall be submitted to kellie.konopinski@va.gov by 8/13/2026 at 11:00 am.

Kellie Konopinski Contracting Officer

CONTINUATION PAGE

The purpose of this amendment is to answer questions for RFQ 36C25026Q0724 for Radioactive Isotopes for the VA Ann Arbor Healthcare System and Toledo CBOC.

Questions (Vendor questions in blue and government answers in red):

Vendor Question 1 (Government answers in red): I have a few questions regarding FDG that is on the RFQ. Can you please provide an answer to the following questions?

0. Weekend doses? No, standard hours of operation are Mon-Friday 0630-1600. A weekend dose would only be requested on extremely rare occurrence.

0. Bulk medrad or unit dose? Current is request is Unit Dose, Future request in 2028 may include combination of Unit Doses and Bulk.

0. Calibration times for each camera location? May Vary depending on patient needs, Routine is usually though 0715, 0800, 0845, 0930, 1015, 1100, 1145, 1300, 1345, 1430. Times may be altered, duplicated, or increased in the future depending on physician staffing levels and current installment of 2nd PET camera.

0. Number of patients per day per camera location? FDG PET is Ann Arbor location only. Patients 0-15/day. Average 6/7 FDG per day. Increased in future possible depending on physician staffing levels and current installment of 2nd PET camera.

0. Activity required for dose? 10mCi (brain FDG), 12mCi (FDG WB and FDG Skull-Midthigh). May see dose activity lowered pending installment of 2nd PET camera completion due to technology advancements of low dose with faster imaging times.

I also noticed that a PSMA agent was not listed on the volume sheet, is this product not in play? No, PSMA has awarded current contractual status already on separate contract.

Vendor Question 2: Are the PSMA PET isotopes (i.e., Gallium 68 Illuccix or F18 Pylarify) part of this RFQ? If not, do you have an idea as to when they will be submitted for RFI or RFQ? Our facility utilizes F-18 Pylarify and is currently awarded on a separate multi-year contract.

Vendor Question 3: All the F18 items on the S02 price schedule have an asterisk except for F-18 Fluorodeoxyglucose (FDG). We would need to subcontract this item, like any other vendor. Does the VA wish to remove this item, solicit it separately, or add an asterisk, so that PET items can be solicited separately? F-18 FDG will not be asterisk nor removed. This is a high volume and most common PET radiopharmaceutical that multiple vendors should be able to supply either from own manufacturing or awardee can subcontract.

Vendor Question 4: If we have a previous BAA with Ann Arbor / Toledo VAMC, can we submit that in lieu of signing a new version? A National BAA or current BAA can be submitted with the RFQ; however, the Privacy Officer may request a new one after award if it is not a National BAA.

Vendor Question 5: How do we access this training, or can we provide an equivalent to this training?

Required Training:

TMS 10204 Privacy and HIPAA Focused Training TMS 10176 VA Privacy & Information Security Awareness & ROB It is accessed through TMS, and instructions will be provided after award.

Vendor Question 6: Will the Government accept an exception to the Business Associate Agreement requirement and evaluate our quotation without execution of the BAA? The Privacy Officer has required a BAA on this contract, so it is required.

Vendor Question 7: Can the Government clarify which specific requirements within Section B.3 are applicable to a contractor whose responsibilities are limited to supplying radiopharmaceutical products and who will not have access to VA IT systems or maintain VA data on behalf of the Government? The VA Information Security Officer (ISO) has required all information in the contract that is in the RFQ. He stated: This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

While they may not access the systems per se, they will have access to VA information, so it would apply in this case.

And they must retain records with regard to where all of the material is transported. That information is maintained for a specific period of time.

Vendor Question 8: The solicitation identifies required training related to Privacy, HIPPA, and Security awareness. Given that this procurement is for the purchase and delivery of commercial radiopharmaceutical products from a licensed radiopharmacy, and not for the performance of services on behalf of the VA, are these training requirements mandatory for contractor personnel who will not access VA information systems, networks, or records? The Privacy Officer has required these trainings.

Vendor Question 9: Requirement 19 references the contractor's ability to "work within NMIS" and requires packaging documentation to contain a barcode compatible with the NMIS system. Siemens Healthineers does not anticipate requiring access to VA information systems in order to perform under this requirement.

Can the Government clarify:

a. Whether contractor access to NMIS is required for contract performance; and- No, vendor does not access NMIS. Not part of performance. Ability to work “within” is based on packing slip barcode information being accurate and able to upload appropriately into NMIS. Future ability for NMIS to place electronic orders from NMIS to vendor.

b. The specific barcode compatibility requirements necessary to satisfy Requirement 19, including whether existing commercial radiopharmacy barcode formats are acceptable? Current PETNET barcodes are sufficient and work with no issues. Ability of accurate barcode information transferred to NMIS will be a requirement in contract performance.

Vendor Question 10: Can the Government clarify how offerors should present additional radiopharmaceuticals, including products for which the offeror may be the sole FDA-approved manufacturer, that are not specifically identified as contract line items within the schedule but may support current or future Nuclear Medicine Service requirements? You can provide all information that needs to be filled in on the spreadsheet as a separate attachment, and I can add them to the award if it is something we are interested in adding to the contract.

Vendor Question 11: The following item is not included on the price sheet and is used by VA Ann Arbor. Can you amend the price list to add this, or can we include pricing as a separate line item?

GE Healthcare Oxyquinoline Solution IN-111 (Camera Calibration) / SKU IN15PA / 1 vial of 1.0 mCi The spreadsheet includes a lint item that states In-111 Oxine (which is Oxyquinoline). This is the same requirement.