S06 36C25726Q0111 0001.pdf

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)

0001 12-04-2025

None

36C671

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

36C671

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

To all Offerors/Bidders

36C25726Q0111

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 12-15-2025 1200 CST

X 1

The Purpose of this amendment is to provide a response to industry proposed questions

NOTE TO ALL POTENTIAL OFFERORS:

Technical questions shall be accepted by the Government in writing no later than 8:00am (CST), December 8, 2025.

RFQ closing date has been extended from December 5, 2025 to December 12, 2025 (12:00PM CST)

Please reference RFQ for Appendix A-H; in addition, please see continuation pages for VA responses to industry questions

Please ensure you acknowledge the amendment by providing a sign copy of this amendment.

TOMMY HAIRE

CONTINUATION PAGE

Department of Memorandum Veterans Affairs

Date: December 4, 2025

From: Contracting Officer

Subj: Industry questions & VA response to RFQ 36C25726Q0111

To: FILE

1. CLIN 001- Can you confirm that this will be administering all competency tests for each employee. Or Clarify the testing that this includes? For instance, will it include the employee qualification tests? That testing would include glove/fingertip, post media fill glove/fingertip, and post media fill surface sample?

It is ONLY the glove/fingertip test (GFT) and post media fill GFT. The total number of GFT requested accounts for both initial qualification and semi-annual competency tests. The media fill looks like is covered in CLIN 002. This is correct, the media fill for all employees is covered in CLIN 002. ALL surface sampling (including post media fill surface sampling) is covered in CLIN 005.

2. CLIN 003- can you please clarify what is included- thinking this would be post media fill glove/fingertip and post media fill surface sample? No, this is comparable to CLIN 002. However, it is a competency test APART from the media fill test. It is “specific” for those who compound hazardous drugs.

3. CLIN 004- can you please clarify if this is watching an employee cleaning? Yes, this is observation of the cleaning technique used by the employee and making an assessment based on criteria that we have established.

4. CLIN006- can you please confirm that this will include the standard cleanroom tests: Airflow, HEPA integrity testing, room air exchange rate, particle counts and room pressures. Yes, you are correct. We also require smoke visualization to be recorded for our PEC certs, but that would be covered under CLIN 007 and CLIN

008.

5. How many total HEPA filters are in the spaces? A total of 14 ceiling HEPA filters.

We also have 4 HEPA filtered pass throughs, 6 LAFW with HEPA filters, and 4

BSCs with supply and exhaust HEPA filters.

6. CLIN 0010- can you confirm the number of drugs that will need to be tested for the HD swabs? Cyclophosphamide, 5-FU, Ifosfamide, Platinum analogues

Cleanroom & PEC Details

• Total number of HEPA-filtered cleanrooms/suites Our classified spaces consist of 3 anterooms, 4 buffer rooms. Within these rooms we have a total of 14 ceiling HEPAs. NOTE: We also have 4 HEPA filtered pass throughs.

• Square footage of each classified space (ISO 7/ISO 8 ante room, buffer room, chemo, etc.)

Pharmacy Cleanroom suite:

• hazardous ISO 7 anteroom is 120.1 sqft

• non-hazardous ISO 7 buffer room is 219.6 sqft

• hazardous ISO 7 buffer room is 173.4 sqft

Mobile Pharmacy Trailer:

o non-hazardous ISO 8 anteroom is 15.3 sqft o non-hazardous ISO 7 buffer room is 117.8 sqft o hazardous ISO 7 anteroom is 20 sqft o hazardous ISO 7 buffer room is 107.9 sqft

• Total number and types of PECs (e.g., BSCs, CAIs, CACIs), including model numbers if available LAFW: Baker EdgeGARD (Model# EG-6320) Qty: 2

LAFW: Baker EdgeGARD (Model# EG-4320) Qty: 2

LAFW: Germfree 3 series (Model# BVBI-3SSRX) Qty: 1

LAFW: Germfree 4 series (Model# BVBI-4SSRX) Qty: 1

BSC: Baker SterilGARD (Model# SG604) Qty: 2

BSC: Germfree 3 series (Model#: BBF-3SSRX) Qty: 2

• Whether any hazardous compounding (USP <800>) is performed on-site YES

• Frequency preference: semiannual or annual certification SEMIANNUAL

Environmental Monitoring

• Desired EM scope: viable air, viable surface, nonviable particle counts Based on our existing plan we would need 22 viable air samplings and 22 viable surface samplings. We would need viable air and nonviable particle counts conducted at each semiannual certification; however, we would need viable surface sampling done monthly. Non-viable particle counts are based on most current CAG standards.

• Any existing sampling plans or required plate counts. Attached

• Required incubation and reporting specifications, if applicable. all microbiological samples shall be analyzed by an ISO/IEC 17025 accredited laboratory accredited under the Environmental Microbiology Lab Accreditation Program (EMLAP). Speciation should be done down to the genus level. All environmental wipe samples shall be analyzed by an ISO/IEC 17025 accredited laboratory accredited under the Industrial Hygiene Laboratory Accreditation Program (IHLAP).

Personnel Competency Testing

• Total number of staff requiring: currently 31 employees require testing. Almost all have already completed initial qualifications and only require semi-annual competency testing. This number does not account for NEW employees which may be onboard after the contract is awarded. (VA has requested more than is necessary as part of the requirement to cover new staff brought on later who would need initial qualification and to also cover any failures of existing staff.

o Gloved fingertip testing o Media fill testing

• Preferred testing schedule (on-site, same day, staggered, etc.) testing shall occur on-site in a staggered fashion. Any failures would be retested during the subsequent months. In the past, we spread all employees out over the 12-month POP. This also allows us to only have to test about 5 or 6 employees each month.

Please NOTE: The Mobile Pharmacy Trailer is at the Garland location.

• Please confirm the CSP risk categories to be compounded at each facility.

Category 1 and 2 for both facilities

• Considering the floor plan provided on pages 22 and 23 of the RFQ, where is room TB520 as referred to on page 5, located? TB520 is the pharmacy cleanroom trailer at the Garland facility. It is shown at the top of page 23. On which page is the Garland cleanroom key? Top of page 23. The 3 boxes below the key seem to have gotten cut off. The 3 boxes from left to right are… VAS=Viable air sample; SS=Surface sample; and ES=Environmental wipe sample.

• Are wipe sampling kits, media fill broth, and agar plates for fingertip samples provided by VA? No. This is the responsibility of the contractor.

• Are there any specifications for approved wipe sampling kits according to facility SOPs? All environmental wipe samples shall be analyzed by an ISO/IEC 17025 accredited laboratory accredited under the Industrial Hygiene Laboratory Accreditation Program (IHLAP).

• If employee sample plates require identification of microorganisms, where will the samples be sent according to facility SOPs? It will be the responsibility of the contractor to send these off to be identified, the contractor will then report those results back to us. NOTE: We require all microbiological samples shall be analyzed by an ISO/IEC 17025 accredited laboratory accredited under the Environmental Microbiology Lab Accreditation Program (EMLAP). Speciation should be done down to the genus level.

• Approximately how many compounders will need to be assessed annually at each facility? Approx 30.

• Are the cleanrooms already certified or will they need to be commissioned? The Dallas facility is currently certified. The Garland facility was commissioned and certified in the past, but the certification has expired and will need to be re-certified.