RFQ_36C25626Q0509 0001.pdf

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Attached to
Q301-- Pharmacy Gloved Fingertip and Media Filled Testing
Solicitation number
36C25626Q0509
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This is Amendment 0001 to a federal solicitation (36C25626Q0509) issued by the Department of Veterans Affairs, Network Contracting Office 16 Ozarks. The amendment was issued on April 2, 2026, with an effective date of March 25, 2026, and is addressed to all offerors and bidders. The primary purpose of this amendment is to provide responses to 15 Requests for Information (RFIs) previously received regarding the solicitation.

The RFI responses address clarifications on the contract's scope of work, which involves compounding personnel testing services in accordance with USP 797 standards. Key clarifications include: (1) clean room and hood inspections are excluded and covered under a separate FMS contract; (2) CLIN 0002's quantity of 3 refers to 3 oversight personnel requiring annual testing, plus 52 compounding personnel tested semiannually; (3) CLIN 0005's quantity of 6 does not reflect actual visit frequency, as the current contractor performs 12 monthly visits combining surface sampling, room certification, and personnel assessments; (4) hazardous drug surface testing includes Cyclophosphamide, Ifosfamide, Paclitaxel, Platinum Analogues, and 5-Fluorouracil, with chemical wipes included in sample pricing; (5) media-fill bags and incubation are provided entirely by the contractor using single-plate sampling methodology; (6) each unit across CLINs 0001-0004 represents complete testing sets; (7) CLIN 0003 includes three consecutive successful testing events with surface sampling; (8) CLIN 0004's 114 individual plates are flexible for GFT/MFT or surface samples as needed; (9) hazardous drug wipe testing per USP 800 is required under CLIN 0004; and (10) CETA-certified technician requirements apply to personnel performing services, particularly room certification-related activities.

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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)

1 4 N/A J-FFP

0001 04-02-2026

N/A

None

36C256

Department of Veterans Affairs Network Contracting Office 16 Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston TX 77056-5643 Robert Arabie, Contract Specialist robert.arabie@va.gov

36C256

Department of Veterans Affairs Network Contracting Office 16 Ozarks Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston TX 77056-5643

To all Offerors/Bidders

36C25626Q0509

03-25-2026

X

X X

X One (1)

The purpose of amendment 0001 is to provide responses to RFIs received. Please see attached.

RFI RESPONSES

1. On page 31, there is a reference for reports. It mentions staff results, but also room and hoods. Are hoods and clean room inspections included in this solicitation? No. The clean room and hood inspections are currently covered under a separate contract managed by FMS.

Please refer this question to Dr. Mock for further clarification.

2. 0002 on the price sheet, has the annual GFT & MFT as only 3. Does this refer to only 3 personnel will be tested annually? Yes. The quantity refers to 3 oversight personnel, such as supervisors, who require annual GFT/MFT testing. In addition, 52 compounding personnel undergo testing every six months

3. 0005 Service Charge on the price sheet has the number of 6. Does this mean that 6 trips per year will be made by the technician(s): Currently, the same contractor performs both room certification and personnel testing. This results in a total of 12 trips per month completing monthly surface sampling, room certification, and personnel assessments. The quantity of 6 on line 0005 does not reflect the actual number of required visits under the current process

4. Regarding the chemical drug wipes, it states platinum-containing drugs will be tested. Which platinum-containing drugs are being requested? During the most recent visit, the contractor performed hazardous drug surface testing for the following agents: Cyclophosphamide, Ifosfamide, Paclitaxel, Platinum Analogues, and 5-Fluorouracil

5. The price sheet does not list the chemical wipes. Are these wipes to be included with the plates and surfaces samples? Yes. The chemical wipes are to be included with the plates and surface samples

6. 0004 has 114 plates and surface samples. Is the pharmacy providing their own media fill bags and the contractor is just providing incubation. No. Both the media-fill bags and the incubation process are provided and handled entirely by the contractor.

7. Sample Method:

Which sample collection method will be utilized? According to USP797 standards, both single plate and dual plate collection methods are accepted and are determined based on the type of media utilized. single‑plate sampling method

8. CLIN Structure – Definition of “Unit (EA-each)” Across All CLINs Across CLINs 0001–0004, each line item is presented as a unit (“EA”); however, the specific components included within each unit are not defined. Please clarify:

The exact sample types included per unit. (e.g., gloved fingertip (GFT) plates (left and right), Media-fill tests (MFT), surface samples (SS)

The number of each sample type included per unit.

Whether quantities represent complete testing sets or individual sample/test components. Each Unit represents a complete testing set

9. CLIN 0001 – Semiannual GFT and MFT (Qty: 104) :

Please clarify:

The composition of sample type for each unit (GFT (left and right), MFT, SS).

Whether the quantity of 104 represents complete testing sets or individual sample components.

Represents one complete semiannual competency testing set for a single compounding staff member. Each testing set includes: GFT/MFT and surface sampling and Media-Fill Vial

10. CLIN 0002 – Annual GFT and MFT (Qty: 3) Please clarify:

The number and type of samples included per unit. GFT/MFT and surface sampling and Media- Fill Vial

11. CLIN 0003 – New Employee GFT and MFT (Qty: 7) Please clarify:

The number of GFT plates (left and right), MFT, and any surface samples included per unit.

(This is typically 8 GFT, 1 MFT, 1 SS).

Whether surface sampling is included under this CLIN, as it is not described in the Scope of Work but is included in USP797 requirements.

Each unit represents one complete initial competency testing cycle for a new compounding employee. USP 797 requires three consecutive successful GFT and MFT tests before a new employee may perform sterile compounding. Surface sampling included per test, consisting of one surface sample for each of the three testing events, totaling 3 surface samples per unit The quantity of 7 represents seven complete new hire initial competency testing sets, not individual components.

12. CLIN 0004 – Additional Fingertip Plates and Surface Samples (Qty: 114) Please clarify:

Which sample types are included per unit (final GFT plates (left and right), SS, or both).

The number of each sample type included per unit.

Whether quantities represent individual samples, paired samples, or grouped sets.

The quantity of 114 reflects 114 individual plates, which may be used for GFT/MFT plates or surface samples as needed. It does not represent grouped sets

13. CLIN 0005 – Service Charge (Qty: 6)

Please clarify:

What services are included under this line item (e.g., site visits, reporting, logistics, or other activities).

The basis for the quantity of 6 (e.g., per visit, per event, per reporting cycle). service charge associated with each required site visit personnel testing activities.

14. Hazardous Drug Wipe Testing (USP <800>) Hazardous drug wipe testing is included in the Scope of Work but does not appear in the CLIN structure. Please clarify:

Whether this testing is required under the contract.

Yes, hazardous drug wipe testing is required under the contract in accordance with USP 800

If so, under which CLIN it should be included. CLIN 0004

15. CETA-Certified Technician Requirement The Scope of Work requires one to two CETA-certified technicians; however, the applicable services are not specified. Please clarify:

Which activities require CETA-certified personnel.

The CETA-certification requirement applies to the personnel performing these services, even if the CLINs themselves do not separately list a technician qualification line item (notes this required for room certification)

How is this requirement represented within the CLIN structure.

Potentially under services related CLIN

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