Amen 36C25625Q0275 0003.pdf

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A2 - J065--RFQ: Pharmacy Hoods Semi-Annual Inspection PM Svc
Solicitation number
36C25625Q0275
Issued by

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This is Amendment 0003 to solicitation 36C25625Q0275, providing responses to questions received regarding pharmacy hood inspection services at the Michael E. DeBakey VA Medical Center in Houston, Texas. The amendment extends the offer submission deadline to February 18, 2025 at 3:00 PM CST.

The Q&A clarifies details about hazardous drug (HD) surface wipe sampling, testing standards, and equipment specifications. The facility has 12 pharmacy hoods requiring inspection, including 7 LAFWs, 4 BSCs, and 1 GloveBox, manufactured by LabConco. Surface wipe sampling is required at 20 specific locations to test for compounds including Cyclophosphamide, Fluorouracil, Ifosfamide, Methoxate, and Platinum Analogues. Certification must comply with CETA-CAG requirements and USP 797/800 standards, in addition to CETA & NSF certifications. The most recent incumbent contract was 36C25624P0235, which was a one-year extension of a previous contract.

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Amendment 36C25625Q0275 0002.pdf PDF
Amendment 36C25625Q0275 0001.pdf PDF
S02 36C25625Q0275_RFQ.pdf PDF

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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 1 N/A J-FFP

0003 See blk 16

N/A

36C256

Department of Veterans Affairs

Network Contracting Office 16

Galleria Financial Center

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

Quentin Chew, Contract Specialist

Quentin.Chew@va.gov

36C256

Department of Veterans Affairs

Network Contracting Office 16

Galleria Financial Center

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

To all Offerors/Bidders

36C25625Q0275

2/13/2025

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 02-18-2025 3pm CST x One (1)

The purpose of amendment 0003 is to provide responses to questions received..

See continuation page…

Steven Berkeley, Contracting Officer

VA-VHA-RPOC-2022-170886

mailto:Quentin.Chew@va.gov

CONTINUATION PAGE

Q&A Pharm hoods 36C25625Q0275.

1. What specific hazardous drugs (HDs) should the surface wipe sampling analyze?

Most common are 5-FU, Cyclophosphamide, Methotrexate, and platinum analogues.

2. Are there specific testing standards or protocols we should adhere to beyond what is mentioned in USP 797/800?

CETA-CAG requirements for primary and secondary engineering control certifications (per VHA Directive 1108.12)

3. We would like to know what are the makes and models for the 12 pharmacy hoods needing the inspection. This information will help us ensure accurate and efficient service.

Please see below.

Location Hood Serial # / Manufacturer

Central (2A-290A)

#1 LAFW 190982653 C/LabConco

#2 LAFW 190982654 B/LabConco

#3 LAFW 190982885 B/LabConco

#4 LAFW 190982334 C/LabConco

Contingency SCA (2A-290B)

#1 BSC 190981649 A/LabConco

#2 BSC 190881383 A/LabConco

Oncology Suite

(4C-326) NonHD LAFW 190982881 B/LabConco

(4C-327) HD 1 BSC 190982193 A/LabConco

(4C-327) HD 2 BSC 190982181 A/LabConco

OR (5A-277A)

Hood

#1

LAFW 190982655 B/LabConco

Hood

#2

LAFW 190982882 B/LabConco

Research (4A-360)

GloveBox 4S-15-VF-15553

4. Can this requirement be removed, or a quantity be given for how many HEPA filter change-outs are required?

This is a new question: HEPA filters are changed as needed. The last communication with FMS was to change out all of them and start fresh. HEPA filters are required to be changed. See required. quantity below spreadsheet.

5. Could you please detail the specific number of HD Wipe sampling locations?

20 locations

1. Med storage area shelf in infusion clinic

2. Med storage area cabinet in infusion clinic

3. Med storage area floor

4. Infusion area chair

5. Infusion area floor

6. 2A-290B BSC#1

7. 2A-290B BSC#2

8. 2A-290B cart

9. 2A-290B floor in front of BSC#1

10. 2A-290B floor in front of BSC#2

11. 2A-290B floor in front refrigerator

12. 4C-327 BSC#1

13. 4C-327 BSC#2

14. 4C-327 floor in front of BSC#1

15. 4C-327 floor in front of BSC#2

16. 4C-327 pass through

17. 4C-323 HD storage area refrigerator

18. 4C-323 HD storage area floor in front of refrigerator

19. 4C-323 Work area

20. 4C-325 Anteroom floor

6. Can you also please detail the specific HD drug compounds that need to be analyzed for in the lab report?

Cyclophosphamide

Fluorouracil

Ifosfamide

Methoxate

Platinum Analogues

7. Is this certification required in addition to CETA & NSF?

Yes.

8. We would like to know if this is a brand-new contract OR if there is (was) an incumbent performing these services.

If not brand new, could you please provide the current / previous contract number?

The most recent contract was just a one-year extension from a previous one plus four contract that was not renewed. This is contract 36C25624P0235.

File details come from the government source that posted it. Updated .