36C24425Q0890 0001.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) None 36C244 Department of Veterans Affairs Network Contracting Office 4 Coatesville VAMC 1400 Blackhorse Hill Road Coatesville PA 19320 Cynthia Laemmerhirt cynthia.laemmerhirt@va.gov 00244 Department of Veterans Affairs Network Contracting Office 4

To all Offerors/Bidders

36C24425Q0890

X X X See CONTINUATION Page X The purpose of this amendment is to clarify the solicitation closing date and answer the attached questions.

- The closing date it 09/02/2025 at 10:00 am.

Cynthia Laemmerhirt Contracting Officer

CONTINUATION PAGE

A.1 PRICE SCHEDULE

ITEM INFORMATION

Analysis of GFT (price per plate) Ordering Period: 09-20-2025 - 09-19-2030 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Media Fill EM Analysis of EM (TBC, TFC, TMS Only) Per Vial Submitted.

Surface for Direct Compounding Area (DCA) for personnel Testing (per person)

Monthly Surface (Primary Engineering Control (PEC)/Secondary Engineering Control (SEC)/TSA

Monthly Surface (Primary Engineering Control (PEC)/Secondary Engineering Control (SEC)/MEA

Tryptic Soy Agar Plates/Paddle (10 Plates/Paddles per pack)

Malt Extract Agar Plates/Paddles (10 Plates/Paddles per pack)

Medium Risk Media Fill Test (individual test)

STAT Testing results (Analysis of EM (TBC TFC, TMC Only) Per Plate Submitted, Covers Surface Samples and GFT Samples

HD Sampling Kit (10 Swabs/kit (USP 800)

HD Residue Sampling Locations to include up to one Hazardous Drug per sample location

Wilkes-Barre VAMC - Man Hours for On-site Support (Up to 8 hours/day for an estimate of 12 hrs) 2 days (Day 1-Estimate 8 hrs and Day 2-Estimate 4 hrs) / twice a year

Coatesville VAMC - Man Days for On-site Support (per Day) (Up to 8 hours/ day) 1 day / twice a year

Below are the Questions that have been submitted for Answers.

1. As it is not explicitly stated, does the VA require the following documents to be signed/initialed and dated with the offer:

a. 6500 Append D Rules of Behavior (Page 45 of 87: (4)(2) states: Sign and acknowledge understanding of …….initially and annually thereafter.) To me this reads that completion of this document would be done post award and need not be included during offer submission. Please verify.

Please submit your documents as instructed in the solicitation.

b. D.6 VAR 852.219-75 VA Notice of Limitations on Subcontracting I am not understanding if this is a question. Please submit as instructed in the solicitation.

2. Is there a minimum requirement regarding the number of submissions for document: D.5 Past Performance Questionnaire?

Instructions are in FAR 52.212-2, in the solicitation. Please submit as instructed.

No formal training necessary. We will go over our hand hygiene and garbing with the person.

b. does the VA have specific requirements for the individual providing this service This person is just assisting us with the preparation of the supplies for GFT and media fill. He/she is not conducting any of the actual testing for GFT and media fill. We do have the person conducting the testing on the surface sample and hazardous sampling.

They would just need to do the requirements for packaging and shipping of testing supplies for GFT and media fill, but able to perform the surface sample and hazardous surface sample.

c. Are the number of individuals present during on-site support known?

Only one person is needed for each station (Wilkes-Barre, Coatesville).

4. Pg 32-33 of 87 Task 3 – Surface Sample Plates, (g) contractor will identify which surface sampling method is included with bid. Are you referring to Single or Double plate collection or something else?

All facilities, except for Philadelphia uses single plates. Philadelphia uses paddles.

5. Page 34 of 87. Table 3 is overlayed on top of Table 4. Table 3 appears to be details regarding ISO Class requirements. Please verify.

Seems like a formatting error, when I looked over the attachment, it was not overlayed.

Table 3. Breakdown of Competency and Environmental Monitoring Samples

*Retest until passing result.

Table 4. Action Levels for Surface Sampling

Pharmacy Personnel -New Hire (>/= 10 samples depending on failures)

(No fewer than 3 separate times. The 3 successful completions must be in succession) 6 (Left and right hands)

Pharmacy Personnel – Semiannual /Every 6 months (>/= 8 samples depending on failures)

(Sample collection from left and right fingers) 2 (Left and right hand)

Compounding Equipment, Cleanroom/Buffer room and Anteroom (>/=5 samples per location or equipment)

6. I do have questions about Section 9.1.2 if you’re able to clarify.

· This is requiring someone from the laboratory to come onsite to conduct testing?

· Yes, there are 2 stations that require onsite testing twice a year

· If we don’t provide that service, are we able to use a third party?

· Yes, you can subcontract, if required.

· Confirming that this is not the required biannual the hood certification process

· Correct, that is a different contract and is not included in this one.

The Contractor shall be able to provide contracted personnel, as requested, to support facility requests for onsite support hours, including conducting gloved fingertip and thumb testing, media fill testing, and surface sampling in accordance with USP 797 guidelines and pharmacy requirements. The contracted employee shall assist with the collection, labeling, and preparation of all samples. Sampling schedules will be coordinated to ensure sample delivery aligns with the Contractor’s standard operating hours. Most testing activities will be performed biannually. Any additional staffing required outside of the scheduled testing week will be conducted by the pharmacy designee and samples will be shipped directly to the Contractor for analysis.

7. Notice: CLIN0012 has been changed. Please price accordingly.

End of Document