36C24925Q0381 0001.docx

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Q301--36C249-27-AP-0005 - Sterile Compounding Certification - (TVHS Pharmacy)
Solicitation number
36C24925Q0381
Issued by

About this file

This document is a Request for Quote (RFQ) and amendment for sterile compounding certification services for the Department of Veterans Affairs Tennessee Valley Healthcare System (TVHS). The solicitation (36C24925Q0381) seeks a contractor to perform bi-annual certification, monthly viable testing, and personnel testing for sterile compounding areas at two VA medical centers in Nashville and Murfreesboro, Tennessee. The contract period spans four 12-month ordering periods from October 1, 2025, to September 30, 2029, with services including environmental sampling, equipment certifications, and laboratory testing of primary and secondary engineering controls in sterile compounding spaces.

Key requirements include monthly air and surface sampling, bi-annual certifications of biological safety cabinets and laminar airflow workstations, HEPA filter integrity testing, personnel gloved fingertip and media fill testing, and comprehensive reporting. The vendor will provide all testing supplies, laboratory incubation, and reporting services, with VA staff conducting personnel testing. The solicitation requires detailed line-item pricing for various testing and certification services, with specific quantities for each facility. The amended solicitation extends the response deadline to August 14, 2025, at 10:00 Central Time, and includes clarifications to previous questions about testing protocols, sampling locations, and contract specifications.

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Other files

File Type Posted
36C24925Q0319 LineItems FINAL.xlsx XLSX spreadsheet
36C24925Q0381 0002.docx DOCX document
36C24925Q0319 LineItems REVISED.xlsx XLSX spreadsheet
Sterilgard BSC Operating Manual.pdf PDF
Murfreesboro Sterile Compounding Area.pdf PDF
36C24925Q0381_1.docx DOCX document
Nashville Sterile Compounding Area.pdf PDF
Wage Determination No 2015-4647 Revision 29.docx DOCX document
LIMITATIONS ON SUBCONTRACTING CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION.docx DOCX document
36C24925Q0381 LineItems.xlsx XLSX spreadsheet

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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) 07-31-2025 Department of Veterans Affairs Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 204 Murfreesboro TN 37129 90C Network Contracting Office 9 Department of Veterans Affairs Network Contracting Office (90C) 1639 Medical Center Parkway Suite 204 Murfreesboro TN 37129 To all Offerors/Bidders

36C24925Q0381 07-31-2025

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to:

08-14-2025 10:00 CDT

See CONTINUATION Page X

1. The purpose of this amendment is to provide answers to questions submitted by interested vendor, correct the line items for clarification and added extra testing to Line Items.

2. The questions and answer to request for quote is addressed in following pages.

3. Please complete the revised Line items shows in this amendment and excel spread sheet "36C24925Q0319 Line Item revised".

4. Due to the amendment, this solicitation close date will be extended to 08/14/2025 @ 10:00 Central Time.

Christina Lawrence Contracting Officer Questions/Clarifications and answers for RFQ notice #36C24925Q0381 for TVHS VAMC Sterile Compounding Bi-annual Certification, Monthly Viable Testing, and Personnel Gloved Fingertip and Media Fill Testing

1. Page 30 of 88 3.2.1. In regard to the monthly viable testing, provide clarification regarding who is responsible for sample collection. The SOW reads that the contractor rather than the facility will collect surface and air samples for the primary and secondary engineering controls.

A: Correct- all environmental sampling (air and surface) and all certifications will be conducted by the vendor. This includes monthly air and surface sampling. All personnel sampling (fingertips, surface sample after media fill, media fill) will be conducted by the VA staff but vendor to provide the testing supplies (plates/media fill) and the lab for incubation and reporting.

2. Page 31 of 88 [4] reporting Requirements states that reports are to be delivered within 12 days. Personnel testing that includes Media Fill Test take up to 14 days. USP797 protocols for Media Fill Tests state that "the first colony check is after 7 days of incubation begins and the second is after 14 total days of incubation.”

A: Can you extend the reporting time to allow for the full incubation time as well as an additional day for quality control and reporting at 15 days? It says 12 business days which is usually 16-17 total days given weekends not counted as business days. If we need to change the verbiage, we can to 17 days?

3. Item numbers 1001, 2001, 3001, 4001. Quantity [JB] - please clarify what is meant by this and if you need an amount for this item.

A: This is not a line item to bid—it is an overall placeholder and should say Base year 1, 2, etc.

4. Item numbers 1027, 2027, 3027, 4027. Initial Testing generally involves 3 GFT for right hand and left hand, one Media fill bag and a surface sample for a total of 6 GFT, 1MFT, and 1SS with ID. Are you doing an additional initial GFT per hand for a total of 8 plus the MFT and Surface Sample. Just to clarify, you want one price for the entire initial testing/incubation.

A: Initial testing includes—3 post garbing fingertips (6 plates), 1 post media fill fingertip (2 plates), 1 media fill, 1 surface sample. Yes.

5. Item Numbers 1028 (2, 3, 4): again, just for clarification - one price for the entire Ongoing.

A: Yes

6. Clarification - line items 1029, 1030 (and all OYs) Do you want a sleeve of media included for each? Do you require media fill kits and media plates for 1027, 1028 including OYs?

A: This would be however kits etc. are provided. If you have to include a full sleeve when sending for one employee, then can figure it that way. The “one sleeve media” does not have to be how it is provided as long as the amount of media is received for the testing that is needed.

7. MO (example, line item 1002): Is this 10 per month time 12 months for a total of 120.

A: 1002 are the air samples for Murfreesboro to conduct the 10 months of the year that are not the months of the certification. The 2 months air samples for Murfreesboro that are for the certification are line item 1008.

8. Are media plates required for BY and OY for air and surface samples in addition to the self-serve items?

A: Yes. the vendor will be providing plates for the air and surface samples monthly and the vendor will be on site to do the collection of those samples. The self serve items for personnel testing are also provided by the vendor along with lab incubation. The vendor does NOT come on site for personnel testing—VA employees will do this testing with the supplies from the vendor.

9. CLIN1001 – Are you requesting the total cost of CLINs 1002 through 1030 combined? Should the unit price be based on a six-month period? Are you looking for the total cost for one full year?

A: Year 1 starts with #1 and year 2 starts with #2 so each grouping is for a full year. An example is that line 1010 “LFCB Murf (2)” means that Murfreesboro has 2 LFCBs to certify and then you look at quantity column for the year is 2. So 2 certifications for the year with 2 LFCBs at Murfreesboro. We would like each priced out per line item with a year total

10. Will both surface and air testing be performed monthly at each facility? Please confirm.

A: Yes- air and surface at both facilities monthly

11. For CLINs 1027–1030, which begin with “Self-Serve Sampling”.

a. Will the VA be conducting these tests? YES

b. Is the vendor responsible only for providing supplies and incubation, or will they also be on-site to perform the tests? Vendor is only providing supplies/kits for testing and incubation. Staff at the facilities will conduct the testing and send off the tests to be incubated at the vendor’s lab.

c. In the past, we were on-site monthly to perform them—has this changed? This will change with this contract. We only need the testing supplies and the use of a lab so that we have the flexibility to test whenever is best for our staff.

12. Can you confirm the number of rooms at each facility? From the drawings, it appears.

All rooms are highlighted in red

· Murfreesboro: 3 rooms (G12HH, G12MM, G12DD) plus 1 HD storage room(G12X). Is this correct?

6 total rooms-5 total clean rooms for certification plus one HD storage room HD Buffer (G12HH) HD Anteroom (G12GG) IV Buffer1 (G12CC) IV Buffer2 (G12MM) IV Anteroom (G12DD) HD Storage (G12K)

· Nashville: 6 rooms (G107A, G107B, G107C, G107F, G107G, G107H) plus 1 HD storage room (G107). Is this correct? Correct

13. I did not see a CLIN for Air flows, I am thinking this can be grouped in with the room testing CLINs. That would be in CLINs 2 and 15. Is this acceptable.

A: Yes- all required USP testing for the secondary engineering controls for the “room testing” or broken out if better.

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
12.00
MO
__________________
__________________

Viable Air Samples Murf (10) Contract Period: Base POP Begin: 10-01-2025 POP End: 09-30-2026

12.00
MO
__________________
__________________

Viable Surface Samples Murf (17)

12.00
MO
__________________
__________________

Viable Air Samples Nash (13)

12.00
MO
__________________
__________________

Viable Surface Samples Nash (23)

2.00
MO
__________________
__________________

HEPA Filter Integrity Test Murf (5)

2.00
MO
__________________
__________________

Clean Room Certification Murf (5)

2.00
MO
__________________
__________________

LFCB Murf (2)

2.00
MO
__________________
__________________

HD Storage RAER and Pressure Murf (1)

2.00
MO
__________________
__________________

HEPA Filters Integrity Test Nash (6)

2.00
MO
__________________
__________________

Clean Room Certification Nash (6)

2.00
MO
__________________
__________________

BSC Certification Nash (2)

2.00
MO
__________________
__________________

LFCB Certification Nash (2)

2.00
MO
__________________
__________________

HD Storage RAER and Pressure Nash (1)

12.00
MO
__________________
__________________

Overnight Shipping Fees of Viable Samples (Surface and Air)

12.00
MO
__________________
__________________

Report Generation Fees

12.00
MO
__________________
__________________

Technician Service Fees/Travel

2.00
MO
__________________
__________________

BSC Certification Murf (1)

20.00
EA
__________________
__________________

Self-Serve Sampling: Initial Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (8 plates per tech, Media fill, post surface sample)

190.00
EA
__________________
__________________

Self-Serve Sampling: Ongoing Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (4 plates per tech, Media fill, post surface sample)

30.00
EA
__________________
__________________

Self-Serve Sampling: Ongoing garbing retest, incubation Analyses: (2 plates per test, one sleeve media)

10.00
EA
__________________
__________________

Self-Serve Sampling: Ongoing garbing Inital, incubation Analyses: (6 plates per test, one sleeve media)

40.00
EA
__________________
__________________

Extra Viable Surface Samples if needed due to failure etc.

10.00
EA
__________________
__________________

Extra Viable AIr Samples if needed due to failure etc.

4.00
EA
__________________
__________________

Extra Room Certification if needed due to failure etc.

2.00
EA
__________________
__________________

Extra BSC Certification if needed due to failure etc.

2.00
EA
__________________
__________________

Extra LFCB Certification if needed due to failure etc.

2.00
EA
__________________
__________________

Extra HEPA Filter Integrity Test if needed due to failure etc.

2.00
EA
__________________
__________________

HEPA Filter Change and Integrity Test if needed due to failure etc.

4.00

__________________
__________________

Extra technician Service Fees/Travel if needed due to failure etc.

1.00
JB
__________________
__________________

Viable Air Samples Murf (10) Contract Period: Option 1

10.00
MO
__________________
__________________

Viable Surface Samples Murf (17)

POP Begin: 10-01-2026 POP End: 09-30-2027

10.00
MO
__________________
__________________

Viable Air Samples Nash (13)

10.00
MO
__________________
__________________

Viable Surface Samples Nash (23)

10.00
MO
__________________
__________________

HEPA Filter Integrity Test Murf (5)

2.00
MO
__________________
__________________

Clean Room Certification Murf (5)

2.00
MO
__________________
__________________

LFCB Murf (2)

2.00
MO
__________________
__________________

HD Storage RAER and Pressure Murf (1)

2.00
MO
__________________
__________________

HEPA Filters Integrity Test Nash (6)

2.00
MO
__________________
__________________

Clean Room Certification Nash (6)

2.00
MO
__________________
__________________

BSC Certification Nash (2)

2.00
MO
__________________
__________________

LFCB Certification Nash (2)

2.00
MO
__________________
__________________

HD Storage RAER and Pressure Nash (1)

2.00
MO
__________________
__________________

Overnight Shipping Fees of Viable Samples (Surface and Air)

2.00
MO
__________________
__________________

Report Generation Fees

2.00
MO
__________________
__________________

Technician Service Fees/Travel

2.00
MO
__________________
__________________

BSC Certification Murf (1)

2.00
MO
__________________
__________________

Self-Serve Sampling: Initial Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (8 plates per tech, Media fill, post surface sample)

2.00
MO
__________________
__________________

Self-Serve Sampling: Ongoing Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (4 plates per tech, Media fill, post surface sample)

2.00
MO
__________________
__________________

Self-Serve Sampling: Ongoing garbing retest, incubation Analyses: (2 plates per test, one sleeve media)

2.00
MO
__________________
__________________

Self-Serve Sampling: Ongoing garbing Inital, incubation Analyses: (6 plates per test, one sleeve media)

2.00
MO
__________________
__________________

Extra Viable Surface Samples if needed due to failure etc.

12.00
MO
__________________
__________________

Extra Viable AIr Samples if needed due to failure etc.

12.00
MO
__________________
__________________

Extra Room Certification if needed due to failure etc.

12.00
MO
__________________
__________________

Extra BSC Certification if needed due to failure etc.

2.00
MO
__________________
__________________

Extra LFCB Certification if needed due to failure etc.

20.00
EA
__________________
__________________

Extra HEPA Filter Integrity Test if needed due to failure etc.

190.00
EA
__________________
__________________

HEPA Filter Change and Integrity Test if needed due to failure etc.

30.00
EA
__________________
__________________

Extra technician Service Fees/Travel if needed due to failure etc.

10.00
EA
__________________
__________________

Viable Air Samples Murf (10)

1.00
JB
__________________
__________________

Viable Surface Samples Murf (17) Contract Period: Option 2 POP Begin: 10-01-2027 POP End: 09-30-2028

10.00
MO
__________________
__________________

Viable Air Samples Nash (13)

10.00
MO
__________________
__________________

Viable Surface Samples Nash (23)

10.00
MO
__________________
__________________

HEPA Filter Integrity Test Murf (5)

10.00
MO
__________________
__________________

Clean Room Certification Murf (5)

2.00
MO
__________________
__________________

LFCB Murf (2)

2.00
MO
__________________
__________________

HD Storage RAER and Pressure Murf (1)

2.00
MO
__________________
__________________

HEPA Filters Integrity Test Nash (6)

2.00
MO
__________________
__________________

Clean Room Certification Nash (6)

2.00
MO
__________________
__________________

BSC Certification Nash (2)

2.00
MO
__________________
__________________

LFCB Certification Nash (2)

2.00
MO
__________________
__________________

HD Storage RAER and Pressure Nash (1)

2.00
MO
__________________
__________________

Overnight Shipping Fees of Viable Samples (Surface and Air)

2.00
MO
__________________
__________________

Report Generation Fees

2.00
MO
__________________
__________________

Technician Service Fees/Travel

2.00
MO
__________________
__________________

BSC Certification Murf (1)

2.00
MO
__________________
__________________

Self-Serve Sampling: Initial Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (8 plates per tech, Media fill, post surface sample)

2.00
MO
__________________
__________________

Self-Serve Sampling: Ongoing Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (4 plates per tech, Media fill, post surface sample)

2.00
MO
__________________
__________________

Self-Serve Sampling: Ongoing garbing retest, incubation Analyses: (2 plates per test, one sleeve media)

2.00
MO
__________________
__________________

Self-Serve Sampling: Ongoing garbing Inital, incubation Analyses: (6 plates per test, one sleeve media)

2.00
MO
__________________
__________________

Extra Viable Surface Samples if needed due to failure etc.

2.00
MO
__________________
__________________

Extra Viable AIr Samples if needed due to failure etc.

12.00
MO
__________________
__________________

Extra Room Certification if needed due to failure etc.

12.00
MO
__________________
__________________

Extra BSC Certification if needed due to failure etc.

12.00
MO
__________________
__________________

Extra LFCB Certification if needed due to failure etc.

2.00
MO
__________________
__________________

Extra HEPA Filter Integrity Test if needed due to failure etc.

20.00
EA
__________________
__________________

HEPA Filter Change and Integrity Test if needed due to failure etc.

190.00
EA
__________________
__________________

Extra technician Service Fees/Travel if needed due to failure etc.

30.00
EA
__________________
__________________

Viable Air Samples Murf (10)

10.00
EA
__________________
__________________

Viable Surface Samples Murf (17)

1.00
JB
__________________
__________________

Viable Air Samples Nash (13) Contract Period: Option 3 POP Begin: 10-01-2028 POP End: 09-30-2029

10.00
MO
__________________
__________________

Viable Surface Samples Nash (23)

10.00
MO
__________________
__________________

HEPA Filter Integrity Test Murf (5)

10.00
MO
__________________
__________________

Clean Room Certification Murf (5)

10.00
MO
__________________
__________________

LFCB Murf (2)

2.00
MO
__________________
__________________

HD Storage RAER and Pressure Murf (1)

2.00
MO
__________________
__________________

HEPA Filters Integrity Test Nash (6)

2.00
MO
__________________
__________________

Clean Room Certification Nash (6)

2.00
MO
__________________
__________________

BSC Certification Nash (2)

2.00
MO
__________________
__________________

LFCB Certification Nash (2)

2.00
MO
__________________
__________________

HD Storage RAER and Pressure Nash (1)

2.00
MO
__________________
__________________

Overnight Shipping Fees of Viable Samples (Surface and Air)

2.00
MO
__________________
__________________

Report Generation Fees

2.00
MO
__________________
__________________

Technician Service Fees/Travel

2.00
MO
__________________
__________________

BSC Certification Murf (1)

2.00
MO
__________________
__________________

Self-Serve Sampling: Initial Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (8 plates per tech, Media fill, post surface sample)

2.00
MO
__________________
__________________

Self-Serve Sampling: Ongoing Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (4 plates per tech, Media fill, post surface sample)

2.00
MO
__________________
__________________

Self-Serve Sampling: Ongoing garbing retest, incubation Analyses: (2 plates per test, one sleeve media)

2.00
MO
__________________
__________________

Self-Serve Sampling: Ongoing garbing Inital, incubation Analyses: (6 plates per test, one sleeve media)

2.00
MO
__________________
__________________

Extra Viable Surface Samples if needed due to failure etc.

2.00
MO
__________________
__________________

Extra Viable AIr Samples if needed due to failure etc.

2.00
MO
__________________
__________________

Extra Room Certification if needed due to failure etc.

12.00
MO
__________________
__________________

Extra BSC Certification if needed due to failure etc.

12.00
MO
__________________
__________________

Extra LFCB Certification if needed due to failure etc.

12.00
MO
__________________
__________________

Extra HEPA Filter Integrity Test if needed due to failure etc.

2.00
MO
__________________
__________________

HEPA Filter Change and Integrity Test if needed due to failure etc.

20.00
EA
__________________
__________________

Extra technician Service Fees/Travel if needed due to failure etc.

GRAND TOTAL
__________________

See attached document: 36C24925Q0319 LineItems REVISED.

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