About this file

This Standard Form 1449 is a solicitation for Pharmacy Clean Room Hood Testing & Certification services for the St. Cloud VA Health Care System. The contract is a 100% Service-Disabled Veteran-Owned Small Business (SDVOSB) set-aside with a total size standard of $19 Million for NAICS code 541380. The performance period spans five years, from February 1, 2026 to January 31, 2031, with a base year and four option years. The contractor will be responsible for testing and certifying pharmacy clean rooms, biological safety cabinets, laminar airflow workbenches, and conducting various environmental and surface sampling in accordance with USP <797> and USP <800> standards.

Key details include a solicitation issue date of December 4, 2025, with technical questions due by December 11, 2025, at 10:00 AM CST. The contractor must provide comprehensive testing services including non-viable particle counting, viable microbial and fungal air and surface testing, airflow measurements, pressure differential testing, HEPA filter integrity testing, and other specialized certifications. Additional requirements include providing surface sample plates, conducting media fill tests, gloved fingertip testing, and offering 4 hours of USP 797/USP 800 consulting per contract year. The primary point of contact is Evan Beachy from the VA Network Contracting Office 23, located in Coralville, Iowa.

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Other files for this federal contract opportunity

Other files attached to H365--Pharmacy Clean Room Hood Testing & Cert - STC (VA-26-00011944) (FIRST Testing MUST be conducted on February 2nd and 3rd - NO EXCEPTIONS), newest first.
File Type Posted
S05 Technical Questions and Answers.pdf PDF
36C26326Q0103 0001_1.docx DOCX document
Wage Determination 2015-4953.pdf PDF
36C26326Q0103_1.docx DOCX document

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PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

656-26-2-045-0004

36C26326Q0103 12-04-2025

Evan Beachy – email: evan.beachy@va.gov 319-688-3629 12-18-2025

10:00 CST

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

1303 5TH STREET, SUITE 300

CORALVILLE IA 52241

X 100

X

541380

$19 Million

N/A

X

36C656

DEPARTMENT OF VETERANS AFFAIRS

St. Cloud VA Health Care System 4801 Veterans Dr.

St. Cloud MN 56303

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

System Electronic Invoicing System Tungsten Electronic Invoicing VA Tungsten Number is: AAA544240062 Refer to VAAR Clause 852.232-72

1-877-489-6135

See CONTINUATION Page

The St Cloud VA Health Care System is requesting Pharmacy Clean Room Hood Testing & Certification.

See attached Statement of Work for this requirement.

Period of Performance:

Base Year: 02/01/2026 to 01/31/2027

Option Year 1: 02/01/2027 to 01/31/2028 Option Year 2: 02/01/2028 to 01/31/2029

Option Year 3: 02/01/2029 to 01/31/2030 Option Year 4: 02/01/2030 to 01/31/2031

This is a 100% SDVOSB set-aside solicitation.

All technical questions will need to be sent to Evan Beachy at evan.beachy@va.gov no later than December 11, 2025, at 10:00am, CST

Solicitation due date located in Box 8.

Attached Wage Determination - 2015-4953 (Stearns County)

See CONTINUATION Page

656-3660160-045-822400-2580656-3660160-045-822400 656-26-2-045-0004

PO #TBD

X X

X 1

John Milroy

VA-VHA-RPOC-2025-0054

36C26326Q0103

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES ..................................... Error! Bookmark not defined.

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...37

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.5 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.6 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.7 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.9 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

E.2 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.3 52.216-1 TYPE OF CONTRACT (APR 1984)

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.5 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

E.6 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION

FEB 2025)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C263 Erica Miller

NETWORK CONTRACTING OFFICE 23

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [X]

b. Semi-Annually []

c. Other []

ELECTRONIC INVOICING: The Department of Veterans Affairs, Financial Services Center (FSC), has changed the accounts payable process and has transitioned to electronic invoicing.

Your participation in this existing process is required in order to continue providing products or services to the Department of Veteran Affairs in compliance with the Improper Payments Elimination and Recovery Act of 2010 (IPERA) and Mandate AN97.

TUNGSTEN NETWORK

To begin submitting electronic invoices, free of charge, please visit the following website:

https://authentication.tungsten-network.com/login and review the electronic invoicing process.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

STATEMENT OF WORK

St. Cloud Veterans Affairs Health Care System Pharmacy Clean Room and Hood Testing and Certification

1. Background: The St. Cloud VA Health Care System is required to maintain compliance of all primary and secondary engineering controls (PECs and SECs) used for compounding sterile preparations. This requirement will describe all testing and certification activities required for PECs and SECs. The intent of this contract is to have a vendor provide the required testing and services identified in the most current versions of United States Pharmacopeia (USP) Chapter <797> and Chapter <800> in addition to any services required by the St. Cloud VA Health Care System using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) professionals. The United States Pharmacopeial (USP) establishes standards for cleanroom design, environmental monitoring, and certification and recertification of the compounding area. Testing procedures must be maintained in compliance with all the current applicable standards. The Certification Guide for Sterile Compounding Facilities CAG-003-2006 or current guidelines must also be used.

2. Contractor Qualifications/Requirements:

i. The contractor’s testing personnel must have at least 2 years of experience and training on the subject matter outlined in this Statement of Work as well as fundamental practices and precautions within current USP <797> and <800> standards and operations within ISO 5 and 7 environments (donning/doffing personal protective equipment and hand washing procedures).

ii. All testing and certifications must be reviewed and signed by a NSF/ANSI-49 and Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) Registered Certified Professional (RCP) for Sterile Compounding Facility (SCF) as required by VA Directive 1108.12 to ensure consistent certification procedures using the Certification Application Guide (CAG-003-2006) for Sterile Compounding Facilities or current standards. Copies of pertinent certifications, accreditations, and/or licenses must be provided if requested.

iii. All testing outlined in this Statement of Work must either be completed by or supervised by a technician with a CETA National Board of Testing (CNBT) certification.

iv. Contractor must have a backup technician in addition to the assigned technician whose primary assigned coverage area includes the St. Cloud VA location to ensure that the scheduled work is completed within 2 business days if unanticipated issues arise with getting the technician on site for the scheduled services.

v. The laboratory must be American Industrial Hygiene Association (AIHA) accredited for all viable sampling and hazardous drug wipe sampling analysis and ISO/IEC 17025 certified by an external accrediting body for surface sample, gloved fingertip testing (GFT) and media fill testing (MFT).

3. Scope of Work:

i. Access/Scheduling: The onsite work hours are 8:00 AM to 4:30 PM Central Standard

Time (CST) Monday through Friday, excluding federal holidays.

Federal holidays observed by the Federal Government can be located at https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

Any work on site must be coordinated and approved at least 1 week prior to any testing or services.

Contractor employees will be escorted by VA staff.

The COR/Compounding Program Manager will collaborate with other service lines to determine if any work has a significant impact on the operations of the facility, especially the pharmacy compounding schedule.

The vendor must follow all federal, state, and Veterans Affairs codes, regulations, and standards. All services will be coordinated through the designated COR.

ii. Requested Services:

Table 1: Overview of Requested Services

Item # Overview of Services

Location (Room/Space) and/or Service Description

Frequency or Quantity of

Testing 1 Clean Room Suite and Containment Segregated

Compounding Area Certification (C-SCA)

• Anteroom (Rm 104)

• Positive Pressure Buffer

Room (Rm 104A)

• Negative Pressure Buffer

Room (Rm 104B)

• C-SCA Nonsterile HD Storage

Room (Rm 105)

At least every 6 months per

USP 797.

2 PEC Testing and Certification

• #2 Vertical LAFW’s in Positive Pressure Buffer Room (Rm 104A)

• #2 BSC’s in Negative Pressure Buffer Room (Rm 104B)

• #1 BSC in Nonsterile HD Storage Room C-SCA (Rm 105)

At least every 6 months per

USP 797.

3 Nonviable Particle Testing

• All PECs (#2 Vertical LAFW’s, #3 BSC’s)

• Anteroom (Rm 104)

• Positive Pressure Buffer

Room (Rm 104A)

• Negative Pressure Buffer

Room (Rm 104B)

At least every 6 months per

USP 797.

4 Viable Environmental Sampling

• Refer to diagram attached At least every 6 months per USP 797 by certifier, https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

Monthly surface sampling done by facility (10 months) 5 Airflow Smoke Pattern

Testing (with video)

• #2 Vertical LAFW’s in Positive

Pressure Buffer Room (Rm 104A)

• #2 BSC’s in Negative Pressure Buffer Room (Rm 104B)

• #1 BSC in Nonsterile HD Storage Room C-SCA (Rm 105)

At least every 6 months per

USP 797.

6 Pressure Differential • C-SCA Nonsterile HD Storage Room (Rm 105)

• Anteroom (Rm 104)

• Positive Pressure Buffer

Room (104A)

• Negative Pressure Buffer

Room (104B)

At least every 6 months per

USP 797.

7 Air Changes Per Hour • Anteroom (Rm 104)

• Positive Pressure Buffer

Room (Rm 104A)

• Negative Pressure Buffer

Room (Rm 104B)

• C-SCA Nonsterile HD Storage

Room (Rm 105)

At least every 6 months per

USP 797.

8 HEPA Filter Leak Test • #7 HEPA filters within Cleanroom Suite (Rm 104, 104A, 104B)

• #2 HEPA-filtered pass-throughs connected to Rm 104B

At least every 6 months per

USP 797.

9 Hazardous Drug Wipe Sampling

• Refer to item 9 description below

At least every 6 months per

USP 797.

10 Surface Sample Plate

Sleeves (10-packs)

• Surface sample plates to be provided and delivered monthly to St. Cloud VA for monthly viable surface sampling and employee sampling/testing in aseptic manipulation

Three sleeves (30 plates) per month

11 Post-Garbing Gloved Fingertip Test (GFT) Incubation/Resulting

• Annually for Pharmacists

• Semi-annually for Technicians

• Initial sample for employees requires 6 samples

Max of 220 samples per year (right hand and left hand are two samples)

12 Post-MFT Gloved Fingertip Test

Incubation/Resulting

• Annually for Pharmacists

• Semi-annually for Technicians

Max of 180 samples per year (right hand and left hand are two samples) 13 Post-MFT Surface

Sample Incubation/Resulting

• Annually for Pharmacists

• Semi-annually for Technicians

Max of 90 samples per year 14 Media Fill Test (MFT)

Incubation/Resulting

• Annually for Pharmacists

• Semi-annually for Technicians

Max of 90 samples per year

Item 1 – Clean Room Suite and C-SCA Certification: The contractor will test and certify the ante room and buffer rooms within the cleanroom suite (Rm 104, 104A, and 104B) in accordance with ISO 14644-1 Classifications of Air Cleanliness, CETA CAG 03-2006, and CETA CAG-009-00 specifications. The contractor will also test and certify the C- SCA Nonsterile HD Storage Room (Rm 105) according to the most current USP <797> and <800> specifications. The contractor will provide cleanroom testing and certification services with the frequency required by the most current USP <797> and USP <800> standards. USP Compliance Testing for Cleanrooms and Controlled Environment certification will include but is not limited to the following:

• Non-Viable Particle Counting under dynamic operating conditions

• Viable Microbial and Fungal Air Testing under dynamic operating conditions

• Viable Microbial and Fungal Surface Testing under dynamic operating conditions

• Airflow Volume Measurements

• Air Velocity Profile

• Room Air Exchange Rates

• Room Pressure Differential Testing of Each Opening (in water columns)

• HEPA Filter Integrity Testing (performed without breaching ceiling)

• Temperature and Relative Humidity Measurements

• Airflow displacement and visualization tests, when needed/applicable

USP Compliance Testing for the C-SCA Nonsterile HD Storage Room and BSC will include but is not limited to the following:

• Non-Viable Particle Counting under dynamic operating conditions (for the BSC)

• Airflow Volume Measurements

• Air Velocity Profile

• Room Air Exchange Rates

• Room Pressure Differential Testing of Each Opening (in water columns)

• Temperature and Relative Humidity Measurements

• Smoke visualization test under dynamic conditions, when requested/applicable

Item 2 – PEC Testing and Certification: The contractor must test and certify each PEC according to current USP <797> and <800> standards using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-003-2006) and/or ANSI/NSF-49 or the equivalent.

PECs include two sterile Class II Biological Safety Cabinets (BSC’s) and two sterile Vertical Laminar Airflow Workbenches (LAFW’s) within the pharmacy’s cleanroom suite and one nonsterile Class II BSC within a C-SCA HD Storage Room.

All PECs used for compounded sterile preparations must be certified to:

• Provide ISO Class 5 or better environment

• Provide unidirectional HEPA-filtered airflow

The list of tests, depending on CETA and manufacturer guidance for the type of PEC, includes, but is not limited to:

• Airflow velocity testing, including inflow velocity and exhaust airflow volume rate where applicable.

• Non-Viable Particle Counting under dynamic operating conditions

• HEPA filter integrity/leak testing

• Viable Microbial and Fungal Air Testing under dynamic operating conditions

• Viable Microbial and Fungal Surface Testing under dynamic operating conditions

• Induction leak/back-streaming test

• Cabinet leak test

• Airflow smoke visualization pattern test under dynamic operating conditions

• Exhaust alarm testing (for BSC certification only)

For each PEC that passes the required certification tests, the contractor will supply each unit with a certification sticker within 24 hours that has the following information:

• Company name, address, and phone number

• Unit make, model, and serial number

• Report number reflecting the room certification

• Date tested/passed certification

• Next recertification date

• Technician signature

Item 3 – Nonviable Environmental Sampling (Total Particle Counts): The contractor must perform environmental nonviable particle testing under dynamic operating conditions for all ISO Class 5 PECs and ISO Class 7 SECs at each certification visit. The contractor must derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard. Testing must be performed by qualified operators using current state-of-the-art electronic equipment with results per USP797, Section 4.1.

Item 4 – Viable Environmental Sampling (Air and Surface): The contractor must perform viable environmental (air) sampling and surface sampling for fungi and bacteria under dynamic operating conditions at each certification visit and at the request of the COR/POC in classified areas that includes hazardous and non-hazardous buffer rooms, the anteroom, and all PECs. Air sampling should be conducted using a high-volume impaction device. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected. All samples must be incubated at temperatures and time periods that comply with the most updated USP <797> standards. The lab chosen to analyze the samples must be verified prior to testing and be ISO/IEC 17025 certified. Any laboratory results greater than the action level requires immediate notification to the COR/POC upon receipt of these results.

Additionally, microorganisms must be identified and recovered to the genus level automatically if CFU action levels are exceeded for any viable sample based on current USP <797> standards. Surface sampling areas must include:

• The interior of the PECs and equipment contained in it

• Staging or work areas near the PEC

• Frequently touched surfaces

• Pass-through chambers

Air sampling: At least 1000 liters of air must be tested at each location. Samples less than 1000 liters will not be acceptable.

Air and Surface sampling growth media: The contractor must use Tryptic Soy Agar (TSA) contact plates for bacteria and TSA, Malt Extract Agar (MEA) or Sabouraud

Dextrose agar (SDA) contact plates for fungi. TSA may be used for both bacteria and fungi.

Item 5 – Smoke Pattern Testing: This will be completed in accordance with CAG-003- 2006 for each pharmacy PEC initially, semi-annually, and when changes are made to the PEC or room configuration. The testing will be video-recorded, and the contractor must have experience with collecting these videos. The facility will designate a minimum of one pharmacy technician to conduct simulated drug compounding in each PEC during the smoke visualization testing. The testing must show that first air conditions/unidirectional airflow are achieved at the critical site during all compounding tasks within the respective PEC. It is important that the contractor recognizes that this testing is beyond the typical scope of an equipment certification. These videos are to capture both the effective operation of the PEC and the effective compounding techniques of the pharmacy staff. The contractor should understand that coordination with the pharmacy staff and management is imperative in collecting useful PEC smoke visualization videos as intended by CAG-003-2006.

Item 6 – Pressure Differential Requirements: The contractor must include in their report differential pressure readings from each C-SCA, buffer room, and anteroom to all surrounding areas. The report must indicate whether the room is required to be a negative or positive pressure room per USP<797> (or USP <800> when applicable). The contractor must report all pressures to an accuracy of 0.001” water column (3 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s).

Item 7 – Air Changes Per Hour: The contractor must calculate the total room volume for each buffer, anteroom, and C-SCA nonsterile hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations must be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor must calculate air changes per hour (ACPH) for each buffer, anteroom, and containment segregated compounding area (C-SCA) and include their findings in the report. If a room does not meet USP <797> or USP <800> requirements for ACPH the identified site, the POC(s) must be informed immediately.

Item 8 – HEPA Filter Leak Testing: The contractor must perform a proper High Efficiency Particulate Air (HEPA) filter leak test of all ceiling unit, pass-through, and hood HEPA filters at each certification visit. The POCs must be notified immediately of a leak or compromise in the integrity of any HEPA filters.

Item 9 – Environmental HD Wipe Sampling: The contractor will at a minimum provide environmental wipe sampling testing kits for hazardous drug surface residue/contamination semi-annually. The kits used to complete wipe sampling must be verified prior to ensure appropriateness of detectability and method used. If retesting is needed more frequently than semi-annually, this will be done by the St. Cloud VA Health Care System.

The drugs required for testing include:

• Cyclophosphamide

• Doxorubicin HCl

• Etoposide

• Irinotecan HCl

• Paclitaxel

• Cisplatin

• Gemcitabine

• Carboplatin

• Oxaliplatin

• 5-Fluorouracil

• Additional drugs Additional drugs may be requested based on identified need by site.

Upon identified need, the site will notify the contractor and clarify additional cost which will be agreed upon by both parties prior to testing.

A minimum of 10 wipe samples will be completed semi-annually. Areas to be sampled include:

• Interior of all PECs and equipment contained in it (i.e. camera/BD Cato)

• Pass through chambers

• Surfaces in staging or work areas/carts near the PECs

• Areas adjacent to PECs (i.e. floors directly under C-PEC, staging, dispensing area)

• Areas immediately outside the hazardous drug buffer room or C-SCA

• Patient administration areas (i.e. infusion center)

Item 10 – Surface Sample Plates: The contractor must provide enough surface sample plates/sleeves for the facility to complete monthly surface sampling on all applicable surfaces for the months that the contractor does not complete this as part of their certification visits. Surface sample plates must meet the criteria/requirements specified in the most updated USP <797>. Plates must have a raised convex surface and contain general microbial growth media, such as Tryptic Soy Agar (TSA) and supplemented with neutralizing additives (i.e. lecithin and polysorbate 80). Additionally, contractor must also provide surface sample plates each month for St. Cloud VA employee training in aseptic manipulation.

Items 11 through 14 – Employee IV Training Sample Incubation and Reporting: In addition to monthly surface sampling incubation and resulting, the contractor must utilize a lab that is ISO/IEC 17025 certified that is capable of incubating the St. Cloud VA pharmacy employee IV training samples to include gloved fingertip, surface sample, and a media fill tests according to the most updated USP <797> standards. The lab must be able to incubate the samples listed in items 11 through 14 at the incubation time frames and temperatures listed in USP <797>. Additionally, the contractor must provide a formal, final report of these results to the St. Cloud VA that includes all the reporting requirements and components specified in USP <797>. For failing surface sample results only, attempt must be made to identify any microorganism recovered to the genus level. Estimated annual quantities of each sample are listed in items 11-14.

i. Report Requirements: The testing and certification reports must include at a minimum the following information:

• Pass/fail notifications for each test performed, if applicable

• Date of testing

• Date of next required certification

• Standards used to test room/equipment

• Summary of findings/test results and recommendations

• Room number and/or specific location of testing

• Room sketch (location of supply/exhaust diffusers, equipment, room dimensions, HEPA filters)

• Type of PEC certified

• Serial number of PEC/equipment certified

• Action level for ISO area tested

• Date and time samples are collected

• Specific temperature or temperature range samples/ were incubated

• The date/time period samples were incubated

• Viable particle counts (CFU’s), action levels for target ISO level

• Nonviable particle counts (CFU’s), action level for target ISO level

• Gloved fingertip counts (CFU’s), action level for initial or subsequent sampling

• Media fill test pass/fail

• The bacterial/fungal species grown on samples, if identified due to exceeded

CFU limits o The identification of highly pathogenic microorganisms will be highlighted in the report.

• Sketch identifying location of each sample obtained

• Certificates of analysis of media used, if applicable

• Total room area and volume

• Copy of lab report

• Notes

• Name of technician collecting samples and performing testing

• Comments indicating when dynamic operating conditions were used o If dynamic conditions were used, then the number of personnel present during these tests must be documented

• Room humidity and temperatures

• Room air changes per hour

• Pressure differentials in water columns

ii. Service Charges and Additional Visits: If additional testing/certification, troubleshooting, adjustments, or repairs are required, the contractor must provide additional service visits to ensure continuation of pharmacy operations and compliance with USP 797, USP 800 and all CETA Application guides. These additional visits will only be utilized at the request of the VATR and/or POCs and must be performed within 1 week of a request. The additional site visit line item must include all costs associated with labor, equipment, materials (including replacement parts), travel, per diem, lodging, mileage, movement/shipping of equipment, overnight pay or any other costs the contractor may incur while visiting the facility outside of the normal recertification visits. The cost must cover a site visit which may exceed a single workday (depending on the additional work required).

iii. Place of Performance

St. Cloud VA Health Care System 4801 Veteran’s Drive St. Cloud, MN 56303

iv. Points of Contact:

COR: Administrative Officer for Pharmacy (320) 255-6480 x7185

VA POC: Compounding Program Manager: (320)-255-6480 x6932 Alternate VA POC: Associate Chief of Pharmacy Operations: (320) 255-6465

v. Report Distribution: The contractor will immediately notify the COR and Compounding Program Manager with any results indicating failure, so the appropriate steps can be taken. A formal written report including all required documentation and services specified in this Statement of Work will be provided to designated points of contact no more than 21 days from the certification evaluation. Requests for report clarification and edits may be requested on a case-by-case basis. These reports will be provided via email to the COR/POC.

The contractor will be notified by the St. Cloud VA Health Care System of any updates to these points of contact on an as needed basis.

vi. Testing Frequency: Frequency of requested testing is shown in Table 1 above.

Certification testing of the IV rooms and hoods must occur at least every 6 months from the date of the previous certification, which will require 2 certifications per contract year except for the Base Year which will be three (3) certifications in the contract year.

First Certification must be held on February 2nd and 3rd

Additionally, more frequent testing or changes to the frequency of testing than what is requested in Table 1 may occur due to the following reasons:

• If the PEC or room is relocated/altered

• If a major service to the compounding facility is performed

• To assess/verify corrective actions associated with negative/failing results

• If USP standards change during the performance period or option years

• At the request of the COR/POC

The St. Cloud VA also requires the following additional task as outlined in the current USP <797> and USP <800>:

• 4 hours of USP 797/USP 800 consulting per contract year

vii. Contractor Equipment Calibration Standards: All equipment used for testing and sampling will be provided by the contractor. All equipment used must be calibrated within the last 12 months to meet manufacturer and industry requirements/standards. Certification of equipment calibration must be included in the certification reports. The calibration certification must also be kept with the contractor technician for review by the COR/POC at the time of recertification, if requested.

viii. Contractor Furnished Materials:

• All materials and tools to complete the work identified

• Contractor to ensure all staff that perform on-site testing arrive wearing non-shedding clothing

• All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal microorganisms into the clean environments being tested. All equipment will be wiped down/cleaned prior to taking into the clean testing environments.

NARA RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their

[Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a).

These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. [Agency] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C.

2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity.

When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [Agency] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy.

8. The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The [Agency] owns the rights to all data and records produced as part of this contract.

All deliverables under the contract are the property of the U.S. Government for which [Agency] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flowdown of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

B.2 PRICE/COST SCHEDULE

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

9.00 EA __________________ __________________

Certification and inspection: Class II Biological Safety Cabinet (BSC)(2 sterile BSC units, 1 nonsterile BSC unit, semi-annual testing) NOTE: 3 Times Base Year ONLY Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: H365 - Inspection - Medical, Dental, and Veterinary Equipment and Supplies

6.00 EA __________________ __________________

Certification of LAFW (2 vertical LAFW, semi-annual testing) NOTE: 3 Times Base Year ONLY Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

21.00 EA __________________ __________________

Clean Room HEPA Filter Test (per filter) Semi-annual (7 HEPA Filters, semi-annual) NOTE: 3 Times Base Year ONLY Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

9.00 EA __________________ __________________

Clean room suite certification per USP797 and USP800 Specifications (ACPH, Pressure Relationships, Nonviable air sampling etc.) for ISO Class 7 spaces - (3 rooms: anterroom, positive pressure buffer room, negative pressure buffer room - semi-annual) NOTE: 3 Times Base Year ONLY Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

3.00 EA __________________ __________________

Room certification for Segregated compounding areas (C-SCA) hazardous drug storage area - Pressure differential, 12 ACPH,externally vented (1 unit

- semi-annual) NOTE: 3 Times Base Year ONLY Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

63.00 EA __________________ __________________

Viable Air and Surface sampling in PECs and Rooms for fungal and microbial contamination - (14 surface samples and 7 air samples - Semi-annual) NOTE: 3 Times Base Year ONLY Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

USP-797 / USP-800 Consulting per hour (twice per year -semiannual - total of 2 hours) (TELEPHONE CONSULT ONLY WITHOUT TRAVEL) NOTE: 3 Times Base Year ONLY Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

126.00 EA __________________ __________________

Plates, lab fees for monthly surface sampling. St. Cloud VA staff will conduct the surface sampling and send the plates to the lab. Once a month 14 samples will be completed. St. Cloud VA would conduct the monthly surface sampling for the 10 months and send to lab. Contract would allow purchase of the plates and send to the site. Contractor will conduct sampling on the months they are here for certification. (Testing once per month - 10 months by VA employees and 2 months by contractor) NOTE: 3 Months Base Year ONLY - 9 months VA employees Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Wipe Test (hazardous drug material traces) semi-annual. At least 10 samples. St. Cloud VA will conduct wipe tests and send them to the lab.

Contract would allow purchase of the kit and send to testing site. Any remediation and follow-up wipe testing would be paid for and done by St.

Cloud VA. (Testing twice per year) NOTE: 3 Times Base Year ONLY Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

15.00 EA __________________ __________________

Smoke visualization study with video for each PEC (4 sterile PECs plus 1 non-sterile PEC, semi-annual testing) NOTE: 3 Times Base Year ONLY Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

5.00 EA __________________ __________________

Trip charge (2 scheduled trips per year, 2 unscheduled trips per year only if needed for additional testing, troubleshooting, repairs, adjustments, etc) NOTE: 3 Scheduled for Base Year ONLY Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

36.00 EA __________________ __________________

Surface Sample Sleeves (PACK OF 10) 3 Sleeves per month Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

90.00 EA __________________ __________________

Media Fill Sample (MFT) Incubation/Resulting Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

220.00 EA __________________ __________________

Post PPE Gloved Fingertip Sample (GFT) Incubation/Resulting Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Post MFT Surface Sample Incubation/Resulting Contract Period: Base

POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

180.00 EA __________________ __________________

Post MFT - Gloved Fingertip Sample (GFT) Incubation/Resulting Contract Period: Base POP Begin: 02-01-2026 POP End: 01-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services sterile BSC units, 1 nonsterile BSC unit, semi-annual testing) Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

4.00 EA __________________ __________________

Certification of LAFW (2 vertical LAFW, semi-annual testing) Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

14.00 EA __________________ __________________

semi-annual) Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

(ACPH, Pressure Relationships, Nonviable air sampling etc.) for ISO Class 7 spaces - (3 rooms: anterroom, positive pressure buffer room, negative pressure buffer room - semi-annual) Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028

2.00 EA __________________ __________________

Room certification for Segregated compounding areas (C-SCA) hazardous drug storage area - Pressure differential, 12 ACPH,externally vented (1 unit

- semi-annual) Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

42.00 EA __________________ __________________

microbial contamination - (14 surface samples and 7 air samples - Semi-annual) Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services of 2 hours) (TELEPHONE CONSULT ONLY WITHOUT TRAVEL) Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

140.00 EA __________________ __________________

the surface sampling and send the plates to the lab. Once a month 14 samples will be completed. St. Cloud VA would conduct the monthly surface sampling for the 10 months and send to lab. Contract would allow purchase of the plates and send to the site. Contractor will conduct sampling on the months they are here for certification. (Testing once per month - 10 months by VA employees and 2 months by contractor) Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services samples. St. Cloud VA will conduct wipe tests and send them to the lab.

Contract would allow purchase of the kit and send to testing site. Any remediation and follow-up wipe testing would be paid for and done by St.

Cloud VA. (Testing twice per year) Contract Period: Option 1

POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

10.00 EA __________________ __________________

non-sterile PEC, semi-annual testing) Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services needed for additional testing, troubleshooting, repairs, adjustments, etc) Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Post MFT Surface Sample Incubation/Resulting Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 1 POP Begin: 02-01-2027 POP End: 01-31-2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services sterile BSC units, 1 nonsterile BSC unit, semi-annual testing) Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services semi-annual) Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

(ACPH, Pressure Relationships, Nonviable air sampling etc.) for ISO Class 7 spaces - (3 rooms: anterroom, positive pressure buffer room, negative pressure buffer room - semi-annual) Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 drug storage area - Pressure differential, 12 ACPH,externally vented (1 unit

- semi-annual) Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services microbial contamination - (14 surface samples and 7 air samples - Semi-annual) Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services of 2 hours) (TELEPHONE CONSULT ONLY WITHOUT TRAVEL) Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services the surface sampling and send the plates to the lab. Once a month 14 samples will be completed. St. Cloud VA would conduct the monthly surface sampling for the 10 months and send to lab. Contract would allow purchase of the plates and send to the site. Contractor will conduct sampling on the months they are here for certification. (Testing once per month - 10 months by VA employees and 2 months by contractor) Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services samples. St. Cloud VA will conduct wipe tests and send them to the lab.

Contract would allow purchase of the kit and send to testing site. Any remediation and follow-up wipe testing would be paid for and done by St.

Contract Period: Option 2

POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services non-sterile PEC, semi-annual testing) Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services needed for additional testing, troubleshooting, repairs, adjustments, etc) Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Post MFT Surface Sample Incubation/Resulting Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Contract Period: Option 2 POP Begin: 02-01-2028 POP End: 01-31-2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services sterile BSC units, 1…

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