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

618-26-4-109-1194 36C26326Q0571 04-14-2026 Joey Bloomer 515-699-5549 04-28-2026 17:00

CDT

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

3600 30TH STREET, BUILDING 7M

DES MOINES IA 50310

X X 541380 $19 Million N/A X 36C263

DEPARTMENT OF VETERANS AFFAIRS

MINNEAPOLIS VA MEDICAL CENTER

ONE

VETERANS

DRIVE

MINNEAPOLIS MN 55417

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

3600 30TH STREET, BUILDING 7M

DES MOINES IA 50310

DEPARTMENT OF VETERANS AFFAIRS

FMS-VA-2(101)

FINANCIAL SERVICES CENTER

PO BOX 149971

AUSTIN TX 78714-9971

See CONTINUATION Page

PROVIDE CLEANROOM TESTING SERVICES IN ACCORDANCE WITH THE

STATEMENT OF WORK.

THIS SOLICITIATION IS SET ASIDE 100% FOR SMALL BUSINESSES.

REVIEW AND FOLLOW THE INSTRUCTIONS TO OFFERS

IN SECTION E - E.1 ADDENDUM TO FAR 52.212-1.

EMAIL ALL REQUIRED AND COMPLETED DOCUMENTS TO:

JOEY BLOOMER, JOSEPH.BLOOMER@VA.GOV

WAGE DETERMINATION IS ATTACHED.

See CONTINUATION Page X X X

JOEY BLOOMER

VA-VHA-RPOC-2025-0046

Table of Contents

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 JOEY BLOOMER

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

3600 30TH STREET, BUILDING 7M

DES MOINES IA 50310

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

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Bi-Annual IV Testing IV Personnel Contract Period: Base POP Begin: 09-01-2026 POP End: 08-31-2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Quarterly Air Testing

POP Begin: 09-01-2026 POP End: 08-31-2027

Monthly Surface Testing

POP Begin: 09-01-2026 POP End: 08-31-2027

Bi-Annual Media Fill Testing

POP Begin: 09-01-2026 POP End: 08-31-2027

Microbial Identification

POP Begin: 09-01-2026 POP End: 08-31-2027

Bi-Annual IV Testing IV Personnel Contract Period: Option 1 POP Begin: 09-01-2027 POP End: 08-31-2028

Quarterly Air Testing

POP Begin: 09-01-2027 POP End: 08-31-2028

Monthly Surface Testing

POP Begin: 09-01-2027 POP End: 08-31-2028

Bi-Annual Media Fill Testing

POP Begin: 09-01-2027 POP End: 08-31-2028

Microbial Identification

POP Begin: 09-01-2027 POP End: 08-31-2028

Bi-Annual IV Testing IV Personnel Contract Period: Option 2 POP Begin: 09-01-2028 POP End: 08-31-2029

Quarterly Air Testing

POP Begin: 09-01-2028 POP End: 08-31-2029

Monthly Surface Testing

POP Begin: 09-01-2028 POP End: 08-31-2029

Bi-Annual Media Fill Testing

POP Begin: 09-01-2028 POP End: 08-31-2029

Microbial Identification

POP Begin: 09-01-2028 POP End: 08-31-2029

Bi-Annual IV Testing IV Personnel Contract Period: Option 3 POP Begin: 09-01-2029 POP End: 08-31-2030

Quarterly Air Testing

POP Begin: 09-01-2029 POP End: 08-31-2030

Monthly Surface Testing

POP Begin: 09-01-2029 POP End: 08-31-2030

Bi-Annual Media Fill Testing

POP Begin: 09-01-2029 POP End: 08-31-2030

Microbial Identification

POP Begin: 09-01-2029 POP End: 08-31-2030

Bi-Annual IV Testing IV Personnel Contract Period: Option 4 POP Begin: 09-01-2030 POP End: 08-31-2031

Quarterly Air Testing

POP Begin: 09-01-2030 POP End: 08-31-2031

Monthly Surface Testing

POP Begin: 09-01-2030 POP End: 08-31-2031

Bi-Annual Media Fill Testing

POP Begin: 09-01-2030 POP End: 08-31-2031

Microbial Identification

POP Begin: 09-01-2030 POP End: 08-31-2031

B.3 STATEMENT OF WORK

Environmental Microbiology Laboratory Analytical Services

1. GENERAL REQUIREMENTS:

An ISO/TEC 17025 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP) will process (receive, incubate, analyze, dispose, record and report results electronically) for microbiological surface and air samples, Gloved Fingertip and Thumb (GFT) samples, and Media Fill Testing (MFT) samples that will be collected and submitted by the Minneapolis VA Health Care System (MVAHCS). Contractor must be compliant will all applicable federal and local licensing boards. Samples will be processed according to the most current version of CAG-009-2023 (or its successor) and results will be compared to recommendations provided in USP <797> (most current version).

Sterile irradiated trypticase soy agar (TSA) plates supplemented with neutralizing additives (e.g., lecithin ad polysorbate 80) as this agar supports both bacterial and fungal growth will be provided by the contractor free of charge with no limit on the number of plates pursuant to this contract including cost of shipping the plates to the MVAHCS. The MVAHCS will cover costs of shipping the plates back to the laboratory for incubation and analysis after sample collection is completed. MVAHCS require 2 sizes of TSA plates:

· 100 mm concave plates for gloved fingertip samples

· 55 mm convex plates for viable air and surface sampling

A certificate of analysis (COA) from the TSA plate manufacturer will be provided for each lot of growth media to verify that the media meets the expected growth promotion, pH, and sterilization requirements or the COA will be readily available online to download from the TSA plate manufacturer.

The contractor shall process personnel related assessment testing GFTs samples according to CAG-009-2023 (or its successor), and USP <797> 2023 standards. GFT results will be reported for each plate after the initial incubation period and after the final incubation period with the amount of colony forming units (cfu) present as cfu per plate reported. If there is no growth present that shall be indicated on the report (0 CFU or < 1 CFU).

The contractor shall process MFT testing samples according to CAG-009-2023 (or its successor) and USP <797> 2023 standards. MFT results will be reported as Pass (negative) or Fail (positive). Failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container–closure unit(s) on or before 14 days.

The contractor shall process viable surface and air samples according to the most current version of CAG-009-2023 and USP <797> 2023 standards. If cfu measured during viable sampling exceed USP <797> threshold levels, the report will at minimum identify genus and, when possible, species of any microorganism recovered on the report, in addition to the sample name and the number of CFU after the initial incubation period and after the final incubation period. If there is no growth present that shall be indicated on the report (0 CFU or < 1 CFU).

2. SCOPE:

The contractor shall perform routine work detailed in this Statement of Work (SOW) on a regular schedule, mutually agreed upon by the Contractor and Contracting Officer Representave (COR).

The number of surface sampling, air sampling, gloved fingertip testing (GFTs) and media fill testing (MFT) may change throughout the contract period. This is MVAHCS best estimate of the number and type expected to be tested and sampled by the contract. MVAHCS reserves the right to delete or add units as required.

If the numbers of listed items will be exceeded, no work is authorized without the prior written approval of the Contracting Officer (CO) to account for it. Work items or services not already included in this SOW, but relevant to it, may be ordered by the CO without further competition. Only the CO has the right to obligate funding or order work not expressly detailed in this SOW. The Government shall not be held responsible for payment for any work performed by the Contractor that is outside the scope of this contract or without the prior approval of the CO.

3. Task:

a. Bacteria and Fungi surface incubation and sample analysis

b. Bacteria and Fungi air incubation and sample analysis

c. Bacteria and Fungi direct compounding area surface incubation and sample analysis

d. Gloved Fingertip and Thumb Sample incubation and sample analysis

e. Media Fill Testing sample incubation and sample analysis

MVAHCS Pharmacy personnel will collect, label, and prepare all samples (air, surface, GFT, and MFT) for shipping pursuant to instructions provided by the contractor ensuring viability of samples during shipping. Every effort will be made to ship samples the same day as collection or will be dropped off at the laboratory within a 25-mile radius of the medical center during normal laboratory hours to meet the needs of the MVAHCS. Days of sampling will be coordinated so delivery occurs according to contractor’s normal hours.

4. Surface & Air Sample Plates:

MVAHCS will collect all surface and air samples. Viable surface and air sampling media must be sterile and contain general microbial growth agar [e.g. typticase soy agar (TSA)] supplemented with neutralizing additives (e.g. lecithin & polysorbate 80) as this agar supports both bacterial and fungal growth. The agar plates must have a raised convex surface. The media plate must fit into impact air sampler model SAS Super 100 /180.. One media plate will be used at each sampling site.

The MVAHCS has 7 sterile compounding areas (BR-118, BR-118B, BR-118C, BR-119, 2R-103 A &B, 3F-117A).

Surface testing of the direct compounding area of pharmacy compounding personnel after a medial fill test is conducted by each employee as well as routine monthly viable surface sampling is completed in all classified sterile compounding areas and Segregated Compounding Areas (SCAs) including:

· Pass-through chambers

· The interior of the Primary Engineering Controls (PECs) and any equipment contained within

· Staging or work area(s) near the PEC

· Frequently touched surfaces Viable air sampling is completed bi-annually in all classified sterile compounding areas and Segregated Compounding Areas (SCAs) including the interior of the Primary Engineering Controls (PECs) and other predetermined areas in the sterile compounding areas.

* Note: Additional surface and air sampling may be performed during certification of new facilities and equipment, after servicing facilities or equipment, in response to identified problems, in response to identified trends, or in response to changes that could impact the sterile compounding environment.

Number of viable surface and air samples per year: 1100 (55mm TSA plates)

a. Routine surface samples per month: Minimum of 61 plates x 12 months = 732 plates

b. Routine air sampling bi-annually: Minimum of 30 plates x 2 = 60 plates

c. Technician DCA surface sample after MFT: Minimum of 100 plates

1) 25 technicians Non-hazardous x 1 plate bi-annually = 50 plates

2) 25 technicians Hazardous x 1 plate bi-annually = 50 plates

d. Pharmacists DCA surface sample after MFT: Minimum 70 plates

1) 35 pharmacist Non-hazardous x 1 plate annually = 35 plates

2) 35 pharmacist Hazardous x 1 plate annnually = 35 plates

e. Enverify Kit sample plates: Minimum of 20 plates

1) 3 technicans + 1 pharmacist program manager x 5 plates per person = 20 plates

f. Additional plates for retesting: 118 plates

One TSA sample will be obtained per sample location. Contractor will incubate surface sampling plates immediately upon receipt at a temperature of 30-35° C for no less than 48 hours and then at 20°–25°C for no less than 5 additional days. Sampling plates will be stored during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates).

Failure is indicated if cfu of any surface sample plate is greater than the action level for the classified area based on USP <797> Table 8. If levels exceed the action levels in USP <797> Table 8, an attempt must be made to identify any microorganism recovered to the genus level, and when possible, to species of the microorganism recovered. A photograph of the failed plate(s) will be sent via email to the Pharmacy Program Manager for CSPs & HDs and/or designee(s).

Table 8. Action Levels for Surface Sampling

(cfu / media device)

USP <797> 2023

Failure is indicated if cfu of any air sample plate is greater than the action level for the classified area based on USP <797> Table 7. If levels exceed the action levels in USP <797> Table 7, an attempt must be made to identify any microorganism recovered to the genus level, and when possible, to species of the microorganism recovered. A photograph of the failed plate(s) will be sent via email to the Pharmacy Program Manager for CSPs & HDs and designee(s).

Table 7. Action Levels for Viable Airborne Particle Air Sampling

[cfu/cubic meter (1000 L) of air / media device]

Contractor will report the number of cfu on each plate after initial and final incubation as cfu per plate, with sample location and sample date. Also, the contractor will report the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. As appropriate, the report will identify any microorganism exceeding the action levels as outline in USP <797>. Contractor personnel who analyze sampling plates including reading of plates, counting cfu, and performing identification of recovered microorganisms will be a licensed and qualified environmental microbiologist.

All results will be transmitted to the facility within one business day of final analysis electronically via email to the Pharmacy Program Manager for CSPs & HDs and designee(s).

5. Gloved Fingertip Sampling Plates:

Pharmacy sterile compounding staff must be evaluated in Gloved Fingertip and Thumb Sampling (GFTs) every 6 months to demonstrate competence in garbing and hand hygiene, as set forth in USP <797>. Pharmacists with direct oversight of sterile compounding must be evaluated annually in Gloved Fingertip and Thumb Sampling (GFTs) to demonstrate competence in garbing and hand hygiene, as set forth in USP <797>. Any newly hired staff will be tested on an ad hoc basis. MVAHCS completes competency assessments in both non-hazardous and hazardous drug sterile compounding.

Number of GFT samples per year: ~ 900 (100 mm TSA plates)

a. New employees: Minimum of 30 (100 mm TSA plates)

1) 3 sets (right and left hands) TSA plates for initial GFTs x 5 new employees per year

b. Technicians: Minimum of 400 (100 mm TSA plates)

1) 25 technicians non-hazardous x 4 plates bi-annually = 200 plates

2) 25 technicians hazardous x4 plates bi-annually = 200 plates

c. Pharmacists with direct oversight: Minimum of 280 (100mm TSA plates)

1) 35 pharmacist non-hazardous x 4 plates annually = 140 plates

2) 35 pharmacist hazardous x 4 plates annnually = 140 plates

d. Additional plates for re-testing: 190 (100 mm plates) MVAHCS will collect GFTs samples using one TSA plate per hand using sterile media containing general microbial growth agar {e.g., trypticase soy agar (TSA)} supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) as this agar supports both bacterial and fungal growth.

Contractor will incubate fingertip sampling plates immediately upon receipt at a temperature of 30-35° C for no less than 48 hours and then at 20°–25° C for no less than 5 additional days. Sampling plates will be stored during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates). Contractor will record and report the number of cfu per hand (left hand, right hand) observed after initial incubation and total number of colonies observed after final incubation, with individuals name and date of testing. Also, the contractor will report the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results for each employee. Contractor personnel who analyze sampling plates including reading of plates, counting cfu, and performing identification of recovered microorganisms will be a licensed and qualified environmental microbiologist.

Failure is if total cfu for both hands is greater than the action level for the type sampling (e.g., initial, bi-annual, or annual). The contractor will notify the USP Program Manager, or if unavailable, the Chief Pharmacy Services, within 1 (one) business day of any failure. Contractor will provide photograph of the failed plate(s) via email to the Pharmacy Program Manager for CSPs & HDs and designee(s).

All results will be transmitted to the facility within one business day of final analysis electronically via email to the Pharmacy Program Manager for CSPs & HDs and designee(s).

Table 1. Action Level for Gloved Fingertip Sampling and Thumb Sampling

(cfu, total from BOTH hands)

6. Media Fill Samples:

MVAHCS will collect media fill tests (MFTs) designed and developed by the MVAHCS Pharmacy Designated Person(s). The contractor will be provided with the final MFT sample (one sample) per staff member tested. The MVAHCS will purchase MFT kits separately outside of this contract.

Number of MFT samples per year: ~ 200 bags

a. New employees: Minimum of 10 bags

1) 5 new employees: 1 bag bi-annually = 10 bags

b. Technicians: Minimum of 100 bags

1) 25 technicians non-hazardous x 1 bag bi-annually = 50 bags

2) 25 technicians hazardous x 1 bag bi-annually = 50 bags

c. Pharmacists with direct oversight: 70 bags

1) 35 pharmacist non-hazardous x 1 bag annually = 35 bags

2) 35 pharmacist hazardous x 1 bag annnually = 35 bags

d. Additional bags for retesting: 20 bags

Contractor will incubate final MFT containers in an incubator immediately upon receipt at a temperature of 20°–25°C for 7 (seven) days followed by 7 (seven) days at 30°–35°C to detect a broad spectrum of microorganisms.

Contractor will report results as Pass / Faill as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. Contractor personnel who analyze the MFTs including reading results will be a licensed and qualified environmental microbiologist and/or technician.

Failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container closure unit(s) on or before 14 days. The contractor will notify the Pharmacy Program Manager for CSPs & HDs and designee(s), within 1 (one) business day of any failure.

All results will be transmitted to the facility within one business day of final analysis electronically via email to the Pharmacy Program Manager for CSPs & HDs and designee(s).

7. Place of Performance:

Minneapolis VA Health Care System (MVAHCS) Inpatient Pharmacy Department 1 Veterans Drive Minneapolis, MN 55417 612-725-2040

8. Period of Performance:

Performance Years

9. Contractor Qualifications:

An ISO/TEC 17025 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP). Contractor is responsible for having the the appropriate federal, state, and local licenses. Copies of pertinent certifications, licenses, and EMLAP accreditation will be required.

10. Performance Requirement Summary:

a. Facility surface sampling analysis for viable particles from samples taken in the Segregated Compounding Area (SCA), Anteroom, Non-hazardous buffer room, hazardous drug buffer room, OR Satellite (anteroom & buffer room), Segregated Compounding Areas (3F-117A and the hazardous drug storage room), and associated Primary Engineering Controls (PECs)

1) Viable surface sampling analysis

2) Viable air sampling analysis

3) Identification to at least genus for any growth that exceed the levels in USP <797> 2023 Table 7 and Table 8, and when possible, to species of the microorganism recovered.

b. Personnel-related competency assessments include the following:

1) Gloved Fingertip and Thumb Sample incubation and sample analysis

2) Media Fill Testing incubation and sample analysis

3) Surface sample of direct compounding incubation and analysis

4) Identification to at least genus for any growth that exceed the levels in USP <797> and when possible, to species of the microorganism recovered for GFTs and direct compounding area surface samples only.

11. Sampling Reports:

Results of viable surface and air samples, GFTs, and MFTs must be submitted to the Pharmacy Program Manager for CSPs & HDs and/or designee(s), within one (1) business days of the receipt of the results. Send reports to:

· Mara Moresette, PharmD, Pharmacy Program Manager for CPS and HDs

· Mara.Moresette@va.gov

· Sheila Kuehne, PharmD, Associate Chief of Inpatient Operations

· Sheila.Kuehne10@va.gov

· Murray Leraas, PharmD, Inpatient Pharmacy Operations Supervisor

· Murray.Leraas2@va.gov

· Jeanna Montero, CPhT, IV Technician Supervisor

· Jeanna.Montero@va.gov

a. Viable surface samples will be reported out by room location (e.g., BR-118, BR-118B, BR-118C, BR-119, 2R-103 A & B, 3F-117A) by the contractor to the site. Multiple rooms should not be included on the same report.

b. Viable air samples will be reported out by room location (e.g., BR-118, BR-118B, BR-118C, BR-119, 2R-103 A & B, 3F-117A) by the contractor to the site. Multiple rooms should not be included on the same report.

If viable air and surface samples are submitted on the same chain of custody form, it will be acceptable to report both air and surface samples on the same result report for the room.

c. Each employee will have their own individual results reported by the contractor to the site. The report will include the employee’s name and clearly identify the type of test (e.g., post garbing GFT, post media fill GFT, surface sample of the DCA, and/or media fill bag). Multiple employees should not be included on the same report. Pass/Fail notifications should be included where applicable.

d. Final reports for viable air and surface sampling, GFTs and MFTs must contain the following information 100% of the time:

1) Name of report (e.g., name of employee or room)

2) Date of sampling

3) Date received

4) Date Analyzed

5) Date reported

6) Sample ID & Location

7) Incubation temperatures and timeframes

8) Media lot and expiration dates

9) ISO Classification

10) Preliminary cfu counts after initial incubation

11) Final cfu counts after final incubation

12) Total number of cfu per plate

13) Note if sample result is above or below USP <797> action level

14) Identification of organisms to the genus level and when possible, to species of the microorganism recovered

15) Signed by lab personnel conducting the lab results.

Failure to follow these procedures may result in delay of payment or nonpayment.

12. Communication:

The contractor shall provide the MVAHCS Inpatient Pharmacy Service with a reliable mailing address for sample drop off within the designated business hours.

The contractor shall have ability to accept samples during usual business hours Monday to Friday excluding Federal Holidays.

The contractor shall maintain two-way communication between the Pharmacy Program Manager for CSPs and HDs and designee(s) via phone and/or email during normal business hours.

The contractor shall immediately (within 24 hours) notify the POC via phone or email upon receipt of sample(s) damaged during transit at no additional cost to the MVAHCS.

Contractor shall notify the Pharmacy Program Manager for CSPs & HDs and designee(s) of any unusual events, including but not limited to, incubator temperature excursions and other such incidents that may affect the integrity of the sample(s) within 24 hours of observation with no additional cost to the Government.

Contractor shall provide standard operating procedure on request that describes the process for handling, incubation, and analysis for each sampling plate or MFT.

Points of Contact (POC):

· Mara Moresette, PharmD, Pharmacy Program Manager for CPS and HDs

· Mara.Moresette@va.gov

· 612-467-2468

· Sheila Kuehne, PharmD, Associate Chief of Inpatient Operations

· Sheila.Kuehne10@va.gov

· 612-467-3103

· Murray Leraas, PharmD, Inpatient Pharmacy Operations Supervisor

· Murray.Leraas2@va.gov

· 612-629-7508

· VA Mobile Phone: 612-986-6364

· Jeanna Montero, CPhT, IV Technician Supervisor

· Jeanna.Montero@va.gov

· 612-467-6889

· Lynn Peterka, Administrative Officer / Contracting Officer Representative

· Lynn.Peterka@va.gov

· 612-629-7929

13. Contingency Service:

The contractor shall immediately (within 6 hours) contact the Pharmacy Program Manager for CSPs & HDs and designee(s) via a phone call or email to the provided distrubution group of any service interruptions that may arise once identified [e.g., not passing fungal accrediation (EMPAT), etc.]. It is the responsibility of the contractor to provide contingency testing services to minimize any delay or inconveniences.

14. Inspection:

The Government reserves the right to inspect the contractor's facility, licenses, certificates, and equipment or require documentation of compliance. If conducted, such inspections do not constitute a warranty by the Government that the contractor’s facility, licenes, certificates, and/or equipment are properly maintained.

36C26326Q0571

Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

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

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 1 DAY OF CONTRACT EXPIRATION.

(End of Clause)

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

(a) The Government may extend the term of this contract by written notice to the Contractor within 1 DAY OF CONTRACT EXPIRATION; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 7 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:

(a) Workers' compensation and employers liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

(b) General Liability: $500,000.00 per occurrences.

(c) Automobile liability: $200,000.00 per person; $500,000.00 per occurrence and $20,000.00 property damage.

(d) The successful bidder must present to the Contracting Officer, prior to award, evidence of general liability insurance without any exclusionary clauses for asbestos that would void the general liability coverage.

(End of Clause)

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

(a) Definitions. As used in this clause— American Security Drone Act-covered foreign entity means an entity included on a list that the Federal Acquisition Security Council (FASC) develops and maintains and publishes in the System for Award Management (SAM) at https://www.sam.gov (section 1822 of Pub. L. 118-31, 41 U.S.C. 3901 note prec.).

Backhaul means intermediate links between the core network, or backbone network, and the small subnetworks at the edge of the network (e.g., connecting cell phones/towers to the core telephone network). Backhaul can be wireless (e.g., microwave) or wired (e.g., fiber optic, coaxial cable, Ethernet).

Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Covered article, as defined in 41 U.S.C.