Q301--Cleanroom Testing - Sources Sought Notice Minneapolis VA Medical Center

The Minneapolis VA Medical Center requires Cleanroom Testing services in accordance with the draft Statement of Work (SOW) below. This is a sources sought/proof of capability solicitation looking for vendors to perform the services per the SOW for market research purposes.
NO AWARDS OF A CONTRACT WILL BE MADE FROM THIS ANNOUNCEMENT.
If you are a vendor that can complete the work described in the SOW with competitive pricing, please send your contact and organization information with a descriptive proof of capability to: contact@example.gov on or before March 24th, 2026. Only emailed responses will be considered. Additionally, please provide answers as appropriate to the following questions in the table below with your response to this sources sought. Failure to respond to the following questions may affect the acquisition strategy. 1. Identify your organization's socio-economic category. 2. State whether any of the requested services may be ordered against a government contract awarded to your organization (e.g Federal Supply Schedule (FSS), General Services Administration (GSA), etc.). 3. State if subcontracting is contemplated for this requirement and what percentage of the work will be subcontracted and for what tasks.   *If applicable, VAAR 852.219-75 VA Notice of Limitations on Subcontracting Certificate of Compliance for Services and Construction, will apply to the potential solicitation if set-aside for Veteran Owned Small-Businesses or Service Disabled Veteran Owned Small-Businesses.* *If applicable, FAR 52.219-14 Limitations on Subcontracting, will apply to the potential solicitation if set-aside for Small-Businesses.*
Statement of Work for Environmental Microbiology Laboratory Analytical Services 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).
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. Task: Bacteria and Fungi surface incubation and sample analysis Bacteria and Fungi air incubation and sample analysis Bacteria and Fungi direct compounding area surface incubation and sample analysis Gloved Fingertip and Thumb Sample incubation and sample analysis 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.
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 25 technicians Non-hazardous x 1 plate bi-annually = 50 plates 25 technicians Hazardous x 1 plate bi-annually = 50 plates
d. Pharmacists DCA surface sample after MFT: Minimum 70 plates 35 pharmacist Non-hazardous x 1 plate annually = 35 plates 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 ISO Class Surface Sampling Action Levels (cfu / media device) 5 >3 7 >5 8 >50 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 ISO Class Air Sampling Action Levels [cfu/cubic meter (1000 L) of air / media device] 5 > 1 7 > 10 8 > 100 USP <797> 2023 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).
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) New employees: Minimum of 30 (100 mm TSA plates) 3 sets (right and left hands) TSA plates for initial GFTs x 5 new employees per year
Technicians: Minimum of 400 (100 mm TSA plates) 25 technicians non-hazardous x 4 plates bi-annually = 200 plates 25 technicians hazardous x4 plates bi-annually = 200 plates c. Pharmacists with direct oversight: Minimum of 280 (100mm TSA plates) 35 pharmacist non-hazardous x 4 plates annually = 140 plates 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
Gloved Fingertip and Thumb Sampling Action Levels (cfu, total from BOTH hands) Initial after garbing x 3 > 0 On-going after garbing > 0 After media fill > 3 USP <797> 2023
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 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). Place of Performance:
Minneapolis VA Health Care System (MVAHCS) Inpatient Pharmacy Department 1 Veterans Drive Minneapolis, MN 55417 +1 (555) 000-0000
Period of Performance: Performance Years 2026 Base 9-1-2026 to 8-31-2027 2027 (Option year 1) 9-1-2027 to 8-31-2028 2028 (Option year 2) 9-1-2028 to 8-31-2029 2029 (Option year 3) 9-1-2029 to 8-31-2030 2030 (Option year 4) 9-1-2030 to 8-31-2031

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.
Performance Requirement Summary: 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) Viable surface sampling analysis Viable air sampling analysis 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. Personnel-related competency assessments include the following: Gloved Fingertip and Thumb Sample incubation and sample analysis Media Fill Testing incubation and sample analysis Surface sample of direct compounding incubation and analysis 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.
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 contact@example.gov Sheila Kuehne, PharmD, Associate Chief of Inpatient Operations contact@example.gov Murray Leraas, PharmD, Inpatient Pharmacy Operations Supervisor contact@example.gov Jeanna Montero, CPhT, IV Technician Supervisor contact@example.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: Name of report (e.g., name of employee or room) Date of sampling Date received Date Analyzed Date reported Sample ID & Location Incubation temperatures and timeframes Media lot and expiration dates ISO Classification Preliminary cfu counts after initial incubation Final cfu counts after final incubation Total number of cfu per plate Note if sample result is above or below USP <797> action level Identification of organisms to the genus level and when possible, to species of the microorganism recovered Signed by lab personnel conducting the lab results.
Failure to follow these procedures may result in delay of payment or nonpayment.
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 contact@example.gov +1 (555) 000-0000 Sheila Kuehne, PharmD, Associate Chief of Inpatient Operations contact@example.gov +1 (555) 000-0000 Murray Leraas, PharmD, Inpatient Pharmacy Operations Supervisor contact@example.gov +1 (555) 000-0000 VA Mobile Phone: +1 (555) 000-0000
Jeanna Montero, CPhT, IV Technician Supervisor contact@example.gov +1 (555) 000-0000 Lynn Peterka, Administrative Officer / Contracting Officer Representative contact@example.gov +1 (555) 000-0000
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. 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.