COMBINED SYNOPSIS_ Environmental testing, incubation and certification of all the VISN 1 pharmacy locations_100% SB SET-ASIDE
Description
This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format Revolutionary FAR Overhaul (RFO) in Federal Acquisition Regulation (FAR) subpart 12.202, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.
This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-06 effective 10-01-2025.
This solicitation is designated as a 100% Small Business (SB) set-aside.
The associated North American Industrial Classification System (NAICS) code for this procurement is 541380, with a small business size standard of $19.0 million. The FSC/PSC is H266.
The Department of Veterans Affairs is seeking a 5-year VISN 1 BPA requiring testing, incubation and certification of all the VISN 1 facility s primary engineering controls (PECs), and sterile clean rooms used for preparation of Compounded Sterile Preparations (CSPs). All specifications are required by VA pharmacy policy and USP 797/800 clean room regulations.
All interested companies shall provide quotations for the following:
ITEM NUMBER
DESCRIPTION
QUANTITY
UNIT OF MEASURE
COST
0001
Every 6 month room certification (Non-Hazardous) - including Viable and Non-viable sampling, air exchanges, HEPA leak testing etc.
1
Each
0002
Every 6 month room certification (Hazardous) - including Viable and Non-viable sampling, air exchanges, HEPA leak testing etc.
1
Each
0003
Every 6 month room certification (Ante/buffer)- including Viable and Non-viable sampling, air exchanges, HEPA leak testing etc.
1
Each
0004
Every 6 month HOOD (Primary Engineering) certification (Non-Hazardous), including HEPA filter leak testing
1
Each
0005
Every 6 month HOOD (Primary Engineering) certification (Hazardous), including HEPA filter leak testing
1
Each
0006
Every 6 month Surface sampling (Non-Hazarous)
1
Each
0007
Every 6 month Surface sampling (Hazarous)
1
Each
0008
Monthly Surface Sampling (non-hazardous)
1
Each
0009
Monthly Surface Sampling (Hazardous)
1
Each
0010
Competency Testing (fingertip and media fill) - New Employee
1
Each
0011
Competency (fingertip and media fill) - Ongoing Employees
1
Each
0012
As needed room certification (Non-Hazardous) - including Viable and Non-viable sampling, air exchanges, HEPA leak testing etc.
1
Each
0013
As needed room certification (Hazardous) - including Viable and Non-viable sampling, air exchanges, HEPA leak testing etc.
1
Each
0014
As needed room certification (Ante/Buffer room) - including Viable and Non-viable sampling, air exchanges, HEPA leak testing etc.
1
Each
0015
As needed HOOD (Primary Engineering) certification (Non-Hazardous), including HEPA filter leak testing
1
Each
0016
As needed HOOD (Primary Engineering) certification (Hazardous), including HEPA filter leak testing
1
Each
Place of Performance
Address:
Department of Veterans Affairs
All VISN 1 locations as listed below
Country:
UNITED STATES
STATEMENT OF WORK PART A GENERAL INFORMATION
A.1 INTRODUCTION: This requirement is for testing, incubation and certification of all the VISN 1 facility s primary engineering controls (PECs), and sterile clean rooms used for preparation of Compounded Sterile Preparations (CSPs). PECs include biological safety cabinets (BSCs), laminar airflow workstations (LAFWs) hoods, compounding aseptic containment isolators (CACI), and compounding aseptic isolators (CAI). Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797> 2022 (or most recent) guidelines and Controlled Environment Testing Association (CETA) Certification Guide for Sterile Compounding Facilities for USP Compliance (CAG-003).
A.2 BACKGROUND: VISN 1 is pursuing VISN-wide contract for standardizing testing criteria appropriate for all PECs used pursuant to USP Chapter <797> and Chapter <800> standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals/companies to establish consistent PEC certification procedures using the CETA Certification Guide for Sterile Compounding Facilities for USP Compliance (CAG-003) 2022 (or current) version).
The USP establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care, effective January 13, 2018, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities under the FD&C Act and applying the Insanitary Conditions at Compounding Facilities Guidance for Industry, November 2020 (or current version).
Certification procedures defined in CETA CAG including, but not limited to, 003 (CETA Certification Guide for Sterile Compounding Facilities for USP Compliance), 014 (Airflow Visualization Study), and 009 (Viable Environmental Monitoring for Sterile Compounding Facilities) shall be performed by a CETA National Board of Testing (CNBT) certified testing individual/company no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed. Documentation of competency and training related to the certification of primary and secondary engineering control for technician(s) who conduct on-site certification will be provided by the contractor.
A.3 SCOPE OF WORK:
A.3.1 NSF 49 Field Testing Requirements for Biological Safety Cabinets
The contractor shall certify all Class II biosafety cabinets to the current version of NSF/ANSI 49-2020 (or higher) specifications as well as CETA CAG 003. All equipment used to certify biological safety cabinets shall have ISO/IEC 17025 accredited calibration certification. Any unit that fails to meet specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified point(s) of contact (POC) as soon as practicable.
For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:
Company name and address
Unit make, model and serial number
Report number
Location (room number)
Certification date
Recertification date
Technician signature
A.3.2 Fume Hood/Testing and Certification
The contractor shall test and certify each fume hood to the manufacturer s specifications. Tests shall include: face velocity test, airflow smoke pattern test and low flow alarm test. In the event that the fume hood has an air flow monitor (AFM) or controller (AFC), the contractor shall confirm the unit is calibrated and operating within +/-10% of actual velocity. If it is not calibrated appropriately the contractor shall calibrate the AFM or AFC. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to calculate the face velocity. The contractor shall report each individual face velocity reading and the average of those readings, a pass/fail grade for the airflow smoke pattern test and a pass/fail grade for the low flow alarm test. Any failures shall be reported directly to the POC(s) as soon as practicable.
For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:
Company name and address
Certification date
Recertification date
Average face velocity
Sash height (only for fume hoods)
Technician name and signature
A.3.3 PEC Testing and Certification
The contractor shall test and certify each PEC to the most current version of The Institute of Environmental Sciences (IEST) RP CC002 (Unidirectional-flow, clean-air devices), CETA CAG -003, and to the manufacturer s specifications. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to perform all testing. The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and backstreaming test. Any failures shall be reported directly to the identified site point of contact(s) as soon as practicable.
Horizontal laminar flow cabinets shall be certified according to IEST RP-CC-002 Testing Laminar Air Flow Devices and in accordance with CETA CAG -003. All annual and semi-annual on-site certifications for Biological Safety Cabinets (BSCs) must be accomplished in accordance with the most current National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II (laminar flow) Biosafety Cabinetry. The list of tests includes, but is not limited to:
HEPA filter leak test
Cabinet leak test
Inflow velocity test to include exhaust airflow volume rate
Airflow Smoke pattern test
Electrical leakage and ground circuit resistance and polarity tests
Lighting intensity test
Vibration test
Noise level test
Ultraviolet (UV) lamp test
Laminar Flow Hoods certifications must be accomplished in accordance with the most current version of the National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II Biosafety Cabinetry, Annex F, test method A-D, 1992 or most current issue.
Fume hoods certifications must be accomplished in accordance with the most current version of the ANSI/ASHRAE 110-2016.
For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:
Company name and address
Unit make, model and serial number
Report number
Location (room number)
Certification date
Recertification date
Technician name and signature
A.3.4 Viable and Non-viable Particle Counts
For the PECs, viable and non-viable particle counts samples will be collected. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797>. Refer to the description of these tests in the section A.3.5.3 and A.3.5.4 for details.
A.3.5 USP<797> Testing for Pharmacy Clean Rooms
The contractor will provide comprehensive cleanroom testing and certification services every 6 months for required semi-annual certifications to include:
HEPA filter integrity testing
Airflow testing: Airflow testing is performed to determine acceptability of the air velocity, the room air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions.
Total particle count testing
Room pressurization monitoring
Temperature and Humidity monitoring
Air pattern analysis
Microbiological air and surface monitoring
Dynamic airflow smoke pattern test for each PEC (contractor to leave video of smoke test on site prior to completion of certification process).
Written Report
Based upon findings noted in semi-annual certifications, or as necessary after an environmental excursion or physical change to the spaces or PECs occurs, additional applicable re-certification tests will be completed to reassess applicable areas and are included within this contract.
A.3.5.1 Air Changes per Hour
The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hour (ACPH) for each buffer and ante room and include their findings in the report. Comparison of ACPH will be completed both for USP <797> standards as well as those referenced VHA HVAC Design Manual, which are more stringent than USP <797>.
In the event that a room does not meet USP<797> or VHA HVAC Design Manual requirements for ACPH the identified site POC(s) shall be informed immediately.
A.3.5.2 Pressure Requirements
The contractor shall include in their report differential pressure readings from each buffer/ante room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797>. All readings and acceptance criteria shall be documented to at least one thousandths of an inch water column (e.g., 0.020 w.g. and not 0.02 w.g.) or one tenth of a pascal (e.g., 2.5 Pa). Pressure differentials will be reflected on a report showing the sketch of the room(s).
A.3.5.3 Viable Environmental Sampling
The contractor shall perform viable environmental (air and surface) sampling every 3 months for fungi and bacteria using high volume impaction samplers to conduct the sampling. While it is acceptable per USP <797> standards to utilize Tryptic Soy Agar (TSA) media for bacteria, and another media specific to fungal VISN 1 requires all air samples to utilize TSA media which supports growth of both bacteria and fungi.
Air sampling: A sufficient volume of air (1000 liters) shall be tested at each location to maximize sensitivity. Samples of less than 1000 liters will not be acceptable.
Surface Sampling: Surface samples will be collected in each room, the interior of each ISO Class 5 PEC, pass through chambers connecting to classified areas, and frequently touched surfaces. Surface sampling will be performed at the end of the largest CSP batch of the day.
Any laboratory results equal to or greater than the action level will require notification of the POC(s) immediately upon receipt of results.
Reports to include at a minimum:
Date and time sampling was taken.
All Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the species grown to the genus level.
Medial lots used for samples
Comments indicating when dynamic conditions were used
Certificates of analysis of media used
Sketch identifying location of each sample obtained
A.3.5.4 Monthly Surface Sampling, Personnel Competency Assessment, and Gloved Fingertip (GFT) and Media Fill Test (MFT)
Monthly Surface Sampling:
For those months without a scheduled semi-annual certification or quarterly environmental sampling collection, the contractor shall collect surface samples for the assessment of ongoing compliance.
Surface samples will be taken from each of the following classified areas:
Class 5 PEC
Pass through chambers connecting to classified areas.
Equipment contained within PEC
Staging or work area(s) near the PEC
Frequently touched surfaces
Surface sample locations and quantity will be reviewed with and verified by local points of contact for each location by contractor.
Surface samples will be collected, sent through the same laboratory used for viable environmental sampling, incubated with appropriate temperature and storage time, and analyzed all in accordance with 2022 USP <797> (or more recent) requirements.
Personnel Competency Assessment
Contractor shall offer service to complete and document assessment of competency of compounding personnel including gowning/garbing observation, GFT and MFT, and post-test surface sample. Facilities will have the option to utilize contractor to complete competency assessment during scheduled monthly contractor onsite visits. If facilities elect to utilize this service, they will clearly communicate with the contractor at the time of visit scheduling of this need, as well as the number of staff requiring competency assessment.
Gloved Fingertip (GFT) and Media Fill Test (MFT)
If facility elects for contractor to complete competency assessment, contractor will include materials and assessment of GFT/MFT results in accordance with 2022 USP <797> (or more recent) requirements.
If facility elects to complete competency assessment internally, facility will capture GFT/MFT samples. Facility collected samples will be sent through contractor to same laboratory used for environmental sampling for consistency. Contractor and laboratory will ensure incubation temperatures, and storage times comply with 2022 USP <797> (or more recent) requirements:
Report:
Through either contractor or facility captured GFT/MFT, contractor will utilize the same laboratory used for viable environmental sampling to incubate and analyze samples.
Results will be reported as number of cfu per hand with notation of whether cfu action level is exceeded through reporting total number of cfu from both hands.
Competency assessment and documentation will be in accordance with 2022 USP <797> (or more recent) requirements.
A.3.5.5 Environmental Wipe Sampling for Hazardous Drug Residue
The contractor will perform environmental wipe sampling for hazardous drug surface residue semiannually (e.g., every 6 months), or more frequently as needed to verify containment. The kits used to complete wipe sampling must be verified prior to use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs.
The drugs required for testing include:
Cyclophosphamide
Ifosfamide
Methotrexate
Fluorouracil
Platinum-containing drugs
Additional Drugs
Additional drugs may be requested based upon identified need per site.
Upon identified need, the applicable site will work directly with the contractor where additional cost will be clarified and agreed upon by both parties prior to testing.
A minimum of 6 surface samples will be completed per certification. Facilities can elect to work with contractor to expand beyond the minimum as they see fit but will be coordinated and communicated with contractor prior to certification visit. Surface sampling will include the following minimum areas:
Interior of PEC and equipment contained in it.
Pass-through chambers
Surfaces in staging or work areas near PEC
Areas adjacent to PECs (e.g., floors directly under C-PEC, staging, and dispensing area)
Areas immediately outside the hazardous drug buffer room or C-SCA
Patient administration areas
A.3.5.6 Nonviable Particle Testing
The contractor shall perform environmental nonviable particle testing semiannually (e.g., every 6 months). The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:
ISO Class 5: not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any area primary engineering control (BSC or LAFW).
ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per cubic meter of air for any buffer area or hazardous compounding ante room.
ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any non-hazardous compounding ante room.
A.3.5.7 HEPA Filter Replacement and Minor Repairs
The contractor shall complete any identified HEPA filter replacement during certification visit in instances where a need is identified, and replacement is available on site. If HEPA filter changes must be postponed until a filter can be supplied, the contractor will install the new HEPA filter and conduct leak testing at an agreed upon time with the facility.
The contractor shall complete additional minor repairs associated with clean room certification and operations that are identified during certification visit, and within contractor ability to resolve which may include, but are not limited to:
PEC Chemo Decontamination
LAFW filter or blower replacement
BSC filter or blower replacement
Repairs may include parts if agreed upon by facility prior to installation.
A.3.5.8 Report Requirements
All of the following information should be included in the report for clean room certification. Pass/Fail notifications (in addition to actual findings) should be included on a per-test basis where applicable.
Executive summary or summary of findings
Recommendations to resolve any identified discrepancies
Room number and/or location
Room type (e.g., oncology prep room)
Date of testing
Date of next required certification
Standards used to test room
Notes
Room sketch (location of supply/exhaust diffusers, equipment, room dimensions)
Total room area and volume
Humidity and Temperature of each room assessed for certification
Air changes per hour with assessment based both from USP <797> standards as well as those referenced within the VHA HVAC Design Manual
Pressure differential
Particle Count Tests
Nonviable particle counts
Viable particle count analysis
Picture of viable particle test location in room
Number of personnel present in each PEC and SEC during total particle-count tests
Environmental viable sample results
Environmental Wipe Sampling for Hazardous Drug Residue results
Dynamic Airflow Smoke-Pattern Test Results
Smoke test video (either embedded in report, or a link to the video)
Number of personnel present in each PEC and SEC
Confirm/distinguish dynamic and static conditions if applicable
Note: All PECs shall follow report requirements for a non-USP<797> units but shall include viable and nonviable particle sampling.
A.3.5.9 Report Distribution
The contractor will immediately notify identified points of contact with any results indicating failure. A formalized written report including all required aspects specified in this Statement of Work will be provided in a timely manner with receipt by identified points of contact no more than 14 days from certification evaluation.
All completed reports will be provided via email to ____is there a visn group that wants all reports? In addition, facility specific reports will be provided to the following points of contact:
(402) Togus ME
(405) White River Junction VT
(518) Bedford, MA
(523) Boston HCS
(608) Manchester, NH
(631) Northampton, MA
(650) Providence, RI
(689) Connecticut HCS
Additional sites may be added due to the Department of Veterans Affairs realignment.
Contractor will be notified by facility of any updates to identified points of contact list on an as needed basis.
Within the first 10 calendar days of each quarter, the contractor will provide via email to ____is there a visn group that wants all reports? a schedule of pending visits for the quarter per site including scheduled dates and planned tests (i.e. semi-annual certification, re-certification, viable sampling, etc.)
Testing Frequency:
Certification procedures defined in CETA CAG-003 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual/company no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.
Environmental sampling (air and surface) will be completed quarterly (every 3 months), or more frequently if required to assess corrective actions associated with prior negative results. Government captured surface samples will be completed each month between contractor captured results.
Recertification procedures may be required in between scheduled semi-annual certifications based upon certification findings which may include any applicable certification test or environmental sampling. Recertification visits will be scheduled and completed within 2 weeks of request from the facility.
Environmental wipe sampling for hazardous drug residue will be performed every 6 months, or more frequently if required to verify containment.
STATEMENT OF WORK PART C SUPPORTING INFORMATION
C.1 Place of Performance:
Facility Name
Address
Specific PEC and Clean Room Information Per Site:
Providence VAMC:
Hood
Providence VAMC
1
2
3
4
Physical Location (Building #)
BLD 1, Room 253C
BLD 1, Room 253E
BLD 1, Room 238
BLD 1, Room 238A
Manufacturer
BakerÂ
 BakerÂ
 Baker
BAKER
Model Number
 EG6252
 SG604M
 SS500
CS500
Serial Number
 131250
131249
143624
143623
Make
 LFU
 Class II Type A2
 CAI
CACI
EE#
 EE87612
EE87613
EE84019
EE84018
Clean Rooms:
Non-Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 253B (Anteroom) and Room 253C (Prep Room)
ISO 8, ISO 7 and ISO 5 for Ante room, Buffer Room and Laminar Flow Hood
Baker EdgeGARD HF Horizontal Flow Clean Bench
Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 253D (Anteroom), Room 253E (Prep Room), and Room 253F (Storage area).
ISO 8, ISO 7, ISO 7 and ISO 5 for Storage Area, Ante room, Buffer Room and Biosafety Cabinet
Baker SterilGARD E3 Class II, Type A2 Biological Safety Cabinet
Non-Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 238 (Anteroom and Prep Room)
Unclassified, unclassified and ISO 5 for Ante room, Buffer Room and CAI
Baker SterilShield SS500 CAI
Inpatient Pharmacy Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 238A (Anteroom and Prep Room)- Contingency
Unclassified, unclassified and ISO 5 for Ante room, Buffer Room and CACI
Baker ChemoShield CS500 CACI
HEPA Filter Information for cleanroom suites:
Quantity:
6 Total HEPA Filters
Location(s)
6 Ceiling Supply Diffusers
Test Port Status:
installed circa 2018/2019 and are functional.
Changes to facility PEC will be communicated in a timely manner to contractor and facility costs will be adjusted accordingly based on these changes. Contractor to provide unit-based costs for services to allow for adjustments in equipment.
C.2 Period of Performance: Contract period is from date of award for five (5) years. Performance is to begin 15 calendar days from date of award.
C.3 Special Considerations:
C.3.1 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.
C.3.2 Government Furnished Materials and Services:
The Government will provide all necessary personnel protective equipment (PPE) required for contractors on site.
The Government will provide oversight and verification of contractor personnel completion of donning of PPE and hand hygiene prior to testing/sampling.
The Government will, on rare occasion, provide office or meeting space to discuss test results, projects, or plans.
The Government will provide replacement HEPA filters, when applicable.
May also provide desk phone service as needed.
C.3.3 Qualifications of Key Personnel: VISN 1 is seeking a qualified contractor that meets the following specifications:
Provide three references showing the completion of at least 3 jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center.
All certifications must be signed by an NSF 49 certified technician. A copy of NSF 49 certifications must be attached to the bid documentation for any technicians that will be performing work at the facility.
All cleanroom performance testing must be performed by a technician with a CETA National Board of Testing (CNBT) certification. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility. New and updated copies of certification must be provided for all new contractor employees performing work under this contract.
Provide AIHA accredited laboratory certification for all USP<797> viable sampling analysis. Certification must be attached with bid documentation.
Provide copy of clean room certification report for evaluation.
C.3.4 Security Requirements: There are no security requirements required for this work, as samples are retrieved by the vendor and a test report is received in return.
C.3.5 Additional Considerations
The contractor (or Representative) shall contact the facility identified POC(s) to schedule work and prior to the beginning of work. Scheduling of work will be at the direction of facility identified POC(s) to ensure services are incorporated into current facility certification cycles.
Local facility POC(s) will provide the contractor with additional facility specific procedures which include: check in and check out procedures; contractor badging requirements; parking procedures; and any additional facility specific procedures. The contractor will be expected to adhere to those procedures. Services are to be performed during the hours between 8:00 AM and 4:00 PM Eastern Standard Time (EST), excluding federal holidays. Due to the workload of the pharmacy during business hours, the contractor may need to work after 4:00 PM EST to accommodate the compounding schedule at the pharmacy. Contractors that are willing to perform after-hours work should include this information in their bid documentation. If a contractor is willing to perform services after 4:00pm EST this service must be included within the bid pricing as no extra charge. The ability to perform work after hours is not required; however, preferences will be given to contractors that offer flexible work hours.
C3.6 Invoicing
Payment will be made monthly in arrears, invoices will be prepared by the Contractor, and submitted through Tungsten Network (formerly known as OB10) http://www.tungstennetwork.com/us/en/. A properly prepared invoice shall contain:
Invoice Number and Date
Contractor s Name and Address
Accurate Purchase Order Number
Itemized service(s) and applicable cost:
Supply or Service provided (i.e., PEC certification, travel costs, etc.)
Period Supply or Service Provided
Total Amount Due
Contractor questions about the e-invoicing program (Tungsten Network), contact information is as follows:
Tungsten e-Invoice Setup Information: 1-877-489-6135
Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com
FSC e-Invoice Contact Information: 1-877-353-9791
FSC e-invoice email: vafsccshd@va.gov
Web Address: HTTP://WWW.FSC.VA.GOV/EINVOICE.ASP
The contractor will provide an electronic copy of each invoice to the identified POC(s) referenced in A.3.5.6
Contractor Quality Control and Assurance Requirements:
The Contractor will be required to provide their Quality Control and Assurance program. This program shall detail all steps required to maintain and continuously provide a clean room environment in accordance with published criteria for USP 797 and USP 800 Sterile Compounding areas.
The Government intends to take the Contractors Quality Control Plan and implement it in the Quality Assurance Surveillance Plan (QASP). Please see provision 52.212-2 for further instructions on how to submit to the Contracting Officer.
The full text of FAR provisions or clauses may be accessed electronically at https://www.acquisition.gov/browse/index/far.
The following solicitation provisions apply to this acquisition:
1. FAR 52.212-1 Instructions to Offerors Commercial Items (DEVIATION OCT 2025)
Award shall be made to the SB class quoter whose quotation is determined to be the lowest price.
The respondent must be verifiable as a SB in SAM and on the SBA (Small Business Administration) SBS website.
2. FAR 52.212-2 (DEVIATION OCT 2025) The government will evaluate information based on the following evaluation criteria:
(1) Full capability to supply all Line-Item requirements listed above, at the lowest price.
The following contract clauses apply to this acquisition:
FAR 52.212-4, Contract Terms and Conditions Commercial Items (OCT 2025)
ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (AUG 2025): Provisions 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 version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR.
The following provision is incorporated into 52.212-1 as an addendum to this solicitation:
52.212-1 Instructions to Offerors Commercial Products and Commercial Services (DEVIATION OCT 2025) (a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the Request for Quote (RFQ). However, the small business size standard for a concern that submits a quote, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees if the acquisition
(1) Is set aside for small business and has a value above the simplified acquisition threshold;
Or
(2) Uses the HUBZone price evaluation preference regardless of dollar value, unless
the quoter waives the price evaluation preference; or
(3) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged
women-owned, or women-owned small business set-aside or sole-source award regardless
of dollar value.
(b) Submission of Quotes. Submit signed and dated quotes to the office specified in this Request for Quote (RFQ) at or before the exact time specified. Quotes may be submitted on letterhead stationery, or as otherwise specified in the RFQ. As a minimum, quotes must show
(1) The solicitation number;
(2) The time specified in the solicitation for receipt of quotations;
(3) The name, address, and telephone number of the quoter;
(4) A technical description of the items being quoted in sufficient detail to evaluate
compliance with the requirements in the solicitation. This may include product literature, or
other documents, if necessary.
 (5) Terms of any express warranty;
 (6) Price and any discount terms;
 (7) "Remit to" address, if different the mailing address;
(8) A completed copy of the representations and certifications Federal Acquisition Regulation
(FAR)Â 52.212-3Â (see FARÂ 52.212-3(b) for those representations and certifications that
the quoter shall complete electronically).
(b) Submission of Quotes (cont d):
     (9) Acknowledgment Request for Quotation amendments;
(10) Past performance will not be considered in simplified acquisition procurements.
(11) Quote should include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Quotes that fail to furnish required representations and certifications, information requested in (1) to (9) and accept the terms and conditions of the solicitation may be excluded from consideration.
(c) Period for acceptance of Quotes. The quoter agrees to hold the prices in its quote firm for 30 calendar days from the date specified for receipt of quotes unless another time period is specified in an addendum to the solicitation.
(d)Â Product samples. NA
(e) Multiple Quotes. Quoters are requested to submit one (1) quote presenting the best discounted price for Triple top-down cleaning of pharmacy compounding cleanroom spaces to sanitation.
(f) Late submissions, revisions, and withdrawals of quotes.
(1) Quoters are responsible for submitting quotes so as to reach the Government office
designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 12:00 PM, local time, for the designated Government office on the date that quotes are due. (Time specified is 04-22-2026 at 12:00 p.m. (EDT)).
(2) Any quotation received at the Government office designated in the solicitation after the exact time specified for receipt of quotes is "late" and may not be considered unless it is received before purchase order issuance and the Contracting Officer (CO) determines that accepting the late quotation would not unduly delay the acquisition.
(3) If an emergency or unanticipated event interrupts normal Government processes so that quotations cannot be received at the Government office designated for receipt of quotes by the exact time specified in the solicitation, and urgent Government requirements preclude a notice of an extension of the closing date, the time specified for receipt of quotes will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.
(g) Issuance of Purchase Order. The Government may issue a purchase order to one or more quoters as identified in the Request for Quote (RFQ). Therefore, the quoter s initial quote should contain the best terms and the discounted price. Therefore, the quoter s initial quote should contain the best terms from a price and technical standpoint. However, the Government may reject any or all quotes if such action is in the public s best interest. The Contracting Officer (CO) may issue a purchase order to other than the quoter with the lowest priced quotation.
(h) Multiple awards. The Government may issue a purchase order for any item or group of items of a quotation, unless the quoter qualifies the quotation by specific limitations. Unless otherwise provided in the schedule, quotations may not be submitted for quantities less than those specified. The Government reserves the right to issue a purchase order for a quantity less than the quantity quoted, at the unit prices quoted, unless the quoter specifies otherwise in the quotation.
(1) Availability of requirements documents cited in the solicitation.
(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to- GSA Federal Supply Service Specifications Section Suite 8100 470 East L Enfant Plaza, SW Washington, DC 20407 Telephone (202) 619-8925, Facsimile (202) 619-8978.
(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision. Additional copies will be issued for a fee.
(2)Â NA: Applies to DoD.
(3) NA: Applies to DoD.
(4) Nongovernment (voluntary) standards must be obtained from the organization responsible
for their preparation, publication, or maintenance.
(j) Unique entity identifier (UEI). Applies to all quotes that exceed the micro-purchase threshold, and quotes at or below the micro-purchase threshold if the solicitation requires the contractor to be registered in the System for Award Management (SAM).)
The quoter must enter, in the block with its name and address on the cover page of its quote, the annotation "Unique Entity Identifier" followed by the unique entity identifier that identifies the quoter's name and address. The quoter also must enter its Electronic Funds Transfer (EFT) indicator, if applicable.
The EFT indicator is a four-character suffix to the UEI. The suffix is assigned at the discretion of the quoter to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity.
If the quoter does not have a UEI, it should contact the entity designated at www.sam.gov for UEI establishment directly to obtain one. The quoter should indicate that it is a quoter for a Government contract when contacting the entity designated at www.sam.gov for establishing the UEI.
(k)Â [Reserved]
(l)Â Requests for information. The CO will not notify unsuccessful quoters that responded to this Request for Quotation (RFQ). However, quoters may request information on purchase order(s) resulting from this solicitation with the CO.
(End of Provision)
To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:
"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."
OR
"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"
Quoters shall list exception(s) and rationale for the exception(s), if any.
Submission of your response shall be received not later than April 22, 2026 @ 12:00 p.m. EST at jerry.choinski@va.gov .
Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).
Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.
Government Point of Contact:
Contract Specialist
Jerry Choinski
jerry.choinski@va.gov
U.S. Department of Veterans Affairs
Connecticut VAMC
555 Willard Avenue
Newington, CT 06111
