Q301--Sterile Compounding Certification -(TVHS Pharmacy) 4 Ordering Periods

Department of Veterans Affairs Tennessee Valley Veterans Affairs Healthcare System (VAHCS) Sterile Compounding Bi-annual Certification, Monthly Viable Testing, and Personnel Gloved Fingertip and Media Fill Testing Sources Sought Notice This Sources Sought Notice is for informational and planning purposes only and does not constitute a solicitation. Network Contracting Office 9 is seeking potential sources for Pharmacy Certifications. This is not a solicitation or a request for proposal and shall not be construed as an obligation or commitment by the Government. An award will not be made on any offers submitted in response to this notice, and it shall not be implied the Government is committed to providing any solicitation or award following this notice. The Government will not pay for any information received in response to this request, nor will the Government compensate a respondent for any costs incurred in developing the information provided. The Department of Veterans Affairs, Network Contracting Office 9, is seeking sources that can provide the Sterile compounding bi-annual certification, monthly viable testing, and personnel gloved finertip and medica fill testing in accordance with (IAW) Statement of Work. SCOPE OF WORK Bi-annual Certification: All primary and secondary engineering controls (SECs) must be tested to the most current CETA Certification and USP ,797>, USP<800> guidelines every 6 months. Viable air sampling with genus (and species if available) identification if actionable level of colony forming units (cfus) are found Viable surface sampling with genus identification (and species if available) if actionable level of colony forming units (cfus) are found Primary engineering control certifications for biologic safety cabinets and laminar airflow workstations to include (if applicable) Non-viable particle count Downflow Velocity test HEPA filter integrity leak test (and patching if needed) Low airflow alarm test Video airflow smoke studies Secondary engineering control certifications to include: Air changes Pressure differentials Non-viable particle counts Temperature and pressure monitor verification HEPA filter integrity leak test (and patching if needed) Hazardous drug storage room testing to include: Air exchanges Pressure differential Temperature and pressure monitor verification. Monthly Viable Testing: All primary and secondary engineering controls must be tested for viable growth to the most current CETA Certification and USP797/USp800 guidelines monthly at both campuses. The Contractor will perform testing within the first 10 days of each month to ensure results are returned prior to the last day of the same month. Viable air sampling with genus (and species if available) identification if actionable level of colony forming units (cfus) are found Viable surface sampling with genus identification (and species if available) if actionable level of colony forming units (cfus) are found Provide a viable sampling results report no later than 12 business days after testing completed. fPersonnel Testing: Contractor will provide testing supplies for gloved fingertip and media fill testing for employees. Media must be in compliance with USP Chapter<797> TVHS designated employees will oversee the testing of compounders but utilizing supplies and lab services provided by the contractor. Contractor will provide Certified Environmental Microbiology Laboratory - ISO/IEC 17025:2005 Accreditation to incubate and report. Incubation, processing and reporting must be in accordance with USP Chapter <797>. Billing: All above services and other items (ie. per diem, travel etc.) billed in an itemized fashion and separately for each campus. REPORTING REQUIREMENTS: The Contractor must provide a preliminary report at the time of certification testing completion, viable sampling results reports no later than 12 business days after testing completed, and a comprehensive biannual certification electronic report no later than 45 business days after testing is completed, unless greater time is agreed upon in advance by the COR. Personnel testing reports must be received no later than 12 business days. All reports must include all items required by USP<797>, USP <800> and CETA testing. If the contractor cannot report within the specified timeline, an extension must be requested and agreed upon by TVHS. CONTRACTOR QUALIFICATIONS: The Contractor will provide all parts, labor, equipment, material, travel expenses to test and certify the operation and performance of equipment systems and personnel per the Statement of Work (SOW) listed in Section 3. All testing and observations must be performed by properly trained and appropriately accredited on-site field certification technicians. These certified technicians must be trained on all the types of equipment listed in this SOW. All training and competency must be recent and in-date. Documentation shall be provided to the VA certifying that each field certification technician has been trained and certified in the work required by this SOW as follows: Contractor must have a working knowledge of most recent publications of USP<797> Pharmaceutical Compounding-Sterile Preparations Contractor must have a working knowledge of NSF/ANSI 49-2016 Biosafety Cabinetry: Design, Construction, Performance and Field Certification. Contractor must be able to provide a technician with current certification as a Registered Cleanroom Certified Professional for Sterile Compounding Facilities by the CNBT for cleanroom certification. Proof of current CETA-accredited certification for a specific individual must be provided to facility s Point of Contact (POC for the technician performing the work and/or the person who reviews and signs and reviews) the reports. Contractor must follow all TVHS facility Standard Operation Procedures (SOP)s for the sterile compounding area at all times. Note: A Certified Industrial Hygienist (CIH) credential does not waive any of the above certification requirements. Technicians must successfully demonstrate competency in garbing and hand hygiene when performing work in classified areas. Due to the sensitive nature of the work area, prior to entering sterile compounding areas (buffer room, ante room), the Contractor will always maintain a clean work area by wearing appropriate personal protective equipment (set forth by USP <797> standards) and cleaning any equipment with at least 70% sterile isopropyl alcohol. Contractor must have working knowledge of current ISO standards. Contractor must have technicians available in a reasonable proximity to the facilities to eliminate/minimize travel expenses, to meet the time frames for testing and to accommodate possible multiple dates for testing each month if there is a failure. PLACE OF PERFORMANCE: Tennessee Valley Healthcare System has two campuses requiring testing: Nashville VA Medical Center, 1310 24th Ave S, Nashville, Tennessee 37212 and Alvin C. York VA Medical Center, 3400 Lebanon Pike, Murfreesboro, TN 3129. TERM OF CONTRACT AND PRICING: This contract is for four 12 month ordering periods (48 months). All pricing to be given and billed per line item completed. Travel expenses and any other costs not listed above must be listed separately. Report generation may be built into prices above or listed separately. Invoices should be submitted monthly for total work completed and may be combined for both campuses if completed during the same travel time. PERFORMANCE PERIOD: The contract term is for 12 months with three additional ordering periods of 12 months each beginning upon signature and to start October 1, 2025. TVHS will issue a delivery order only for the current fiscal year. The VA's obligation under this contract shall terminate at the end of each fiscal year. TVHS shall unilaterally renew by issuing a renewal delivery order that shall be effective on the first day of each succeeding fiscal year. The information above is intended to be descriptive, and not restrictive, to indicate the quality of equipment that will be satisfactory. It is the responsibility of the interested source to demonstrate to the Government that the interested source can provide equipment that fulfills the required specifications. If you are interested, and can provide equipment that meets or exceeds the specifications listed, please provide the requested information below: The anticipated North American Industry Classification System (NAICS) code is 541511. Please include the following information: [ ] yes [ ] no - Small Business (SB) [ ] yes [ ] no - HUBZone [ ] yes [ ] no - Small Business 8(a) [ ] yes [ ] no - Small Disadvantaged Business (SDB) [ ] yes [ ] no - Women-Owned (WO) Small Business [ ] yes [ ] no - Service Disabled Veteran Owned Small Business (SDVOSB) [ ] yes [ ] no - Veteran Owned Small Business (VOSB) [ ] yes [ ] no - Large Business [ ] yes [ ] no FAR 52.219-14 Certify compliance with limitation on subcontracting [ ] yes [ ] no Is this product available on your GSA/FSS or other GWAC Contract? If so, what is your contract number?_____________________ [ ] yes [ ] no Does your equipment conform to the Buy American Act and FAR 52.225-1? 52.225-1 Buy American-Supplies | Acquisition.GOV Company Name: POC: UEI: Address: Email: In addition to providing the information requested above, responding companies are encouraged to include any relevant information (specifications, cut sheets, brochures, capability statement, experience etc.) to confirm the company s ability to meet the requirements outlined in this request. Responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract or agreement. This notice shall not be construed as a commitment by the Government to issue a solicitation, or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Please respond to this Sources Sought notice by June 20, 2025, at 10:00AM CT via email to contact@example.gov. Disclaimer and Important Notes: This Sources Sought notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Sources Sought notice that is marked as proprietary will be handled In accordance with (IAW) FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Sources Sought notice.