Q301--BI-ANNUAL CERTIFICATION AND MONTHLY PHARMACY STERILE COMPOUNDING AREA VIABLE SAMPLING Base Plus Option Years

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. Background: The Department of Veterans Affairs Medical Center, NCO 9 Network Contracting Office, on behalf of the Tennessee Valley VA Medical Center and Alvin C. York VA Medical Center is conducting market research through this source sought notice to seek sources to identify potential experienced businesses that are capable of meeting the requirements per the Statement of Work (SOW) below. Purpose and Objectives: Your responses to the information requested will assist the Government in determining the appropriate acquisition method. NAICS code: 541380 and sized standard is 16.5 Million NOTE: Respondent claiming SDVOSB and VOSB status must be registered and CVE verified in VetBiz Registry www.vetbiz.gov. Project requirements: Base + 4 Years Contract Agreement Base Year-2020-2021: October 1, 2020-September 30, 2021 Year 1-2021-2022: October 1, 2021- September 30, 2022 Year 2-2022-2023: October 1, 2022- September 30, 2023 Year 3-2023-2024: October 1, 2023- September 30, 2024 Year 4-2024-2025: October 1, 2024- September 30, 2025 STATEMENT OF WORK STATEMENT OF WORK FOR BI-ANNUAL CERTIFICATION AND MONTHLY PHARMACY STERILE COMPOUNDING AREA VIABLE SAMPLING A. GENERAL GUIDANCE Title of Project: Pharmacy Bi-annual Certification and Monthly Viable Surface and Viable Air Testing for ISO/USP regulated sterile compounding areas and equipment within the Department of Pharmacy. Scope of Work: The contractor shall provide: Bi-annual certification of all primary and secondary engineering controls in accordance with the most current CETA Certification guidelines (CAG 000 through CAG-010-2011 or most current version). This includes all hazardous and non-hazardous buffer rooms, anterooms, negative pressure storage rooms and primary engineering controls. For this testing the contractor shall provide: Viable air sampling with genus (and species if available) identification if colony forming units (cfus) are found Viable surface sampling with genus identification (and species if available) if cfus are found Primary engineering control certifications including video smoke studies Secondary engineering control certifications including air changes, pressures and any other CETA required tests HEPA filter integrity testing Provide a preliminary report at the time of certification testing completion, a viable sampling results report no later than 12 business days after testing completed, and a comprehensive electronic report no later than 45 business days after testing is completed. All above services and other items (ie. per diem, travel etc.) billed in an itemized fashion and separately for each campus Monthly environmental sampling, including viable surface and air microbiologic testing in all ISO-classified areas, including all TVHS Pharmacy primary and secondary engineering controls in accordance with the most current CETA Certification guidelines: Viable air sampling with genus (and species if available) identification if cfus are found Viable surface sampling with genus identification (and species if available) if cfus are found All above services and other items (ie. per diem, travel etc.) billed in an itemized fashion and separately for each campus Provide a timely electronic report no later than 12 business days after testing is completed. Report shall include the cfus with genus identification (and species if available, locations of samples and recommendations for remediation. Background: VA TVHS seeks a USP 797 Clean Room CETA-Certified contractor for the purpose of maintenance of VA TVHS Pharmacy Service s compliance with USP 797/800 requirements and to provide a second layer of oversight over internal processes. Performance Period: The contract term is for 12 months with four options of 12 months each beginning upon signature of the contract. VA 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. VA TVHS shall unilaterally renew by issuing a renewal delivery order that shall be effective on the first day of each succeeding fiscal year. Hours of work: Work required in the performance of the contract shall be performed during hours agreed upon between the Contractor and TVHS Pharmacy Supervisors. Type of Contract Firm Fixed Price Calibration/Certification Procedures: Certifiers Instrument Calibration: Certificates of Calibration substantiating NIST (National Institute of Standards & Technology) traceability annual compliance with requirements, and minimum sensitivities of instruments used in conducting testing in accordance with national Sanitation Standard No. 49; and ISO Standard 146447; or alternate standards as identified by the contractor. Anticipated period of performance: 10/01/2020 thru 09/31/2025. Other important considerations: Cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition. Capability statement /information sought: Response to this announcement shall not to exceed 10 pages and should include the following information: (1) A tailored capability statement indicating the firm s ability to provide a product and related services; (2) The respondents DUNS number, organization name, address, point of contact, and size and type of business (e.g., SDVOSB/VOSB, etc,) pursuant to the applicable NAICS code; (3) Information should be provided electronically in a Microsoft Word or Adobe PDF format. Please e-mail your response with the above information to contact@example.gov with the subject line "Sources Sought Notice # 36C24920Q0286 by 10:00 a.m. on 07/17/2020. Any question should be emailed to contact@example.gov. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).