F107--Pharmacy Sterile Environmental Monitoring Compounding Area Certification, Testing, Preventative Maintenance Service, Employee Competencies

1. INTRODUCTION: This notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs (VA). The VA is currently conducting market research to locate qualified, experienced and interested potential sources. Responses will not be considered as quotes, nor will any award be incurred by interested parties in responding to this sources sought announcement. NCO 1 Contracting is seeking interested sources for a future solicitation and procurement. At this time, no solicitation exists. This requirement is for testing and certification of all Providence VA Medical Center s primary engineering controls (PECs) and secondary engineering controls (ISO classified clean rooms and hazardous drug storage areas), which are utilized for preparation of Compounded Sterile Preparations (CSPs) for human administration. PECs include biological safety cabinets (BSCs), laminar airflow workstation (LAFW) hoods, and compounding aseptic containment isolators (CACI), used to create an ISO Class 5 area for aseptic processing. The requirement will also include facilitating gloved fingertip/thumb and media fill testing for compounding personnel at the Providence VAMC. Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797>, or current guidelines. 2. BACKGROUND: Providence Veterans Affairs Medical Center (VAMC) has a requirement for its Pharmacy compounding cleanroom suite to include Sterile Environmental Monitoring, Compounding Area Certification, Testing, Preventative Maintenance Service, Employee Competencies and other related services. The Providence VAMC Pharmacy Service wishes to establish a contract for initial equipment certification, recertification and maintenance using standardized testing criteria appropriate for all PECs. The criteria must meet the most current USP Chapter <797> and Chapter <800> standards, follow the most current Controlled Environment Testing Association (CETA) best practice guidelines, and the work must be performed by a CETA National Board of Testing (CNBT) certified individual to establish consistent PEC/SEC certification procedures. Although USP <797> states that certification procedures such as those outlined CAG-003-2006 shall be performed, Veterans Affairs (VA) will be requiring that CAG-003-2006 be used in lieu of any other such as procedures that may exist. Depending on the period of performance and option year(s), testing procedures shall be maintained in compliance with all current applicable USP standards. 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) also has the authority to inspect VA medical facility sterile compounding facilities. Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified individual no less than every 6 months or whenever the PEC/SEC is relocated/altered or when major service to the sterile compounding facility is performed. Employees at Providence VAMC must complete initial/semi-annual gloved fingertip and thumb sampling and media fill test prior to compounding sterile products for human administration. Procedures for completing these tests are outlined in USP 797 and must be completed no less than every 6 months or if remedial action required. Location: Multiple Pharmacy Locations on campus Providence, RI VAMC 830 Chalkstone Avenue Providence, RI 02908-4734 3. OBJECTIVES: Providence VAMC is looking for small business concerns, especially Service- Disabled Veteran Owned Small Business (SDVOSB) and Veteran Owned Small Business (VOSB) contractors that can provide the requested related services for Providence VAMC within VISN 1. All capable companies are encouraged to respond. The current primary NAICS code is 541380 (Testing Laboratories). 4. SUBMITTAL INFORMATION: Contractors having the skills and capabilities necessary to perform the stated requirements should submit a response as detailed below. Companies should provide clear and unambiguous evidence to substantiate their capability to fulfill the requirements above. Interested parties shall furnish the following minimum information: I. Company name and address ensure your company is registered in the System for Award Management (SAM) at beta.sam.gov. II. Company point of contact name, telephone number, and email address. III. Evidence that you are a small business (if applicable): · Small Business ensure you are listed as small business in SAM, reps and certifications. Provide the NAICS codes you are listed as a small business under. · SDVOSB or VOSB (or in the process of certification) ensure you are certified in the veteran database at www.vetbiz.gov. Provide evidence of certification. IV. If your company holds a Federal Supply Schedule (FSS) Contract, list the Contract Number and SINs. V. Capabilities/Qualifications: A written response providing clear and unambiguous evidence to substantiate the capacity to fulfill this requirement. Description of the capabilities/qualifications/skills your company possesses to perform services described above. VI. Past Experience: Brief summary of the company history relative to similar requirements. Response may provide information on a maximum of three similar projects for which the responder was a prime or subcontractor. It is requested that the above information be provided no later than September 25, 2020 at 4:30PM EDT. Responses should be emailed to the contracting specialist at contact@example.gov.