Q517--Sterile Pharmaceutical Compounding Services

DISCLAIMER This Sources sought is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this notice is marked as proprietary and will be handled accordingly. In accordance with 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 notice. This notice is being issued in an attempt to determine the level of interest among all socioeconomic groups. Responses will assist VA planners in determining an appropriate acquisition and set-aside strategy which best fits VA requirements. Sources Sought Sterile Pharmaceutical Compounding Services The Department of Veterans Affairs Medical Center (VAMC) in Wilmington, Delaware requires a contingency contract in place to compound medications in accordance with the DRAFT Statement of Work (SOW). If you can provide the pharmaceutical compounding services as described in the SOW below, please provide the following information no later than 2:00 PM on Thursday, October 22, 2020 to Maureen Jordan, Contracting Officer at Maureen.Jordan@va.gov: Company Name Socio Economic Status (i.e., Large Business, Small Business, Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), etc.): Email Address Phone Number Physical Address (location and distance (in miles) from VAMC in Wilmington, Delaware) Capability statement pertaining to Scope of Work confirm you are in compliance with the Major Requirements as well as the Contractor Qualifications described below and provide evidence. Interested firms are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications in conjunction with FAR 4.11 required registration in the Systems for Award Management (SAM) database prior to award of a contract. https://www.sam.gov/SAM/ DRAFT - Statement of Work Sterile Pharmaceutical Compounding Service The Department of Veterans Affairs Medical Center, (VAMC) Wilmington, Delaware, located at 1601 Kirkwood Highway, in Wilmington, DE 19805 requires a contract for Sterile Pharmaceutical Compounding Services for patients at the VAMC Wilmington. The Contractor shall provide all labor, supervision and all other resources required to deliver these services in accordance with the Statement of Work. INTRODUCTION/BACKGROUND: Compounding medications is a necessary part of patient care. It must be done using sterile techniques in a dedicated area within the Pharmacy. This area is designated as the Clean Room. If the integrity or functionality of the Clean Room is compromised, the Pharmacy must have a contingency plan in place to compound medications. This plan must comply with the recommendations set forth by the USP 797/800 Advisory Board. OBJECTIVE: The Pharmacy at the VAMC is seeking the emergent acquisition of off-site compounding services through Compounding Pharmacy due to planned/unplanned events, such as but not limited to construction projects, environmental remediation, natural disaster, equipment failure or due to suggestions from the USP 797/800 Advisory Board. This need for this acquisition is determined to be routine and can be awarded within designated Contracting timeframes. To meet the needs of this acquisition, the following must be met: The awarded Vendor must be able to assume all compounding workload from the VAMC Wilmington (460) with short or no notice. As a contingency plan, Vendor services may not be necessary during the awarded contract period of performance. If services are required, the Vendor must fill compounding orders from the VAMC Wilmington (460) until the facility s Clean Room is functional again or the end of the established contract period of performance, whichever comes first. Medications to be compounded may be supplied by the VAMC Wilmington (460), the Vendor or a combination of the two. Turnaround times for compounding services must be clearly defined. These times must be acceptable to the VAMC Wilmington (460). Routine compounding services must be available Monday through Friday, 08:00 AM to 04:30 PM, excluding Federal Holidays. The Facility will arrange delivery and pickup of medications and compounded pharmaceuticals within a 25-mile radius from the facility. If Vendor selected is outside this radius, the Vendor must provide pickup and delivery services. MAJOR REQUIREMENTS: The Contractor/ Vendor must complete the following tasks to meet the needs of this acquisition: The awarded Vendor must maintain their sterile compounding facility in accordance with the government regulations (USP 797/800) & State Board of Pharmacy. The awarded Vendor must ensure that all primary and secondary engineering controls meet sterile compounding guidelines and maintain all compounding records for a period of three years. The records include the name, brand, NDC, manufacturer, lot number and expiration date of all ingredients used in the compounding process. The records must also include identifiers for person compounding and checking the final product. The facility must also maintain all records of USP 797 and 800 compliance including but not limited to education and training of the staff, glove and media testing, surface samples, air pressure/temperature and humidity. The Government and the Contractor understand and agree that the services to be delivered under this contract by the Contractor to the Government are non-personal services and the parties recognize and agree that no employer-employee or master-servant relationships exist or will exist under the contract between the Government and the Contractor s employees. GOVERNMENT FURNISHED INFORMATION OR MATERIAL: This acquisition does not include Government-furnished property (GFP). MEETINGS AND REVIEWS: All required reports for state and federal laws and licensing will be maintained and furnished upon request. Performance will be measured through metrics that demonstrate the impact of delay in therapy/interruption of treatment plans. TRAVEL REQUIREMENTS: N/A CONTRACTING OFFICER'S REPRESENTATIVE (COR): The identified COR and technical representative for this acquisition is: Name: Alicia Fitzgerald COR Certification Level: 2 Expiration Date: 7/16/2021 Phone Number: 302-994-2511 x5574 Email: Alicia.fitzgerald@va.gov "No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification." REPORTS/DELIVERABLES: All PERIOD OF SERVICE: Delivery must occur within the timeframes designated by the Federal Government. CONTRACTOR QUALIFICATIONS: The awarded Vendor must maintain all licensing/certifications for USP 797/800, State Board of Pharmacy for employees and ensure all staff do not use/disclose Protected Health Information or PHI while processing orders from the VAMC Wilmington. The awarded Vendor must ensure staff are competent in all aspects of sterile compounding including but not limited to cleaning, aspects of technic, garbing, media fill/glove testing & transportation. The VAMC Wilmington reserves the right to request copies of licensure and training if required as part of mandatory facility compliance surveys or inspections. SECURITY/NATIONAL AGENCY CHECK REQUIREMENTS: N/A