Q517--Sources Sought for Sterile Compounding Services

The purpose for this source sought notice is to locate interested companies that can furnish the REQUIREMENTS listed in the SOW that is attached. Offeror's capability to meet this requirement including any current contracts with more than 2 years of Period of Performance (Civilian or Government) to include meeting the below listed accreditations or similar standards, facility description, capabilities, and certifications. Responses must show clear and convincing evidence that your company and its employees have the capabilities, training, and qualifications to provide this service to be considered as a source. The following information is requested in a response to this RFI: 1. General Company information- Offeror's company name, DUNS, full address, point of contact, title, phone number, and email address. Name: Address: Contact Person: Phone number: Email address: DUNS number: Cage Code Number: Company website if available: 2. Business Type Please put a check mark or circle around the type of business you are below: a) Large b) 8(a) c) HubZone d) Small Business e) Small Disadvantaged Business f) Woman Owned Small Business g) Service-Disabled Veteran Owned Small Business h) Veteran Owned Small Business ***Note - All Veteran Owned Businesses must be registered in VetBiz at http://www.vip.vetbiz.gov/general_user/register/default.asp to be considered a Veteran Owned Business. Socioeconomic status (whether Service Disable Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, 8(a), Woman Owned, Small Disadvantaged, etc.). If stating SDVOSB or VOSB status, your company must be verified with the seal/icon or show pending verification in VetBiz Registry (https://www.vip.vetbiz.gov//) to be considered as a SDVOSB or VOSB source. 3. How long has your company provided these services? See attached Past Performance. 4. Provide information for any current or past VA contracts for these products and services. 5. Is your company registered in the System for Award Management at WWW.SAM.GOV? The NAICS code for the procurement is 446110 and the small business size standard is $30 Million dollars. Any future RFP will be conducted in accordance with FAR Parts 12 and 15. The Government may elect to award a Firm Fixed Price contract resulting from the solicitation. Responses to this market survey should be e mailed to contact@example.gov. No telephone responses will be accepted. Please provide a detailed response to the below Performance Work Statement stating how you can meet all aspects stated. It is requested that responses be received no later than 2:00 pm Central, October 22nd, 2020. *NOTE* SDVOSB Contractors to provide documentation to fulfill capabilities of the following clause: FAR 52.219-27. No solicitation document is available currently; this notice is to acquire information only. Vendors interested in providing an offer will have to respond to a separate solicitation announcement. STATEMENT OF WORK 1. BACKGROUND: The Central Arkansas Veterans Healthcare System (CAVHS) & the Veteran s Affairs Fayetteville Arkansas VA Medical Center has a requirement for compounding hazardous chemotherapy agents for both of the campuses. These compounding services are necessary to provide chemotherapy treatments to Veterans diagnosed with specific medical conditions. CAVHS and VAMC has approximately 10 12 patients on any given day Monday Friday for Chemotherapy Infusion. Compounding must be done at an FDA 503A compliant facility and meet all state and federal laws. Contract is an emergent request for a period of performance as follows: Contract will be a fixed price, Indefinite-Delivery-Indefinite-Quantity, contract. Period of performance will be as follows: Base period: December 26, 2020 December 25,2021 Option Year 1: December 26, 2021 December 25,2022 Option Year 2: December 26, 2022 December 25,2023 Option Year 3: December 26, 2023 December 25,2024 Option Year 4: December 26, 2024 December 25,2025 2. SCOPE OF WORK: Services Non Personal; Contractor shall provide all chemotherapy agents, IV Tubing, closed system drug transfer devices, and any other items deemed necessary. All Hazardous Chemotherapy Agents will be aseptically compounded based on patient specific orders. Orders will be submitted via a secure network or fax. Once submitted, VA staff will confirm receipt of order with the Contractor via phone or email. Orders from CAVHS and VAMC will be submitted by 3:00pm CST. Compounded orders shall be transported via Courier, overnight mail service, or any other means necessary to ensure receipt prior to infusion date/time to the following locations: Orders for Little Rock, AR: Central Arkansas Veterans Health Care System Inpatient Pharmacy GC 189 4300 West 7th Street Little Rock, AR 72205 Orders for Fayetteville, AR: Fayetteville Veterans Health Care System Inpatient Pharmacy 1100 North College Avenue Fayetteville, AR 72703 Items shall be delivered to the VA by 9:00am, the day after orders are submitted. Compounding, labeling, and beyond use dating/expiration dating will be based on USP 797, USP 800 and Federal Law. A list of the common chemotherapy agents will be provided directly to the Contractor. All drugs are to be supplied by the Contractor. See Attachment 1 for common chemotherapy agents used. This list is not inclusive, and agents may be added or deleted as the mission needs change. Contractor shall invoice for billable units for the amount of medication utilized for each individual patient. Contractor shall provide current and future certification reports for the sterile compounding areas and compounding hoods. In the case of any failures, contractor shall provide action plans for corrections of deficiencies and testing results showing the failures have been corrected. Contractor shall update and provide the VHA PBM Assessment Guide for Compounded Sterile Preparations within VAMCs and Outsourced Compounding Pharmacies at time of solicitation response and annually (See Attachment 2) Shipping is included with the order and there is no additional cost for any items delivered for the weekend. All shipments for weekend delivery will be arranged as needed to ensure delivery can be successfully completed. Specifications below for compatibility needs: Bag Spike Rule: All chemo and Mabs Primary IV Set: BD Secondary Set (REF 11426965) or interchangeable set Secondary IV Set: BD Secondary Set (REF 2204-0007) or interchangeable set In line Filter: All necessary compounded materials per manufacture recommendation Filter Rules: Filter is required for Abatacept, Avelumab, Cabazitaxel, Cetuximab, Daratumumab, Durvalumab, Pembrolizumab, Ramucirumab, Siltuximab, and others as recommended by manufacturing guidelines. Special Priming: Prime tubing with base fluid prior to adding medications Total Volume Calculations Overfills in IV Bags: Total volume only calculated when specified in order. No adjustments made for overfill. Close System Device: Equashield Pre meds: none Other: Occasionally need 5 FU in WalkMed bags 3. WORK HOURS: CAVHS pharmacy is open to receive medications 24/7. 4. CONTINGENCY PLANNING: The Contractor shall have a contingency backup plan in the event that compounding facility is affected by any certification discrepancies, equipment malfunctions, natural disasters, or other matters affecting performance of the contract. Contingency locations must meet the same criteria as stated herein. 5. COMPLIANCE WITH APPLICABLE LAWS AND REGULATIONS: The Contractor shall ensure that services provided to the Government under this contract comply with all applicable laws, statutes, regulations, and guidelines. The Contractor shall also ensure that all services provided to the Government under this contract comply with all Government mandated procedures, standards, and requirements. Information Systems Officer, Information Protection: The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non volatile memory units will remain in VA control and will not be removed from VA custody. Privacy Officer: The contractor will have access to protected Patient Health Information (PHI) but it will not have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de identified. Records Manager: 1. Records Manager: a. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. b. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. d. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. f. The Government Agency owns the rights to all data/records produced as part of this contract. g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. 6. QUALITY ASSURANCE SURVEILLANCE PROGRAM: The Government will monitor the Contractor s performance under this contract with the below performance objectives: Task ID Indicator Standard Acceptable Quality Level Method of Surveillance Incentive Rating General 1 Orders processed accurately Contractor shall ensure all orders are processed per prescription order 100% Labeling Positive Past Performance &Exercise of Option Period 2 Orders received prior to infusion date/time Contractor shall comply with all safety requirements 100% Validated receipt of order Positive Past Performance &Exercise of Option Period 3 Contractor maintains certifications required for compounding Contractor shall furnish copies of certificates and complete VHA PBM Assessment Annually 100% Validated receipt of certificates and/or assessment Positive Past Performance &Exercise of Option Period