Q517--586-21-1-043-0003 Pharmacy Compounding Services

This is a SOURCES SOUGHT NOTICE ONLY This SOURCE SOUGHT NOTICE is for the purpose of Market Research. Response to this notice will be used for information and planning purposes. No proposals or quotes are being requested or accepted with this notice. THIS IS NOT A SOLICITATION FOR PROPOSALS or QUOTES and NO CONTRACT SHALL BE AWARDED FROM THIS NOTICE. This notice shall NOT be construed as solicitation or as an obligation on the part of the Department of Veterans Affairs (VA). Responses to this notice is not a request to be added to a prospective bidders list or to receive a copy of the solicitation. The Network Contracting Office (NCO) 16 is seeking preferably Service-Disabled Veteran Owned Small Businesses, Veterans Owned Small Businesses, or Small Businesses (but will accept other than small business for market research purposes), capable of providing Pharmacy Compounding Services for the G.V. Sonny Montgomery VA Medical Center, Jackson, MS per the DRAFT statement of work below. The NAICS code is 446110 Pharmacies and Drugs and the Size Standard is $30 million. Responses must be received by no later than 10:59 p.m. Central Standard Time, Thursday, June 11, 2020. Responses shall be emailed to contact@example.gov. Capabilities Statements to include DUNS number. Facsimile or Telephonic responses will not be accepted. Note: All interested parties are reminded to be registered, active and verified in the following to be considered for Award (as applicable). SAM: https://www.sam.gov/portal/public/SAM/ VETBIZ: https://www.vip.vetbiz.gov/Public/Search/Default.aspx (SDVOSB/VOSB) VETS 4212 (Veteran owned small Business are reminded of Reporting Requirements): https://www.dol.gov/vets/vets4212.htm DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary 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 RFI. DRAFT STATEMENT OF WORK 1. BACKGROUND: The G.V Sonny Montgomery VA Medical Center (GVSMVAMC) has a requirement for compounding hazardous chemotherapy agents for the Jackson, MS location as a compounding contingency plan for the facility. These compounding services are necessary to provide chemotherapy treatments to Veterans diagnosed with specific medical conditions. The GVSMVAMC has approximately 7-9 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 will be a firm-fixed price, Indefinite-Delivery-Indefinite Quantity, contract. Period of performance will be as follows: Base period: October 1, 2020 through September 30, 2021 Option Period 1: October 1, 2021 through September 30, 2022 Option Period 2: October 1, 2022 through September 30, 2023 Option Period 3: October 1, 2023 through September 30, 2024 Option Period 4: October 1, 2024 through September 30, 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. Contractor shall provide documentation of FDA 503A compliance and Pharmacy license upon solicitation response. Contractor shall provide copies of any renewal certificates/licensures during the course of this contract. 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 GVSMVAMC will be submitted by 11:00am 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 Biloxi, MS: G.V. Sonny Montgomery VAMC Inpatient Pharmacy Attn: Laura Mahaffey 1500 E. Woodrow Wilson Drive Jackson, MS 39216-5199 Items shall be delivered to the VA by 11:00 am CST, 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. All drugs are to be supplied by the Contractor. A list of the common chemotherapy agents will be provided directly to the Contractor. The 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 prescription order. 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 Alaris Pump Infusion Set 2426-0007 for BD Alaris Smartpumps Secondary IV Set: CareFusion Low Sorbing Set (for PVC free compounds) In-line Filter: LS In-line Filter, Alaris SmartSite Filter Rules: N/A Infusion Pumps: BD Alaris Smartpumps Special Priming: Prime tubing with base fluid prior to adding medications Total Volume Calcutions Overfills in IV Bags: Total volume will be calculated for drug and base fluid without overfill. No adjustments made for overfill. Close System Device: Equashield Equashield Syringe: All chemo and Mabs for intravenous injection Leur-lok Syringe: All chemo and Mabs for subcutaneous or intramuscular injection Pre-meds: none 3. WORK HOURS: The GVSMVAMC pharmacy is open to receive medications 24/7. The ten (10) federal holidays observed by the Federal Government for this requirement are: New Year s Day January 1 Martin Luther King Day Third Monday in January Washington s Birthday Third Monday in February Memorial Day Last Monday in May Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11 Thanksgiving Day Fourth Thursday of November Christmas Day December 25 Also included would be any other day specifically declared by the President of the United States of America to be a Federal Holiday. 4. CONTINGENCY PLANNING: The Contractor shall have a contingency backup plan if 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. 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 End of Document