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The Department of Veterans Affairs is seeking vendors to provide sterile compounding services for chemotherapy agents at the Southeast Louisiana Veterans Healthcare System in New Orleans, LA. The service must comply with FDA 503A regulations and state/federal laws.
Provide sterile compounding services for chemotherapy agents, including aseptic compounding, transportation, and documentation of compliance with FDA 503A and state/federal laws.
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 Sterile Compounding Services for the Southeast Louisiana Veterans Healthcare System, 2400 Canal St. New Orleans, LA 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 12:00 p.m. Central Standard Time, Wednesday, June 24, 2020. Responses shall be emailed to [email protected]. 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. STATEMENT OF WORK
BACKGROUND: The Southeast Louisiana Veterans Health Care System has a requirement for compounding pharmaceutical agents for the New Orleans, LA location as a compounding contingency plan for the facility. These compounding services are necessary to provide pharmaceutical treatments to Veterans diagnosed with specific medical conditions. The New Orleans VA has up to 30 patients on any given day for infusion services. Compounding must be done at an FDA 503A compliant facility and meet all state and federal laws.
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 pharmaceutical 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 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 the New Orleans VA will be submitted by 12:00 pm 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 location: Southeast Louisiana Veterans Health Care System 4D121 Inpatient Pharmacy 2400 Canal Street New Orleans, LA 70119 Items shall be delivered to the VA by 9:00 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. Contractor shall invoice for billable units for 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. 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. The
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