Q999--Total Parenteral Nutrition Compounding Bags

6

Sources Sought Notice

DESCRIPTION

This is not a solicitation. This is a Request for Information (RFI), Sources Sought only for the LTC Charles S. Kettles VA Medical Center, 2215 Fuller Road, Ann Arbor, Michigan 48105-2303. Information collected during this Sources Sought may be used in a set-aside procurement. If a solicitation is issued, the Federal Government will do so in accordance with Federal Acquisition Circular 2024-03.

The North American Industry Classification System (NAICS) Code Number is 325412 Pharmaceutical Preparation Manufacturing. The NAICS Size Standard is 1,300 average number of employees.

Contractors that deem themselves capable of meeting the requirements shall provide the information below to Michele R. Bartelt, Contracting Officer, at Michele.Bartelt@va.gov no-later-than 2:00 PM Eastern Standard Time on November 05, 2024 and reference the 36C25025Q0095 - Total Parenteral Nutrition (TPN) Compounding Bags. The following information is required to be submitted to prove Contractors Capabilities meet this requirement.

capability statement,

proof of ability to make 503A and 503B Sterile compounding products,

proof of ability to meet same-day delivery requirements,

proof vendor is approved by Pharmacy Compounding Accreditation Board and current USP 797 and USP 800 Compliance.

REQUIREMENTS

The LTC Charles S. Kettles VA Medical Center has a bona-fide-need for a Pharmaceutical Admixture Organization. This Sources Sought/Market Survey Notice is being published to identify all sources that can provide customized, patient-specific Total Parenteral Nutrition (TPN) Compounding Bags with same-day delivery services. This service is required beginning on January 05, 2025, to January 04, 2026, with four (4) Ordering Periods that shall be exercisable solely at the discretion of the Federal Government in strict accordance with all schedules, specifications, terms, conditions, and provision of this Contract.

FBO: Origin on TPN s Deliveries not to exceed $25.00 per day.

FBO: Destination for any Cardioplegia Drugs

Planned Place of Performance: LTC Charles S. Kettles VA Medical Center

2215 Fuller Road

Ann Arbor, Michigan, USA 48105-2303

This Service Contract will be awarded as an IDIQ Contract for a five (5) year ordering period at the discretion of the Federal Government.

The Contractor shall provide the following:

Web Based Ordering Program, as well as a back-up fax program to receive drug orders for processing.

The LTC Charles S. Kettles VA Medical Center, employees shall be issuing their own security codes for log-on access to the web-based system.

An after hours contact, telephone number.

Templates shall be made available for ordering Intravenous Solutions (IV Solutions) Total Parenteral Nutrition (TPN) Compounding Bags, Lipids Emulsion, and Cardioplegia orders.

The Contractor shall provide a comprehensive ingredient listing with pricing.

The Contractor shall provide individually prescribed, Compound Sterile Cardioplegia Solutions and TPN s IV Solutions that meets patient-specific needs and shall accept orders for same day processing 24/7 days a week between the hours of 8:30 am and 4:30 pm, Eastern Standard Time (EST). In addition, the Contractor shall provide same-day delivery to the LTC Charles S. Kettles VA Medical Center, Inpatient Pharmacy, between the hours of 6:00 pm to 8:00 pm (EST).

Contractor must be able to make 503A and 503B Sterile compounding products.

The contractor solutions shall have a minimum stability of 36-hour expirations as well as all solution bags shall be labeled with expiration date and time.

The contractor shall label all TPN bags and per patient solutions with the following information: the adults TPN bags with the agreed upon label definition by both entries and the LTC Charles S. Kettles VA Medical Center may modify labels when changing formats.

Contractor shall provide the VA Monthly reports. QA Data, sterility testing, and Quarterly reports. End-product testing is required for outsourcing facilities per federal regulations, reporting lab analysis for sterile compounding and sterile technique cleaning of the IV hoods with the positive and negative results. Vendor shall provide itemized drug cost sheet and additives. Specialty drugs and vitamins.

The contractor solutions shall have a minimum stability of 36-hour expirations as well as all solution bags shall be labeled with expiration date and time.

All contractor staff participates in a continuous quality assessment and improvement program, which meets requirements, developed by Joint Commission Accreditation HealthCare Organization (JCAHO), Federal Drug Administration. (FDA) and Information Security Officer, (ISO 9000) and the contractor shall be approved by Pharmacy Compounding Accreditation Board.

Vendor must be approved by Pharmacy Compounding Accreditation Board and current USP 797 and USP 800 Compliance.

Contractor shall meet all Federal, State, and JCAHO requirements for quality assurance. The plan will be reviewed to see if the contractor is compliant with these requirements. If it is found that the expectations have not been met, then necessary VA staff will meet to discuss what changes need to be made and then Contractor shall meet with the pharmacy staff to go over any changes that need to be instituted.

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.