Q517--compouding and delivery of customized parenteral nurtition memphis VAMC pharmacy

Project: Customized Patient Specific Parenteral

Nutrition Department: Pharmacy Service

Address Lt. Col. Luke Weathers, Jr. VAMC 116 N. Pauline Steet, Memphis, TN 38105

Contract Title: Customized Patient-Specific Parenteral Nutrition with Same Day Delivery for Lt. Col. Luke Weathers, Jr. VAMC

Background. Pharmacy Service at the Lt. Col. Luke Weathers, Jr. VAMC is looking to outsource the Parenteral Nutrition compounding process to meet the needs of patients requiring parenteral nutrition.

Scope. Pharmacy Service at the Lt. Col. Luke Weathers Jr VAMC is requesting customized, patient-specific parenteral nutrition compounding services with same day delivery for the Inpatient Pharmacy.

Specific Tasks.

The contractor shall compound and provide customized, patient specific PNs with same day delivery.

Lt. Col. Luke Weathers, Jr. VAMC Expectations of Vendor:

Vendor must be a pharmacy approved by the Pharmacy Compounding Accreditation

Board

Vendor will be visited, at minimum, once annually by Lt. Col. Luke Weathers, Jr. VAMC

Pharmacy Services to review compounding practices and requirements.

Daily Schedule

Vendor Hours of Operation

Vendor hours of operation will cover 7 days per week including holidays.

Assistance after hours is available by phone at no additional charge.

Order Transmission Times

Parenteral Nutrition may be ordered seven days per week.

Vendor will receive orders throughout the day with the cutoff time being 15:00.

Delivery time

Parenteral Nutrition ordered by 15:00 will be delivered by 19:00.

Vendor will make every effort to accommodate late or early orders.

Delivery will be arranged on a case-by-case basis.

Period of Performance:

Base year: 04/01/2025-09/30/2025

Option Year 1: 10/01/2025-09/30/2026

Option Year 2: 10/01/2026-09/30/2027

Option Year 3: 10/01/2027-09/30/2028

Option Year 4: 10/01/2028-09/30/2029

Ordering

Order will be submitted via fax by Lt. Col. Luke Weathers, Jr. VAMC pharmacist using standardized order form template.

1. Included cover sheet will include ordering pharmacist contact information.

All orders will be screened using the Vendor s standard minimum/maximum

values.

Vendor will provide Lt. Col. Luke Weathers, Jr. VAMC with inventory

information if the change in inventory prohibits parenteral nutrition from being compounded as ordered.

Delivery

Delivery service will be provided by an employee of the vendor pharmacy to ensure stability of the compounded product during transport. Third party courier services may not be used.

Location of Delivery

1. Vendor will deliver all products to the Inpatient Pharmacy at the Lt. Col. Luke Weathers, Jr. VAMC- 116 N. Pauline Street, Memphis, TN, 38105, DB1102

Receipt of Delivery

Upon receipt of the Vendor shipment, the receiving Lt. Col. Luke Weathers, Jr. VAMC employee will verify the count of parenteral nutrition bags and sign the Vendor packing list as confirmation of receipt.

Lt. Col. Luke Weathers, Jr. VAMC Pharmacy Service will retain one copy of the packing list.

Labeling

Vendor will label all parenteral nutrition bags in compliance with USP General Chapter and applicable laws and regulations.

Labels are to include at a minimum:

Patient Name

Assigned internal identification number

Active ingredient(s) and their amount(s), concentration(s)

Administration instructions

Rate of administration

Storage conditions if other than controlled room temperature

Beyond Use Date

The contractor solutions shall have a minimum stability of 24- hour expiration as well as all solution bags shall be labeled with expiration date and time. Compounded products are given to patients the same evening they are dropped off.

Dosage form

Total amount or volume

Order volume must be listed on the PN bag.

Compound volume must be listed on the PN.

Overfill must be listed on the label.

Route(s) of administration

Indicate the preparation is compounded

Compounding facility name and contact information

Labels are to include when applicable:

Route(s) of administration

Special handling instructions

Warning statements

Product Recall

Vendor shall notify the COR and the Contracting Officer administering the contract within three (3) business days of any recall, removal, modification, or defect of items supplied under contract for appropriate action.

Resolution in such circumstances may be made by replacement of item at no cost to the Lt. Col. Luke Weathers, Jr. VAMC, full credit of item toward future purchase, or any other method agreeable to both parties. Any freight costs incurred as a result shall be borne by the Vendor or credited to the Lt. Col. Luke Weathers, Jr. VAMC as appropriate.

Returns

Any item found to be defective or technically unacceptable, as verified by the Vendor and/or Lt. Col Luke Weathers, Jr. VAMC pharmacy staff, shall be returned to the Vendor and replaced or credited in the same manner as specified under Product Recall.

The Vendor shall not be liable for replacement or crediting the Lt. Col. Luke Weathers, Jr. VAMC for any item due to misuse or abuse by the Lt. Col. Luke Weathers, Jr. VAMC personnel.

Vendor Communication with the Lt. Col. Luke Weathers, Jr. VAMC

Daily communication with the Lt. Col. Luke Weathers, Jr. VAMC pharmacists will occur as needed by telephone or fax to discuss prescription content, order entry, delivery exceptions and to confirm that all orders have been received.

Quality

Vendor will:

Meet all applicable federal, state, and JCAHO requirements for quality assurance.

Make quality reporting information available to the Lt. Col. Luke Weathers, Jr. VAMC upon request.

If requested, able to provide quarterly quality assurance reports required by USP to include environmental monitoring and control media fill validation, final product testing, personnel credentials status, and employee training.

Follow standard operating procedures and guidelines outlined in USP .

Comply with all applicable local, state, and federal rules and regulations.

Use only fully trained and qualified employees.

Ensure all final products are checked by a licensed pharmacist.

Security compliance

See security requirements below.

Record management compliance

See Records management obligations below

Invoicing

Contractor shall submit monthly electronic invoices through VA s invoice presentment and payment system (IPPS). The invoice should be itemized by prescription number and should include PO number, date of service, sold to information, billing period, packing slip number, patient RX number, product group, description, quantity, unit of measure, unit price, extended price and grand total.

Invoices summited via Tungsten Network -https://authentication. Tungsten - network.com/login.

Contact numbers for Vendor

Fax: (901) 872-7595 1. Call (901) 872-2648 after faxing after-hours or on weekends

Phone: (901) 872-2648

After hours: (901) 872-2648 and (901) 485-8199

Lt. Col. Luke Weathers, Jr. VAMC will be notified of any changes in contact information

Vendor Expectations of the Lt. Col. Luke Weathers, Jr. VAMC:

Order Cutoff Times

Orders will be submitted by 15:00, except in extenuating circumstances.

The Lt. Col. Luke Weathers, Jr. VAMC changes:

Changes in policies, systems, order forms, and formulary will be communicated to Vendor with sufficient time to respond to the changes.

Order Clarification

The Lt. Col. Luke Weathers, Jr. VAMC shall respond to Vendor order clarification questions with at least one hour remaining before scheduled delivery.

Clarifications can be directed to the pharmacist at the phone number listed on the order cover sheet or the 24/7 Pharmacy.

Order Correctness:

The Lt. Col. Luke Weathers, Jr. VAMC will check all orders for therapeutic correctness before submitting to Vendor.

Verification: The Lt. Col. Luke Weathers, Jr. VAMC pharmacy personnel will check all Vendor parenteral nutrition against the original provider s orders before dispensing to the patient.