Chemotherapy Infusion SOW.docx

STATEMENT OF WORK

1. BACKGROUND:

The Department of Veterans Affairs has a requirement for compounding hazardous chemotherapy agents for the Kansas City VA Medical Center (KCVAMC) located at 4801 E Linwood Blvd, Kansas City, MO 64128. These compounding services are necessary to provide chemotherapy treatments to Veterans diagnosed with specific medical conditions. KCVAMC has approximately 10‐24 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:

The Government anticipates awarding Firm-Fixed Price Multiple-Award Blanket Purchase Agreements (BPA) for this requirement. There is no minimum price required and this is for contingency purposes.

Estimated Period of Performance: July 31, 2023 – December 31, 2023

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.

Prescription orders will be submitted via encrypted email or fax. Once submitted, VA staff will confirm receipt of order with the Contractor via phone or encrypted email.

· Orders from KCVAMC will be submitted by noon CST to receive next day by 9am CST.

· Each prescription will include the following:

· Patient name

· Patient address (with first order for each patient)

· Patient phone number (with first order for each patient)

· Gender

· Date of Birth

· Height

· Weight

· Allergies

· Drug dosage

· Diluent and volume

· Rate

· Administration/procedure date

· Prescribing physician/signature

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 Kansas City, MO:

Kansas City VA Medical Center Inpatient Pharmacy Room V2-710 4801 Linwood Boulevard Kansas City, MO 64128

Items shall be delivered to the KCVAMC by 9:00am 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.

A list of the common chemotherapy agents and supplies will be provided directly to the Contractor.

All drugs are to be supplied by the Contractor. See attachment “KCVAMC Common Supplies and Chemotherapy Agents List”. 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.

Shipping fees shall be included with the order. 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

Refer to attachment “KCVAMC Common Supplies and Chemotherapy Agents List” for more details for each individual chemotherapy agent. The Contractor will refer to this list to understand what tubing, filters, and other supplies are used for each compounded chemotherapy agent.

3. WORK HOURS:

KCVAMC Inpatient Pharmacy (Room V2-710) 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 USP 797, USP 800, and other applicable guidelines for sterile compounding chemotherapy agents. 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: