6505--Non-PET Radiopharmacy Doses Iowa City VA Healthcare System

Statement of Work (SOW) / Performance Work Statement (PWS)

To provide radiopharmaceutical isotopes to the Department of Veterans Affairs Iowa City VA Health Care System (VAHCS) for use in the Nuclear Medicine Imaging Service.

• Contractor shall supply radiopharmaceutical isotopes as specified in the Price/Cost Schedule.

• Products will be delivered in Unit Dose (UD) amounts only.

• Required products may be inhalable, ingestible, or injectable.

• Contractor must be licensed by the Nuclear Regulatory Commission and regularly established in the business of providing radiopharmaceuticals.

• Personnel preparing and providing products must be licensed and subject to VA Chief of Staff review and Facility Director approval.

• Contractor must comply with NRC Information Notice 92-72 regarding transporting radioactive materials and provide annual proof of training for delivery personnel.

• Contractor must comply with all applicable hazardous waste regulations.

• Contractor is responsible for providing requested radiopharmaceuticals at the requested time. If unavailable, the contractor must obtain doses from another source.

• All radiopharmaceuticals must be provided in single dose containers.

• Product Delivery: Critical due to STAT diagnostic imaging requirements. Deliveries must be made within one hour for STAT/emergency requests. Delays beyond one hour may have severe consequences.

• Product Quality: Radioactivity quantity will not deviate more than +10% from specified quantities at calibration. Contractor must perform quality control procedures and make results available upon request. Deficient products must be replaced expediently.

• Accuracy of delivered order: All daily deliveries must match the order placed.

• Timeliness of deliveries: All daily deliveries must arrive as specified.

• Compliance of shipping containers: Containers must be secured and labeled according to NRC and DOT regulations.

• Radiation safety review: Package surveys and wipes must meet NRC and DOT guidelines.

• Communication of industry issues: Industry shortages or product recalls must be communicated within 24 hours.

• Place of Performance: Department of Veterans Affairs, Iowa City VA Health Care System (VAHCS), 601 HWY 6 West, Iowa City, Iowa 52246.

• Period of Performance: IDIQ will consist of a base period plus four ordering periods (estimated, dependent upon award date).

• Licensing: Contractor and sub-contractors must be licensed by the Nuclear Regulatory Commission. Personnel must be licensed by a State, Territory, or Commonwealth of the U.S. or the District of Columbia.

• Identification: Contractor employees must wear a Contractor-issued identification badge with employee name and contractor name. The VA will not issue Government identification badges.

• Delivery: Up to three deliveries per day may be required. Orders for pre-scheduled patients (90%) placed at least one day prior. Orders for non-pre-scheduled patients (10%) may be phoned in same day. "Called when needed" shipments must be delivered within one hour prior to dose calibration time.

• Quality Assurance: A radiopharmacist must be available to set up the QA program, act as a reference source, provide reference services for research drugs, and provide instruction on new radiopharmaceutical products.

• Contract Ceiling: The contract ceiling limit is set at $XXXX for the lifetime of the contract.

Notice of Intent / Sole Source

This document is a Notice of Intent (NOI) to award a sole source, firm-fixed-price contract for Radiopharmaceutical Products for the Iowa City VA Healthcare System. The proposed award is to Hot Shots NM LLC (SAM UEI: MKESZ56EH4Q1).

Market research indicated that Hot Shots NM LLC is the only company capable of maintaining and supporting the required Radiopharmaceutical Products and meeting the stringent delivery requirements due to their radiopharmaceutical pharmacy located in Iowa. This action is being taken under the authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1.

• Contract Type: Firm Fixed Price
• NAICS Code: 325412 (Pharmaceutical Preparation Manufacturing)
• PSC Code: 6505 (Drugs and Biologicals)

This is not a request for competitive quotes. However, interested vendors who believe they can satisfy the requirement may submit a capability statement. This statement should include documentation from the proprietary rights holder (Hot Shots NM LLC) confirming the vendor's ability to provide the service as an authorized reseller, dealer, or third party.

Capability statements and supporting documentation should be emailed to Emanuel Nevarez, Contracting Officer, at emanuel.nevarez@va.gov. The subject line should read: "36C26326Q0526 Non-PET Radiopharmacy Doses".

Submissions will be reviewed solely to determine if a competitive procurement is warranted. The decision to compete this requirement is at the Government's discretion.

• Statement of Work (SOW) Non-PET