36C24419Q1118-001.docx

STATEMENT OF WORK

A. SCOPE

The VA Pittsburgh Healthcare System, University Drive in Pittsburgh, Pennsylvania, located at University Drive C Pittsburgh, PA 15240 has a requirement for a United States Nuclear Regulatory Commission (US NRC) and Food and Drug Administration (FDA) Licensed Contractor to provide radiopharmaceuticals for the Nuclear Medicine Department for patient care. The VA Pittsburgh Healthcare System, University Drive in Pittsburgh, Pennsylvania intends to award a base year plus two option years, firm fixed price. Requirements Contract to a licensed Radio-pharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in Pennsylvania with a period of performance for base year of October 1, 2019 through September 30, 2020. Period of performance for option year one of October 1, 2020 through September 30, 2021. Period of performance for option year two of October 1, 2021 through September 30, 2022. The successful awardee agrees in accordance with the terms and conditions stated herein, to furnish Radiopharmaceuticals in accordance with Local, State, and Federal Regulations. The successful awardee shall be able to provide all of the items listed in the Schedule of Supplies with deliveries when required. Multiple awards will not be made.

B. BACKGROUND

The VA Pittsburgh Healthcare System, University Drive in Pittsburgh is responsible for providing high quality and timely commodities and services for our Veterans. The Department of Veterans Affairs (VA) has been directed to preferentially procure medical radioisotopes from non-High Enriched Uranium (HEU) sources. The Department of Veterans Affairs (VA) is also directed to ensure that the best possible medical supplies are procured timely and in accordance with proper regulations with vendors that are licensed and monitored according to Local, State, and Federal Regulations. Under the Atomic Energy Act, the United States Nuclear Regulatory Commission (NRC) is responsible for regulating uses of radioactive material including radio pharmaceuticals. The NRC requires all nuclear medicine facilities to be licensed. The license assures that the facility has a radiation protection program to protect both the patients and the staff. In addition, the staff must meet certain standards of training and experience before they are allowed to administer radioactive material to patients. Each state has one or more radiation programs that ensure safe use of radioactive materials. The NRC has transferred regulatory authority over the use of this material to 35 NRC Agreement States. In these states, the regulatory authority inspects the facility to ensure the staff is trained properly and the equipment is operating safely. FDA’s Center for Drug Evaluation and Research regulates the radio pharmaceuticals, ensuring effectiveness and patient safety. The mission of the National Institute of Standards and Technology (NIST) is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life.

C. STATEMENT OF WORK

1. Contractor shall have available an adequate supply of contract products to meet the requirements of the Government at his/her distribution points.

1. Contractor shall label all supplies as to the amount of radiopharmaceutical, preparation time, expiration time, date and provide a bar code label affixed to the container to allow scanning data into a nuclear medicine information management system.

1. All packaging of radioactive material MUST BE clearly labeled “RADIOACTIVE” on the outside of the shipping carton, in accordance with the Nuclear Regulatory Commission’s and Department of Transportation’s rules and regulations.

1. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

1. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, OSHA and all other agency rules and regulations (Federal and State), with reference to furnishing and delivering radioactive pharmaceuticals.

1. Contractor shall accept returns for full credit under the following conditions:

5. Product(s) ordered or shipped in error

5. Product(s) damaged in shipment

5. Concealed shipping damages

5. Recalled product(s)

5. Outdated products in unopened, original container (expired stock)

5. The product is the property of the Contractor upon receipt by the courier

1. Standard Radiopharmaceutical Ordering:

The Contractor is required to deliver radiopharmaceuticals and/or services as shown in the schedule of supplies/services to:

Nuclear Medicine Department Pittsburgh VA Medical Center University Drive Campus University Drive C, Pittsburgh, PA 15240

Contractor’s employees will check in with and be given escorted access to the Nuclear medicine department by VA Police personnel for all deliveries. Deliveries will be made Monday thru Friday from 6AM to 4:30PM. Contractor shall provide emergency deliveries as requested by the VA Pittsburgh Nuclear Medicine Department or by the on-call Nuclear Medicine technologist after normal work hours, on weekends and all Federal holidays.

Due to the potential of emergent needs for various radiopharmaceuticals with differing half-lives, the Contractor is required to maintain a full service radiopharmacy within a distance from the city of Pittsburgh Pa. that enables a delivery time of not more than 2 hours from the time a radiopharmaceutical dose is ordered.

Orders for radiopharmaceuticals and listed services will be placed daily before the close of business for the next working day. Only certified Nuclear Medicine technologists employed by the Pittsburgh VA are authorized to place orders.

The delivery order shall include the following information:

6. contract item(s) and quantity

6. time(s) of delivery

6. VA Contract Number (VA244-15-D-0001) – provided at the time of award

6. VA Funding document number (646CXxxxxx) - provided at the time of funding modification

Only certified Nuclear Medicine technologists employed by the Pittsburgh VA are authorized to place orders. Orders can be placed by the Pittsburgh VAMC via telephone, fax, or e-mail or Contractor’s web-based portal.

The Government does not take possession until the supplies are physically handed to a VA employee authorized to receive the shipment.

1. Ordering Contact Information: Contractor shall provide contact information for the placement of orders for items listed in the “Schedule of Supplies and Services” Section.

1. DELIVERY COMMITMENT: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. This termination decision would be made solely at the Government’s discretion.

1. All charges incurred for delivery shall be included in the contract pricing schedule. The Awardee shall not be paid any additional ‘surcharges’ which are not specifically delineated in the pricing schedule (i.e. fuel, transportation, or ANY other surcharges).

General Contract Terms and Conditions FY 2020 Radiopharmaceutical doses:

All doses of radiopharmaceuticals will be delivered in suitable shielded lead containers, correctly labeled and sealed. Lead containers for the radiopharmaceutical supplied by the contractor shall be picked up by the contractor from the original delivery location for waste disposal at no additional cost to the Government. Mislabeling of doses as to amount or type of radiopharmaceutical cannot be tolerated.

The contractor is fully responsible for the safe delivery of radiopharmaceuticals according to the rules and regulations of the U.S. Nuclear Regulatory Commission. The contractor is responsible to be completely familiar with and shall strictly adhere to such rules and regulations.

Security and Confidentiality:

Contractor is responsible for maintaining ADP security if and when any Automated Data Processing is utilized by the contractor whether the utilization of such a procedure is at the request of the Government or is a result of contractor preference. The contractor is responsible for maintaining patient information in confidence in accordance with the Privacy Act and HIPPA.

Contractor must be escorted at all times by VA staff while making deliveries inside the facility, or contractor must check in with the VA Police and obtain a Contractor ID badge in accordance with VAPHS policy if making unescorted deliveries. Contractor must also complete VA Privacy and Information Security Awareness and Rules of Behavior training by self-enrolling in TMS. Training must be verified by COR prior to contractor making unescorted deliveries.

Administration:

Contractor will bill on a monthly basis. All services rendered by the contractor will be itemized by date of service, item provided which will correspond with the line item number on the schedule of supplies/services, the amount of each line item purchased will correspond to the unit or other descriptive information in the schedule of supplies/services, unit cost and purchase order number. The contractor will not bill the Government and the Government will not pay any cost incurred by the contractor due to raw material shortage to produce either the specific line item or to procure any material required for Quality Control of line item production equipment. The Government will not pay for an increase in any line item price due to nuclear reactor maintenance, nuclear reactor malfunction, terror threats causing a supply chain disruption, naturally occurring disasters causing a supply chain disruption or other production or industry-wide supply shortage which ultimately results in the contractors cost to produce any item listed in the schedule of supplies/services to rise.

The contractor will not bill the Government any additional transportation charges incurred by the contractor when multiple deliveries throughout the day are required. The contractor will not bill the Government non-standard delivery trip charges. The contractor will not bill the Government any weekday, after hours, emergent or deliveries made on Federal holidays. The cost required for these types of deliveries are to be factored into the radiopharmaceutical(s) pricing. The contractor will not bill the Government nor assess the Government for any fuel surcharges or fuel charges incurred by the contractor to obtain diesel, any form of unleaded gasoline, ethanol blends, hybrid blends including natural gas or hydrogen or other fuels obtained during a time of fuel shortage or any other economic conditions such as gasoline exceeding a set price per gallon.

The Government will not be billed for any additional freight charges assessed on any item or service listed in the schedule of supplies/services. Scheduled deliveries will be made during the VA’s (the Government) normal business hours of 6:30AM – 4:30PM Monday through Friday. All deliveries regardless of the number per business day will be considered scheduled deliveries. Scheduled deliveries during the VA’s normal business day will incur no additional freight charges regardless of the number of deliveries per VA business day and regardless of how such deliveries may be defined by the contractor.

The Government will not be billed under the contractors definition of unit dose production and its application regarding pre calibration times and activity. The Government will not be assessed additional charges if the contractors and/or manufacturers prescribing information is below that of the individual unit dose or procedure (as shown in the line item procedure or unit dose in the schedule of supplies/services) order in terms of volume, activity, calibration or activity at time of calibration.

The contractor will not apply or assess charges based on local pharmacy standards to calculate billing as it applies to what the contractor considers excessive pre-calibration. All billing for any radiopharmaceutical, supplies or services listed in the schedule of supplies/services is strictly limited to the listed price on the schedule of supplies/services.