Statement of Work 3 NOTICE OF INTENT TO SOLE SOURCE DATSCAN The Corporate Michael J. Crescenz VA Medical Center, 3900 Woodland Avenue, Philadelphia, Pennsylvania has a requirement for brand name DaTscan (loflupane I 123 injection). DaTscan is required by the medical center to visually assess and diagnose parkinsonian syndrome. VA has only located one vendor capable of providing DaTscan and intends to issue a sole source contract to that vendor. This notice is being posted so that any unknown vendors who are capable of providing this item may come forward and express their interest and capability in providing DaTscan to VA. If your company/organization is capable of providing the required item, please provide your entities capability statement to LaShawn Knight or Andrew Taylor, Contracting Officer by 15:00. Wednesday, September 8, 2021 via email to
[email protected] and
[email protected] . In addition to your capability statement please also provide any applicable distribution agreements regarding DaTscan, the size and socioeconomic status of your company, and any other information pertinent to this requirement. Reference Procurement ID number 36C24421Q1214 in the subject of the email. ***This is not a request for quote, no quotes should be sent in response to this notice. CPL Michael J. Crescenz Veterans Administration Medical Center Statement of Need Date August 20, 2021 Client Philadelphia Veterans Administrative Medical Center Job Name Radiopharmaceutical I-123 Ioflupane (DaTscan) Requested by Nuclear Medicine/Diagnostic Imaging From Gerald Watts, Program Analyst Summary CMCVAMC requires a licensed vendor by the Nuclear Regulatory Commission to provide radiopharmaceuticals and calibration sources for the Nuclear Medicine Department. These radiopharmaceuticals are required for imaging procedures. The Calibration sources are required for equipment quality control testing. This particular product is the only imaging agent that provides visual evidence to aid in the assessment and diagnosis of parkinsonian syndrome. These items are to be delivered directly to the Diagnostic Imaging section of Nuclear Medicine (secured receiving areas), room 3A101B, Philadelphia Veterans Administration Medical Center, Department of Veterans Affairs, 3900 Woodland Avenue, Philadelphia, Pennsylvania 19104. Project Scope This SOW covers the following activities and deliverables. The vendor agrees to perform these services with the standard of care, skill, and diligence normally provided by a professional organization in the performance of similar services. It is understood that the contractor must perform the services based, in part, on information furnished by this Medical Center; however, the vendor is given notice that the Medical Center will be relying on the accuracy, competence and completeness of the contractor s services in utilizing the results of such services. The Nuclear Medicine staff of the CMCVAMC, when needed for next day delivery during work hours will place all orders daily. There may be orders placed during other than normal working hours, to be delivered within a 45-minute window for an emergency. The vendor must be able to fulfill this requirement. All items delivered to the Nuclear Medicine department as specified above. CMCVAMC will require credit statements (itemized returned doses) and monthly invoices. Electronic daily dose tracking systems should be available for the Medical Center s use in certifying and tracking per patient doses delivered. DELIVERABLES:. Unit per dose (I-123 Ioflupane) - DATScan The contractor shall have available an adequate supply of contract products to meet the requirements of the CMCVAMC Healthcare System. The contractor shall label all unit doses of delivered radiopharmaceuticals, with the amounts, preparation time, expiration time, date, etc., and provide a bar code labeled insert to allow scanning the product data into the nuclear medicine information management system (NMIS). If the Contractor s system varies from our current (Pinestar) NMIS information system, the Contractor shall provide their system as well as data migration, technical support and training of staff on its use at no additional Price to the Government. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE with the proper class and exposure levels on the outside of the shipping container. The contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. The contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, NHPP, FDA, OSHA and all other agency rules and Regulations (Federal and State). Radiopharmaceutical Returns for Credit: The Contractor shall be responsible to accept returns for full credit toward future orders only under the following conditions: a. Product(s) ordered or shipped in error. b. Product(s) damaged in shipment c. Concealed shipping damages d. Recalled product(s) e. Outdated products in unopened, original container (specifically authorized for return by manufacturer). The contractor shall invoice at least once per month showing period covered, billing date, name of preparation, quantity and amount. Schedule Only authorized VA Nuclear Medicine personnel shall place orders during the normal workday, and first delivery shall be received no later than 08:00 am the following workday to the CMCVAMC Nuclear Medicine Department. Depending on Medical Center patient care requirements, the contractor shall provide routine delivery and pick-up as many times as required by the CMCVAMC. The delivery order shall include the following information: Contracted item and quantity, time(s) of delivery, and applicable VA order number. Authorized CMCVAMC Personnel via telephone, fax, or e-mail shall only place orders. The contractor agrees to accept unused radiopharmaceutical and provide reimbursement per unit dose applicable towards future orders. After the contract award, the CMCVAMC will furnish the name(s) of Nuclear Medicine personnel who are authorized to place orders against the Contract. The Contractor will be furnished with a copy of the user s license as per Nuclear Regulatory Commission guidelines. Same-Day Delivery Same-Day Delivery requires delivery and receipt at the CMCVAMC Nuclear Medicine department no later than 2 hours after order is placed during normal business hours. Nuclear Medicine normal business hours are considered Monday through Friday: 6:30 am 4:30 pm except Federal Holidays. The following are Federal Holidays: New Year s Day Birthday of Martin Luther King, Jr. (day of observance) President s Day Memorial Day Independence Day Labor Day Columbus Day Veteran s Day Thanksgiving Christmas Day Pricing Items will be in unit dose, daily, and on an as needed basis in accordance with patient requirements. Key Assumptions All annual quantities are estimates, contractor will only be paid for items and quantities actually ordered and delivered.