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65--Notice of Intent to Sole Soure DatScan

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36C24419Q0670Federal

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The Corporate Michael J. Crescenz VA Medical Center in Philadelphia requires a sole source contract for brand name DaTscan (Ioflupane I 123 injection), a radiopharmaceutical agent necessary for the visual assessment and diagnosis of parkinsonian syndrome. This unique imaging agent is critical to the Nuclear Medicine Department's diagnostic procedures, and the VA has identified only one suitable vendor capable of supplying it. The contract includes delivery of unit doses with appropriate labeling and barcoding for integration into the medical center’s nuclear medicine information system, along with compliance with all regulatory requirements from agencies such as the Nuclear Regulatory Commission, FDA, and Department of Transportation. The vendor must support next-day delivery, emergency deliveries within a 45-minute window, and provide electronic dose tracking, quality control, and monthly invoicing. The contract stipulates that only authorized VA personnel can place orders, which must be delivered directly to the Nuclear Medicine Department at the Philadelphia facility. The vendor is responsible for handling returns under specific conditions including errors, damages, recalls, or outdated product. Packaging must be properly labeled as radioactive, and the contractor must provide technical support and training if their information management system differs from the center's existing system. Overall, the contract emphasizes strict adherence to professional standards, regulatory compliance, reliable supply, and responsiveness to urgent medical needs.

General Info

Sole source contract for DaTscan delivery, regulatory compliance, next-day and emergency supply.

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

PA

Set-Aside

NONE

Documents

0

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special-notice

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 244-NETWORK Contract Office 4 (36C244)
ContactsNo contacts available
OfficePITTSBURGH, PA, 15215, USA
Office AddressPITTSBURGH, PA, 15215, USA
ContactsNo contact information available

Full Description

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Notice of Intent to Sole Source 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, pease provide your entities capability statement to Caroline Robinette, Contracting Officer by 4:30 p.m. Friday, April 10, 2019 via email to contact@example.gov. 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 36C24419Q0670 in the subject of the email. ***This is not a request for quote, no quotes should be sent in response to this notice. Statement of Need: 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.

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