Inactive

Radiopharmceuticals Nuclear Med Dept.

Inactive

STATEMENT OF REQUIREMENT 1. General Description: Radiopharmaceuticals, preparations of doses, and testing performed at the Vendor s facility must provided by a board-certified radiopharmacist and del... STATEMENT OF REQUIREMENT 1. General Description: Radiopharmaceuticals, preparations of doses, and testing performed at the Vendor s facility must provided by a board-certified radiopharmacist and delivered to the Nuclear Medicine Department in the St. Louis VA Medical Center (STL VAMC) located at 915 North Grand Boulevard St. Louis, MO 63106. Due to the critical need to have some PET/CT radiopharmaceuticals in a timely manner, the Vendor must be able to deliver doses to STL VAMC by 6:30 AM each day that doses are requested. Also, pertaining to the delivery of PET/CT radiopharmaceuticals, the Vendor may be required to provide a second daily delivery, after the initial daily delivery, if deemed necessary by the STL VAMC PET Imaging Department staff. 2. Duties: a. Vendor shall hold a current unrevoked US Nuclear Regulatory Commission (USNRC) and/or Federal Drug and Admnistration (FDA) license to produce and distribute radiopharmaceuticals for human administration, and a license to receive, and dispose of radioactive waste. b. Personnel assigned by the Vendor to perform services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. c. Vendor shall immediately notify the STL VAMC, upon any action be from the USNRC agreement state and/or FDA to suspend or modify the vendor or supplier. 3.  Administration: a.  Vendor will bill on a monthly basis. Obligation/PO number must be listed on the invoice. b.  All services rendered will be itemized by date of service, radiopharmaceutical provided, and unit cost. Orders can be placed orally by telephone, by fax, or by an electronic web based form.            4.  Security and Confidentiality: Vendor is responsible for maintaining Automated Data Processing (ADP) security. Vendor is responsible for maintaining patient information in the strictest confidence in accordance with the Privacy Act. Delivery personnel will be bonded by the Vendor.                     5.   Work Hours: STLVAMC PET Imaging Department Regular Work Hours: Monday through Friday, 6:00 AM to 3:30 PM. Holidays: New Year's Day, Martin Luther King's Birthday, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving, and Christmas, and any other day specifically declared by the President of the United States to be a national holiday. 6. Delivery: For all PET radiopharmaceuticals, orders normally will be placed by 3:30 PM. Delivery of radiopharmaceuticals shall be required by 6:30 AM the following work day. For all PET radiopharmaceuticals, due to the demands of the Medical Center care requirements, if the STL VAMC PET imaging department staff deems necessary, a second daily delivery will need to be arranged with the Vendor. This order will be placed in a reasonable amount of time to allow delivery within four hours of order placement. In the event that the requirements may be determined in advance, a longer delivery time will be scheduled accordingly for any radiopharmaceuticals. All deliveries will be made to the PET/CT department Rm: A-011 in the basement of Bldg 1 at John Cochran Medical Center. The delivery order shall specify: contract item (s) and quantity, time (s) of delivery and applicable VA order number. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards relating to shipment of radioactive materials. Deliveries will be supervised by the COR or their designee before beginning delivery operations. Vendor will contact the COR prior to delivery to arrange for delivery supervision. Radiopharmaceuticals not used will be returned for credit the next work day (including the bulk doses). If shipments are contracted to be delivered specifically on Mondays, but Monday is a holiday, then the shipment will take place the next regular work day. Time of delivery specified or mutually agreed to at the time of receipt of telephone,fax, or web order shall become mandatory. Failure to perform in accordance with the time of delivery may be grounds for termination of contract. 7. Person Authorized to Place Orders: In addition to the Contracting Officer, the COR is authorized to place orders under this contract, as well as any Certified Nuclear Medicine Technologist employed by the St. Louis VA Medical Center. 8. Contract Administration Data All contract administration functions will be retained by the Department of Veterans Affairs. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. Contracting Officer s Representative Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer, the designated representative for this contract will be determined at award. Acronyms and Definitions CDR: Contract Discrepancy Report. Report issued by the Government to the contractor to document a supply or service found to be unacceptable during contract performance. CLIN: Contract Line-Item Number. Unit of work (or service) to be performed (or delivered) by the contractor as a pay item. CO: Contracting Officer. A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings. COR: Contracting Officer s Representative. An individual, including a Contracting Officer s Representative (COR), designated and authorized in writing by the contracting officer to perform specific technical or administrative functions. QA: Quality Assurance. Actions taken by the government to assure contracted services meet PWS requirements. Personnel Non-Personal Services This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service s performing services herein. Such contract service s shall be accountable solely to the Contractor who, in turn, is responsible to the Government. Contractor Compliance with the Immigration and Nationality Act of 1952 The Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals. Hours of Operations Business hours for the VAMC follow: a. Administrative hours: Monday through Friday, 8:00 a.m. - 4:30 p.m. b. National Holidays: The 10 holidays observed by the Federal Government are: New Year s Day; Martin Luther King s Birthday; Presidents Day; Memorial Day; Juneteenth Independence Day Independence Day; Labor Day; Columbus Day; Veterans Day; Thanksgiving; Christmas; and any other day specifically declared by the President of the United States to be a national holiday. (c.) Off-Duty hours: Friday through Monday, 4:30 p.m. - 8:00 a.m.; Monday through Thursday, 4:30 pm 8:00 am. Quality Control CONTRACT PERFORMANCE MONITORING. The COR may perform surveillance of services by any of the methods listed below: a. Observing actual performance; b. Inspecting the services to determine whether or not the performance meets the performance standards; and c. Review of any other appropriate records. (1) When unacceptable performance occurs, the COR shall inform the Contractor and the Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file. When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor program manager. The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor has to present this corrective action plan to the COR. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer. (2) Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer representative(s); The Government shall periodically evaluate the Contractor performance by appointing a Contracting Officers Representative (COR) to monitor performance to ensure services are received. The Government representative(s) shall evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. The Government Contracting Officer shall make final determination of the validity of customer complaint(s). (3) If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may - (4) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.