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SOURCES SOUGHT NOTICE Description This Sources Sought notice is issued to identify and determine the level of interest among both Large and Small businesses including qualified VETBIZ registered Servi... SOURCES SOUGHT NOTICE Description This Sources Sought notice is issued to identify and determine the level of interest among both Large and Small businesses including qualified VETBIZ registered Service Disabled and Veteran Owned Small Businesses (SD/VOSB). Responses will assist VA planners in determining an appropriate acquisition approach and/or set-aside strategy which meets procurement regulations. This Request for Information Sources Sought Notice is looking for sources for the product described below: Radiopharmaceuticals and associated supplies for the Chillicothe VA Medical Center in Chillicothe, Ohio. Please see the attached DRAFT Statement of Work (below) for more requirement-specific information. The VA is contemplating use of a five-year indefinite-delivery/indefinite-quantity contract or a blanket purchase agreement to fulfill the needs of the Chillicothe VAMC. Interested vendors are requested to respond to this notice no later than 09:00 AM EST 12 October 202 via email to percy.johnson2@va.gov. Vendor response shall include the following: (a) Company name (b) Address (c) Point of contact (d) Phone and/or email of primary point of contact (e) Unique Entity Identifier/DUNS (f) Type of business (e.g., Large or Small) (g) A capability statement: Maximum of two (2) pages summarizing products offered matching the DRAFT Statement of Work requirements. Please email capability statements and/or questions to: percy.johnson2@va.gov. Telephone inquiries will not be accepted. The Government will not reimburse vendors for responding to this request for information. This sources sought is for market research purposes only and shall not be construed as a request for quotation. Attachment: DRAFT Statement of Work DRAFT STATEMENT OF WORK 1. Contract Title. Nuclear Medicine Isotopes 2. Background. The procurement of Radiopharmaceutical Isotopes is required to continue current standard of care for Nuclear Medicine patients at the Chillicothe VA Medical Center. This is a necessary medications to be able to perform a Nuclear Medicine exam. 3. Scope. The scope of this project is to procure Radiopharmaceutical Isotopes and deliver it to the Chillicothe VA Medical Center. The Radiopharmaceutical Isotopes will be delivered by the vendor. 4. Specific Tasks. This contract encompasses the vendor to deliver Radiopharmaceutical Isotopes at the Chillicothe VA Medical Center. Vendor shall provide routine delivery and pick-up of Radiopharmaceutical items during the hours of 8:00 a.m. to 4:30 p.m., Monday through Friday, excluding holidays. Orders can be placed via telephone, fax or email by staff nuclear medicine technologists or physicians assigned to the Nuclear Medicine Service at the Chillicothe VAMC and will indicate the required calibration time. Delivery personnel will be required to display a photo ID badge at all times. All routine deliveries of radiopharmaceuticals, ordered by 4:30 p.m. the previous day, shall be at the VA facility by at least 0.5 hours before the requested calibration time the next business day. All standing orders shall be delivered as routine. Emergency and additional request orders may be made and shall be delivered within one (1) hour of placement of the order, 24 hours a day, 7 days a week. Orders placed after 4:30 P.M. weekdays, and on weekends shall be considered an emergency. Emergencies are defined for the purpose of delivery timeframe requirements only and should not include a separate charge. Pre-calibrated doses should not expire within 4 hours of calibration time requested by the Nuclear Medicine Service. Pre-calibrated doses of F-18 and F-18 compounded doses shall not expire within 2 hours of the calibration time. Stat Orders (emergency doses ordered during normal business hours: 8:00 a.m. 4:30 p.m.) shall be delivered within one (1) hour of placement of the order. The 10 Federal Holidays observed by the Federal Government are: New Year s Day January 1 Martin Luther King s Birthday 3rd Monday in January Presidents Day 3rd Monday in February Memorial Day Last Monday in May Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25th The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday. All products provided under this contract shall meet all requirements of the Nuclear Regulatory Commission (NRC). All products provided under this contract shall be packaged and shipped in accordance with the requirements of the NRC and Department of Transportation (DOT). All products returned will also be packaged in accordance with the requirements of the NRC and DOT. All products provided under this contract shall be from an FDA approved source with an available NDC number from the manufacturer. Compliance with all OSHA manufacturing, packaging and shipping regulations is required. The awardee shall provide a copy of Type A package certification and certificates of DOT and OSHA training for couriers prior to the commencement of this contract. The contractor shall guarantee the quality of all radiopharmaceuticals. Quality control shall include percent tag and MO99 breakthrough as appropriate. The Contractor shall provide Quality Control on each agent dispensed. Only those products that pass quality control may be sent to the VA. The Contractor shall provide complete documentation on Quality Control results upon request. The contractor shall label all products to indicate the amount of radiopharmaceutical, preparation time, expiration time and date, comply with specific facility requirements. The contractor shall invoice at least once a month in accordance with VAAR 852.232-72, indicating the purchase order number, period covered, billing date, name of preparation, quantity, and dollar amount. Each radiopharmaceutical dose should be identified as a line item on the invoice, and hard copies of invoices shall be sent to: VAMC Chillicothe, 17273 State Route 104, Attn: Nuclear Medicine Service, Chillicothe, Ohio 45601. The contractor shall not add to the invoice the cost of overages or damaged products. Any cost incurred as a result of overages, or to replace damaged or incorrect products will be at expense to the contractor. Replacements shall be received within 48 hours of notification by the Chillicothe VAMC. The Contractor shall provide upon request, documentation of inventory, disposal and patient dose records, which documents compliance with Nuclear Regulatory Commission (NRC). RECALLED AND DEFECTIVE PRODUCTS: the Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor shall be liable for costs of processing recalls, i.e., administrative and clinical services to replace recalled / defective products. It is preferred that where applicable the contractor will provide Low Enriched Uranium (LEU) sourced Tc products vice High Enriched Uranium (HEU) sourced. The contactor should indicate which products and in which years that products will come from LEU sources. This will begin on contract start date and continue throughout the remainder of the term of the contract. Performance Period will begin on the date of contract award and extend for twelve (12) months with four (4), one (1) year option periods to extend the term of the contract. Deliverables: 5. Performance Monitoring Performance will be monitored by detailing if the vendor delivers the Radiopharmaceutical Isotopes in the manner described in tasks above. 6. Security Requirements The C&A requirements do not apply, and that a Security Accreditation Package is not required. Access to VA Information and VA Information Systems a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. A Business Associates Agreement (BAA) is not required per VA Information and Information System Security/Privacy Requirements for IT Contracts dated August 2008 if the following exception applies:                  -Contract Personnel with limited and intermittent access to equipment connected to facility networks on which limited VA sensitive information may reside, including medical equipment contractors who install, maintain, and repair networked medical equipment such as CT scanners, EKG systems, ICU monitoring, etc. In this case, Veterans Health Administration facilities must have a duly executed VA Business Associate Agreement (BAA) in place with the vendor in accordance with VHA Handbook 1600.1, Business Associates, to assure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in addition to the contract. Contract personnel, if on site, should be escorted by VA IT Staff. 7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). N/A 8. Other Pertinent Information or Special Considerations. N/A Identification of Possible Follow-on Work. Potential follow-on work will be detailed in the warranty information for the equipment. b. Identification of Potential Conflicts of Interest (COI). None c. Identification of Non-Disclosure Requirements. None d. Packaging, Packing and Shipping Instructions. The vendor will deliver Radiopharmaceutical Isotopes to the Chillicothe VA Medical Center as listed: Chillicothe VA Medical Center Bldg. 31, Radiology Department 17273 State Route 104 Chillicothe, OH 45601 The delivery will be arranged with our Nuclear Medicine Technologist at the Chillicothe Facility. e. Inspection and Acceptance Criteria. Nuclear Medicine Technologists will inspect and have the final decision on acceptance of the isotopes. 9. Risk Control. N/A 10. Place of Performance. All provided work will be done at the Chillicothe VA Medical Center listed above. The contracted price on the quote includes all isotope. 11. Period of Performance. The period of performance is pending which will be determined as the isotopes are delivered. 12. Delivery Schedule. To be delivered after awarded contract to the Chillicothe VA Medical Center as listed above.