Inactive

Sources Sought Synopsis Only This is not a solicitation announcement. This is as sources sought synopsis only. The purpose of this synopsis is to gain knowledge of potential qualified sources and thei... Sources Sought Synopsis Only This is not a solicitation announcement. This is as sources sought synopsis only. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification (hubzone, 8(a), small business, small disadvantage business, Veteran owned small business (VOSB), Service disabled Veteran owned small business (SDVOSB), or large business) relative to NAICS 325412, Pharmaceutical Preparation Manufacturing, with a size standard of 1,250 employees. Note that if VA s pending market research establishes that two or more VOSB or SDVOSB, who are certified and verified in VA s Vendor Information Pages (VIP) site https://www.vip.vetbiz.gov, can perform the service, VA will set aside the underlying solicitation per 38 U.S.C. §8127. Responses to this synopsis shall be used by the Government to make appropriate acquisition decisions. After review of the responses to this source sought synopsis, a solicitation announcement may be published on SAM.gov and/or GSA eBuy. Responses to this source sought synopsis are not considered adequate responses to the solicitation announcement. All interested offerors must respond to the solicitation announcement in addition to responding to this source sought announcement. General Requirements: The Department of Veterans Affairs (VA), Network 7 Contracting Office. Product Information: Radiopharmaceutical and Non-Radio Pharmaceutical Items for Ralph H. Johnson VA Medical Center, Charleston, South Carolina as per the statement of work for a base year with options. PERFORMANCE WORK STATMENT RADIOPHARMACEUTICAL AND NON-RADIO PHARMACEUTICAL ITEMS The Ralph H. Johnson VA Medical Center requires delivery of Radiopharmaceutical and Non-Radio Pharmaceutical Items unit doses in order to perform a variety of Nuclear Medicine diagnostic procedures. The twenty-four (24) hours shelf life of Radiopharmaceutical prevents stocking and storing. Radiopharmaceutical unit doses cannot be ordered prior to twenty-four (24) hours of a patient treatment; therefore, on-time daily delivery is vital to patient care. Requests will be placed daily, if required, for next day delivery during normal working hours of 7:00 am 5:00 pm Monday through Friday excluding Federal Holidays, consisting of: New Year s Day Martin Luther King s Birthday President s Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Contractor shall provide all labor, supervision, and transportation necessary to meet the twenty-four (24) hours delivery for normal daily unit does and three (3) hours for emergency deliveries. Quantities expressed in the schedule are estimates based on historical usage for one year. However, quantities and types of Radiopharmaceuticals may vary based on patient demand. It is understood that the contractor must perform the services based, in part, on information furnished by the Ralph H. Johnson VA Medical Center; however, the contractor 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. Contractor shall perform these services with a standard of care, skill, and diligence normally provided by a professional organization in the performance of similar services. CAPABILITY OR PERFORMANCE: Manufacturing of radiopharmaceutical isotopes requires pharmaceutical industry expertise within the safety constraints of a nuclear facility. All Radiopharmaceutical Items and Non-Radio Pharmaceutical Items are to be furnished by contractor in strict accordance applicable local, state and federal laws governing the receipt, handling, preparation and delivery of these isotopes for human use. Contractor shall provide the protocol followed (such as Food and Drug Administration (FDA) and or professional standards or guidelines) in determining expiration time or date on Radiopharmaceutical doses. FINANCIAL RESPONSIBILITY: The required Radiopharmaceuticals shall be furnished from an established business that is financially responsible and able to show evidence of reliability, ability, experience, equipment, and personnel directly employed by the business and supervised by them to render prompt and satisfactory service. AUTHORIZED STAFF TO PLACE ORDERS: The Radiopharmaceutical orders are to be placed by authorized Nuclear Medicine Professional staff. Upon award, the contractor will be furnished with the names of the Ralph H. Johnson VAMC personnel that are authorized to place orders against the contract. The following personnel are authorized to telephone and/or fax Radiopharmaceutical orders: Supervisory Nuclear Medicine Technologist Nuclear Medicine Technologists Other VA Medical Center Staff as designated DELIVERY: All Radiopharmaceutical Items and Non-Radio Pharmaceutical Items shall be ordered as needed by the Nuclear Medicine staff, for next day delivery. Requests will be placed daily during normal working hours of 7:00 am 5:00 pm Monday through Friday excluding Federal Holidays. All Radiopharmaceuticals shall be delivered in properly shielded containers with disposable impenetrable biohazard liners. Shipping containers and their labeling must comply with all federal and state regulations. Copies of the Quality Control Information on the shipping certificate are to be sent DAILY to the Nuclear Medicine Section, Ralph H. Johnson VA Medical Center Charleston, South Carolina. All deliveries shall be delivered to the Nuclear Medicine technologist on duty at the Ralph H. Johnson VAMC, Nuclear Medicine (secured receiving area), 109 Bee street, Room B206C; Charleston, SC 29401-5799. If deliveries are to be received before 0700 Monday through Friday, Contractor must be escorted to the hot lab by VA Police. Delivery personnel will be required to sign in and out of visitor s logbook located in Nuclear Medicine hot lab before leaving. The first daily delivery shall be made to Nuclear Medicine (secured receiving area) by 7:00 a.m. unless prior authorization arrangements have been made. Delivery shall be made directly to Nuclear Medicine Technologist, Nuclear Medicine (secured receiving area), Room B206C. Requests for emergency delivery during regular work hours (Monday through Friday 7:00 am-5:00 pm) shall be delivered within three (3) hours of placing the order. If the ordered Radiopharmaceutical is not available and cannot be delivered to the Ralph H. Johnson VAMC when needed; Contractor shall notify the VA Nuclear Medicine Department within one (1) hour of emergency request and four (4) hours of non- emergency request. Contractor shall obtain the needed doses from another source, including another Radiopharmacy, to be delivered as near the requested time in order to provide timely care to the Veteran patients. Contractor may only substitute another Radiopharmaceutical for the requested one with VA Nuclear Medicine and contracting office s approval. When this is done, the VA will pay for the lower priced Radiopharmaceutical. All charges incurred for delivery shall be included in the fee schedule to include fuel surcharges. No delivery charge shall be made for additional deliveries during normal working hours of Monday Friday between the hours of 7:00 am-5:00 pm. Delivery personnel will be bonded by the contractor. Contractor shall provide supporting documentation of DOT certification for transport of Radiopharmaceuticals. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. Vendor will provide accurate emergency phone contact information for orders that are placed after normal working hours. LICENSURE: Contractor shall provide verification of a valid radioactive material license issued by the SC State Department of Health/Division of Radiological Health or the U.S. Nuclear Regulatory Commission. Proof of such licensure will be considered as verification that the Contractor has approved distribution procedures in place to ensure security of radioisotopes during receipt, preparation and delivery, as well as required training for delivery personnel and any others that may come in contact with Radiopharmaceuticals. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, and all other Federal and State agency rules and regulations. Contractor shall provide the protocol followed (such as FDA and or professional standards or guidelines) in determining expiration time or date on radiopharmaceutical doses. Contractor shall state what procedures or guidelines are followed to ensure an aseptic environment. Contractor shall provide steps followed to ensure purity and sterility during preparation of Radiopharmaceuticals. Contractor shall declare the steps taken daily to ensure such efficacy. Contractor shall guarantee of the quality and efficacy of labeled compounds (Radiopharmaceuticals). Contractor shall provide MSDS sheets (Material Safety Data Sheets) and updates as necessary on all delivered products for the medical center. Contractor shall be Occupational Safety and Health Administration (OSHA) compliant. OSHA needle stick legislation requires that healthcare facilities must: Annually update their Exposure Control Plan (ECP) Use appropriate sharps devices or needleless systems Solicit frontline employee input to assist in the identification, evaluation and selection of new technology Establish sharps injury log to better track needle sticks To further ensure safety, Contractor shall: meet applicable regulatory requirements for USP <795>, USP <797>, USP <823> and cGMP Part 212 ensure the integrity of each prescription by complying with stringent internal quality processes and standard operating procedures offer quality and safety-related continuing education courses on USP<797>, cGMP and radiation safety principles utilize safety products, to protect against needle sticks and contamination from blood borne pathogens use adequate syringe shields, to reduce radiation exposure. The Contractor must provide evidence that they have the ability to provide TC-99m from facilities that produce non-HEU (High Enriched Uranium) radioisotopes. NOTE-ALL Technectium-99m (Tc-99m) SHALL BE PROCURED FROM NON-HEU companies. QUALITY CONTROL MANUAL: Contractor shall provide a copy of their pharmacy s current Quality Control Manual. Contractor shall discuss any discrepancies in results. Copies of the Quality Control Information on the shipping certificate are to be sent DAILY to the Nuclear Medicine Section, Ralph H. Johnson VA Medical Center Charleston, South Carolina. RECORD KEEPING / DOCUMENTATION: Accurate records must be kept for quality control, all inventories of shipments, all radiation safety requirements, all radiopharmaceutical characteristics and patient identification. Contractor shall meet all Nuclear Regulatory Commission, department of Transportation, National Health Physics Program, Food and Drug Administration, Occupational Safety and Health Administration, and all other agency rules and regulations (Federal and State). This information must be provided with every shipment. QUALITY MANAGEMENT PROGRAM (QMP): Contractor shall provide its Quality Management Program (QMP). This program shall include, but not limited to: The Contractors procedure for the preparation of Radiopharmaceuticals Where preparation of Radiopharmaceuticals is carried out. Quality Control guidelines the Contractor follows for the dispensing, packaging and delivery of Radiopharmaceuticals for human use Verification of the steps followed to test labeling efficiency of Radiopharmaceutical kits and the frequency of this testing. The contractor shall test all products for quality control periodically and only those products that pass quality control may be sent to Ralph H. Johnson VAMC. The testing and the detailed report shall be furnished to Ralph H. Johnson VAMC at no additional cost. All quality control testing/procedures shall be performed as required by Federal and State regulatory agencies. RADIOACTIVE LABEL & LABEL DOSE: Contractor shall label all unit doses of delivered Radiopharmaceuticals with the amounts, preparation time, expiration time and date, etc. and provide a bar labeled insert to allow scanning data in the nuclear medicine information management system (NMIS). If the contractor's system varies from the current (BioDose) NMIS information system, the contractor shall provide their system as well as data migration, technical support, and training to staff on its use at no additional cost to the government. All Radiopharmaceuticals shall be calibrated and labeled with concentration, calibration time, total volume, total activity and expiration time and date. All technetium products shall be tested for molybdenum contamination and the amount of molybdenum present shall be stated. Each syringe and vial that contains unsealed byproduct material must be labeled to identify the radioactive drug. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded. All packaging of radioactive materials must be clearly labeled "radioactive" with the proper class and exposure levels, preparation time, expiration time and date and VA order number on the outside of the shipping container in order to comply with specific requirements. All shipping containers must be free of radioactive contamination both inside and outside and adequately packaged to prevent damage during handling and storage. Contractor must supply with each shipment /order/delivery a system for spent (used) syringes, which meets OSHA's Bio Hazard Policy/ Regulations and is needless. Contractor shall provide steps followed to ensure purity and sterility during preparation of Radiopharmaceuticals. Contractor shall state what procedures or guidelines are followed to ensure an aseptic environment. Contractor shall guarantee of the quality and efficacy of labeled compounds (Radiopharmaceuticals). Contractor shall declare steps taken daily to ensure such efficacy. CREDIT: Contractor shall offer credit for unit doses that are not to be used or cancelled. The Ralph H. Johnson VAMC shall require credit statements (itemized returned doses) and monthly invoices. An electronic daily dose tracking system should be available for the Medical Center s use in certifying and tracking per patient doses delivered. There will be no additional fees added to the invoices outside of the schedule/ price list that is provided by the vendor. This includes delivery fees, daily fees, service fees, dose prep fees and dose disposal fees. Contractor shall accept returns for credit under the following conditions: Product(s) ordered or shipped in error Product(s) damaged in shipment Concealed shipping damages Recalled product(s) Outdated products in unopened, original container (specifically authorized for return by manufacturer) Unused doses of patients who fail to keep their appointments. Incorrectly delivered dose for any reason shall be credited for the full amount. Incorrectly delivered doses shall not exceed one per month. Recalled dose(s) for any reason shall be credited for the full amount. It is the offeror s responsibility to provide the Ralph H. Johnson VAMC with recall notices on any product that has been delivered to the Nuclear Medicine Department may be defective. Notification shall be made to the Contracting Officer Representative (COR) via the most expedient method. Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one (1) per quarter; four (4) per year, from date of award. Emergency call back fees shall not be charged for regular work hours (Monday Friday 7:00 am-5:00 pm) on days not observed as a holiday by the VA, i.e. Christmas Eve, Good Friday, etc. The contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the contractor s expense. Replacements shall be received within forty-eight (48) hours of notification from the Ralph H. Johnson VAMC. Cold kits shall be returned to vendor for credit or replacement if expiration date is exceeded. PERFORMANCE/QUALITY: Contractor shall have available an adequate supply of the contract products to meet the requirements of the facilities listed above at its distribution points. Incorrectly delivered doses shall not exceed one (1) per month. Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one per quarter, i.e. four (4) per year. It is the offeror s responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer Representative via the most expedient method. All technetium products shall be tested for molybdenum contamination and the amount of molybdenum present shall be stated. Contractor shall provide complete documentation of quality control results upon request. Product information including supplier s source of Radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier s license and procedures shall be provided at no additional charge. Contractor will perform quality control on each agent dispensed. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Only those products that pass Quality Control may be sent to the VA Nuclear Medicine Service. The supplier will demonstrate documentation of Quality Control performance of any item upon request of the VA Nuclear Medicine Service. All products are purchased subject to acceptance by the VA, Nuclear Medicine Service. Products that fail to meet Quality Control criteria of Nuclear Medicine will not be accepted. Products will be rejected and may be discarded if found unsatisfactory by the Nuclear Medicine s Quality Control when they are received, or later if deterioration of the product occurs before the expiration date. The VA will not be financially liable for unacceptable materials. Product information including supplier's source of Radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier's license and procedures shall be provided upon request at no additional charge. INVOICING: Invoices shall be paid monthly in arrears. Invoices shall show period covered, billing date, name of preparation, quantity and amount. Contractor shall submit certified invoices monthly within 15 days after the end of billing month to the Contracting Officer s Representative (COR) via e-mail to be reviewed for accuracy prior to submission to the Department of Veteran Affairs Financial Services Center for processing. Should the COR find discrepancies; contractor shall correct any discrepancies identified within two (2) business days and provide the Contracting Officer s Representative (COR) with the revised invoice. QUALIFICATIONS: Personnel assigned by the contractor to perform the services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by VA Facility Director. PERSONNEL POLICY: The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for these personnel: worker's compensation professional liability insurance health examinations, income tax withholding and Social Security payments. Such personnel shall not be considered VA employees for any purpose and shall be considered employees of the contractor. ~END OF PWS~ In response to this announcement. If you are interested and capable of providing the required services, please complete the information below: Company Name: Address: Contact Name: Phone No: Email: DUNS: This notice is neither a request for competitive proposal nor solicitation of offerors. This notice is to assist the VA in determining sources only and a solicitation is currently not available. Information received because of this notice shall only be considered solely for the purpose of determining whether to conduct a competitive procurement and the type of set-aside if appropriate. This notice does not represent a commitment by the Government to pay for costs incurred in the preparation and submission of information or any other costs incurred as a response to this announcement. Responses to this notice shall be submitted via email to darius.crane@va.gov Telephone responses shall not be accepted. Responses must be received no later than Jun 04, 2021 by 1:00 p.m. EST. In your response to this notice pace in the subject line of your email ATTENTION: 36C24721Q0755 ISOTOPES If a solicitation is issued it shall be announced later and all interested parties must respond to that solicitation announcement separately from this response. The form attached to this source sought notice may be used to make it easier for the contractor to respond to this source sought request. However, any format may be used if the required information is provided. Responses to this source sought notice is not a request to be added to a prospective bidders list or to receive a copy of the solicitation.