Inactive

Page 3 of 6 THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY. This Request for Information (RFI) is intended for information and planning purposes only at this time; and... Page 3 of 6 THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY. This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. No solicitation exists. Therefore, do not request a copy of a solicitation. The Department of Veterans Affairs (VA), VISN 4, Network Contracting Office 4 (NCO 4), is seeking information and potential qualified sources capable of meeting the following minimum requirements and salient characteristics below for a brand name or equal to the PYLARIFY (Piflufolastaf F-18) Injection / Mfg. #PYL-C / NDC #71258-022-01 . STATEMENT OF WORK Lebanon VA Medical Center Part I: General Information Introduction: Fixed Price Procurement and Delivery of PET Isotope Pylarify (F-18 PSMA) to the Lebanon VAMC. Background: The VA Medical Center in Lebanon, PA, will be in receipt of a PET/CT scanner spring 2022 and is establishing a contract to meet the need for delivery, storage, inventory management, packaging and shipment preparation, distribution, and transportation for PET Isotope Pylarify (F-18 PSMA) in support of the VA Medical Center Nuclear Medicine needs. It is the intent of this contract to have a supply of PET Isotope Pylarify (F-18 PSMA) readily available for shipment/transportation and continuous Inventory Management Services during normal, and other than normal working hours as described in this Statement of Work. Offerors shall furnish and deliver F.O.B. Destination all items as listed in the Schedule of Supplies and Services and others that may be needed in the future. The Government prefers vendors who provide non-High Enriched Uranium sources (non-HEU). Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing PET radiopharmaceuticals. Scope: The contractor shall provide PET Isotope Plyarify (F-18 PSMA) and Inventory Management Services, in the way of barcoding, necessary to document receipt of listed PET isotope Pylarify (F-18 PSMA) for the Lebanon VA Medical Center. The contractor shall perform to the standards in the contract and meet all necessary Federal regulatory requirements and guidelines. Part II Work Requirement: Deliverables PET Isotopes estimates per year: Isotope Est volume F18 PSMA 70 Contractor shall provide up to two deliveries per day during normal business hours at approximately 6:30 am and 11:00am at no additional charge. Contractor shall ensure that orders placed each day (Monday Friday by 2:30PM) are available for delivery the next day. A second order may be placed each business day (by 10 AM) for same day delivery. If additional isotopes (M/F or holidays/weekends) then a delivery charge shall be added to the cost of the radiopharmaceuticals as specified. Contractor shall provide an adequate supply of contract products to meet the requirements of Lebanon VA Medical Center. Contractor shall label all supplies as to the type and amount of radiopharmaceutical, lot number, preparation time, expiration time, date, etc., and provide a bar labeled insert to allow scanning data into a nuclear medicine information management system. Contractor shall provide any software updates needed and available throughout the duration of the contract to properly record the dose data into a Nuclear Medicine Information System. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Contractor shall hold a current unrevoked NRC and/or agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material, and FDA license to produce and distribute radiopharmaceuticals for human administration. Contractor shall provide copy of their radioactive material license with their proposal. Contractor shall immediately notify the Contracting Officer and Contracting Officer Representative, upon any action by the NRC or an agreement state and/or FDA to suspend or modify the radioactive materials license. 10. Contractor shall meet all Nuclear Regulatory Commission (NRC), Department of Transportation, FDA, OSHA and all other agency rules and regulations (Federal and State). Contractor must maintain all certifications throughout the performance of contract. 11. Contractor shall provide evidence of special driver s licenses (competency) due to transporting hazardous materials. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, F.D.A., OSHA and all other agency rules and regulations (Federal and State). 12. Contractor shall test all products for Quality Control at an agreed upon frequency and only those products that pass quality control may be sent to the VA. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request. 13. Quantity of radioactivity, Calibration time and dose range for each requested radiopharmaceutical will be provided by the Nuclear Medicine service. If dose is not given in a range, then the quantity of radioactivity for the supplied radiopharmaceutical will not deviate more than ±20%. 14. Contractor shall pick up scheduled items, used and unused, for proper disposal at no cost to the Government. 15. Contractor shall perform quality control on each agent dispensed. 16. All defective or inferior products shall be replaced within the timeline specified at no costs to the VA. 17. Any substitutions of product shall have the written approval of the VA Nuclear Medicine Service and the Contracting Officer or his/her designee. 18. It is the Contractor 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 and the Nuclear Medicine Contracting Officer Representative Amy Landis utilizing the most expedient method. 19. Contractor shall accept returns for credit under the following conditions: Product(s) 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). 20. Contractor/supplier shall abide by (CFR 10) Title Code of Federal Regulations, which states: A Licensee may use for medical use only: a. By-product material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35, and the equivalent regulations of an Agreement State. b. Reagent kits that have been manufactured, labeled, packed, and distributed in accordance with the approval by the Commission pursuant to S32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. 21. Contractor must adhere to the provisions of Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI) as required by complying with rules governing the security, use and disclosure of protected health information by covered entities, including the Department of Veteran Affairs. GENERAL ORDERING Normal orders shall be placed during the workday, and delivery shall be required by 7:30 am the following workday to the Lebanon VA Medical Center, Nuclear Medicine Department. Contractors shall ensure that orders placed each day (Monday Friday by 4:30PM) shall be delivered by the next business day (Monday Friday by 6:30 AM. A second order may be placed each business day by 10AM, for same day delivery. If there is need for an additional delivery of Isotopes (Monday Friday or holidays/weekends) then a delivery charge can be added to the cost of the radiopharmaceuticals (See Schedule of Supplies and Services). Due to the demands of the Medical Center patient care requirements, contractor shall provide routine delivery and pick-up as many times as required by the Lebanon VA Medical Center. In the event that the requirements may be determined in advance, a longer delivery time may be scheduled accordingly. In accordance with the following: The delivery order shall include the following information: contract item (s) and quantity, time (s) of delivery, and applicable VA order number. Orders can be placed by the Lebanon VA Medical Center via telephone, fax, or e-mail. Ordering Contact Information: Contractor shall provide contact information for the placement of orders for items listed in the Schedule of Supplies and Services The Lebanon VA Medical Center CORs assigned to this contract will be the only individuals authorized to place orders under this contract: David Eckman, David.Eckman@va.gov TBD (Back-Up COR) POC: April Kurtz, April.Kurtz@va.gov Emergency Ordering Procedures: An added cost is provided IAW with line items 1 & 2 of the schedule of items for the base for emergency preparation and delivery service of radiopharmaceuticals at other than normal working hours. Normal business hours are considered Monday through Friday: 6:30 am 4:30 pm. The Lebanon VA Medical Center considers the following Emergency duty hours: Weekdays (Monday Friday) 4:30 pm 6:30 am Weekends (Saturday/Sunday) All hours Federal Holidays: A list of the expected Federal Holidays is as follows: New Year s Day, Birthday of Martin Luther King, Jr., Washington s Birthday, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically declared by the President of the United States to be a national holiday. Part III Supporting Information: Place of Performance Delivery Location: Radiopharmaceuticals shall be delivered to: (Room G025) located within the Nuclear Medicine Department Lebanon VA Medical Center 1700 S. Lincoln Ave Lebanon, PA 17042 Access to this room during non-business hours shall be obtained by contacting VA Police Service. Period of Performance: The Government is requesting a one (1) year contract with a period of performance, April 1, 2022, to March 31, 2023. Contracting Officer Representative: Delivery shall be coordinated with the designated Contracting Officer Representative (COR). Nominated COR: David Eckman Phone: (717) 272-6621 x6068 Email: David.Eckman@va.gov Note: The COR has no authority to change the terms and conditions of the awarded contract. Deliveries: All orders will be agreed upon between the contractor and the Department of Veterans Affairs prior to shipment. No delivery charge shall be made for additional deliveries during normal working hours, 7:00a.m.-4:00 Monday Friday. Emergency Deliveries: Requests for emergency doses shall be delivered within 90 minutes of placing the order. Emergency and priority studies consist of less than 20% of the daily schedule. Radioactive shipments prepared in advance to anticipate emergency or routine studies are not acceptable. After Hours delivery: Weekend (Saturday/Sunday) and all Federal Holiday (or any other day specifically declared by the President of the United States to be a national holiday) deliveries shall be made by contacting the Veterans Medical Center Police to unlock Room G025 for placement of the packages in the designated pass-through. Contractor Early Deliveries: When the Contractor offers an earlier delivery date and time than specified, the Government reserves the right to award whether in accordance with the requested schedule or in accordance with the earlier schedule offered by the contractor. If a contractor offers a longer delivery than that requested, the Government may award based on that schedule. If the contract offers no other delivery schedule, the delivery requested shall apply. Delivery proposed Delivery of supplies by the scheduled date will be complete except as otherwise authorized by the Ordering Personnel. The Government may terminate this contract in whole or in part if the contractor fails to meet the required delivery schedule. The Contractor shall be liable for a fixed, occurring amount until the Government may reasonably obtain delivery of similar supplies. The contractor shall not be charged with damages when the delay in delivery arises out of causes beyond the control and without the fault or negligence of the contractor. Delivery date and time specified may be adjusted by the Contracting Officer. The Contractor will be notified of this change at least seven (7) days prior to the original or adjusted delivery date. Delivery Commitment: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. All charges incurred for delivery shall be included in the fee schedule to include fuel surcharges. Contractor shall provide on an as-needed basis miscellaneous supplies and/or services including but not limited to the following: OSHA compliant monitoring devices. Sealed sources for QA procedures. Dose calibrator calibration. Annual calibration of survey meters. RSO safety audits for Federal compliance. Damages In-transit: Under FOB Destination procedures, any in-transit damage is the responsibility of the provider. The contractor is responsible for notifying the Contracting Officer or Contracting Officer Representative within 24 hours after loss or damage of material is known by the contractor. The contractor shall be responsible for initiating action to replace all damaged or missing material to the Government. Packaging and Shipment Preparation: All unit dose radiopharmaceuticals delivered must have a bar code with it so the dose can be scanned into the department s dose tracking system that it owns. All radiopharmaceuticals shall be delivered in ready-to-use unit dose form in lead-shielded containers. Plastic shrink wrap fitted at union of container cap and base should be present to ensure an untampered seal. Calibration/labels: All radiopharmaceuticals shall be calibrated and labeled with concentration, calibration, time, total volume, total activity, lot number and prescription number. Supplier Source Information: 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. Added charges: Contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the contractor. Replacements shall be received within three (3) hours of notification by the VA. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. 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. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 3. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. 6. SECURITY INCIDENT INVESTIGATION a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 7. LIQUIDATED DAMAGES FOR DATA BREACH a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (Made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least three (3) relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 9. TRAINING a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. Records Management Language for Contracts When Federal agencies acquire goods or services, they need to determine what Federal records management requirements should be included in the contract. Federal contractors often create, send, or receive Federal records. Federal contracts should provide clear legal obligations describing how the contract employees must handle Federal records. Agency records officers, procurement counsel, and acquisitions officers must discuss how to integrate records management obligations into their existing procurement processes. NARA has developed the following language to be included as an agency-specific term and condition in Federal contracts for a variety of services and products. The majority of contracts should include language on records management obligations, but each contract should be evaluated individually. For example, the data-rights paragraph (Paragraph 10 below) may not be appropriate for all contracts. Instead, agencies may be better served by one of the established data-rights clauses in the Federal Acquisition Regulations. This language should not replace specific records management requirements included within Federal information system contracts. RECORDS MANAGEMENT OBLIGATIONS A.  Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.  B.  Definitions Federal record as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.  The term Federal record: includes [Agency] records. does not include personal materials. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract. may include deliverables and documentation associated with deliverables. C.  Requirements Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safegua...