Q522--Intent to Sole Source Pharmaceutical PetNet Dosages | New Base plus

4 STATEMENT OF WORK Procurement of Amyvid and 18FDG in Shielded Delivery and Administration System Ralph H. Johnson VA Medical Center Radiology Nuclear Medicine Department 109 Bee Street Charleston, SC 29401 Part 1: General Information Introduction The Ralph H. Johnson VA Medical Center (RHJVAMC) administers fluorine-18 labelled fluorodeoxyglucose (FDG) radioisotopes for Positron Emission Tomography (PET) imaging on a daily basis for clinical nuclear medicine procedures. In addition, RHJVAMC also provides PET imaging studies utilizing Amyvid (Florbetapir), a radioactive diagnostic agent for Alzheimer s disease (AD). FDG and Amyvid are United States Food and Drug Administration (FDA) approved drugs for use in PET and are essential to insure our veterans are provided with optimal patient care. Background Since its development in 1976, FDG has had a profound influence on research in neurosciences. After injection of the FDG, the radioisotope will travel to areas that use glucose for energy, which closely correlates with certain types of tissue metabolism. The PET scanner will then form two-dimensional or three-dimensional images of FDG distribution within the body. In this way, it demonstrates body physiology and not simply body anatomy such as x-rays, CT s or MRIs. The subsequent discovery in 1980 that it accumulates in tumors underpins the evolution of PET as a major clinical tool in cancer diagnosis. FDG is now the standard radiotracer used for PET neuroimaging and cancer patient management. The images can be assessed by a Nuclear Medicine physician or radiologist to provide diagnoses of various medical conditions. Amyvid is used to produce PET scans that estimate the brain -amyloid neuritic plaque density in patients with cognitive impairment. -amyloid protein is a type of protein that forms in patients with AD and some other cognitive disorders. Neuritic plaques, also called amyloid plaques, are abnormal clumps of brain cells mixed with -amyloid protein. A negative Amyvid scan indicates few to no neuritic plaques and reduces the likelihood that any cognitive impairment is due to AD. A positive scan indicates moderate to frequent plaques. This amount of -amyloid plaque can be found in patients with AD, in patients with other types of cognitive impairment, and in older people with normal cognition. Amyvid and FDG are regulated by the United States Nuclear Regulatory Commission (USNRC) through RHJVAMC s radioactive material license (RAM) and administered under the supervision of the Radiation Safety Office (RSO) and Radiologist. Accordingly, procurement and use of these radiopharmaceutical drugs must meet federal regulations to ensure safety and minimize health risks to both the staff and patients. Hence, only qualified vendors that meet the FDA and USNRC regulations can provide these radiopharmaceuticals to the RHJVAMC. Scope Contractor shall provide all single-unit doses of FDG and Amyvid used for routine PET/CT studies and evaluation of Alzheimer s Disease, respectively, in Radiology s PET/CT department of the RHJVAMC located in Charleston, SC. The purpose of the SOW is to identify the vendor requirements necessary for procurement of unit doses of Amyvid and FDG Dose delivery must meet DOT regulations, USNRC ALARA, and Government weight guidelines. The deliveries must come from an FDA and USNRC licensed supplier. In turn, the radioisotopes delivered shall allow the RHJVAMC Department of Radiology to perform clinical imaging studies as required by necessary patient care protocols. D. Applicable Documents 10 Code of Federal Regulations Part 35: United States Nuclear Regulatory Commission- Medical Use of Byproduct Material 49 Code of Federal Regulations Part 173 Subpart I: Class 7 (Radioactive) Materials Department of Veteran Affairs Materials Permit: Reference # 030-01212 Amendment # 61 Part II: Requirements E. Ordering Requirements The contractor shall provide personnel for orders of FDG and Amyvid to be placed by RSO certified Nuclear Medicine personnel during standard hours of care Monday through Friday between the hours of 0700 (7:00 AM EST) and 1700 (5:00 PM EST). Orders will be placed almost exclusively on the business day prior to the scheduled delivery date. The contractor shall calibrate all radiopharmaceutical doses to ensure proper activity ranges ± 10% of the specified ordered dose per specific requirements provided by RHJVAMC personnel based on guidelines outlined in 10 CFR Part 35. The FDG dose activities shall be calibrated for either 7 mCi or 12 mCi ± 10% of activity, or as specified by RHJVAMC. The calibrated Amyvid dose activities shall be calibrated for 10 mCi ± 10% of activity, or as specified by RHJVAMC. The Contractor shall notify the RHJVAMC s PET/CT Department immediately should the inability arise to provide FDG and Amyvid doses by the required date and time. Notification shall be made within two (2) hours of the Contractor becoming aware of the inability to provide the required doses. F. Delivery Requirements In complying with ALARA (as low as reasonably achievable) requirements as well as USNRC recommendations for achieving and maintaining a safe work environment, RHJVAMC requires the qualified vendor to deliver each unit dose of FDG in a shielded dose administration container (referred to as a pig ), which is stored inside a shielded shipping container. This configuration provides the lowest reasonably achievable radiation exposure to the staff and patients at RHJVAMC. Each radiopharmaceutical must be properly compounded, dispensed, calibrated and delivered for a specific patient at a specific time on a specific date by the approved vendor. The dose activity (radioactivity) of Amyvid and FDG has a short half-life (110 minutes), which requires that the dose be delivered at a specific time and at the required dose activity in order for the imaging/therapy study to be properly performed. The contractor shall provide Monday to Friday deliveries at the times specified by the PET/CT technologist, provided RHJVAMC placed a sought order sometime during the business day prior to the required delivery day. Each dose shall be delivered and received by RHJVAMC no later than 30 minutes before the dose calibration time. Doses are to be delivered to the PET/CT department Hot Lab of RHJVAMC, located on the second floor of the hospital in Room B212E. A radiopharmaceutical shall not be considered delivered unless: (1) it is delivered in a proper dose administration and shipping system; (2) the radiopharmaceutical arrives at the specified point of destination; (3) the contractor/contractor s agent has placed the radiopharmaceutical in the custody of a RSO certified personnel; and (4) the radiopharmaceutical is delivered on time and at the specified dose activity. Other Requirements The production facility of the Amyvid and FDG must be approved by the FDA (or the approval request pending and on file with the FDA), with registration in good standing, to produce Amyvid and FDG for human use. The offeror must be licensed, with the license in good standing, by either the USNRC, or the relevant State Radioactive Materials Licensing Agency (provided that the State has an agreement with the USNRC which makes its approval a sufficient alternative to USNRC approval), for the production and/or distribution of FDG and Amyvid . This requirement may also be applied to any subcontractor, sub-subcontractor, manufacturer, carrier, or other entity which the offeror is relying upon to create or handle the FDG, depending on the offeror s performance approach. The packaging and transport of all deliveries shall meet relevant U.S. Department of Transportation requirements for radioactive materials. 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 that 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 contractors 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. 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. MARCH 12, 2010, VA HANDBOOK 6500.6 APPENDIX B B-1 VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE NOTE: This clause will undergo official rule making by the Office of Acquisitions and Logistics. The below language will be submitted for public review through the Federal Register. The final wording of the clause may be changed from what is outlined below based on public review and comment. Once approved, the final language in the clause can be obtained from the Office of Acquisitions and Logistics Programs and Policy. 1. SUBPART 839.2 INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS 839.201 Contract clause for Information and Information Technology Security: a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). b. In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources. 2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008) As prescribed in 839.201, insert the following clause: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. MARCH 12, 2010, VA HANDBOOK 6500.6 APPENDIX C C-1 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/subcontrator 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. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. 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. VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-2 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. MARCH 12, 2010, VA HANDBOOK 6500.6 APPENDIX C C-3 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. i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. 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…