BRAND NAME OR EQUAL THYROID UPTAKE AND WELL SYSTEAM
STATEMENT OF WORK THYROID UPTAKE SYSTEM PROJECT SCOPE AND REQUIREMNTS: The Contractor shall provide the equipment, delivery, and warranty for one (1) Thyroid Uptake System Brand name or Equal for VA N... STATEMENT OF WORK THYROID UPTAKE SYSTEM PROJECT SCOPE AND REQUIREMNTS: The Contractor shall provide the equipment, delivery, and warranty for one (1) Thyroid Uptake System Brand name or Equal for VA North TX that is compatible with other thyroid uptake systems at VA North TX. The equipment will be in the Nuclear Medicine Department of the Dallas VA Medical Center. The physical address of housing this equipment is as follows: VA North TX Health Care System Nuclear Medicine Service—115 Dallas, TX 75216 Contractor will provide instructional training upon delivery. Minimum one-year full-service warranty required. This to include parts, and other industry standard features. Must meet or exceed all diagnostic imaging industry safety standards. Prior to acceptance of equipment, the equipment must pass all acceptance testing, which at a minimum includes accrediting body standards, if required. Trade in of Thyroid Uptake System is to be included. Minimum Equipment Requirements: Captus 4000e Thyroid Uptake System Thyroid Uptake Stand Computer – 20” All in One Touch Screen Flat Panel, Windows 8 platform Ink Jet Printer Collimator Well Counter Multichannel Analyzer Interface PC Board Fully Automated Quality Assurance Section Four Thyroid Uptake predefined protocols Wipe Tests MCA DICOM interface (Optional) Bioassay Custom Protocols PERSONNEL CLEARANCES AND PRIVACY CONSIDERATIONS: The Vendor will ensure that their personnel and subcontractor personnel meet the privacy standards as set forth by HIPPA (Health Insurance Portability and Accountability Act of 1996) with respect personal and confidential information that they may come upon, while servicing medical equipment DOCUMENTATION: Contractor will provide the COR, and/or the Nuclear Medicine Service’s designee with individual written reports which describe the maintenance and repair service performed on the equipment in sufficient detail so as to be acceptable by field inspectors of the Joint Commission of Accreditation of Healthcare Organizations. This shall include a list of all parts replaced, all service performed as well as a statement that the equipment is operating per manufacturer’s specifications after repair. The service report will be signed by the contractor’s service technician, and by designated VANTHCS personnel. A copy will be given to the VANTHCS for their internal records. HOURS OF WORK: Hours of work for preventive maintenance, emergency repairs, and deliveries are defined as Monday through Friday from 8:00 a.m. to 4:30 p.m., excluding federal holidays or as otherwise arranged with the Contracting Officer Technical Representative (COTR) and/or Biomedical Engineering Team. The following holidays observed by the Federal Government are: New Year’s Day Birthday of Martin Luther King, Jr. (day of observance) Washington’s Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day (Any other day designated as a National Holiday by the President of the United States.) Documentation: At the completion of each service call or scheduled maintenance (if needed and is purchased through this procurement), the contractor shall provide a written service report to the primary and/or alternate contact person. This report should clearly indicate the following: Date of Service Name of vendor service technician/engineer Type of service performed Model and Serial number if applicable VA barcode (EE#) of the component of the system if applicable Description of the service completed List of any parts replaced Preventive Maintenance: If applicable for any ancillary equipment: The Contractor shall perform annual preventive maintenance (PM) procedures during the contract year as arranged with the COTR. Preventive maintenance procedures shall be in accordance with the published preventive maintenance manuals for the equipment listed in the schedule. The Contractor shall utilize the Original Equipment Manufacturer’s established procedures and checklists, (or Contractor-supplied equivalent satisfactory to the COTR). A Field Service Report shall be supplied to the COTR at the completion of each preventive maintenance procedure. Preventive maintenance procedures shall include, but are not limited to, the following: Cleaning of equipment (not housekeeping). Completing Original Equipment Manufacturer field service updates for operational and reliability engineering change notices. Aligning, calibrating and lubricating the equipment. Performing remedial maintenance of non-emergent nature. Testing and replacing faulty and worn parts. Inspecting/replacing electrical wiring and cables for wear and fraying. Inspecting all mechanical components including, but not limited to, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, and motors for mechanical integrity, safety, and performance to Original Equipment Manufacturer specifications. Returning the equipment to operating condition defined in the Original Equipment Manufacturer specifications. Replacing any Original Equipment Manufacturer labels, decals, and/or warning tags that are not legible. Providing documentation of services performed. The Contractor shall notify the COTR of the existence or development of any defects in, or repairs to the equipment covered under this contract which the Contractor considers he/she is not responsible for under the terms of the contract (such as operator misuse). All exceptions to the Preventive Maintenance Inspection schedule shall be arranged and approved in advance with the Contracting Office. Parts: The Contractor shall furnish all parts as necessary to maintain the equipment, covered by this contract, in accordance with the Conformance Standards Section. The Contractor stipulates that he/she has ready access to new standard parts (manufactured, supplied by the manufacturer, or equal thereto). All parts supplied shall be of current manufacture and have full compatibility with existing equipment. Documentation of intended parts source(s) shall be provided to the Contracting Officer upon request. Coverage shall include priority parts delivery including any shipping and handling fees. Competency of Personnel Servicing Equipment: The Contractor’s staff shall include a “fully qualified” Field Service Representative assigned to this area and a “fully qualified” Field Service Representative who shall serve as the backup. “Fully qualified” is based upon training and on experience in the field. For training, the Field Service Representatives must have successfully completed a formalized training program for the equipment covered under this contract. For field experience, the Field Service Engineers must have a minimum of one (1) year of experience providing preventive maintenance and emergency repair services on the same make and model of equipment covered under this contract. Test Equipment: Upon request of the COTR or the Contracting Officer, the Contractor shall provide a copy of the current Calibration Certification of all test equipment which is to be used by the Contractor to perform service under this contract. Calibration of equipment shall be traceable and in conformance with test equipment Original Equipment Manufacturer standards. Safety Requirements: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer shall notify the Contractor of any safety issues and the action necessary to correct these issues. Such notice, when served on the Contractor or his representative at the work site, shall be deemed sufficient for the corrective actions to be taken. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the Contractor in default. Contracting Officer Technical Representatives: Prior to contract award, the Contracting Officer shall designate a VA Medical Center employee as the COR. VANTHCS will appoint one (1) COR for this contract from Nuclear Medicine Service. When a service call has been placed, the contractor will contact the Nuclear Medicine Service at (214) 857-0132, and the Biomedical Engineering Service at (214) 857-1020. All vendors will sign in & out with biomedical engineering prior to reporting to the Nuclear Medicine Service. All work coordination shall be made through the COR. The Contractor shall be provided a copy of the letter of delegation authorizing the COR at the commencement of the term of the contract. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer. Information technology security requirements: 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. The contractor shall comply with all Federal laws and regulations the VA has developed when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor. The information made available to the contractor by VA for the performance of this contract will be used only for the purposes of performance under this contract. The certification and accreditation requirements do not apply to this requirement and a security accreditation package is not required. RECORDS MANAGEMENT STATEMENT 1. 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 safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. 3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. 4. [FACILITY] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [FACILITY] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [FACILITY]. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [FACILITY] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). 6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [FACILITY] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. 7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [FACILITY] policy. 8. The Contractor shall not create or maintain any records containing any non-public [FACILITY] information that are not specifically tied to or authorized by the contract. 9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. 10. The [FACILITY] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [FACILITY] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. 11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. PRIVACY 1. Contractors and any Subcontractors must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996. This includes both the Privacy and Security Rules published by the Department of Health and Human Services (HHS). 2. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities, Veterans Health Administration (VHA). In accordance with HIPAA, the Contractor may be required to enter into a Business Associate Agreement (BAA) with VHA. 3. Business associates must follow VHA privacy policies and practices when applicable. All Contractors and business associates must receive privacy training annually. 4. For Contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or Contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually Identifiable Health Information as determined by VHA. 5. For Contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required upon request. U. General Security 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. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS 1. A Contractor/Subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, sub-Contractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. 2. 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. 3. 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. 4. Custom software development and outsourced operations must be 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. 5. 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 INFORMATION CUSTODIAL LANGUAGE 1. 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). 2. 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 sub-Contractor 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. 3. 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. 4. 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. 5. 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. 6. If VA determines that the Contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be enough 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. 7. 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. 8. 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. 9. 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. 10. 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. 11. Notwithstanding the provision above, the Contractor/sub-Contractor 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. 12. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the Contractor/sub-Contractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. GENERAL RULES OF BEHAVIOR 1. Rules of Behavior are part of a comprehensive program to provide complete information security. These rules establish standards of behavior in recognition of the fact that knowledgeable users are the foundation of a successful security program. Users must understand that taking personal responsibility for the security of their computer and the information it contains is an essential part of their job. 2. The following rules apply to all VA Contractors. I agree to: (a) Follow established procedures for requesting, accessing, and closing user accounts and access. I will not request or obtain access beyond what is normally granted to users or by what is outlined in the contract. (b) Use only systems, software, databases, and data which I am authorized to use, including any copyright restrictions. (c) I will not use other equipment (OE) (non-Contractor owned) for the storage, transfer, or processing of VA sensitive information without a VA CIO approved waiver, unless it has been reviewed and approved by local management and is included in the language of the contract. If authorized to use OE IT equipment, I must ensure that the system meets all applicable 6500 Handbook requirements for OE. (3) Not use my position of trust and access rights to exploit system controls or access information for any reason other than in the performance of the contract. (4) Not attempt to override or disable security, technical, or management controls unless expressly permitted to do so as an explicit requirement under the contract or at the direction of the COTR or ISO. If I am allowed or required to have a local administrator account on a government-owned computer, that local administrative account does not confer me unrestricted access or use, nor the authority to bypass security or other controls except as expressly permitted by the VA CIO or CIO's designee. (5) Contractors’ use of systems, information, or sites is strictly limited to fulfill the terms of the contract. I understand no personal use is authorized. I will only use other Federal government information systems as expressly authorized by the terms of those systems. I accept that the restrictions under ethics regulations and criminal law still apply. (6) Grant access to systems and information only to those who have an official need to know. (7) Protect passwords from access by other individuals. (8) Create and change passwords in accordance with VA Handbook 6500 on systems and any devices protecting VA information as well as the rules of behavior and security settings for the system in question. (9) Protect information and systems from unauthorized disclosure, use, modification, or destruction. I will only use encryption that is FIPS 140-2 validated to safeguard VA sensitive information, both safeguarding VA sensitive information in storage and in transit regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA. (10) Follow VA Handbook 6500.1, Electronic Media Sanitization to protect VA information. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders. (11) Ensure that the COTR has previously approved VA information for public dissemination, including e-mail communications outside of the VA as appropriate. I will not make any unauthorized disclosure of any VA sensitive information through the use of any means of communication including but not limited to e-mail, instant messaging, online chat, and web bulletin boards or logs. (12) Not host, set up, administer, or run an Internet server related to my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA unless explicitly authorized under the contract or in writing by the COTR. (13) Protect government property from theft, destruction, or misuse. I will follow VA directives and handbooks on handling Federal government IT equipment, information, and systems. I will not take VA sensitive information from the workplace without authorization from the COTR. (14) Only use anti-virus software, antispyware, and firewall/intrusion detection software authorized by VA. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with VA. (15) Not disable or degrade the standard anti-virus software, antispyware, and/or firewall/intrusion detection software on the computer I use to access and use information assets or resources associated with my performance of services under the contract terms with VA. I will report anti-virus, antispyware, firewall or intrusion detection software errors, or significant alert messages to the COTR. (16) Understand that restoration of service of any VA system is a concern of all users of the system. (17) Complete required information security and privacy training, and complete required training for the particular systems to which I require access. RECORDS MANAGEMENT (1) Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. (2) Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. (3) Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records. (4) Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. (5) Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. (6) The Government Agency owns the rights to all data/records produced as part of this contract. (7) The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. (8) Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electroni...
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