REQUIREMENT SPECIFICATIONS / STATEMENT OF WORK SCOPE: The Contractor shall provide Cost Per Reportable Results (CPRR) Coagulation testing for VA Medical Centers throughout VISN20 (see below participation VISN 20 medical centers). Installation and operational training will be provided by Vendor at Government s facility. Vendor will provide Field Service Support. Vendor will also supply Government with sufficient supplies, reagents, consumables, and training to execute the coagulation analyzer in the performance of the testing listed for each site based on estimated patient results per month. Equipment will be defined by the facility. Participating Locations: Alaska VA Healthcare System: 1201 North Muldoon Road, Anchorage, AK 99504 Boise VA Medical Center: 500 West Fort Street. Boise, ID 83702 Eugene Health Care Center: 3355 Chad Dr., Eugene, OR 97408 VA Portland Health Care System: 3710 SW U.S. Veterans Hospital Road, Portland, OR 97239 Roseburg VA Health Care System: 913 NW Garden Valley Blvd., Roseburg, OR 97471 VA Southern Oregon Rehabilitation Center: 8495 Crater Lake Hwy., White City, OR 97503 VA Puget Sound Health Care System - American Lake Division: 9600 Veterans Dr Southwest, Tacoma, WA 98493 VA Puget Sound Health Care System: 1660 S. Columbian Way, Seattle, WA 98108 Mann-Grandstaff VA Medical Center: 4815 N. Assembly Street, Spokane, WA 99205 Jonathan M. Wainwright Memorial VA Medical Center: 77 Wainwright Drive, Walla Walla, WA 99362 Map and locations for Medical Centers and Clinics within the V20 Northwest Network can be found at the following link: https://www.va.gov/directory/guide/region.asp?ID=1020. GENERAL REQUIREMENTS: Cost per Reportable Result (CPRR) Equipment (including installation) All related consumables and supplies for testing and collection to include expedited shipping, if requested. All necessary services to keep equipment in manufacturer's operating conditions, both preventive maintenance and emergency repairs. Training for personnel operating equipment. All items above provided at no charge for CPRR. COST PER REPORTABLE RESULT CPRR: Program: The pricing and terms are governed by the Federal Supply Schedule contract between the vendor and the Department of Veterans Affairs. Cost per Patient Reportable Result (CPRR): as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) 5-year equipment use, (2) all reagents, standards, Vendor provided quality Controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution: repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge. Parameters: The calculation for price and quantity of reagents are based on an estimated annual number of reportable results provided by the Government. The quantities of the annual supply needs shall be sufficient for testing performed within the following parameters: Numbers of reportable results performed by the Government are within ten percent of the annual estimated reportable results as indicated by the annual supply list. Use of the instrument(s) are in accordance with instrument usage information provided by Government (Primary, Back-up or Alternate). Test volumes are determined by the Government. Two levels of quality control to be run a minimum of every 8 hours per test, and as required by the manufacturer every test day. Calibrators for periodic calibration checks and as necessary to validate systems following major repair or resolution of negative quality control trends. Adjustments: The Government and vendor will conduct reviews annually to monitor contract performance against agreed upon efficiencies, operational assumptions and product utilization (CPPR parameters). The vendor will notify the Government when such reviews indicate an adjustment to the quarterly standing order shipments may be required. The Government will cooperate with the vendor in the conduct of the reviews. The vendor, their personnel, and their sub-vendors 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.839.201 Contract Clause for Information and Technology Security. EQUIPMENT: Vendor will provide leased Coagulation Analyzer(s) to meet VISN20 facilities usage needs. Installation: The vendor shall deliver and install all leased equipment under this BPA to the requesting facility after an order is placed. Equipment shall be installed within 45 business days after receipt of order. Equipment shall not be considered installed until a VA employee certifies that the equipment is properly functioning and has the necessary supplies to perform its required function. The vendor shall maintain a record of installation to include location, model number, serial number, and date of installation. Removal: The vendor shall un-install and remove all leased equipment (less any hard drive with Personal Protective Information PPI) under this BPA from the requesting facility upon request. The Vendor will turn over the hard drive to OIT staff. OIT will produce form VA0751 for the destruction of the Hard Drive. Equipment shall be removed within 30 days of request. Equipment shall be considered removed upon a VA employee certification that the equipment and all accessories have been taken by an employee of the vendor and there is no disruption and /or damage to the surrounding area. The vendor shall maintain a record of removal to include location, model number, serial number, decontamination certification, and date of removal. Equipment Requirements: Vendor shall provide coagulation systems that meet the following requirements: Primary and back-up instruments will be provided as necessary for each facility. A selection of instruments will be available based on volume, test menu needs and thru put requirements of each individual facility. All sites will have PT, PTT, Fibrinogen, and D- Dimer testing available. Heparin Xa and other factor assays will be available and may be included in the CPRR contract. All instruments must be new (non-refurbished) equipment. All equipment shall come with any required accessories to perform normal duties, to include but not limited to, UPS units, power conditioning units, and properly programmed printers and monitors. Carts for the analyzer will be provided at no charge to the government if requested by the facility. The analyzers will be VA Laboratory Information System (LIS) interfaceable with Data Innovations. The vendor will supply LIS specifications and assist with the interface connections. Instruments that have the ability to have access to the internet must follow VA IT security policies and have a national MOU-ISA. The internet access must be verified and adhered to before and during all internet access. A quality assurance program that includes a minimum of 20 other labs for peer review of quality control data as a component. There must be enough labs that will allow VISN 20 to assess the mean/SD/CV comparisons. The quality control software on the analyzers and the ancillary computers shall be the newest version of Windows available, or equivalent and offers easy presentation of data to the operator. Operation of software uses minimal computer strokes to move from testing to reagent to data analysis and/or other screens. Reagents shall be loaded with not more than a 5-minute delay of patient testing. Time from standby to operation processing samples is less than 3 minutes. Time required for routine maintenance activities shall take less than 30 minutes daily and less than 60 minutes weekly/monthly. Size of instrumentation shall be bench top depth no more than 32 inches. If a stand is requested by facility, it is included in the contract at no additional cost. Instrumentation shall have cap piercer ability. Instrumentation shall have the ability to process tubes and/or sample cups. Instruments shall have the capability to run icteric and lipemic specimens without specimen manipulation by the Technologist. Instrumentation shall have "Automatic re-run capability and/ or Auto reflex testing capability. Software shall be able to have at least two lot numbers of reagents stored onboard at the same time. Ability to program Quality Control material testing at specific times or when accessing new vial. Ability to document Quality Control and instrument corrective actions. Methodology must provide acceptable verification for reference interval, correlation coefficient and Deming slope. UPTIME GUARANTEE/ PERFORMANCE PENALTY: Vendor agrees that all equipment provided shall be operable and available for use no less than 98% of operational time per month. Each instrument at site shall be computed separately. Operational time is 24 hours per day, 7 days a week. Downtime is defined as when the instrument is not able to produce clinically acceptable results: and will be computed from the time the Government notified the hotline, and the instrument can produce acceptable results. Scheduled maintenance is excluded from downtime. METHOD VALIDATIONS: Once the instrument has been installed according to the Vendor specifications at the Government location, the vendor will supply a Technical Representative to perform method validation studies. The Method validations will be completed to include the necessary studies required for Clinical Laboratory Information Act (CLIA), College of American Pathologist (CAP), Clinical Laboratory Standards Institute (CLSI), and Department of Veterans Affairs (VA) regulatory agencies. Validations shall include precision, linearity and current system to new system correlations as well as establishment of normal and therapeutic ranges not to deviate significantly from current facility ranges. The VA will not accept equipment until it passes initial validation testing. Must correlate with current method for all available tests in all ranges. The vendor shall assist with validation and lot conversion studies at least once a year, either on or off site, coordinated by each facility, and shall provide statistical analysis and a summary report of findings. MAINTENANCE AND REPAIRS: Vendor shall provide preventative and corrective maintenance per manufacturer's recommendation. This shall include software upgrades and parts and labor, to maintain all Coagulation equipment and accessories. At a minimum, preventative maintenance shall be twice annually, beginning six (6) months after installation. Vendor shall furnish all transportation, equipment, parts, tools and labor to accomplish the required maintenance. Telephone service support shall be available 24 hours/day,7days a week. Onsite Field Service support shall be available Monday- Friday 8am- 4:30 pm, local time. Onsite repairs shall be initiated within 24 hours of first notification from Technical Hotline to Field Service engineer. The Field Service representative shall call to schedule onsite service, if necessary, within 2 hours of notification from Technical Assistance Hotline. Efforts shall be made by the vendor to minimize disruption to the Government and employees (i.e. reschedule if work interferes with normal operation, access equipment when convenient to the needs of the VA, etc.) Vendor shall maintain cleanliness of work area and minimize dust and contaminants to areas adjacent to the job site. Vendor shall furnish a malfunction incident report to the facility upon completion of repair call within 2 business days after the completion of work. The report shall include as a minimum the following: Date and time notified. Date and time of arrival. Serial number, type and model number(s) of equipment. Time spent for repairs. Description of malfunction and repair. Proof of repair that included documentation of a sample run of quality control verifying acceptable performance. Each instrument provided by the vendor shall maintain an uptime of 98% in each month of the term of the agreement. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflects a downtime of 5% or greater of the normal working days in one calendar month, it is the responsibility of the vendor to immediately replace the broken laboratory equipment with new equipment at no additional cost to the Government. The responsibility for maintaining the equipment furnished in operating conditions in accordance to manufacturer's instruction shall solely be the responsibility of the vendor. For each instrument provided, the vendor shall treat each notification for an emergency/repair service call form the Government as a separate and new service call. The following are guaranteed throughout the life of this BPA: Priority scheduling of requests for service. Unlimited Emergency Service. No charges for labor, travel or any other related expenses. Unlimited Parts. No charge for replacement parts, or accessories, which become marginal or defective due to normal use during the agreement period. Factory Authorized Product Updates and Modifications. Installed at no additional charge for improved product performance and reliability. Factory trained and Authorized Service Engineers. Continual upgrading and certification of engineers in latest instrument technology. TRAINING: With the exception of specific training requirements stated herein, which shall have precedence: vendor shall provide "operator" training in accordance with the terms, conditions, and provisions of the vendor's existing Federal Supply Service Contract. Listed below are the training requirements: The vendor shall provide, at no cost to the Government, two technical operator training slots for each instrument per facility within the first year, with one provided prior to instrument installation. The training will include all travel (to and from training center), hotel, meals, lodging, transportation, tuition and books. Vendor will provide one (1) additional off-site training each consecutive year after initial training, per instrument, to include: all travel (to and from training center), hotel, meals, lodging, transportation, tuition and books. The Vendor shall have an on-going training program for VISN 20 Employees by the Technical Service Representatives on any new products or updates on the product lines. All materials for training will be provided at no additional cost to the Government. REAGENTS, CONTROLS, AND SUPPLIES: Routine Reagents, controls and Disposables (supplies) for Coagulation Testing of Prothrombin Time (PT) and Partial Thromboplastin Time (APTT), D-Dimer and Fibrinogen, shall be provided by the vendor and shall adhere to the following requirements. Other reagents, controls and Disposables for Heparin Xa and additional factor assays reagents will be available as items separate from the CPPR. Reagents including controls and Disposables shall be identified prior to delivery. Reagents including controls and disposables to be listed in a separate Table. The table should include annual reagent volumes, costs, and shipping charges for each quarterly standing order delivery. Reagent manufacturer shelf life shall be no less than 12 months (Excluding D-Dimer which requires a minimal shelf life of no less than 6 months.) On board reagent stability will be no less than 24 hours. Controls will have minimal stability of 8 hr. Reagents for the analyzer are marked for easy recognition by the operator and shall contain the appropriate facility Purchase Order number in the delivery address. Vendor will supply a list of reagents, controls and disposables that will be shipped as part of the order. Supplies will be shipped on a standing order schedule, agreed upon by the Government and Vendor. All or part of a future quarterly Standing order may be advanced up to 10 days ahead of the scheduled ship date of the standing order. Delivery shall be within four (4) business days of the prior agreed upon shipment date or it shall be considered late. Vendor shall provide sufficient reagents and supplies for performance of patient results for all VISN 20 sites. Consumables will be provided on demand as needed, if the consumable allotments are insufficient to meet the needs of the facility. Reagent lot numbers are sequestered (same lot numbers for PT and PTT) for the BPA members. Additional Supplies may be purchased according to the agreed price schedule. The government may order additional supplies as required, at the prices listed. Vendor shall supply all changes to the maintenance schedules that affect reagent or cleaning reagent volumes and shall be coordinated with the VA facility Points of Contact to implement the changes in accordance with manufacturer's recommendations. THE VENDOR WILL BE RESPONSIBLE FOR THE FOLLOWING: COST PER REPORTABLE RESULT PROGRAM, REAGENTS, CONTROLS AND SUPPLIES: Routine Reagents and Disposables including testing for PT, PTT, D-Dimer, Heparin Xa and Fibrinogen. Reagents including controls and Disposables to be listed in separate Table. Includes Annual kits included in the contract including shipping charges for quarterly shipping of standing orders. Vendor shall supply a list of reagents, controls and disposables that will be shipped as part of the agreement. Supplies will be shipped on a standing order schedule, agreed upon by the Government and Vendor. All or part of a future quarterly Standing order may be advanced up to 10 days ahead of the scheduled ship date of the standing order. D-Dimer and Fibrinogen reagents shall be shipped as a standing order or on an as needed basis, whichever is preferred by the facility. If not on a standing order, the individual facility will call for the reagent. Other Special orders are subject to shipping charges. Vendor shall provide sufficient reagents and supplies for performance of patient results for all VISN 20 sites. Changes in maintenance schedules that affect reagent or cleaning reagent volumes will be approved by the Vendor in accordance with manufacturer's recommendations. Additional reagents, if required, will be provided by the vendor at no additional charge. THE GOVERNMENT WILL BE RESPONSIBLE FOR THE FOLLOWING: COST PER REPORTABLE RESULT PROGRAM: During the agreement the Government will report each month to the vendor, in writing or electronically, the number of reportable results generated in the previous month. The vendor will invoice the Government based on the report of reportable tests. VISN designated Pathology and Laboratory Manager or designee will act as Contracting Officer Representative (COR) for this contract. 12. INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY 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. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS 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. 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. 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. 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. 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 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). 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 on-site 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR. INFORMATION SYSTEM DESIGN AND DEVELOPMENT Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. The contractor/subcontractor agrees to: Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies: The Systems of Records (SOR); and The design, development, or operation work that the contractor/ subcontractor is to perform Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency. "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records. "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph. "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 10 days. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 10 days. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. VA prohibits the installation and use of personally owned or contractor/ subcontractor- owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA- approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction, or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive; VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre- approved and described in the purchase order or contract. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. SECURITY INCIDENT INVESTIGATION 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 COR 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. 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. 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. 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. LIQUIDATED DAMAGES FOR DATA BREACH 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. 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. Each risk analysis shall address all relevant information concerning the data breach, including the following: Nature of the event (loss, theft, unauthorized access); Description of the event, including: date of occurrence; data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected; 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; Amount of time the data has been out of VA control; The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); Known misuses of data containing sensitive personal information, if any; Assessment of the potential harm to the affected individuals; Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and 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. 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 $42.00 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification; One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. TRAINING 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: 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; Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; Successfully complete the appropriate VA privacy training and annually complete required privacy training; and 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.] The contractor shall provide to the contracting officer and/or the COR 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. 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.
