Vitreoretinal Surgical System
Added: Feb 01, 2018 4:00 pm 13 Vitreoretinal Surgical System The Southeast Louisiana Veterans Healthcare System (SLVHCS), 2400 Canal Street, New Orleans, LA 70119, is seeking a Vitreoretinal Surgical System, per the following Statement of Work. This is a sources sought notice only and it is not a solicitation notice. Please DO NOT provide a quote at this time. The purpose of this sources sought notice is to gain knowledge of qualified potential contractors and their socioeconomic size classification in accordance with NAICS code 339112, small business size standard of 1,000 employees. This item is not on the SBA Manufacturer s Waiver List. Responses will be used by the Government to make appropriate acquisition decisions. After a review of the responses to the sources sought notice, a solicitation announcement may be posted to GSA or FBO based on the results from this notice. A response to this sources sought notice is not an adequate reply to the forthcoming solicitation. This is not a solicitation and in no way obligates the Government to award any contract. Additionally, a response to this sources sought notice is not a request to be added to a prospective bidders list or to receive a copy of the solicitation. The purpose of this sources sought is strictly for market research purposes. Please send all responses to Deborah Newman at Deborah.newman2@va.gov NLT 12:00 pm CST on Feb. 7, 2018. Statement of Work Vitreoretinal Surgical System and Installation Southeast Louisiana Veterans Health Care System New Orleans, LA 07/28/2017 1. PURPOSE 1.1 The overall purpose is to provide and install (1) Vitreoretinal Surgical System at Southeast Louisiana Veterans Health Care System (SLVHCS) Surgery Service Diagnostic and Treatment Building located at 2400 Canal St, New Orleans, LA 70119. 2. SCOPE 2.1 The Contractor shall provide, transport, install, and test all listed equipment. All products must meet all salient characteristics defined in this section. 2.2 All equipment and installation must meet manufacturers and VA specifications. 2.3 The Contractor shall furnish all supplies, equipment, facilities and services required for delivery and installation of the supplies and equipment. 2.4 The Contractor is responsible for any missing parts and components not included to carry out the installation. 2.5 SALIENT CHARACTERISTICS 2.5.1 Constellation LXT Suggested Brand name/ Part No: Alcon Laboratories/ 8065751550 Specifications/Salient Characteristics: Must be able to be utilized on both that anterior and posterior segments of the eye Must be able to be utilized for Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic retinopathy); choroidal neovascularization secondary to age-related macular degeneration; retinal tears and detachments; macular edema, retinopathy of prematurity; choroidal neovascularization; leaking microaneurysms. Must have capability to be used for trabeculoplasty for the treatment of both conic and primary open angle glaucoma and refractory glaucoma Must have capability to be used for iridotomy/ iridectomy for the treatment of conic/ primary open angle glaucoma, acute angle closure glaucoma, and refractory glaucoma Device shall be capable of being utilized for the treatment of internal sclerostomy, lattice degeneration, central and branch retinal vein occlusion, suturelysis, as well as vascular and pigment skin lesions that have an impact on the ocular system Must have a modifiable duty cycle that allows for independent control flow of the vacuum and cut rate Must have the following duty cycle options that can operate at any cut rate Port biased open 50/50 Port biased closed System must have a high sped vitrectomy probe delivery system that can operate at 7,500 cpm with dual pneumatic drive technology in 20,23,25+, and 27+ Must include an integrate pressurized infusion system that is capable of constantly monitoring infusion pressure System must have an illumination system that can deliver illumination for tissue visualization. The system must be able to incorporate the utilization of radio frequency identification device technology to aid in the recognition of probe gauge sizes so that the system can automatically adjust the light intensity for the specified probe size Must come with an ISPAN tank Stand Must come with an ISPAN tank regulator Must include a 532nm green laser Must have voice confirmation that provides notification of parameter settings and laser accessory insertions Must include a multifunction foot pedal Dual laser ports that allow for the utilization of multiple devices 2.5.2 Ngenuity System Suggested Brand name/ Part No: Alcon Laboratories/ 8065830001 Specifications/Salient Characteristics: Utilized to assist in the performance of Digitally Assisted Vitreoretinal Surgery 3D high-dynamic range surgical camera HDR imaging 120 FPS 6 mega pixels 3840x1080 resolution Capable of providing 3D Full HD Progressive Scans as well as real-time video 24-bit color digital processing capabilities Compatible with Alcon, Leica, and Zeiss Surgical Microscopes Automatic exposure control Adjustable stereoscopic iris Digital white balance with memory 3D compact image processing unit Capable of real-time low latency image transmission Capable of streaming both 3D and 2D simultaneously Capable of supporting multiple digital inputs I7 6700 CPU processor 4GB VRAM, 1600+ Cores graphics chip Windows 7 Embedded, 64-bit operating system 3D imaging and Guidance OS imaging software Wired touchpad keyboard 16GB DDR3 RAM Memory 120GB SSD and 2TB storage HDD Capable of 100+ hours of 3D HD recording, 1080p 60 fps for both eyes Flat panel display 3d 4K Ultra HD 55 monitor 3840x2160 resolution Two channel speaker system Frame rate of 60fps for each eye simultaneously Passive polarized 3D Console Must include a medical grade isolation transformer Twelve circular polarized 3D glasses Must have 4 lockable casters Must include stainless steel push bar, component storage, medical grade ac extension cable Ngenuity TrueMedia 3D/2D HD video and file management software Capable of capturing snapshots in JPEG and PNG formats Capability to auto record Capacity of 100+ hours of 3D HD video recording OneTouch 3D HD video recording and snapshots Ngenuity TrueEdit 3D/2D HD video editing software Must support AVI, MOV, MP4, MPEG, WMV video input types Must support BMP, JPEG, PNG, and TIFF still image types Must support AVI, MOV, and MP4 video output types Must support the following resolutions 320 x 120 up to 3840 x 1080 Frame Size Must be capable of real-time and batch processing Must be capable of editing 3D and 2D files Multi-tead rendering mode Capable of fade, dissolve, and text overlays Export frame rate of 30fps Windows 7, 8, or 8.1 operating system and Mac OS with the Boot Camp partition 2.5.3 Keeler LIO Headset Suggested Brand name/ Part No: Alcon Laboratories/ 8065752987 Specifications/Salient Characteristics: Must be a Laser Indirect Ophthalmoscope designed for utilization with the Vitreoretinal Surgical System Must have at a minimum 2 illumination spot sizes Must have at a minimum 2 treatment spot sizes Must include at a minimum a 20-foot cable 2.5.4 Passive Laser Filter Suggested Brand name/ Part No: Alcon Laboratories/ 8065751051 Specifications/Salient Characteristics: Fixed passive laser filter designed for utilization with the purepoint laser system 2.5.5 Constellation Fragmentation Handpiece Suggested Brand name/ Part No: Alcon Laboratories/ 8065750888 Specifications/Salient Characteristics: Handpiece that is designed for utilization with the constellation LX T system Must be autoclavable Must have an ergonomic design 2.5.6 Constellation ISPAN C3F8 Intraocular Gas 125GM Suggested Brand name/ Part No: Alcon Laboratories/ 8065797105 Specifications/Salient Characteristics: Constellation ISPAN C3F8 Intraocular Gas 125GM compatible with the Constellation system 2.5.7 Constellation ISPAN SF6 Intraocular Gas 125GM Suggested Brand name/ Part No: Alcon Laboratories/ 8065797005 Specifications/Salient Characteristics: Constellation ISPAN SF6 Intraocular Gas 125GM compatible with the Constellation system 2.5.8 532 Laser Safety Glasses Suggested Brand name/ Part No: Alcon Laboratories/ 8065750107 Specifications/Salient Characteristics: 532nm Wavelength safety glasses Each pair of glasses must come with a case 2.5.9 Installation/ Training Specifications/Salient Characteristics: Vendor shall install/ assemble equipment in the GYN outpatient clinic Install/ Assembly will require vendor to move equipment from warehouse to clinic location Vendor will be responsible for providing required equipment such as fork lifts, pallet jacks, and manpower to move and assemble equipment After installation, the vendor shall remove all garbage and rubbish from facility Contractor shall provide On-site training of the equipment to the clinicians who will be utilizing the equipment Contract shall provide a plan of what will be covered and the number of personnel that they can training Number of hours of training must be indicated The contractor shall provide a training program to the Biomedical Engineering technicians and in-house clinical personnel. Technical training must provide Biomedical Engineering with the tools and knowledge to fully operate and maintain the system. A training schedule shall also be provided. Vendor must provide a schedule and plan for training prior to training detailing what the training will consist of and how many hours of training will be included 2.5.10 Constellation Service Contract 08/31/2018-08/30/2019 Suggested Brand name/ Part No: Alcon Laboratories/ 900000099 Specifications/Salient Characteristics: The vendor shall be responsible for all repairs including the cost of labor, material, and travel associated with the required repairs. The service agreement must allow for unlimited technical support services. The vendor shall be responsible for covering the shipping cost of repaired and or replaced equipment and shall provide next day shipment of loaner equipment. 2.5.11 Constellation Service Contract 08/31/2019-08/30/2020 Suggested Brand name/ Part No: Alcon Laboratories/ 900000099 Specifications/Salient Characteristics: The vendor shall be responsible for all repairs including the cost of labor, material, and travel associated with the required repairs. The service agreement must allow for unlimited technical support services. The vendor shall be responsible for covering the shipping cost of repaired and or replaced equipment and shall provide next day shipment of loaner equipment. 2.5.12 Constellation Service Contract 08/31/2020-08/30/2021 Suggested Brand name/ Part No: Alcon Laboratories/ 900000099 Specifications/Salient Characteristics: The vendor shall be responsible for all repairs including the cost of labor, material, and travel associated with the required repairs. The service agreement must allow for unlimited technical support services. The vendor shall be responsible for covering the shipping cost of repaired and or replaced equipment and shall provide next day shipment of loaner equipment. 2.5.13 Constellation Service Contract 08/31/2021-08/30/2022 Suggested Brand name/ Part No: Alcon Laboratories/ 900000099 Specifications/Salient Characteristics: The vendor shall be responsible for all repairs including the cost of labor, material, and travel associated with the required repairs. The service agreement must allow for unlimited technical support services. The vendor shall be responsible for covering the shipping cost of repaired and or replaced equipment and shall provide next day shipment of loaner equipment. 2.5.14 Ngenuity System Service Contract 08/31/2018-08/30/2019 Suggested Brand name/ Part No: Alcon Laboratories/ 900107309 Specifications/Salient Characteristics: One (1) Preventative Maintenance Visits. The vendor will contact government to schedule a preventative maintenance visits on a mutually convenient weekday between the hours of 8:00 a.m. and 5:00 p.m. The preventative maintenance visit will include a system verification of the Equipment by a trained vendor representative. If the vendor representative determines that alignment(s), adjustment(s), and/or replacement of part(s) are necessary they will perform these services during the visit at no additional cost to the government. Parts and Labor. The vendor will provide parts and labor (during the hours specified above) necessary to service and maintain the Equipment per the vendors published operating specifications at no additional charge. Unscheduled Service. During the Term, the vendor will provide unscheduled service visits, at no additional cost, between the hours of 8:00 a.m. and 5:00 p.m., Monday tough Friday. The vendor will provide an on-site technician within 48 hours. Any service visits that Customer authorizes outside of these hours or on weekends will be billed separately. The government acknowledges that the vendor cannot and does not absolutely guarantee response times to service calls. Modifications for Safety or Reliability. If the vendor determines that a modification to the Equipment (whether hardware or software) is necessary to address safety or reliability concerns identified by the vendor, then the vendor will install the modification in the Equipment as soon as practical at no additional cost to the government. Equipment Verification. The vendor reserves the right to verify the condition of the Equipment prior to becoming obligated hereunder if the Equipment has ever been serviced by someone other than a vendor authorized service representative, or if the Equipment has not been serviced by the vendor for more than 45 days prior to the Effective Date. Software Upgrades. During the term, if the vendor releases a system software upgrade, the vendor will complete the upgrade in the equipment at no additional cost to the customer. This does not include any hardware upgrades. Emergency Telephone Consultation. The vendor will provide emergency telephone consultation 24 hours a day, 7 days per week at no additional charge. 2.5.15 Ngenuity System Service Contract 08/31/2019-08/30/2020 Suggested Brand name/ Part No: Alcon Laboratories/ 900107309 Specifications/Salient Characteristics: One (1) Preventative Maintenance Visits. The vendor will contact government to schedule a preventative maintenance visits on a mutually convenient weekday between the hours of 8:00 a.m. and 5:00 p.m. The preventative maintenance visit will include a system verification of the Equipment by a trained vendor representative. If the vendor representative determines that alignment(s), adjustment(s), and/or replacement of part(s) are necessary they will perform these services during the visit at no additional cost to the government. Parts and Labor. The vendor will provide parts and labor (during the hours specified above) necessary to service and maintain the Equipment per the vendors published operating specifications at no additional charge. Unscheduled Service. During the Term, the vendor will provide unscheduled service visits, at no additional cost, between the hours of 8:00 a.m. and 5:00 p.m., Monday tough Friday. The vendor will provide an on-site technician within 48 hours. Any service visits that Customer authorizes outside of these hours or on weekends will be billed separately. The government acknowledges that the vendor cannot and does not absolutely guarantee response times to service calls. Modifications for Safety or Reliability. If the vendor determines that a modification to the Equipment (whether hardware or software) is necessary to address safety or reliability concerns identified by the vendor, then the vendor will install the modification in the Equipment as soon as practical at no additional cost to the government. Equipment Verification. The vendor reserves the right to verify the condition of the Equipment prior to becoming obligated hereunder if the Equipment has ever been serviced by someone other than a vendor authorized service representative, or if the Equipment has not been serviced by the vendor for more than 45 days prior to the Effective Date. Software Upgrades. During the term, if the vendor releases a system software upgrade, the vendor will complete the upgrade in the equipment at no additional cost to the customer. This does not include any hardware upgrades. Emergency Telephone Consultation. The vendor will provide emergency telephone consultation 24 hours a day, 7 days per week at no additional charge. 2.5.16 Ngenuity System Service Contract 08/31/2020-08/30/2021 Suggested Brand name/ Part No: Alcon Laboratories/ 900107309 Specifications/Salient Characteristics: One (1) Preventative Maintenance Visits. The vendor will contact government to schedule a preventative maintenance visits on a mutually convenient weekday between the hours of 8:00 a.m. and 5:00 p.m. The preventative maintenance visit will include a system verification of the Equipment by a trained vendor representative. If the vendor representative determines that alignment(s), adjustment(s), and/or replacement of part(s) are necessary they will perform these services during the visit at no additional cost to the government. Parts and Labor. The vendor will provide parts and labor (during the hours specified above) necessary to service and maintain the Equipment per the vendors published operating specifications at no additional charge. Unscheduled Service. During the Term, the vendor will provide unscheduled service visits, at no additional cost, between the hours of 8:00 a.m. and 5:00 p.m., Monday tough Friday. The vendor will provide an on-site technician within 48 hours. Any service visits that Customer authorizes outside of these hours or on weekends will be billed separately. The government acknowledges that the vendor cannot and does not absolutely guarantee response times to service calls. Modifications for Safety or Reliability. If the vendor determines that a modification to the Equipment (whether hardware or software) is necessary to address safety or reliability concerns identified by the vendor, then the vendor will install the modification in the Equipment as soon as practical at no additional cost to the government. Equipment Verification. The vendor reserves the right to verify the condition of the Equipment prior to becoming obligated hereunder if the Equipment has ever been serviced by someone other than a vendor authorized service representative, or if the Equipment has not been serviced by the vendor for more than 45 days prior to the Effective Date. Software Upgrades. During the term, if the vendor releases a system software upgrade, the vendor will complete the upgrade in the equipment at no additional cost to the customer. This does not include any hardware upgrades. Emergency Telephone Consultation. The vendor will provide emergency telephone consultation 24 hours a day, 7 days per week at no additional charge. 2.5.17 Ngenuity System Service Contract 08/31/2021-08/30/2022 Suggested Brand name/ Part No: Alcon Laboratories/ 900107309 Specifications/Salient Characteristics: One (1) Preventative Maintenance Visits. The vendor will contact government to schedule a preventative maintenance visits on a mutually convenient weekday between the hours of 8:00 a.m. and 5:00 p.m. The preventative maintenance visit will include a system verification of the Equipment by a trained vendor representative. If the vendor representative determines that alignment(s), adjustment(s), and/or replacement of part(s) are necessary they will perform these services during the visit at no additional cost to the government. Parts and Labor. The vendor will provide parts and labor (during the hours specified above) necessary to service and maintain the Equipment per the vendors published operating specifications at no additional charge. Unscheduled Service. During the Term, the vendor will provide unscheduled service visits, at no additional cost, between the hours of 8:00 a.m. and 5:00 p.m., Monday tough Friday. The vendor will provide an on-site technician within 48 hours. Any service visits that Customer authorizes outside of these hours or on weekends will be billed separately. The government acknowledges that the vendor cannot and does not absolutely guarantee response times to service calls. Modifications for Safety or Reliability. If the vendor determines that a modification to the Equipment (whether hardware or software) is necessary to address safety or reliability concerns identified by the vendor, then the vendor will install the modification in the Equipment as soon as practical at no additional cost to the government. Equipment Verification. The vendor reserves the right to verify the condition of the Equipment prior to becoming obligated hereunder if the Equipment has ever been serviced by someone other than a vendor authorized service representative, or if the Equipment has not been serviced by the vendor for more than 45 days prior to the Effective Date. Software Upgrades. During the term, if the vendor releases a system software upgrade, the vendor will complete the upgrade in the equipment at no additional cost to the customer. This does not include any hardware upgrades. Emergency Telephone Consultation. The vendor will provide emergency telephone consultation 24 hours a day, 7 days per week at no additional charge. 2.6 DELIVERY AND INSTALLATION 2.6.1 DELIVERY 2.6.1.1 Contractor shall deliver all equipment to the Southeast Louisiana Veterans Health Care System (SLVHCS) Central Energy Plant building 2400 Canal St, New Orleans, LA 70119 on August 31, 2017. 2.6.1.2 Deliver materials to job in manufacturer's original sealed containers with brand name marked thereon. 2.6.1.3 Package to prevent damage or deterioration during shipment, handling, storage and installation. Maintain protective covering in place and in good repair until removal is necessary. 2.6.1.4 Deliver specified items only when the site is ready for installation work to proceed. 2.6.1.5 Store products in dry condition inside enclosed facilities. 2.6.1.6 Any government requested delayed delivery up to 90 days after initial award delivery date, shall be at no additional cost to the Government. 2.6.1.7 A pre-delivery meeting will be conducted 5 days prior to initial award delivery date for verification of delivery and installation dates. 2.6.1.8 Delivery and Installation will be coordinated tough the COR. 2.6.2 INSTALLATION 2.6.2.1 All equipment shall be assembled in accordance with the manufactures guidelines by the vendor. 2.6.2.2 Install all equipment to manufacturer s specifications maintaining Federal, and Local safety standards 2.6.2.3 Installation must be completed by September 5, 2017. All work shall be completed between 8:00 a.m. and 4:30 p.m. Monday Friday. All federal holidays, excluded. Federal holidays are available at the Federal Holiday OPM Site. 2.6.2.4 If there is an operational conflict with installation, night or weekend installation may be required. Government will provide a 72 hours' notice of change of installation hours. 2.6.2.5 The contractor shall coordinate all deliveries, staging areas, installations, and parking arrangements with the COR. 2.6.2.6 The Contractor shall remove all related shipping debris and cleanup any construction associated with delivery and installation of the specified items. Contractor shall remove all packaging from the SLVHCS premises. The Contractor shall be responsible for any damage to the building that occurs due to Contractor error or neglect. 2.7 SITE CONDITIONS 2.7.1 There shall be no smoking, eating, or drinking inside the hospital at any time. 3. INSPECTION AND ACCEPTANCE: 3.1 The Contractor shall conduct a joint inspection with the COR upon delivery of equipment. 3.2 Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s). 3.3 The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer. 4. DELIVERABLES 4.1 Operation and Maintenance Manuals 4.1.1 Binders - Quantity (2) each for items 2.5.1-2.5.17 4.1.2 Digital Copies- Quantity (1) each for items 2.5.1-2.5.17 4.2 Deliver compilation of all manufacturer recommended maintenance schedule and operation materials packaged in binder(s) to COR upon completion of installation. 5. OPERATOR TRAINING: 5.1 Contractor shall provide On-site training of the equipment to the Users. Scheduling of operator training shall be coordinated with the SLVHCS COR after installation is complete. 6. PROTECTION OF PROPERTY 6.1 Contractor shall protect all items from damage. The Contractor shall take precaution against damage to the building(s), grounds and furnishings. The Contractor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Contractor. 6.2 The Contractor shall perform an inspection of the building(s) and grounds with the COR prior to commencing work. To ensure that the Contractor shall be able to repair or replace any items, components, building(s) or grounds damaged due to negligence and/or actions taken by the Contractor. The source of all repairs beyond simple surface cleaning is the facility construction contractor (or appropriate subcontractor), so that building warranty is maintained. Concurrence from the VA Facilities Management POC and COR is required before the Contractor may perform any significant repair work. In all cases, repairs shall utilize materials of the same quality, size, texture, grade, and color to match adjacent existing work. 6.3 The Contractor shall be responsible for security of the areas in which the work is being performed prior to completion. 6.4 Contractor shall provide floor protection while working in all VA facilities. All material handling equipment shall have rubber wheels. 7. SECURITY REQUIREMENTS 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. 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 tough 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. 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 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. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. 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 in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. l. 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 COTR. 6. SECURITY INCIDENT INVESTIGATION a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 7. LIQUIDATED DAMAGES FOR DATA BREACH a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $ _______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 8. 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-day s 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. 9. TRAINING a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber SecurityAwareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. 7. REFERENCE (S): 1. VA Affairs Handbook 6500, Risk Management Framework for VA Information Systems Tier 3: VA Information Security Program, 10 Mar 2015. 2. Veterans Health Administration Procurement Manual (VHA PM) 11/3/2014. 3. VA Handbook 1901.01, Health Information Management and Health Records 19 Mar 15. 4. VHA Handbook 1605.5, Business Associate Agreements 22 July 2014 5. Privacy Act of 1974 (5 U.S.C. 552a). 8. WARRANTY 8.1 The contractor shall provide a one year manufacturer s warranty on all parts and labor. 8.2 The warranty shall include all travel and shipping costs associated with any warranty repair.
36C25618Q0260 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 16
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