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Complete Intraoperative Neuromonitoring Service (IONM) Southeast Louisiana Veterans Healthcare System (SLVHCS) New Orleans VA Medical Center / Surgery Department New Orleans, LA 70119 THIS IS NOT A SO... Complete Intraoperative Neuromonitoring Service (IONM) Southeast Louisiana Veterans Healthcare System (SLVHCS) New Orleans VA Medical Center / Surgery Department New Orleans, LA 70119 THIS IS NOT A SOLICITATION. This is a Request for Information (RFI)/ Sources Sought Notice only and is issued in accordance with Federal Acquisition Regulation (FAR) 10 Market Research, in order to conduct market research. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. This RFI is issued solely for information and planning purposes and does not constitute a solicitation or a guarantee to issue a solicitation in the future. This RFI does not commit the Government to contract for any supply or service. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. Not responding to this RFI does not preclude participation in any future solicitation, if issued. This announcement is based on the best information available at this time and is subject to future modification. The Southeast Louisiana Veterans Health Care System (New Orleans VA Medical Center) located at 2400 Canal Street, New Orleans, LA 70119 is seeking a contractor that can meet/exceed the government s objectives for the following requirement: Complete Intraoperative Neuromonitoring Service (IONM). The contractor will be required to provide the equipment, labor, materials, accessories, and supplies necessary for Complete Intraoperative Neuromonitoring (IONM) Service so that seven surgical operating rooms can be supported. The Complete Intraoperative Neuromonitoring (IONM) Services that are required include but are not limited to the following: As needed and case-by-case service that enables the facility to offer IONM options for patients under the direct medical care within the operating room. The umbrella of IONM services include complex surgical procedures such as: Spine surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and if necessary, Interventional Neuroradiology which are done during scheduled timeframes and during emergencies 24 hours a day, 7 days a week, & 365 day a year. Instruction to Offerors Guidance: This sources sought notice is not a Request for Quote (RFQ)/Request for Proposal (RFP) and no solicitation is being issued at this time. This notice shall not be construed as a commitment by the Government to issue a solicitation or to ultimately award a contract, nor does it restrict the government to a specific acquisition approach. Any information provided to the Government as a result of this sources sought notice is strictly voluntary. Responses will not be returned. No entitlement to payment or direct or indirect costs or charges by the Government will arise as a result of contractor submission of responses or the Government s use of such information. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification, Service Disabled/Veteran Owned Small Business. (SDVOSB/VOSB), Hubzone, 8(a), small, small disadvantage, woman owned small business, or large business) relative to NAICS 621111, Offices of Physicians (except Mental Health Specialists), with a small business size standard of $14 million. The Product Service Code (PSC) is Q999, Medical Other Medical Services. NAICS code 621111, shall be represented in contractor s System for Award Management profile registration prior to award. This Sources Sought Notice is intended to identify eligible contractors in any socioeconomic category who can support this requirement. An eligible contractor is a contractor who possesses the qualifications, capability, and relevant experience to meet/exceed the government s Statement of Objectives for this requirement. Instructions for Submission: Interested contractors shall respond by e-mail only to Veronica Maskell, Contract Specialist veronica.maskell@va.gov. Responses are due no later than Tuesday, November 23, 2022 by 10:00 a.m. Central Standard Time (CST), New Orleans, LA. Respondents shall include as part of their submission: Indicate if you can meet/exceed the government s objective and provide Complete Intraoperative Neuromonitoring (IONM) Service in support of seven surgical operating rooms for patients that require complex surgeries on a scheduled and unscheduled basis. Services must be available 24 hours a day, 7 days a week, & 365 day a year. A brief summary of relevant experience, relevant past contracts, and applicable qualifications/capabilities (as it pertains to this requirement) must be included. (It is the government s expectation that the contractor would be able to provide a detailed, innovative plan and a cost-effective pathway/solution to meet/exceed the objectives that are contained in the document entitled Statement of Objectives (SOO)- Complete Intraoperative Neuromonitoring Service (IONM), dated November 08, 2022 that is contained within this sources sought notice A future solicitation for this requirement will be all or nothing meaning that the Contractor would have to meet/exceed all objectives requested and be able to provide all deliverables/services that have been requested. Please do not submit a price quote/proposal as this request is for market research/informational purposes only. REQUIREMENT QUESTIONS: If/when this requirement is solicited there will only be a limited time window to address vendor solicitation questions. It is recommended that interested vendors (who are examining this requirement and who have questions) submit these questions along with their response to this Sources Sought Notice. SUMMARY OF OBJECTIVES/DELIVERABLES/SERVICES REQUIRED: IONM: Base Period (which includes Deliverables 1, 2, & 3 and the service agreement. May 1, 2023- April 30, 2024 IONM: Option Year One (1) which includes Deliverables 1, 2, & 3 and the service agreement May 1, 2024- April 30, 2025 IONM: Option Period Two (2) which includes Deliverables 1, 2, & 3 and the service agreement May 1, 2025- April 30, 2026 IONM: Option Period Three (3) which includes Deliverables 1, 2, & 3 and the service agreement May 1, 2026- April 30, 2027 IONM: Option Period Four (4) which includes Deliverables 1, 2, & 3 and the service agreement May 1, 2027- April 30, 2028 The following document is contained within this Sources Sought Notice: Statement of Objectives (SOO)- Complete Intraoperative Neuromonitoring Service (IONM), dated November 08, 2022. See subsequent pages to follow. Statement of Objectives (SOO) Complete Intraoperative Neuromonitoring Service (IONM) Southeast Louisiana Veterans Health Care System New Orleans, Louisiana November 08, 2022 1. Program Objective 1.1 The objective is to provide the equipment, labor, materials, accessories, and supplies necessary for a Complete Intraoperative Neuromonitoring (IONM) Service that support any of the seven surgical operating rooms. The primary goal of IONM is the identification of intraoperative neural insults at a stage that allows intervention to eliminate or minimize resultant neural injury. To meet this goal, evoked potentials are monitored iteratively throughout a procedure with preservation or degradation of signals reflecting the state of the corresponding neural pathways. Alternatively, continuous data may be gathered using electroencephalography or electromyography to gain insight into the brain and nerves, respectively. The Department of Veteran Affairs surgical specialties are located at Southeast Louisiana Veterans Health Care System (SLVHCS) Diagnostics and Treatment Building within Surgery Service located at 2400 Canal St, New Orleans, LA 70119. 2. Scope 2.1 The offeror shall provide as needed and case-by-case service that enables SLVHCS to offer IONM options for patients under the direct medical care within the operating room. The IONM services should be able to cover complex surgical procedures such as: Spine surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and if necessary, Interventional Neuroradiology. The IONM Offeror must be experience and available to cover scheduled and emergency cases 24/7/365, typically within one hour of notification (onsite technical and online professional services). Because of the surgical complexity, the Offeror will have experience providing service to veterans within a military, Naval, or VA Medical Center. DELIVERABLES (REQUIRED SERVICES) 2.1.1 DELIVERABLE #1: Complete Intraoperative Neuromonitoring (IONM) Service The service must be capable of providing real-time data; in addition, the Offeror will offer the most recent technology and hardware. The Offeror will work closely with the surgeons, nursing staff, schedulers, Clinical Engineering, and Sterilization and Processing Service. If necessary, the system will have the ability to communicate with VISTA Imaging and Computerized Patient Record System (CPRS) to allow for the transfer of data into the patient's Electronic Medical Records. It is essential that the proposed operating system integrates into existing infrastructures and exchanges data with other systems using common standard interfaces. Finally, it is the responsibility of the offeror to provide a surgical system that has the ability to function with the current power (electrical) supply. The online Neurologists will provide real-time monitoring via HIPPAA & HITECH (or similar) compliant telemedicine. The Offeror shall provide scheduled services throughout the contract period. In the event of the absence of contractor s personnel for any reason, the contractor shall bear the responsibility of providing replacement personnel to provide the scheduled services. All and any replacement personnel must meet the Credentialing & Privileging requirements prior to providing care to SLVHCS patients. Finally, the Offeror will provide a complete Quality Assurance program that monitors, track any successes or complications, and trends that are reported to the SLVHCS Facility Surgical Work Group (FSWG) quarterly. The Quality Assurance Surveillance Plan (QASP) is managed by the Offeror and presented to the FSWG. 2.1.2 DELIVERABLE #2: Program Management and Offeror Qualifications The offeror is expected to provide all project management services under this contract. Project management services are assumed by the Government to be integral and inherent in the performance of all service tasks of this contract. As such, the project management services under this contract should be factored into the price of other services and not as separate CLINs on this contract. The offeror shall provide a draft comprehensive management plan with the proposal that includes all items necessary for the successful completion of this project. Face to face installation meetings and related activities shall begin within 30 days of contract award and shall be conducted at SLVHCS offices. 2.2 The Offeror shall provide, transport, install, participate in the simulations, be available in live surgical cases, and test the medical equipment prior to utilization. 2.3 All equipment and installation must meet manufacturers and VA specifications. The Offeror will ensure that Clinical Engineering inspect the equipment each time it enters the medical facility. 2.4 The Offeror shall furnish all supplies, accessories, equipment, consumables, transportation, delivery, training, and services. The Offeror shall use Right Fax to transmit the reports. 2.5 The Offeror is responsible for any missing parts and components to complete the requested service. 2.6 The Offeror must be accredited and certified by The Joint Commission. 2.7 If necessary, the IONM will support Deep Brain Simulation and Transcranial Doppler cases. 2.8 The Offeror will ensure that all professional staff have the necessary licenses and certifications. Must have CNIM Certified Surgical Neurophysiologists. 2.9 The Offeror shall provide the necessary personnel to service more than one surgical operation simultaneously. 3.0 DELIVERABLE #3: Hardware Upgrades It is expected that all equipment be kept up to date with modern technology and hardware. If hardware upgrades become available after award of this contract but prior to installation of the equipment, the offeror is required to offer them to the Contracting Officer for consideration. 3.1 The equipment shall be FIPS 140-2 compliant. 3.2 The laptop shall be encrypted and password protected to FIPS 140-2 encryption standards. 3.3 The Offeror shall comply with VA Directive 6500. 4.0 PERIOD OF PERFORMANCE: The period of performance will be for a base year of 12 months and two option years that are each for a period of 12 months in length. Base Period: Period of 12 months which begins on the contract award date. Option Period 1: Period of twelve months immediately following the end of the base year. Option Period 2: Period of twelve months immediately following the end of the option year one. Option Period 3: Period of twelve months immediately following the end of the option year two Option Period 4: Period of twelve months immediately following the end of the option year three 5.1 PLACE OF PERFORMANCE: Southeast Louisiana Veterans Healthcare System, 2400 Canal Street, New Orleans, LA. 70112. 6. SERVICE AGREEMENTS 6.1 Service Agreement: Base Period The Offeror shall provide a full-service plan that covers the complex surgical procedures (such as: Spine surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and if necessary, Interventional Neuroradiology) which also includes (but is not limited to) the following: A method that minimizes the amount of time delay between surgical procedures. On-site and offsite personnel 24/7/364 that includes emergencies for requested surgical procedures. Preventative maintenance of the medical equipment shall be the responsibility of the Offeror. 6.2 Service Agreement: Option Period 1 The Offeror shall provide a full-service plan that covers the complex surgical procedures (such as: Spine surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and if necessary, Interventional Neuroradiology) which also includes (but is not limited to) the following: A method that minimizes the amount of time delay between surgical procedures. On-site and offsite personnel 24/7/364 that includes emergencies for requested surgical procedures. Preventative maintenance of the medical equipment shall be the responsibility of the Offeror. 6.3 Service Agreement: Option Period 2: The Offeror shall provide a full-service plan that covers the complex surgical procedures (such as: Spine surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and if necessary, Interventional Neuroradiology) which also includes (but is not limited to) the following: A method that minimizes the amount of time delay between surgical procedures. On-site and offsite personnel 24/7/364 that includes emergencies for requested surgical procedures. Preventative maintenance of the medical equipment shall be the responsibility of the Offeror. 6.3 Service Agreement: Option Period 2: The Offeror shall provide a full-service plan that covers the complex surgical procedures (such as: Spine surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and if necessary, Interventional Neuroradiology) which also includes (but is not limited to) the following: A method that minimizes the amount of time delay between surgical procedures. On-site and offsite personnel 24/7/364 that includes emergencies for requested surgical procedures. Preventative maintenance of the medical equipment shall be the responsibility of the Offeror. 6.3 Service Agreement: Option Period 2: The Offeror shall provide a full-service plan that covers the complex surgical procedures (such as: Spine surgery, Neurosurgery, Vascular Surgery, Otolaryngology, Cardiac Surgery, Thoracic Surgery, Orthopedics, and if necessary, Interventional Neuroradiology) which also includes (but is not limited to) the following: A method that minimizes the amount of time delay between surgical procedures. On-site and offsite personnel 24/7/364 that includes emergencies for requested surgical procedures. Preventative maintenance of the medical equipment shall be the responsibility of the Offeror. 7.0 CONDITIONS REQUIRED FOR EXECUTION OF SERVICES: During the execution of the contract and for all performance periods the contractor shall adhere to the conditions set forth in the contract clause 52.246-4 INSPECTION OF SERVICES FIXED-PRICE (AUG 1996) which are listed below. (a) Definitions. "Services," as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services. (b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires. (c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work. (d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties. (e) If any of the services do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by reperformance, the Government may (1) require the Contractor to take necessary action to ensure that future performance conforms to contract requirements and (2) reduce the contract price to reflect the reduced value of the services performed. (f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may (1) by contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service or (2) terminate the contract for default. 8. PROTECTION OF PROPERTY 8.1 During the execution of the contract and for all performance periods the contractor shall adhere to the conditions set forth in contract clause 52.237-2 PROTECTION OF GOVERNMENT BUILDINGS, EQUIPMENT, AND VEGETATION (APR 1984) - The Contractor shall use reasonable care to avoid damaging existing buildings, equipment, and vegetation on the Government installation. If the Contractor's failure to use reasonable care causes damage to any of this property, the Contractor shall replace or repair the damage at no expense to the Government as the Contracting Officer directs. If the Contractor fails or refuses to make such repair or replacement, the Contractor shall be liable for the cost, which may be deducted from the contract price. 9. CONTRACTOR REQUIRED SERVICES (Summary): 9.1 The contractor is responsible for providing the services, tasks, and deliverables described herein and summarized below during the performance periods indicated. IONM: Base Period (which includes Deliverables 1, 2, & 3 and the service agreement. IONM: Option Year One (1) which includes Deliverables 1, 2, & 3 and the service agreement IONM: Option Period Two (2) which includes Deliverables 1, 2, & 3 and the service agreement IONM: Option Period Three (3) which includes Deliverables 1, 2, & 3 and the service agreement IONM: Option Period Four (4) which includes Deliverables 1, 2, & 3 and the service agreement 10. 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 through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 3. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. 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. 4. 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. 5. 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...