Inactive

Research Study - Power Home Sleep Apnea Weight Loss

Inactive Total Small Business Set-Aside (FAR 19.5)

Pre-Solicitation Notice to solicit for a contractor to provide services, for a home sleep apnea weight loss study for the Puget Sound VAMC Research Office, 1660 South Columbian Way, Seattle WA 98108. ... Pre-Solicitation Notice to solicit for a contractor to provide services, for a home sleep apnea weight loss study for the Puget Sound VAMC Research Office, 1660 South Columbian Way, Seattle WA 98108. This is not a solicitation. The Department of Veterans Affairs intends to solicit for a Firm Fixed Priced Purchase Order for one (1) year period of performance to commence 4/1/2023 through 3/31/2024. The overall goal is to meet the VA Puget Sound Health Care System research office need by mailing level 3 HSAT units to the Veterans home, retrieve the HSAT after its use, score the HSAT, and provide results to the study staff of POWER in accordance with the Performance Work Statement (PWS) that will be included with the solicitation. The home sleep apnea tests will be conducted among 400 individuals (200 intervention, 200 control) at one time point. The solicitation will be issued as a 100% Small Business set aside on or about 03/01/2023. The applicable NAICS code is 621610 with a $16.5 Mil Size Standard. The FSC/PSC is Q403. Copies of the solicitation will not be available for mailing. All prospective Small Business contractors must be registered in the System for Award Management (SAM) prior to award of the contract. Registration may be accomplished at www.sam.gov. Questions concerning this procurement may be directed to the Contracting Officer Ann Marie Stewart at annmarie.stewart@va.gov.

Inactive

SOURCES SOUGHT NOTICE Sources Sought: This is NOT a solicitation for a proposal, proposal abstract, or quote. The purpose of this notice is to obtain information regarding qualified business sources. ... SOURCES SOUGHT NOTICE Sources Sought: This is NOT a solicitation for a proposal, proposal abstract, or quote. The purpose of this notice is to obtain information regarding qualified business sources. The responses to the information requested will assist the Government in determining the appropriate acquisition method. STATEMENT OF WORK (SOW) Title. Home Sleep Apnea Testing for the POWER (Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach) Study Background. VA Puget Sound Health Care System is seeking a contract to conduct sleep studies for project titled Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach (POWER). We are conducting a large pragmatic randomized trial of a lifestyle intervention among Veterans with obstructive sleep apnea (OSA) and obesity, a population of nearly 1 million in the Veterans Health Administration. Obesity is a key driver of OSA severity, but care for obesity is rarely offered to patients with OSA. Our trial, POWER, tests a self-directed and remote intervention aimed at achieving weight loss among patients with OSA. A critical endpoint of this trial will be to test whether the intervention improves OSA severity. The severity of OSA is measured by the number of respiratory events detected per hour of sleep. This is typically measured by a home sleep apnea test (HSAT). We are planning to conduct home sleep apnea tests among 400 individuals (200 intervention, 200 control) at one time point: 12 months after randomization (400 total sleep studies). To align with existing VA clinical practice guidelines, we plan to use level 3 home sleep apnea testing devices. Contractor is to ship HSAT units directly to participants homes, retrieve the device, and perform all necessary data cleaning and scoring. This method is increasingly used by VA Medical Centers to perform HSATs. The Contractor will provide a mail-based service for OSA testing using level 3 HSAT devices. Scope. Using a secure web-based portal or secure fax, POWER study staff will provide the Contractor the name, address, and telephone numbers for Veterans to be approached for participation in home sleep apnea testing. These Veterans will be randomly selected from the larger sample of Veterans participating in the randomized control trial proposed in POWER). The Contractor will mail a level 3 HSAT unit to the Veterans home, retrieve the HSAT after its use, score the HSAT, and provide results to the study staff of POWER. Tasks. The specific tasks that will be part of this SOW include the following: Mailing a level 3 HSAT unit to Veteran participants homes. (Up to 400 unique Veterans-200 control and 200 interventions, up to n=400 total HSAT tests). Vendor will only bill for sleep studies sent. Provide standard manufacturer specific instructions to Veterans around the proper use of a level 3 HSAT unit. These instructions will include how to wear the HSAT unit while they sleep, and how to turn the device on and off. Provide technical support via telephone for the Veterans who have questions around the use of the HSAT. Provide Veterans with a telephone number to call if they have questions. Provide the Veteran with a method to ship the HSAT unit back to their facility. Once HSAT is returned to their facility, score the sleep study according to American Academy of Sleep Medicine standards. This scoring will include: Identifying apneas Identifying hypopneas with 4% oxygen desaturation Identifying hypopneas with 3% desaturation Identifying oxygen desaturation events at the 3% and 4% thresholds Measuring the time spent with oxygen saturation below 90% Measuring the time spent with oxygen saturation below 88%. Create a report for each Veteran including the following metrics: Apnea hypopnea index using 4% oxygen desaturation hypopnea definition Apnea hypopnea index using 3% oxygen desaturation hypopnea definition Oxygen desaturation index using the 4% oxygen desaturation definition Oxygen desaturation index using the 3% oxygen desaturation definition Percentage of recording time spent below an oxygen saturation of 90% Time spent below an oxygen saturation of 90% Percentage of recording time spent below an oxygen saturation of 88% Time spent below an oxygen saturation of 88% Send each Veteran s report to POWER study staff through a secure web-based portal or secure fax within 2 weeks of HSAT completion. Deliverables. Deliverable Date Deliverables (note N s are estimates, up to 400 studies total) 1st Quarter N=100 HSAT studies including: Mailing a level 3 HSAT unit to the Veteran participants home. Providing instructions to Veterans around the proper use of a level 3 HSAT unit Providing technical support for the Veterans who have questions around the use of the HSAT Retrieving the HSAT unit once the sleep study is complete Scoring the sleep study Provide the POWER study staff with data files of study results. 2nd Quarter N=100 HSAT studies including: Mailing a level 3 HSAT unit to the Veteran participants home. Providing instructions to Veterans around the proper use of a level 3 HSAT unit Providing technical support for the Veterans who have questions around the use of the HSAT Retrieving the HSAT unit once the sleep study is complete Scoring the sleep study Provide the POWER study staff with data files of study results. Deliverable Date Deliverables 3rd Quarter N=100 HSAT studies including: Mailing a level 3 HSAT unit to the Veteran participants home. Providing instructions to Veterans around the proper use of a level 3 HSAT unit Providing technical support for the Veterans who have questions around the use of the HSAT Retrieving the HSAT unit once the sleep study is complete Scoring the sleep study Provide the POWER study staff with data files of study results. 4th Quarter N=100 HSAT studies including: Mailing a level 3 HSAT unit to the Veteran participants home. Providing instructions to Veterans around the proper use of a level 3 HSAT unit Providing technical support for the Veterans who have questions around the use of the HSAT Retrieving the HSAT unit once the sleep study is complete Scoring the sleep study Provide the POWER study staff with data files of study results. Performance Monitoring. Contractor must have demonstrated 1 year of prior experience conducting similar mailed services of HSAT units for VA or VA Community Care Networks/Tricare. Contractor must guarantee ability to use validated level 3 HSAT units, which are a requirement of this study. There will be regular conference calls/meetings with the POWER project team to review project deliverables and milestones. The Project Principal Investigator will provide oversight of the work, which will be measured by meeting project deadlines in a timely fashion and regularly assessed quality of the work in achieving the stated project goals. This regular performance evaluation will be recorded in minutes that will be available to the Station POC for review. The Station POC will work with the Project Principal Investigator and the research team to complete the required annual performance evaluation. Security Requirements. Vendor does not require access to VA internal network. The C&A requirements do not apply, and Security Accreditation package is not required. Vendor will store collected sleep data on a temporary basis while conducting the project. 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 COTR. 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 COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. The contractor/subcontractor shall certify to the COTR 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: (a) The Systems of Records (SOR); and (b) 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 working 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 working 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 COTR 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 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 COTR. 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 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 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. 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 fo...