Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JULY 19, 2025 SAM #8636
SPECIAL NOTICE

66 -- Critical Care Ionized Calcium and Comprehensive Electrolyte Profile Analyzer

Notice Date

7/17/2025 9:27:34 AM
 

Notice Type

Special Notice
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

256-NETWORK CONTRACT OFFICE 16 (36C256) RIDGELAND MS 39157 USA
 

ZIP Code

39157
 

Solicitation Number

36C25625Q0957
 

Response Due

7/31/2025 1:00:00 PM
 

Archive Date

08/30/2025
 

Point of Contact

Joseph Warren, Contracting Officer, Phone: 479-444-5011
 

E-Mail Address

joseph.warren@va.gov
(joseph.warren@va.gov)
 

Awardee

null
 

Description

NOTICE OF INTENT TO AWARD SOLE SOURCE I. The Department of Veterans Affairs, Network Contracting Office (NCO) 16 in support of the Central Arkansas Veterans Healthcare System (CAVHS) located in Little Rock, Arkansas intends to issue and award a sole source, firm-fixed price type contract with a base year and four one year option periods with one large business source, Nova Biomedical Corporation at 200 Prospect St., Waltham, MA, 02454-3407. Contractor will provide all reagents below that are compatible without delay with Nova 8-Primary Tube Autosampler. Reagents are required to meet agency CFR21 standard as the facility is registered as an FDA facility. Reagents requested are for performing the measurement of Ionized Calcium in blood samples of patients. II. The North American Industry Classification (NAICS) code for this acquisition is 325413-In-Vitro Diagnostic Substance Manufacturing. Standard in number of employees is 1,250. III. This purchase will be made under Simplified Acquisition Procedures and Other than Full and Open Competition, as authorized by FAR 6.302-1 and in accordance with FAR 13.106-1(b). The Government intends to award a Firm-Fixed-Price contract, in accordance with FAR 16.202-1. IV. The anticipated award date is October 1, 2025 plus four one year options exercised at the discretion of the government. The Government intends to award a Firm-Fixed-Price contract V. Please note that this is not a request for competitive quotes and is being posted for informational purposes only. Interested contractors, in addition shall provide the following information as an attachment to your response: 1. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. 2. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each. 3. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? Yes ___No ___ If yes, please identify which companies you are considering a Joint Venture and the ownership of each company. 4. Do you have an existing BPA, GSA or VA, Federal Supply Schedule contract, if yes, please include the contract details in your response. 5. Are you a small or large business manufacturer? 6. Are your reagents approved by the AABB and FDA? 7. Are you an authorized distributor of Nova Biomedical Corporation? 8. Is your company capable of meeting the shipping request per the Draft SOW that included but not limited to the shipment every two weeks or every 28 days as follows: For item #1 deliver 5 PGs every 28 days with shipment. Deliver 5PGs every 2 weeks with shipment VI. Interested parties shall identify their interests and capability to respond to this requirement within ten (10) calendar days of the publication of this notice. Any response to this notice shall show clear and convincing evidence that competition would be advantageous to the Government. Interested parties shall submit clear evidence with the capability to meet government requirement. To include but not limited to: 1. Capability to provide and deliver on an as needed basis name brand or equal products as the Nova Biomedical Corporation reagents and supplies that are compatible to government owned equipment chemistry analyzer. See Attached DRAFT SCOPE OF WORK (SOW) VII. Questions regarding this notice should be sent to Contracting Officer Joseph Warren no later than July 31, 2025 by 3:00pm (CST) at joseph.warren@va.gov Draft Statement of work 1. PURPOSE 1.1. The Department of Veterans Affairs, Little Rock, AR (CAVHS), seeks to establish a CPRR (Cost Per Reportable Result) contract for Instrumentation that can perform Ionized Calcium that can be aspirated directly from plasma or serum of a blood vacutainer collection tube without additional hands-on preparation besides the as needed transfer of sample into a single sample vial. The Government seeks to award a CPRR (Cost Per Reportable Result) to a single contractor for Comprehensive Electrolyte Profile Instrumentation for rapid analysis of Ionized Calcium and other electrolytes. Additional tests/reagents/instrumentation may be added through bilateral modifications to the contract as needed by CAVHS. 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 materials, parts, tools, 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 in order to carry out the installation. 2.5. SALIENT CHARACTERISTICS 2.5.1. Specifications/Salient Characteristics Tabletop Instrument (less than 16in x 16in 20in(height)) Acceptable Samples: o Whole blood (heparinized), arterial, venous, mixed venous o 100 µL Sample draw requirement Required testing: o Ionized Calcium that can be aspirated directly from plasma or serum of a blood vacutainer collection tube without additional hands-on preparation aside from the as needed transfer of sample into a single sample vial. Must be listed in the instrument manual. Off label use is not acceptable. Available testing: o Na o K o Cl o iCa o iMg o pH o Hct Bidirectional connectivity Data management system Disposable technology that eliminates maintenance Stat results (120 seconds or less) Clot protection Automated Liquid QC Optional mobile cart with UPS Communication Protocols - ASTM, HL7, or POCT01-A2 connectivity formats All replacement parts, labor and travel expenses for any unscheduled service will be covered by the vendor (not to include accessory items) All applicable instrument shipping charges covered by vendor for life of contract Service will ship replacement unit within 48 hours of request if needing repair at no cost to CAVHS Technical support and troubleshooting during normal business hours (M-F 8am-5pm EST) 2.6. This instrumentation must perform Ionized Calcium testing that can be aspirated directly from plasma or serum of a blood vacutainer collection tube without the need of additional hands-on preparation except for as needed transfer of sample into a single sample vial. 2.7. The Contractor shall furnish all clinical products (Instrument, printers, barcode scanners, replacement parts, reagents, kits, sensor cards, and consumables), packaging, and shipping required to furnish items for the equipment provided to the Central Arkansas Veterans Healthcare System (CAVHS) Pathology and Laboratory Medicine Service (P&LMS). These products are required to perform specialized diagnostic testing on clinical patient specimens and must meet stringent quality control and compliance standards. 2.8. Instrument must be capable of aspirating sample directly from plasma or serum of a blood vacutainer collection tube without additional hands-on preparation besides the as needed transfer of sample into a single sample vial. 2.9. Equipment must maintain, or preferably reduce the overall labor required to accomplish the required testing by each laboratory. Proposed equipment shall meet or exceed throughput of existing equipment. 2.10. The instrument must not require extensive daily, weekly, monthly, or as needed maintenance. Preferable maintains or reduces overall labor/time spent when compared to current instrumentation. 2.11. A total equipment footprint, that when installed in the laboratory, shall not impact the functionality/operations of that laboratory or will preferably reduce the overall footprint when compared to the laboratory s current equipment 2.12. Ancillary support equipment - The Contractor shall provide, install and maintain throughout the life of the contract , as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. UPS(s) with surge suppressor and line conditioner (including preventative maintenance, battery replacement and repair), cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, preventative maintenance and repair, etc.), and universal interface equipment, etc. at no cost to the Government. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. at no charge to the government. 2.13. Equipment Preventative Maintenance/Repair Service. 2.13.1. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on instrumentation and any incremental support/ancillary equipment, e.g. Equipment Preventative Maintenance/Repair Service. A technical assistance center shall be available by by telephone 24 hours per day, 7 days per week with a maximum call back response time 1 hour. 2.13.2. Equipment repair service shall be provided 5 days per week during core business hours for the laboratory. 2.13.3. Equipment repair response time (on-site arrival) shall be no more than 48 hours once a determination is made that on-site service is required 2.13.4. Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within a timely manner with regard to the scheduled due date to ensure compliance with accrediting agencies. V16 labs are currently accredited by The Joint Commission and their published allowances are as follows: § Quarterly/every quarter = every 3 months (90 days), plus or minus 10 days § Every 6 months = 6 months (180 days) from the last event, plus or minus 20 days § Annually/every 12 months/once a year/every year = 1 year from the last event, plus or minus 30 days 2.13.5. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: § date and time notified § date and time of arrival § serial number, type and model number of equipment § time spent for repair, and § proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. § Brief description of problem/issue, parts/items replaced, adjustments or realignments performed and any other information relevant to the repair. 2.13.6. Any assay/instrument calibrations and QC analysis required following service/repairs/PMs shall be performed by the service engineer. (see proof of repair above for QC documentation) 2.13.7. The service call shall include a discussion communicating repair and outcomes with appropriate on-duty technologist. 2.13.8. Each notification for an emergency repair service call shall be treated as a separate and new service call. 2.13.9. Contractor shall promptly provide a return goods authorization for return of equipment being replaced. 2.13.10. Maintenance and service requirements apply to all equipment placed under the contract 2.14. DELIVERY AND INSTALLATION 2.14.1. DELIVERY 2.14.1.1.1. Contractor shall deliver all equipment to the Central Arkansas Veterans Healthcare System (CAVHS) Anatomic Pathology Laboratory Rm 2D-171 Chemistry Section of P&LMS at 4300 W. 7th St. Little Rock, AR 72205. 2.14.2. INSTALLATION 2.14.2.1.1. Install all equipment to manufacturer s specifications maintaining Federal, and Local safety standards. 2.14.2.1.2. 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. 2.14.2.1.3. 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. 2.14.2.1.4. The contractor shall coordinate all deliveries, staging areas, installations, and parking arrangements with the COR. 2.14.2.1.5. 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 VA premises. The Contractor shall be responsible for any damage to the building that occurs due to Contractor error or neglect. 2.15. SITE CONDITIONS 2.15.1. 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. DELIVERY/STORAGE REQUIREMENTS 4.1. Deliver materials to job in manufacturer's original sealed containers with brand name marked thereon. 4.2. 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. 4.3. Deliver specified items only when the site is ready for installation work to proceed. 4.4. Store products in dry condition inside enclosed facilities. 4.5. Any government requested delayed delivery up to 90 days after initial delivery date, shall be at no additional cost to the Government. 4.6. A pre-delivery meeting will be conducted 60 days prior to initial negotiated delivery date for verification of delivery and installation dates. 4.7. Delivery and Installation will be coordinated through the COR. 5. DELIVERABLES 5.1. Operation and Maintenance Manuals 5.1.1. 2 complete sets of operators manuals for 2.5.1 (hard and digital if available) 5.1.2. 2 complete sets of Technical manuals for 2.5.1 (hard and digital if available) 5.2. Consumables 5.2.1. CAVHS government point of contact will place an order for required products 5.2.2. Delivery of products shall be coordinated with the government point of contact 5.2.3. Product shipments shall arrive within 1-7 business days of order placement 5.2.4. Products shall be pre-packaged in OEM s sealed containers and marked with brand name 5.2.5. Products shall be packaged to prevent damage or deterioration during shipment, handling, and storage 5.2.6. Products shall be delivered only when the site is ready to proceed 5.3. Parts 5.3.1. Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies/equipment (i.e. replacement parts) for the CAVHS. No remanufactures or gray market items will be acceptable. 5.3.2. Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed medical supplies/equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies and medical equipment. 5.3.3. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right to enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discover of such items. 5.4. Inspection and Acceptance 5.4.1. The Pathology and Laboratory government point of contact shall ensure all items are satisfactory prior to acceptance. Disputes shall be resolved by the CO. 5.5. Deliver compilation of all manufacturer recommended maintenance schedule and operation materials packaged in binder(s) to COR upon completion of installation. 6. Period of Performance: 6.1. October 1, 2025 September 30, 2026 with four (4), additional one (1) year option periods to be exercised at the government discretion. **Options subject to availability of reagents and supplies. 6.2. Option Year 1: October 1, 2026 September 30, 2027 6.3. Option Year 2: October 1, 2027 September 30, 2028 6.4. Option Year 3: October 1, 2028 September 30, 2029 6.5. Option Year 4: October 1, 2029 September 30, 2030 7. OPERATOR TRAINING: 7.1. Contractor shall provide On-site training of the equipment to the Users. Operator training shall be coordinated with the CAVHS COR after installation is complete. 8. CONTRACT ADMINISTRATION: 8.1. Changes to Contract or SOW: The CO is the only individual authorized to approve changes or modify any of the requirements under this SOW or impending contract. The Contractor shall communicate with the government point of contact on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue changes affecting price, quantity or performance of this contract. Costs incurred by the Contractor through the actions of parties other than the CO shall be borne by the Contractor. 8.2. Payments: The Contractor shall submit requests for payment electronically to the VA s Tungsten Network. Invoices shall be paid in arrears, upon receipt of a properly prepared invoice submitted to: https://www.fs.va.gov/einvoice.asp Invoices shall include, at a minimum, the following information: Name and address of the contractor Invoice date and number Contract Number, Purchase Order Number, contract line item number Monthly invoice number Detailed description of quantity, unit of measure, unit price and extended price of the products provided 9. PROTECTION OF PROPERTY 9.1. 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. 9.2. 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. 9.3. The Contractor shall be responsible for security of the areas in which the work is being performed prior to completion. 9.4. Contractor shall provide floor protection while working in all VA facilities. All material handling equipment shall have rubber wheels. 10. SECURITY REQUIREMENTS 10.1. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 10.2. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. 10.3. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. 10.4. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. 11. CONTRACTOR SECURITY REQUIREMENTS 11.1. The C&A requirements do not apply, and that a Security Accreditation Package is not required. 11.2. 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. 12. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS 12.1. A contractor/subcontrator 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. 12.2. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. 12.3. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. 12.4. 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. 12.5. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 13. VA INFORMATION CUSTODIAL LANGUAGE 13.1. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data 13.2. - General, FAR 52.227-14(d) (1). 13.3. 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. 13.4. 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. 13.5. 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. 13.6. 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. 13.7. 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 13.8. payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. 13.9. 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. 13.10. 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. 13.11. 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. 13.12. 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. 13.13. 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. 13.14. 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. 14. SECURITY INCIDENT INVESTIGATION 14.1. 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. 14.2. 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. 14.3. 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. 14.4. 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. 15. LIQUIDATED DAMAGES FOR DATA BREACH 15.1. 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. 15.2. 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 d...
 

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