SPECIAL NOTICE
66 -- Supply: Hematology Autoimmune Reagent Rental CPT (Siemens)
- Notice Date
- 2/12/2024 9:21:22 AM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 248-NETWORK CONTRACT OFFICE 8 (36C248) TAMPA FL 33637 USA
- ZIP Code
- 33637
- Solicitation Number
- 36C24824Q0419
- Response Due
- 2/16/2024 7:00:00 AM
- Archive Date
- 03/17/2024
- Point of Contact
- Leonora Simmons, Contract Specialist, Phone: 813-972-7592
- E-Mail Address
-
leonora.simmons@va.gov
(leonora.simmons@va.gov)
- Awardee
- null
- Description
- THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. The Department of Veterans Affairs, James A. Haley Veteran's Hospital Tampa, located AT 13000 at Bruce B. Downs, Blvd, Tampa, FL. 33612 intends to solicit and negotiate a sole source requirement, contract for Analyzer Systems (lease of equipment) Reagents and test kits with Siemens, a large business located at 511 Benedict Ave., TerryTown, PA. 10591. This procurement is conducted under FAR 15.002 (a) Sole source acquisitions. Under the authority of (FAR) 6.302-1, ""Only one responsible source and no other supplies or services will satisfy Agency requirements. In accordance with (IAW) FAR 5.207(c)15, the reason justifying the lack of competition is that, after extensive Market Research, no other responsible source was identified that could meet the Government s needs. IAW FAR 5.207(c)16, all responsible sources may submit a capability statement, proposal, or quotation, which will be used for future procurement. This notice of intent is not a request for competitive proposals. Interested parties may identify their capability to be considered for future procurements. NAICS Code 334516 Analytical Laboratory Instrument Manufacturing 1,000 employees apply to this procurement. See the Statement of Need below: All information must be received by 10: 00 A.M.EST, 02/15/2024, and will be reviewed to see if it meets the Government s needs. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Interested parties may e-mail information to leonora.simmons@va.gov. NLT than 02/15/2024. STATEMENT OF NEED 1. GENERAL: 1.1 Contractor to provide a Food and Drug Administration (FDA) approved, Cost-Per-Test (CPT) autoimmune analyzer testing system, reagents, supplies, and consumables capable of performing FDA-approved patient testing. CPT assays to include Vitamin B12, Folate, ACTH, Homocysteine, Alpha-feto Protein (AFP), Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Prolactin, Insulin-like Growth Factor 1 (IGF 1), Beta-2-Microglobulin, Helicobacter pylori, Thyroglobulin, Thyroglobulin Antibody (TG), Thyroid Peroxidase Antibody (TPO), and Allergens. The requirement is for James A. Haley VA Medical Center (JAH VAMC), Pathology & Laboratory Medicine Service, Hematology Department, Tampa, Florida. 1.2 The requirement is for James A. Haley VA Medical Center (JAH VAMC), Pathology & Laboratory Medicine Service, Hematology Departments, Tampa, Florida. This requirement includes any other future JAH VAMC testing location deemed necessary by VA care providers. 2. BACKGROUND: 2.1 Currently, The James A. Haley Veterans Hospital (JAHVH), Pathology & Laboratory Medicine Service has a short-term (6 months) contract with Siemens Healthcare Diagnostics, reference number 36C24823N0993 procurement in place to enable the hospital to continue to lease and order the required DA-approved, automated immunoassay analyzer testing systems and test kits. The reference contract will expire on 03/31/2024, the JAHVH needs to pursue a base and four option year contract. The contract will include vendor-provided equipment, FDA-approved reagents, supplies, and consumables for immunoassay testing to provide care for our VA patient population. 3. PURPOSE: 3.1 The ability to continue to perform autoimmune testing using the Contractor s existing FDA-approved automated analyzer system utilizing FDA-approved reagents, supplies, and consumables to provide care for our VA patient population via a base + four (4) years contract. 4. SCOPE: 4.1 JAH VAMC is requesting equipment and test kits that meet all the minimum physical, functional, and performance features of the listed salient characteristics in this section. These salient characteristics are essential to the technical requirements to continue to meet the needs of the government. The Contractor shall maintain this testing system and continue to provide these assay requirements for a period of performance from 04/01/2024 through 03/31/2029. 5. EQUIPMENT: 5.1 The contractor shall provide an FDA-approved, fully automated, and integrated analyzer testing system, printer, computer, Uninterruptable Power Supplies (UPS) for the analyzer, and accessories required for equipment usage. 5.2 Below are the salient characteristics of the autoimmune FDA-approved instrument and FDA-approved reagents capable of performing Vitamin B12, Folate, ACTH, Homocysteine, Alpha-feto Protein (AFP), Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Prolactin, Insulin-like Growth Factor 1 (IGF 1), Beta-2-Microglobulin, Helicobacter pylori, Thyroglobulin, Thyroglobulin Antibody (TG), Thyroid Peroxidase Antibody (TPO), and Allergens testing with specific functionality and performance-based requirements of the system: 5.3 General instrument characteristics include ability to run FDA-approved patient testing for 100% of the below listed tests on FDA-approved, fully automated, random access, testing platform with priority processing: a. Sufficient capacity and throughput to meet the volume and service demands as defined in the tests and volumes listed in section a. above. b. Bar-coded primary patient sample tube entry capabilities. c. Ability to run multiple assay protocols simultaneously. d. Contractor shall provide all necessary software and hardware for the systems valid, acceptable, bidirectional interface data transmission through Data Innovation (DI) Instrument Manager (IM) middleware network connections. e. Contractor shall provide all necessary system interface hardware and software upgrades as required for VA network compliance. f. Contractor shall provide all upgrades to the equipment hardware and operating system software. g. Operator and Service Manual shall be furnished with each model supplied. Electronic formats are acceptable. h. Procedures shall be provided in accordance with the Clinical and Laboratory Standards Institute (CLSI) in editable format. i. Contractor to provide all test kits, reagents, calibrators, controls, supplies, consumables, and Contractor assistance required for any instrument and method validations. j. Additional testing may be added in support of patient care needs as determined by care providers. k. Computer systems (CPUs, Monitors, Keyboards, Printers), and UPSs provided by the Contractor for the instrument throughout the contract period. l. Electrical Characteristics: 100-240 VAC at 50-60Hz, 1000 Watts. 6.0 DELIVERABLES: 6.1 2 IMMULITE 2000 Xpi Immunoassay Testing Site System - Fully Automated System (Tampa-Hematology) - Lease/Service/Maintenance., qty 12 MO. Dimensions: 182.88 (h) x 160.02 (w) x 91.44 (d) cm; 72 (h) x 63 (w) x 36 (d ) inches 6.2 VersaCell X3 Testing Site System - Fully Automated System (Tampa-Hematology) - Lease/Service/Maintenance., qty 12 MO. Dimensions: 1.02 (w) X 1.09 (d) X 1.56 (h) m; 40.16 (w) X 42.91 (d) X 61.42 (h) inches 7.0 Reagent Kits. Immunoassay One Year Estimated Test Volumes: Description/Part Number - Test Kits Qty Unit ACTH 5 KT TUMOR MARKER AFP 26 KT ALTERNARIA TENUIS IgE 16 KT ALLERGEN, ASP.FUMIGATUS 16 KT ALLERGEN, AUSTRALIAN PINE 28 KT ALLERGEN, BAHIA GRASS 28 KT ALLERGEN, BERMUDA GRASS 16 KT MICROGLOBULIN-B 2 3 KT ALLERGEN, CAT DANDER/EPITHELI 16 KT ALLERGEN, COCKROACH 28 KT ALLERGEN, COMMON RAGWEED 16 KT ALLERGEN, DERMA FARIAE 16 KT ALLERGEN, DERMA PTERONYSSINU 16 KT ALLERGEN, DOG DANDER 16 KT ALLERGEN, ELM 28 KT ALLERGEN, EPICOCCUM PURPUR 28 KT FOLATE 180 KT FSH HORMONE 13 KT ALLERGEN, FUSARIUM MONOLIFORM 25 KT ALLERGEN, GIANT RAGWEED 28 KT HELICOBACTER PYLORI IgE 3 KT HOMOCYSTEINE 3 KT ALLERGEN, HOUSE DUST, GREER 16 KT TOTAL IGE 7 KT INSULIN LIKE GROWTH FACTOR IGF-1 5 KT ALLERGEN JOHNSON GRASS 28 KT ALLERGEN, LAMBS QUARTERS 28 KT LUTEINIZING HORMONE LH 13 KT ALLERGEN, MOUNTAIN CEDAR 28 KT OAK IgE 16 KT ALLERGEN, ORCHARD GRASS 16 KT ALLERGEN, PECAN 28 KT ALLERGEN, PENICILLIUM NOTAT 16 KT ALLERGEN, PERENNIAL RYE GRASS 16 KT PROLACTIN 13 KT ALLERGEN, ROUGH MARSH ELDER 28 KT ALLERGEN, ROUGH PIGWEED 28 KT ALLERGEN, SHEEP SORREL 28 KT ALLERGEN, STEMPHYLIUM BOTRYOS 28 KT THRYROGLOBULIN 5 KT THYROGLOBULIN ANTIBODY 6 KT THYROID PREOXIDASE ANTIBODY 5 KT ALLERGEN, TIMOTHY GRASS 16 KT VITAMIN B-12 230 KT ALLERGEN, WHITE MULBERRY 28 KT 8. FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: 8.1 Must provide the following functional and performance capabilities to ensure equipment is utilized and maintained according to the requirements of the system: a) Preventive Maintenance shall be performed per manufacturer s guidelines. b) Instrument service to be provided during routine business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements will be coordinated between the contractor and VA laboratory personnel. c) Expected response to service call time from initial call to Contractor to service engineer arriving on site should be no more than 24 hours. d) Technical Support Hotline must be available for in-house troubleshooting. 8.2 The Cost per test includes costs covering (a) FDA-approved instrument system (lease), (b) equipment use, computers, printers, and accessories including Uninterruptable Power Supply (UPS) for the instrument, (c) Software and hardware, (d) all aspects of computer interfacing for the analyzer system, (e) reagents offered by the vendor, (f) all necessary supplies and consumables, (g) all necessary service, maintenance, and parts to keep the equipment in good operating condition to fulfill the test requirements and produce high-quality patient results, (h) operational hardware and software upgrades, (i) user training for government personnel, and (j) upon expiration of order(s) and/or termination and/or replacement of equipment, will provide equipment decontamination, turn-in hard drives with VA sensitive information to VA IT Department, and return packing and shipping at no additional charge. 8.3. All work is to be performed in accordance with the guidelines established by Federal, State, and local ordinances, with the FDA, and manufacturer s guidelines, and with all terms, conditions, provisions, schedules, and specifications provided herein. 8.4. The contractor will provide analyzers or testing systems, parts and all operational upgrades to the equipment hardware and operating system software that materially affects the performance of the equipment, without additional charge to the government. 8.5. All models shall perform satisfactorily at any laboratory temperature between 59- and 86 degrees F (15 and 30 degrees Celsius). All models shall perform satisfactorily at any laboratory relative humidity of 10 to 70%. 8.6. With all equipment, Ownership of Equipment shall remain with the contractor for the life of the contract. All equipment accessories (hardware and software) furnished by the contractor shall accompany the equipment when returned to the contractor. 8.7. The contractor, upon expiration of order(s) at termination and/or replacement of equipment, will remove the equipment and turn in any hard drives containing VA sensitive information to VA IT Department. 8.8. The contractor shall disconnect the equipment and shall be responsible for packing, shipping, and charges required to remove the equipment within ten business days. 8.9. With all equipment, the standard and acceptance of performance shall begin on the contract awarded date. It shall end on the earlier date of when a certificate of acceptance has been signed or the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformation with the contractor s technical specification or as quoted in any contract at effectiveness level of 90% or more. 8.10. In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of the performance test shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. 8.11. Operational use time for performance testing for a system is defined as the accumulated time during which the equipment is in actual use. 8.12. System failure downtime is 24 hours when any machine in the system is inoperable due to equipment failure. 8.13. Downtime for each incident shall start from the time the government makes a bona fide attempt to contact the contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition. 8.14. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for the computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. 8.15. The government shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. 8.16. Operations use time and downtime shall be measured in hours and whole minutes. 9. GOVERNMENT S RESPONSIBILITY: 9.1 The user will perform daily routine operator maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. 10. TRAINING OF OPERATING PERSONNEL: N/A 11. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE: 12. Reagents Delivery terms, Quality of Reagents, Supplies, and Consumables: 12.1. The VA shall require the delivery of reagents, supplies, and consumables for all services required within 30 days of the contract awarded date. 12.2. The contractor shall deliver reagents, supplies, and consumables, shipping cost included, from monthly call orders placed by the JAHVH representative, (COR). 12.3. The contractor shall ensure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce high-quality, accurate patient results. 12.4. The FDA-approved reagent quality must be high enough to satisfy the proficiency testing standards of the College of American Pathologists (CAP) and Joint Commission (JC). 13. MAINTENANCE: 13.1. The contractor shall provide maintenance (labor, parts, and shipping) to keep the equipment in good operating condition and subject to security regulations. 13.2. The government shall provide the contractor access to the equipment to perform maintenance services. 13.3. Preventive Maintenance (PM) by the contractor shall be provided regular, scheduled maintenance to ensure the continued reliable operation of the equipment. These preventative maintenance visits shall be performed semi-annually by the manufacturer s operation and maintenance instructions for the supported equipment. 14. SERVICE: 14.1. Emergency repairs shall be performed within 24 hours after notification by the COR that the equipment is inoperative. 14.2. The scheduled maintenance and service shall be performed by a qualified engineer with notice to the Contracting Officer Representative (COR). James A Haley VA Hospital, Pathology & Laboratory Medicine Service is open 24 hours a day, 7 days a week including holidays. 14.3. Telephone response does not satisfy this requirement. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable his maintenance representative to receive such notification. 14.4. The contractor shall provide all parts, labor, and shipping needed to repair the malfunction. 14.5. The travel, per diem and other expenses associated with the repair will be borne by the contractor. Otherwise, all services will be performed at no charge to the Government during this period. 14.6. The contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. 14.7. The report shall include, as a minimum, the following: (a date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run. 15. TECHINCAL UPGRADES: 15.1. Contractor shall provide supplemental operating training to the government personnel, without additional charge to the government, upon installation of an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished. 16. WARRANTY OF EQUIPMENT: 16.1. Government requirement for standard manufacturer industry warranty term. The government does not accept an extended warranty, which requires advance payment. 17. DELIVERY SCHEDULE: Delivery performance shall start on 04/01/2024. 18. PLACE OF DELIVERY: 18.1. Department of Veterans Affairs, James A. Haley Veterans Hospital, 13000 Bruce B. Downs, Blvd. Tampa, FL. 33612. With Sensitive Data and Training VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS: a. 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. b. 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. c. 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. d. 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. Contractor Personnel Security Requirements: All contractor employees who require access to the Department of Veterans Affairs computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract the contractor will be responsible for the actions of those individuals that provide or perform work for the VA. 1. Position Sensitivity The position sensitivity has been designated as ( low) risk. 2. Background Investigation The level of background investigation commensurate with the required level of access is National Agency Check (NACI) with written inquiries. 3. Contractor Responsibilities: a. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM), the contractor shall reimburse the VA within 30 days. The website which provides information on the cost of the security investigation is: www.opm.gov\extra\investigate Select Federal Investigations Notices (FIN 01-01) b. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain U.S. citizenship and can read, write, speak, and understand the English language. c. The contractor will provide to the Contracting Officer prior to award the following: (1) List of names of contract personnel. (2) Social security numbers of contractor personnel. (3) Home address of contractor personnel or the contractor address. The Contracting Officer will submit the above information to the Office of Security and Law Enforcement, Washington, D.C. The Office of Security and Law Enforcement will provide the necessary investigative forms (these forms are indicated in paragraph 3.d. below) to the contractor s personnel, coordinate the background investigations with OPM and notify the Contracting Officer and contractor of the results of the investigation. d. The contractor shall submit or have their employees submit the following required forms to the VA Office of Security and Law Enforcement within 30 days of receipt: (i) Standard From 85P, Questionnaire for Public Trust Positions (ii) Standard Form 85P-S, Supplemental Questionnaire for Selected Positions (iii) FD 258, U.S. Department of Justice Fingerprint Applicant Chart (iv) VA Form 0710, Authority for Release of Information Form (v) Optional Form 306, Declaration for Federal Employment (vi) Optional Form 612, Optional Application for Federal Employment d. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract. e. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default. 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 the 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 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 the VA s information is returned to the VA or destroyed in accordance with the VA s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, the 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 1600.1, 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, the confidentiality of medical quality assurance records, and/or Title 38 U.S.C. 7332, the 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 COR. 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 COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. 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. LIQUIDATED DAMAGES FOR DATA BREACH: a. Consistent with the requirements of 38 U.S.C. ยง5725, 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. However, it is the policy of theVA to forego the collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency. 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, the VA must secure from a non-department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. The contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1)Nature of the event (loss, theft, unauthorized access); (2)Description of the event, including: (a)date of occurrence; (b)data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, and disability code; (3)Number of individuals affected or potentially affected; (4)Names of individuals or groups affected or potentially affected; (5)Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6)Amount of time the data has been out of VA control; (7)The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8)Known misuses of da...
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