Description
Pre-solicitation Notice of Intent to Sole Source Pre-Solicitation Notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source contract with affiliate Rhode Island Hospital, The purpose of this acquisition is to obtain a 5-Year BPA: 12/01/2025 11/30/2030. Tests to be included: The contractor shall provide STAT and Non-STAT Clinical Lab Testing Services and Anatomic Pathology Consultation services. Services with CPT codes between 80000 and 90000 as well as new or generic codes are included in this agreement. Contractor shall provide professional and technical services for the Anatomic Pathology Consultation services to include materials, supplies, equipment and qualified supervision specified herein. All Anatomic Pathology consultation services shall be performed at the Contractor s facility. The Contractor will service as the back-up testing facility for VAMC as part of the VAMC contingency plan should a catastrophic event occur disabling all testing at the VAMC. The VA would make other arrangements if the Contractor was impacted by a catastrophic event as well. For clinical laboratory samples, the VAMC will provide an electronic generated patient list containing at a minimum the patient s full name, hospital identification number, tests to be performed, sample collection date/time, ordering provider s full name, sample type and date of birth. For specialized and anatomic pathology specimens, the VAMC will utilize the contractor provided requisition, which may include additional clinical information. VA Rhode Island Healthcare System - STAT and Non-STAT Clinical Lab Testing Services and Anatomic Pathology Consultation Services Performance Work Statement (PWS) General: Services are required to perform off-site STAT and Non-STAT Clinical Lab Testing Services and Anatomic Pathology Consultation Services for the Department of Veterans Affairs Medical Center, Providence (hereinafter referred to as VAMC). The Anatomic Pathology Consultation Services shall cover for both the technical and professional component. The services will be provided in a state-of-the-art civilian medical facility. The standard of services shall be of quality; meeting or exceeding those outlined in the licensing and accreditation section of this PWS. Contactor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA). Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary to perform laboratory services as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract. Objectives: STAT and Non-STAT Clinical Lab Testing Services Anatomic Pathology Consultation Services (off-site) for select cases Serve as back-up testing facility should a catastrophic event occur disabling all testing at the VAMC. Scope: The contractor shall provide STAT and Non-STAT Clinical Lab Testing Services and Anatomic Pathology Consultation services. Services with CPT codes between 80000 and 90000 as well as new or generic codes are included in this agreement. Contractor shall provide professional and technical services for the Anatomic Pathology Consultation services to include materials, supplies, equipment and qualified supervision specified herein. All Anatomic Pathology consultation services shall be performed at the Contractor s facility. The Contractor will service as the back-up testing facility for VAMC as part of the VAMC contingency plan should a catastrophic event occur disabling all testing at the VAMC. The VA would make other arrangements if the Contractor was impacted by a catastrophic event as well. For clinical laboratory samples, the VAMC will provide an electronic generated patient list containing at a minimum the patient s full name, hospital identification number, tests to be performed, sample collection date/time, ordering provider s full name, sample type and date of birth. For specialized and anatomic pathology specimens, the VAMC will utilize the contractor provided requisition, which may include additional clinical information. Period of Performance: The period of performance shall be for five (5) years, one (1) base year, and four (4) 12-month option years. Option years are exercised at the discretion of the Government. Locations: The following VA Medical Centers will utilize these services: VA Providence, RI, 830 Chalkstone Ave, Providence, RI 02908 The Government reserves the right to add additional VISN 1 Laboratories to this agreement. General Information: The Contracting Laboratory: Will provide Anatomic Pathology consultative services. This will include associated services needed to complete the consultation. Will provide Clinical Pathology testing services as needed. Will provide faxed results as well as a hard copy. Printed reports will include: The name and address of the contract laboratory where each test was performed The specimen accession number of the contract laboratory The name of the contract Laboratory Director or Medical Director The date and time the specimen is received by the laboratory and completed The pathologist or technologist signature as appropriate A phone number to contact the Contract Laboratory concerning the test results The Contract Laboratory s CLIA (Clinical Laboratory Improvement Act of 1988) certification number The patient s name The patient s SSN The patient s age or date of birth The patient s sex The Medical Center/CBOC specimen identification number The specimen collection date The Contractor s report date and time The test name The test result(s) The unit of measurement for quantitative tests The normal or expected range (reference range adjusted for age, sex, or race when appropriate). The report status (i.e., final or interim) Other interpretive information appropriate for the test(s) CPT code Will forward representative H&E stained slides of the skin, and H&E and Gomori Trichrome stains of the muscle & nerve specimens to the VAMC within seven (7) days after case completion to allow comparisons with histology specimens submitted in parallel and compliance with VA specimen retention requirements (25 years). For cases where technical component only is requested, case materials must be returned to the Providence VA Medical Center for interpretation. Shall not release patient s records that include test results, without the specific written consent to release such information as provided by the patient, to any person other than the ordering healthcare provider or designee. All member records shall be treated as confidential to comply with all state and federal laws regarding the confidentiality of patient s records. This provision shall survive termination of this Agreement. Shall certify and ensure that all employees, officers, or agents do not use Protected Health Information received from any VAMC site that would constitute a violation of any applicable provision in standards set forth in the Health Insurance Portability and Accountability Act (HIPAA). Shall provide telephone number(s) and contact person(s) to be used by the VA Medical Center to make specimen problem inquiries and problem solving at all times. Agrees to maintain the minimum acceptable service, reporting systems. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency. Shall assign a specific local account representative. Must provide a current Laboratory Manual containing the following information: Department hours of operation Accreditation Technical Staff Service Departments (Method of contracting, phone numbers, hours of availability) Quality Assurance Information such as but not limited to specimen labeling and rejection criteria Billing Procedures & fee schedules for services provided Procedures and criteria for phoning reports and other important information Report forms Licensing and accreditation Contracting Laboratory: Must have all licenses, permits, accreditation certificates required by Federal law and State law in the state of Rhode Island. Must hold a CLIA license and be accredited by the College of American Pathologists (CAP) or The Joint Commission (TJC). Copies of all certifications and renewal certifications will be provided upon submission of a proposal to the Contracting Officer and Contracting Officer s Representative (COR). Medical Director must be licensed Physician with suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP or TJC standards. Must submit a copy of the professional certification and/or licensure of the Laboratory Director and/or Medical Director to the COR with proposal. Must comply with the regulatory requirements of Health and Human Services Healthcare Financing Administration. Must notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure. Contractor Personnel assigned by the Contractor to perform the services covered by this contract shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board. Contract Performance Monitoring: Quality Control: The contractor must operate a successful quality control program. The quality control program must include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor s quality control program is the means by which the contracting laboratory assures that work complies with the requirement of the contract. Quality Assurance: The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint commission and regulations required as required for performing the type of services required. Federal Holidays: New Year s Day Labor Day Martin Luther King Jr. s Birthday Columbus Day President s Day Veteran s Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day Hours of Operation: The contractor is responsible for conducting business, between the hours of 8am 4:30pm EST/EDT Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The Contractor must always maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. All certifications must be kept current with any change of personnel assigned to this contract. Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided to the contracting laboratory. Key Personnel: The following personnel are considered key personnel by the government: Wendy Strollo, Program Director, VISN 1 Network Consolidated Laboratory Jaqueline LaCroix, Quality Manager/Health Systems Specialist, VISN 1 Network Consolidated Laboratory Holly Charpentier, Program Support Medical Laboratory Scientist VISN 1 Network Consolidated Laboratory Gina Hawthorne, Laboratory Manager, VA Providence Dr. Michael Waisberg Chief of Pathology & Laboratory Medicine Service, VA Providence The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 4:30p.m EST/EDT, Monday thru Friday, except Federal holidays or when the government facility is closed for administrative reasons. Identification of Contractor Employees: All contract personnel attending meetings and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. Business Associate Standard: Contractor Personnel Security Requirements The Contractor shall follow all Government rules and regulations regarding information security to prevent disclosure of sensitive information to unauthorized individuals or organizations, and shall adhere to all VA Privacy & Security, the Privacy Act and HIPAA requirements when obtaining and reviewing information. 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. Attachment A Estimated Yearly Workload: CPT Code Description Est. Qty. per Year 88305 Muscle & Nerve Biopsies: Tissue Exam Technical Component Only 10 88305 Muscle & Nerve Biopsies: Tissue Exam Technical & Professional Components 10 88313 Muscle & Nerve Biopsies: Special Stains Grp 2 10 88314 Muscle & Nerve Biopsies: Histochemical Stains Add-On 10 88341 Muscle & Nerve Biopsies: Immunohisto Antb Addl Slide 10 88342 Muscle & Nerve Biopsies: Immunohisto Antb 1st Stain 10 88348 Muscle & Nerve Biopsies: Electron Microscopy 10 88346 Dermatopathology: Immunofluorescent Antb 1st Stain 20 88368 Dermatopathology: Insitu Hybridization manual, ALK-Fish 20 81261, G0452 Dermatopathology: B cell receptor igH Gene Rearrangement 10 81340,81342,G0452 Dermatopathology: T Cell Rearrangement/Clonality 10 80143 Acetaminophen, Serum 2 82803 Blood Gases, Complete, Arterial 2 80053 BMP 2 85025 CBC,Plt & Auto Diff 2 82375,82810,83050,85018 Co-oximetry Panel 2 82375 Carboxyhemoglobin 2 85610 Prothrombin Time 2 80179 Salicylate 2 80197 Tacrolimus (Fk-506) 200 84484 Troponin 2 80202 Vancomycin 2 Autopsy 2 87186 Evaluation of antimicrobial drug (antibiotic, antifungal, antiviral) 2 A hospital laboratory is not required to have a business associate contract to disclose protected health information to a reference laboratory for treatment of the individual.  See 45CFR 164.502(e), exceptions to the Business Associate Standard. VAAR (VA Acquisition Regulation) clause: All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.  The A&A requirements do not apply, and a Security Accreditation Package are not required. Privacy Language for Statement of Work (SOW) Contactor policies and procedures shall comply with all VA Privacy & Security, the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA). NARA Language - Records Management Language for Statement of Work (SOW): The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract: Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.  Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.  Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.  Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.   Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.   The Government Agency owns the rights to all data/records produced as part of this contract.  The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.  Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].   No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.   Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.    VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE  1. GENERAL   Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.  2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS   a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.  b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.   c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.   d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.   e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.   3. VA INFORMATION CUSTODIAL LANGUAGE   a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).   b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.  c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.  d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations, and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations, and policies in this contract.   e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.  f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.  g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.  h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.  i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request.   j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.  k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.  l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.   4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT   a. 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.   b. 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.   c. 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.   d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.   e. 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.   f. 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.   g. The contractor/subcontractor agrees to:   (1) 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.  (1) 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   (2) 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.   h. 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.   (1) 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.   (2) 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.  (3) 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.   i. 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.   j. 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 _15_ days.   k. 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 _15_ days.   l. 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.   5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE   a. 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.   b. 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.  c. 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.   d. 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 of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.   e. 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.   f. 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 of 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.   g. 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.   h. 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:   (1) Vendor must accept the system without the drive.   (2) 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   (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.   (4) 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.   (a) 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   (b) 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.  (c) 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.   6. SECURITY INCIDENT INVESTIGATION   a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.   b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.   c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.   d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.   7. LIQUIDATED DAMAGES FOR DATA BREACH   a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.   b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA  must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.   c. Each risk analysis shall address all relevant information concerning the data breach, including the following:   (1) Nature of the event (loss, theft, unauthorized access).   (2) Description of the event, including:   (a) date of occurrence.  (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected.  (4) Names of individuals or groups affected or potentially affected.  (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text.  (6) Amount of time the data has been out of VA control.  (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons).  (8) Known misuses of data containing sensitive personal information, if any.  (9) Assessment of the potential harm to the affected individuals.  (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate: and  (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.   d. Based on the determinations of the independent risk analysis; the contractor shall be responsible for paying to the VA liquidated damages in the amount of $_100.00_ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:   (1) Notification.  (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports.  (3) Data breach analysis.  (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution.  (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and  (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.  8. SECURITY CONTROLS COMPLIANCE TESTING   On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.  9. TRAINING   a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:   (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems.   (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training.  (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and  (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]   b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.   c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.  Â