6550--Intent to Sole Source Histology Reagents and Supplies

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole-source contract pursuant to 10 U.S.C 2304 (C)(1), as implemented by FAR 6.302-1(a)(2) and 6.301-1(c), only one responsible source and no other supplies or services will satisfy agency requirements and brand-name descriptions. The Department of Veterans Affairs Medical Center, located at 1400 VFW Parkway, West Roxbury, MA, 02132, requires the reagents and supplies listed in the attached Statement of Objectives. The Government intends to award a firm-fixed-price sole source contract. The government's determination not to compete with this proposed contract based on responses to this notice is solely within its discretion. This notice of intent is not a request for competitive proposals. It is a written notice to inform the public of the Government's intent to award on a sole-source basis. Interested parties may identify their interest and capability to respond to the requirement. Any response to this notice must show clear and convincing evidence that competition will be advantageous to the Government. Please contact Manasés Cabrera, Contracting Specialist with the responses or questions regarding this requirement at [email protected]. This notice will close on February 17, 2025, at 4:30 PM Eastern Standard Time (EST) Histology Reagent and Supplies Statement of Objectives Items to be provided: Histology reagents and supplies for contract period TBD. Histology reagents and supplies will be ordered on as needed basis. Lab Sites and POC s VA Boston Healthcare System  West Roxbury Campus  1400 VFW Parkway  West Roxbury, MA 02132  VA Connecticut Healthcare System  West Haven Campus  950 Campbell Avenue  West Haven, CT 06516  VA Providence  830 Chalkstone Avenue  Providence, RI   02908   Name   Title   Office   Telephone   E-mail Address   Wendy Strollo  NCL Program Director  NCL Office  203-841-5591  [email protected]  Holly Charpentier  Program Support NCL  NCL Office  802-296-1349  [email protected]  Jacqueline Hite  Program Support NCL  NCL Office  203-601-0563  [email protected]  Required: The Government reserves the right to add additional testing kits during the life of this agreement.    The Government reserves the right to add additional VISN 1 Laboratories to this agreement.  VA White River Junction   215 North Main Street  White River Junction, VT  05009-001    VA Manchester  718 Smyth Road  Manchester, NH  03104    VA Central Western Massachusetts Healthcare System  Northampton Campus  421 North Main Street  Leeds, MA 01053  VA Boston Healthcare System  Brockton Campus  940 Belmont Street  Brockton, MA 02301  VA Bedford Healthcare System  200 Springs Road  Bedford, MA 01730  VA Boston Healthcare System  Jamaica Plain Campus  150 S. Huntington Avenue  Boston, MA 02130  VA Connecticut Healthcare System  Newington Campus  555 Willard Ave.  Newington, CT 06111  VA Maine  1 VA Center  Augusta, ME  04330   The annual quantity is only an estimate and volumes are not guaranteed. Volumes may vary during the life of the agreement.  The test kits will be shipped and replenished in quantities as requested by the individual site laboratory. The laboratory departments will request the kits on an as-needed basis.  Each site will be invoiced for their own delivery orders. The Contractor will provide direct delivery to the requesting lab at the contractor s expense. The Laboratory department will order using their usual procedures and referencing the purchase agreement pricing. They will be invoiced for their own orders.  Each laboratory may order any of the reagent kits listed in this contract.  All pricing includes FOB destination with 2-day shipping upon order.  All reagents and supplies should have the longest outdates possible, with a minimum of 6 months before expiration when received on-site.  Contractor will supply a quarterly and/or yearly report to the Contracting Officer s Representative (COR) as requested that indicates the products and quantities purchased each month. The report will consist of a breakdown which includes: the facility name, products obtained under this agreement, and the volume per month.  In the event of a recall, contractor must comply with all applicable rules and regulations regarding notice to customers. Contractor shall reimburse the VA for any costs actually incurred to comply with recall instructions and process provided by the contractor to sequester, package and return, as applicable. In the case of a company merger and/or acquisition, contractor will immediately notify the Contracting Officer for this BPA and provide a contingency plan of services to assure that no break in services is experienced by the participating facilities Safety Data Sheets (SDS) are required. Any product formulation changes must be accompanied with an updated SDS Please contact lab service contacts prior to if substitutions or alternate products are being considered. Laboratory supplies are specific and highly specialized, and substitutions may not be appropriate. Essential Physical Characteristics: Item # Description FSC5735CS 10 Neut Buff Formin 5L CS FSC23245684CS 10% Neutral Buffered Formalin Protocol 1 CS M082101-2 Agilent Mo a Hu Cytoker cl MNF 116 1ML CONCENTRATE EA 6GRA3 ANTIMICROBIAL POLYETHYLENE TACKY MAT CLEAR 24"X36" 30 SHEET Pk 4 PK ALI084G7 BIOCARE MEDICAL CD34 Q Series 7ML EA ALI3121G7 Biocare Medical CLAUDIN-4 Q SERIES 7ML EA PM405AA Biocare Medical GATA 3 6ml Predilute EA API3149AA Biocare Medical Kappa Light Chain L1C1 6ML EA API3063AA Biocare Medical Lambda Light Chain N10 2 6ml EA PP422AA Biocare Medical NKX3.1 Rabbit Polyclonal 6ml Predilute EA BCCAPI3066AAEA Biocare Medical P40 6ML PREDILUTE EA API438AA Biocare Medical PAX 8 6ml predilute EA API3099AA Biocare Medical SOX 10 EA PM087AA Biocare Medical TTF 1 6ml Predilute EA API3121AA CLAUDIN-4 PREDILUTE 6ML EA FSC6215CS Fisher Scientific Dehydrant 100 5L CS CZSAMW3000EA Epic Slides White Charged EA FSC22042936CS Epredia SlideMate Microscope Slides 144/pk EA 8300 Excelsior Wast Was Drwr 5 cs EA FSCB9990612CSPK Filter Formaldehyde 6 pk EA FSC23245669EA Fisher Scientific OG-6 PAP STAIN 4L EA FSC23245698EA Fisher Scientific PROTOCOL DECALCIFYN SOL A IL EA FSC23245682EA Fisher Scientific PROTOCOL DECALCIFYN SOL B 1L (for bone) EA FSC23245653EA Fisher Scientific PROTOCOL GILL HEMATOXYLIN 1X EA FSC21870076EA Fisher Scientific RPMI 1640 EA FSC22050210EA Fisher Scientific STAIN PAPANICOLAOU EA-50 EA FSC5735SSCS Fisher Scientific Syntri Safegrd nbf CS FSC6615SSCS Fisher Scientific Syntri Safegrd Xylene CS FSC6215SSCS Fisher Scientific Syntrisafegrd Dehydrnt CS STLFGP0811PK Formaguard Plus Neutralizing Pads 8x11 25/pk EA ELM6259370EA Fume Filter 2 case EA MERMER500PLUSPK HISTOLOGY MICROTOME BLADES,HIGH PROFILE PLATINUM EA SC271408 INSM1 CLONE A-8, 200 g/ml EA FSC06666APK kim wipes (4.4 x 8.4 in) EA 3800145ACS LEICA 2450 1 PREMIER COVER GLASS FOR AUTOMATED COVERSLIPPER CS LMI14046435914EA LEICA ACTIVATED CARBON FILTER EA LMI14047432273EA LEICA ACTIVATED CARBON FILTER EA PA0909 LEICA AE1/AE3 BOND RTU PRIMARY 7ML EA PA0204 LEICA BCL 6 BOND RTU PRIMARY EA PA0117 LEICA BCL2 BOND RTU PRIMARY EA CS9100 LEICA BOND ASPIRATING PROBE CLEANING KIT EA S21.4610 LEICA BOND COGNITIVE PRINTER RIBBON & LABELS 6 PACK EA S21.2129 LEICA BOND COVERTILE CLEANING RACK EA AR9222 LEICA BOND DEWAX SOLUTION EA AR9551 LEICA BOND ENZYME PRETREATMENT KIT EA S21.1971 LEICA BOND MIXING STATIONS EA OP79193 LEICA BOND OPEN CONTAINERS 7ML PK DS9800 LEICA BOND POLYMER REFINE DETECTION KIT KT DS9390 LEICA BOND POLYMER REFINE RED EA OPT9719 LEICA BOND TITRATION INSERTS 50 X EA OPT9049 LEICA BOND TITRATION KIT EA AR9961 LEICA BOND TM EPITOPE RETRIEVAL 1 - 1L EA AR9640 LEICA BOND TM EPITOPE RETRIEVAL 2 - 1L EA AR9352 LEICA BOND TM PRIMARY ANTIBODY 500ML EA AR9590 LEICA BOND TM WASH SOLUTION 10X CONCENTRATE 1L EA S21.2001 LEICA BOND UNIVERSAL COVERTILES EA S21.4611 LEICA BOND UNIVERSAL COVERTILES PK PA0346 LEICA CALRETININ BOND RTU 7ML EA PA0270 LEICA CD10 BOND RTU PRIMARY 7ML EA PA0088 LEICA CD138 BOND RTU PRIMARY 7ML EA PA0473 LEICA CD15 MMA BOND RTU 7ML EA PA0200 LEICA CD20 L26 BOND RTU 7ML EA PA0169 LEICA CD23 BOND RTU PRIMARY 7ML EA PA0553 LEICA CD3 BOND RTU PRIMARY 7ML EA PA0790 LEICA CD30 JCM182 BOND RTU 7ML EA PA0212 LEICA CD34 BOND RTU PRIMARY 7ML EA PA0042 LEICA CD45 BOND RTU PRIMARY 7ML EA PA0168 LEICA CD5 BOND RTU PRIMARY 7ML EA PA0308 LEICA CD61 BOND RTU PRIMARY7ML EA PA0375 LEICA CDX2 EP25 BOND RTU 7ML EA PA0515 Leica ChromograninA 5H7 BOND 7ML EA DS9665 LEICA CHROMOPLEX 1 DUAL DETECTION EA PA0046 LEICA CYCLIN D1 EP12 BOND EA PA0022 LEICA CYTOKERATIN 20 BOND RTU 7ML EA PA0942 LEICA CYTOKERATIN 7 BOND RTU 7ML EA PA0094 LEICA CYTOKERATIN AE1 AE3 BOND RTU EA PA0032 LEICA DESMIN BOND RTU PRIMARY EA 3801320 LEICA EMBEDDING MEDIUM 10-2LB bags EA PA0800 LEICA Glypican 3 1G12 Mab CM EA PA0801 LEICA Hepatocyte Specific 7ML EA IHC5994-A LEICA HPP ASR BOND 7ML EA PA0118 LEICA Ki67 BOND RTU PRIMARY EA PA0129 LEICA MUM1 BOND RTU PRIMARY 7ML EA PA0064 LEICA NAPSIN A (IP64) BOND RTU 7ML EA PA0016 LEICA P16 6H12 BOND RTU PRIMARY 7ML EA PA0057 LEICA P53 BOND RTU PRIMARY 7ML EA 39602004 Leica- PARAPLAST PLUS 8/1kg/cs EA PA0552 LEICA Pax 5 BOND RTU PRIMARY 7ML EA PA0031 Leica S 100 EP32 BOND RTU PRIMARY EA PA0813 LEICA SOX 10 POLYCLONAL CM BOND 7ML EA PA0299 LEICA SYNAPTOPHYSIN BOND RTU PRIMARY 7ML EA LOO6961300EA Organic Filter for Fume EA WHA5802385EA Paper Fltr Fold 38.5mm EA 8332 Paraffin Histo Lp EA FSC1337416EA PARAFILM 2in. W x 250 ft. L EA MOPBE045EA PATHCLOUD Foaming Disinfectant EA API3154DSAA PIN 4 COCKTAIL (CK HMW+P63+AMACR) PREDILUTE 6ML EA 4583 Sakura Finetek Tissue Tek OCT COMPOUND 12/case CS 6045 Sakura Finetek Tissue Tek VIP 6 6AI PARAFFIN WASTE BAGS FOR VIP6 CS HAZ FEE Shipping charges for any chemical EA SHA6766007CS Stain Eosin Y Alc Shndn 2 x 1LT CS FHCA83910001EA THERMAL TRANSFER RIBBON EA FSC7411258CS Vapor Filter Small 6 cs CS 89508-402 VWR SCIENTIFIC ENCORE PREMIUM MICROTOME BLADES EA FSC6615CS Fisher Scientific Xylene 5L CS 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).  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/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.   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 vulnerablity 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-day s 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