Scanning Tenders

Details: Sources Sought Notice sources Sought: This Is Not A Solicitation For A Proposal, Proposal Abstract, Or Quote. The Purpose Of This Notice Is To Obtain Information Regarding Qualified Business Sources. The Responses To The Information Requested Will Assist The Government In Determining The Appropriate Acquisition Method. statement Of Work (sow) the Contractor Shall Render Genetic Testing Laboratory Services In Accordance With This Statement Of Work To Support The Health Science Research Department At Durham Va Medical Center Under The Direction Of Dr. Deepak Voora, Executive Director Of National Pharmacogenomics Program At Va Central Office, For The Study/iir Titled, Reducing Veterans' Risk Of Atherosclerotic Cardiovascular Disease Through Pharmacogenomics Informed Statin Prescribing Funded By The Va Durham Healthcare System And Delivered To The Indianapolis Va Health Care System. description: Genomic Medicine Research Has Many Complexities Requiring Specialized Services, Skills, And Expertise, Including Complex Laboratory Analyses Requiring Specialized Equipment And Expertise In The Generation And Interpretation Of Genomic Data; Large Complex Genomic Datasets With Particular Storage, Privacy, And Information Security Requirements; Clinical Expertise In How Genomic Medicine Interventions Might Inform Health Care And Impact Health Outcomes; And Sensitivity To The Ethical, Psychosocial, Legal, And Regulatory Considerations Of Genomic Medicine Research. background: This Research Grant Proposes A Single Center, Randomized Clinical Trial Of Precision Statin Prescribing Versus Usual Care To Be Conducted At The Indianapolis Va Health Care System. Four-hundred And Ten (410) Veteran Patients Who Are At Risk For Cardiovascular Events And Have A Class I Indication For Statin Therapy, But Are Not Currently Prescribed One, Will Be Recruited And Randomly Allocated To Receive Either 1) Genetic Test Report That Provides An Assessment Of Their Risk For Cardiovascular Disease Events Based On A Polygenic Risk Score (prs) For Coronary Artery Disease And Their Risk Of Statin Associated Musculoskeletal Symptoms Based On Slco1b1 Genetic Testing Or 2) Usual Care. Specimens For Genetic Testing Will Be Collected Via Saliva Kit Administered With The Assistance Of Research Staff And Shipped Using A Common Carrier Delivery Service And Standard Chain Of Custody. description Of Work: The Contractor S Laboratory Services Shall Be In Accordance With Clinical Laboratory Improvement Amendments (clia) And Be A College Of American Pathologists (cap) Certified Clinical Diagnostic Genetic Testing Laboratory In Order To Successfully Perform The Required Genetic Testing For This Study. the Performing Laboratory Will Perform Dna Testing For A Prs For Cad And Slco1b1 Based Dna Sequencing, Pcr, Or Array-based Technologies, Analysis, Interpretation, And Reporting For This Study. the Certification And Accreditation (c&a) Requirements Do Not Apply, And That A Security Accreditation Package Is Not Required. primary Contractor Duties Include, But Are Not Limited To: specimen Accessioning, Extraction, And Test Management dna Sequencing And/or Genotyping For polygenic Risk Score (prs) For Coronary Artery Disease Cad genome Wide Genotyping/sequencing whole Genome Imputation variant Calling sample Qc genetic Variant Qc ancestry Specific Prs Calculation For Cad prs Interpretation And Report In Pdf Format slco1b1 Genetic Testing genotyping/sequencing variant Calling sample/variant Qc Star Allele Diplotype And Phenotype Interpretation Based On The Clinical Pharmacogenetics Implementation Consortium (cpic) Guidelines. reporting In Pdf Format each Laboratory Tests Unit Shall Include: saliva Swab Dna Collection Kit genome-wide Genotyping With Illumina Iscan Microarray Technology whole Genome Imputation variant Calling sample Qc (call Rate, Nominal Coverage, Heterozygosity Rate) genetic Variant Qc (genotype Probability) ancestry Specific Prs Calculation For Cad Prs cad Prs Reporting In Pdf Format slco1b1 Testing And Reporting In Pdf Format deliverables: Specific Items To Be Delivered To The Va Investigators, Include, But Are Not Limited To: human Specimen Sample Collection Supplies And Shipping Materials, Compliant With All Current Federal Regulations. clinical Polygenic Risk Score And Slco1b1 Report For Participants Randomized To The Genetic Testing Arm Of The Study. a Required Total Of An Estimated 68 Tests Per Year For Three (3) Years. other Pertinent Information: the Contractor Shall Provide Services For Both Components Of Necessary Testing: 1. Polygenic Risk Score For Coronary Artery Disease And 2. Slco1b1 Genetic Testing. the Contractor Shall Provide An Existing Ldt That They Have Available For The Purposes In This Statement Of Work, As Va Does Not Have An Ldt For These Purposes. The Vendor Shall Have An Existing Ldt As The Va Will Use The Ldt Within One Month Of The Contract Being Awarded. the Contractor Shall Not Work In Conjunction With Another Laboratory For The Polygenic Risk Score Or The Genetic Testing For Slco1b1 As Subcontracting Out And Shipping Samples From One Contractor S Laboratory To Another Is Not Within Best Interest Of The Va S Need At This Time. the Contractor S Services Shall Be Available Readily To Render To Va, In House, At Time Of Contract Award. timeframe: The Estimated Beginning And Ending Dates During Which The Contractor Is Required To Perform Work For Va Durham Are 1/13/2025 To 1/12/2026 With The Option To Renew Yearly Through 1/13/2028. va Information And Information System Security And Privacy Language 1. General. This Entire Section Applies To All Acquisitions Requiring Any Information Security And Privacy Language. Contractors, Contractor Personnel, Subcontractors And Subcontractor Personnel Will Be Subject To The Same Federal Laws, Regulations, Standards, Va Directives And Handbooks, As Va Personnel Regarding Information And Information System Security And Privacy. 2. Va Information Custodial Language. This Entire Section Applies To All Acquisitions Requiring Any Information Security And Privacy Language. a. The Government Shall Receive Unlimited Rights To Data/intellectual Property First Produced And Delivered In The Performance Of This Contract Or Order (hereinafter Contract ) Unless Expressly Stated Otherwise In This Contract. This Includes All Rights To Source Code And All Documentation Created In Support Thereof. The Primary Clause Used To Define Government And Contractor Data Rights Is Far 52.227-14 Rights In Data General. The Primary Clause Used To Define Computer Software License (not Data/intellectual Property First Produced Under This Contractor Or Order) Is Far 52.227-19, Commercial Computer Software License. b. Information Made Available To The Contractor By Va For The Performance Or Administration Of This Contract Will Be Used Only For The Purposes Specified In The Service Agreement, Sow, Pws, Pd, And/or Contract. The Contractor Shall Not Use Va Information In Any Other Manner Without Prior Written Approval From A Va Contracting Officer (co). The Primary Clause Used To Define Government And Contractor Data Rights Is Far 52.227-14 Rights In Data General. c. Va Information Will Not Be Co-mingled With Any Other Data On The Contractor S Information Systems Or Media Storage Systems. The Contractor Shall Ensure Compliance With Federal And Va Requirements Related To Data Protection, Data Encryption, Physical Data Segregation, Logical Data Segregation, Classification Requirements And Media Sanitization. d. Va Reserves The Right To Conduct Scheduled Or Unscheduled Audits, Assessments, Or Investigations Of Contractor Information Technology (it) Resources To Ensure Information Security Is Compliant With Federal And Va Requirements. The Contractor Shall Provide All Necessary Access To Records (including Electronic And Documentary Materials Related To The Contracts And Subcontracts) And Support (including Access To Contractor And Subcontractor Staff Associated With The Contract) To Va, Va's Office Inspector General (oig), And/or Government Accountability Office (gao) Staff During Periodic Control Assessments, Audits, Or Investigations. e. The Contractor May Only Use Va Information Within The Terms Of The Contract And Applicable Federal Law, Regulations, And Va Policies. If New Federal Information Security Laws, Regulations Or Va Policies Become Applicable After Execution Of The Contract, The Parties Agree To Negotiate Contract Modification And Adjustment Necessary To Implement The New Laws, Regulations, And/or Policies. f. The Contractor Shall Not Make Copies Of Va Information Except As Specifically Authorized And Necessary To Perform The Terms Of The Contract. If Copies Are Made For Restoration Purposes, After The Restoration Is Complete, The Copies Shall Be Destroyed In Accordance With Va Directive 6500, Va Cybersecurity Program And Va Information Security Knowledge Service. g. If A Veterans Health Administration (vha) Contract Is Terminated For Default Or Cause With A Business Associate, The Related Local Business Associate Agreement (baa) Shall Also Be Terminated And Actions Taken In Accordance With Vha Directive 1605.05, Business Associate Agreements. If There Is An Executed National Baa Associated With The Contract, Va Will Determine What Actions Are Appropriate And Notify The Contactor. h. The Contractor Shall Store And Transmit Va Sensitive Information In An Encrypted Form, Using Va-approved Encryption Tools Which Are, At A Minimum, Federal Information Processing Standards (fips) 140-2, Security Requirements For Cryptographic Modules (or Its Successor) Validated And In Conformance With Va Information Security Knowledge Service Requirements. The Contractor Shall Transmit Va Sensitive Information Using Va Approved Transport Layer Security (tls) Configured With Fips Based Cipher Suites In Conformance With National Institute Of Standards And Technology (nist) 800-52, Guidelines For The Selection, Configuration And Use Of Transport Layer Security (tls) Implementations. the Contractor S Firewall And Web Services Security Controls, As Applicable, Shall Meet Or Exceed Va S Minimum Requirements. j. Except For Uses And Disclosures Of Va Information Authorized By This Contract For Performance Of The Contract, The Contractor May Use And Disclose Va Information Only In Two Situations: (i) In Response To A Qualifying Order Of A Court Of Competent Jurisdiction After Notification To Va Co (ii) With Written Approval From The Va Co. The Contractor Shall Refer All Requests For, Demands For Production Of Or Inquiries About, Va Information And Information Systems To The Va Co For Response. k. Notwithstanding The Provision Above, The Contractor Shall Not Release Va Records Protected By Title 38 U.s.c. § 5705, Confidentiality Of Medical Qualityassurance Records And/or Title 38 U.s.c. § 7332, Confidentiality Of Certain Medical Records Pertaining To Drug Addiction, Sickle Cell Anemia, Alcoholism Or Alcohol Abuse Or Infection With Human Immunodeficiency Virus (hiv). If The Contractor Is In Receipt Of A Court Order Or Other Requests For The Above Mentioned Information, The Contractor Shall Immediately Refer Such Court Order Or Other Requests To The Va Co For Response. l. Information Made Available To The Contractor By Va For The Performance Or Administration Of This Contract Or Information Developed By The Contractor In Performance Or Administration Of The Contract Will Be Protected And Secured In Accordance With Va Directive 6500 And Identity And Access Management (iam) Security Processes Specified In The Va Information Security Knowledge Service. m. Any Data Destruction Done On Behalf Of Va By A Contractor Shall Be Done In Accordance With National Archives And Records Administration (nara) Requirements As Outlined In Va Directive 6300, Records And Information Management, Va Handbook 6300.1, Records Management Procedures, And Applicable Va Records Control Schedules. n. The Contractor Shall Provide Its Plan For Destruction Of All Va Data In Its Possession According To Va Directive 6500 And Nist 800-88, Guidelines For Media Sanitization Prior To Termination Or Completion Of This Contract. If Directed By The Cor/co, The Contractor Shall Return All Federal Records To Va For Disposition. o. Any Media, Such As Paper, Magnetic Tape, Magnetic Disks, Solid State Devices Or Optical Discs That Is Used To Store, Process, Or Access Va Information That Cannot Be Destroyed Shall Be Returned To Va.the Contractor Shall Hold The Appropriate Material Until Otherwise Directed By The Contracting Officer S Representative (cor) Or Co. Items Shall Be Returned Securely Via Va-approved Methods. Va Sensitive Information Must Be Transmitted Utilizing Va-approved Encryption Tools Which Are Validated Under Fips 140-2 (or Its Successor) And Nist 800-52. If Mailed, The Contractor Shall Send Via A Trackable Method (usps, Ups, Fedex, Etc.) And Immediately Provide The Cor/co With The Tracking Information. Self-certification By The Contractor That The Data Destruction Requirements Above Have Been Met Shall Be Sent To The Cor/co Within 30 Business Days Of Termination Of The Contract. p. All Electronic Storage Media (hard Drives, Optical Disks, Cds, Back-up Tapes, Etc.) Used To Store, Process Or Access Va Information Will Not Be Returned To The Contractor At The End Of Lease, Loan, Or Trade-in. Exceptions To This Paragraph Will Only Be Granted With The Written Approval Of The Va Co. 3. Access To Va Information And Va Information Systems. This Section Applies When Any Person Requires Access To Information Made Available To The Contractor By Va For The Performance Or Administration Of This Contract Or Information Developed By The Contractor In Performance Or Administration Of The Contract. a. A Contractor/subcontractor Shall Request Logical (technical) Or Physical Access To Va Information And Va Information Systems For Their Employees And Subcontractors Only To The Extent Necessary To Perform The Services Specified In The Solicitation Or Contract. This Includes Indirect Entities, Both Affiliate Of Contractor/subcontractor And Agent Of Contractor/subcontractor. b. Contractors And Subcontractors Shall Sign The Va Information Security Rule Of Behavior (rob) Before Access Is Provided To Va Information And Information Systems (see Section 4, Training, Below). The Rob Contains The Minimum User Compliance Requirements And Does Not Supersede Any Policies Of Va Facilities Or Other Agency Components Which Provide Higher Levels Of Protection To Va S Information Or Information Systems. Users Who Require Privileged Access Shall Complete The Va Elevated Privilege Access Request Processes Before Privileged Access Is Granted. c. All Contractors And Subcontractors Working With Va Information Are Subject To The Same Security Investigative And Clearance 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 Shall Be In Accordance With Va Directive And Handbook 0710, Personnel Suitability And Security Program. The Office Of Human Resources And Administration/operations, Security And Preparedness (hra/osp) Is Responsible For These Policies And Procedures. Contract Personnel Who Require Access To Classified Information Or Information Systems Shall Have An Appropriate Security Clearance. Verification Of A Security Clearance Shall Be Processed Through The Special Security Officer Located In Hra/osp. Contractors Shall Conform To All Requirements Stated In The National Industrial Security Program Operating Manual (nispom). d. 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. e. The Contractor Shall Notify The Cor/co In Writing Immediately (no Later Than 24 Hours) After Personnel Separation Or Occurrence Of Other Causes. Causes May Include The Following: (1) Contractor/subcontractor Personnel No Longer Has A Need For Access To Va Information Or Va Information Systems. (2) Contractor/subcontractor Personnel Are Terminated, Suspended, Or Otherwise Has Their Work On A Va Project Discontinued For Any Reason. (3) Contractor Believes Their Own Personnel Or Subcontractor Personnel May Pose A Threat To Their Company S Working Environment Or To Any Companyowned Property. This Includes Contractor-owned Assets, Buildings, Confidential Data, Customers, Employees, Networks, Systems, Trade Secrets And/or Va Data. (4) Any Previously Undisclosed Changes To Contractor/subcontractor Background History Are Brought To Light, Including But Not Limited To Changes To Background Investigation Or Employee Record. (5) Contractor/subcontractor Personnel Have Their Authorization To Work In The United States Revoked. (6) Agreement By Which Contractor Provides Products And Services To Va Has Either Been Fulfilled Or Terminated, Such That Va Can Cut Off Electronic And/or Physical Access For Contractor Personnel. f. In Such Cases Of Contract Fulfillment, Termination, Or Other Causes; The Contractor Shall Take The Necessary Measures To Immediately Revoke Access To Va Network, Property, Information, And Information Systems (logical And Physical) By Contractor/subcontractor Personnel. These Measures Include (but Are Not Limited To): Removing And Then Securing Personal Identity Verification (piv) Badges And Piv Interoperable (piv-i) Access Badges, Va-issued Photo Badges, Credentials For Va Facilities And Devices, Va-issued Laptops, And Authentication Tokens. Contractors Shall Notify The Appropriate Va Cor/co Immediately To Initiate Access Removal. g. Contractors/subcontractors Who No Longer Require Va Accesses Will Return Vaissued Property To Va. This Property Includes (but Is Not Limited To): Documents, Electronic Equipment, Keys, And Parking Passes. Piv And Piv-i Access Badges Shall Be Returned To The Nearest Va Piv Badge Issuance Office. Once They Have Had Access To Va Information, Information Systems, Networks And Va Property In Their Possessions Removed, Contractors Shall Notify The Appropriate Va Cor/co. 4. Training. This Entire Section Applies To All Acquisitions Which Include Section 3. a. All Contractors And Subcontractors Requiring Access To Va Information And Va Information Systems Shall Successfully Complete The Following Before Being Granted Access To Va Information And Its Systems: (1) Va Privacy And Information Security Awareness And Rules Of Behavior Course (talent Management System (tms) #10176) Initially And Annually Thereafter. (2) Sign And Acknowledge (electronically Through Tms #10176) Understanding Of And Responsibilities For Compliance With The Organizational Rules Of Behavior, Relating To Access To Va Information And Information Systems Initially And Annually Thereafter; And (3) Successfully Complete Any Additional Cyber Security Or Privacy Training, As required For Va Personnel With Equivalent Information System Or Information Access [to Be Defined By The Va Program Official And Provided To The Va Co For Inclusion In The Solicitation Document I.e., Any Rolebased Information Security Training]. b. The Contractor Shall Provide To The Cor/co A Copy Of The Training Certificates And Certification Of Signing The Organizational Rules Of Behavior For Each Applicable Employee Within Five Days Of The Initiation Of The Contract And Annually Thereafter, As Required. c. Failure To Complete The Mandatory Annual Training 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 Required Training Is Complete. 5. Security Incident Investigation. This Entire Section Applies To All Acquisitions Requiring Any Information Security And Privacy Language. a. The Contractor, Subcontractor, Their Employees, Or Business Associates Shall Immediately (within One Hour) Report Suspected Security / Privacy Incidents To The Va Oit S Enterprise Service Desk (esd) By Calling (855) 673-4357 (tty: 711). The Esd Is Oit S 24/7/365 Single Point Of Contact For It-related Issues. After Reporting To The Esd, The Contractor, Subcontractor, Their Employees, Or Business Associates Shall, Within One Hour, Provide The Cor/co The Incident Number Received From The Esd. b. To The Extent Known By The Contractor/subcontractor, The Contractor/ Subcontractor's Notice To Va Shall Identify The Information Involved And The Circumstances Surrounding The Incident, Including The Following: (1) The Date And Time (or Approximation Of) The Security Incident Occurred. (2) The Names Of Individuals Involved (when Applicable). (3) The Physical And Logical (if Applicable) Location Of The Incident. (4) Why The Security Incident Took Place (i.e., Catalyst For The Failure). (5) The Amount Of Data Belonging To Va Believed To Have Been Compromised. (6) The Remediation Measures The Contractor Is Taking To Ensure No Future Incidents Of A Similar Nature. c. After The Contractor Has Provided The Initial Detailed Incident Summary To Va, They Will Continue To Provide Written Updates On Any New And Relevant Circumstances Or Facts They Discover. The Contractor, Subcontractor, And Their Employes Shall Fully Cooperate With Va Or Third-party Entity Performing An Independent Risk Analysis On Behalf Of Va. Failure To Cooperate May Be Deemed A Material Breach And Grounds For Contract Termination. d. Va It Contractors Shall Follow Va Handbook 6500, Risk Management Framework For Va Information Systems Va Information Security Program, And Va Information Security Knowledge Service Guidance For Implementing An Incident Response Plan Or Integrating With An Existing Va Implementation. e. 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 The Va Office Of 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. f. The Contractor Shall Comply With Va Handbook 6500.2, Management Of Breaches Involving Sensitive Personal Information, Which Establishes The Breach Management Policies And Assigns Responsibilities For The Oversight, Management And Reporting Procedures Associated With Managing Of Breaches. g. With Respect To Unsecured Protected Health Information (phi), The Contractor Is Deemed To Have Discovered A Data Breach When The Contractor Knew Or Should Have Known Of Breach Of Such Information. When A Business Associate Is Part Of Vha Contract, Notification To The Covered Entity (vha) Shall Be Made In Accordance With The Executed Baa. h. If The Contractor Or Any Of Its Agents Fails To Protect Va Sensitive Personal Information Or Otherwise Engages In Conduct Which Results In A Data Breach Involving Any Va Sensitive Personal Information The Contractor/subcontractor Processes Or Maintains Under The Contract; The Contractor Shall Pay Liquidated Damages To The Va As Set Forth In Clause 852.211-76, Liquidated Damages Reimbursement For Data Breach Costs 6. Information System Design And Development. This Entire Section Applies To Information Systems, Systems, Major Applications, Minor Applications, Enclaves, And Platform Information Technologies (to Include The Subcomponents Of Each) Designed Or Developed For Or On Behalf Of Va By Any Non-va Entity. a. Information Systems Designed Or Developed On Behalf Of Va At Non-va Facilities Shall Comply With All Applicable Federal Law, Regulations, And Va Policies. This Includes Standards For The Protection Of Electronic Protected Health Information (phi), Outlined In 45 C.f.r. Part 164, Subpart C And Information And System Security Categorization Level Designations In Accordance With Fips 199, Standards For Security Categorization Of Federal Information And Information Systems And Fips 200, Minimum Security Requirements For Federal Information Systems. Baseline Security Controls Shall Be Implemented Commensurate With The Fips 199 System Security Categorization (reference Va Handbook 6500 And Va Trusted Internet Connections (tic) Architecture). b. Contracted New Developments Require Creation, Testing, Evaluation, And Authorization In Compliance With Va Assessment And Authorization (a&a) Processes In Va Handbook 6500 And Va Information Security Knowledge Service To Obtain An Authority To Operate (ato). Va Directive 6517, Risk Management Framework For Cloud Computing Services, Provides The Security And Privacy Requirements For Cloud Environments. c. Va It Contractors, Subcontractors And Third-party Service Providers Shall Address And/or Integrate Applicable Va Handbook 6500, Va Handbook 6517, Risk Management Framework For Cloud Computing Services And Information Security Knowledge Service Specifications In Delivered It Systems/solutions, Products And/or Services. If Systems/solutions, Products And/or Services Do Not Directly Match Va Security Requirements, The Contractor Shall Work Though The Cor/co To Identify The Va Organization Responsible For Governance Or Resolution. Contractors Shall Comply With Far 39.1, Specifically The Prohibitions Referenced. d. The Contractor (including Producers And Resellers) Shall Comply With Office Of Management And Budget (omb) M-22-18 And M-23-16 When Using Third-party Software On Va Information Systems Or Otherwise Affecting The Va Information. This Includes New Software Purchases And Software Renewals For Software Developed Or Modified By Major Version Change After The Issuance Date Of M22-18 (september 14, 2022). The Term Software Includes Firmware, Operating Systems, Applications And Application Services (e.g., Cloud-based Software), As Well As Products Containing Software. The Contractor Shall Provide A Self Attestation That Secure Software Development Practices Are Utilized As Outlined By Executive Order (eo)14028 And Nist Guidance. A Third-party Assessment Provided By Either A Certified Federal Risk And Authorization Management Program (fedramp) Third Party Assessor Organization (3pao) Or One Approved By The Agency Will Be Acceptable In Lieu Of A Software Producer's Self Attestation. e. The Contractor Shall Ensure All Delivered Applications, Systems And Information Systems Are Compliant With Homeland Security Presidential Directive (hspd) 12 And Va Identity And Access Management (iam) Enterprise Identity Management Requirements As Set Forth In Omb M-19-17, M-05-24, Fips 201-3, Personal Identity Verification (piv) Of Federal Employees And Contractors (or Its Successor), M-21-31 And Supporting Nist Guidance. This Applies To Commercial Off-the-shelf (cots) Product(s) That The Contractor Did Not Develop, All Software Configurations And All Customizations. f. The Contractor Shall Ensure All Contractor Delivered Applications And Systems Provide User Authentication Services Compliant With Va Handbook 6500, Va Information Security Knowledge Service, Iam Enterprise Requirements And Nist 800-63, Digital Identity Guidelines, For Direct, Assertion-based Authentication And/or Trust-based Authentication, As Determined By The Design And Integration Patterns. Direct Authentication At A Minimum Must Include Public Key Infrastructure (pki) Based Authentication Supportive Of Piv And/or Common Access Card (cac), As Determined By The Business Need And Compliance With Va Information Security Knowledge Service Specifications. g. The Contractor Shall Use Va Authorized Technical Security Baseline Configurations And Certify To The Cor That Applications Are Fully Functional And Operate Correctly As Intended On Systems In Compliance With Va Baselines Prior To Acceptance Or Connection Into An Authorized Va Computing Environment. If The Defense Information Systems Agency (disa) Has Created A Security Technical Implementation Guide (stig) For The Technology, The Contractor May Configure To Comply With That Stig. If Va Determines A New Or Updated Va Configuration Baseline Needs To Be Created, The Contractor Shall Provide Required Technical Support To Develop The Configuration Settings. Far 39.1 Requires The Population Of Operating Systems And Applications Includes All Listed On The Nist National Checklist Program Checklist Repository. h. The Standard Installation, Operation, Maintenance, Updating And Patching Of Software Shall Not Alter The Configuration Settings From Va Approved Baseline Configuration. Software Developed For Va Must Be Compatible With Va Enterprise Installer Services And Install To The Default Program Files Directory With Silently Install And Uninstall. The Contractor Shall Perform Testing Of All Updates And Patching Prior To Implementation On Va Systems. i. Applications Designed For Normal End Users Will Run In The Standard User Context Without Elevated System Administration Privileges. j. The Contractor-delivered Solutions Shall Reside On Va Approved Operating Systems. Exceptions To This Will Only Be Granted With The Written Approval Of The Cor/co. k. The Contractor Shall Design, Develop, And Implement Security And Privacy Controls In Accordance With The Provisions Of Va Security System Development Life Cycle Outlined In Nist 800-37, Risk Management Framework For Information Systems And Organizations: A System Life Cycle Approach For Security And Privacy, Va Directive And Handbook 6500, And Va Handbook 6517. l. The Contractor Shall Comply With The Privacy Act Of1974 (the Act), Far 52.224-2 Privacy Act, And Va Rules And Regulations Issued Under The Act In The Design, Development, Or Operation Of Any System Of Records On Individuals To Accomplish A Va Function. m. The Contractor Shall Ensure The Security Of All Procured Or Developed Information Systems, Systems, Major Applications, Minor Applications, Enclaves And Platform Information Technologies, Including Their Subcomponents (hereinafter Referred To As Information Systems ) Throughout The Life Of This Contract And Any Extension, Warranty, Or Maintenance Periods. This Includes Security Configurations, Workarounds, Patches, Hotfixes, Upgrades, Replacements And Any Physical Components Which May Be Necessary To Remediate All Security Vulnerabilities Published Or Known To The Contractor Anywhere In The Information Systems (including Systems, Operating Systems, Products, Hardware, Software, Applications And Firmware). The Contractor Shall Ensure Security Fixes Do Not Negatively Impact The Information Systems. n. When The Contractor Is Responsible For Operations Or Maintenance Of The Systems, The Contractor Shall Apply The Security Fixes Within The Timeframe Specified By The Associated Controls On The Va Information Security Knowledge Service. When Security Fixes Involve Installing Third Party Patches (such As Microsoft Os Patches Or Adobe Acrobat), The Contractor Shall Provide Written Notice To The Va Cor/co That The Patch Has Been Validated As To Not Affecting The Systems Within 10 Business Days. 7. Information System Hosting, Operation, Maintenance Or Use. this Entire Section Applies To Information Systems, Systems, Major Applications, Minor Applications, Enclaves, And Platform Information Technologies (cloud And Noncloud) Hosted, Operated, Maintained, Or Used On Behalf Of Va At Non-va Facilities. a. The Contractor Shall Comply With All Federal Laws, Regulations, And Va Policies For Information Systems (cloud And Non-cloud) That Are Hosted, Operated, Maintained, Or Used On Behalf Of Va At Non-va Facilities. Security Controls For Collecting, Processing, Transmitting, And Storing Of Va Sensitive Information, Must Be In Place. The Controls Will Be Tested By Va Or A Va Sanctioned 3paoand Approved By Va Prior To Hosting, Operation, Maintenance Or Use Of The Information System Or Systems By Or On Behalf Of Va. This Includes Conducting Compliance Risk Assessments, Security Architecture Analysis, Routine Vulnerability Scanning, System Patching, Change Management Procedures And The Completion Of An Acceptable Contingency Plan For Each System. The Contractor S Security Control Procedures Shall Be The Same As Procedures Used To Secure Va-operated Information Systems. b. Outsourcing (contractor Facility, Equipment, Or Staff) Of Systems Or Network Operations, Telecommunications Services Or Other Managed Services Require Assessment And Authorization (a&a) Of The Contractor S Systems In Accordance With Va Handbook 6500 As Specified In Va Information Security Knowledge Service. Major Changes To The A&a Package May Require Reviewing And Updating All The Documentation Associated With The Change. The Contractor S Cloud Computing Systems Shall Comply With Fedramp And Va Directive 6517 Requirements. c. The Contractor Shall Return All Electronic Storage Media (hard Drives, Optical Disks, Cds, Back-up Tapes, Etc.) On Non-va Leased Or Non-va Owned It Equipment Used To Store, Process Or Access Va Information To Va In Accordance With A&a Package Requirements. This Applies When The Contract Is Terminated Or Completed And Prior To Disposal Of Media. The Contractor Shall Provide Its Plan For Destruction Of All Va Data In Its Possession According To Va Information Security Knowledge Service Requirements And Nist 800-88. The Contractor Shall Send A Self-certification That The Data Destruction Requirements Above Have Been Met To The Cor/co Within 30 Business Days Of Termination Of The Contract. d. All External Internet Connections To Va Network Involving Va Information Must Be In Accordance With Va Trusted Internet Connection (tic) Reference Architecture And Va Directive And Handbook 6513, Secure External Connections And Reviewed And Approved By Va Prior To Implementation. Government-owned Contractor-operated Systems, Third Party Or Business Partner Networks Require A Memorandum Of Understanding (mou) And Interconnection Security Agreements (isa). e. Contractor Procedures Shall Be Subject To Periodic, Announced, Or Unannounced Assessments By Va Officials, The Oig Or A 3pao. The Physical Security Aspects Associated With Contractor Activities Are Also Subject To Such Assessments. The Contractor Shall Report, In Writing, Any Deficiencies Noted During The Above Assessment To The Va Cor/co. The Contractor Shall Use Va S Defined Processes To Document Planned Remedial Actions That Address Identified Deficiencies In Information Security Policies, Procedures, And Practices. The Contractor Shall Correct Security Deficiencies Within The Timeframes Specified In The Va Information Security Knowledge Service. f. All Major Information System Changes Which Occur In The Production Environment Shall Be Reviewed By The Va To Determine The Impact On Privacy And Security Of The System. Based On The Review Results, Updates To The Authority To Operate (ato) Documentation And Parameters May Be Required To Remain In Compliance With Va Handbook 6500 And Va Information Security Knowledge Service Requirements. g. The Contractor Shall Conduct An Annual Privacy And Security Self-assessment On All Information Systems And Outsourced Services As Required. Copies Of The Assessment Shall Be Provided To The Cor/co. The Va/government Reserves The Right To Conduct Assessment Using Government Personnel Or A Third-party If Deemed Necessary. The Contractor Shall Correct Or Mitigate Any Weaknesses Discovered During The Assessment. h. Va Prohibits The Installation And Use Of Personally Owned Or Contractor-owned Equipment Or Software On Va Information Systems. If Non-va Owned Equipment Must Be Used To Fulfill The Requirements Of A Contract, It Must Be Stated In The Service Agreement, Sow, Pws, Pd Or Contract. All Security Controls Required For Government Furnished Equipment Must Be Utilized In Va Approved Other Equipment (oe). Configuration Changes To The Contractor Oe, Must Be Funded By The Owner Of The Equipment. All Remote Systems Must Use A Va-approved Antivirus Software And A Personal (host-based Or Enclave Based) Firewall With A Va-approved Configuration. The Contractor Shall Ensure Software On Oe Is Kept Current With All Critical Updates And Patches. Owners Of Approved Oe Are Responsible For Providing And Maintaining The Anti-virus Software And The Firewall On The Non-va Owned Oe. Approved Contractor Oe Will Be Subject To Technical Inspection At Any Time. i. The Contractor Shall Notify The Cor/co Within One Hour Of Disclosure Or Successful Exploits Of Any Vulnerability Which Can Compromise The Confidentiality, Integrity, Or Availability Of The Information Systems. The System Or Effected Component(s) Need(s) To Be Isolated From The Network. A Forensic Analysis Needs To Be Conducted Jointly With Va. Such Issues Will Be Remediated As Quickly As Practicable, But In No Event Longer Than The Timeframe Specified By Va Information Security Knowledge Service. If Sensitive Personal Information Is Compromised Reference Va Handbook 6500.2 And Section 5, Security Incident Investigation. j. For Cases Wherein The Contractor Discovers Material Defects Or Vulnerabilities Impacting Products And Services They Provide To Va, The Contractor Shall Develop And Implement Policies And Procedures For Disclosure To Va, As Well As Remediation. The Contractor Shall, Within 30 Business Days Of Discovery, Document A Summary Of These Vulnerabilities Or Defects. The Documentation Will Include A Description Of The Potential Impact Of Each Vulnerability And Material Defect, Compensating Security Controls, Mitigations, Recommended Corrective Actions, Fbonotice Cause Analysis And/or Workarounds (i.e., Monitoring). Should There Exist Any Backdoors In The Products Or Services They Provide To Va (referring To Methods For Bypassing Computer Authentication), The Contractor Shall Provide the Va Co/co Written Assurance They Have Permanently Remediated These Backdoors. k. All Other Vulnerabilities, Including Those Discovered Through Routine Scans Or Other Assessments, Will Be Remediated Based On Risk, In Accordance With The Remediation Timelines Specified By The Va Information Security Knowledge Service And/or The Applicable Timeframe Mandated By Cybersecurity & Infrastructure Security Agency (cisa) Binding Operational Directive (bod) 22-01 And Bod 19-02 For Internet-accessible Systems. Exceptions To This Paragraph Will Only Be Granted With The Approval Of The Cor/co. 8. Security And Privacy Controls Compliance Testing, Assessment and Auditing. This Entire Section Applies Whenever Section 6 Or 7 Is Included. a. Should Va Request It, The Contractor Shall Provide A Copy Of Their (corporation S, Sole Proprietorship S, Partnership S, Limited Liability Company (llc), Or Other Business Structure Entity S) Policies, Procedures, Evidence And Independent Report Summaries Related To Specified Cybersecurity Frameworks (international Organization For Standardization (iso), Nist Cybersecurity Framework (csf), Etc.). Va Or Its Third-party/partner Designee (if Applicable) Are Further Entitled To Perform Their Own Audits And Security/penetration Tests Of The Contractor S It Or Systems And Controls, To Ascertain Whether The Contractor Is Complying With The Information Security, Network Or System Requirements Mandated In The Agreement Between Va And The Contractor. b. Any Audits Or Tests Of The Contractor Or Third-party Designees/partner Va Elects To Carry Out Will Commence Within 30 Business Days Of Va Notification. Such Audits, Tests And Assessments May Include The Following: (a): Security/penetration Tests Which Both Sides Agree Will Not Unduly Impact Contractor Operations; (b): Interviews With Pertinent Stakeholders And Practitioners; (c): Document Review; And (d): Technical Inspections Of Networks And Systems The Contractor Uses To Destroy, Maintain, Receive, Retain, Or Use Va Information. c. As Part Of These Audits, Tests And Assessments, The Contractor Shall Provide All Information Requested By Va. This Information Includes, But Is Not Limited To, The Following: Equipment Lists, Network Or Infrastructure Diagrams, Relevant Policy Documents, System Logs Or Details On Information Systems Accessing, Transporting, Or Processing Va Data. d. The Contractor And At Its Own Expense, Shall Comply With Any Recommendations Resulting From Va Audits, Inspections And Tests. Va Further Retains The Right To View Any Related Security Reports The Contractor Has Generated As Part Of Its Own Security Assessment. The Contractor Shall Also Notify Va Of The Existence Of Any Such Security Reports Or Other Related Assessments, Upon Completion And Validation. e. Va Appointed Auditors Or Other Government Agency Partners May Be Granted Access To Such Documentation On A Need-to-know Basis And Coordinated Through The Cor/co. The Contractor Shall Comply With Recommendations Which Result From These Regulatory Assessments On The Part Of Va Regulators And Associated Government Agency Partners. 9. Product Integrity, Authenticity, Provenance, Anti-counterfeit And Anti-tampering. This Entire Section Applies When The Acquisition Involves Any Product (application, Hardware, Or Software) Or When Section 6 Or 7 Is Included. a. The Contractor Shall Comply With Code Of Federal Regulations (cfr) Title 15 Part 7, Securing The Information And Communications Technology And Services (icts) Supply Chain , Which Prohibits Icts Transactions From Foreign Adversaries. Icts Transactions Are Defined As Any Acquisition, Importation, Transfer, Installation, Dealing In Or Use Of Any Information And Communications Technology Or Service, Including Ongoing Activities, Such As Managed Services, Data Transmission, Software Updates, Repairs Or The Platforming Or Data Hosting Of Applications For Consumer Download. b. When Contracting Terms Require The Contractor To Procure Equipment, The Contractor Shall Purchase Or Acquire The Equipment From An Original Equipment Manufacturer (oem) Or An Authorized Reseller Of The Oem. The Contractor Shall Attest That Equipment Procured From An Oem Or Authorized Reseller Or Distributor Are Authentic. If Procurement Is Unavailable From An Oem Or Authorized Reseller, The Contractor Shall Submit In Writing, Details Of The Circumstances Prohibiting This From Happening And Procure A Product Waiver From The Va Cor/co. c. All Contractors Shall Establish, Implement, And Provide Documentation For Risk Management Practices For Supply Chain Delivery Of Hardware, Software (to Include Patches) And Firmware Provided Under This Agreement. Documentation Will Include Chain Of Custody Practices, Inventory Management Program, Information Protection Practices, Integrity Management Program For Sub-supplier Provided Components, And Replacement Parts Requests. The Contractor Shall Make Spare Parts Available. All Contractor(s) Shall Specify How Digital Delivery For Procured Products, Including Patches, Will Be Validated And Monitored To Ensure Consistent Delivery. The Contractor Shall Apply Encryption Technology To Protect Procured Products Throughout The Delivery Process. d. If A Contractor Provides Software Or Patches To Va, The Contractor Shall Publish Or Provide A Hash Conforming To The Fips Security Requirements For Cryptographic Modules (fips 140-2 Or Successor). e. The Contractor Shall Provide A Software Bill Of Materials (sbom) For Procured (to Include Licensed Products) And Consist Of A List Of Components And Associated Metadata Which Make Up The Product. Sboms Must Be Generated In One Of The Data Formats Defined In The National Telecommunications And Information Administration (ntia) Report The Minimum Elements For A Software Bill Of Materials (sbom). f. Contractors Shall Use Or Arrange For The Use Of Trusted Channels To Ship Procured Products, Such As U.s. Registered Mail And/or Tamper-evident Packaging For Physical Deliveries. g. Throughout The Delivery Process, The Contractor Shall Demonstrate A Capability For Detecting Unauthorized Access (tampering). h. The Contractor Shall Demonstrate Chain-of-custody Documentation For Procured Products And Require Tamper-evident Packaging For The Delivery Of This Hardware. summary: this Is A Sources Sought Notice And Not A Request For Quotes. This Request Is Solely For The Purpose Of Conducting Market Research To Enhance Vha S Understanding Of The Market S Offered Products, Services, And Capabilities. The Government Will Not Pay Any Costs For Responses Submitted In Response To This Sources Sought. this Sources Sought Notice Provides An Opportunity For Respondents To Submit Their Notice Of Ability, And Their Available Products And Services In Response To The Requirement. Vendors Are Being Invited To Submit Information Relative To Their Potential Of Fulfilling This Requirement In The Form Of A Capability Response That Addresses The Specific Requirement Identified In This Sources Sought. this Sources Sought Is To Facilitate The Contracting Officer S Review Of The Market Base, For Acquisition Planning, Size Determination, And Procurement Strategy. response Commitment: i. Response: all Potential Sources Are Invited To Submit, In Writing, A Capability Statement With Sufficient Information To Substantiate Your Business Is Reasonably Capable Of Performing The Work. The Capability Statement Must Clearly Demonstrate A Business S Ability To Fulfill The Requirement. The Burden Of Proof Rests With The Contractor; Therefore, Written Responses Must Provide Clear And Unambiguous Evidence To Substantiate Capabilities Appropriate To Satisfy This Need. a. Capability Statement With General Understanding Of The Industry And Current Knowledge And Subcontract Networks That Would Be Used To Support The Requirement As Identified Herein. Subcontractors Will Need The Security Requirements Listed In This Sources Sought. Submittals Furnished Will Not Be Returned To The Sender. No Debriefs Will Be Conducted. Eligibility In Participating In A Future Acquisition Does Not Depend Upon A Response To This Notice. responses Shall Provide Administrative Information, And Shall Include The Following As A Minimum: Company Name, Sam Uei Number, Company Mailing Address, Phone Number, Fax Number, Name And Title Of Designated Point Of Contact And E-mail Of Designated Point Of Contact. company Business Size And Status (i.e., Large Business, Small Business, Service-disabled Veteran Owned Small Business, Women-owned Small Business, Etc.), The Number Of Years In Business. b. Proprietary Information Is Neither Requested Nor Desired. If Such Information Is Submitted, It Must Clearly Be Marked "proprietary" On Every Sheet Containing Such Information, And The Proprietary Information Must Be Segregated To The Maximum Extent Practicable From Other Portions Of The Response (e.g., Use An Attachment Or Exhibit). submit Responses Email Only To Karly.gabrysiak@va.gov ii. Timeline: a. This Request Will Close On 01/06/2025 At 8am Est. notes: 1. This Sources Sought Is For Planning Purposes Only, And Does Not Constitute A Commitment, Implied Or Otherwise, That A Procurement Action Will Follow. The Department Of Veterans Affairs Will Use The Information Submitted In Response To This Notice At Its Discretion And Will Not Provide Comments To Any Submission; However, The Department Of Veterans Affairs Reserves The Right To Contact Any Respondent To This Notice For The Sole Purpose Of Enhancing The Department Of Veteran Affairs Understanding Of The Notice Submission. 2. The Content Of Any Responses To This Notice May Be Reflected In Any Subsequent Solicitation, Except For Content Marked Or Designated As Business Confidential Or Proprietary Which Will Be Fully Protected From Release Outside The Government. the Department Of Veteran Affairs Contracting Office Point Of Contact: name: Karly Gabrysiak title: Contract Specialist e-mail Address: Karly.gabrysiak@va.gov

Details: Notice Of Sources Sought The Purpose Of This Sources Sought Announcement Is For Market Research To Make Appropriate Acquisition Decisions And To Gain Knowledge Of Potential Qualified Service-disabled Veteran Owned Small Businesses (sdvosb), Veteran Owned Small Businesses (vosb), And Small Businesses Interested And Capable Of Providing The Services Requested, As Well As Any Large Businesses. The Results From This Source Sought Notice Will Be Used To Determine The Appropriate Set-aside. The Intended Contract Is A Firm-fixed Price Service Contract. The Department Of Veterans Affairs, Nco20 Is Looking For Vendor Sources For The Following Requirement: A Blanket Purchase Order (base + 4 Option Years) For Urinalysis Testing See Attachments For More Information: Attachment A: V20 Estimated Urinalysis Test List Volume Attachment B: V20 Participating Medical Centers And Pocs Attachment C: V20 Bpa Price List (must Be Filled Out) Required Information In Your Response To Sources Sought: In Order To Be Considered A Valid Source That Can Impact The Set-aside Determination Of A Possible Future Solicitation, Potential Contractors Shall Provide, At A Minimum, The Following Information To Peter.park2@va.gov By Below Response Deadline: 1) Company Name, Address, And Point Of Contact, Phone Number, E-mail Address, And Uei. Provide Any Existing Gsa/fss Contract Number This Requirement Can Be Fulfilled Under. 2) Please Identify Your Company S Size In Comparison To The Anticipated North American Industry Classification System (naics) Code 334516 Analytical Laboratory Instrument Manufacturing. To Be Considered A Small Business Your Company Must Have Less Than 1,000 Employees. This Notice Is To Determine The Marketplace For This Specific Requirement. Please Check One Of The Following: [ ] Yes [ ] No Service Disabled Veteran Owned Small Business (sdvosb) [ ] Yes [ ] No Veteran Owned Small Business (vosb) [ ] Yes [ ] No Small Business Manufacturers [ ] Yes [ ] No All Other Small Business (sb) [ ] Yes [ ] No Other Than Small Business 3) Any Service-disabled Veteran Owned Businesses Or Veteran Owned Businesses Who Respond To A Solicitation On This Project Must Provide A Sba Certification And Be Registered With U.s. Small Business Administration Veteran Small Business Certification (vetcert) Located At Https://veterans.certify.sba.gov/. 4) Only Authorized Service Representatives/providers Of The Manufacturer Will Be Considered. No Used, Refurbished, Remanufactured, Or Counterfeit Parts Will Be Allowed. Please Provide A Proof Of Authorized Service Provider Letter From Manufacturer. 5) Please Complete The Attached Price List (attachment C). This Is Not A Quote. 6) Capabilities Statement Addressing The Requirements In The Statement Of Work To Include: References For Similar Services Currently Being Provided Or Previously Provided At The Required Service Levels As Outlined In The Statement Of Work. The Government Is Not Obligated To Nor Will It Pay For Or Reimburse Any Costs Associated With Responding To This Sources Sought Notice. This Notice Shall Not Be Construed As A Commitment By The Government To Issue A Solicitation Or Ultimately Award A Contract, Nor Does It Restrict The Government To A Particular Acquisition Approach. The Government Will In No Way Be Bound To This Information If Any Solicitation Is Issued. Notice To Potential Offerors: All Offerors Who Provide Goods Or Services To The United States Federal Government Must Be Registered In The System Award Management (sam Located On The Web At Www.sam.gov). It Is Desirable That Any Offeror To Have Completed Their Business Online Representations And Certifications Application In The System For Award Management (sam). Service Address: Various Stations In Nco 20 See Attachment Point Of Contact: Peter Park Contracting Officer Peter.park2@va.gov Response Deadline: 12/20/2024 By 3:00pm Pacific Time Statement Of Work: Bpa For Visn 20 Cprr Urinalysis Testing Bpa Language The Government Will Award A Cprr Bpa To A Single Contractor For Urinalysis Testing. Contractor Agrees To The Following Terms Of The Bpa Exclusively With Visn 20 And Awarded In The Final Bpa. Under This Agreement, The Bpa Holder Shall Provide Cprr Urinalysis Testing For All Visn20 Medical Facilities. The Vha Facilities Within Visn20 Listed On This Bpa Are Authorized To Order Any Item Listed On The Price/cost Schedule At The Listed Price. No Items May Be Ordered Off This Bpa Unless They Are Listed On The Price/cost Schedule. Additional, Related Items May Be Added Without Further Competition To The Price/cost Schedule With The Award Of A Modification By The Administering Contracting Officer (co). The Administering Co Is The Only Vha Employee Authorized To Modify This Bpa. Obligation Of Funds This Bpa Does Not Obligate Any Funds. The Government Is Only Obligated To The Extent Of Authorized Task Orders Issued Under This Bpa. Period Of Agreement This Bpa Is Effective From The Date Of Award For A Period Of 5 Years. Option To Extend The Term Of The Bpa The Government May Extend The Term Of This Bpa For A Period Of Up To Six (6) Months, Exercisable In Increments Of Not Less Than One (1) Month. By Written Notice To The Contractor At Any Time Prior To The Expiration Of The Bpa, Provided That The Government Shall Give The Contractor A Preliminary Written Notice Of Its Intent To Extend At Least 30 Days Before The Bpa Expires. The Preliminary Notice Does Not Commit The Government To An Extension. Prices And Terms Visn20 Has Provided An Estimated Annual Volume By Test As Reflected In Attachment A. Pricing Is Based On The Average Annual Test Volume. The Government Estimates The Volumes As Listed In Attachment A But Does Not Guarantee Volumes As Listed; They Are Estimates Only And The Government Doesn T Guarantee That All Listed Stations Will Participate In The Bpa. The Government Estimates, But Does Not Guarantee, That Individual Bpa Orders Placed Against This Agreement May Reach $825,000.00/per Order. This Order Limit May Be Increased By Mutual Agreement Of The Parties As Necessary, In Whole Or Part. The Authorized Ceiling Limit Of The Agreement Is Set At $4,500,000.00 Over The Period Covered By The Agreement; This Ceiling Is Also Not A Guarantee. The Ceiling Limit May Also Be Raised In Association With Order Limit Increases Or Other Conditions Which, By Mutual Agreement Of The Parties, Maybe Considered Necessary. Authorization For Individual Task Orders Above The Stated Task Order And/or Ceiling Limits Must Be Coordinated Through The Contracting Officer Before Larger Valued Orders Can Be Issued And Prior To Commencement Of Work. All Unauthorized Work, Regardless Of Amount, Will Be Processed Through The Ratification Process. Price/cost Schedule Estimated Quantities And Pricing Per Facility Order Placement All Properly Warranted Cos Serving Visn20 Are Authorized To Place Orders Under This Bpa. Task Orders Will Be Placed Against This Bpa Using Outlook Email Messages, Electronic Data Interchange (edi), Fax Internet Portal, Paper Or Oral Communications. Delivery Order Oversight Each Ordering Location Will Designate A Contracting Officer's Representative (cor) Or Poc (if Dollar Amounts Warrant A Cor, And Subject To Co Approval), Who Will Be Responsible For Verifying Contract Compliance And Certify Invoices. Requirement Specifications / Statement Of Work Scope: The Contractor Shall Provide Automated Clinical Laboratory Urinalysis Testing For Urine Dipstick Chemistries, Urine Microscopic Analysis, And Body Fluid Analysis (as Applicable) To Produce Cost Per Reportable Results (cprr) For The Locations Listed Below. Installation And Operational Training Will Be Provided By The Vendor At The Government S Facility. Vendor Will Provide Field Service Support. Vendor Will Also Supply Government With Sufficient Supplies, Reagents, And Training To Execute The Urinalysis Analyzer In The Performance Of The Testing Listed For Each Site Based On Estimated Patient Results Per Month. Equipment Will Be Defined By The Facility. Participating Locations: Alaska Va Healthcare System: 1201 North Muldoon Road, Anchorage, Ak 99504 Boise Va Medical Center: 500 West Fort Street. Boise, Id 83702 Eugene Health Care Center: 3355 Chad Dr., Eugene, Or 97408 Va Portland Health Care System: 3710 Sw U.s. Veterans Hospital Road, Portland, Or 97239 Roseburg Va Health Care System: 913 Nw Garden Valley Blvd., Roseburg, Or 97471 Va Southern Oregon Rehabilitation Center: 8495 Crater Lake Hwy., White City, Or 97503 Va Puget Sound Health Care System - American Lake Division: 9600 Veterans Dr Southwest, Tacoma, Wa 98493 Va Puget Sound Health Care System: 1660 S. Columbian Way, Seattle, Wa 98108 Mann-grandstaff Va Medical Center: 4815 N. Assembly Street, Spokane, Wa 99205 Jonathan M. Wainwright Memorial Va Medical Center: 77 Wainwright Drive, Walla Walla, Wa 99362 Map And Locations For Medical Centers And Clinics Within The Visn 20 Northwest Network Can Be Found At The Following Link: Https://www.va.gov/directory/guide/region.asp?id=1020. General Requirements: Leased (cost Per Reportable Result) Equipment. All Related Consumables And Supplies. All Necessary Service To Keep Equipment In Manufacturer's Operating Conditions, Both Preventive Maintenance And Emergency Repairs. Training For Personnel Operating Equipment. Cost Per Reportable Result Cprr: Cost Per Patient Reportable Result (cprr): As Defined In The Federal Supply Schedule Fsc Group 66, Part Iii, Cost-per-test Clinical Laboratory Analyzers - Contractors Are Required To Provide A Price For A Reportable Patient Result. The Per Patient Reportable Result Price Shall Include Costs Covering: (1) 5-year Equipment Use, (2) All Reagents, Standards, Vendor Provided Quality Controls, Supplies, Consumable/disposable Items, Parts, Accessories, And Any Other Item Required For The Proper Operation Of The Contractor S Equipment And Necessary For The Generation Of A Patient Reportable Result. This Per Patient Reportable Result Price Shall Also Encompass All Costs Associated With Dilution; Repeat And Confirmatory Testing Required To Produce A Single Patient Reportable Result. It Shall Also Include The Material To Perform As Well As All Other Costs Associated With Quality Control, Calibration And Correlation Study Testing That Is Prescribed By The Clinical And Laboratory Standards Institute (clsi). (3) All Necessary Maintenance To Keep The Equipment In Good Operating Condition (this Element Includes Both Preventive Maintenance And Emergency Repairs) And (4) Training For Government Personnel. Contractors Shall Provide Delivery, Installation And Removal Of Equipment At No Additional Charge. Parameters: The Calculation For Price And Quantity Of Reagents In The Annual List Included In The Contract As Based On An Estimated Annual Number Of Reportable Results Provided By The Government. The Annual Quantities Of Supplies Shall Be Sufficient For Testing As Long As The Reportable Results Are Submitted In Compliance With The Following Parameters: Numbers Of Reportable Results Actually Performed By The Government Are Within Ten Percent Of The Annual Estimated Reportable Results As Indicated By The Annual Supply List. Use Of The Instrument(s) Are In Accordance With Instrument Usage Information Provided By Government (primary, Back-up Or Alternate). Test Volumes Are Determined By The Government. No More Than 10 Percent Repeats. Two Levels Of Quality Control To Be Run As Required By The Manufacturer Every Test Day. Calibrators For Periodic Calibration Checks And Demand To Validate Systems Following Major Repair Or Resolution Of Negative Quality Control Trends. Adjustments: The Government And Vendor Will Conduct Ongoing Reviews No Less Than Annually To Monitor Contract Performance Against Agreed Upon Efficiencies, Operational Assumptions, And Product Utilization (cppr Parameters). The Vendor Will Notify The Government When Such Reviews Indicate An Adjustment To The Quarterly Standing Order Shipments May Be Required. The Government Will Cooperate With The Vendor In The Conduct Of The Reviews. Vendor, Their Personnel, And Their Sub Vendors Shall Be Subject To The Federal Laws, Regulations, Standards, And Va Directives And Handbooks Regarding Information And Information System Security As Delineated In This Contract.839.201 Contract Clause For Information And Technology Security. Equipment: Vendor Will Provide Urinalysis Analyzer(s) For Lease To Meet Visn20 Facilities Usage Needs. Installation: The Vendor Shall Deliver And Install All Rented Or Purchased Equipment Under This Contract After An Order Is Placed. Equipment Shall Be Installed Within 30 Business Days After Receipt Of Order. Equipment Shall Not Be Considered Installed Until Va Employee Certifies That The Equipment Is Properly Functioning And Has The Necessary Supplies To Perform Its Required Function. The Vendor Shall Maintain A Record Of Installation To Include: Location, Model Number, Serial Number, And Date Of Installation. Removal: The Vendor Shall Un-install And Remove All Rented Equipment Under This Bpa From The Requesting Facility Upon Request. Equipment Shall Be Removed Within 30 Days Of Request. Equipment Shall Be Considered Removed Upon A Va Employee Certification That The Equipment And All Accessories Have Been Taken By An Employee Of The Vendor And There Is No Disruption And /or Damage To The Surrounding Area. The Vendor Shall Maintain A Record Of Removal To Include: Location, Model Number, Serial Number, And Date Of Removal. Equipment Requirements: Vendor Shall Provide Urinalysis Systems That Meet The Following Requirements: Instrument Shall Include Chemical Analysis Of Urine (to Include Bilirubin, Urobilinogen, Ph, Specific Gravity, Glucose, Protein, Blood, Nitrites, Ketones And Leukoesterase) Without Interference From Urines With Common Abnormal Colors (red, Orange, Etc.). Instrument Shall Also Identify Formed Elements Including But Not Limited To, Red Blood Cells, White Blood Cells, Epithelial Cells (differentiating Transitional, Renal, And Squamous) Crystals, Casts, Bacteria, And Yeast Without The Need To Consistently Verify With Manual Microscopy. There Must Be A Direct, Automated Specimen Pathway Between The Chemistry Urinalysis Specimen Sampling And Testing And The Microscopic Urinalysis Sampling And Testing. Equipment Shall Provide Accurate Test Assay Results For Sample Specimens Up To The Manufacturer's Defined Maximum Tests Per Hour Without Excessive Malfunctions, Breakdowns, Or Service Calls. Instrumentation Shall Have Auto Reflex Testing Capability For Specimens Which Require Sediment Analysis. System Shall Have A Minimum Throughput Of 60 Samples Per Hour On The Microscopic Side. The Instrument Shall Have Customer Defined Rule Criteria To Reduce The Number Of Manual Reviews And Off-line Testing Required By The Operator. The System Shall Have The Ability For Auto-validation, Should The Facility Choose To Auto Validate Results. Instrument Shall Auto-classify Formed Elements With Limited Review By The Operator. Microscopic Analysis Must Be Fully Quantitative. Microscopic Analysis Must Have The Ability For The Instrument To Identify Cellular Microscopic Components And Provide Reviewable Digital Images. Instrument Must Offer Limited To No Carryover From Sample To Sample To Reduce Interference. Instrument Must Have The Ability To Continuously Feed At Least 300 Chemistry Strips Without Operator Re-load. Time From Standby To Operation Processing Samples Is Less Than 3 Minutes. Time Required For Routine Maintenance Activities Shall Take Less Than 30 Minutes Daily And Less Than 30 Minutes Weekly/monthly. All Testing Shall Be Fda Approved, Including Body Fluids If Available. Current Waste Stream Analysis And Sds (safety Data Sheets) Shall Be Provided To All Locations. Editable Electronic Copy In Clsi (clinical And Laboratory Standards Institute) Format Of Operating Procedures Shall Be Furnished With Each Instrument Supplied To All Participating Facilities. Testing Shall Include Current Laboratory Assays, But The Va Reserves The Right To Add Additional Tests To Test Menu. Protocols In Place For Various Degrees Of Urine Turbidity. A Selection Of Instruments Will Be Available Based On Volume, Test Menu Needs And Throughput Requirements Of Each Individual Facility. Instrument Shall Allow Patient Sample To Be Used For Repeats Or Reruns On The Same Or Different Instrument. All Instruments Must Be New (non-refurbished) Equipment. Contractor Shall Provide All Upgrades To The Equipment Hardware And Operating System Software, At No Additional Cost To The Government. (note Current Va Security Regulations Require Windows Based Operating Systems Be Windows 10 Or Higher). Instruments That Have The Ability To Have Access To The Internet Must Follow Va It Security Policies. The Internet Access Must Be Verified And Adhered To Before And During All Internet Access. Contractor S Software Is Required To Be Compatible And Interface Immediately Upon Award With Governmental Systems Which Include Cprs, Vista, And Cerner. Contractor Must Provide Evidence With Their Solicitation Response That Their Software Is Already Accepted For Use By Vha It Systems. All Equipment Shall Come With Any Required Accessories To Perform Normal Duties, To Include But Not Limited To, Properly Programmed Printers And Monitors, And Ups. The Analyzers Will Be Va Laboratory Information System (lis) Interfaceable, And The Vendor Will Supply Lis Specifications And Assist With The Interface Connections. Operation Of Software Uses Minimal Computer Strokes To Move From Testing To Reagent To Data Analysis Or/and Other Screens. Size Of Instrumentation Shall Be No More Than 65 W X 21 D. If Stand Is Required, It Is Included In The Contract At No Additional Cost. Upgrades Shall Be Delivered And Installed Within 60 Days Of Issuance To The Commercial Market. An Operator's Manual Shall Be Furnished With Each Instrument Supplied To Va And Updates To Manual Shall Be Provided In A Timely Manner. Uptime Guarantee/ Performance Penalty: Vendor Agrees That All Equipment Provided Shall Be Operable And Available For Use No Less Than 98% Of Operational Time Per Month. Each Instrument At Site Shall Be Computed Separately. Operational Time Is 24 Hours Per Day 7 Days A Week. Downtime Is Defined As When The Vendor Is Not Able To Produce Clinically Acceptable Results On The System Monitor And Will Be Computed From The Time The Government Notified The Hotline During Normal Working Hours Until The Field Service Engineer Returns The Instrument To The Government And The Government Can Produce Acceptable Clinical Results. Scheduled Maintenance Is Excluded From Downtime. Method Validations: Once The Instrument Has Been Installed According To The Vendor Specifications At The Government Location The Vendor Will Supply A Technical Representative To Perform Method Validation Studies During All Equipment Installations At All Facilities. The Method Validations Will Be Completed To Include The Necessary Studies Required For Clinical Laboratory Information Act (clia), College Of American Pathologist (cap) And Department Of Veterans Affairs (va) Regulatory Agencies And Shall Include Precision, Linearity And Current System To New System Correlations As Well As Establishment Of Normal And Therapeutic Ranges. The Va Will Not Accept Equipment Until It Passes All Validation Testing. Validation Testing Will Be Conducted On The Facilities Primary And Secondary Testing Methods. The Va Will Provide All The Samples Necessary For The Validation Studies. Maintenance And Repairs: Vendor Shall Provide Preventative And Corrective Maintenance Per Manufacturer's Recommendation. This Shall Include Software Upgrades And Parts And Labor, To Maintain All Urinalysis Equipment And Accessories. At A Minimum, Preventative Maintenance Shall Be Twice Annually, Beginning Six (6) Months After Installation. Vendor Will Furnish All Transportation, Equipment, Tools And Labor To Accomplish The Required Maintenance. Emergency Repairs Shall Be Performed After Initial Telephone Notification That The Equipment Is Inoperative. The Field Service Representative Will Call To Schedule Onsite Service Within 2 Hours Of Notification From Technical Assistance Hotline If Necessary. The Vendor Shall Provide The Government With A Designated Point Of Contact And Telephone Number And Shall Make Arrangements To Enable His Maintenance Representative To Receive Such Notification. Telephone Service Support Shall Be Available 24 Hours/day,7days A Week. Onsite Field Service Support Shall Be Available Monday- Friday 8am- 4:30 Pm (local Time). Onsite Repairs Shall Be Initiated Within 24 Hours Of First Notification From Technical Hotline To Field Service Engineer. Efforts Shall Be Made By The Vendor To Minimize Disruption To Governments And Employees (i.e. Reschedule If Work Interferes With Normal Operation, Access Equipment When Convenient To The Needs Of The Va, Etc.) Vendor Shall Maintain Cleanliness Of Work Area And Minimize Dust And Contaminants To Areas Adjacent To The Job Site. Vendor Shall Furnish A Malfunction Incident Report To The Installation Upon Completion Of Repair Call Within 2 Business Days After The Completion Of Work. The Report Shall Include As A Minimum The Following: Date And Time Notified. Date And Time Of Arrival. Serial Number, Type And Model Number(s) Of Equipment. Time Spent For Repair. Description Of Malfunction And Repair. Proof Of Repair That Included Documentation Of A Sample Run Of Quality Control Verifying Acceptable Performance. Each Instrument Provided By The Vendor Shall Maintain An Uptime Of 98% In Each Month Of The Term Of The Agreement. During The Term Of The Contract, Should The Repair Record Of Any Individual Piece Of Laboratory Equipment Reflect A Downtime Of 5% Or Greater Of The Normal Working Days In One Calendar Month, It Is The Responsibility Of The Vendor To Immediately Replace The Broken Laboratory Equipment With New Equipment At No Additional Cost To The Government. The Responsibility For Maintaining The Equipment Furnished In Operating Condition In Accordance To Manufacturer's Instruction, Shall Solely Be The Responsibility Of The Vendor. The Contractor Shall Not Leave A Service Call Open Pending Verification That Repairs Are Completed By The Contractor's Maintenance Personnel. For Each Instrument Provided, The Vendor Shall Treat Each Notification For An Emergency/repair Service Call Form The Government As A Separate And New Service Call. The Following Are Guaranteed Throughout The Life Of This Contract: Priority Scheduling Of Requests For Service. Unlimited Emergency Service. No Charges For Labor, Travel Or Any Other Related Expenses. Unlimited Parts. No Charge For Replacement Parts Which Become Marginal Or Defective Due To Normal Use During Agreement Period. Factory Authorized Product Updates And Modifications. Installed At No Additional Charge For Improved Product Performance And Reliability. Factory Trained And Authorized Service Engineers. Continual Upgrading And Certification Of Engineers In Latest Instrument Technology. Training: With The Exception Of Specific Training Requirements Stated Herein, Which Shall Have Precedence; Vendor Shall Provide "operator" Training In Accordance With The Terms, Conditions, And Provisions Of The Vendor's Existing Federal Supply Service Contract. Listed Below Are The Training Requirements: The Vendor Shall Provide, At No Cost To The Government, On-site Training And Key Operator Training For At Least 2 Operators Per Instrument Per Site. Provide Initial In-depth Training For Two Key Operators At The Facility And For Each Individual Instrument Provided. Provide Annual Training For One Va Equipment Operator, Per Each Instrument, For The Participating Medical Center. Provide On-site Vendor Operator Training For All Personnel Who Will Run Instrument With Training Provided For All Applicable Shifts. The Vendor Shall Have An On-going Training Program For Employees By The Technical Service Representatives On Any New Products Or Updates On The Product Lines. All Materials For Training Will Be Provided At No Additional Cost To The Government. The Vendor Will Provide Competency Assessment Protocols For Use At Each Site Consistent With Federal (clia) And Cap Training Requirements. Reagents, Controls And Supplies: Routine Reagents, Controls And Disposables (supplies) For Chemical And Microscopic Urinalysis Testing Shall Be Provided By The Vendor And Shall Adhere To The Following Requirements. Reagents Including Controls And Disposables Shall Be Identified Prior To Delivery. Reagents Including Controls And Disposables To Be Listed In A Separate Table. The Table Should Include Annual Reagent Volumes, Costs, And Shipping Charges For Each Quarterly Standing Order Delivery. Reagent Manufacturer Shelf Life Shall Be No Less Than 12 Months. Reagents For The Analyzer Are Marked For Easy Recognition By The Operator And Shall Contain The Appropriate Facility Purchase Order Number In The Delivery Address. Vendor Will Supply A List Of Reagents, Controls And Disposables That Will Be Shipped As Part Of The Order. Supplies Will Be Shipped On A Standing Order Schedule, Agreed Upon By The Government And Vendor. All Or Part Of A Future Quarterly Standing Order May Be Advanced Up To 10 Days Ahead Of The Scheduled Ship Date Of The Standing Order. Delivery Shall Be Within Four (4) Business Days Of The Prior Agreed Upon Shipment Date Or It Shall Be Considered Late. Vendor Will Provide Sufficient Reagents And Supplies For Performance Of Patient Results For All Visn 20 Sites. Consumables Will Be Provided On Demand As Needed If The Consumable Allotments Are Insufficient To Meet The Needs Of The Facility. Vendor Shall Supply All Changes To The Maintenance Schedules That Affect Reagent Or Cleaning Reagent Volumes And Shall Be Coordinated With The Va Facility Point Of Contact To Implement The Changes In Accordance With Manufacturer's Recommendations. Space Availability: All Proposed Urinalysis Equipment Must Fit The Existing Space At Each Visn 20 P&lms Facility's, Without The Need For Renovation Work. Small Scale Re-arrangement Of Furniture Is Acceptable. Fitting Existing Space Shall Include Conforming To The Current Structural Parameters Of Each Lab, In Each Facility, In Terms Of Delivery, Installation And Lab Space. (i.e., Equipment Size, Weight, Packaged Size For Delivery, Electrical/voltage). Special Requirements: In Addition To The General Requirements For The Urinalysis Cprr Requirements Stated Above, The Contractor Shall Meet The Following Special Requirements: Equipment Shall Have A Fully Established Va Veterans Health Information Systems And Technology Architecture (vista) Computer System And Cerner Interface Program Via Data Innovations Middleware, With All Downloads/software Necessary To Transfer Data Into Patient Files In Va Vista And Cerner Computer Systems Via Data Innovations Middleware, At No Additional Cost To Va. Provide Bi-directional Interface With Data Innovations And Appropriate Quality Control Analysis System And All Components Necessary To Interface With Va Vista And Cerner Computer System. The Contractor Shall Provide An Auto Verification Package Through Data Innovations For Validation Utilizing The Instrument Manager Which Includes Rules And Technical Support For The Duration Of This Contract. Contractor Shall Assist In The Establishment, Testing, Deployment, And Troubleshooting In The Full Capacity Of The Middleware Before Implementation Date. The Contractor Is Responsible For Verifying Any Software Upgrades With The Instrument During Its Life, Will Be Compatible With Data Innovations Middleware. Contractor Shall Provide Automated, Walk-away Urinalysis Chemistry Analyzer With Peripherals With Direct, Automated Sample Pathway To An Automated, Walk-away Microscopic Urinalysis Analyzer With Peripherals For Sampling And Testing. Shall Provide Data Backup. Systems Shall Provide Ease Of Use (uncomplicated Menus), With Minimal Maintenance Required. Shall Provide Flexibility In Test Volumes. Shall Be Easy To Troubleshoot. Provide Extended Expiration Date Of Supplies. Uninterruptible Power Supply (surge Protection, Battery Backup) Provided By Vendor For All Associated Electrical Instruments And Ancillary Components Excluding Printer. Provide A Water System, If Required. If A Printer Is Required To Produce Patient Or Qc Reports, One Shall Be Provided Per System And Replaced If Broken. Cessation Of Testing: If, For Any Reason, Contractor Ceases Testing Of Any Urinalysis Assays, The Contractor Must Notify The Va Contracting Office And Laboratories, 60 Calendar Days Prior To The Change. Until A New Solicitation Can Be Issued, Or The Problem Resolved, The Contractor Shall Be Held Liable For All Costs If Performance Is Ceased, As The Lab Facility May Have To Resort To Outsourcing The Tests In Order To Continue Patient Care. The Vendor Will Be Responsible For The Following: Cost Per Reportable Result Program Reagents, Controls And Supplies: Routine Reagents And Disposables. Reagents Including Controls And Disposables To Be Listed In Separate Table. Vendor Will Supply A List Of Reagents, Controls And Disposables That Will Be Shipped As Part Of The Agreement. Supplies Will Be Shipped On A Standing Order Schedule, Agreed Upon By Government And Vendor. All Or Part Of A Future Quarterly Standing Order May Be Advanced Up To 10 Days Ahead Of The Scheduled Ship Date Of The Standing Order. Vendor Will Provide Sufficient Reagents And Supplies For Performance Of Patient Results For All Visn 20 Sites. The Quality Of The Products Shall Be High Enough To Satisfy Proficiency Testing Standards Of The College Of American Pathologists (cap) And The Joint Commission (tjc). Changes In Maintenance Schedules That Affect Reagent Or Cleaning Reagent Volumes Will Be Approved By The Vendor In Accordance With Manufacturer's Recommendations. Additional Reagents, If Required, Will Be Provided By The Vendor At No Additional Charge. The Government Will Be Responsible For The Following: Cost Per Reportable Result Program: Cppr Periodic Payments: Refer To Attachment A For Volumes. Test Description Estimated Volume Per Year Price Per Reportable. During The Agreement The Government Will Report By The 10th Of Each Month, To The Vendor In Writing Or Electronically, The Number Of Reportable Results Generated In The Previous Month. The Vendor Will Invoice The Government Based On The Report Of Reportable Tests. Laboratory Manager Or Designee Will Act As Contracting Officer Representative (cotr) For This Contract. Security: Returning Leased Equipment Constitutes A Risk. Va Employees Must Sanitize Va Sensitive Information Residing On Leased Equipment Before Releasing That Equipment From Direct Va Control, Or The Media Will Not Be Returned Upon Termination Of The Contract. Per Visn 20 Va Information Security Policies, No Hard Drives Or Computer Disks Containing Va Patient Information Will Be Removed From Va Facilities. At The Time Of Turn-in Or Removal Due To Failure, The Va Facility Will Remove All Sensitive Data From Information Systems Storage Devices Or Render The Data From These Systems Unreadable. No Federal Information Processing Equipment Will Be Discontinued From Rental/lease Or Exchange Without Compliance With This Require. Contract Personnel Will Not Have Direct Access To A Va System Or Va Sensitive Information. All Work/maintenance Will Be Accomplished By Va Laboratory Personnel As An Intermediary. If Contract Leased/purchased Equipment Contains Sensitive Information (pii/phi) To Be Directly Uploaded To/downloaded From Va Systems, A Mou/isa Shall Be Established Between The Vendor And Va. Unidirectional, Deidentified Data From Contract Leased/purchased Equipment To The Va Network Shall Be Protected In Accordance With Established Va Security Policy. Quality Assurance Monitoring: The Contractor Service Requirements Are Summarized Into Performance Objectives That Relate Directly To Mission Essential Items. The Performance Thresholds Briefly Describe The Minimum Acceptable Levels Of Service Required For Each Requirement. These Thresholds Are Critical To Mission Success. Information And Information System Security/privacy General Contractors, Contractor Personnel, Subcontractors, And Subcontractor Personnel Shall Be Subject To The Same Federal Laws, Regulations, Standards, And Va Directives And Handbooks As Va And Va Personnel Regarding Information And Information System Security. Access To Va Information And Va Information Systems A Contractor/subcontractor Shall Request Logical (technical) Or Physical Access To Va Information And Va Information Systems For Their Employees, Subcontractors, And Affiliates Only To The Extent Necessary To Perform The Services Specified In The Contract, Agreement, Or Task Order. All Contractors, Subcontractors, And Third-party Servicers And Associates Working With Va Information Are Subject To The Same Investigative Requirements As Those Of Va Appointees Or Employees Who Have Access To The Same Types Of Information. The Level And Process Of Background Security Investigations For Contractors Must Be In Accordance With Va Directive And Handbook 0710, Personnel Suitability And Security Program. The Office For Operations, Security, And Preparedness Is Responsible For These Policies And Procedures. Contract Personnel Who Require Access To National Security Programs Must Have A Valid Security Clearance. National Industrial Security Program (nisp) Was Established By Executive Order 12829 To Ensure That Cleared U.s. Defense Industry Contract Personnel Safeguard The Classified Information In Their Possession While Performing Work On Contracts, Programs, Bids, Or Research And Development Efforts. The Department Of Veterans Affairs Does Not Have A Memorandum Of Agreement With Defense Security Service (dss). Verification Of A Security Clearance Must Be Processed Through The Special Security Officer Located In The Planning And National Security Service Within The Office Of Operations, Security, And Preparedness. Custom Software Development And Outsourced Operations Must Be Located In The U.s. To The Maximum Extent Practical. If Such Services Are Proposed To Be Performed Abroad And Are Not Disallowed By Other Va Policy Or Mandates, The Contractor/subcontractor Must State Where All Non-u.s. Services Are Provided And Detail A Security Plan, Deemed To Be Acceptable By Va, Specifically To Address Mitigation Of The Resulting Problems Of Communication, Control, Data Protection, And So Forth. Location Within The U.s. May Be An Evaluation Factor. The Contractor Or Subcontractor Must Notify The Contracting Officer Immediately When An Employee Working On A Va System Or With Access To Va Information Is Reassigned Or Leaves The Contractor Or Subcontractor's Employ. The Contracting Officer Must Also Be Notified Immediately By The Contractor Or Subcontractor Prior To An Unfriendly Termination. Va Information Custodial Language Information Made Available To The Contractor Or Subcontractor By Va For The Performance Or Administration Of This Contract Or Information Developed By The Contractor/subcontractor In Performance Or Administration Of The Contract Shall Be Used Only For Those Purposes And Shall Not Be Used In Any Other Way Without The Prior Written Agreement Of The Va. This Clause Expressly Limits The Contractor/subcontractor's Rights To Use Data As Described In Rights In Data - General, Far 52.227-14(d) (1). Va Information Should Not Be Co-mingled, If Possible, With Any Other Data On The Contractors/subcontractor's Information Systems Or Media Storage Systems In Order To Ensure Va Requirements Related To Data Protection And Media Sanitization Can Be Met. If Co-mingling Must Be Allowed To Meet The Requirements Of The Business Need, The Contractor Must Ensure That Va's Information Is Returned To The Va Or Destroyed In Accordance With Va's Sanitization Requirements. Va Reserves The Right To Conduct On Site Inspections Of Contractor And Subcontractor It Resources To Ensure Data Security Controls, Separation Of Data And Job Duties, And Destruction/media Sanitization Procedures Are In Compliance With Va Directive Requirements. Prior To Termination Or Completion Of This Contract, Contractor/ Subcontractor Must Not Destroy Information Received From Va, Or Gathered/ Created By The Contractor In The Course Of Performing This Contract Without Prior Written Approval By The Va. Any Data Destruction Done On Behalf Of Va By A Contractor/subcontractor Must Be Done In Accordance With National Archives And Records Administration (nara) Requirements As Outlined In Va Directive 6300, Records And Information Management And Its Handbook 6300.1 Records Management Procedures, Applicable Va Records Control Schedules, And Va Handbook 6500.1, Electronic Media Sanitization. Self-certification By The Contractor That The Data Destruction Requirements Above Have Been Met Must Be Sent To The Va Contracting Officer Within 30 Days Of Termination Of The Contract. The Contractor/subcontractor Must Receive, Gather, Store, Back Up, Maintain, Use, Disclose And Dispose Of Va Information Only In Compliance With The Terms Of The Contract And Applicable Federal And Va Information Confidentiality And Security Laws, Regulations, And Policies. If Federal Or Va Information Confidentiality And Security Laws, Regulations And Policies Become Applicable To The Va Information Or Information Systems After Execution Of The Contract, Or If Nist Issues Or Updates Applicable Fips Or Special Publications (sp) After Execution Of This Contract, The Parties Agree To Negotiate In Good Faith To Implement The Information Confidentiality And Security Laws, Regulations, And Policies In This Contract. The Contractor/subcontractor Shall Not Make Copies Of Va Information Except As Authorized And Necessary To Perform The Terms Of The Agreement Or To Preserve Electronic Information Stored On Contractor/subcontractor Electronic Storage Media For Restoration In Case Any Electronic Equipment Or Data Used By The Contractor/subcontractor Needs To Be Restored To An Operating State. If Copies Are Made For Restoration Purposes, After The Restoration Is Complete, The Copies Must Be Appropriately Destroyed. If Va Determines That The Contractor Has Violated Any Of The Information Confidentiality, Privacy, And Security Provisions Of The Contract, It Shall Be Sufficient Grounds For Va To Withhold Payment To The Contractor Or Third Party Or Terminate The Contract For Default Or Terminate For Cause Under Federal Acquisition Regulation (far) Part 12. If A Vha Contract Is Terminated For Cause, The Associated Baa Must Also Be Terminated And Appropriate Actions Taken In Accordance With Vha Handbook 1600.01, Business Associate Agreements. Absent An Agreement To Use Or Disclose Protected Health Information, There Is No Business Associate Relationship. The Contractor/subcontractor Must Store, Transport, Or Transmit Va Sensitive Information In An Encrypted Form, Using Va-approved Encryption Tools That Are, At A Minimum, Fips 140-2 Validated. The Contractor/subcontractor's Firewall And Web Services Security Controls, If Applicable, Shall Meet Or Exceed Va's Minimum Requirements. Va Configuration Guidelines Are Available Upon Request. Except For Uses And Disclosures Of Va Information Authorized By This Contract For Performance Of The Contract, The Contractor/subcontractor May Use And Disclose Va Information Only In Two Other Situations: (i) In Response To A Qualifying Order Of A Court Of Competent Jurisdiction, Or (ii) With Va's Prior Written Approval. The Contractor/subcontractor Must Refer All Requests For, Demands For Production Of, Or Inquiries About, Va Information And Information Systems To The Va Contracting Officer For Response. Notwithstanding The Provision Above, The Contractor/subcontractor Shall Not Release Va Records Protected By Title 38 U.s.c. 5705, Confidentiality Of Medical Quality Assurance Records And/or Title 38 U.s.c. 7332, Confidentiality Of Certain Health Records Pertaining To Drug Addiction, Sickle Cell Anemia, Alcoholism Or Alcohol Abuse, Or Infection With Human Immunodeficiency Virus. If The Contractor/subcontractor Is In Receipt Of A Court Order Or Other Requests For The Above Mentioned Information, That Contractor/subcontractor Shall Immediately Refer Such Court Orders Or Other Requests To The Va Contracting Officer For Response. For Service That Involves The Storage, Generating, Transmitting, Or Exchanging Of Va Sensitive Information But Does Not Require C&a Or An Mou-isa For System Interconnection, The Contractor/subcontractor Must Complete A Contractor Security Control Assessment (csca) On A Yearly Basis And Provide It To The Cor. Information System Design And Development Information Systems That Are Designed Or Developed For Or On Behalf Of Va At Non-va Facilities Shall Comply With All Va Directives Developed In Accordance With Fisma, Hipaa, Nist, And Related Va Security And Privacy Control Requirements For Federal Information Systems. This Includes Standards For The Protection Of Electronic Phi, Outlined In 45 C.f.r. Part 164, Subpart C, Information And System Security Categorization Level Designations In Accordance With Fips 199 And Fips 200 With Implementation Of All Baseline Security Controls Commensurate With The Fips 199 System Security Categorization (reference Appendix D Of Va Handbook 6500, Va Information Security Program). During The Development Cycle A Privacy Impact Assessment (pia) Must Be Completed, Provided To The Cor, And Approved By The Va Privacy Service In Accordance With Directive 6507, Va Privacy Impact Assessment. The Contractor/subcontractor Shall Certify To The Cor That Applications Are Fully Functional And Operate Correctly As Intended On Systems Using The Va Federal Desktop Core Configuration (fdcc), And The Common Security Configuration Guidelines Provided By Nist Or The Va. This Includes Internet Explorer 7 Configured To Operate On Windows Xp And Vista (in Protected Mode On Vista) And Future Versions, As Required. The Standard Installation, Operation, Maintenance, Updating, And Patching Of Software Shall Not Alter The Configuration Settings From The Va Approved And Fdcc Configuration. Information Technology Staff Must Also Use The Windows Installer Service For Installation To The Default "program Files" Directory And Silently Install And Uninstall. Applications Designed For Normal End Users Shall Run In The Standard User Context Without Elevated System Administration Privileges. The Security Controls Must Be Designed, Developed, Approved By Va, And Implemented In Accordance With The Provisions Of Va Security System Development Life Cycle As Outlined In Nist Special Publication 800-37, Guide For Applying The Risk Management Framework To Federal Information Systems, Va Handbook 6500, Information Security Program And Va Handbook 6500.5, Incorporating Security And Privacy In System Development Lifecycle. The Contractor/subcontractor Is Required To Design, Develop, Or Operate A System Of Records Notice (sor) On Individuals To Accomplish An Agency Function Subject To The Privacy Act Of 1974, (as Amended), Public Law 93-579, December 31, 1974 (5 U.s.c. 552a) And Applicable Agency Regulations. Violation Of The Privacy Act May Involve The Imposition Of Criminal And Civil Penalties. The Contractor/subcontractor Agrees To: Comply With The Privacy Act Of 1974 (the Act) And The Agency Rules And Regulations Issued Under The Act In The Design, Development, Or Operation Of Any System Of Records On Individuals To Accomplish An Agency Function When The Contract Specifically Identifies: The Systems Of Records (sor); And The Design, Development, Or Operation Work That The Contractor/ Subcontractor Is To Perform Include The Privacy Act Notification Contained In This Contract In Every Solicitation And Resulting Subcontract And In Every Subcontract Awarded Without A Solicitation, When The Work Statement In The Proposed Subcontract Requires The Redesign, Development, Or Operation Of A Sor On Individuals That Is Subject To The Privacy Act; And Include This Privacy Act Clause, Including This Subparagraph (3), In All Subcontracts Awarded Under This Contract Which Requires The Design, Development, Or Operation Of Such A Sor. In The Event Of Violations Of The Act, A Civil Action May Be Brought Against The Agency Involved When The Violation Concerns The Design, Development, Or Operation Of A Sor On Individuals To Accomplish An Agency Function, And Criminal Penalties May Be Imposed Upon The Officers Or Employees Of The Agency When The Violation Concerns The Operation Of A Sor On Individuals To Accomplish An Agency Function. For Purposes Of The Act, When The Contract Is For The Operation Of A Sor On Individuals To Accomplish An Agency Function, The Contractor/subcontractor Is Considered To Be An Employee Of The Agency. "operation Of A System Of Records" Means Performance Of Any Of The Activities Associated With Maintaining The Sor, Including The Collection, Use, Maintenance, And Dissemination Of Records. "record" Means Any Item, Collection, Or Grouping Of Information About An Individual That Is Maintained By An Agency, Including, But Not Limited To, Education, Financial Transactions, Medical History, And Criminal Or Employment History And Contains The Person's Name, Or Identifying Number, Symbol, Or Any Other Identifying Particular Assigned To The Individual, Such As A Fingerprint Or Voiceprint, Or A Photograph. "system Of Records" Means A Group Of Any Records Under The Control Of Any Agency From Which Information Is Retrieved By The Name Of The Individual Or By Some Identifying Number, Symbol, Or Other Identifying Particular Assigned To The Individual. The Vendor Shall Ensure The Security Of All Procured Or Developed Systems And Technologies, Including Their Subcomponents (hereinafter Referred To As "systems"), Throughout The Life Of This Contract And Any Extension, Warranty, Or Maintenance Periods. This Includes, But Is Not Limited To Workarounds, Patches, Hotfixes, Upgrades, And Any Physical Components (hereafter Referred To As Security Fixes) Which May Be Necessary To Fix All Security Vulnerabilities Published Or Known To The Vendor Anywhere In The Systems, Including Operating Systems And Firmware. The Vendor Shall Ensure That Security Fixes Shall Not Negatively Impact The Systems. The Vendor Shall Notify Va Within 24 Hours Of The Discovery Or Disclosure Of Successful Exploits Of The Vulnerability Which Can Compromise The Security Of The Systems (including The Confidentiality Or Integrity Of Its Data And Operations, Or The Availability Of The System). Such Issues Shall Be Remediated As Quickly As Is Practical, But In No Event Longer Than 10 Days. When The Security Fixes Involve Installing Third Party Patches (such As Microsoft Os Patches Or Adobe Acrobat), The Vendor Will Provide Written Notice To The Va That The Patch Has Been Validated As Not Affecting The Systems Within 10 Working Days. When The Vendor Is Responsible For Operations Or Maintenance Of The Systems, They Shall Apply The Security Fixes Within 10 Days. All Other Vulnerabilities Shall Be Remediated As Specified In This Paragraph In A Timely Manner Based On Risk, But Within 60 Days Of Discovery Or Disclosure. Exceptions To This Paragraph (e.g. For The Convenience Of Va) Shall Only Be Granted With Approval Of The Contracting Officer And The Va Assistant Secretary For Office Of Information And Technology. Information System Hosting, Operation, Maintenance, Or Use For Information Systems That Are Hosted, Operated, Maintained, Or Used On Behalf Of Va At Non-va Facilities, Contractors/subcontractors Are Fully Responsible And Accountable For Ensuring Compliance With All Hipaa, Privacy Act, Fisma, Nist, Fips, And Va Security And Privacy Directives And Handbooks. This Includes Conducting Compliant Risk Assessments, Routine 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 Cor And Approved By Va Privacy Service Prior To Operational Approval. All External Internet Connections To Va's Network Involving Va Information Must Be Reviewed And Approved By Va Prior To Implementation. Adequate Security Controls For Collecting, Processing, Transmitting, And Storing Of Personally Identifiable Information (pii), As Determined By The Va Privacy Service, Must Be In Place, Tested, And Approved By Va Prior To Hosting, Operation, Maintenance, Or Use Of The Information System, Or Systems By Or On Behalf Of Va. These Security Controls Are To Be Assessed And Stated Within The Pia And If These Controls Are Determined Not To Be In Place, Or Inadequate, A Plan Of Action And Milestones (poa&m) Must Be Submitted And Approved Prior To The Collection Of Pii. Outsourcing (contractor Facility, Contractor Equipment Or Contractor Staff) Of Systems Or Network Operations, Telecommunications Services, Or Other Managed Services Requires Certification And Accreditation (authorization) (c&a) Of The Contractor's Systems In Accordance With Va Handbook 6500.3, Certification And Accreditation And/or The Va Ocs Certification Program Office. Government- Owned (government Facility Or Government Equipment) Contractor-operated Systems, Third Party Or Business Partner Networks Require Memorandums Of Understanding And Interconnection Agreements (mou-isa) Which Detail What Data Types Are Shared, Who Has Access, And The Appropriate Level Of Security Controls For All Systems Connected To Va Networks. The Contractor/subcontractor's System Must Adhere To All Fisma, Fips, And Nist Standards Related To The Annual Fisma Security Controls Assessment And Review And Update The Pia. Any Deficiencies Noted During This Assessment Must Be Provided To The Va Contracting Officer And The Iso For Entry Into Va's Poa&m Management Process. The Contractor/subcontractor Must Use Va's Poa&m Process To Document Planned Remedial Actions To Address Any Deficiencies In Information Security Policies, Procedures, And Practices, And The Completion Of Those Activities. Security Deficiencies Must Be Corrected Within The Timeframes Approved By The Government. Contractor/subcontractor Procedures Are Subject To Periodic, Unannounced Assessments By Va Officials, Including The Va Office Of Inspector General. The Physical Security Aspects Associated With Contractor/ Subcontractor Activities Must Also Be Subject To Such Assessments. If Major Changes To The System Occur That May Affect The Privacy Or Security Of The Data Or The System, The C&a Of The System May Need To Be Reviewed, Retested And Re- Authorized Per Va Handbook 6500.3. This May Require Reviewing And Updating All 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. 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 Cor. The Government Reserves The Right To Conduct Such An Assessment Using Government Personnel Or Another Contractor/subcontractor. The Contractor/subcontractor Must Take Appropriate And Timely Action (this Can Be Specified In The Contract) To Correct Or Mitigate Any Weaknesses Discovered During Such Testing, Generally At No Additional Cost. Va Prohibits The Installation And Use Of Personally-owned Or Contractor/ Subcontractor- Owned Equipment Or Software On Va's Network. If Non-va Owned Equipment Must Be Used To Fulfill The Requirements Of A Contract, It Must Be Stated In The Service Agreement, Sow Or Contract. All 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. All Electronic Storage Media Used On Non-va Leased Or Non-va Owned It Equipment That Is Used To Store, Process, Or Access Va Information Must Be Handled In Adherence With Va Handbook 6500.1, Electronic Media Sanitization Upon: (i) Completion Or Termination Of The Contract Or (ii) Disposal Or Return Of The It Equipment By The Contractor/subcontractor Or Any Person Acting On Behalf Of The Contractor/subcontractor, Whichever Is Earlier. Media (hard Drives, Optical Disks, Cds, Back-up Tapes, Etc.) Used By The Contractors/ Subcontractors That Contain Va Information Must Be Returned To The Va For Sanitization Or Destruction Or The Contractor/subcontractor Must Self-certify That The Media Has Been Disposed Of Per 6500.1 Requirements. This Must Be Completed Within 30 Days Of Termination Of The Contract. Bio-medical Devices And Other Equipment Or Systems Containing Media (hard Drives, Optical Disks, Etc.) With Va Sensitive Information Must Not Be Returned To The Vendor At The End Of Lease, For Trade-in, Or Other Purposes. The Options Are: Vendor Must Accept The System Without The Drive; Va's Initial Medical Device Purchase Includes A Spare Drive Which Must Be Installed In Place Of The Original Drive At Time Of Turn-in; Or Va Must Reimburse The Company For Media At A Reasonable Open Market Replacement Cost At Time Of Purchase. Due To The Highly Specialized And Sometimes Proprietary Hardware And Software Associated With Medical Equipment/systems, If It Is Not Possible For The Va To Retain The Hard Drive, Then; The Equipment Vendor Must Have An Existing Baa If The Device Being Traded In Has Sensitive Information Stored On It And Hard Drive(s) From The System Are Being Returned Physically Intact; And Any Fixed Hard Drive On The Device Must Be Non-destructively Sanitized To The Greatest Extent Possible Without Negatively Impacting System Operation. Selective Clearing Down To Patient Data Folder Level Is Recommended Using Va Approved And Validated Overwriting Technologies/methods/tools. Applicable Media Sanitization Specifications Need To Be Pre- Approved And Described In The Purchase Order Or Contract. A Statement Needs To Be Signed By The Director (system Owner) That States That The Drive Could Not Be Removed And That (a) And (b) Controls Above Are In Place And Completed. The Iso Needs To Maintain The Documentation. Security Incident Investigation The Term "security Incident" Means An Event That Has, Or Could Have, Resulted In Unauthorized Access To, Loss Or Damage To Va Assets, Or Sensitive Information, Or An Action That Breaches Va Security Procedures. The Contractor/ Subcontractor Shall Immediately Notify The Cor And Simultaneously, The Designated Iso And Privacy Officer For The Contract Of Any Known Or Suspected Security/privacy Incidents, Or Any Unauthorized Disclosure Of Sensitive Information, Including That Contained In System(s) To Which The Contractor/ Subcontractor Has Access. To The Extent Known By The Contractor/subcontractor, The Contractor/ Subcontractor's Notice To Va Shall Identify The Information Involved, The Circumstances Surrounding The Incident (including To Whom, How, When, And Where The Va Information Or Assets Were Placed At Risk Or Compromised), And Any Other Information That The Contractor/subcontractor Considers Relevant. With Respect To Unsecured Protected Health Information, The Business Associate Is Deemed To Have Discovered A Data Breach When The Business Associate Knew Or Should Have Known Of A Breach Of Such Information. Upon Discovery, The Business Associate Must Notify The Covered Entity Of The Breach. Notifications Need To Be Made In Accordance With The Executed Business Associate Agreement. In Instances Of Theft Or Break-in Or Other Criminal Activity, The Contractor/subcontractor Must Concurrently Report The Incident To The Appropriate Law Enforcement Entity (or Entities) Of Jurisdiction, Including The Va Oig And Security And Law Enforcement. The Contractor, Its Employees, And Its Subcontractors And Their Employees Shall Cooperate With Va And Any Law Enforcement Authority Responsible For The Investigation And Prosecution Of Any Possible Criminal Law Violation(s) Associated With Any Incident. The Contractor/subcontractor Shall Cooperate With Va In Any Civil Litigation To Recover Va Information, Obtain Monetary Or Other Compensation From A Third Party For Damages Arising From Any Incident, Or Obtain Injunctive Relief Against Any Third Party Arising From, Or Related To, The Incident. Liquidated Damages For Data Breach 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. 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. Each Risk Analysis Shall Address All Relevant Information Concerning The Data Breach, Including The Following: Nature Of The Event (loss, Theft, Unauthorized Access); Description Of The Event, Including: Date Of Occurrence; Data Elements Involved, Including Any Pii, Such As Full Name, Social Security Number, Date Of Birth, Home Address, Account Number, Disability Code; Number Of Individuals Affected Or Potentially Affected; Names Of Individuals Or Groups Affected Or Potentially Affected; 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; Amount Of Time The Data Has Been Out Of Va Control; The Likelihood That The Sensitive Personal Information Will Or Has Been Compromised (made Accessible To And Usable By Unauthorized Persons); Known Misuses Of Data Containing Sensitive Personal Information, If Any; Assessment Of The Potential Harm To The Affected Individuals; Data Breach Analysis As Outlined In 6500.2 Handbook, Management Of Security And Privacy Incidents, As Appropriate; And 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. 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 $42.00 Per Affected Individual To Cover The Cost Of Providing Credit Protection Services To Affected Individuals Consisting Of The Following: Notification; One Year Of Credit Monitoring Services Consisting Of Automatic Daily Monitoring Of At Least 3 Relevant Credit Bureau Reports; Data Breach Analysis; Fraud Resolution Services, Including Writing Dispute Letters, Initiating Fraud Alerts And Credit Freezes, To Assist Affected Individuals To Bring Matters To Resolution; One Year Of Identity Theft Insurance With $20,000.00 Coverage At $0 Deductible; And Necessary Legal Expenses The Subjects May Incur To Repair Falsified Or Damaged Credit Records, Histories, Or Financial Affairs. 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. Training 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: 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; Successfully Complete The Va Cyber Security Awareness And Rules Of Behavior Training And Annually Complete Required Security Training; Successfully Complete The Appropriate Va Privacy Training And Annually Complete Required Privacy Training; And 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.] The Contractor Shall Provide To The Contracting Officer And/or The Cor 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. 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.