VETERANS AFFAIRS, DEPARTMENT OF USA Tender

The Department Of Veterans Affairs (va), Network Contracting Office (nco) 17, Is Issuing This Notice Of Intent (noi) To Inform Industry Contractors Of The Government S Intent To Execute A Sole Source Award Under Far Part 8 Required Sources Of Supplies And Services, Specifically Far 8.405-6(a)(1)(i)(c). the Intended Contractor Is Beckman Coulter, Inc., A Large Business, Headquartered At 250 S Kraemer Blvd, Brea, Ca 92821. the Laboratory Of Pathology & Laboratory Medicine Service At Audie L. Murphy Va Hospital And Kerrville Is In Need Of The Uninterrupted Provision Of Hematology Per Reportable Reagent Rental Agreement Testing Services. These Services Involve The Use Of Existing Instruments, Reagents, Consumables, Validations, And Training. We Require This Continuity For A Period Of Six (6) Months, With The Possibility To Extend For An Additional Six (6) Months. This Extension Is Necessary To Ensure The Seamless Transition To A New Agreement Signed On 09/15/2023, During Which The (nco) 17 Contracting Offices Will Bring The New Testing Procedures Into Full Operation. Maintaining The Current Contract And Retaining The Hematology Analyzers, Slide Maker, And Differential Instrument Is Of Utmost Importance To Ensure The Well-being Of Our Patients While We Work Towards The Complete Functionality Of The New Instrumentation. (see Attachment A - Statement Of Work (sow)). beckman Coulter, Inc Is The Only Contractor That Is Capable To Provide These Services, Due To The Highly Specialized Services Required Under This Contract, Discontinued Use Would Result In Substantial Duplication Of Cost To The Government That Is Not Expected To Be Recovered Through Competition And Will Result In Unacceptable Delays In Fulfilling The Agency S Requirements. this Procurement Is Being Conducted Using Commercial Items Procedures Pursuant To Far Part 12 And Far Part 8, Specifically Far 8.405-6(a)(1)(i)(c) Allowing The Contracting Officer (co) To Solicit From One Source In The Interest Of Economy And Efficiency, And A Logical Follow-on Action To An Original Federal Supply Schedule (fss) Order. the North American Industry Classification System (naics) For This Requirement Is, 334516 In-vitro Diagnostic Substance Manufacturing. Product/service Code For This Requirement Is 6550 In Vitro Diagnostic Substances, Reagents, Test Kits And Sets. The Small Business Administration (sba) Size Standard For This Sector Is 1,000 Employees. this Notice Of Intent Is Neither A Formal Solicitation Nor A Request For Competitive Proposals. No Solicitation Document Is Available And Telephone Requests Will Not Be Honored. No Award Will Be Made On The Basis Of Unsolicited Quotations Or Offers Received In Response To This Notice. Any Response To This Notice Must Show Clear, Compelling, And Convincing Evidence That Competition Will Be Advantageous To The Government. The Intent Of This Synopsis Is For Informational Purposes Only. Information Received Will Normally Be Considered Solely For The Purpose Of Determining Whether To Conduct A Competitive Procurement. A Determination By The Government Not To Compete This Action Based On This Notice Is Solely Within The Discretion Of The Government. all Inquiries And Concerns Must Be Addressed In Writing Via E-mail To Ognian D. Ivanov at Ognian.ivanov@va.gov With The Following Information Referenced In The Subject Line, 36c25724q0212 Audie Kerrville Hematology Cprr Bridge. A Determination By The Government Not To Compete This Proposed Procurement Based On The Responses To This Notice Is Solely Within The Discretion Of The Government. Information Received Will Be Considered Solely For The Purpose Of Determining Whether To Conduct A Competitive Procurement. All Interested Parties Who Are Responsible, Certified, And Capable May Identify Their Interest And May Submit Capability Statement Which Shall Be Considered By The Agency No Later Than 10:00 Am, Central Time On January 5, 2024 To Ognian Ivanov At Ognian.ivanov@va.gov. The Interested Parties Bear Full Responsibility To Ensure Complete Transmission And Timely Receipt. attachment A statement Of Work (sow) Laboratory Hematology Cprr background the South Texas Veterans Health Care System (stvhcs) Has A Need For A 6-month Bridge Cost Per Reportable Reagent Rental Agreement To Include The Kerrville Va Medical Center. The Stvhcs Currently Has A Hematology Cprr Agreement For Hematology Testing At Audie And Kerrville Va S. scope the Intent Of The South Texas Veterans Healthcare System (stvhcs) Pathology & Laboratory Medicine Service (p&lms) Is To Provide Continuous And Accurate Hematology Testing To Providers While We Are Concurrently Working To Validate And Install Upgraded Hematology Instrumentation. the Contractor Shall Provide The Required Reagents, Quality Control Materials, Consumables, And Service Maintenance, Peripherals, And Technical Training. Estimated Test Amounts Audie Vamc: 93480 Cbc 2520 Reticulocyte 420 Body Fluid Cell Count 96420 Tests Total estimated Test Amounts Kerrville Vamc: 12,600 Cbc 0 Reticulocyte 0 Body Fluid Cell Count 12,600 Tests Total location: audie L. Murphy Va Hospital 7400 Merton Minter Blvd. san Antonio, Texas 78229 kerrville Va Medical Center P&lms Laboratory 3600 Memorial Blvd, kerrville, Texas, 78208 period Of Performance: 6-month Bridge the Following Will Be The Analyzer Configurations Required: site quantity system audie Vamc 2 cbc Analyzer 1 slide Maker / Stainer 1 slide Imaging System 1 automation Line Connection To The Existing Power Express Automation Line With All Above Items Integrated. 1 middleware Auto Verification Solution W/ Qc Management Integrating All Systems Above. kerrville Vamc 1 cbc Analyzer 1 middleware Auto Verification Solution W/ Qc Management Integrating All Systems Above. test Menu (required): cbc - Complete Blood Count wbc - White Blood Cell Count diff - Automated Differential rbc - Red Blood Cell Count mch - Mean Corpuscular Hemoglobin mcv - Mean Corpuscular Volume mchc - Mean Corpuscular Hemoglobin Concentration rdw - Red Cell Distribution Width plt - Platelet mpv - Mean Platelet Volume ipf - Immature Platelet Fraction ig - Immature Granulocyte ret Reticulocyte ret-he Reticulated Hemoglobin nrbc Nucleated Red Blood Cell bf - Body Fluids mn Mononuclear Cells Body Fluid pmn Polymorphonuclear Body Fluid tc Total Cells Body Fluid wbc-bf White Blood Count Body Fluid rbc-bf Red Cell Count Body Fluid additional Definitions: Cap College Of American Pathologists Jc The Joint Commission system Specifications And Tasks (requirements): primary Analyzer(s) Base Equipment Offered That Shall Fully Support The Scope Of Operations (minimal Requirements). Depending Upon The Technical Functionality And The Capabilities Of The Individual Manufacturer S Instrumentation, One Analyzer Or Multiple Analyzers May Be Required To Meet The Productivity Specifications Defined Herein. In Those Instances, The Additional Analyzer(s) Shall, Likewise, Be Considered Primary Instrumentation And Be The Mirror Image Of The Primary Instrumentation And Shall Meet All The Technical Specifications Of This Solicitation. the Contractor Shall Provide The Linearity Ranges For All Analytes On The System And State Which Body Fluid Samples Are Fda Approved For Analysis. quality Control Materials the Contractor Shall Provide 3 Levels Of Whole Blood Commercial Quality Controls And 2 Levels Of Body Fluid Commercial Body Fluid Quality Controls To Be Analyzed On Each Analyzer(s) According To The Following Schedule: vamc San Antonio Peripheral Blood Qc Once Every 8-hour Shift. body Fluid Qc Once Every 8-hour Shift. va Mc Kerrville Peripheral Blood Qc Once Every 8-hour Shift. the Contractor Shall State The Control Stability And Expected Frequency Of The Adjustment Of Ranges Within Lot Numbers (to Include Both Whole Blood And Body Fluids). the Contractor Shall Explain How A Valid Target Range Is Verified For Each New Lot Of Control Per Cap Or Jc Guidelines. the Contractor Shall Explain Their Process For Monitoring Analytic Imprecision Per Cap/jc Guidelines. the Contractor Shall Explain How Qc Is Documented When The Control Results Exceed The Defined Acceptability Limits Per Cap/jc Guidelines. the Contractor Shall Explain How A Moving Averages System That Is Sensitive To Analyzer Calibration, Patient Populations, And/or Instrument Problems Is Used In Combination With The Other Control System. automatic Enrollment In A Quality Assurance Program That Has Peer Participation Of At Least 50 Participants That Are Not Part Of The Stvhcs Network. Reports Of Peer Data Will Be Current And Available Within 2 Weeks Of The Data Submission For Hard Copy Review. the Contractor Shall Have A Quality Control Program That Compares Facility Data To Peers Using The Same Lot And Provide A Monthly Report Of Such Data. operational Features The Instrumentation Offered Shall Have The Following: the Capability Of Performing Analysis On 100% Of The Tests Listed In Test Menu. sufficient Capacity And Throughput To Meet The Volume And Service Demands As Defined In Sow. the Hematology Analyzer Shall Streamline With Automation All Aspects Of Testing, Thereby Enhancing Operational Efficiency, Improving Turnaround Times, Supporting Improved Patient Outcomes, Improving Patient And Provider Satisfaction, And Improving The Productivity Of The Using Facility. This Would Include The Ability To Connect All Instrumentation From The Cbc Analyzer, Slide Maker Stainer, And The Slide Imaging System. the Offered Equipment Shall Be Capable Of Producing Accurate And Reproducible Results By Established Diagnostic Methods. The Equipment Shall Provide Accurate Tests Results Without Excessive (>2 Per Month) Malfunctions, Breakdowns, Or Service Calls. safety Features To Avoid Unnecessary Exposure To Biohazardous And Chemical Material. The Exposure To And The Volume Of Biohazardous And Chemical Material Generated By The Equipment Must Be Minimal And Require A Minimum Amount Of Handling. a Bi-directional, Bar-coded Computer Interface Compatible With The Current Va Laboratory Information System. The Fully Operational Interface (both Hardware And Software) Shall Be Immediately Available For Implementation To The Va Computerized Hospital Information System. the Equipment Shall Have Positive Sample Identification, Random Access, And The Accuracy Of The Barcode Reading Must Have Less Than A 1% Failure Rate To Reduce Possible Sources Of Errors And To Improve Laboratory Efficiency. equipment Must Be Able To Support Multiple Barcode Formats (code 39, Code 128) That May Be Enabled Concurrently. equipment Must Accept, At A Minimum, 10 Characters In Specimen Identifier That Is Alphanumeric (letters And Numbers). ability To Prioritize Stat Testing Without Compromising Existing Programmed Testing. This Includes The Ability To Identify Stat Testing In The Slide Imaging System. minimal Daily, Monthly, And Periodic Maintenance. The Contractor Is To Define The Actual Hands-on Maintenance Time Required To Perform Each Task. The Contractor Is To Include The Analyzer Time Required To Perform Each Maintenance Task. The Contractor Shall List Which Are User-level And Which Tasks Are Service Level. ability To Store And Retransmit Records (24 Hours Of Maximal Instrument Throughput) In Case Of Interface Outage. The Equipment Shall Have The Ability To Edit The Sample/patient Identifier After Interface Downtime And Then Be Able To Resend The Sample/patient Information To The Host For Verification. the Analyzer(s) Shall Have On Board Reagent Stability Sufficient To Accommodate Both High And Low Volume Use Per Each Facility S Needs. The Contractor Is To Provide Expiration Dates Of At Least Three (3) Months For Reagents. No Requirements For Sample Pre-treatment. the Analyzer(s) Shall Have An On-board Reagent Inventory System That Is Capable Of Monitoring Reagent Usage And Provide Reagent Inventory Upon Request, In Real Time. the Contractor Shall List All Reagents Used For Whole Blood And Body Fluid Analysis And State The On-board Stability/expiration Date For All Reagents, Controls, And Calibrators. the Contractor Shall State The Size Of The Reagents And If The Reagents Are Color-coded. the Contractor Shall List The Different Reagent Sizes Available For The Proposed Analyzer(s) And Indicate If The Reagents Are Interchangeable Between The Different Analyzer(s). the Analyzer Has The Ability To Detect And Alert The Operator Of Low Liquid Levels And The Potential Of Depletion For Any Supply On The Analyzer. the Contractor Shall State If The Reagents Can Be Replenished While The Instrument Is In Operation, Without Halting Or Pausing The Analyzer. the Contractor May Describe Any Practices That They Have Implemented That Would Streamline Inventory Management. the Contractor Shall Specify Their Routine Shipment Table Of Supplies And How Much Storage Space Would Be Needed For Each (i.e., Room Temperature, Refrigerated, And/or Frozen). the Contractor Shall Work With Each Facility To Adjust Reagent Supply To Match Workload Changes And To Provide The Option For Each Facility To Establish A Monthly Or Quarterly Shipment Table. The Contractor Shall Work With Each Facility Annually To Adjust The Shipment Table If Needed. the Contractor Shall State What Their Policy Is In Regard To Adjusting A Standing Order Or Ordering An Additional Shipment Of Supplies (i.e., Is There An Additional Fee Charged For Changing The Standing Order, Is There A Limit To The Number Of Times You Can Adjust A Standing Order And Is There A Fee For The Additional Shipment Of Supplies). the Contractor Will Maintain At Minimum A 90-day Supply Of Reagents At Each Facility. the Testing Must Have No Requirements For Sample Pre-treatment. ability To Detect Short Samples. The Contractor Shall Explain The Mechanism To Detect Insufficient Blood Volume For Testing Or A Short Sample. The Contractor Is To Explain How Short Samples Are Analyzed On The Proposed Analyzer. ability To Detect A Clotted Sample. The Contractor Shall Explain The Mechanism To Detect A Clotted Specimen. The Contractor Shall Explain The Mechanism To Remove A Clot From The Analyzer And If It Is Performed Automatically. capability To Perform Dilutions When Defined Limits Are Exceeded. The Capability Of Calculating Any Manually Programmed Dilutions. The Contractor Shall Explain The Dilution Process. capability To Detect And Flag Out Of Range Quality Control And Lock Out The Possibility Of Performing Patient Testing When Qc Is Unacceptable. ability To Accept Various Types Of Sample Containers. The Contractor Shall List Any Tube Type That Cannot Be Used. systems With 2 Or More Analyzers Should Have The Capability Of Making Slides And Staining Slides Without Removing The Primary Tube From The System. systems With 2 Or More Analyzers Should Have The Capability Of Digitally Imaging The Slide Without Removing The Slide From The Primary System. systems With 2 Or More Analyzers Should Have The Capability Of Attaching To An Automation Line. systems With 2 Or More Analyzers Should Have The Capability Of Adding Addition Systems Such As That Of A1c Analyzers If Required In The Future. system Must Have The Ability To Turn If Configuration In The Laboratories Limited Space Requires Additional Space. technical Features- The Instrumentation Must Be Approved By The Food And Drug Administration (fda) And Shall Have The Following: on-board Qc Data Management System With A Minimum Storage Capacity Of 90 Days Of Qc Files And Includes Levy-jennings Graphs. Analyzer Must Have The Ability To Capture, Store And Electronically Transfer Qc Data. ability To Edit Or Correct Errors In Qc Files Manually With Or Without Password Protection. ability To Have On-board Documentation For Out-of-range Qc And Instrumentation Problems. ability To View/print Daily, Monthly Qc Results And Levy-jennings Graphs. ability To Visually Alert The Operator Of Qc (westgard And User Defined Rules) Failures. ability To Electronically Transfer Qc To Contractor Without The Need For Manual Entry. ability To Monitor Instrument Performance And Provide A Proactive Alerting System For Samples With Unusual Results Requiring A Manual Review. on Board Reagent Inventory System, In Real Time, That Can Be Printed At Selected Time Intervals For Reagent Documentation To Include Dates And Time In Use And Reagent Lot Numbers. ability To Calibrate In All Sample Modes. The Contractor Is To State How Many Sample Paths The Analyzer Has And If The Calibration Is Performed By The User Or The Field Service Representative. the System Shall Have A Design That Removes The Possibility Of Sample Carryover. The Contractor Shall Provide Documented Evidence Confirming The System Design Removes The Possibility Of Any Sample Carryover. long Calibration Stability. The Contractor Is To State The Calibration Frequency And The Criteria For Calibration Verification. the System Can Customize Repeat/reflex Testing By Automatically Returning Specimens To The Sample Aspiration Module Without Operator Intervention, Thereby Reducing Retrieval Time And Eliminating Operator Intervention. the Analyzer May Have A Programmable Automatic Cleaning And Shutdown Feature. The Contractor Shall Explain How Often Shutdown Needs To Be Performed, The Time Required For Shutdown, And The Start-up Process. the Ability To Have On-board Maintenance Records That Can Be Printed And/ Or Modified For Additional User Defined Maintenance Tasks. digital Slide Imaging Program Shall Allow For Up To The Following Number Of Users At Any One Time Per Site. vamc San Antonio 6 Licenses vamc Kerrville 2 Licenses digital Slide Imaging Program Must Be Setup For The Entire System So That Slides Can Be Read From Another Connected Facility For Pathologists Review And During Short Staffing Situations. slide Imaging Program Must Have The Capability To Be Setup On More Than 2 Computers, However, Only The Number Of Licensed Would Be Able To Access The Program Concurrently. the System Must Have The Capability To Program Automatic Repeats On Suspect Samples. hardware Features- The Instrumentation Shall Have The Following: a Total Equipment Footprint That When Installed In The Laboratory Shall Not Impact The Functionality/operations Of That Laboratory. The Offered Hematology Analyzer(s) Shall Conform To The Facilities Existing Space. The Contractor Shall Provide The Weight And Dimensions Of Their Proposed Equipment. vamc San Antonio Space Available = 16 Ft X 10 Ft vamc Kerrville Space Available = 3ft X 4 Ft note: This Space Does Not Include Any Space Requirements For Water Systems That May Be Required For Reagent Concentration. The Vendor Will Notify The Va Of Any Additional Required Space For These Systems. the Contractor Shall List Any Analyzer/utility Requirements Needed (i.e., Electrical, Water, Plumbing, Reagent, And Bio-hazardous Disposal, Etc.). the Contractor Shall Indicate Any Routine And/or Special Items Required To Operate/maintain The Equipment/analyzer In Optimal Condition Such As But Not Limited To Paper, Printer Cartridges, Drainage Systems, Surge Protectors, Etc. an On-board Monitor/screen That Is Easily Readable In Addition To The Keyboard And Mouse. The Analyzer May Have A Touch-screen Interface. a Laser Jet Printer That Has The Capability Of Printing A Patient Report With Patient Demographic Information That Includes Minimally The Patient S Name And Accession Or Unique Identifier Number (uid). The Contractor Is To Provide A Replacement Printer On An Annual Basis Or As Needed. an Uninterruptible Power Supply With Line Conditioner For Each Instrument Provided. Equipment Shall Include 120-volt Ups That Has A 2 3-hour Backup Capability For All Analyzers. The Contractor Shall Be Responsible For Replacing The Ups, Should It Become Dysfunctional And Provide Battery Replacement As Needed. an Auto Sampling System That Includes Cap Piercing Closed Tube Aspiration, Auto-loader, And Auto-mixing. primary Tube Sampling. clot Detection. The Contractor Shall Define The Methodology For Clot Detection. manual Sampling Mode That Reads Barcode Label; Ideally Both Closed And Open Manual Sampling Modes Is Desirable. specific Equipment Requirements the Contractor Shall Supply Cabinetry, Wagons, Or Carts For All Analyzer(s). the Contractor Shall Supply The Environmental Requirements (i.e., Humidity And Temperature) For The Proposed Equipment To Perform Satisfactorily In The Laboratory. the Option For An Integrated Laboratory Robotics System (automated Track Or Connectivity) With Connected Hematology Analyzer(s). A Turnkey System With Single Inlet And Single Outlet With Connectivity To The Hematology Analyzer(s) And/or Slide Maker And Stainer Will Be Provided To Those Facilities Requiring This Option. the Contractor Shall Supply All The Necessary Parts And Supplies For The Operation And Maintenance Of The Automated Track And/or Slide Maker And Stainer. The Contractor Shall List Any Consumable Part Not Included In The Cprr For Any Component Of The Slide Maker And Stainer And/or Automated Track. the Flowing Specifications For The Automated Track/system And Middleware/support Software: provision Of Data Manager Software/computer That Electronically Links The Testing Instrumentation To Manage Data, Results, And Workflow. slide Maker And Stainer Are Available To Either Connected Hematology Analyzer. single Inlet And Outlet Lane. the Middleware Shall Allow For An Unlimited Number Of Users In An Effort To Store Historical Data. the Middleware Shall Allow The User To Define/set-up Decision Rules And Provide A Proactive Alerting System For Alerts Or Unusual Test Results. the Capability To Set-up Decision Rules/flagging Criteria For Specimens Requiring A Slide And/or Manual Review. The Decision Rules/flagging Shall Also Be Applicable To The Slide Maker And Stainer. automated Repeat And/or Reflex Testing Based On Established Rules Developed By The Stvhcs For Each Individual Facility. the Contractor Shall Assist Each Facility Throughout All 5 Years Of The Contract With Optimizing Operation And Utilization Of The Data Management Support Software (to Include Building Rules) To Enhance Productivity And The Management Of Workflow. the Contractor Shall Provide, Maintain, And Upgrade The Support Software/middleware For The Duration Of The Contract. all Major Software Updates Must Be Included. ability To Auto-verify Results. specimen Archival Through Mapping Of Specimens To Designated Racks For Easy Retrieval Once The Rack Has Been Moved Off The Line. the Option For An Integrated Laboratory Slide Imaging System (automated Track Or Connectivity) With Connected Hematology Analyzer(s). A Turnkey System With Single Inlet And Single Outlet With Connectivity To The Hematology Analyzer(s) And/or Slide Imaging System Will Be Provided To Those Facilities Requiring This Option. This Would Assist With Staffing Shortages Across The Va Systems. system Shall Support Continuous Feed Technology. system Shall Have A Throughput Of At A Minimum 35 Slides / Hr. vendor Must Be Capable Of Providing Remote Support To Middleware. vendor Must Be Capable Of Providing 24/7 Support. middleware Shall Allow Must Be Such That No Additional Software Is Required For Oit Computer Systems. middleware Must Provider Operational Instructions For When Samples Do Not Auto Verify. middleware Must Have The Functional Ability To Perform Reports And Lookbacks. middleware Must Be Capable Of Interfacing With Slide Imaging System To Assist With Streamlined Lis Builds. size Specifications: The Equipment Must Fall Within The Following Footprints: san Antonio Vamc: 16x 10 Feet kerrville Vamc: 3 X 4 Feet method Performance/validation Requirements For Whole Blood And Body Fluids at Installation/set-up The Contractor/technical Support Specialist Shall Perform All Validation Studies Including Installation/set-up, Correlation Studies (evaluation/comparison Data Sufficient To Satisfy Cap Standards), Reference Range Studies, Staff Training, In-service To Laboratory Personnel And Clinicians, And Assist With Any Methodology Problems And/or Questions. The Service Must Be Available During Regular Office Hours On A 5 Day/week Basis. method Performance/comparison Shall Be At The Expense Of The Contractor, Shall Include Linearity Material And Reagents, And Be Consistent With Current Clsi Guidelines And Related Documents, Cap Or Jc Standards And Federal Regulations. correlation Studies For Each Analyte. A Minimum Of 40 Samples Or Whatever Each Individual Facility May Require For Each Sample Type Spanning The Reportable Range, Shall Be Run By The Present And The Proposed Method. In Systems Where Multiple Sampling Modes Exist, Mode To Mode Correlation Studies Must Also Be Performed. The Contractor Shall Analyze Results And Provide Statistical Data To Support Acceptance Of The New Method For Above Studies. Statistics Shall Consist Of At Least Mean, Bias, Slope, Y-intercept, Correlation Coefficient, Receiver Operating Characteristic (roc) Analysis, And Meet Current Standards Defined By Clsi. analytical Measurement Range (amr) Validation Shall Be Performed On Proposed Instrument(s) For Each Test To Validate The Reportable Range. The Material Must Have Values, Which Are Near The Low, Mid, And High Values Of The Amr And Be Of Appropriate Matrix For The Clinical Specimens Assayed By That Method. A Minimum 5-point Linearity Analysis That Adheres To The Beer-lambert Law And Spans The Entire Range Shall Be Performed As A Minimum. precision Study Using Normal And Abnormal Control Material. This Shall Consist Of A Within Run Precision Study Of 10 Normal And 10 Abnormal Controls And A Day-to-day Precision Study Of Normal Controls And Abnormal Controls For 10 Days (may Be Run Twice A Day) For A Total Of 20 Values Per Level Of Control. Intra-stvhcs Facility Variations Should Be Kept At An Absolute Minimum. sensitivity. Sensitivity May Be Validated Concurrently With Correlation Studies. Mathematical Calculations To Determine Efficiency, Sensitivity, False Positive Rate, And False Negative Rate Are Applied. specificity Studies. A Review Of Product Literature And Assay Inserts To Determine Any Adverse Effects For Increased Bilirubin, Hemolysis, Lipemia, Cold Agglutinin, Or Other Interrupting Substances. carryover Studies. Successful Carryover Studies Shall Be Completed By The Contractor On All Analyzers During Installation. These Studies Shall Be Performed Using Either Contractor Developed Program(s) Or Program(s) Developed By A Third Party (cap/clsi). The Programs Shall Be Provided To Each Laboratory At No Charge. stability Studies. The Contractor Shall Provide Manufacturer Verified Documentation Of Sample Stability For Specimens Up To 48 Hours After Collection Or Perform The Required Studies. the Contractor Shall Provide Equipment Installation And Possible Reinstallation Costs If The Equipment Is Required To Be Moved Due To Construction Or Laboratory Design. reference Range- A Reference Range Must Be Determined For Each Test Following Clsi Guidelines. Samples Used For The Reference Range Study Must Be Representative Of The Patient Population Being Tested. Reference Range Assessment Must Be Performed For Each Lab. One Of The Following Protocols Shall Be Used: a Verification Of The Manufacturer S Suggested Reference Range May Be Performed As Long As The Suggested Range Is Based On A Comparable Population Of Test Subjects. The Manufacturer Shall Provide Specific Information Defining How The Suggested Range Was Determined. A Minimum Of 20 Reference Individuals Shall Be Used To Verify The Manufacturer S Range. Any Apparent Outliers Should Be Discarded, And New Specimens Obtained To Provide A Statistically Valid Verification. if The Suggested Manufacturer S Range Is Not Appropriate For The Patient Population, A Reference Range Shall Be Established. Establishing A Reference Must Follow Clsi Guidelines. This Requires A Minimum Of 120 Reference Individuals To Be Used To Establish A Reference Range. The Reference Interval Should Be Determined Using The Nonparametric Method. reports: The Contractor Shall Supply Accurate Data For Annual Contract Renewal By The Required Time Frames, Ensure Timeliness Of Billing Reconciliations, And Have The Ability To Use The Appropriate Billing Method Required By The Va. Additional Invoice Charges Associated With Reagent And/or Supply Wastage Or Repair Parts Included At No Charge (per Fss Awarded Contract) Shall Not Be Accepted. test Counts For Billing Will Begin After All Cap Required Studies, Performed At Installation Of New Equipment, Are Reviewed, And Approved By The Laboratory Director. support Features- commercial Marketing. The Equipment Models Being Offered Shall Be In Current Production As Of The Date This Offer Is Submitted. For Purposes Of This Solicitation, Current Production Shall Mean That The Clinical Laboratory Analyzer Model Is Being Offered As New Equipment. Discontinued Models That Are Only Being Made Available As Remanufactured Equipment Are Not Acceptable. start-up Reagents/installation. The Contractor Shall Provide All Reagents, Calibrators, Controls, Linearity Material, Consumable/disposable Items, Parts, Accessories, And Any Other Item Included On The List Of Supplies Defined In The Federal Supply Schedule Contract And Required To Establish Instruments For Operation For Performance Of Acceptance Testing At Installation And During Training Of Staff On Site. The Contractor Shall Perform, To The Satisfaction Of The Government, All Validation Studies Including Precision, Method Comparison With Current Analyzer, Accuracy (recovery), Linearity (reportable Range), Calibration Verification, Verification Of Reference Interval, And Determination Of Sensitivity And Specificity At No Cost To The Government. The Contractor Shall Perform All The Statistical Analysis As Stated In The Method Performance/validation Section Above And Report Data In An Organized, Clearly Comprehensible Format. at Installation Of New Equipment, The Contractor Shall Provide The Physical Installation Of The Equipment. Installation Shall Include, At A Minimum, Uncrating An/or Unpacking Of All Equipment, Hardware Set-up And Hook-up Of The System, Removal Of Trash, And Documentation That The Analyzer(s) Is Functioning Within The Correct Specifications. training. The Contractor Shall Provide An Instrument Training Program That Is Coordinated With And Timely To The Equipment Installation, Sufficient To The Size And Scope Of The Facility S Services And Minimally Equivalent To The Terms And Conditions For Training Defined In The Contractor S Federal Supply Schedule Fsc Group 66, Part Iii, Cost-per-test Clinical Laboratory Analyzers Contract. This Shall Include Training On The Operation Of The System, Data Manipulation, And Basic Trouble Shooting And Repair. Thereafter, The Contractor Shall Provide Training For Minimally One Operator Per Analyzer Per Year At The Discretion Of The Government For Each Model Of Instrumentation Placed. Utilization Of The Training Slots Shall Be Mutually Agreed Upon Between The Va And The Contractor. basic Operator Training Shall Be Provided By The Contractor On-site For All Operators On All Shifts. the Contractor Shall Provide All Education/training On Site During Installations Or Update To The Equipment. The Training Is To Include Staff On All Shifts. Training Shall Include Basic Operation, Quality Control, Interpretation Of Results, Reporting Of Results, Required User Performed Maintenance, And Troubleshooting. The Contractor Or Application Specialist Shall Provide A Documented Record Of Training (training Checklist) Completed For All Trained Staff Before Leaving Site Following Installation At The Facility. the Contractor Shall Provide On-site Refresher Instrument Training, Wet Workshops, Advanced Troubleshooting, Or Any Appropriate Training In Renewal Option Years Of The Contract If So, Exercised At No Cost To The Facility. the Contractor Shall Supply All Necessary Procedure Manuals, Troubleshooting Manuals, Operator Manuals, And Safety Data Sheets (sds) On A Cd Or On-line. The Procedures Shall Be In Clinical Laboratory Standards Institute (clsi) Format. The Contractor Shall Provide Assistance In Creating Preventative Maintenance, Quality Control And/or Logs To Meet The Needs Of Each Facility. equipment Preventative Maintenance/repair Service. The Contractor Shall Be Able To Provide Emergency Equipment Repair And Preventative Maintenance On All Primary And Secondary Instrumentation, Slide Maker And Stainer, And/or Automated Track System And Any Incremental Support Equipment, E.g., Water System, Offered According To The Following Terms: service Requirements a Technical Assistance Center Shall Be Available By Telephone 24 Hours Per Day, 7 Days Per Week With A Maximum Call Back Response Time Of 1 Hour. The Contractor Shall Provide Technical Support Services At No Additional Charge To All Stvhcs Facilities. service Shall Include, At No Charge, All Labor, Travel, And All Replacement Parts Necessary To Make Repairs. The Contractor Shall Provide All Replacement Parts At No Charge And Any Components Necessary For The Operation Of The Equipment To Produce Patient Results. the Contractor Shall Provide Instrument Support Service Sufficient To Provide Assistance With Troubleshooting And Repair Of The Analyzers. The Contractor May List Their Service Options Available. Or The Following Service Options May Be Available: 24 Hours/day, 7 Days/week Due To Extended Facility Hours/days. the Contractor Shall Specify The Cut-off Time For Same Day Service. for Any Site That May Encounter The Rare Occasion When Both The Primary And Secondary Analyzers Are Both Inoperable (service Has Now Escalated To Emergency Status), Service Shall Immediately Dispatch A Field Service Engineer For Repair. The Contractor Shall Explain Their Policy In Relation To Service If The Occasion Should Occur When Both The Primary And Secondary Analyzer Are Both Inoperable. The Support Service Shall Follow-up All Downtime Calls Within 1 Hour. The Fsr Always Shall Keep The Facility Informed Of The Timeline For When Repairs Are To Be Completed. All Repairs On Instrument Shall Be Complete (at No Cost To The Facility) Within 24 Hours From The Time The Field Service Engineer Arrives. The Field Service Engineer Shall, Prior To Departure, Provide The Visited Site With Written Or Electronic Documentation Of Services Performed. the Contractor Shall Provide A Preventative Maintenance Schedule To Include A Minimum Of 2 Scheduled Preventative Visits Per Year Or As Frequently As Published In The Manufacturer S Operator S Manual And Within 2 Weeks Of The Scheduled Date For The Duration Of The Contract. technical Support Shall Place A Service Call For Repairs If The Technologist Is Unable To Repair The Analyzer Within One Hour Of Troubleshooting With The Hotline Or On Weekends/holidays/irregular Tours When The Technologist May Be Unable To Work With The Hotline Due To The Facility S Staffing. a Malfunction Incident Report Shall Be Furnished To The Laboratory Upon Completion Of Each Repair Call. The Report Shall Include, As A Minimum, The Following: date And Time Notified. date And Time Of Arrival serial Number, Type, And Model Number Of Equipment time Spent For Repair, And proof Of Repair That Includes Documentation Of A Sample Run Of Quality Control Verifying Acceptable Performance. each Notification For An Emergency Repair Service Call Shall Be Treated As A Separate And New Service Call. the Contractor Shall Pay All Routine Shipping Fees For Supplies, Consumables, And Equipment To Perform Testing At Initial Installation And With Routine Supply Delivery. the Contractor Shall Supply The National Average Of Service Calls Per Analyzer. upgrades - The Contractor Shall Provide Upgrades To Both The Equipment Hardware And Software To Maintain The Integrity Of The System And The State-of-the Art Technology, At No Additional Charge To The Government. These Shall Be Provided And Installed As They Become Commercially Available At Each Site Within Two Months Of The Issuance Or Date Of First Commercial Availability. This Requirement Only Applies To System Upgrades That Enhance The Model Of Equipment Being Offered, I.e., New Version Of Software, Correction Of Hardware Defect, Upgrade Offered To Commercial Customers At No Additional Charge, Upgrade To Replace Model Of Equipment No Longer Contractor Supported, Etc. This Does Not Refer To Replacing The Original Piece Of Equipment Provided Under The Contract; However, It Does Refer To Significant Changes In The Hardware Operational Capability. ancillary Support Equipment - The Contractor Shall Provide, Install, And Maintain Through The Life Of The Contract, As Indicated, All Ancillary Support Equipment To Fully Operate The Analyzer As Defined In These Specifications, E.g., Cabinetry To Support/house The Analyzer (if Necessary), Water Systems (including Consumable Polishers, Filters, Etc.), And Universal Interface Equipment, Etc. In Addition, The Contractor Shall Include All Ancillary Components That Are Customarily Sold Or Provided With The Model Of Equipment Proposed, E.g., Starter Kits, Tables/stands, Etc. the Track System May Have The Ability, By Automation, To Integrate The Hematology Analyzer And Diabetes Testing (hemoglobin A1c) Into One Platform. the Contractor May Provide Innovative Technology For Slide Review And/or Interpretation That Can Be Interfaced With The Existing Hardware. the System May At A Future Date Be Integrated With Another Automated Line And At Such Time, The Contractor Will Coordinate With The Laboratory To Develop Solutions For Line / Automation Integration. interface Requirements the Contractor Is To Conduct And Complete The Medical Equipment Pre-procurement Assessment (va Directive 6550 Appendix A) For The Office Of Information Technology (oi & T) For Each Facility For Any Medical Devices That Will Be Connected To The Va Information Network. The Contractor Then Shall Provide Evidence Of Va Approved Remote Network Communication System That Continuously Collects And Monitors Performance Data Of The Analytical Systems Following All The Policies And Procedures Outlined In The Va Directive 6500, Information Security Program, And Its Handbooks To Ensure Appropriate Security Controls Are In Place (see Attached Addendum). the Contractor Shall Be Responsible For Providing All Hardware Required For The Connection, Implementation, And Operation Of The Interface To The Universal Interface And Any Incremental Fee That Is Required Each Time An Instrument Is Added To An Existing Universal Interface System. the Contractor Shall Provide All Necessary Software Support For Ensuring That Successful Interfacing Has Been Established. Specific Requirements For The Communication Of The Data Streams Will Be Unique To The Instrument System Involved And Dictated By The Manufacturer Itself. Information Necessary To Make The Determination For Type And Amount Of Interfacing Equipment Will Be Supplied In Attachment 2 (hematology Configuration). if A Site Already Has A Universal Interface Box, The Contractor Is Responsible For Everything Leading Up To The Box Including Any Incremental Fee Required To Add Additional Equipment (e.g., Licenses, Ports/cards, Cables, Software, Etc.) To The Universal Interfacing System. if A Site Does Not Have A Universal Interface And One Is Needed To Optimally Interface The Instrument, Then The Contractor Is Responsible For The Acquisition Of The Universal Interface Box And Everything Else Needed To Connect With Va Computerized Hospital Information System. routing Must Be Fully Supported By All Laboratory Instrument Interface Partners, Especially Data Innovations, Inc., And Cerner interface Must Use Automatic Host Query To Download Sample Ids, Test Requests And Patient Demographics. automatic Host Query Must Seamlessly Integrate With Onboard Patient Sample Barcode Scanning And Translation. instrument Interface Must Transmit Test Results To The Host Computer System Via Automatic Upload. should There Be Any Software Upgrades In The Instrument During Its Life, The Contractor Is Responsible For Seeing That The Interface Can Accommodate Any Changes In The Data Stream Going To The Va Computerized Hospital Information System. the Contractor Will Always Maintain Compatibility Of Systems With Whatever Host Lis Is In Place, Especially When The Contractor S Software Is Upgraded. the Contractor Shall Provide, Maintain, And Upgrade The Antivirus Software On The Analyzer(s) And/or Middleware For The Duration Of The Contract. the Contractor Shall Provide Documentation Of Successful Interfacing With Other Va Facilities (provide 2 Vamc References To Include Contact Person, Facility Address, Email, And Telephone Number) in Lieu Of An Lis Interface, The Contractor May Provide A Tcp/ip Interface Preapproved/certified By Vaco For Use With Va Computer Systems And Applications Such As Vista. Proof Of Certification Must Be Provided. The Contractor Will Provide All Necessary Information (including Logical Ports) For Va Staff To Write An Access Control List. the System Shall Have An Automatic Back-up Function To Store All Data From The Hard Drive. The Contractor Shall Describe The Back-up Option. commercial Offerings - The Contractor Shall Provide Any Additional Support Material That Is Routinely Provided To Equivalent Commercial Customers And Assists In Regulatory Compliance, E.g., Computer Disc Containing Their Procedure Manual In Clsi Format Or An On-line Procedure Manual In The Instrument Software. characterization Of Waste The Contractor Shall Provide Documentation That It Has Characterized The Hazardous Nature Of All Wastes Produced By All Equipment, Devices, Reagents, And Discharges In Accordance With The Requirements Of The Code Of Federal Regulations Title 40 Protection Of The Environment Part 261 Et Seq. And Applicable State And Local Requirements. Documentation Shall Include A Description Of The Characteristics Of The Hazardous Waste Produced As A Byproduct Of The Instrument Operations, Safety Data Sheets (sds) Meeting The Requirements Of The Occupational Safety And Health Administration (osha) And Environmental Protection Agency (epa), The Analytical Process Used To Determine The Hazardous Nature And Characteristics Of The Waste, And The Analytical Test Results. Testing Of Hazardous Waste Is To Be Done In Accordance With Testing Protocol Specified For Each Individual Waste As Described In The Code Of Federal Regulations Title 40 To Decide If The Waste Is A Hazardous Waste Or Otherwise Regulated. the Determination And Description Shall Address The Following: waste Toxicity (reference 40 Cfr §261.11 And 40 Cfr §261.24) waste Ignitability (reference 40 Cfr §261.21) waste Corrosivity (reference 40 Cfr §261.22) waste Reactivity (reference 40 Cfr §261.23) hazardous Waste From Non-specific Sources (f-listed) (reference 40 Cfr §261.31) discarded Commercial Products (acutely Toxic Or P-listed And Toxic Or U-listed) (reference 40 Cfr §261.33) solid Waste (reference 40 Cfr §261.2) exclusions (reference 40 Cfr §261.4) the Contractor Will Provide Written Instructions And Training Material To Ensure Vha Laboratory Staff Are Trained As Needed To Properly Operate Devices With Special Emphasis To Managing And Disposing Of Hazardous Waste In Accordance With Epa And State Requirements. Additionally, The Training Provided By The Contractor Must Fulfill Resource Conservation And Recovery Act (rcra) Requirements For Training As Applicable To Devices. contractor Shall Provide A Description Of All Wastes The Process Or Equipment May Discharge So That The Facility Can Determine Whether The Discharge Meets Local Publicly Owned Treatment Works (potw), State And Federal Discharge Requirements. At A Minimum The Characteristics Of Ignitability, Corrosivity, Reactivity And Toxicity As Defined In 40 Cfr §261 Must Be Determined And Documented. Any Mercury Containing Reagents Must Be Identified In Any Concentrations. All Test Results Shall Be Provided. All Listed Chemicals (f, U, K And P) Found In 40 Cfr §261 Shall Be Provided In Product Information And Their Concentrations Documented. For Those Materials With A Positive Hazardous Waste Determination, A Mechanism For The Laboratory To Meet Local Discharge Requirements (i.e., Mercury, Thimerosal, And Formaldehyde) Must Be Developed And Sds Sheets Must Be Provided In Advance For Review. At A Minimum, Documentation Shall Include, But Not Be Limited To The Concentration/measures Of The Elements And Parameters Listed Below And Must Be Included With Vendor Response: barium (total) cadmium (total) chromium (total) copper (total) cyanide (total) lead (total) mercury (total) nickel (total) silver (total) zinc (total) arsenic (total) selenium (total) tin (total) ph flash Point (to Higher Than 200 F) bod; Biochemical Oxygen Demand the Documentation The Contractor Provides Will Be Used To Work With The Vamc And The Public And/or Private Organization (e.g., Potw) To Determine Whether The Waste From Each Device Can Legally Be Disposed Of Via The Sewerage System. implementation/transition Timeframe - The Implementation Of The Services/requirements Described In This Solicitation Shall Be Completed No Later Than 90 Days After The Award. This Timeline Is Based On A Reasonable Attempt Of The Contractor To Complete All The Necessary Implementation Requirements Within The Stated Timeframe. Contractor Shall Not Be Penalized For Implementation Timelines That Extend Beyond The 90-day Timeframe If The Extension Is Through No Fault Of The Contractor And Is A Result Of Delays Due To The Government. upon Award, The Transition Period For The Awarded Contract To Have All Equipment And Peripherals Installed And Operational Shall Be From Date Of Award Through 90 Days. During This Same Period All Initial Training Of Va Personnel In The Operation And Maintenance Of Said Award Shall Also Be Completed. contractor Shall Provide With Its Quotation An Implementation Plan For Installation Of New Equipment. Contractor S Submitted Plan Shall Not Exceed 90 Days For The Transition Of All Services Under The Awarded Contract Including Installation And Training Of Personnel, Transition Of All Testing Materials, Reagents, And Supplies, Etc., Performance Of All Correlations And Validations. Failure Of The Contractor To Conform To The Transition Period Shall Be Considered As Sufficient Cause To Terminate The Contract For Cause Under The Termination For Cause Clause Of The Contract. security & Privacy due To The Threat Of Data Breach, Compromise Or Loss Of Information That Resides On Either Va-owned Or Contractor-owned Systems, And To Comply With Federal Laws And Regulations, Va Has Developed An Information And Information Technology Security Clause To Be Used When Va Sensitive Information Is Accessed, Used, Stored, Generated, Transmitted, Or Exchanged By And Between Va And A Contractor, Subcontractor Or A Third Party In Any Format (e.g., Paper, Microfiche, Electronic Or Magnetic Portable Media) the Contractor, Their Personnel, And Their Subcontractors 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. 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 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 Onsite 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 Cotr. 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 Cotr And Simultaneously, The Designated Iso And Privacy Officer For The Contract Of Any Known Or Suspected Security/privacy Incidents, Or Any Unauthorized Disclosure Of Sensitive Information, Including That Contained In System(s) To Which The Contractor/subcontractor Has Access. 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. security Controls Compliance Testing on A Periodic Basis, Va, Including The Office Of Inspector General, Reserves The Right To Evaluate Any Or All The Security Controls And Privacy Practices Implemented By The Contractor Under The Clauses Contained Within The Contract. With 10 Working-days Notice, At The Request Of The Government, The Contractor Must Fully Cooperate And Assist In A Government-sponsored Security Controls Assessment At Each Location Wherein Va Information Is Processed Or Stored, Or Information Systems Are Developed, Operated, Maintained, Or Used On Behalf Of Va, Including Those Initiated By The Office Of Inspector General. The Government May Conduct A Security Control Assessment On Shorter Notice (to Include Unannounced Assessments) As Determined By Va In The Event Of A Security Incident Or At Any Other Time. delivery contract Must Deliver And Maintain A Minimum 90 Days Of Reagents At The Site. contract Must Deliver Analyzer To Sites Within 30 Days Of Awarded Contract And Assist With The Installation, Setup, Validations, Studies, And Initial Training. service Will Be Provided For All Analyzers. phone Support 24/7. remote Support 24/7. technical Support M-f 8am 5pm. catastrophic Support Meaning If All Analyzers Are Down At One Site, Technical Support Is Dispatched Immediately. technical Support Must Call With Solutions Within 1 Hour Of Personnel Submitting Request For Technical Support.