J065 Service Contract For Neuwave Ablation System

View Changes Va Handbook 6500 6 March 12 2010 Appendix C C 12 Statement Of Work Preventive Amp Corrective Maintenance Of The Johnson Amp Johnson Neuwave Microwave Ablation System Visn 1 Medical Centers General Information Contractor Shall Provide All Labor Equipment Materials Apparatus Tools Transportation Supervision And Disposal Necessary To Provide Preventive And Corrective Maintenance Services On The Neuwave Ablation System The Services Shall Include Emergency Service Unlimited Parts Preventative Maintenance Factory Authorized Updates Modifications Technical Support And Application Support As Outlined In The Scope Of Work The Equipment Is Located At The Following Addresses Va Connecticut Healthcare System West Haven Campus 950 Campbell Ave West Haven Ct 06516 Va Maine Healthcare System Togus 1 Va Center Augusta Me 04330 Type Of Contract Firm Fixed Price Service Contract Contract Performance Period Base Year Plus Three Option Year Renewals Contract Transaction Number 689 21 1 7441 0008 Scope Of Work Requirements For Equipment 1 Equipment Identification Site Va Connecticut Manufacturer Johnson Amp Johnson J Amp J Model Neuwave Microwave Ablation System Sn Nm19nea00734 Site Va Maine Manufacturer Johnson Amp Johnson J Amp J Model Neuwave Microwave Ablation System Sn Nm19nea00758 2 Conformance Standards Contractor Shall Provide Service And Ensure That The Equipment Functions In Accordance With The Equipment Manufacturer S Technical Performance Specifications Contractor Shall Conform To All Regulations To Include But Not Be Limited To Federal State And Local Governing Any Chemicals Equipment Or Work Which May Be Used Or Performed In The Work Under This Contract 3 Operational Uptime Requirements The Neuwave Ablation System Shall Be Operable And Available For Use 98 Of The Normal Operating Hours Of The Equipment As Detailed In Paragraph 13 Hours Of Coverage Downtime Will Be Computed From Notification Of Problem During Normal Work Hours 4 Guaranteed Response Time The J Amp J Field Service Engineers Fse Will Use Commercially Reasonable Efforts To Respond To Customer S Requests Within 24 Hours Of Notification To J Amp J Customer Service Center 5 Live Phone Support Service Shall Include Phone Support With J Amp J Technical Support Engineers Between 6 00 A M 8 00 P M Eastern Time 6 After Hours Phone Support Service For After Hour Phone Support Shall Include 24 Hours 7 Days A Week And 365 Days A Year For Technical Assistance When Required 7 Software Enhancements Periodic Software Enhancements Shall Be Provided As Part Of The Firm Fixed Price Contract And Shall Be Considered Within Scope 8 Preventive Maintenance Perform System Maintenance Inspections As Necessary To Maintain Factory Specifications 9 Parts Exchange All Parts Required For The Repair Of The System Excludes Instruments And Accessories Are Covered 10 Part Protection Preferred Pricing On Repairs Or Replacement Due To Accidental Damage Not Included In The Accidental Damage Coverage 11 Labor Amp Travel Expenses All Labor And Travel Conducted During Normal Business Hours Monday Through Friday 8 00Am 5 00Pm Relative To Customer S Local Time Excludes J Amp J Company Holidays 12 Certified Trained Technicians And Key Personnel The Scheduled Maintenance And Service Calls Shall Be Performed By J Amp J Trained Personnel In Accordance With The Agreement Technicians Shall Include Fully Qualified Facility Service Engineers Fse And A Fully Qualified Fse Who Will Serve As The Backup And Show Proof Of Competency As Shown By Training Conducted On Said System Fully Qualified Is Based Upon Training And On Experience In The Field For Training The Fse S Has Successfully Completed A Formalized Training Program For The Equipment Identified In This Statement Of Work For Field Experience The Fse S Has A Minimum Of Two Years Of Experience Except For Equipment Newly On The Market With Respect To Scheduled And Unscheduled Preventive And Remedial Maintenance Proof Of Training Shall Be Provided Upon Demand And Be Immediately Sent Via Fax Upon Demand To The Cor All Fse S And Technicians Shall Be Authorized By The Contractor To Perform The Maintenance Services All Work Shall Be Performed By Fully Qualified Competent Fse s The Cor And Or Designated Representative Specifically Reserve The Right To Reject Any Of The Contractor s Personnel And Refuse Them Permission To Work On The Vamc Equipment It Is Anticipated That Any Hospital Regulatory Inspections Tjc Etc Will Have The Vendor Providing Proof That They Meet Industry Standards Of Quality And Traceable Standards As Used To Calibrate This Device System At The Time Of The Maintenance Event 13 Hours Of Coverage A Normal Hours Of Coverage Are Monday Through Friday From 08 00 Am To 05 00 Pm Excluding Federal Holidays All Service Repairs Will Be Performed During Normal Hours Of Coverage Unless Requested Or Approved By The Contracting Officer S Representative Cor B Preventive Maintenance Will Be Performed In Accordance With Manufacturer s Recommendations Preventive Maintenance Will Be Performed During Normal Hours Of Coverage Or As Agreed To By User And The Cor Note Hardware Software Update Upgrade Installations Will Be Scheduled And Performed Outside Normal Hours Of Coverage At No Additional Charge To The Government Unless It Would Be Detrimental To Equipment Up Time To Be Determined By The Cor Or Designated Representatives Government Provides Software Hardware Upgrade Update There Shall Be No Additional Charge For Time Spent At The Site During Or After The Normal Hours Of Coverage Awaiting The Arrival Of Additional Fse And Or Delivery Of Parts D Federal Holidays Observed By The Vamc Are New Years Day Martin Luther King Day Presidents Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day And Christmas Day Scheduled Maintenance Will Be Excluded From Downtime Normal Work Hours Are 08 00 Am To 05 00 Pm Monday Thru Friday Excluding Federal Holidays Operational Uptime Will Be Computed During A Month Long Time Period Repeated Failure To Meet This Requirement Can Subject The Contractor To Default Action 14 Unscheduled Maintenance Emergency Repair Service A Contractor Shall Maintain The Equipment In Accordance With The Manufacturer s Specifications The Contractor Shall Provide Repair Service Which May Consist Of Calibration Cleaning Oiling Adjusting Replacing Parts And Maintaining The Equipment Including All Intervening Calls Necessary Between Regular Services And Calibrations All Required Parts Shall Be Furnished B The Cor Or Government Designated Representatives Are Authorized To Request And Approve Service Calls From The Contractor C Response Time Contractor s Fse Must Respond With A Phone Call To The Cor Or Designated Representative Within 1 Hour After Receipt Of Telephoned Notification During Normal Hours Of Coverage If The Problem Cannot Be Corrected By Phone The Fse Will Commence Work On Site Physical Response Within 2 Hours After Receipt Of This Second Notification And Will Proceed Progressively To Completion Without Undue Delay For Example If Hours Of Coverage Are 08 00 Am To 05 00 Pm Mon Thru Fri A 2 Hour Response Means If A Call Is Placed At 8 45 Am Monday August 10Th The Fse Must Start On Site Service Before 10 45 Pm Monday August 10Th 15 Scheduled Maintenance A The Contractor Shall Perform Preventive Maintenance Pm Service To Ensure That Equipment Performs In Accordance With Item 3 Conformance Standards An Outline Of The Pm Procedures And Schedule Shall Be Provided To The Cor Or Designated Representative The Contractor Shall Provide And Utilize Procedures And Checklists With Worksheet Originals Indicating Work Performed And Actual Values Obtained As Applicable This Documentation Shall Be Provided To Cor Or Designated Representative At The Completion Of The Pm Preferably In Electronic Format The Contractor Shall Provide Written Description Of Preventive Maintenance Inspections Pmi This Description Shall Include An Itemized List Of The Procedures Performed Including Electrical Safety At Minimum The Contractor Will Perform Electrical Safety Testing In Accordance With Nfpa 00 Standards Pm Services Shall Include But Need Not Be Limited To The Following 1 Cleaning Of Equipment 2 Reviewing Operating System Software Diagnostics To Ensure That The System Is Operating In Accordance With Section 3 Conformance Standards Or The Manufacturer s Specifications 3 Calibrating And Lubricating The Equipment 4 Performing Remedial Maintenance Of Non Emergent Nature 5 Testing And Replacing Faulty And Worn Parts And Or Parts Likely To Become Faulty Fail Or Become Worn 6 Inspecting And Replacing Where Indicated Electrical Wiring And Cables For Wear And Fraying 7 Inspecting And Replacing Where Indicated All Mechanical Components 8 Returning The Equipment To The Operating Condition Defined In Section 3 Conformance Standards 9 Providing Documentation Of Services Performed 10 Inspecting And Calibrating The Hard Copy Image Device B Pm Services Shall Be Performed In Accordance With The Original Equipment Manufacture Guidelines And During The Hours Defined In The Hours Of Coverage All Exceptions To The Pm Schedule Shall Be Arranged And Approved In Advance With The Cor Or Designated Representative C Service Is To Be Requested And Coordinated Only Through The Designated Cor So As To Be Assured That It Is Covered Within The Scope Of The Contract Work Day 8 5 Typical And So That Records Are Available For Inspection By Accrediting Organizations Any Services Not Coordinated By The Cor Will Not Be Considered Authorized And Completed And Will Be Considered To Fail To Meet The Terms Of The Contract D Preventative Maintenance Should Occur In Intervals In Accordance To The Oems Recommendations Of At Least 2 Times Each Year 16 Parts The Contractor Shall Furnish And Replace Parts To Meet Uptime Requirements The Contractor Has Ready Access To All Original Equipment Manufacturer Oem Parts Including Unique And Or High Mortality Replacement Parts All Parts Supplied Shall Be From The Oem The Contract Shall Include All Parts All Parts Shall Be Of Current Manufacture And Have Complete Versatility With The Presently Installed Equipment All Parts Shall Perform Identically To The Original Equipment Specifications 18 Parts And Services Not Covered Or Excluded By Contract Authorization Received By The Cor For Any Work Or Parts Outside The Scope Of This Contract Must Be Received Prior To Performance Of Work Or Payment Will Not Be Authorized Parts That Are Not Covered By This Contract Will Be Purchased By The Va Medical Center The Contractor Under The Terms Of This Contract Shall Accomplish The Full Installation And Complete Testing Of These Parts Separate Purchase Order Numbers For Components Parts Not Covered Under This Contract For Preventive Maintenance Will Be Issued When Detailed Information With Pricing To The Cor Is Submitted 19 Service Manuals Tools Equipment The Vamc Shall Not Provide Tools Test Equipment Service Manuals Or Service Diagnostic Software To The Contractor The Contractor Shall Obtain Have On File And Make Available To Its Facility Service Engineer S Fse All Operational And Technical Documentation Such As Operational And Service Manuals Schematics And Parts List Which Are Necessary To Meet The Performance Requirements Of This Contract The Location And Listing Of The Service Data Manuals By Name And Or The Manuals Themselves Shall Be Provided To The Cor And Co Upon Request 20 Documentation Reports The Documentation Shall Include Detailed Descriptions Of The Scheduled And Unscheduled Maintenance I E Emergency Repairs Procedures Performed Including Replaced Parts And Prices For Outside Normal Working Hour Services Required To Maintain The Equipment In Accordance With Section 3 Conformance Standards Or The Manufacturer s Specifications Such Documentation Shall Meet The Guidelines As Set Forth In The Conformance Standards Section The Engineering Service Report Esr Will Consist Of A Separate Pm Report For The Item S Covered Under The Specific Contract Grouping Different Equipment From Different Contracts On One Esr Is Prohibited Service Reports Must Be Sent To The Cor Or The Requesting Entity Upon Completion Of Each Service Issue In Addition Each Esr Must At A Minimum Document The Following Data Legibly And In Complete Detail A Name Of Contractor And Contract Number B Name Of Fse Who Performed Services C Contractor Service Esr Number Log Number D Date Time Starting And Ending Equipment Downtime And Hours On Site For Service Call E Va Purchase Order Number S Covering The Call If Outside Normal Working Hours F Of Problem Reported By The Cor Or Designated Representative G Identification Of Equipment To Be Serviced 1 Inventory Id Number 2 Manufacturer s Name 3 Device Name 4 Model Number 5 Serial Number 6 Any Other Manufacturer s Identification Numbers H Itemized Of Service Performed Including If Applicable Costs Associated With After Normal Working Hour Services Including 1 Labor And Travel 2 Parts With Part Numbers 3 Materials And Circuit Location Of Problem Corrective Action I Total Cost To Be Billed If Applicable I E Part S Not Covered Or Service Rendered After Normal Hours Of Coverage J Signatures 1 Fse Performing Services Described 2 Authorized Va Employee Who Witnessed Service Described Note Any Additional Charges Claimed Must Be Approved By The Cor Or Designated Representative Before Service Is Completed 21 Reporting Requirements The Contractor Shall Be Required To Report To The Clinical Engineering Department To Log In This Check In Is Mandatory When The Service Is Completed The Fse Shall Document Services Rendered On A Legible Esr S The Fse Shall Be Required To Log Out With Biomedical Engineering And Submit The Esr S To The Cor Or Designated Representative All Esrs Shall Be Submitted To The Equipment User For An Acceptance Signature And To The Cor Or Designated Representative For An Authorization Signature If Cor Or Designated Representative Is Unavailable A Signed Authorized Copy Of The Esr Will Be Left With The User Va Connecticut Cor Tyler Moxam 203 932 5711 X2872 Secondary Va Connecticut Clinical Engineering Point Of Contact Thomas Hostetler 203 932 5711 X3385 Primary Va Maine Clinical Engineering Points Of Contacts Nina Warah 207 623 5772 Primary And Timothy Damon 207 314 8079 Secondary 22 Payment Invoices Will Be Paid In Arrears On An Annual Basis Invoices Shall Include At A Minimum The Following Information Contract Number Purchase Order Task Order Number Contractor Name Item S Covered To Include Serial S By The Pmi And Covered Period Of Service All Invoices Shall Be Mailed To The Department Of Veterans Affairs Financial Services Center S Address As Follows Fms Va 1 650 P O Box 149971 Austin Tx 78714 23 Additional Charges There Shall Be No Additional Charge For Time Spent At The Site During Or After The Normal Hours Of Coverage Awaiting The Arrival Of Additional Fse And Or Delivery Of Parts 24 Reporting Required Services Beyond The Contract Scope The Contractor Shall Immediately But No Later Than 24 Twenty Four Consecutive Hours After Discovery Notify The Cor And Or Designated Representative In Writing Of The Existence Or The Development Of Any Defects In Or Repairs Required To The Scheduled Equipment Which The Contractor Considers He She Is Not Responsible For Under The Terms Of The Contract The Contractor Shall Furnish To The Cor Or Designated Representative A Written Estimate Of The Cost To Make Necessary Repairs 25 Condition Of Equipment The Contractor Shall Accept Responsibility For The Equipment Failure To Inspect The Equipment Prior To Contract Award Will Not Relieve The Contractor From Performance Of The Requirements Of This Contract 26 Test Equipment Prior To Commencement Of Work On This Contract The Contractor Shall Provide The Vamc With A Copy Of The Current Calibration Certification Of All Test Equipment Which Is To Be Used By The Contractor On Vamc s Equipment This Certification Shall Also Be Provided On A Periodic Basis When Requested By The Vamc Test Equipment Calibration Shall Be Traceable To The Original Equipment Manufacture S Standard 27 Identification Parking Smoking And Va Regulations The Contractor s Fse s Shall Wear Visible Identification At All Times While On The Premises Of The Vamc The Contractor Shall Park In The Appropriate Designated Parking Areas Information On Parking Is Available From The Va Police Section The Vamc Will Not Invalidate Or Make Reimbursement For Parking Violations Of The Contractor Under Any Conditions Smoking Is Prohibited Inside Any Buildings At The Vamc Possession Of Weapons Is Prohibited Enclosed Containers Including Tool Kits Shall Be Subject To Search Violations Of Va Regulations May Result In Citation Answerable In The United States Federal District Court Not A Local District State Or Municipal Court 28 Training The Contractor Shall Provide First Call Clinical Engineering Training For Current Qualified Technicians At The Vamc During Regular Service Hours Of Monday Through Friday From 8 00Am 5 00 Pm Est This Is Not An Ongoing Training And Will Only Be Provided On An Annual Basis As Required All Training For Upgrades To Equipment Shall Be Considered Within Scope Throughout The Life Of The Contract 29 Transportation Charges All Costs Associated With Transportation From Shipping Point To The Destination Specified Above And All Costs Of Removal After Contract Completion Shall Be Paid By The Contractor And Incorporated In The Price Proposal The Contractor Shall Be Responsible For All Damage In Transit Including Any Transportation Costs For Replacement 30 Compliance With Osha Bloodborne Pathogens Standard The Contractor Shall Comply With The Federal California Osha Bloodborne Pathogens Standard The Contractor Shall Have Methods By Which All Employees Are Educated As To Risks Associated With Bloodborne Pathogens Have Policies And Procedures Which Reduce The Risk Of Employee Exposure To Bloodborne Pathogens Have Mechanisms For Employee Counseling And Treatment Following Exposure To Bloodborne Pathogens Provide Appropriate Personal Protective Equipment Clothing Such As Gloves Gowns Masks Protective Eyewear Mouthpieces For The Employee During Performance Of The Contract 31 Miscellaneous Additional Equipment May Be Added And Or Removed Throughout The Life Of This Contract And Shall Be Considered Within Scope 32 Contractor Personnel Security Requirements Security Requirements All Contractor Personnel Shall Obtain A Short Term Identification Badge Issued By The Cor Or Government Designated Representative Such Badge Shall Be Worn By The Individual And Prominently Displayed At All Times While On Va Property No Employee Of The Contractor Shall Enter The Project Site Without A Valid Identification Badge Issued By The Va In Order To Obtain A Short Term Identification Badge Contractor Personnel Shall Present To The Cor A Valid Non Expired Photo Identification Issued By A Us Federal State Or Local Government Agency Escort Will Be Provided As Required In Sensitive Work Areas The C Amp A Requirements Do Not Apply And The Security Accreditation Package Is Not Required The Identified Sole Source Vendor Shall Be Subject To The Federal Laws Regulations Standards And Va Directives And Handbooks Regarding Information And Information System Security As Delineated In Standard Acquisition Guidelines Per The Va Handbook 6500 6 No Va Sensitive Information Will Be Transferred Shared Or Stored With Said Vendor As Such No Additional Mechanisms Will Be Needed To Ensure The Protection Of Information Tyler Moxam 07 22 2020 Cor Signature Date Name Tyler Moxam Title Biomedical Engineer Requesting Service Representative If Different Than Above Date Name Title

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