6640--CPT, Microbiology Testing B+4, Saginaw

This is a REQUEST FOR INFORMATION and SOURCES SOUGHT for AUTOMATED MICROBIOLOGY SENSITIVITY AND IDENTIFICATION SYSTEMS AND BLOOD CULTURE SYSTEMS IN CURRENT USE AT THE VA FACILITIES LISTED BELOW. This is in preparation for a 5-year, single award, BPA or IDIQ. Contractors that deem themselves capable of meeting the requirement shall provide the below information to Brooke Hansen, Contracting Officer, at Brooke.Hansen@va.gov no-later-than Wednesday, October 25, 2023 at 4:30PM, EDT, referencing (36C25024Q0050). Responses shall include: (1) Business Name and Address, (2) GSA Contract Number and expiration date, if applicable (3) Point of Contact Name, Phone Number and E-mail Address (4) DUNS and NAICS code (5) Business Size SMALL or LARGE (6) Type of Small Business (if applicable): service disabled veteran owned, veteran owned small business, 8a, HUBZone, woman-owned, etc. (7) A concern that is not a manufacturer of the supply shall provide the manufacturers name and size standard (8) Country of Origin. If the concern is the manufacture and the sole distributor, please provide documentation to that effect. Please see requirements below: STATEMENT OF WORK AUTOMATED MICROBIOLOGY SENSITIVITY AND IDENTIFICATION SYSTEMS AND BLOOD CULTURE SYSTEMS IN CURRENT USE AT THE VA FACILITIES LISTED BELOW SCOPE OF PROCUREMENT: The contractor shall provide to the Veterans Affairs facilities (listed below) a Cost-Per-Test contract that will include all equipment, installation, a single middleware management system, software, hardware, printer, toner, all parts and materials, technical manuals, reagents, consumable supplies (contractor shall provide sensitivity cards (AST) for the purpose of quality control for every shipment or new lot number at no cost to the government), shipping and handling costs associated with receipt of reagents, all preventative and repair maintenance agreement, operator training in the operation of and performance of preventive maintenance, startup Quality Control (QC) and validation cards/panels, (if the contractor discontinues cards/panels, the contractor shall provide the requested number of cards/panel and reagents to perform the extra QC for validation studies at no charge), appropriate ATCC microorganisms for startup and weekly QC, bi-directional interface bar-coded computer interface compatible with the VA laboratory information system for identification (biochemical and mass spectroscopy methods), susceptibility testing, and blood culture testing. The contractor shall provide to the Veterans Affairs Facilities (listed below) a Cost-Per-Test (CPT) contract for an automated Blood Culture (BC) system that will include all equipment [including uninterruptible power supply (UPS) and UPS batteries], installation, BC bottles, (if the contractor discontinues bottles, the contractor shall provide the requested number of BC bottles to perform the validation studies at no charge), all preventative maintenance, consumable supplies, bi-directional bar-coded computer interface compatible with the VA laboratory information system (currently Data Innovations to VA VISTA/DHCP system), training of end users, and system maintenance (including parts, labor and travel) and all shipping costs (delivery and removal) during the term of the agreement. The contractor shall provide to the Veterans Affairs Facilities (listed below) a Cost-Per-Test (CPT) contract for identification and susceptibility testing of select microorganisms that will include all equipment [including uninterruptible power supply (UPS) and UPS batteries], installation, all preventative maintenance, consumable supplies, bi-directional bar-coded computer interface (single interface for all microbiology systems) compatible with VA laboratory information system (currently Data Innovations to VA VISTA/DHCP system), training of end users, and system maintenance (including parts, labor and travel) and all shipping costs (delivery and removal) during the term of the agreement. VA Ann Arbor Healthcare System 2215 Fuller Rd. Ann Arbor, MI 48105 Battle Creek VA Medical Center 5500 Armstrong Road Battle Creek, MI 49037 Aleda E. Lutz VA Medical Center 1500 Weiss Street Saginaw, MI 48602 John D. Dingell VA Medical Center 4646 John R St. Detroit, MI 48201 Northern Indiana Healthcare System (VANIHCS) Ft. Wayne Campus 2121 Lake Avenue Fort Wayne, IN 46805 DEFINITIONS: Cost per Test (CPT) - 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 each test that can be performed on its equipment. The per test price shall include costs covering (1) 1 year equipment use with 4 one year options to be exercised at the sole discretion of the government; (2) all reagents, standards, quality controls, calibration and correlation study testing, validation material, 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 and reporting of a test result; (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 for all equipment supplied. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. Contractor Middleware Management System - For the purposes of this solicitation, this is a separate component or module that electronically connects the testing instrumentation of all analyzers to manage data, results and workflow of blood culture, identification system (biochemical and MALDI-TOF) and sensitivity systems. (Not to be confused with middleware for interfacing equipment with the hospital/laboratory information system.) DEFINITION OF NEED: The VISN 10 facilities request a base year CPT contract that includes 4 additional option years to be exercised at the sole discretion of the government for the selected microbiology blood culture system and for the selected automated microbiology susceptibility and identification system, to include yeast identification/susceptibility, by both biochemical and mass spectroscopy methods. The contractor shall provide all equipment necessary to provide CPT analysis of susceptibility and identification (by biochemical and Matrix-Assisted Laser Desorption Ionization Time of Flight Mass Spectrometer (MALDI-TOF-MS methodology) of select microorganisms and automated microbiology blood culture systems, any start up supplies for validation studies, monitors, keyboards, personal computers, barcode scanners, external hard drives, laser printers and ink cartridges/jets. The contractor shall provide all cables and hardware/software necessary to connect any of the system components. The contractor shall include all parts materials, labor supervision, calibrators, technical manuals, operator training, and necessary transportation to perform preventative maintenance. All the equipment and ancillary supplies provided will be new (not refurbished, remanufactured, or previously used or demonstrated). The system shall read bar-coded labels of patient identification, calibrators, and controls. The system shall read bar-coded labels of patient identification and bottle identification for loading new bottles and management of all bottles on board the analyzer. The system shall have a bi-directional bar-coded computer interface compatible with the VA laboratory information system (currently Data Innovations to VA VISTA/DHCP system, using a TCP/IP connection. The system shall also have the same compatibility between Data Innovations and the Cerner Electronic Health System, which the medical centers included in this acquisition may be utilizing in the future. All instruments must have the ability to communicate via a single middleware. The equipment must be user friendly and not be labor intensive, including ease of set-up. The system, software, and blood culture bottles must provide self-contained continuous computerized automated monitoring of blood culture bottles for microorganism growth; immediate, preprogrammed criteria; notification of termination of maximum programmed incubation period when no microorganism growth is detected. The system, software and bottles shall meet the standards of: College of American Pathologists (CAP), Clinical and Laboratory Standards Institute (CLSI), The Joint Commission (TJC), 1988 Clinical Laboratory Improvement Act (CLIA), Federal Drug Administration (FDA), Federal, State, and local policies. The system shall be able to support varied programmed bottle incubation periods for any selected culture. The system shall make assignment of blood culture bottle locations within the incubator unit. The system shall keep a computerized log of time of detection of positive organism growth in any bottle. The system shall have the capability of maintaining all data for up to 24 hours in the event of normal electrical power interruptions. The system shall avoid any exposure to biohazardous material. A selection of blood culture (BC) bottle configurations (for low volume samples; antimicrobial agent removal resins) and formulations capable of maximizing growth potential of various microorganisms (i.e. aerobic/anaerobic bacteria, and fungi) shall be available. Culture media should be made available Resin based/ or broth based (at the discretion of the facility) for better evaluation of sepsis without hindering microscopic observation of gram stain. Contractor shall provide complete validation and implementation of new resin/or broth-based media to replace charcoal-based media. BC Bottles shall be color-coded to easily distinguish their utility or intended purpose. BC Bottles shall be FDA approved for culture of normally sterile body fluids other than blood. BC Bottles shall contain tear-off (duplicate) labels to attach to culture worksheets and contain the corresponding unique bar-coded bottle numbers. BC Bottles formulated for aerobic incubation shall not require venting prior to incubation. Patient samples and the results that are in progress and completed assays are displayed on instrument for technologist s review. Contractor shall supply laser printer and ink cartridges/jets for life of the contract. Must have printed hard copy results for computer down time via analyzer remote printer. Contractor shall supply barcode readers and have capability to read VA laboratory information system barcodes, as well, for life of the contract. The accompanying software (and all no charge updates) will be user friendly, have the capability to modify organism nomenclature, modify susceptibility interpretations, to be able to create in-house rules for conditional reporting of drug-bug combinations, ability to alert the user of any unusual susceptibility patterns including but not limited to: oxacillin resistance, vancomycin resistance, extended beta lactamase producers (presumptive and confirmatory testing), inducible clindamycin resistance, carbapenemase producers, and recommend suggestions for additional testing. The accompanying software will be able to provide accurate identification and recommend suggestions for additional testing. The system will also contain pre-determined rules and regulations as noted by the CAP, CLSI, CLIA and FDA. Offeror shall provide a single middleware system to support blood culture, identification (biochemical and MALDI-TOF), and sensitivity systems managing and coordinating data between multiple analyzers. Centralized data can be stored, organized, and accessed from a single platform. This creates efficiency in workflow as well as data retrieval for various reasons including the need to access data as a result of accrediting agencies inquiries, thereby mitigating the risk of inspection findings due to the inability to retrieve data efficiently. The workflow of data from analyzers using a streamlined middleware system allows for automatic transfer of data between analyzers, for data transformations and calculations for generating reports and alerts. This consolidated middleware allows for efficient integration with other systems and applications such as the Laboratory Information systems, the electronic health record, and data visualization tools, creating a seamless data exchange and operability between different systems and enabling a more comprehensive and efficient management and analysis of data. Therefore, utilizing one database, rather than multiple, increases efficiency in workflow within the microbiology department, which is becoming increasingly necessary when staffing is limited. Furthermore, staff training is also simpler for generalist technologists, when learning a single middleware system, rather than multiple middleware systems. Contractor shall be responsible for maintaining current and up-to-date antimicrobial susceptibility testing interpretation guidelines in the software as published by the Food and Drug Administration (FDA). Contractor shall have 90 days from the release of any updates or changes issued by the FDA to implement said changes in the software for the duration of the contract. The system shall avoid any exposure to biohazardous material. Equipment shall include continuous, on-board, reagent inventory monitoring i.e. lot number(s) reagent on board, expiration date monitoring, number of tests/pipettes/reagent left in assay material. Patient samples and the results that are in progress and completed assays are displayed on instrument for technologist s review. Instrument has system to ensure no sample carry-over. Contractor shall supply an adequate uninterruptible power system(s) (UPS) and UPS batteries to support the testing equipment for life of the contract. Contractor shall supply laser printer and ink cartridges/jets for life of the contract. Must have printed hard copy results for computer down time via analyzer remote printer. Contractor shall supply barcode readers and have capability to read VA laboratory information system barcodes, as well, for life of the contract. The system will be able to easily generate quality control reports and provide for workflow management capabilities. Contractor shall supply secured external hard drives/flash drives (or similar technology) for automatic database backups/archiving. If CD/DVD/similar media are required, then they will be supplied by contractor for the life of the contract. Contractor will supply actual testing/analyzing equipment, personal computers, monitors, cables, keyboards, wiring, etc. for the life of the contract. Must provide ability to incorporate new methodologies. Contractor will include regular service maintenance agreements in contract. The CPT price must include all consumables required to perform testing. Contractor shall provide AST cards for the purpose of quality control for every shipment or new lot number at no cost to the government. The system will afford flexibility for the end user in the types of identification and susceptibility cards/panels being offered. The system will afford flexibility for the end user in the selection of blood culture bottle configurations and formulations being offered If any card/panel types in use experience recalls or limitations on reporting then contractor will supply at no cost the supplies/reagents/media/etc. necessary to continue an alternative form of testing until the situation is rectified to everyone s satisfaction or the testing is no longer required by the VISN 10 facilities. If any blood culture bottle formulation in use experiences recall or limitation on reporting, then contractor will supply at no cost the supplies/reagents/media/etc. necessary to continue an alternative form of testing until the situation is rectified to everyone s satisfaction or the testing is no longer required by the Veterans Affairs Facilities. Technical, software, hardware, privacy, security, and online help will be available through the contractor 24/7 by telephone, including weekends and recognized (federal) holidays. If on-site service call is necessary, the contractor shall be present within 24 hours or less. Contractor shall provide technical specialist to perform all necessary set up and to prepare all installation, validation, and quality control reports for the institution s evaluation. Contractor shall provide an up-to-date procedure manual in CLSI format on a portable storage device (i.e. CD-ROM, disk, etc.) and/or an on-line CLSI formatted procedure manual in the instrument software. In addition, there is to be a printed hard copy version. Contractor shall supply specialized instrument training at no additional cost, for 2 personnel and make available at time of equipment installation. This shall include training on all systems operations a, data manipulation, trouble shooting, maintenance and repair. This training is to be completed within 180 days of the purchase order completion. Same training will apply for 1 (one) additional personnel for each remaining valid contract year. The contractor shall also make available a technical specialist for on-site, in-house training for all shifts in the laboratory. The contractor, at its discretion may make training available at its facility on terms and conditions mutually agreed upon by the Agency and the contractor consistent with commercial offerings (Preferred method). Contractor will provide without additional cost all ancillary components that are customarily sold or provided with the model of equipment proposed. Medical centers included in this request need MALDI_TOF_MS as an additional faster bacterial identification system. The device must analyze material from microbial cultures to provide organism identification within minutes. This instrument must include a Food and Drug Administration approved broad library of gram positive, gram negative, aerobic, anaerobic as well as yeast and fungi. The instrument must be FDA 21 CFR Part 11 Compliant. The instrument must be fully integrated with the antimicrobial susceptibility testing platform I place with automatic linking of organism ID to sensitivity. PARTS: The contractor shall furnish all parts as necessary to maintain and update the equipment covered by this contract, in accordance with the Conformance Standards. The contractor guarantees that it has ready access to new standard parts (manufactured, supplied by the manufacturer, or equivalent substitute) for needed repairs. All parts supplied shall be non-refurbished and shall have full compatibility with existing equipment. Documentation of intended parts source(s) shall be provided to the Contracting Officer upon request. NOTE: Contractor acknowledges the fact that upon termination of the contract by any means that any components of the system which contain any type of demographics, or personal identifying information will be sanitized according to VA regulations by destruction of hard drives, performed by the VA. A smaller footprint is required. These instruments must also produce minimum biohazard waste. BRIEF SUMMATION OF SUPPORT FEATURES: The contractor shall provide all labor, materials, blood culture bottles, equipment, (including UPS and UPS batteries) and equipment parts and service, reagents, supplies, consumable, disposable items, parts, accessories, shipping and handling costs, and any other item(s) required to establish fully operational microbiology testing systems and microbiology blood culture systems including appropriate start up and weekly ATCC quality control strains, to comply with College of American Pathologists, Joint Commission and Clinical and Laboratory Standards Institute (CLSI) regulations. Shipping and handling costs shall be the responsibility of the contractor and shall be included in the offer. The contractor shall provide at no charge software upgrades to maintain the integrity of the system as a state-of-the-art system. These shall be provided as they become released, installed by the contractor (as appropriate) and supported by in-house technical training (as appropriate). The contractor shall provide all ancillary support equipment to fully operate the instrumentation as defined in these specifications. Remote access for the system troubleshooting shall be considered on a case-by-case basis. If provided, it shall only be through a VPN interface subject to the Department of Veterans Affairs IMS approval. Modems are no longer considered acceptable by the VA Information Security Office. The contractor shall provide all universal interface equipment to interface equipment with the VA laboratory information system. Currently, the Veterans Affairs facilities utilize Data Innovations(DI) as the universal interface. Contractor equipment must offer a bi-directional interface with the existing Data Innovations and VISTA/DHCP. Contractor equipment must also offer a bi-directional interface with Data Innovations and the Cerner Electronic Health Records Management System (EHRM), which medical centers, included in this acquisition, may be utilizing in the future. The contractor shall provide everything required for the installation, implementation, testing, and operations of the interface right up to the universal interface box, including the software license fee that may be required each time an instrument or software update is added to an existing system (e.g. ports, cards, panels, software, flash drives, licenses, etc.). If there are any software/hardware/panel upgrades for the contractor system during the life of the contract, the contractor is responsible for ensuring that the interface support system can accommodate any changes in the data stream going to and from the VA s laboratory information system and VA s computerized patient record system (CPRS), and the Cerner Electronic Health Records Management System, which may be utilized in the future by the medical centers included in this contract. Any additional costs, e.g., consulting fees, travel expenses, and extra equipment, etc. will be borne by the contractor. During the life of contract if DI becomes obsolete, contractor shall provide the support to its successor. Currently VA computer system is nationally supported by Microbiology Class I interface. Contractor shall provide support to any future upgrade to VA supported system and any enhancement to the universal interface. 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 contractor shall provide an up-to-date procedure manual in CLSI format on a portable storage device (i.e. CD-ROM, disk, etc.) and/or an on-line CLSI formatted procedure manual in the instrument software. In addition, there is to be a printed hard copy version. The contractor shall provide support and resources during the validation and migration to new Laboratory Information System (Cerner Millennium) with no extra cost to the Government. This shall include connectivity testing by assisting with order and result transmission between Cerner, Data Innovations, Contractor middleware, automation lines, and analyzers. The contractor shall provide support services to interface the middleware systems to set up, configure and test the lab instruments, DI/IM systems, and Cerner LIS/EMR systems to validate that end-to-end lab tests orders, results and quality control metrics are all connected and functioning in an accurate and optimate manner at the VA facilities. This shall also include validation support in which the contractor shall be the sole point of contact and work with designated laboratory personnel at each site during their validation period to assist with troubleshooting issues, configuration, connectivity, written rules algorithm, auto-verification. The contractor shall also provide go-live support for all VA facilities in this contract during their Cerner transition and go-live. Go-live is defined as the time at which the modified rules are moved into the production environment and the sites begin reporting the first results. The contractor shall also provide training as required by new LIS configuration. Training. The Contractor shall provide instrument training program for three (3) key operators for analyzers (one key operator training slot for each analyzer for the first year), middleware, from each facility that is coordinated with and is 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 systems, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally two (2) key operators (could be used for any two of the three analyzers) per facility per year at the discretion of the Government. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor for the life of the contract. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant. In addition to the training above the following shall be provided: Basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable. Advanced training shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization. HARDWARE/SOFTWARE: Computer Interfacing Requirements The fully operational interface (internal or native to the system) network (Ethernet) interface (Hardware and software) must be immediately available for implementation to the Veterans Affairs facilities laboratory information system at the time of contract award. Network interface shall be capable of supporting TCP/IP network protocol in both IPV4 and IPV6. If the contractor is not capable of supporting TCP/IP network interface, then it shall be the contractor s responsibility to provide a Lantronix serial to Ethernet conversion unit with all associated cabling and connectors. The Veterans Affairs facilities laboratory shall determine the model or Lantronix requirement (MSS100 or MSS4) and provide the contractor with the model needed. Computer access will be granted on a need-to-know basis, and security of computerized information will be maintained at all times. The Veterans Affairs facilities shall be interfaced for instrumentation that is being provided. The contractor shall ensure interfacing for all instrumentation that is offered. The contractor is 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 (see requirements below). Likewise, the contractor will 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 selected. All cables and hardware necessary to connect any of the systems together are included if required, and all parts materials, labor supervision, calibrators, technical manuals, operator training and transportation necessary to perform preventative maintenance on the selected system. If a site already has a universal interface box, the contractor is responsible for contractor provided equipment and hardware that leads to the interface box. This responsibility includes assuming 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 all other parts, equipment, or other hardware needed to connect the system with the Veterans Affairs facilities laboratory information system. If there are any software upgrades in the instrument during the life of the contract, the contractor is responsible for assuring that the interface can accommodate any changes in the data stream going to the Veterans Affairs facilities laboratory information system. The contractor shall provide all ancillary support equipment to fully operate the instrumentation as defined in these specifications. Remote access for system troubleshooting shall be provided only through a VPN interface subject to Department of Veterans Affairs Information Management Systems (IMS) approval. Modems are no longer considered acceptable for use by the VA Information Security Office and are prohibited from use. The contractor shall provide without additional cost all ancillary components that are customarily sold or provided with the model of equipment proposed, (e.g., starter kits, tables/stands, etc.). The contractor shall provide a current procedure manual on a portable storage device (i.e. CD-ROM, disk, etc.) and/or an on-line procedure manual in the instrument software. In addition, there is to be a printed hard copy version. The procedure manual shall be formatted in accordance with current, approved CLSI guidelines. The contractor must provide availability of printed (hard copy) patient results routinely and in the event of interface downtime for the system. The contractor must provide electronic patient data, quality control, and maintenance (when applicable) archiving that complies with College of American Pathologist (CAP), and The Joint Commission (TJC) requirements for the system. In addition to software, the analyzer must have a hardware data manager to meet the facilities operational goals and shall include the following capabilities. Archiving of results Data collection Interference management LIS backup and storage management Rule based decision processing Auto verification, if applicable The operating systems (OS) shall either be a proprietary OS or one that is approved by VA to be on the VA network (i.e. minimally Windows 10). The contracted middleware shall also be compatible with being installed on a virtual machine running as an OS or Windows Server 2019. Support services shall also be available to upgrade operating systems if at any time the current OS becomes obsolete and is no longer approved to be on the VA network (for all instruments and middleware). Additionally, the contractor may make training available at its facility on terms and conditions mutually agreed upon by the Veterans Affairs facilities and the contractor that are considered with commercial offerings. SUPPORT FEATURES: The contractor shall coordinate all validation analyses and report this data in an organized, clearly comprehensible format, a sample of which is to be provided with the proposal to the CO. The contractor shall provide assistance with the establishment of references to include the handling of data with appropriate software to establish references based on current CAP, TJC, and CLSI regulations. Equipment should be able to reconfigure to add third party vendor equipment. TECHNICAL SUPPORT: The contractor will provide technical support, perform method validation as outlined and submit all data and/or required statistical analysis in a binder(s) for on-site staff approval. Availability of a support hotline 24 hours a day, 7 days a week including all holidays. Provide in-house assistance in validating new test/assays. IMPLEMENTATION/TRANSITION TIMEFRAME: The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the contract with seamless transition for the patient care. 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 of a contract, the transition period for the awarded Contractor to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial onsite 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. At the end of 90 days, the awarded Contractor shall have full and sole responsibility for services under the awarded contractor. HOURS OF WORK: Contractor s technical support hotline shall return all technical service request calls within two hours. Technical hotline will be available 24 hours per day, 7 days per week and will perform emergency repair service within 24 hours of the time of notification of the malfunction. The vendor shall provide, at no charge, all labor, travel and non-refurbished parts necessary to make repairs. Warranty for the entire agreement period to include unlimited, on-demand, service 7 days per week 8:00am to 5:00pm including holiday coverage. The eleven holidays observed by the Federal Government are Veterans Day, New Year s Day, Martin Luther King Day, President s Day, Memorial Day, Juneteenth Day, Independence Day, Labor Day, Columbus Day, Thanksgiving Day, and Christmas Day. Also, any other day declared by the President of the United States to be a national holiday. STANDARD AND QUALITY OF PERFORMANCE: This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification or as quoted in any proposal at an effectiveness level of 90% or more. If equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled Termination for cause. (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when more than the minimum of 100 hours. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. During the term of the contract, shall the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR and/or contracting officer to replace the malfunctioning equipment with new equipment. The Contractor shall reimburse the VA facilities for any services (i.e. currier, reference lab, etc.) that were needed due to prolonged downtime. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. The same terms and conditions apply to ancillary/support equipment provided under this contract, i.e., water system UPS, etc. An annual compliance report addressing preventive maintenance inspections, as well as Safety/Environmental/Infection Control inspections, shall be reported to the COR in the month of September. Government s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order, at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer. The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason shall purge all patient sensitive information prior to departure from the facility. Prior to termination or completion of this contract, Contractor/subcontractor shall not destroy information received from VA, or gathered/created by the Contractor during performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor shall 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 shall be sent to the VA Contracting Officer within 30 days of termination or completion of the contract. 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 shall 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 shall be retained by the VA for sanitization or destruction. This shall be completed within 30 days of termination or completion of the contract or disposal or return of the IT equipment, whichever is earlier. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information shall not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are: Contractor shall accept the system without the drive. VA s initial medical device procurement includes a spare drive which shall be installed in place of the original drive at time of turn-in; or VA shall 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 Contractor shall have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device shall 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 Information Security Officer (ISO) needs to maintain the documentation. ENVIRONMENT OF CARE/QUALITY CONTROL: Routine and recurrent preventative maintenance inspections shall be the responsibility of the contractor. All significant problems shall be reported verbally to the Contracting Officer Representative (COR) AND Microbiology supervisor within 24 hours. A written corrective plan of action shall be submitted to the COR within 5 working days. The Veterans Affairs facilities timeframes and priorities for completion of action plan items will be mutually agreed upon by the contractor and the Contracting Officer. An annual compliance report addressing preventative maintenance inspections, as well as Safety, Environmental, and Infection Control inspections, shall be reported to the COR. The contractor shall perform preventative maintenance inspections, during the contract period arranged with the COR or Microbiology supervisor, in accordance with the published preventative maintenance schedule for the selected system, but preventive maintenance shall be performed no less than annually. The contractor shall utilize the original equipment, manufacturer s established procedures and checklists, (or contractor-supplied equivalent satisfactory to the COR). A Field Service Report shall be supplied to the COR and Microbiology supervisor at the completion of each preventative maintenance inspection, and repair service call. In addition, the Field Service Representative will inform the technologist on duty during the service call regarding problems found and any corrective action taken while performing the maintenance and repair call. SAFETY REQUIREMENTS: In the performance of the contract, the contractor shall take such safety precautions as the CO may determine to be reasonably necessary to protect the lives and health of the occupants of the building. The CO shall notify the contractor of any safety issues and the action required to correct these issues. Such written or verbal notice, when served on the contractor or its representative at the work site shall be deemed sufficient for the corrective actions to be taken. If the contractor fails or refuses to comply within 24 hours on the notification of the safety issue, the CO may issue an order stopping all or part of the work and hold the contractor in default. DOCUMENTATION/REPORTS: The contractor shall submit a legible field service report which shall include detailed descriptions of the preventive maintenance inspection or emergency repair services performed, including replaced parts and estimated prices required for the service call. NOTE: Any additional charges claimed must have been approved by the CO before service was performed. The contractor shall perform all validation/statistical analyses and report this data in an organized, clearly comprehensible format, a sample of which is to be provided with the proposal to the CO. The contractor shall provide assistance with the establishment of reference parameters to include the handling of data with appropriate software to establish references based on current CAP, TJC, CLSI, and FDA standards. TERM OF CONTRACT: The contract will be effective for one (1) year from the date of the contract award, with four (4) pre-priced option years. The contract is subject to the availability of appropriated funds. THE JOINT COMMISSION COMPLIANCE STANDARDS: GENERAL: The contractor shall continuously meet or exceed all The Joint Commission Hospital standards. All applicable VA and VHA policies, procedures and directives shall be followed by the contractor. The patient population treated at the Veterans Affairs facilities consists of veterans with varying physical, psychiatric, and psychological needs. Their conditions are in many cases, directly related to the individual s service to this country. PATIENT RIGHTS: Protection of all patients rights is of highest priority. Patient privacy and confidentiality shall be always maintained. Computer access will be granted on a need-to-know basis, and security of computerized information will be always maintained. No patients shall be subject to any research activity without his/her fully informed consent, subject to study approval by the Investigational Research Board (IRB). The contractor shall abide by the VAMC Code of Ethics, which addresses marketing, admission/transfer/referral/discharge processes, and billing issues. PATIENT SAFETY: The VAMC shall inform the contractor of all applicable Sentinel Event or other Patient Safety Alerts received by the VAMC. For every applicable alert, the contractor shall take the necessary steps to redesign processes to prevent occurrence and provide written feedback to the COR describing preventative actions taken. All events related to patient injury, medication errors, and other breeches of patient safety will be reported to the COR utilizing the VAMC Incident Report. All events related to patient injury, medication errors, and other breeches of patient safety will be documented utilizing the contractor s format, and reported to the COR. The VAMC shall provide the contractor with VAMC Sentinel Event definitions in the start-up phase. The contractor shall verbally notify the VAMC COR immediately when a Sentinel Event has occurred, which is to be followed by written notification within one (1) business day or sooner if requested by the medical center. The VAMC shall determine when a Root Cause Analysis (RCA) is required of the contractor. The contractor shall conduct all Root Cause Analysis according to VAMC policy and within established guidelines. Completed RCAs shall be provided to the VAMC COR. PERFORMANCE IMPROVEMENT: The contractor shall fully participate in the VAMC Performance Improvement (PI) program. This will entail monitoring of clinic processes, data analysis, and collaborative design and operationalization of improvement opportunities. Contractor PI activities may be directed by the VAMC, VISN or VHA, as well as accreditation or licensing bodies. The contractor shall abstract, compile, and report PI data as requested by the VAMC. VA Data collection methodology, report format, and reporting deadlines will be defined by the VAMC. In all cases, the contractor shall continually assess for, and act upon, clinical and administrative improvement opportunities. VA monitoring for continuous compliance with The Joint Commission standards shall be directed by VAMC staff, and communicated to the contractor through the COR. VA aggregate and/or practitioner-specific data collected by the VAMC will be provided to the contractor in accordance with established reporting schedules. VA measures related to contract compliance will be identified by the COR. The contractor shall effectively manage daily operations, information and support systems, and conserve physical and financial assets while meeting the mission of the VAMC. The provision of contracted services will be described in writing the nature and scope of services provided through contractual agreement. Leaders monitor contracted services by establishing expectations for the performance of the contracted services. Leaders take steps to improve contracted services that do not meet expectations. INFORMATION MANAGEMENT: The VAMC Information Management plan shall be followed by the contractor. Documentation and record keeping shall be in accordance with VAMC policies and procedures. VAAR-852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (Interim Oct 2008) must be included in the document. CONFLICT OF INTEREST: Conflict of Interest acknowledgement document(s) must be signed by all procurement officials and copies filed in the OPF in accordance with VHA Handbook 1660.3. Contracting Officials, CORs, selection officials, and others involved in the contracting processes are free from any actual or perceived conflicts of interest. The Contracting Officer will monitor compliance and will review the selection board for conflicts. REPORTING REQUIREMENTS: Upon arrival, the contractor (agent) is required to sign as required by each facility. When the service is completed, the contractor (agent) shall document services rendered on a legible Field Service Report and present to the COR and Microbiology supervisor for signature, during normal working hours. After normal business hours, the contractor will e-mail the Field Service Report to the COR or designee. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT: The contractor s service personnel staff shall include a fully qualified Field Service Representative assigned to each Veterans Affairs facilities and a fully qualified Field Service Representative (FSR) who shall serve as the Backup to ensure 7 days per week 8:00 am to 5:00 pm including holiday coverage. Fully qualified is defined as training and experience in the field. The Field Service Representative (FSR) has successfully completed a documented formalized training program for the equipment covered under the contract. For field experience, the Field Service Representative (FSR) must have minimum of one (1) year of experience providing preventative maintenance and emergency repair services on the same make and model of equipment covered under this contract. The contractor shall provide written assurance of the competency of their personnel by detailing a list of Field Service Representative along with applicable training and years of service experience on the specific devices covered in this agreement and a written assurance of competency. All related documentation, such as completed competency checklists or educational training records, shall be maintained by the contractor and available for VAMC upon request. The contractor shall maintain a culture that promotes self-development and learning which is designed to maintain or enhance learning competencies. TEST EQUIPMENT: Upon request of the COR, Microbiology supervisor, or the CO, the contractor shall provide copy of the current Calibration Certification of all test equipment which is used by the contractor to perform service under this contract. Calibration of equipment shall be traceable and in conformance with test equipment Original Equipment Manufacturer standard. CONFORMANCE STANDARDS: Contract shall maintain full compliance with applicable Federal and State regulations. All services provided under this contract shall be performed in conformance with the Food and Drug Administration (FDA), Nation Fire Protection Agency (NFPA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA) and other applicable national, state and local regulatory agencies. Contractor shall maintain a CLIA certificate of accreditation, and The Joint Commission (JC), and/or the College of American Pathology (CAP) accreditation. The contractor shall notify the Contracting Officer of the existence or development of any defects in, or repair to the equipment covered under this contract, which the contractor considers he/she is not responsible for under the terms of the contract (such as operator misuse). The instrumentation shall perform all analysis for the required tests with safety and precision as defined by the Clinical Laboratory Improvement Act of 1988(CLIA 88), the Clinical and Laboratory Standards Institute (CSLI), the College of American Pathologists (CAP), and the Food and Drug Administration (FDA). All analyzers shall be FDA approved. All exceptions to the preventative maintenance inspection schedule shall be arranged and approved in advance with the CO. The contractor shall notify the CO of the existence of development of any defects in, or repair to the equipment covered under this contract which the contractor considers he/she is not responsible for under the terms of the contract (i.e. operator misuse). On-site warranty, for the Veterans Affairs Facilities to include preventative maintenance for the entire agreement period to include unlimited, on-demand, on-site service visits 7 days per week, 8:00 am to 5:00 pm and 24/7 hotline technical support for the selected equipment at each Veterans Affairs Facility. MEDICAL LIABILITY INSURANCE LIMITS: In accordance with VAAR 852.237-7, Indemnification and Medical Liability Insurance, the contractor shall maintain liability insurance or self-insurance of not less than $1,000,000.00 per specialty per occurrence. PAYMENT: The COR will make certification of invoices for Pathology and Laboratory Medicine Service (PALMS). All invoices will be processed in accordance with the Prompt Payment Act. Any discrepancy between the terms of the contract and the amount of the invoice will be promptly referred to the VA Contracting Officer for resolution. Invoices for contract services shall be submitted online through the e-invoice/Tungsten website. Separate purchase order for will be built for each facility. BUSINESS ASSOCIATE AGREEMENT SHALL BE INCLUDED Estimated Volumes: Fluctuation in volumes may occur that will not affect pricing. Total Number of ID Tests for 5 Year Period Facility Year 1 Year 2 Year 3 Year 4 Year 5 Total Tests Yearly Increase Estimation Ann Arbor 838 880 924 970 1,018 4,630 5% Battle Creek 931 950 969 989 1009 4848 2% Detroit 400 408 416 424 432 2080 2% NIHCS 460 469 478 487 496 2390 2% Saginaw 207 211 215 219 223 1075 2%   Total Number AST Tests for 5 Year Period Facility Year 1 Year 2 Year 3 Year 4 Year 5 Total Tests Yearly Increase Estimation Ann Arbor 4,344 4,561 4,789 5,029 5,280 24,003 5% Battle Creek 1358 1386 1414 1443 1472 7073 2% Detroit 3600 3672 3745 3820 3897 18,735 2% NIHCS 380 388 396 404 412 1980 2% Saginaw 2158 2201 2245 2290 2336 11230 2%   Total Number of Yeast ID Cards for 5 Year Period Facility Year 1 Year 2 Year 3 Year 4 Year 5 Total Tests Yearly Increase Estimation Ann Arbor 88 93 97 102 107 487 5% Battle Creek 0 0 0 0 0 0 N/A Detroit 60 61 62 63 64 310 2% NIHCS 120 122 125 127 130 624 2% Saginaw 0 0 0 0 0 0 2%   Total Number of Yeast Susceptibility Cards for 5 Year Period Facility Year 1 Year 2 Year 3 Year 4 Year 5 Total Tests Yearly Increase Estimation Ann Arbor 176 185 194 204 214 973 5% Battle Creek 0 0 0 0 0 0 N/A Detroit 123 125 128 131 133 640 2% NIHCS 0 0 0 0 0 0 N/A Saginaw 0 0 0 0 0 0   Total Number of Neisseria/Haemophilus Cards for 5 Year Period Facility Year 1 Year 2 Year 3 Year 4 Year 5 Total Tests Yearly Increase Estimation Ann Arbor 110 116 122 128 134 610 5% Battle Creek 0 0 0 0 0 0 N/A Detroit 60 61 62 63 64 310 2% NIHCS 80 82 83 85 86 416 2% Saginaw 20 20 21 21 22 104 2% Total Number of ID by Mass Spec. for 5 Year Period Facility Year 1 Year 2 Year 3 Year 4 Year 5 Total Tests Yearly Increase Estimation Ann Arbor 12,875 13,519 14,195 14,904 15,650 71,143 5% Battle Creek 0 0 0 0 0 0 N/A Detroit 7600 7907 8065 8226 8391 40,189 2% NIHCS 0 0 0 0 0 0 N/A Saginaw 5957 6076 6198 6322 6448 31001 2%   Estimated Volumes: Fluctuation in volumes may occur that will not affect pricing. Total Number of Blood Cultures Bottles for 5 Year Period Volume of Bottles per Year Facility Base Year Year 1 Year 2 Year 3 Year 4 Total Bottles Yearly Increase Estimation Ann Arbor 12,600 12,852 13,109 13,371 13,639 65,571 2% Battle Creek 0 0 0 0 0 0 N/A Detroit 5600 5712 5826 5943 6062 29,143 2% NIHCS 3000 3100 3200 3300 3400 16,000 1-2% Saginaw 134 137 140 143 146 700 2%   Total Number of AFB/Sterile AFB Fluid Bottles for 5 Year Period Volume of Bottles per Year Facility Base Year Year 1 Year 2 Year 3 Year 4 Total Bottles Yearly Increase Estimation Ann Arbor 0 0 0 0 0 0 N/A Battle Creek 0 0 0 0 0 0 N/A Detroit NIHCS 0 0 0 0 0 0 N/A Saginaw 0 0 0 0 0 0 N/A   Evaluation Factors: Highly reliable instrumentation with less than 0.2% downtime over life of the contract. Overall simplified process for setup. Streamline process for reagent implementation and Minimum maintenance for reagent levels. IQCP policy. Availability of phenotype matching. Able to reconfigure to add third party vendor equipment. Training and Validation process. Equipment Implementation plan. Number of recalls for reagents per year. Past performance review. Location of Service Personnel Communication/single interface between all three analyzers provided (blood culture, Identification by both biochemical and MALDI-TOF methodologies), and sensitivity). Ability to identify bacteria and yeast by both biochemical method and Mass Spectroscopy methods. Ability to perform susceptibility testing for both bacteria and yeast. Minimum biohazard waste and/or plastic waste.