SOURCES SOUGHT
66 -- CPT, Microbiology Testing B+4, Saginaw
- Notice Date
- 10/16/2023 8:00:01 AM
- Notice Type
- Sources Sought
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- 250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
- ZIP Code
- 45428
- Solicitation Number
- 36C25024Q0050
- Response Due
- 10/25/2023 1:30:00 PM
- Archive Date
- 11/09/2023
- Point of Contact
- Brooke Hansen, Contract Specialist, Phone: No phoned inquiries will be accepted.
- E-Mail Address
-
brooke.hansen@va.gov
(brooke.hansen@va.gov)
- Awardee
- null
- Description
- 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 proceduremanual 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 appro...
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