6550--VISN2 Micro Biology and Maldi-TOF long term.

Page 8 of 8 This is a Sources Sought Notice only. This is not a Request for Quote. The purpose of this notice is to conduct market research and obtain information from qualified Contractors who are able to meet the requirements listed. This is not a solicitation. A solicitation will be issued at a later date. This notice does not restrict the Government to a particular acquisition approach. All information submitted in response to this announcement is voluntary. The Government will not pay for information requested nor will it compensate any Contractor for any cost incurred in developing information provided to the Government. The U.S. Department of Veterans Affairs, Network Contracting Office 2, James J. Peters VAMC requires a standardized microbiological system for the identification (ID) and antimicrobial susceptibility testing (AST) of microorganisms which shall have the capability of performing or reporting the clinical parameters as defined for the VISN 2 Downstate facilities in accordance with the terms and conditions stated herein. The analyzers shall be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Please See the list of requirements. The NAICS Code is 325413, with a Small Business Set size standard of 1,250 Employees. Interested Contractors are reminded that in accordance with FAR 4.12, prospective Contractors shall complete electronic annual representations and certifications in conjunction with FAR 4.11 required registration in the System for Award Management (SAM) database prior to award of a contract. Your response needs to address how you will meet the Government's requirements. All Contractors that are interested, regardless of their business type, and qualified to meet these requirements are asked to submit the following information: 1) Company Name: 2) Company Address: 3) DUNS Number: 4) Company POC Name: 5) Company POC Phone Number: 6) Company POC Email Address: 7) Company Website: 8) Business type: (Large, Small, Woman-Owned, VOSB/SDVOSB, etc.): 9) You MUST be able to provide a SINGE ANALYZER PLATFORM and be able to confirm how and using what equipment. You must also be able to provide ALL required testing, and list which tests you cannot provide (if applicable). Please identify your company's small business size standard and applicable NAICS code. For more information refer to http://www.sba.gov/content/table-small-business-size-standards. Note: If claiming SDVOSB or VOSB, the firm must be registered, and CVE verified in VetBiz Registry http://www.vetbiz.gov/; also include VetBiz certification. Please send your responses by email (no phone calls) no later than 11 AM on July 17, 2020 to Wilmen Joa, Contract Specialist, at contact@example.gov, referencing the following 36C24220Q0871- VISN2 Micro Biology and Maldi-TOF long term. DO NOT SEND QUOTES AT THIS TIME STATEMENT OF WORK CLINICAL LABORATORY Microbiological System For Identification and Antibiotic Susceptibility of Microorganisms SCOPE: The purpose of this contract to provide VISN 2 Downstate facilities with standardized microbiological system for the identification (ID) and antimicrobial susceptibility testing (AST) of microorganisms which shall have the capability of performing or reporting the clinical parameters as defined for the VISN 2 Downstate facilities in accordance with the terms and conditions stated herein. The analyzers shall be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Our goal is for the Veterans Administration to obtain the greatest overall benefit in response to the requirements. A listing of estimated yearly quantities by participating facilities to be provided under this agreement is located in Attachment B. Quantities as listed are estimated based upon prior history of actual volumes and are not a guaranteed minimum. This contract will include an identification and susceptibility system and an identification system such as Matrix-Assisted Laser Desorption/Ionization - Time of Flight Mass Spectrophotometer (MALDI-TOF). The Contractor shall propose the suggested/recommended equipment/reagents for all sites that meet the requirements of each facility as each facility is unique in its needs. All offers must include an identification and susceptibility system for: Hudson Valley Healthcare System All offers must include a susceptibility system and, an identification system (used as needed) for the following sites: East Orange VAMC New York Harbor Healthcare System/Manhattan campus only Northport VAMC All offers must include MALDI-TOF system in their offering for the following sites: East Orange VAMC New York Harbor Healthcare System/Manhattan campus only Northport VAMC The Contractor shall provide all equipment, reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, cabinetry to support/house the analyzer (if necessary) and universal interface equipment, and any other item required for the proper operation of its' contractor owned organism identification (ID) and antimicrobial susceptibility (AST) analyzer for Microbiology and peripherals necessary for the generation of Microbiology Testing services for VISN 2 Downstate. The Contractor will provide analyzers and supplies to each facility in accordance with Attachment B. DEFINITIONS: Cost Per Kit: The cost per kit pricing shall detail the number of tests in each kit, and based on testing volume found in Attachment B, the proposed number of kits that will be required by each site. The cost per kit price shall also encompass all costs associated with dilution, repeat and confirmatory testing required producing a single patient reportable result and the kits required to perform quality control, and correlation study testing that is prescribed by Clinical and Laboratory Standards Institute (CLSI). PRICING SCHEDULE: VISN2 DOWNSTATE will provide an estimated volume of tests performed as reflected on the Attachment B for each site. Pricing shall be based on the average daily test volume per analyzer systems proposed. The Government estimates the volumes listed in the attached spreadsheet per facility but does not guarantee volumes as listed; they are ESTIMATES ONLY. All offers shall reflect pricing based on the requirement of each site, and not spread cost across all sites. Offers must include a schedule of kits and supplies offered and per item cost with any tiered pricing for volumes and/or percentage of use in the Schedule of Pricing. The Contractor will detail if the cost per kit will include the use of the analyzer systems, all reagents, saline, standards, controls, supplies, consumable/disposable items (for example plastic tubes), parts, accessories and any other item required for the proper operation and maintenance of the contractor s equipment and necessary for the generation of a patient reportable result; a dedicated printer and toner; a minimum of two (2) preventive maintenance services per year per site; a repair service for each piece of equipment proposed delivery and installation of equipment at no additional cost. The Contractor shall provide pricing for each kit and supplies in accordance with the cost per kit definition contained above, or other option for pricing, that can be performed on the quoted analyzer. The cost per kit shall include all costs for: The use of the analyzer for the life of the contract. All validation materials required prior to live testing. All consumables, reagents, standards, controls and supplies. All quality control organisms and materials. Inter-laboratory Quality Control comparison program. All validation materials required for the use of new or change of panels to meet CLSI guidelines throughout the life of the contract. On-site training by contractor s experts for initial training of all staff. Contractor will provide training for any updates throughout the life of the contract. Delivery and installation of equipment at no additional cost. Pricing will be fixed-price for the duration of the contract in accordance with the terms and conditions of the contractor s Federal Supply Schedule Contract and FAR Part 13.303. An alternative shall be cost per kit and supplies and cost for lease of equipment. The Contractor will detail the Lease Buy-Back policy available at the end of the contract term. TERMS OF AGREEMENT: The contract shall be in effect from date of award to September 30th of the award year, four (4) additional Option Years and one six-month extension. GENERAL REQUIREMENTS: The contractor shall provide all supplies and services as described herein to the participating VAMC facilities. The contractor shall provide a complete document detailing the electric and data requirements of the proposed analyzers/system. If the analyzer/system requires deionized water (DI), we require the inclusion of a DI water system including maintenance of the DI system throughout the life of the contract. We require the inclusion of an Uninterruptable Power System (UPS) for each analyzer proposed and the inclusion of maintenance and replacement, if needed, throughout the life of the contract. Clinical laboratory assays currently performed at the VISN 2 Downstate facilities shall include, but not limited to, the following assays: Automated Organism Identification Automated Antimicrobial Susceptibility Detection of antibiotic resistance Rules for Unusual ID & AST results Software to prepare site specific reports The contractor shall provide to each facility a copy of operating procedures in Clinical and Laboratory Standards Institute (CLSI) (Microsoft Office WORD) format. We require the system to be capable of bar-code scanning for specimens, panels, and quality controls materials. Quality Control materials shall be included in the contract for all tests in use. We require the inclusion of the cart/table/stand if necessary, to house each analyzer systems if it is not a floor model TECHNICAL REQUIREMENTS IDENTIFICATION and SUSCEPTIBILITY The Contractor shall provide FDA approved automated identification and antibiotic susceptibility systems/analyzers with the capability of reporting susceptibility tests in accordance with FDA/CLSI guidelines. Remanufactured or discontinued models are unacceptable for this contract. The system shall be FDA approved to identify Candida auris: Candida auris is a multidrug-resistant yeast that causes invasive infections and persists in the environment. Correct identification of Candid auris is crucial to treating patients and preventing infections. We require instrumentation that will identify Candida auris to the genus and species level, so we are not required to send yeast to a reference laboratory for further identification. Offered models of organism identification and antimicrobial susceptibility analyzers for clinical microbiology laboratory shall be capable of producing accurate and reproducible assays on biological and other specimens by established in vitro diagnostic methods. Models shall provide accurate test assay result for sample specimens up to the manufacturer's defined maximum testing capabilities without excessive malfunctions, breakdowns, or service calls. The system shall offer a comprehensive array of bacterial antimicrobial susceptibility panels which each individual facility may select to meet individual needs. Contractor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions for their methodology at time of proposal. The system shall have a comprehensive and extensive data base of bacteria, anerobic bacteria and yeast that is consistent with CLSI guidelines and FDA approved. System shall be an open system which can accommodate user-defined methods such as, entering susceptibility for drugs, selection of organisms, etc. MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization - Time of Flight Mass Spectrophotometer) MALDI-TOF is required as an additional faster bacterial identification system. The device must analyze material from microbial cultures to provide organism identification within minutes. The analyzer must include an FDA-approved broad library of gram positive, gram negative, anaerobic bacterial organisms as well as yeast, fungi and mycobacteria to limit the amount of work needed on self-validation/verification studies. The analyzer must be FDA 21 CFR Part 11 Compliant. A preparatory apparatus and equipment must be provided for specimen preparation, and there must be an easy method for securely linking specimen information to each spot on the target slide. The analyzer must be fully integrated with the antimicrobial susceptibility testing platform in place with automatic linking of organism identification to sensitivity. The system shall be FDA approved to identify Candida auris: Candida auris is a multidrug-resistant yeast that causes invasive infections and persists in the environment. Correct identification of Candid auris is crucial to treating patients and preventing infections. We require instrumentation that will identify Candida auris to the genus and species level, so we are not required to send yeast to a reference laboratory for further identification. DATA MANAGEMENT The system shall have a data management system with varied options for analysis and reporting/review of cumulative patient data on organism s isolated and antimicrobial profiles and allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until such time as the contractor applies necessary software updates. The contractor shall provide hardware and operating system software upgrades necessary to maintaining the integrity of the system at no additional charge to the Government during the lifetime of the analyzer. These enhancements shall be delivered and installed at each participating VISN 2 facility within 60 days of issuance to the commercial market. Changes in CLSI guidelines shall be implemented into the software upgrades in a timely manner. A printer for each analyzer shall be provided by the Contractor and the provision of toner throughout the life of the contract. The analyzer/system shall also offer independent, manual processing and printing of a chartable result in the event of LIS downtime. Analyzers proposed shall be capable of bi-directional, bar-coded, computer interface with VistA (at a minimum shall be capable of downloading patient demographics from host computer, integrating this information with test results and uploading to the host computer). Provide bi-directional interface for Data Innovations middleware or whichever middleware the facilities are using. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA VistA hospital information system at the time of award and includes all medical center facilities. The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established with these systems. Specific requirements for the communication of the data streams shall be unique to the analyzer system involved and dictated by the manufacturer itself. Ability to recall and re-transmit test results to host computer. SOFTWARE Contractor shall provide software upgrades at no charge when CLSI guidelines change or are updated, or when there are changes in bacterial nomenclature. We require the system to be able to retrieve previously completed results and store these results for a minimum of two years. We require the system to store quality control results for reagents and panels tested. We require the system to alarm/flag repeat testing of unusual isolates, susceptibilities, and drug-bug combination. We require the system to flag an alert to the operator of isolates that are defined as public health risks and isolates that should be reported to the public health department. We require the system to detect and alert the operator of analyzer problems and insufficient reagent. We require the ability to define rules to alarm/flag reflex testing to confirm unusual results per CLSI & FDA guidelines. We require the system to notify the operatory of the on-board sample capacity and when capacity is reached. We require the ability to review Quality Control and patient results directly on the system. We require the system to continue to process quality control and patient testing during LIS downtime. If needed, we require the ability to print a patient result during downtime. Once LIS function is restored, we prefer the ability to upload all completed testing. If middleware is needed to accomplish any or all the above, we require the inclusion of the middleware and all related software, hardware, and licenses to be included in the CPT. If available, we prefer the inclusion of remote connection of the system to the contractor to assist in troubleshooting. MAINTENANCE AND REPAIR: We require the inclusion of a Service and Maintenance agreement for the full term of the contract to include all analyzer systems, software and hardware, seven days per week during business hours. Enhanced service options should be included in the proposal to enable each site to select the level of service to meet their needs. We require the inclusion of the performance of a minimum of one preventive maintenance service per year per analyzer system prosed for each site. The Contractor shall detail the level of service offered and the cost associate with each level of service, and if the service and maintenance costs are included in the cost per kit and supplies, or in the lease payment. The Contractor shall detail their policy for emergency service and repair and the expected arrival time for the field service engineer after the initial call is placed. A technical assistance or support center shall be available by telephone hotline 24/7 days/week with a maximum call back response time of 1 hour, and on-site service (if required) within 4 hours following the determination that site service is required. (this can be a service level option). We require a full detailed service report after each repair and each preventive maintenance. The contractor shall not leave a service call open pending verification that repairs completed by the contractor s maintenance personnel. For each analyzer provided the contractor shall treat each notification for an emergency/repair service call from the Government as a separate and new service call. INVENTORY CONTROL REAGENTS, SUPPLIES AND DISPOSABLES DELIVERY OF SUPPLIES. Shall be in accordance with National Statement of Work. Any unexpected changes in methodology/technology shall be at the expense of the Contractor. ALERT/NOTIFICATION OF DELAYS. In shipments as well as all technical advisory/recalls/alerts, prior to or simultaneously with field alerts shall be forwarded to the department supervisor, lab chiefs, and the VISN 2 DOWNSTATE clinical systems program office manager. SPECIAL HANDLING FOR EMERGENCY ORDERS OF SUPPLIES: In the event that the consumables are found to be defective and unsuitable for use with the contractor s equipment, or the contractor has failed to comply with the requirements for routing supply delivery, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority delivery from the government activity. If either circumstance has occurred, the contractor will deliver to the government site in the most expeditious manner possible without additional cost to the Government. QUALITY OF SUPPLIES: The contractor shall maintain on Government provided space a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other material or commonly stocked parts required to properly perform tests on the offered equipment. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision/reproducibility and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP), Clinical Laboratory Standards Institute (CLSI) and the Joint Commission on Accreditation (JC). IMPLEMENTATION PLAN The Contractor shall provide an implementation plan for the complete transition of all services under the awarded CPT including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all comparisons and validations. This transition shall be completed no later than 60 days after the award of the CPT. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. SITE PREPARATION: The Contractor shall assess each site for placement of the new analyzer systems. The contractor shall review daily workflow at each site to facilitate the proposal of the most cost-effective solution. Specifications shall be furnished in writing by the Contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer s claimed specifications. The Contractor shall assess the laboratory department where the testing will be performed in each facility to ensure the right size equipment is provided based on space and test volume. Contractors will use the contact list (ATTACHMENT A) to make an appointment to inspect the site where equipment will be placed and where services will be performed. COMPARISON AND VALIDATION OF ANALYZER The Contractor shall perform at each site current to new analyzer comparison studies and quality control verification studies at no cost. We require the contractor to provide a written copy of all completed studies. This process shall be completed within four (4) weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations. TRAINING We require the inclusion of initial training for two key operators from each site for each analyzer system proposed, and for one key operator from each site annually for the remainder of the contract term. The training on the operation of the system shall include data manipulation, preventative maintenance and basic trouble shooting and repair. Any training program that involves off-site travel shall include the cost of airfare, room and board for each participant. The contractor will provide on-site initial operator training for all applicable personnel who will run analyzer. A training and competency checklist shall be provided by the Contractor for all on-site training. PAST PERFORMANCE Past performance will be evaluated based on a defined questionnaire queried to current users provided by the contractor. Contractor shall provide, as part of its offer, a list of VA and non-VA sites currently using interfaces for the analyzer offered. ATTACHMENT A Northport VA Medical Center Hudson Valley VA Health Care System New York Harbor VA Health Care System/Manhattan Campus New Jersey VA Health Care System ATTACHMENT B PRODUCT DESCRIPTION Northport Hudson Valley NY Harbor Manhattan New Jersey TOTAL Gram Negative Identification Card +1 (555) 000-0000 3400 10246 Gram Positive Identification Card +1 (555) 000-0000 1800 6336 Gram Negative Susceptibility Cards 1560 1069 4620 4800 12049 Gram Positive Susceptibility Card 1360 1083 3520 2400 8363 Neisseria Identification Card 40 40 580 0 660 Yeast Identification 60 0 240 400 700 Susceptibility Card 160 0 320 0 480 Anaerobe Identification Card 60 0 180 0 240 Mold 40 0 40 Mycobacteria 20 0 20 Delivery The awarded contractor must provide an implementation plan for delivery, installation, set-up, training and connectivity with VA systems to each facility within 30 days of award. Equipment and testing should be fully functional at the facilities within 3 months of date of award. Period of Performance: October 01, 2020 to September 30, 2025. Security Requirements: The selected contractor will be required to complete a Business Associate Agreement (BAA).