66--VA249-18-AP-5952 Vitek 2 Cost Per Reportable Result

Request for Information-Sources Sought Notice 36C24919Q0010 This is a Request for Information (RFI) to conduct market research to determine the availability of vendors capable of providing the requirement for a microbiological system for the identification and sensitivity of microorganisms. The instrument 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). This requirement is for the James H. Quillen Mountain Home VA Medical Center. This RFI does not guarantee the issuance of an RFQ. If you have the availability to provide the requirement please respond to this RFI with a capabilities statement. This RFI is issued solely for information and planning purposes. It does not commit the Government to contract for any supply or service whatsoever. The VA is not, at this time, seeking proposals and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested vendor s expense. Not responding to this RFI does not preclude participation in any future RFQ, if any is issued. Any information submitted by respondents to this RFI is strictly voluntary. All submissions become Government property and will not be returned. Requirement The James H. Quillen VA Medical Center requires a Cost Per Reportable Result (CPRR) Vitek 2 system and applicable reagents. This requirement is for a period of one year: January 1, 2019 - December 31, 2019, with four additional option years. Equipment: Part Number Description Quantity 4700216 SYS-VITEK 2 0060 1 Estimated quantities of disposables: Item Number Description Estimated Yearly Quantity 21341 GN Test Kit VTK2 170 boxes 21342 GP Test Kit VTK2 80 boxes 21343 YST Test Kit VTK2 12 boxes 21347 ANC ID 12 boxes AST-GN-GP Vitek 2 GN and GP AST Cards 200 boxes GENERAL REQUIREMENTS: (1) The system shall provide self-contained, automated identification and antibiotic susceptibility testing system for aerobic, facultative, fastidious, and anaerobic microorganisms and yeasts. (2) The system shall have a data management system with varied options for analysis and reporting/review of cumulative patient data on organisms isolated and antimicrobial profiles, and allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until such time as the vendor applies necessary software updates. (3) The system shall have battery backup capable of maintaining data for at least 24 hours in the event of a facility power failure. (4) The vendor shall provide hardware/software upgrades necessary to maintaining the integrity of the system at no additional charge to the government. These must be provided as they become available and as they are being offered to commercial customers. Changes in CLSI guidelines shall be implemented into the software upgrades in a timely manner. (5) The vendor shall provide to each facility a copy of operating procedures in Clinical and Laboratory Standards Institute (CLSI) digital format at time of installation using software compatible with VA (Microsoft Office WORD). (6) Interfacing: Instrumentation 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). (7) The system shall also offer independent, manual processing and printing of a chartable result in the event of LIS downtime. (8) A printer for the analyzer shall be provided by the Contractor. (9) Ancillary Equipment and Supplies: The Contractor shall provide, install and maintain, as indicated, any and all ancillary support equipment, consumables/supplies, parts and accessories necessary to fully operate the bacterial and susceptibility analyzer as defined in these specifications, e.g., McFarland standards, cabinetry to support/house the analyzer (if necessary) and universal interface equipment, Uninterruptible Power Supply (UPS) capable of supporting the full scope of equipment operation with a built-in line conditioner, for each proposed analyzer. 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. (10) Maintenance and Repair: The Contractor shall be able to provide emergency equipment repair and preventative maintenance and any incremental support equipment, e.g. water system, offered according to the following terms: (a) A technical assistance or support center shall be available by telephone hot-line 24/7 days/week with a maximum call back response time of 1 hour with on-site service provided, not to exceed 24 hours following determination that site service is required. The technical assistance center shall be staffed with personnel who are fluent in English without the use of an interpreter. (b) Ability to provide equipment service on a 24-hour/day 7 days/week basis for hospital-based systems. (c) Scheduled preventative maintenance calls shall occur at a frequency to meet the minimum manufacturer s requirements to keep the equipment in optimal operating condition. (d) Every notification for a repair service call shall be treated as a separate and new service call. (e) During the term of the term of the contract, should 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 will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the contractor. The Government agrees to maintain the equipment according to manufacturer s specifications. Each instrument provided by the contractor shall maintain an uptime of 90% in each month of the term of the agreement. (11) Training: The Contractor shall provide training on the operation of the system, data manipulation, preventative maintenance and basic trouble shooting and repair for 2 key operators. Any training program that involves off-site travel shall include the cost of airfare, room and board for each participant. A training or competency checklist shall be provided by the Contractor. (12) Site Preparation: Site preparation 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 be responsible for assessing the space available in each facility in order to ensure the right size equipment is provided; thereby not creating a safety hazard. (13) Implementation and Transition: The Contractor shall provide with its quotation a transitioning plan for the complete transition of all services 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 date of award. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. (14) Comparison and Validation of Analyzer: The Contractor shall perform at each site, to the satisfaction of the Government, at no cost to the Government all comparison and validation studies to include any linearity material and reagents needed for such correlation. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI (formerly NCCLS) and related documents, CAP Standards and Federal Regulations. TECHNICAL REQUIREMENTS: (1) The system shall have a comprehensive and extensive data base of bacteria and yeast species that is consistent with CLSI guidelines. Vendor shall provide software upgrades at no charge to the government when CLSI guidelines change or are updated, or changes in bacterial nomenclature. (2) The system shall offer a comprehensive array of bacterial antimicrobial susceptibility panels which each individual facility may select to meet individual needs. Vendor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions for their methodology at time of proposal. (3) The system shall offer detection of organisms that carry a carbapenemase. (4) The system shall be capable of producing an anti-biogram of organisms by selected body sites. (5) The system shall have a built-in quality control program to regularly monitor system performance. Please note that requirements defined to date may change before a final solicitation is released. RFI requirements are as follows: Please acknowledge if your company is an authorized provider of the Vitek 2 system and support services. Submit responses and related information via email to contact@example.gov by 8:00am CST, October 15, 2018. Proprietary/Confidential material shall be clearly marked on every page that contains such. Include the name, phone number, and email address of the lead from your organization. VA reserves the right not to respond to any or all emails or materials submitted.