66--BacT/Alert 3D Control Module (Reagent) - Base +4 Option Year Requirement

Request for Information-Sources Sought Notice 36C24918Q9710 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 blood culture system which shall have the capability of performing and reporting blood cultures. The instrument shall be able to simultaneously perform the complete blood culture 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). The instrument must be approved by the Food and Drug Administration (FDA). 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) BacT/ALERT 3D 480 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 4700109 SYS-BacT/ALERT 3D 0480 1 Estimated quantities of disposables: Item Number Description Estimated Yearly Quantity 259789 BacT/Alert SA 50 cases 259790 BacT/Alert SN 50 cases GENERAL REQUIREMENTS: (1) The system shall provide self-contained, continuous, computerized, automated monitoring of blood culture bottles with immediate, active (e.g. audible and visual alarm) notification of microorganism growth based upon preprogrammed criteria and notification of termination of maximum programmed incubation period when no microorganism growth is detected. (2) Blood culture bottle configurations (optimal and low volume samples) and formulations capable of maximizing growth potential of various microorganisms (e.g. aerobic and anaerobic bacteria and yeast) shall be available. (3) The system shall have sufficient capacity and throughput to meet the volume and service demands as defined in the Prices and Terms. The system should allow a minimum capacity of 480 bottles. (4) The system will be capable of processing inoculated bottles that have been incubated off line for up to 12 hours. (5) 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. (6) 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 blood culture analyzer(s) as defined in these specifications, e.g., cabinetry to support/house the analyzer (if necessary), 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. (7) Maintenance and Repair: The Contractor shall be able to provide emergency equipment repair and preventative maintenance and any incremental support equipment, 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) Every notification for a repair service call shall be treated as a separate and new service call. (d) During 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. (e) Scheduled preventative maintenance calls shall occur at a frequency to meet the minimum manufacturer s requirements to keep the equipment in optimal operating condition. The company will be responsible for tracking and scheduling all preventive maintenance. This must conform to instrument specifications and all regulatory requirements. Documentation of the maintenance will be provided to the laboratory at the time of completion. This maintenance must be provided within 2 weeks of the recommended schedule. (f) The system must require minimal daily and periodic maintenance. The reading chambers must be modular in nature allowing for the isolation of a given problem without having to shut the entire system down. (8) Training: The Contractor shall provide training at the time of installation to include 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. (9) 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 the facility in order to ensure the right size equipment is provided; thereby not creating a safety hazard. (10) Implementation and Transition: The Contractor shall provide with its quotation a transitioning plan for the complete transition of all services under the awarded agreement including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. This transition shall be completed no later than 120 days after the award of the agreement. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. (11) Comparison and Validation of Analyzer: The Contractor shall assist, to the satisfaction of the Government, at no cost to the Government, all comparison and validation studies to include any materials 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 and shall be consistent with current CLSI (formerly NCCLS) and related documents, CAP Standards and Federal Regulations. (12) The vendor shall provide 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). b. TECHNICAL REQUIREMENTS: (1). Bar-code System. The system shall support bar-code recognition of inoculated bottles for tracking of bottles at entry into the system and throughout incubation until such time as the incubation has finalized as positive or negative for growth. (2) Data Management System. (a) Shall be able to support varied programmed bottle incubation periods from any selected culture from 5 days to 21 days. (b) Shall be capable of maintaining a computerized log for detection time of positive growth of any bottle with an audible and visual alert system when positive growth is detected. (c) Shall be capable of maintaining all data for up to 30 minutes in the event of normal electrical power interruptions via battery backup. (d) Shall have a built-in quality control program to regularly monitor performance of vital components. (e) The capability to record, store and print the following information: [1] blood culture bottle location [2] length of incubation [3] time to detection [4] growth curve analysis of positive vials [5] required quality control and instrument maintenance information [6] patient demographic information and specimen results (3) Blood Culture Bottles. (a) Shall be easily distinguished (e.g. color coded) for utility or intended purpose. (b) Shall be approved for culture of normally sterile body fluids other than blood. (c) Shall be bar-coded with unique identifiers for loading and system monitoring. (d) Shall be formulated as not to require venting prior to incubation of aerobic bottles. (4) Safety: The system must have sufficient safety features to avoid unnecessary exposure to bio-hazardous and chemical materials. The exposure to and the volume of bio-hazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. 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 BacT/ALERT 480 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.