6550--VISN 1 -Lab- Automated Blood Culture Testing CPT (Sources Sought Notice)

This is a SOURCE SOUGHT NOTICE in support of the VISN 1 Healthcare System with locations throughout New England, for market research purposes only to determine the availability of potential businesses with capabilities to provide the services described below. Potential offerors are invited to provide feedback via e-mail to Julie Lemire at contact@example.gov. Responses will be used to determine the appropriate acquisition strategy for a potential future acquisition. All responses due by 06/05/2020, at 1500. Potential contractors shall provide, at a minimum, the following information: 1) Company name, address, and point of contact, phone number, e-mail address, and DUNS. 2) Is your firm eligible for participation in one of the following small business programs? If so, please indicate the program. Anticipated North American Industry Classification System (NAICS) code is 325413 - In-Vitro Diagnostic Substance Manufacturing. The largest a firm can be and still qualify as a small business for Federal Government programs is no larger than 1250 employees. [ ] yes [ ] no Small Business (SB) [ ] yes [ ] no HUBZone [ ] yes [ ] no Small Business 8(a) [ ] yes [ ] no Small Disadvantaged Business (SDB) [ ] yes [ ] no Women-Owned (WO) Small Business [ ] yes [ ] no Service Disabled Veteran Owned Small Business (SDVOSB) [ ] yes [ ] no Veteran Owned Small Business (VOSB) [ ] yes [ ] no Other (please specify) 3) What types of information is needed to submit accurate offers? 4) Provide a brief capability statement (Max 2 pages) with enough information to determine if your company can meet the requirement. The Capabilities Statement for this source sought is not expected to be a Request for Quotations, Request for Proposals or Invitation for Bids, nor does it restrict the Government to an ultimate acquisition approach, but rather the Government is requesting a short statement regarding the company s ability to provide the services outlined in the draft SOW below. Any commercial brochures or currently existing marketing material may also be submitted with the capabilities statement. Submission of capabilities statement will assist our office in tailoring the requirement to be consistent with industry standards. The capabilities will be evaluated solely for the purpose of determining to Set-Aside for the Small Business (SB) Community or to conduct as an Unrestricted Procurement. Other than small businesses may respond to this notice in the event the market does not indicate SB interest. This synopsis is for information and planning purposes only and is not to be construed as a commitment by the Government. The Government will not pay for information solicited. Respondents will not be notified of the results of the evaluation. Note: Do not include Proprietary, classified, confidential, or sensitive information in responses. Not responding to this Sources Sought does not preclude participation in any future or potential solicitation, or Request for Quotation. It is the intent of the VISN 1 Healthcare System to use the information gathered for market research purposes only. If a formal solicitation is released, it will be posted via the Federal Business Opportunity (http://www.fbo.gov). DESCRIPTION OF THE REQUIREMENT: Performance Work Statement (PWS) Clinical Laboratory Microbiological Blood Culture System INTENT: Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 1 ) to establish a Cost-Per-Test (CPT) Blanket Purchase Agreement (BPA) for Automated Microbiological Blood Culture Systems. The Government will award this CPT BPA to a single Contractor for Automated Microbiological Blood Culture Systems. The BPA shall be under the FSS Contract, Federal Supply Class (FSC) Group 66 III Cost Per Test (CPT), Clinical Laboratory Analyzers. Contractor agrees to the following terms of the BPA exclusively with the VISN facilities listed by Attachment/herein and awarded in the final BPA. However, as requirements change, facilities within VISN 1 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market and added to the base FSS contract. ORDERS: All products ordered under this BPA, placed against the Federal Supply Schedule Award Contract(s), are subject to the terms and conditions of the FSS contract. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals. PRICES AND TERMS: VISN 1 will provide an estimated volume by test as reflected in Attachment A for each individual medical center and outpatient clinic laboratory. Firm Fixed Pricing (FFP) shall be based on the AVERAGE daily test volume per instrument/analyzer for each facility. Pricing shall be based on the CPT (i.e., per blood culture bottle). The Government estimates the volumes per facility as listed in Attachment A but does not guarantee volumes as listed; they are estimates ONLY. TERM OF AGREEMENT: This will be a single award, firm-fixed price BPA with one base year and four, one-year options and shall be effective for the term of the FSS Contract including additional FSS extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the FSS contract upon which this BPA is based, is no longer in force. The resulting BPA shall be automatically extended for the remaining term of the BPA without modification upon any extensions of the Contractor s FSS contract. In addition, where a new FSS contract replaces Contractor s current FSS contract, the resulting BPA may be reassigned under the new FSS contract for the remaining term of the BPA with written agreement between Contractor and the CO. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VISN 1 intends to establish the base year of the agreement for the period of 8/1/2020 through 7/31/2021. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable FSS Contract Number and BPA Number. FSS & BPA identification numbers are assigned through the VHA Procurement Activity. ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK SCOPE OF PROCUREMENT: The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall be able to simultaneously perform the complete profile as described below 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). Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory. If Contractor offers a family of analyzers, VISN 1 technical evaluation panel will determine if instrumentation proposed meets needs of using facility. Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. Special handling for emergency orders of supplies: In the event that the supplies 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 routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. 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 (a) 5 year equipment use, (b) all reagents, standards, quality controls, 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, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (d) training for Government personnel. 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 in order 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. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes. GENERAL REQUIREMENTS: Primary analyzer(s)- Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Operational Features- The instrumentation offered shall have the following: The system shall provide self-contained, continuous, computerized, automated monitoring of blood culture bottles with immediate, active (e.g. audible alarm) notification of microorganism growth based upon preprogrammed criteria and notification of termination of maximum programmed incubation period when no microorganism growth is detected. The system shall allow for operator extension of programmed incubation times, while testing is in progress, without interruption of automatic continuous monitoring. The system shall accept manual entry of organism identification and other additional microbiological information (i.e. gram stain and organism identification). A varied selection of blood culture bottle configurations (low volume samples; antimicrobial agent removal resins) and formulations capable of maximizing growth potential of various microorganisms (e.g. aerobic and anaerobic bacteria, fungi, and mycobacteria) shall be available. Sufficient capacity and throughput to meet the volume, blood culture bottle variety, and service demands as defined in Attachment A. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. The accuracy of the barcode reading must have less than a 1% failure rate. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric An operational system that is automated and provides continuous unattended testing throughout the day for a minimum of five days. The system will be capable of processing inoculated bottles that have been incubated off -line for up to 12 hours. 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 Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: 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. Data Management System: The capability to record, store and print the following information: blood culture bottle location length of incubation time to detection growth curve analysis of positive vials required quality control and instrument maintenance information patient demographic information and specimen results the fill volume of the blood culture bottle detailed epidemiology reports Shall be capable of maintaining all data and if interfaced, retransmit data for up to 24 hours in the event of normal electrical power interruptions via battery backup. Shall have a built-in quality control program to regularly monitor performance of vital components. Shall possess capability to backup all data to a secondary external storage format (e.g. compact disk). Shall have sufficient memory to store patient information and test results for a 3-month period with downloading capability to an external medium for long term storage of patient records and other information. Blood Culture Bottles: Shall be easily distinguished (e.g. color coded) for utility or intended purpose. Shall be bar-coded with unique identifiers for loading and system monitoring. Shall be formulated as not to require venting prior to incubation of aerobic bottles. Shall have expiration date clearly marked. The minimum acceptable expiration date will be no less than 6 months. Hardware Features- The instrumentation shall have the following: A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. An on-board monitor/screen that is easily readable. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient s name and accession or unique identifier number (UID). An uninterruptible power supply with line conditioner for each instrument provided. Specific Equipment Requirements- Transparent Plastic Bottles are required for safety (glass bottle could break if dropped) and disposal cost savings (glass bottles weigh more). Shall have direct draw compatibility with vacutainer blood collection systems so as not to need any special adaptors for direct blood draw into the collection bottles. Shall be formulated as not to require venting prior to incubation of anaerobic bottles. Shall have ample availability/supply of FDA approved media bottles so as to ensure no shortages during life of contract Availability of AFB bottle media is desirable Blood media in bottles do not interfere or hamper gram staining when taken from bottles as needed. Minimum 6-month expiration date on bottles. Additional small unit required dedicated to VACT BSL3 Laboratory for mycobacterial blood cultures. Ability to measure bottle fill level Remote diagnostics capability desired A BAA will be required Method Validation Requirements- The Contractor shall assist each site in the performance of all comparison and validation studies to include any materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all statistical analysis, as applicable, and report data in an organized, clearly comprehensible format. This process shall be consistent with current CLSI Standards and related documents, CAP standards, and Federal Regulations. Reports- The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the BPA. Attachment C may be used as a template to provide these quarterly reports. Support Features- Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall assist the Government with validation and method comparison studies. All materials and reagents needed for such correlation at no cost to the Government. 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 and related documents, CAP Standards and Federal Regulations. Training. The Contractor shall provide an instrument training program that is coordinated with and 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 system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms: Service Requirements A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of one (1) hour. Equipment repair service shall be provided during core business hours. See Attachment A defining core business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Equipment repair response time shall be no more than two (2) hours. Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: date and time notified date and time of arrival serial number, type and model number of equipment time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. Each notification for an emergency repair service call shall be treated as a separate and new service call. Two Service Manuals will be provided to each site for their Clinical Engineering Department s information and use. The desirable Mean between time failure rate is in excess of 365 days. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the BPA , as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), thermometers and universal interface equipment, etc. 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. Interface Requirements The Contractor shall be 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 Attachment A). The Contractor shall provide any and 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 involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A. If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including 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 everything else needed to connect with VA computerized hospital information system. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. At site visit prior to submitting a quote the IT /LIS requirements will be assessed and provided to the site and the NCL Program Director. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software. Characterization of waste The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated. The determination and description shall address the following: Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) Solid Waste (Reference 40 CFR §261.2) Exclusions (Reference 40 CFR §261.4) The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response: Barium (Total) Cadmium (Total) Chromium (Total) Copper (Total) Cyanide (Total) Lead (Total) Mercury (Total) Nickel (Total) Silver (Total) Zinc (Total) Arsenic (Total) Selenium (Total) Tin (Total) pH Flash point (to higher than 200 F) BOD; biochemical oxygen demand The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system 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 BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of 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 BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial 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 BPA 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 BPA for cause under the Termination for Cause clause of the BPA. At the end of 90 days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA. 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 [or BPA] 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 BPA at an effectiveness level of 90% or more. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the sta...