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FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 27, 2018 FBO #5909
DOCUMENT

66 -- PCR Pathogen Detection for VISN 12 Labs - Attachment

Notice Date

1/25/2018
 

Notice Type

Attachment
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Great Lakes Acquisition Center (GLAC);115 S 84th Street, Suite 101;Milwaukee WI 53214-1476
 

ZIP Code

53214-1476
 

Solicitation Number

9350
 

Archive Date

3/26/2018
 

Point of Contact

Jessica Rasmussen
 

Small Business Set-Aside

N/A
 

Description

SOURCES SOUGHT SYNOPSIS The Department of Veterans Affairs is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in, and the resources to support, a requirement to provide laboratory instruments used for identification of organisms in patient specimens. The results of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 334516 Analytical Laboratory Instrument Manufacturing. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals/quotes; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, Web site address, telephone number, and size and type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. Contractors are responsible for providing comprehensive responses to adequately convey the ability to meet the included requirements of the Government. The government will evaluate market information to ascertain potential market capacity to provide services consistent in scope and scale with those described in this notice and otherwise anticipated. BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH FINDINGS, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES, PROCURED THROUGH FULL AND OPEN COMPETITION, OR SOLE SOURCED. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by 12:00 PM CST on 5 February 2018. All responses under this Sources Sought Notice must be emailed to jessica.rasmussen3@va.gov. Below are a list of capabilities and requirements: GENERAL REQUIREMENTS: Primary analyzer(s) Base equipment must 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. In those instances, the additional analyzer(s) must, likewise, be considered primary instrumentation and must meet all technical specifications. The instrument must have the capability of identifying organisms directly from specimens within 1 1.5 hours (60 to 90 minutes) from test setup, including positive blood cultures, nasopharyngeal swab / respiratory specimens and cerebrospinal fluid (CSF) specimens. The instrument must include an FDA-approved broad library of bacteria, yeast and viruses. The system must include the ability to detect antimicrobial resistance genes. The instrument must be FDA 21 CFR Part 11 Compliant. Preparatory equipment / a preparatory apparatus must be provided for specimen preparation. The platform must have minimal hands-on time (5 minutes or less) without batching. The instrument must perform amplification, detection and analysis in one self-contained instrument. The desired instrumentation must have the capability of performing or reporting the clinical parameters, perform all the required tests described 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). Equipment must maintain, or preferably reduce, the number of work stations and/or overall labor required to accomplish the required testing by each laboratory. Equipment must be acquired for each of the clinical laboratories located at the VISN facilities listed in Table 1 below. 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 must 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. 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 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 must 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 must be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. TEST MENU: Refer to Table I for desired test menu and estimated annual volumes. Operational Features- The instrumentation offered must have the following: The capability of performing analysis on 100% of the tests listed in Table I. Separate test cartridges or panels may be required for each test. Sufficient capacity and throughput to meet the volume and service demands as defined in Table I. 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) must 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, 15 characters in specimen identifier that is alpha and/or numeric depending on site. Minimal daily, monthly, and periodic maintenance. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. Technical Features The instrumentation and test panels must be approved by the Food and Drug Administration (FDA) and must have the following, at a minimum: The capability of accurately and reliably identifying organisms directly from specimens including positive blood cultures, respiratory and cerebrospinal fluid (CSF). Direct organism identification from positive blood culture bottles minimally including gram positive bacteria, gram negative bacteria and yeast most commonly isolated from positive blood cultures, along with resistance markers. Respiratory pathogen panel should minimally include 15 bacterial and viral targets. Meningitis panel (cerebrospinal fluid) should minimally include 10 bacterial, viral and yeast targets. The capability of detecting emerging antimicrobial resistance. Comprehensive and extensive data base of bacteria and yeast species that is consistent with FDA / CLSI guidelines. Software or equipment modifications as needed, and when commercially available, to comply with changes in standards for identification or susceptibility testing established by CLSI, Center for Disease Control (CDC) and other governing or authoritative bodies. Allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until such time as the Contractor applies necessary software upgrades. The platform must have the ability to increase throughput by connecting two or more instruments together. The included middleware must include, as standard, the ability for continuous remote notification of critical events and delayed processing steps. The included middleware must be able to manage multiple instruments through a unified interface. Data Management The system requires a valid operator ID in order to run a patient test or access patient data in the instrument(s). For patient safety, the system will have an alpha/numeric keypad or barcode scanner to reliably enter or scan an operator ID and patient ID prior to running the test. Identification of the operator or patient not recognized in data transfer must be alerted in the data management system and not reported to the patient chart. System technology must provide internal quality control (in addition to external controls) to support clinical diagnostics and monitoring. The system has an option whereby the operator can choose to release results. For example, the operator can repeat testing permitting the first result to be bypassed in order to send the second/confirming result. The system has a data management system such that results are capable of being transmitted to the Laboratory Information System (LIS). The data management system allows for the input of information such as test device and QC (Quality Control) lot numbers. The instrument and/or data management system must alert operator(s) of out of range QC and expiring reagents. Software must be able to capture errors to prevent compromised data from reaching a patient s medical record. Alerts can be configured to hold such results in the data management system. Erroneous or questionable results must be able to be held and reviewed prior to entry in the patient medical record and alerted in the interface for review. Capability to record, store and print the following information: Required quality control and instrument maintenance information Patient demographic information and specimen results Hardware Features the instrumentation must have the following, at a minimum: A total equipment footprint that, when installed in the laboratory, must 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). Replacement printers are supplied as needed for the duration of this agreement. An uninterruptible power supply with line conditioner for each instrument provided. Replacement UPS are supplied as needed for the duration of this agreement. Support Features Commercial marketing the equipment must be in current production as of the date of any resultant solicitation quote is submitted. For the purposes of this requirement current production means the clinical laboratory analyzer model is being quoted as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Start-up reagents the contractor must provide all reagents, calibrators, controls, consumable / disposable items, parts, accessories and any other item required to establish the instruments for performance of acceptable testing. The Contractor must assist the Government with validation and method comparison studies. All materials and reagents needed for such correlations must be provided at no cost to the Government. The Contractor must perform all statistical analysis and report data in an organized, clearly comprehensible format. This process must be consistent with current CLSI and related documents, CAP Standards and Federal Regulations. Training the Contractor must provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of each facility s services and equivalent to a training program that the Contractor provides in the commercial market. This must include, but is not limited to, training on the operation of the system, data manipulation and basic trouble shooting and repair. Thereafter, the Contractor must 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 must be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel must include the cost of airfare, room and board for each participant. Equipment Preventative Maintenance / Repair Service the Contractor must provide emergency equipment repair and preventative maintenance on all instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms: A technical assistance center must be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 2 hours. Equipment repair service must be provided during individual facility core business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements must be coordinated between the Contractor and VA laboratory personnel. Equipment repair response time must be no more than 24 hours from the time of the initial call. 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 must be furnished to the Laboratory upon completion of each repair call. The report must 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 must be treated as a separate and new service call. Upgrades - The Contractor must 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 must 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 must 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.), and universal interface equipment, etc. In addition, the Contractor must 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 must 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. The Contractor must provide all necessary software support for insuring 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. 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, 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. Commercial offerings - The Contractor must 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 CSLI format or an on-line procedure manual in the instrument software. Characterization of waste The Contractor must be able to 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 must 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 must 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 must 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 must be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 must 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 must 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 the waste from each device can legally be disposed of via the sewerage system. Implementation/transition timeframe Implementation would be required within approximately 90 days of award. TABLE I Site Estimated Annual Panel Volumes Blood Culture Respiratory Meningitis Milwaukee VAMC 255 132 168 Madison VAMC 109 274 84 Hines VAMC 499 184 206 Lovell FHCC 124 0 0 OPTIONAL: Danville VA 64 34 34
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAGLHS/VAGLHCS/9350/listing.html)
 

Document(s)

Attachment
 

File Name: 9350 9350.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4041427&FileName=9350-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4041427&FileName=9350-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04799827-W 20180127/180125231328-1cf4a989f3511fad404f10b017d61985 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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