SOURCES SOUGHT
65 -- Bacterial ID and Susceptibility Testing
- Notice Date
- 11/14/2018
- Notice Type
- Synopsis
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 2;James J. Peters VA Medical Center;130 West Kingsbridge Road;Bronx NY 10468-3904
- ZIP Code
- 10468-3904
- Solicitation Number
- 36C24219Q0103
- Response Due
- 11/29/2018
- Archive Date
- 1/28/2019
- Point of Contact
- Tina.Cavalieri@va.gov
- Small Business Set-Aside
- N/A
- Description
- 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, and the VA Medical Centers in New York and New Jersey are looking for a contractor that can 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 instruments shall be able to simultaneously perform the complete profile as described below: The selected Systems will service the below Centers: New York Harbor Healthcare System at Manhattan New Jersey Healthcare System at East Orange Northport VAMC Bronx VAMC(James J. Peters VAMC) Hudson Valley Healthcare System See the list of requirements The NAICS Code is 325413 In-Vitro Diagnostic Substance Manufacturing 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.): 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. 9) You MUST be able to provide BOTH Identification and Susceptibility testing and be able to confirm how and using what equipment. You must also be able to provide ALL testing required. 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. If all of the above requirements are not met in vendors response the vendor will be considered non-responsive to this sources sought. Please send your responses by email (no phone calls) no later than Noon on Thursday November 29, 2018 to Tina Cavalieri, Contract Specialist, at Tina.Cavalieri@va.gov, referencing the following in the subject 36C24219Q0103-Bacterial ID and Susceptibility testing. DO NOT SEND QUOTES AT THIS TIME DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTERS VISN 2 Downstate STATEMENT OF WORK (SOW) CLINICAL LABORATORY MICROBIOLOGICAL SYSTEM FOR IDENTIFICATION AND ANTIBIOTIC SUSCEPTIBILITY OF MICROORGANISMS SCOPE: The purpose of this SOW is to provide VISN 2 Downstate Laboratories with standardized microbiological system for the identification (ID) and antimicrobial susceptibility testing (AST) of microorganisms which shall have the capability of performing and reporting the clinical parameters as defined for the VISN 2 Downstate Laboratories 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). This SOW will include identification only systems such as Time of Flight Mass Spectrophotometer (MALDI-TOF). The assessment shall cover the 5 Medical Centers of VISN 2 Downstate herein. 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 Cost Per Test services for VISN 2 Downstate. The Contractor will provide analyzers and supplies to each facility in accordance with Attachment B. Participating VISN 2 Medical Centers are located as follows: Hudson Valley Healthcare System Bronx VAMC East Orange VAMC New York Harbor Healthcare System Northport VAMC DEFINITIONS: Cost Per Test (CPT): The per test cost shall include the use of the analyzer, 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. This also includes a dedicated printer and toner. This CPT price shall also encompass all costs associated with dilution, repeat and confirmatory testing required producing a single patient reportable result. It will also include the material to perform as well as all other costs associated with quality control, and correlation study testing that is prescribed by Clinical and Laboratory Standards Institute (CLSI). We require a minimum of two (2) preventive maintenance services per year per site. We require a service contract to be included in the cost (detailed below). Contractors are required to provide delivery and installation of equipment at no additional cost. PRICING SCHEDULE: VISN2 DOWNSTATE will provide an estimated volume of tests performed as reflected on the attached spreadsheet for each individual medical center. Pricing shall be based on the average daily test volume per analyzer/analyzer. The Government estimates the volumes listed in the attached spreadsheet per facility, but does not guarantee volumes as listed; they are ESTIMATES ONLY. Proposals must include a schedule of items offered and per item cost with any tiered pricing for volumes and/or percentage of use in the Schedule of Pricing. Contract Pricing: Offerors shall provide pricing for each test in accordance with the CPT definition contained above, that can be performed on their quoted analyzer. The CPT shall include all costs for: The use of the analyzer for the life of the awarded 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. The inclusion of a Service Contract (see detail below). A minimum of two (2) preventive maintenance services per year per site. Initial training for two (2) VISN 2 DOWNSTATE personnel operating equipment at contractor s facility and at least one (1) training slot per year for 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 awarded contract. Delivery and installation of equipment at no additional cost. TERMS OF AGREEMENT: The awarded contract shall be in effect from date of award with four (4) additional Option Years. GENERAL REQUIREMENTS: The Contractor shall provide FDA approved automated identification and antibiotic susceptibility systems/analyzers. Remanufactured or discontinued models are unacceptable for the awarded contract. Mass spectrometry 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 and fungi 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 capability of reporting susceptibility tests in accordance with FDA/CLSI guidelines 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. MICROBIOLOGIC SYSTEM SPECIAL REQUIREMENTS: The Contractor shall assess each site for placement of the new analyzer. The contractor shall review daily workflow at each site to facilitate the proposal of the most cost-effective solution. GENERAL REQUIREMENTS: 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. 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. 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 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. This CPT will be fixed-price for the duration of the contract. Contractors offered ID/AST microbiology analyzers shall conform to VISN 2 existing laboratory space. 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. B. INTERFACING: 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. 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 insuring 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. SERVICE AND SUPPORT As this service is critical to the support of providing excellent care to our nation s veterans, service and support to ensure continuous quality of care is needed. The contractor will detail the level of support available at the time of submission. The level of support will include but is not limited to customer service phone support ( hotline ), remote dial-in instrument monitoring, and in-person field service support. The contractor will detail the specific time-frame for on-site support for each instrument system and middleware proposed (i.e. Business Hours, 24/7, days of week, etc.). Help desk personnel, field technicians, and access to this support are a critical element of this acquisition. Service Expectations Service for a malfunctioning analyzer and middleware is an essential component of maintaining testing readiness at all times. We require call-back from Customer Service or Field Service Engineer within one hour of first call for service for a non-functioning analyzer or middleware. If on-site service is needed, we require the arrival of Field Service Engineer within 4 hours of first call. We require the availability for Customer Service hotline 24 hours per day 7 days per week. We require detailed Service Reports for each service call. Service Agreements We require a Service Agreement included in the CPT for all analyzers and middleware proposed. Vendor shall clearly state the cut-off time once the first service call is placed for same-day service arrival. A cut-off time of no earlier than 3:00 pm is preferred. Include service details for weekends and holidays. Uninterrupted Power Supply We require Uninterrupted Power Supply (UPS) systems for all analyzers and middleware hardware proposed. Maintenance, repair and/or replacement of each UPS is required thru the life of the contract. Peripheral Hardware We require the inclusion and maintenance of all peripheral hardware required to run the analyzers and middleware proposed thru the life of the contract. This includes, but is not limited to connectors, cables, Plantronics box, and other items deemed essential by the contractor. Remote Monitoring Remote monitoring into analyzers is preferred to diagnose system problems and facilitate troubleshooting and maintenance is preferred. Clearly state availability of remote monitoring. Information technology (IT) Support We require on-site IT support until communication is established and patient result upload is validated in our Computer Patient Record System (CPRS). We require the provision of all necessary drivers needed to send and receive orders. (PLEASE NOTE: The VA, in conjunction with the DOD, is in the process of developing a new laboratory information system package; implementation date to be determined. In the event this package is implemented during the life of the contract, contractor will provide IT support on site until communication is established and patient results uploaded into CPRS for each analyzer/system in use). D. INVENTORY CONTROL REAGENTS, SUPPLIES AND DISPOSABLES DELIVERY OF SUPPLIES. Shall be in accordance with 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). TRAINING We require initial training for two (2) VISN 2 DOWNSTATE personnel operating equipment at contractor's facility and at least one (1) training slot per year for the life of the contract. 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. 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 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. All questions regarding the requirements and terms and conditions of this solicitation shall be addressed to the Contracting Officer. Any information obtained by the offeror that did not come from the Contracting Officer shall not be considered a change in the solicitation requirement and offerors reliance on such information shall be at offerors own detriment. 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 90 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. 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. TECHNICAL REQUIREMENTS In addition to the general requirements for the Microbiology Cost-Per-Test (CPT) stated above, the contractor shall make every attempt to provide equipment, peripherals and supplies meeting the following requirements, characteristics and capabilities: Characteristics: The system shall have a comprehensive and extensive data base of bacteria, fungus and mycobacterium species that is consistent with CLSI guidelines. Contractor shall provide software upgrades at no charge when CLSI guidelines change or are updated, or when there are changes in bacterial nomenclature. 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. We require the system to be capable of bar-code scanning for specimens, panels, and quality controls materials. System shall be an open system which can accommodate user-defined methods such as, entering susceptibility for drugs, selection of organisms, etc. Quality Control materials shall be included in the contract for all tests in use. Software: 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. ATTACHMENT B PRODUCT DESCRIPTION Bronx Northport Hudson Valley NY Harbor Manhattan New Jersey TOTAL Gram Negative Identification Card 133 50 47 231 130 579 Gram Positive Identification Card 59 10 48 176 90 370 Gram Negative Susceptibility Cards 133 78 52 231 180 677 Gram Positive Susceptibility Card 54 52 39 176 120 437 Neisseria Identification Card 15 2 3 29 0 49 Yeast Identification/ Susceptibility Card 9/0 3/6 3/0 12/16 20/0 47/22 Anaerobe Identification Card 8 2 0 9 0 19 Department of Veteran Affairs Baseline Configurations Microsoft Windows Server The following versions are approved, with baseline compliance, for enterprise use: 2008 R2 (SP1) 2008 R2 (SP1) Core 2012 2012 Core 2012 R2 (Update) 2012 R2 (Update) Core Approved with listed constraints: 2008 x86 (non-core) is approved for SCCM 2007 infrastructure only. No new non-SCCM installations. 2003 is approved for existing installs only. No new installations without approved waiver. 2003 R2 is approved for existing installs only. No new installations without approved waiver. Microsoft Windows Desktop and Laptop Windows 7 Microsoft Windows Medical Device Protection Program (MDPP) Windows 7 Macintosh Mac OS Workstation and Laptop Mac OS 10.10.X - Yosemite Mac OS 10.11.X - El Capitan Linux Red Hat Enterprise Linux 6 Database Platforms SQL SQL Server 2012 SQL Server 2014 Oracle Oracle 11g Oracle 11.2g Oracle 12c Server Virtualization (Virtual Machines) With full virtualization the hypervisor is installed directly onto server hardware. Full virtualization has no underlying Operating System (OS). In Host-based virtualization the hypervisor is installed on the host OS. Moving forward, host-based virtualization is not authorized in VA. The Visibility to Servers (V2S) Application Suite is not to be installed on virtual server hosts; however, Visibility to Everything (V2E) requires a Simple Network Management Protocol (SNMP) configuration be in place on server hosts. VA does require guest Virtual Machines (VM s) have the V2S Application Suite installed: McAfee Virus Scan Enterprise McAfee Host Intrusion Prevention (HIPS) McAfee ePolicy Agent System Center Configuration Manager Client (SCCM) BigFix SNMP ENCASE NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (14-NOV-2018); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
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