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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 08, 2018 FBO #5980
DOCUMENT

66 -- Bacterial ID & Susceptibility Test - Attachment

Notice Date

4/6/2018
 

Notice Type

Attachment
 

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

36C24218Q9140
 

Response Due

4/20/2018
 

Archive Date

5/20/2018
 

Point of Contact

Wilmen Joa
 

Small Business Set-Aside

N/A
 

Description

DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offered and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Responses to this notice must be submitted in writing via email and must be received no later than Friday, April 20, 2018, 11:00 am EST. No telephone inquiries will be accepted. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran-owned small business, HUB Zone, 8(a), small business or large business). Responses to this notice will be used by the Government to make appropriate acquisition decisions. Responses to this notice should include company/individual name, a service capability statement, examples of similar facilities for which you have provided services to, proof of applicable certification. DUNS number, address, a point of contact and social-economic category (ex: SBVOSB, VOSB, 8(a), HUBZone, WOSB, EDWOSB, Small Business). If your firm is a Service-Disabled Veteran-Owned or Veteran Owned Small Business, you must be CERTIFIED in VetBiz (see internet site: http://vip.vetbiz.gov). The contractor must be registered in System for Award Management (SAM), formerly CCR (see internet site: http://www.sam.gov). Responses to this notice must be submitted in writing, and received not later than Friday, April 20, 2018, 11:00 am EST. All interested parties must respond to any related solicitation announcement separately from the responses to this announcement. Email: Wilmen.Joa@va.gov. No telephone inquiries will be accepted. STATEMENT OF WORK (SOW) The purpose of this BPA is for the Contractor to provide VISN 2 south 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 south facilities in accordance with the terms and conditions stated herein. The instruments 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 BPA will include Identification only systems such as Time of flight Mass spectrophotometer (MALDI_TOF) and manual identification systems. The assessment shall cover the 7 Medical Centers of VISN 2 herein. The Contractor shall propose the suggested/recommended equipment/reagents for all sites that meet the requirements of the facility. Contractor shall provide all equipment, reagents, standards, controls, supplies, consumable/disposable items, parts, accessories 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 Reportable Result (CPRR) services for VISN 2. The Contractor will provide analyzers and supplies to each facility in accordance with the estimate given in the Statement of Work. 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 Cost Per Reportable Result (CPRR): The per reportable result price shall include costs covering (a) equipment use, (b) all reagents, standards, 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 of a patient reportable result. This does not include those items approved for exclusion by the government such as printer paper, labels etc. This per patient reportable result 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) (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. GENERAL REQUIREMENTS: Each model of clinical laboratory analyzer offered shall comply with all general requirements stated herein. Each Contractor shall submit as part of their offer, technical data or descriptive literature to ascertain that the equipment offered meets the requirements outlined below. The Contractor shall provide one (1) copy of FSS with their offer. The Contractor shall provide FDA approved automated identification and antibiotic susceptibility systems/analyzers. Remanufactured or discontinued models are unacceptable for this BPA. The Contractor shall state the failure mean time (between failure and mean time to repair) for each piece of equipment offered. Emergency replacement of equipment shall be provided by the Contractor. The vendor(s) shall provide all supplies and services as described herein to the participating VAMC facilities in accordance with the applicable Federal Supply Schedule contract. The Proposed Equipment table below shall be utilized to summarize the equipment and service plans which the contractor proposes. The Schedule of Pricing shall be utilized by interested offerors to submit their cost proposal. This BPA will be fixed-price for the duration of the contract in accordance with the terms and conditions of the vendor s Federal Supply Schedule Contract and FAR Part 13.303. The models being offered are 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 manufactured as new equipment. Offered testing equipment shall be new state-of-the-art equipment. Remanufactured and discontinued models will not be accepted Utilities specification MICROBIOLOGIC SYSTEM SPECIAL REQUIREMENTS: The Contractor shall assess equipment, work flow, volumes and space to meet the individual VISN 2 site requirements with minimum cost. REQUIREMENTS: The system shall provide self-contained, automated identification and antibiotic susceptibility testing system for aerobic, facultative, fastidious, and anaerobic microorganisms and yeasts. 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 vendor applies necessary software updates. Clinical laboratory assays currently performed at the VISN 2 Pathology and Laboratory Medicine Services shall include, but may not be 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 system shall have battery backup capable of maintaining data for at least 24 hours in the event of a facility power failure. The vendor shall provide hardware/software upgrades necessary to maintain the integrity of the system at no additional charge to the government. These must be provided as they become available and as they are being offered to commercial customers. Changes in CLSI guidelines shall be implemented into the software upgrades in a timely manner. The vendor shall provide to each facility a copy of operating procedures in Clinical and Laboratory Standards Institute (CLSI) digital format at the time of installation using software compatible with VA (Microsoft Office WORD). 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 vendor shall provide hardware and operating system software upgrades necessary to maintain the integrity of the system at no additional charge to the Government during the lifetime of the instrument. These enhancements shall be delivered and installed at each participating VISN 2 medical 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. The system shall also offer independent, manual processing and printing of a chartable result in the event of LIS downtime. The vendor(s) shall provide all supplies and services as described herein to the participating VAMC facilities in accordance with the applicable Federal Supply Schedule contract. The Proposed Equipment table below shall be utilized to summarize the equipment and service plans which the contractor proposes. The Schedule of Pricing shall be utilized by interested offerors to submit their cost proposal. This BPA will be fixed-price for the duration of the contract in accordance with the terms and conditions of the vendor s Federal Supply Schedule Contract and FAR Part 13.303. *** The below table is an estimated amount based on previously purchased. *** Type of card BRONX VAMC HUDSON VALLEY VAMC NEW JERSERY VAMC NEW YORK HARBOR (NY/BK) NORTHPORT VAMC Total Gram Negative Identification Card. 21341 127 35 130 110/74 48 459 Gram Positive Identification Card. 21342 55 35 90 80/82 14 356 Gram Negative Susceptibility Cards. 127 55 180 200/170 78 346 Gram Positive Susceptibility Card 55 35 120 110/76 52 136 Neisseria Identification Card 15 3 0 0 1 20 Yeast Identification/Susceptibility Card 9/0 3/0 20/0 10,16/val 3/6 9/5 Anaerobe Identification Card 7 3 0 0 0 8 11) Contractor offered equipment shall perform satisfactorily at any laboratory temperature between 50 and 90 degrees Fahrenheit (10 C and 32 C) and relative humidity between 15 and 85 percent. 12) Contractors offered ID/AST microbiology analyzers shall conform to VISN 2 existing laboratory space. 13) The purpose of this BPA is for the VA to obtain the greatest overall benefit in response to the requirements. A listing of estimated yearly quantities by participating facilities to be provided under this agreement is located in the Proposed Equipment table and the Schedule of Pricing. Quantities as listed are estimated based upon the prior history of actual volumes and are not a guaranteed minimum. PERIOD OF PERFOMANCE     Base: 10/1/2018 - 9/30/2019 Option Year One: 10/1/2019 - 9/30/2020 Option Year Two: 10/1/2020 - 9/30/2021 Option Year Three: 10/1/2021 - 9/30/2022 Option Year Four:10/1/2022 - 9/30/2023 Interfacing: Instrumentation proposed shall be capable of bi-directional, bar-coded, computer interface with VistA (at a minimum shall be capable of downloading patient demographics from the host computer, integrating this information with test results and uploading to the host computer). Provide a bi-directional interface for Data Innovations middleware or whichever middleware the facilities are using. 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 ensuring that successful interfacing has been established with these systems. Specific requirements for the communication of the data streams shall be unique to the instrument system involved and dictated by the manufacturer itself. Ability to recall and re-transmit test results to host computer. 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 Identification and Susceptibility analyzer(s) as defined in these specifications, e.g., McFarland standards, cabinetry to support/house the analyzer (if necessary) and universal interface equipment, Uninterruptible Power Supply (UPS) capable of supporting the full scope of equipment operation with a built-in line conditioner, for each proposed analyzer. The Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, printers, toner/cartridges etc. Maintenance and Repair: The Contractor shall be able to provide emergency equipment repair and preventative maintenance and any incremental support equipment, e.g. water system, offered according to the following terms: With the exception of the specific maintenance and repair requirements stated herein, which shall have precedence; preventive maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement laboratory equipment shall be performed and provided in accordance with the terms, conditions, and provisions of contractor's existing Federal Supply Service Contract for performance of CPRR services as stated in Subsection III of the VA National Acquisition Center contract requirements Solicitation (RFP 797-FSS-03-0001). 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 the 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. Emergency repairs shall be performed after initial telephone notification that the equipment is inoperative. The contractor shall provide the Government with a designated point of contact and telephone number and shall make arrangements to enable his maintenance representative to receive such notification. Ability to provide equipment service on a 24-hour/day 7 days/week basis for hospital-based systems. Scheduled preventative maintenance calls shall occur at a frequency to meet the manufacturer s requirements to keep the equipment in optimal operating condition. Every notification for a repair service call shall be treated as a separate and new service call. The contractor shall be on-site at the affected VA facility to perform emergency repair service to testing and ancillary instruments within twenty-four (24) hours after receipt of initial telephone notification of a malfunction. Contractor shall provide medical center maintenance coverage 24 hours per day, seven days per week including all Federal holidays. Contractor shall be required to provide maintenance and emergency/repair service for each participating site 7 days a week. from 8:00 a.m. until 5:00 p.m., including Federal holidays. Contractor shall provide technical support service to assist in troubleshooting 24 hours per day, seven days per week including Federal holidays. The following facilities require extended hours (on-site 7 days per week, including contractor s holidays; at least 8:00 am 5:00 pm, local Eastern Time) service in accordance with the contractor s FSS contract. Training: With the exception of the specific training requirements stated herein, which shall have precedence; contractor shall provide training in accordance with the terms, conditions, and provisions of contractor's existing Federal Supply Service Contract for performance of CPRR services as stated in Subsection IV of the VA National Acquisition Center contract requirements Solicitation (RFP 797-FSS-03-0001). The Contractor shall provide training as per the National FSS Statement of Work. This shall include training on the operation of the system, data manipulation, preventative maintenance and basic trouble shooting and repair for 2 key operators (see site specific training requirement). 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. Provide on-site vendor operator training for all personnel who will run instrument with training provided for all applicable staff. 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. Site preparation: Specifications shall be furnished in writing by the Contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer s claimed specifications. The Contractor shall be responsible for assessing the space available in each facility in order to ensure the right size equipment is provided; thereby not creating a safety hazard. Offerors or quoters are urged and expected to inspect the site where equipment will be placed and services will be performed in order to satisfy themselves regarding all general and local conditions that may affect the type of equipment offered, to the extent that the information is reasonably obtainable. In no event shall failure to inspect the site constitute grounds for a claim after contract award. Offerors may travel to each site and evaluate each lab s workload, staffing and physical space to select the best-fit instrument requirements prior to the solicitation due date. This site visit shall not be conducted for the purpose of performing equipment presentations or to perform demonstrations of equipment, but shall be for the sole purpose of determining the best fit requirement for contractors offered system. Equipment offered shall fit existing space with no alterations or requirements for site prep work. 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 and Transition: The Contractor shall provide with its quotation a transitioning plan for the complete transition of all services under the awarded BPA including installation and training of personnel, the transition of all testing materials, reagents and supplies, etc., the performance of all comparisons and validations. This transition shall be completed no later than 60 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. Comparison and Validation of Analyzer: The Contractor shall perform at each site, to the satisfaction of the Government, at no cost to the Government all comparison and validation/verification studies to include any material and reagents needed for such correlation. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations. SITE-SPECIFIC REQUIREMENTS: Equipment must meet the volume and turnaround time requirements, if specified, of the using facilities. See the Facilities Specific Requirements and Proposed Equipment table below. VISN 2 SOUTH Walk-away capability required. Minimum of 40 panels capacity. 2 key operators to all-expense paid off site training for each facility. Provide in-house training for other technologists at each facility. Conventional, rapid, and synergy panels. Repair or replacement of printers, UPS, and any other equipment required is at the expense of the contractor. Vendor shall supply all interface software support, and cables needed for bidirectional interface. TECHNICAL REQUIREMENTS: In addition to the general requirements for the Microbiology Cost-Per-Reportable Result (CPRR) 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 and yeast species that is consistent with CLSI guidelines. Vendor shall provide software upgrades at no charge to the government when CLSI guidelines change or are updated, or changes in bacterial nomenclature. Provides a broad test menu available with reliable methodologies and has capability to expand menu options for ID & AST for gram-positive, gram-negative organism, ID of anaerobes, fastidious, and yeast organism. Broad range of FDA approved ID panels for the accurate detection of gram-positive, gram-negative, anaerobes, Haemophilus, Nessieeria, fastidious, HACEK, and yeast organisms, such as; conventional, rapid, combo, and synergy panels. The system shall offer a comprehensive array of bacterial antimicrobial susceptibility panels which each individual facility may select to meet individual needs. Vendor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions for their methodology at time of proposal. Streptococcus MIC panel. Rapid anaerobic, and yeast ID panel. Broad range of FDA approved AST panels with lower concentration of current antibiotics for the detection of resistance patterns which includes D-test, cefoxitin screen, ESBL, KPC, NDM-1, metallo, etc. Resistance detection and confirmation mechanism for the following but not limited to ESBL confirmation, carbapenemase resistance enterobactericeae and/or Acinetobacter (CRE/CRAB), NDM-1, AmpC, Vancomycin resistance Enterococci (VRE), Methicillin resistance S. aureus (MRSA), Vancomycin intermediate resistant S. aureus (VISA/VRSA), etc. with, microbroth dilution MIC, panels. Panels should not require a great deal or comprehensive or extra testing menu to achieve an accurate ID/AST result. Provides and performs bar-code operations for specimens, panels, and controls. Contractor shall provide, as part of its offer, a list of VA sites currently using interfaces for the instrument offered. Cost of auto-verification programming and validation covered in contract should the VA software change allow for this option during the duration of this contract. System shall be an open system which can accommodate user-defined methods such as, entering susceptibility for drugs, selection of organisms, etc. Offeror may provide variants of instrument accommodating various workload requirements and backup needs. Geographical location of like instruments is sufficient to assist in reagent/supply crisis situations. As part of your offer provide the number of instruments operating in the United States and provide information on said equipment, to include record of hardware and software reliability, reagent recall history in past two years, percentage of downtime and average number of service calls per month for each piece of equipment/systems offered. Additionally, offeror shall provide details of the location of maintenance personnel in relation to VISN 2 SOUTH and the amount of territory covered by that personnel and experience of maintenance personnel servicing VISN 2 SOUTH. Vendor shall supply all interface cables needed for bidirectional operation. These cables will be sufficient in length to reach from the analyzer to the DI server. Organism identification and sensitivity panels can be used on all of the automated, semi-automated and manual systems in the manufacturer s line of instruments. Organism identification and sensitivity panels can be read manually if automated or semi-automated analyzer is non-functional or to confirm interpretations from automated or semi-automated analyzers. The QC material shall be included in the contract for all tests in use. Operation and maintenance procedures shall be provided on electronic media, instrument or website. Contractor shall state which medium the procedures are provided. B. Software: Instrument software shall be versatile and easy to use with following capabilities: Look up capabilities for results on samples being processed. Ability to store Quality control of reagents/panels. Ability to alarm/flag repeat testing of unusual isolates, susceptibilities, and drug-bug combination. Contributes to enhanced workflow efficiency and improved patient outcomes Ability to detect and alert/flag operator of instrument problem. Ability to detect and alert/flag operator of empty reagent containers/vials Ability to alarm/flag reflex testing to confirm unusual results per CLSI & FDA guidelines. On-board sample inventory Software allows review of QC and patient results for to help in troubleshooting. Software is upgradeable (provide list of versions). Desirable features of software include programmable rules for reporting, auto-verification, and reflex testing. Recognizes isolates that are declared public health risks and isolates that should be reported to the public health department. Above software features can be accomplished by instrument software or middleware. If middleware is needed, include necessary hardware and software in contract and CPRR calculation. The system shall also offer independent, manual processing and printing of a chartable result in the event of LIS downtime. Equipment shall be versatile and provide efficient hardware capabilities. Uninterruptible power supply (surge protection + battery backup) provided and serviced by vendor for sites requiring such. Hardware upgrades are available as needed and include any necessary training. Laboratory has space for instrument and peripherals. Vendor will supply plan for placement of new analyzer(s) prior to initial method validation and after when transitioning to new instruments. Plans must be site-specific and accurately reflect available space at each site. c. Equipment and software shall at a minimum, provide operator-friendly maintenance requirements. Routine maintenance takes minimal tech time. Routine maintenance, function checks cause little or no delay to testing. Reliable technology used for detection of drug resistance. Instrument troubleshooting is easy and straightforward Instrument is connected via modem to hotline that can view instrument status and remotely control troubleshooting process. Contractor has high percentage of technical services calls answered directly by technician (no message left for call-back). d. Reagent and Standards: Convenient Reagent look-up and Standard Use of instrument Extended reagent shelf life. Reagent storage room temperature vs. refrigerated Reagents have prolonged shelf life and stability once opened/on-board. Various reagent sizes for large/small volume facilities On-board reagent inventory. Instrument alerts operator to regents/consumables needed to complete testing. As new methods are released for instrument, the updates are automatically enabled promptly and at no cost to user. MANDATORY REQUIREMENTS: Software allows user defined configurations such as, suppressions of antibiotic results, antibiotic reporting order, and interpretation and warning flags, etc Accommodates clinical preferences and requests by the laboratory All correlations and CAP required studies will be performed by the Contractor s staff on site. All data calculations will be performed by the Vendor within 30 workdays of completion of the installation.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BroVANAP/VAMD/36C24218Q9140/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24218Q9140 36C24218Q9140.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4208576&FileName=36C24218Q9140-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4208576&FileName=36C24218Q9140-000.docx

 

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

Record

SN04881572-W 20180408/180406231036-af52628f4b33dfc7a8b9eb62c744a2bf (fbodaily.com)
 

Source

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

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