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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 15, 2016 FBO #5410
DOCUMENT

65 -- Blood ID and Susceptibility Testing Cost per test and cost per reportable result FDA approved blood/sterile body fluid culture system - Attachment

Notice Date

9/13/2016
 

Notice Type

Attachment
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN/18PHX;777 E. Missouri, Suite 300;Phoenix AZ 85014
 

ZIP Code

85014
 

Solicitation Number

VA25816N0927
 

Response Due

9/19/2016
 

Archive Date

11/18/2016
 

Point of Contact

Johanne Gingras
 

E-Mail Address

5-4365<br
 

Small Business Set-Aside

N/A
 

Description

THIS IS A SOURCES SOUGHT NOTICE. This is not a request for quotes. A solicitation will be issued at a later date. The Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 18 - New Mexico VA Health Care System (NMVAHCS), 1501 San Pedro Drive SE, Albuquerque, NM, has a requirement for a cost per test or cost per reportable solution for an automated, Food and Drug Administration (FDA) approved testing system (including starter kits, tables, stands, etc.) for identification and susceptibility testing of isolates routinely encountered in a clinical microbiology laboratory. The intent of the projected RFQ is a firm-fixed price 5-year contract to include the following locations: The Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 18 - New Mexico VA Health Care System (NMVAHCS), 1501 San Pedro Drive SE, Albuquerque, NM. SCOPE: The Vendor is requested to provide New Mexico VA Health Care System Pathology & Laboratory Medicine Service with a cost per test or cost per reportable solution for an automated, Food and Drug Administration (FDA) approved testing system (including starter kits, tables, stands, etc.) for identification and susceptibility testing of isolates routinely encountered in a clinical microbiology laboratory. Vendor will provide all equipment, installation, technical manuals, reagents, consumable supplies, interface through Dawning to the Vista system, off site training for two laboratory staff (for operating, maintaining, trouble shooting), preventive and system maintenance (including parts, labor, and travel), and all shipping costs (delivery/removal of analyzer, delivery of standing orders) during the terms of this agreement to support the microbiology identification and susceptibility testing system. Included are the estimated annual volumes for all testing (see attachment 1). Any additional costs (such as Industrial Funding Fees, special shipping and handling fees, or other usage fees) must be clearly indicated in the price quote. The analyzer will be placed in the laboratory, room BD-134 (basement, Building 41) at the New Mexico VA Health Care System Pathology & Laboratory Medicine Service, located at 1501 San Pedro SE, Albuquerque, NM 87108. The contract period will be on year from the date of award, and four (4) option years. MANDATORY REQUIREMENT: System must provide: routine identification and susceptibility testing of isolates including but not limited to: Enterobacertiasceae, Pseudomonas, non- Enterobacertiaceae (Non fermenter), Staphylococcus, Streptococcus, Enterococcus, Yeast, and other miscellaneous organisms. System should have the ability to upgrade to accommodate the capacity needed for increased testing volume, require minimal storage space for reagents, maximum utilization of reagents, and produce minimal biohazardous waste. System Requirements: General Instrument Characteristics oMust provide for a continuous flow throughput of test kits. oMust have capacity for 60 test kits. oModular configuration that allows for and upgrade to a system capacity of 240 ID/AST test kits. oMust automate all of the sample preparation, incubation, optical measurement functions, and ejection of completed test kits. oMust have the option of reading a bar code label off the test card and/or the organism plate. oMust have a stand-alone inoculation device with a rewritable microchip which electronically links specimen accession number and test kit information and transfers this linked information to the computer of the automated microbiology system. oMust perform discrete tests for identification and susceptibilities. oMust be able to protect data by battery backup circuitry. oMust have a power conditioner supplied with the system. System Data Backup oMust include a USB backup drive. oUSB backup drive must be a VA FIPS 140-2 Validated Removable Storage Devices oData backups using an USB drive must have capability of being scheduled and performed automatically. Oldest backups must also auto-delete when the backup drive reaches capacity. Test Kit Physical Characteristics oTest kits must offer additional biohazard safety. Once they are inoculated and sealed using proper procedure, they cannot be spilled. oPrepared test kits must represent a closed system, thereby eliminating biohazard aerosol. oTest kits must contain a factory applied barcode label. oIdentification and Susceptibility test kits must be independent units. oTest system must utilize a 64 well test kit for identification and susceptibility. oThe optical system must read multiple areas of all 64 wells every 15 minutes. oMust incorporate antimicrobial result concentrations in excess of the CLSI guideline breakpoint ranges. oMust be capable of analyzing the antimicrobial results for the detection of resistance using Phenotype recognition for detection of known and unknown MIC distributions. (Not if/then statements which may miss new and unrecognized resistance patterns). oOver 340 tests must be able to be stored in one cubic foot of refrigeration space. oWeight of disposable unit (card) and ancillaries is less than 3 oz. Test Kit Result Characteristics oMust be able to provide identification results in as early as 4 hours and susceptibility test results in as early as 5 hours. oMust provide on-line validation of test kit results. System Software Characteristics oMust have a "windows- type" software platform. oAllows user to compose conditional antimicrobial rules listing specific conditions that, when met, will suppress the reporting of target antimicrobials on individual patient reports. oConditional antimicrobial reporting established by the user for ESBL isolates must be an independent function from the system's on-line validation software and detection of ESBL phenotypes. oMust include a security password protection for unauthorized users. oMust have two-way communication between the system and laboratory information system. oMust track Quality Control runs by lot number, test type, QC organism and expected vs. actual results. The system must also generate cumulative Quality Control reports. oMust contain a report module that has the ability to generate epidemiology and statistical reports as follows: 1.Organism Occurrence 2.Organism Occurrence Trending 3.Percent Susceptible 4.Cumulative Percent Susceptible by MIC 5.Susceptibility Trending 6.Biochemical Pattern Report 7.Workload Unit Report 8.Custom Logbook Reports oMust have the capability to export epidemiological/statistical data to commercially available PC-based software applications. oMust make over 40 standard and user-defined fields available for selecting and sorting parameters when generating patient, logbook, statistical and epidemiological reports. oMust allow the user to define duplicate microorganism isolates in terms of number of days (up to 30 days) to allow for exclusion of duplicate patient isolates from epidemiology reports. On-line Result Validation oMust provide FDA cleared software for on-line identification and susceptibility result validation and resistance mechanism detection. The system must validate results by applying a phenotypic concept utilizing a knowledge base of antibiotic groups, bacterial groups and MIC distribution patterns and comparing these to the test isolate's susceptibility pattern. oMust be able to identify extended spectrum beta lactamase (ESBL) organisms by comparing the test isolate with a comprehensive database of phenotypes for the organisms. oMust be capable of deducing antibiotics based on organism phenotype and CLSI recommended equivalent antibiotic rules. This contract should assist the NMVAHCS to pursue the goal of being a good steward in our community by eliminating, minimizing or mitigating adverse environmental impacts. The following chemicals have been targeted by the EPA specifically for reductions and feasible elimination. Please list any reagents (and in what concentration) that contain the following chemicals: BenzeneCarbon tetrachloride ChloroformDischloromethane Methyl ethyl ketoneToluene Methyl isobutyl ketoneXylenes Tetrachloro-ethyleneCadmium 1,1,1-Trichloro-ethaneChromium Trichloro-ethyleneCyanide LeadMercury Nickel Vendor to provide primary user training for a minimum of two users per instrument with on-site basic operating and maintenance education/training during installations or updates to the equipment. Training is to include all costs of off-site training (transportation, room and board, etc.). Vendor will send timely software upgrades and a Field Technical Representative or a Biomedical Engineer to install the updated software, at no charge. Vendor will offer a standing order for reagents, with the capacity to fill emergency requests on-demand. Vendor will pay routine shipping fees for all supplies, consumables, and equipment to perform testing. Vendor shall provide ancillary components that are necessary for the model of equipment proposed (i.e. starter kits, tables, stands, etc.). The system must include 120 volt UPS system that has 30 minute backup capability in the event of electrical power interruptions. The system should also have provisions for saving data in the event that the capacity of the UPS is exceeded. Installation/Validation Requirements: Technical support specialist to assist in equipment installation/set-up, providing all manpower, procedures, and reagents/supplies to perform validation and correlation studies (evaluation/comparison data sufficient to satisfy College of American Pathologists {CAP} standards), staff training, and addressing all methodology problems and questions. Vendor will provide a minimum of 50 blind validation samples. Must provide required statistical analysis in a binder for on-site Director approval. The process must be completed within four weeks of installation of the system at the site. Vendor must provide two hard copies of up-to-date procedure manuals, trouble shooting manuals, and operator manuals also available in CLSI format available on-line, on CD ROM or computer disk. Software Requirements: Software must be compatible with all barcode styles and have proven bi-directional interface capability with Vista and Dawning. The vendor must provide additional hardware (i.e. Dawning Javelin) and software needed to interface the system and technical assistance with interfacing the system. Required (additional) interface connection license(s) will be provided at vendor cost. The instrument-LIS interface must be bi-directional. The interface must use automatic host query to download sample, IDs, test requests, and patient demographics. Automatic host query must seamlessly integrate with on-board patient sample barcode scanning and translation. The instrument interface must transmit test results to the host computer system via automatic upload. Instrument must have computer capabilities that are compatible with customer LIS software, offer LCD display monitor with built-in speakers and printer. Vendor provides technical support to link Dawning with the instrument by insuring the interface and instruments are communicating properly. Service Requirements: Vendor will provide a preventative maintenance schedule to include a minimum of two scheduled preventative maintenance visits per year. Vendor will be responsible for the removal of the hard drive of the analyzer upon removal/upgrade. The hard drive shall be given to the laboratory ADPACs. Service agreement shall include replacement or repair of all ancillary equipment (i.e. printers, monitors, UPS). Service (travel, parts, labor) is no charge with reagent rental. The vendor shall provide 24-hour, 7 days/week telephone technical support and be able to dispatch on-site support whenever necessary with 24 hours. The vendor shall submit a legible field service report which shall include detailed descriptions of the preventive maintenance inspection or emergency repair services performed, including replaced parts and estimated prices required for the service call. Service agreement shall include replacement or repair of all ancillary equipment (i.e. printers, monitors, UPS). NOTE: Any additional charges claimed must have been approved by the Contracting Office Technical Representative before service was performed. Vendor is to provide alternative testing if the equipment requiring repair is down in excess of 24 hours at no additional cost to the Government. Costs to be reimbursed by vendor for those costs incurred during downtime to include by not limited to, reagents, labor, and reference laboratory services. Technical support for the entire agreement period to include unlimited, on-demand, on-site service visits Monday through Friday, 8:00 A.M. to 5:00 P.M., excluding federal holidays, or as otherwise arranged with the Contracting Officer Technical Representative. The ten holidays observed by the Federal Government are New Year's Day, Martin Luther King Day, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Thanksgiving Day, and Christmas Day. Also, any other day declared by the President of the United States to be a national holiday. The vendor's staff shall include a "fully qualified" Field Service Representative assigned to this area and a "fully qualified" Field Service Representative who shall serve as the Backup. "Fully qualified" is based upon training and on experience in the field. For training, the Field Service Representative must have successfully completed a formalized training program for the equipment covered under the contract. For field experience, the Field Service Engineers must have a minimum of one (1) year of experience providing preventative maintenance and emergency repair services on the same make and model of equipment covered under this contract. In the performance of this contract, the vendor shall take such safety precautions as the Contracting Officer may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer shall notify the vendor of any safety issues and the action necessary to correct these issues. Such notice, when served on the vendor or his representative at the work site shall be deemed sufficient for the corrective actions to be taken. If the vendor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the vendor in default. The applicable NAICS code is 325413 In-Vitro Diagnostic Substance Manufacturing. Commercial contractors have a size standard of 1,250 employees. The resulting contract will have fixed unit costs with estimated annual quantities for the period of 1 Oct 2016 through 30 Sept 2017 plus four Option periods (10/1/2017 thru 9/30/2021). It is anticipated that a Request for Quote will be issued in September 2016. Award of a firm-fixed price IDIQ contract is contemplated by October 1, 2016. This notice is published to conduct market research to determine if there is a sufficient number of certified Service Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Small Businesses (SB), or Large Businesses (LB) capable of performing the requirements to warrant full and open competition. It is strongly recommended that interested parties register in the US Department of Veterans Affairs Vet Biz database and the Small Business Administration (SBA) database. Registration may be accomplished at http://www.vip.vetbiz.gov/ and www.sba.gov/, respectively. Interested parties responding to this sources sought request shall submit the following information at a minimum: (1) company name and address, point of contact with phone number, and DUNS number; (2) documentation relating to capability of performance of reagent orders; (3) intentions of subcontracting program to include set-asides; (4) proof of registration in the VA Vet Biz or SBA websites or intention of registration prior to submission of offers to a solicitation; and (5) any other pertinent company documentation. The response date to this Sources Sought notice is September 16th, 2016 at 12:00NOON EST. This market research is for informational and planning purposes only to determine if full and open competition solicitation is appropriate. The Government will not pay any costs for responses submitted. Electronic submissions are acceptable via johanne.gingras@va.gov. Hard copy submissions will not be acceptable through the US Mail. NO ADDITIONAL INFORMATION IS AVAILABLE OTHER THAN WHAT IS NOTED HEREIN. ALL FIRMS ARE INSTRUCTED NOT TO CALL THE INDIVIDUAL VA MEDICAL CENTERS REQUESTING MORE INFORMATION.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25816N0927/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-16-N-0927 VA258-16-N-0927.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3002194&FileName=VA258-16-N-0927-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3002194&FileName=VA258-16-N-0927-000.docx

 

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

Place of Performance

Address: New Mexico VAHCS;Pathology and Labaoratory;1501 San Pedro Dr SE;Albuquerque, NM

Zip Code: 87108
 

Record

SN04268408-W 20160915/160913234630-85cc6e53bebcb9369cd142155dfb1e5a (fbodaily.com)
 

Source

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

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