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

66 -- Cost per Test and Cost per Reportable Result Blood cultures FDA approved blood/sterile body fluid culture system Base Year (1 Oct 2016-30 Sept 2017) plus 4 Option Years - 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

VA25816N0926
 

Response Due

9/16/2016
 

Archive Date

11/15/2016
 

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 an FDA approved blood/sterile body fluid culture system on a cost per test or cost per reportable result basis that will include all equipment, installation, technical manuals, bottles, consumable supplies (adapters/needles for subculturing), interface through Dawning to the Vista system, off site training (for operating, maintaining, trouble shooting) for two laboratory staff, 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 blood/sterile body fluid culture system provided. 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 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 (and laboratories from V18 who choose to participate) with an FDA approved blood/sterile body fluid culture system on a cost per test or cost per reportable result basis that will include all equipment, installation, technical manuals, bottles, consumable supplies (adapters/needles for subculturing), interface through Dawning to the Vista system, off site training (for operating, maintaining, trouble shooting) for two laboratory staff, 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 blood/sterile body fluid culture system provided. 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. Estimated patient volume of 8400 EACH anaerobic and aerobic tests per year will be analyzed, along with 200 pediatric specimens. New analyzers must run validation testing prior to 10/1/2016. Patient testing cannot be performed until validation testing is performed. Analyzers must be delivered 1 month to 2 month prior to 10/1/2016 depending on the length of time it takes for new analyzers to run validation. The analyzer will be placed in 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 one base year from the date of award, and four (4) option years. MANDATORY REQUIREMENT: System must provide: routine blood cultures, fungal blood cultures, and other body fluid cultures. EQUIPMENT FUNCTIONALITY: A selection of blood culture bottle configurations (for low volume samples; antimicrobial agent removal resins), formulations capable of maximizing growth potential of various microorganisms (i.e. aerobic and anaerobic bacteria, and fungi), and incubation periods for any selected culture shall be available. Vendor will offer a standing order for media, with the capacity to fill emergency requests on-demand. Vendor will pay routine shipping fees for all supplies, consumables, and equipment to perform testing. System shall provide self-contained continuous computerized automated monitoring of blood culture bottles for microorganism growth. Instrument has the ability to flag or alert positive cultures by visual alert, sound alert, and remote alert systems. System should also detect and document "time to positivity". There will also be notification of termination of maximum programmed incubation period when no microorganism growth is detected. The system shall have a bar coding system for loading of new bottles and management of all bottles on board. The onboard barcode reader will be integrated into the handheld device. Scanning capabilities must allow the operator to scan the patient's nine digit social security number for patient identification or a 10 digit unique accession number. The system shall make assignment of blood culture bottle locations within the incubator unit. The system shall have a built in quality control system capable of printing/displaying all internal QC/calibrations (i.e. when QC is out-of-limits) to regularly monitor performance of vital components. No user calibration shall be needed. The risk of sharps exposure and the reduction of medical waste are two important and necessary requirements for the automated culturing system, in order to satisfy OSHA requirements and to maintain cost containment with local biohazardous disposal contracts. Most importantly, the employees who handle blood culture bottles must be adequately protected from sharps exposure due to glass breakage: ?Must have FDA clearance for testing using transparent plastic collection bottles. ?Must have equal recovery and time to detection when compared to glass bottles. ?Non-invasive technology which does not require the venting of bottles. ?Bottles shall be color coded to easily distinguish their utility. ?Bottles shall contain tear off (duplicate) labels to attach to culture worksheets and contain the corresponding unique bar coded bottle numbers. 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: Benzene Carbon tetrachloride Chloroform Dischloromethane Methyl ethyl ketone Toluene Methyl isobutyl ketone Xylenes Tetrachloro-ethylene Cadmium 1,1,1-Trichloro-ethane Chromium Trichloro-ethylene Cyanide Lead Mercury 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 offsite training (transportation, room and board, etc.). Once installed, the Vendor shall provide on-site, in-house training for all shifts in the laboratory. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. On-site refresher training for laboratory staff will be available in option years of contract. Vendor will send timely software upgrades and a Field Technical Representative or a Biomedical Engineer to install the updated software, at no charge. 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 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 two 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 CD ROM or computer disk. Software Requirement oSoftware must be compatible with all barcode styles and have proven bi-directional interface capability with Vista and Dawning. The vendor must provide additional hardware 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. oThe instrument-LIS interface must be bi-directional. oThe interface must use automatic host query to download sample, IDs, test requests, and patient demographics. oAutomatic host query must seamlessly integrate with on-board patient sample barcode scanning and translation. oThe instrument interface must transmit test results to the host computer system via automatic upload. oInstrument must have computer capabilities that are compatible with customer LIS software, offer LCD display monitor with built-in speakers and printer. oVendor provides technical support to link Dawning with the instrument by insuring the interface and instruments are communicating properly. oInstrument/software must be a continuous monitoring system with the capability of tracking bottle growth by plot graph data. oSoftware package capable to track or flag internal calibration, error messages, and internal temperature. oSystem will provide reagent inventory upon request, in real time. Service Requirements: oVendor will provide a preventative maintenance schedule to include a minimum of two scheduled preventative maintenance visits per year. oVendor 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. oService (travel, parts, labor) is no charge with reagent rental. The vendor shall provide 24-hour, 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. oVendor 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, media, labor, and reference laboratory services. oTechnical 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 Representative. oThe 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. oThe 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. o"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. oIn 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 August 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 August 16th, 2016 at 9:00 am 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/VA25816N0926/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-16-N-0926 VA258-16-N-0926.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3001560&FileName=VA258-16-N-0926-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3001560&FileName=VA258-16-N-0926-000.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;1501 San Pedro Dr SE;Albuquerque, NM

Zip Code: 87108
 

Record

SN04269023-W 20160915/160913235218-d207855113fb52e74ed5803e4c25dd97 (fbodaily.com)
 

Source

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

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