Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF MAY 02, 2014 FBO #4542
DOCUMENT

65 -- VITEK MS CLINICAL - Attachment

Notice Date

4/30/2014
 

Notice Type

Attachment
 

NAICS

423450 — Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
 

Contracting Office

Department of Veterans Affairs;W.J.B. Dorn VA Medical Center;6439 Garners Ferry Road;Columbia SC 29209-1639
 

ZIP Code

29209-1639
 

Solicitation Number

VA24714R0609
 

Response Due

5/5/2014
 

Archive Date

7/4/2014
 

Point of Contact

Iridious T. Ruise
 

E-Mail Address

us.ruise3@va.gov<br
 

Small Business Set-Aside

N/A
 

Description

This announcement constitutes a Sources Sought notice for the Department of Veterans Affairs VISN 7 Network Contracting Activity. The following information is provided to assist the Department of Veteran Affairs VA Medical Center Columbia SC in conducting Market Research of Industry to identify potential business, Service Disabled Veterans Owned Small Business or Veterans Owned Small Business, Small Business, Women Owned Business, Large Business contractors to provide the requirement as stated in the Statement of Work and List of Equipment.. The applicable NAICS code is 423450 and size standard 100. The Government does not intend to make an award on the basis of this Sources Sought notice or otherwise pay for the information solicited herein. This notice is for the purpose of identifying potential sources and does not commit the government to make an award and/or issue a solicitation. Interested and qualified firms shall submit their capabilities to perform and provide the equipment, including company name, address, telephone number, contact point and DUNS number of your firm. Responses and questions may be sent to Iridious T. Ruise NLT 1pm EST, 02 May, 2014. Email: iridious.ruise@va.gov. The Source Sought closes 05 May 2014 at 11:00 A.M. EST. Statement of Work for MALDI-TOF instrumentation A.Scope Dorn VAMC Microbiology Laboratory provides medical care services and diagnostic laboratory testing. Identification of organisms isolated from patient cultures (blood cultures, wound cultures, fungal cultures, etc.) are an important part of the work done in this laboratory. The contractor shall provide an automated testing system that identifies microorganisms using Matrix Assisted Laser Desorption Ionization- Time of Flight Mass Spectrometry and has the capability of interfacing with the BioMerieux Vitek 2 system currently in the laboratory for antimicrobial susceptibility testing of these microorganisms. The testing system must be able to identify a variety of microorganisms 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). Instrument and testing methods need not be FDA approved, but should have submitted for approval from the FDA and be available for implementation. The testing system must include the instrumentation necessary to identify common microorganisms encountered in clinically relevant patient samples. All reagents and related consumables, supplies, controls and calibrators must be available for purchase. B.Test Menu Dorn VAMC~15000 cultures per year with approximately 50% requiring at least 1 organism identification1 Instrument C.Technical Features The contractor affirms that the MALDI-TOF testing system performance specifications for proposed instrument meets CLIA and CLSI regulations. Additionally, the contractor's product shall meet the standards specified below. a.Expiration dating period of the consumables shall not be less than six months at the time of delivery to the facility b.The system shall use disposable slides to avoid cross contamination. c.Extraction steps (if needed) must be able to be carried out on the slide used in the process. d.Traceability of each sample on the slide is easy and flexible. e.The MALDI-TOF instrument must be able to link to the Vitek 2 system to link the identification of the organism to the susceptibility card. f.The system shall not require cleaning materials or decontamination of target slides for reuse. g.The database must include clinically relevant microorganisms for the identification of samples from a clinical microbiology laboratory (common organisms isolated from human samples). D.Operation Features The contracted instrument shall possess the capability of performing analysis using Mass spectrometry technology which consists of ionizing chemical compounds to generate charged molecules and measuring their mass-to-charge ratio. These molecular "signatures" can be used for rapid bacterial identification from isolated colonies. Safety features sufficient 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 minimal amount of handling. 1.A computer interface that is capable of connecting to the BioMerieux Vitek 2 system that is currently in our lab at the Dorn VAMC. 2.Minimal daily maintenance such that the analyzer is not required to be down for more than 60 minutes per day. 3.Minimal sample pretreatment. 4.No cleaning of target slides for reuse. 5.Process/Testing errors requiring test to be repeated should be minimal. E.Hardware Features The MS instrument when installed in the Dorn VAMC laboratory shall impose no negative impact on the functionality/operations of the laboratory and shall not require significant and/or costly infrastructure changes to the VA. F.Support Functions The contractor shall have available all reagents, calibrators, controls, consumable/disposable items, parts and accessories required to establish operation and perform all validation studies and method comparison with current analyzer The contractor shall provide key operator training in the proper use of the instrument as part of the purchase price of the analyzer. Training shall be coordinated with and timely to the equipment installation, be consistent with the size and scope of the facility's services and be minimally equivalent to that offered in the commercial marketplace. Training shall include system operations, data manipulation, as well as basic trouble shooting and repair. If training is to be conducted off site, the cost shall be all-including, (e.g. air fare, auto rental, room and board, training materials, etc) for each VA participant. Annual training for at least one operator per year or according to established FSS contract if applicable. The contractor shall provide standard warranty response on instrumentation, as required. The contractor shall provide applicable manuals and schedules upon delivery and installation of equipment. The contractor shall perform annual preventive maintenance inspections during the contract period arranged with the COR in accordance with the published preventive maintenance manuals for the equipment listed on the schedule. The contract shall utilize the original equipment manufacturers established preventative maintenance procedures and checklists. A field service report shall be supplied to the COR at the completion of each preventative maintenance inspection. Preventative maintenance inspection shall include but is not limited to the following: 1.Cleaning of equipment 2.Completing original equipment manufacturer field service updates for operational and reliability engineering changes. 3.Performing remedial maintenance of non-emergent nature. 4.Testing and replacing faulty or worn parts 5.Inspecting/replacing electrical wiring and cables for wear and fraying. 6.Inspecting all mechanical components including but not limited to; cables and mounting hardware, chains, belts, bearings and tracks, motors for mechanical integrity. 7.Returning the equipment to operating condition defined in the original equipment manufacturer specifications. 8.Providing documentation of services provided/performed 9.If the repair record of any individual piece of the contractors equipment reflects a downtime of 5% or greater of the normal working days in one calendar month from the time of dispatch, the designated representative may make a determination to have the contractor replace the malfunctioning equipment with new equipment at no charge to the. The contractor is ultimately responsible for ensuring its equipment is furnished in good condition in accordance with manufacturer's instructions. The VA is ultimately responsible for ensuring the manufacturer's recommended daily, weekly, monthly and periodic maintenance is performed appropriately. 10.Each instrument provided by the contractor shall maintain an uptime of 95% during each month of the term of the agreement. 11.Each notification for an emergency repair service call will be treated as a separate and new service call. 12.One scheduled preventative maintenance call per year, if applicable to manufacturer's recommendations. G.Repair Service: The contractor will provide standard warranty response 8am-5pm, Monday through Friday. Preventative maintenance coverage will be negotiated. During standard response hours, the contractor will make commercially reasonable efforts to provide on-site engineering support within 48 hours of determination that an on-site visit is necessary. Parts will be new standard parts manufactured by the contract for that specific piece of equipment. H.Upgrades The contractor shall 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 customer. 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, including database upgrades, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc. I.Ancillary support Equipment The contractor shall provide accessories required to fully operate the analyzer. In addition, the contractor shall include all ancillary components customarily provided with the model of equipment furnished to the VA, e.g. starter kits. J.Computer Interfacing Requirements A fully operational interface (both hardware and software) must be available to connect to the current bioMerieux Vitek 2 at the time of contract award as agreed upon. K.Commercial Offerings The contractor shall provide any additional support materials routinely provided to equivalent commercial customers and will assist in regulatory compliance, e.g. computer diskette of its procedure manual or an on-line procedure manual in the instrument software. L.Pre Work Orientation The VA will schedule a pre-work orientation meeting/conference call that may include topics such as implementation schedule, fire and safety/disaster procedures, etc. The contractor shall be responsible to ensure that its employees coming to the work site will receive all necessary information. It shall further ensure its employees providing work under this BPA are fully trained and completely competent to perform the work required. M.Waste Characterization The contractor shall provide a statement and description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations that addresses the elements and criteria listed in the Code of Federal Regulations Title 40 "protection of the Environment" part 261 et al. N.. PATIENT SENSITIVE DATA. (a)The terms of the contract will address patient sensitive data subject to the Privacy Act as well as the Health Insurance Portability and Accountability Act (HIPPA) (1996), Public Law 104-191. The treatment and administrative patient records created by, or provided to, the Contractor under this agreement is covered by the VA system of records entitled "Patient Medical Records-VA" (24VA136). Medical records shall be secure, complete, legible, accurate, accessible, organized and maintained in a format that facilitates retrieval of information. Information from VA medical records requested by the patient or any other third party shall be referred to Health Information Services (HIMS) at CAVHS in accordance with Privacy Act of 1974, Title 38 of United States Code (U.S.C.) (U.S.C. 5701, 5705 and 7332), as well as other Federal law, embodied elsewhere in the U.S. Code that bear directly on the privacy of personal data. HIPAA also addresses pertinent issues related to security and confidentiality of individually identifiable information and records that include protected health information. It is the responsibility of the Contractor to assure that patient records are protected against any anticipated threats or hazards to their security or integrity which could result in substantial harm, embarrassment, inconvenience or unfairness to any individual on whom information is maintained. The VHA Handbook 1605.1 released December 31, 2002 is the reference for most of the issues relating to patient records. The Office of Information Security also works with the Privacy Officer at each facility to assure the data is maintained in a secure manner. (b)The computer hard drive will always remain the property of the Dorn VAMC. If for any reason the computer malfunction and need to be replaced, a Dorn VAMC Biomed or IT tech will remove the hard drive. Equipment List: Vitek MS-Clinical (MS Instrument, Prep Station, Acquisition Station, Starter Kit) /4702206 LOCAL STOCK NUMBER: 4702206 -1.00EA Funding/Req. Number: 1 Vitek MS Myla v3.3 /4700565 LOCAL STOCK NUMBER: 4700565 -1.00EA Funding/Req. Number: 1 Myla Vitek2 Connection kit license /411613 LOCAL STOCK NUMBER: 411613 -1.00EA Funding/Req. Number: 1 Vitek MS Virtual Prep Station / 413931 LOCAL STOCK NUMBER: 413931 -1.00EA Funding/Req. Number: 1 Vitek MS Plus Upgrade /4702886 LOCAL STOCK NUMBER: 4702886 -1.00EA Funding/Req. Number: 1 Freight LOCAL STOCK NUMBER: FREIGHT -1.00EA Funding/Req. Number: 1 OWNER/OPERATOR'S MANUAL LOCAL STOCK NUMBER: MANUAL -2.00EA V itek MS Peripherals Vitek MS Acquisition Station Vitek MS Prep Station (With cassette docking station) 1.7 amps @ 120 vac 1.7 amps @ 120 vac Myla Server Computer 1.7 amps @ 120 vac Monitor X2 Heat dissipated (per PC System) 0.3 amps @ 120 vac 1.54 BTU/HR RUO Peripherals Axima PC Saramis Server Computer 1.7 amps @ 120 vac 1.7 amps @ 120 vac Monitor X2 Heat dissipated (per PC System) 0.3 amps @ 120 vac 1.54 BTU/HR Instrument Characteristics "System must have capacity for 192 simultaneous acquisitions. "The system must be FDA cleared for Gram positives, Gram negatives and yeast. "The system must use disposable bar-coded target slides with built-in calibration spots. "Must use direct cell testing for all routine bacteria. No extraction required for routine Gram positive and Gram negative organisms. "Yeast extraction must be on-slide formic acid prior to the addition of matrix solution. No off-board extraction for routine yeast. "Must be able to decentralize target slide set-up through the use of sample prep stations at each plate-reading bench. "System must be able to integrate the set-up of the target slide for identification with the set-up of the susceptibility test to reduce risk of technical error. System Software Characteristics "The system must have a "windows- type" software platform. "System must be able to interface with the LIS and VITEK 2 instrument. "System must include ability for user login for tracking. "System must allow for remote user to review and release results. Contracting Office Address: 6439 Garners Ferry Road Columbia, SC 29209 United States Primary Point of Contact: Iridious T. Ruise iridious.ruise@va.gov Phone: 8037764000x4035
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/CSCVAMC/WJBDDVAMC/VA24714R0609/listing.html)
 

Document(s)

Attachment
 

File Name: VA247-14-R-0609 VA247-14-R-0609_2.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1337892&FileName=VA247-14-R-0609-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1337892&FileName=VA247-14-R-0609-001.docx

 

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

Record

SN03353048-W 20140502/140430235332-04316234b1d3effa00938b764871afe1 (fbodaily.com)
 

Source

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

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |