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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 12, 2016 FBO #5284
DOCUMENT

65 -- Electrophoresis Instrument Spife 4000 (110v) (OR EQUAL) Phoenix VA Medical Center - Attachment

Notice Date

5/10/2016
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

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

ZIP Code

85014
 

Solicitation Number

VA25816Q0388
 

Response Due

6/1/2016
 

Archive Date

7/31/2016
 

Point of Contact

Johanne Gingras
 

E-Mail Address

e.gingras@va.gov<br
 

Small Business Set-Aside

N/A
 

Description

SCOPE: The purpose of this requirement is to procure a clinical laboratory electrophoresis instrument system for the Chemistry Department of the Pathology & Laboratory Medicine Service at the Carl T. Hayden VA Medical Center. The electrophoresis instrument system is used to separate and quantify proteins in serum and urine, to see the way the proteins distribute themselves in a pattern on a gel, and to interpret those patterns and quantities for various disease states. The Chemistry Department seeking a fully automated electrophoresis instrument system that will allow a tech to place the specimen on-board, and then to walk away until the specimen is completely finished testing and is ready to be reviewed. The automation steps include sampling, applicating, diluting for immunofixation, staining, drying, scanning the gel, editing and interpreting results, and transmitting to host. In accordance with Appendix A, Handbook 6500.6 Checklist block 6 and 7, this contract will require Contractor support staff access to VA-sensitive information during instrument install and during instrument service and maintenance. However, the Contractor support staff will not have access to VA internal networks. No VA-sensitive information will be transmitted or stored off-site as part of this contract. Any Contractor support staff that will service the instrumentation for purposes of installation, maintenance, or repair must complete a Contractor Security Control Assessment (CSCA) within 30 days of contract approval and yearly on the renewal date of the contract. In the event that the instrumentation is to be removed from the PVAHCS, the hard drive(s) will first be removed and remain with the PVAHCS due to patient information liabilities. A Business Associate Agreement is required between the PVAHCS and the Contractor. DESCRIPTION OF HOW THE EQUIPMENT BEING REQUESTED OPERATES: The electrophoresis instrument system is a stand-alone platform that includes all the necessary components required to sample, apply, dilute, electrophorese, stain, dry, scan, edit, and interpret patient samples for serum and urine electrophoresis and immunofixation. It should be considered a fully 'walk away' instrument. WHERE WILL THE EQUIPMENT BEING REQUESTED BE USED: The electrophoresis instrument system will be used in the Chemistry Department of the Inpatient Laboratory of P&LMS. GENERAL REQUIREMENTS FOR ELECTROPHORESIS INSTRUMENT SYSTEM (HEREAFTER INSTRUMENT): 1.Specifications as set forth in this proposal are minimum specifications and shall not be construed as limiting the overall quality, quantity, or performance of the instrument. 2.The offerer shall meet or exceed the minimum requirements and shall be held responsible for the performance and overall quality of the requested instrument during the instrument's warranty period. 3.The instrument, based upon the specifications requested, shall be the newest and the most current model. A refurbished is not acceptable. The instrument should be a standard product of the manufacturer of record. The manufacturer of record is defined as a company whose main occupation is the manufacture for sale items of equipment and which: a.Maintains a stock of replacement parts for the item. b.Maintains engineering plans, specifications, operating manuals & maintenance manuals. c.Has published and distributed literature and specifications on the equipment. INSTRUMENT REQUIREMENTS FOR ELECTROPHORESIS INSTRUMENT SYSTEM (HEREAFTER INSTRUMENT): 1.The instrument shall be considered fully 'walk away', meaning the tech can load the patient specimen and then not touch the instrument or patient specimen or gel until the results are ready to be reviewed. 2.The instrument shall be capable of both serum and urine electrophoresis, and also serum and urine immunofixation. 3.The instrument shall utilize gel electrophoresis methodology. 4.The instrument shall have positive sample ID from the tube to the gel to the final reports. 5.The instrument shall have specimen level sensing. 6.The instrument shall have auto-dilution capabilities for immunofixation specimens. 7.The instrument shall have software which allows for editing and interpretation of the reports. 8.The instrument shall have bi-directional LIS capabilities with the VA's Vista system via either Dawning or Data Innovations. 9.The instrument shall show where the gel is in process and time until completion. 10.The instrument should include a minimum amount of maintenance each day. The manufacturer should define maintenance requirements and indicate what maintenance is performed by the user. INSTALLATION, INCLUDING VERIFICATION/VALIDATION, TRAINING: 1.The vendor shall provide the facility with all cross-over supplies and reagents needed at installation and during training of staff. Test counts for billing will begin after review/approval of all correlation/linearity studies performed at installation. 2.The vendor shall provide at installation/set-up and when bringing new tests on-line, a technical support specialist who shall perform all validation studies including: installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards), normal range studies, staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. 3.The vendor or manufacturer shall train three (3) dayshift Chemistry Department staff on the instrumentation; including but not limited to: data management system, quality control package, calibration, normal operation, start-up/shut-down, maintenance, interpretation, reagent parameters and utilization, use of manuals, and hotline support. 4.The vendor/distributor and/or the manufacturer must provide all necessary procedure manuals, troubleshooting manuals and operator manuals. REPAIR AND MAINTENANCE: 1.Manufacturer will a.Provide utility requirements (electrical, media disposal, etc.) which should include all necessary SDS documents. b.Provide environmental requirements (heat/cool, humidity, light, etc.) and recommendations for instrument and testing material storage. 2.Manufacturer will make available, for purchase, all necessary parts, consumables, calibrators, controls, and standards required for proper instrument performance. 3.The Carl T. Hayden VA Medical Center's Bio-Medical Department will be responsible for procuring a service contract with the manufacturer of the instrument. 4.The manufacturer will provide upgrades to equipment at no additional charge to the federal government. SUPPORT SERVICES: 1.The vendor will be assessed for privacy & security risk levels as it relates to efficiency and integrity of the service being provided. Identification of the contractor's sensitivity level as it relates to a position with national security interests will be assessed in accordance with VA directive 0710. A completed security assessment form (VA 2280a) and a business associate agreement will be kept on file. 2.A service hotline with technical support will be through one contractor (preferably the manufacturer of the instrument). All calls must be answered within a reasonable time period via telephone. 3.The vendor or manufacturer shall submit a legible field service report which will include a detailed description of the preventive maintenance inspection or emergency repair services performed, including replaced parts and estimated prices required for the service call. 4.The vendor's or manufacturer'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 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. 5. In the performance of this contract, the vendor and/or manufacturer 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 and/or manufacturer of any safety issues and the action necessary to correct these issues. Such notice, when served on the vendor and/or manufacturer at the work site shall be deemed sufficient for the corrective actions to be taken. If the vendor and/or manufacturer fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the Contractor in default. OTHER: 1.Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory with communication to the vendor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria satisfactorily to the user. 2. The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer. 3.The vendor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, or other vendor related factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. 4.In the event that the any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25816Q0388/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-16-Q-0388 VA258-16-Q-0388_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2724829&FileName=VA258-16-Q-0388-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2724829&FileName=VA258-16-Q-0388-000.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: Carl T. Hayden VAMC;Pathology and Laboratory Medicine Services;650 E Indian School Rd;Phoenix, AZ

Zip Code: 85012
 

Record

SN04111200-W 20160512/160510234218-7328a8b97859738dcd9bbf816aaa3d96 (fbodaily.com)
 

Source

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

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