SOLICITATION NOTICE
Q -- COST PER REPORTABLE RESULT FOR NEPHELOMETRY-BASED ASSAY SYS
- Notice Date
- 4/30/2009
- Notice Type
- Presolicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs, Brecksville (Cleveland) VAMC, Department of Veterans Affairs Medical Center, Department of Veterans Affairs;Brecksville Division;Cleveland VA Medical Center;10000 Brecksville Road;Brecksville Brecksville 44141
- ZIP Code
- 44141
- Solicitation Number
- VA-250-09-RP-0185
- Archive Date
- 5/30/2009
- Point of Contact
- HARVEY J. McGOWAN10000 BRECKSVILLE ROAD<br />
- Small Business Set-Aside
- 8a Competitive
- Description
- Nephelometry AnalyzerSTATEMENT OF WORK 4/8/2009 Prepared by Kristine Dixon and Darcelee Warth Pathology & Laboratory Medicine Service 1.Location : Louis Stokes Cleveland VA Medical Center, 10701 East Blvd, Cleveland, OH 44106, Pathology & Laboratory Medicine Service 2.Order and Delivery: a. Orders for consumables (reagents & supplies) will be either called in by phone, faxed, or ordered online to the vendor as needed. b. The vendor will deliver supplies/reagents/consumables to the Louis Stokes Cleveland VAMC within 3-5 business days (Monday through Friday). c. Vendor will ship supplies and reagents at no cost to the VAMC. 3.Contact Persons: Kristine Dixon, Assistant Chief PALMS 216-791-3800, EXT. 4079 and Darcelee Warth, MT, ASCP, Supervisor, Chemistry Section, 216-791-3800, EXT. 3493. Other employees of the PALMS Department are also available to accept deliveries of the products. 4.Invoicing/ Credit Cards (Payment): Invoices are to be mailed to Kristine A. Dixon monthly. The mailing address is: Louis Stokes Cleveland VA Medical Center 10701 East Blvd. P&LMS 113(W) - ATTN: Kristine Dixon Cleveland, Ohio 44106 The vendor will accept payment only credit cards as a method of payment. 5. Specifications of Product To Be Provided : a.Cost per test arrangement, i.e. a set cost will be negotiated for all required testing. Cost of reagents, consumables, equipment, and maintenance will be figured so that a set cost for each result remains constant. b.Fully automated system - P&LMS requires a fully automated system to efficiently utilize limited staffing and resources. Must have cap piercing mechanism and a sample detection system to determine sample meets minimum volume requirement for analyzer. Computer, hard drive, printer, and software are to be included. Analyzer must have a metering system to quantitate the number of tests, quality controls and calibrators monthly. c.Nephelometry technology - This technology is currently in place at the Louis Stokes Cleveland VA Medical Center. It has performed adequately on peer reviews. Current reference ranges and treating modalities are based on this technology. d.At a minimum, FDA approved testing must include: a.Albumin (mg/dL, serum, CSF) b.Alpha-1-Antitrypsin c.Antithrombin III d.Beta-2 Microglobin (UDR) e.Ceruloplsmin f.Prealbumin g.Transferrin h.Rheumatoid Factor i.C3 j.C4 k.ASO l.C-Reactive protein m.Haptoglobin n.IgA o.IgG (Serum, CSF) p.IgM(Serum) e.Dimensions: Table top unit. Cannot be any larger than 2'2" deep x 4' wide f.Minimum Throughput: 25 samples per hour g.Barcode Scanning: Equipment must have barcode capability and be compatible with common laboratory barcode platforms, including code 128 and code 39. h.Sample Tube Requirements: Instrument must be able to process multiple sized tubes, most commonly 13mm x 75mm and 13mm x 100mm tubes. i.Sampling mechanism: Can automatically sample tubes with low blood volumes. j.UPS system must be included. k.LS Connectivity: Must have bi-directional HL7 interface. Interface must be compatible with Data Innovations (DI) and system must be already interfaced with Vista in a VA Laboratory. DI license must be provided by vendor awarded this contract. 6. Installation and Support: a.Vendor will participate in installation planning meeting with VA staff prior to delivery by phone. b.Operator training for a minimum of 2 VA staff members must be provided by the vendor at no additional cost. Training may be provided on-site. c.Vendor will provide on-site technical support to perform installation and validation (linearity, precision, accuracy, comparability, sensitivity, analytical measurement range validation, and clinical measurement range validation as required to meet College of American Pathologist standards). d.If unable to obtain within the VA facility, the vendor will make specimens with an appropriate range of results for each analyte available for start up studies. e.The vendor will provide technical support by phone during normal business hours, Monday - Friday, 7:00 am to 4:30 pm. 7. Warranty/Maintenance/Service Calls: a.Warranty - 60 months from date of installation, covering all parts, labor and travel. b.Preventative maintenance will be completed by vendor at least once per year at no additional cost. c.On-site service will be provided Monday through Friday, 8:00 am to 5:00 pm at no additional cost when needed. 8. Product Returns: Full credit will be given for all products recalled by the vendor. 8. Responsibilities of the Contractor (1)Provides one year of on-site service during normal business hours (M-F 8 am-5 pm). Field service representatives will present to the VA no later than 24 hours after service call is initiated. (2)All of the Contractor's products will meet the requirements of FDA, state and local law. (3)The contractor will properly package and ship all products according to OSHA and ODOT requirements and will include with each shipment an itemized shipping/packing list. (4)Contractors shall promptly notify Cleveland VAMC by telephone if the products requested are not available in the quantity ordered within the specified time. (5)The contractor will supply the MSDS sheets, operator's manual, assay manual, and if available, a procedure manual on CD to Cleveland VA Medical Center. (6)Contractor will notify Cleveland VAMC, in as timely a manner as is feasible, when information subsequently becomes available to indicate that a product lot demonstrated inaccuracies or discrepancies that could have influence patient results.
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