SOURCES SOUGHT
Q -- HEMOGLOBIN A1c TESTING
- Notice Date
- 10/18/2010
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- VA VHA VISN 10 CONTRACTING ACTIVITY;Brecksville Division;Cleveland VA Medical Center;10000 Brecksville Road;Brecksville, OH 44141-3204
- ZIP Code
- 44141-3204
- Solicitation Number
- VA25011RP0003
- Response Due
- 10/29/2010
- Archive Date
- 11/28/2010
- Point of Contact
- HARVEY J. McGOWAN
- Small Business Set-Aside
- N/A
- Description
- The Louis Stokes Cleveland VA Medical Center is seeking potential sources for Hemoglobin A1c Analyzers System. This is not a solicitation announcement. This is a sources sought synopsis only. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification (service disabled veteran owned small business, veteran owned small business, hub zone, 8(a), small disadvantage business, small business, or large business) relative to NACIS 334516 (size standard of 500 employees). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. Submittal requirements: Responses to this notice should include company name, a service capability statement, three customer references to which you have provided similar services to, copies of applicable licensing, product catalog, address, point of contact, and the size of your business pursuant to the following questions: (1) Is your business large or small (2) If small, does your firm qualify as a small, emerging business, or small disadvantaged business? (3) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act? (4) Is your firm a certified hub zone firm? (5) Is your firm a woman-owned or operated business? (6) Is your firm a certified Service-Disabled Veteran Owned Small or Veteran Owned Small Business? Responses to this notice shall be e-mailed. Other supporting material may be emailed, mailed or faxed to the attention of Harvey J. McGowan, VA VHA VISN 10 Contracting Activity, The Louis Stokes Cleveland VA Medical Center, 10000 Brecksville Road, Brecksville, OH 44141-3204. E-mail address is Harvey.Mcgowan@va.gov. Fax 440-838-6052. Telephone inquires will not be accepted. Responses must be received in writing no later than Friday, October 29, 2010 at 12p.m EST. This notice is to assist the VA in determining sources only. A solicitation is not currently available. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Responses to this sources sought synopsis are not considered adequate responses to any future solicitation announcements. Responses to this sources sought is not a request to be added to a prospective bidders list or to receive a copy of future solicitations. Specifications of Product To Be Provided : a.Cost per test arrangement, i.e. as 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 test result remains constant. b.Fully automated Analyzer system that is capable of directly measuring total A1c hemoglobin by High Performance Liquid Chromatography (HPLC). Contractor must supply all instrumentation, reagents, HPLC cartridges or columns, and calibrators. c.The system must be certified by the national Glycohemoglobin Standardization Program (NGSP) and be traceable to the Diabetes Control and Complications Trial (DCCT) reference method. The instrument provided shall perform all analyses for the required tests with precision as defined by the Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI). d.The system must have primary tube sample loading capacity with automatic barcode reading of whole blood tubes. Must be cap piercing and require no pretreatment of specimens. It must be able to dilute and inject the sample for analysis by HPLC with minimal intervention by the operator. Must be able to accommodate different primary sampling tubes with continual loading. e.System must have bi-directional HL7 interface capabilities to down load work lists from VISTA/Data Innovations (DI) to the instrument and upload results directly to VISTA/DI. f.Dimensions: Analyzers/Instrumentation cannot exceed 11' wide x 28" deep x 27" high. g.Minimum Throughput: 40 samples per hour h.Barcode Scanning: Equipment must have barcode capability and be compatible with common laboratory barcode platforms, including code 128 and code 39. i.UPS system must be included. j.Instrument must be able to store a minimum of 3,000 patient results for data review/search. k.The must be minimal daily maintenance, such that the analyzer is not required to be down for more than 20 minutes per day. Easy access to perform maintenance. l.Calibration must be easy to perform and must maintain stability on the analyzer between calibrations. Calibrators must be traceable to a recognized national standards organization as state by the Clinical Laboratory Standards Institute (CLSI) and/or the College of American Pathologists (CAP). Equipment should run no less than 400 samples between calibration. m.Test kits should contain a minimum of 2,000 tests per kit to minimize the maintenance and calibration. n.Software allows run to stop if quality control fails to avoid loss of entire run. Instrument must be capable of an "auto-stop" at end of the run and if left idle for more than one hour, initiate a self cleaning and shutdown. o.Printer uses regular full size paper p.Equipment will have ability to connect the waste to a drain. q.Current workload is approximately 72,000 tests a year. Contractor will provide at no cost to the government - two Analyzers/instruments to accommodate the workload. 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 two (2) VA staff members must be provided by the vendor at no additional cost. Training must 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 reactive and non-reactive 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. Product Returns: Full credit will be given for all products recalled by the vendor. 8. Responsibilities of the Contractor (1)Provides on-site preventative maintenance twice a year during normal business hours (M-F 7am-4:30 pm). Provides on-site repairs/service as needed. 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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