SOLICITATION NOTICE
Q -- REAGENTS FOR HEMOGLOBIN A1c TESTING
- 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-RQ-0184
- Archive Date
- 5/30/2009
- Point of Contact
- HARVEY J. McGOWAN10000 BRECKSVILLE ROAD<br />
- Small Business Set-Aside
- 8a Competitive
- Description
- Hemoglobin A1c TestingSTATEMENT OF WORK 2/9/2009 Prepared by Kristine Dixon, Dianne Crockett, Loretta Jackson Pathology & Laboratory Medicine Service 1.Location : Louis Stokes Cleveland VA Medical Center, 733 Market Ave. South, Canton, O44702hio, 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, Dianne Crockett, MT, ASCP, Supervisor, Ancillary Testing and Point of Care Testing Section, 216-891-3800, EXT. 4076, Loretta Jackson, Medical Technologist, Canton division, 330-489-4600, EXT 1612. 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. 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 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. HPLC is the method of choice for hemoglobin A1c analysis. There are a number of possible interferences that can cause erroneous A1c results. Chemical modification of the hemoglobin (such as carbamylation due to uremia) and genetic variants of hemoglobin (suck as hemoglobin S, C, F, Barts, etc.) can interfere with accurate measurement. The HPLC clearly displays these possible interferences as extra peaks, and by careful review of the graph, we can determine if the results are reportable or not. 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 1988 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 mix, 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. System must already be interfaced to VISTA somewhere in the VA. f.Software for operation must be user friendly. g.Dimensions: Instrumentation cannot exceed 11' wide x 28" deep x 27" high. h.Minimum Throughput: 40 samples per hour i.Barcode Scanning: Equipment must have barcode capability and be compatible with common laboratory barcode platforms, including code 128 and code 39. j.UPS system must be included. k.Instrument must be able to store a minimum of 3,000 patient results for data review/search. l.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. m.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. n.Test kits should contain a minimum of 2,000 tests per kit to minimize the maintenance and calibration. o.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. p.Printer uses regular full size paper q.Equipment will have ability to connect the waste to a drain. r.Current workload is approximately 72,000 tests a year. Contractor will provide two 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 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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