SOURCES SOUGHT
Q -- New molecular contract HIV/HCV Contractor-Owned Equipment Cost-per-test
- Notice Date
- 12/10/2012
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office;NCO 19;4100 E. Mississippi Avenue, Suite 900;Glendale CO 80246
- ZIP Code
- 80246
- Solicitation Number
- VA25913Q0161
- Response Due
- 12/18/2012
- Archive Date
- 1/17/2013
- Point of Contact
- James P. Hyland
- E-Mail Address
-
hyland@va.gov<br
- Small Business Set-Aside
- N/A
- Description
- THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSAL OR A RQUEST FOR QUOTE. This is a SOURCES SOUGHT request only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. This notice is published for market research purposes only. Requests for a solicitation will not receive a response. The purpose of this sources sought synopsis is to gain knowledge of potential qualified sources. The Government is seeking potential sources for equipment to provide cost per test/cost per reportable laboratory tests in Denver, Colorado, as indicated below. DESCRIPTION: Contractor shall provide all equipment, reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, stand (if required), and any other item required for the proper operation of its' contractor-owned analyzers and peripherals necessary for the generation of the cost per reportable results (CPRR) for molecular testing. Services shall be provided by Contractor to the Eastern Colorado VA Health Care System (ECHCS), 1055 Clermont Street, Denver, CO 80220. The instrument shall be able to simultaneously perform the FDA approved and non-FDA approved assay (one open platform) 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). The following questions must be answered as a response to this Sources Sought Notice: 1.Is this an open platform for molecular assays?Yes: ______No:______ 2.Preferred tests performed on one molecular platform?Yes: ______No: ______ If line 2 above is "No" then how many instruments are needed to perform the preferred tests? __ GENERAL REQUIREMENTS: 1.Offered models of Molecular Pathology Instrumentation shall be capable of producing accurate and reproducible results for HIV viral load, HCV viral load, and HCV Genotyping for all subtypes, in addition but not limited to the above tests such as Chlamydia/Gonorrhea test, and provide an open platform such that extraction can be performed from other specimen sources such as blood, other fluids, or sources, and other available assays by established in vitro diagnostic methods according to manufacturer's guidelines. 2.Models shall provide accurate test assay result for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, run failures such as "QS" invalids" and "clot detection errors" breakdowns, or service calls. 3.Contractor shall provide a FDA approved, fully-integrated and automated analysis instrument that uses a Random Access Platform for nucleic acid analysis of HCV, HIV viral loads, HCV Genotype, in addition to above tests other desirable tests such as Chlamydia/Gonorrhea testing from urine, and genital-cervical specimens. In order to provide the most clinically useful information the assays shall be able to accurately quantify HIV viral loads over a range from 40 or less to at least 10 million copies per milliliter (cp/ml), or greater, and HCV viral loads over a range from 20 or less to at least 50,000,000 international units per milliliter (IU/ml), or greater. Contractor's equipment may provide other assays, a list of all assays shall be included in information provided by the awarded Contractor with the equipment. 4.The Contractor's equipment shall provide fully-integrated real-time Polymerase Chain Reaction (PCR) system that integrates a complete on-board nucleic acid purification system with amplification and detection in contained systems. 5.The Contractor's equipment shall not require an aliquot tube, as long as that item does not limit any assay or test required. 6.The Contractor's equipment shall have the capability to perform accurate HCV genotyping and distinguish the six primary genotypes of Hepatitis C. Equipment performance shall include an accurate viral load characterization for all HCV genotypes and M-type HIV clades. 7.Contractor's equipment shall facilitate running multiple different assays on the same day by allowing the operator to start a new extraction when the first extraction is complete and while the actual PCR assay for the first assay is running. 8.The Contractor's equipment may allow for user programming so that molecular tests developed in-house can be run on the equipment provided. 9.The models being offered shall be in current production as of the date this offer is submitted. Discontinued models that are only being made available as remanufactured equipment shall not be accepted. EQUIPMENT/UNIT REQUIREMENTS: 1.One (1) each Analyzer equipment w/PCR instrument (and any other equipment needed to perform testing); 2.One (1) each Computer for each instrument or as required for completion of any test by the Analyzer equipment provided; 3.One (1) each Printer - 1 for each instrument or as required for completion of the test; and 4.One (1) each Universal Power Supply per instrument or as needed. Maintenance and Repair: The Contractor shall be able to provide emergency equipment repair and preventative maintenance and any incremental support equipment, e.g. main (extraction unit), and PCR unit within 24 hrs of calling for service. INTERFACING: Instrumentation proposed shall be immediately capable of bi-directional, bar-coded, computer interface with VA Laboratory Information System (VISTA), (at a minimum shall be capable of downloading patient specimen number from host computer, integrating this information with test results, and uploading to the host computer). 1.The Contractor shall provide all hardware and software required for the connection, implementation, support and operation of the interface to the universal interface (VISTA) using existing Dawning middleware. 2.Any software upgrades available will be provided and the Contractor shall be responsible for seeing that the interface accommodates any changes in the data stream going to the VISTA. TECHNICAL REQUIREMENTS: 1.Data Management System: (a)Shall be able to support varied programmed for different assay requirement. (b)All software/hardware enhancements that are designed to improve performance of existing functionality shall be provided at no charge. There may be upgrades that are offered as a new product that would be added to the Contract at a negotiated cost. All mandatory upgrades to equipment or software that change test definition files or changes in hardware shall require re-validation: Unless documents are produced stating test definition files are not affected, all software/hardware changes shall be revalidated and supported by kits from the contractor at no charge. (c)The Contractor shall supply test kits for each assay as required by the VA to complete the validation process. (d)Shall be capable of maintaining a computerized log for detection time of steps throughout of assay with an audible alert system for completion or error. (e)Shall be capable of maintaining all data for up to 24 hours in the event of normal electrical power interruptions via battery backup. Shall possess capability to backup all data to a secondary external storage format (e.g. compact disk). (f)Shall have a built-in quality control program to regularly monitor performance of vital components. (g)Shall provide a broad test menu with reliable methodologies and has capability to expand menu options. (h)Provides and performs bar-code operations for sampling, reagents, controls, and calibrators. The system shall support bar-code recognition of specimen tubes for tracking of specimens at entry into the system and throughout processing until such time as the testing has been completed as positive or negative. (i)Shall have quality controls provided to meet CAP standards for FDA approved assays (IVD). (j)Shall provide external peer comparison of QC or equivalent. (k)Shall provide Levy Jennings format, or statistical reporting available for QC review. (l)Shall provide quick turnaround for results, being with 120 minutes to 420 minutes from initiation of each test. (m)Shall provide data management of patient and QC results included with remote access. SPECIAL REQUIREMENTS: In addition to the general and technical requirements for the reagent rental or lease agreement requirements stated above, the Contractor's equipment shall meet the following special requirements: 1.Shall be capable of operating at high altitudes, and low humidity with no interferences; Shall perform satisfactorily at any laboratory temperature between 50 and 90 °F (10-32 °C) and relative humidity between 15 and 85%; 2.Shall provide calibrations per CAP requirements for FDA approved assays. 3.Shall be versatile, require minimal maintenance and easy to use to: (a)Look up capabilities for results on samples being processed. (b)Ability to detect and alert operator of clotted, and/or short samples. (c)Ability to alert user and/or automatically discard empty/expired reagent containers. (d)Software allows review of QC and patient results for single test to help in troubleshooting. Please indicate your interest in this project by providing a capability statement in no more than three (3) pages, via email to James.Hyland@va.gov by December 18, 2012 at 2:00 o'clock p.m., Mountain Time. Do not send marketing or sales brochures.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VARMCCC/VARMCCC/VA25913Q0161/listing.html)
- Place of Performance
- Address: Denver VA Medical Center (ECHCS);1055 Clermont St.;Denver, CO
- Zip Code: 80220-3808
- Zip Code: 80220-3808
- Record
- SN02945800-W 20121212/121210234310-86d1893eb0df25675498b065f2d57bc9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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