Acute Kidney Injury Test
Sources Sought Synopsis
The Department of Veterans Affairs, VISN 8, is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for Acute Kidney Injury Test System. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 325413.
There is no solicitation at this time. This request for capability information does not constitute a request for proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred.
This Sources Sought is to identify vendors who can provide a laboratory Acute Kidney Injury Test System that includes testing meter and tests kits for the detection of Acute Kidney Injury (AKI) markers. AKI is a common hospital-acquired consequence of systemic illness or injury and it complicates several forms of major surgery. AKI is associated with a 10-fold increase in hospital mortality and 2-3 times worse length of stay cost, readmissions, and incidence of chronic kidney disease. Hospitalized patients, particularly those with comorbidities and those undergoing complex procedures are at high risk for developing AKI. The instrument is able to simultaneously perform the complete profile 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 - formerly NCCLS).
A. GENERAL REQUIREMENTS
1. Operational Features - The AKI testing instrumentation must have:
The capability of performing immunoassay testing for the detection two urinary biomarkers: Tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein7 (IGFBP-7) and final result provided as a single AKI Risk score.
AKI Risk Score should be automatically calculated and reported by the analyzer in a single result.
Capacity to perform the test in less than 30 minutes.
Sufficient safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.
A bi-directional, bar-coded computer interface. The fully operational interface (both hardware and software) should be available for implementation to the VA VistA hospital information system.
AKI meter must fit into existing allotment of space. The allotted area is approximately 15 x 16 .
Must have a temporary back-up power source (batteries) in case of power failure.
Provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories.
Provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s need.
Must be able to provide emergency equipment repair and preventative maintenance.
2. Hardware Features - The AKI testing meter must have the following:
Factory calibration
Start-up self-checks of internal systems
Internal temperature checks
LCD Display
Internal printer
3. Locations
Malcom Randall VA Medical Center
1601 SW Archer Road
Gainesville, FL 32608
James A Haley VA Medical Center
13515 Lake Terrace Ln
Tampa, FL 33612
*Additional locations within VISN 8 may be added in the future
If your organization has the potential capacity to provide these contract supplies please provide the following information: 1) organization name, address, email address, website address, telephone number, and size and type of ownership for the organization; and 2) tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.
The government will evaluate market information to ascertain potential market capacity to 1) provide supplies consistent in scope and scale with those described in this notice and otherwise anticipated; 2) secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements.
Based on the responses to this sources sought notice/market research, this requirement may be set-aside for small businesses or procured through full and open competition. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.
Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed supplies are invited to submit a response to this Sources Sought Notice by 4:30 p.m. on October 18th, 2018. All responses under this Sources Sought Notice must be emailed to james.blue3@va.gov
If you have any questions concerning this opportunity, please contact: James Blue at the abovementioned email or at 352-381-5731.
James Blue
james.blue3@va.gov
352-381-5731
Contract Specialist
