6640--Rapid PCR Analyzers and Reagents, Base plus Two Years Indianapolis VA Medical Center SARS-CoV-2 and Influenza Testing

STATEMENT OF WORK

Microbiology Laboratory

Page 1 of 2

1.0 Summary:

The Richard L. Roudebush Veteran Affairs Medical Center, 1481 West 10th Street, Indianapolis, IN 46202-2803 has a requirement for a polymerase chain reaction (PCR) analyzer, reagents, and consumable supplies to be used for specialized molecular diagnostic testing for emergency rooms, primary care settings and satellite testing locations. This action will be for a firm fixed priced, base plus 2 option year contract.

2.0 Background:

SARS-CoV-2 and Influenza A/B testing is utilized on all symptomatic patients and employees as well as at-risk patients pre-operatively and in the Emergency Room. The PCR analyzer, reagents, and consumable supplies must be able to provide for a fast turnaround time for emergent and outpatient situations.

3.0 Requirements:

The instruments will be used daily in the Microbiology Laboratory for nasal and nasopharyngeal specimens received for SARS-CoV-2 and Influenza PCR testing.

Tasks:

To lease three analyzers to be utilized to perform rapid SARS-CoV-2 and Influenza A/B testing which includes reagent product kits and quality control materials as well as supplies necessary to perform testing and maintain the instrumentation. Should provide preventative maintenance and repair service as necessary. Vendor must be on site with analyzer to install and integrate with existing LABLION Laboratory Information System (LIS) software. This task cannot be performed remotely as it will not be connected to external or VA networks.

Deliverables:

Rapid testing, under 25 minutes for result, for both SARS-CoV-2 and Influenza A/B testing concurrently as well as Influenza A/B and RSV testing concurrently, and FDA cleared to be utilized on an asymptomatic population.

Rapid testing for SARS-CoV-2 >96% positive and negative agreement with both symptomatic and asymptomatic individuals.

Requires that the assay be authorized for use on asymptomatic individuals for SARS-CoV-2 and the limit of detection of no more than 25 copies/ml.

4. Period of Performance: (Base plus 2 option years)

Base Year = 03/01/2024 to 02/29/2025

OY 1= 03/01/2025 to 02/28/2026

OY 2= 03/01/2026 to 02/28/2027

5.0 Security:

The selected system will be integrated into the LABLION Laboratory Information System (LIS) standalone software supporting laboratory workflow processes and customizable procedures, HD-imaging, standardized coding, billing reports, and text-to speech functionality.

6.0 Cleaning:

The instrument screen should be capable of being cleaned with a soft, lint-free cloth. The exterior of the analyzer and front buttons should be capable of being cleaned using a soft lint-free cloth moistened with 70% isopropanol.

7.0 Place of Performance:

The testing will be conducted in the Microbiology Department at the Richard L Roudebush Veteran Affairs Medical Center, 1481 West 10th Street, Indianapolis, IN 46202-2803.