Signed_-_Sole_Source_Justification_2019.pdf

Sole Source Justification for the Renewal of the Life Technologies/Applied Biosystems Service Contract for the 3500 Genetic Analyzer, # 25182-190 eyeGENE® currently uses an Applied Biosystems (a Life Technologies company) 3500 genetic analyzer to perform STR marker analysis, which is an important quality assurance measure.

eyeGENE® is a clinical laboratory and must follow the rules established by CLIA, one of which states that that any equipment used for a clinical procedure must have a service contract that includes an annual planned maintenance (PM) procedure. eyeGENE® must therefore purchase a service contract that includes a PM to comply with CLIA regulations.

eyeGENE® previously purchased a one-year service agreement from Life Technologies/Applied Biosystems (PO# HHSN30100024). Life Technologies/Applied Biosystems (AB) does not authorize any third-party service provider to perform maintenance and repair on AB instruments, which includes the AB 3500 genetic analyzer used by eyeGENE®. To comply with our service contract agreement, the required parts and supplies must be obtained from and serviced by a certified AB technician who has been trained in the maintenance of this complex instrument.

This will ensure the continued progress of our research, e.g., service can be expedited if a breakdown occurs. No other company would be able to provide the necessary service required by CLIA for this machine.

Program Signature:________________________________

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