Chemistry and Immunoassay Testing Program Redacted J & A

The WRNMMC Clinical laboratory has a requirement to sustain the use of three (3) Chemistry and Immunochemistry System which includes equipment, reagents, tools, materials, training, and water purification system, Uninterruptible Power Supply (UPS) and services necessary to meet the Chemistry and Immunochemistry testing and analysis requirements.

The system shall consist of all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays as well as any application or software licenses necessary to run the testing/analyzer.

In addition, Initial Method Validations per Clinical Laboratory Improvement Amendments of 1988 (CLIA) / National Committee for Clinical Laboratory Standards (NCCLS) / Department of Pathology and Area Laboratory Services (DPALS) CLIA, NCCLS, and DPALS provide quality management guidelines for essential laboratory operations, including method correlation, linearity verification to maximum dilution, precision, carry-over, normal reference range validation, serum/plasma and blood collection tube validation, initially and with each new assay and/or conversion and for troubleshooting purposes.

Validation Study criteria to be established by Director. Vendor to provide review to Director for acceptability and approval of all assays prior to proceeding with Clinical Testing. To include analyzer decontamination when necessary and removal of all instruments at the termination of the contract. The analyzer systems shall provide users with rapid, reliable test results that are critical for patient care.