| In the age of modern technology, where molecular testing has become more prevalent in clinical laboratories, alarge push for faster methodologywith accurate organism identification has becomethenew expectation by patient providers. This thesis aims to discuss the necessity for validations and verifications in clinical facilities. It isalso seeking to determine if the Biofire FilmArray, a molecular analyzercan be abeneficial and effective toolfor 150-bed hospitals. In the case of West Valley Medical Center, implementation of the FilmArray cost the facility$28,776.50. With their current workload volumes, using only the CMS Financial schedule, it will take approximately 10.4 months to begin showing a profit. Standard culturing techniques ofbodyfluids at the facility take on average 80 hours 25 minutes, which was vastly improved by adding the FilmArray technology. Respiratory specimens were completed within1 hourand9 minutes, while meningitis specimens took1 hour 37 minutes.Importantly, each facility seeking to usethe Biofire FilmArray mustweigh the advantage ofthedecreased turnaround times, with thedisadvantage of anincreasedlaboratory charges, and further compare those with each patient’soverall out-of-pockethospitalcost. If the cost is justifiable and looks to be more beneficial than detrimental to the patient, then the addition of the Biofire FilmArrayis a favorable option.Key Words: validation, verification, cost analysis, Film Array, molecular, laboratory medicine |