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Regulatory Focus

Phenotype-targeted therapies aimed at achieving optimized patient outcomes will likely drive histology laboratories to seek new methodologies and technology to handle the increased testing volumes these new therapies may generate. The rapid influx of both pharmacodiagnostic and increased molecular pathology testing is impacting histology laboratory operations and also driving an increased focus on testing standardization. As greater numbers of histology methods move to the more highly regulated, high complexity testing category, there will be additional regulatory and compliance pressures that histology laboratories will be required to meet. In the United States, the compliance standards of accrediting organizations such as the Joint Commission (JC) and the College of American Pathologists (CAP) mirror the current healthcare environment trends which expect highly standardized testing and a strong focus on patient safety concerns regarding specimen identification integrity throughout the testing process. The renewed focus on minimizing errors is very clearly outlined in accreditation standards for anatomic pathology laboratories within the CAP accreditation checklist.