How do CLIA and the CLIA inspectors view these in-office laboratories? Will the fact that I will be operating in a setting not in a hospital or pathology lab increase the level of scrutiny?
The CLIA rules are the CLIA rules but as in every working environment, individual inspectors will approach his or her job with varied perceptions. Operating a CLIA certified laboratory is serious business and like everything else you do within your practice, this should be approached with professionalism and an effort to ensure quality and adherence to all regulatory requirements. You should assume that an inspector would expect that they would see “hospital or pathology laboratory standard of care”. If you are not prepared to do this, you should reconsider taking on this responsibility. TC DermPath Consultants mission and our turn-key package has been designed by professionals to assure that, assuming you follow our guidelines, inspectors will quickly determine that you are dedicated to quality, your responsibility as Medical Director and adherence to all regulatory requirements.
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