Promoting Good Laboratory Practices for Waived Infectious Disease and Provider-Performed Microscopy Testing

Abstract

Laboratory testing at the point of patient care was documented hundreds of years ago and has greatly expanded in the last 25 years due to improvements in technology, miniaturization, and the availability of rapid tests for a wide variety of analytes and microorganisms. Since the implementation of the Clinical Laboratory Improvement Amendments of 1988, the number of non-traditional testing sites that provide testing with minimal oversight through a Certificate of Waiver (CW) or Certificate of Provider-Performed Microscopy (PPM) has increased. Concerns have been expressed about some practices, and data have identified quality gaps in these sites where testing may be performed by personnel who do not have laboratory training or experience. The Centers for Disease Control and Prevention has developed free educational tools to promote regulatory compliance and good laboratory practices in CW and PPM sites. Uptake and positive reviews of these materials indicate their value as a resource to improve testing quality.