July 2025
Q. What is the best way to check machine precision? Is it acceptable to run precision replicates in quality control mode? Read answer.
Q. Several molecular diagnostic vendors circulate across U.S. hospitals and clinics to provide collection kits to physicians and request that those physicians refer tests outside the institution for what is sometimes described as clinical trials or research. The vendors operate using a pharmaceutical company model of selling proprietary testing directly to physicians and patients and bypassing the laboratory. It is a problem because laboratories are often expected to collect and submit samples and then enter complex reports into the electronic health record.
These companies are farming health systems for business and bypassing the accreditation process. When the testing is used not for research but instead for “the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings,” under U.S. law it is defined as laboratory testing (section 353 of the Public Health Service Act, 42 USC §263a), which is overseen by pathology laboratories and under pathology’s accreditation. Under this legal definition of laboratory testing, those outsourced tests are not research.
Can you comment on this practice from an accreditation perspective? Read answer.