Regulation of physicians' office laboratories. The Idaho experience.
Timely availability of reliable test results enhances the office practitioner's ability to provide high-quality care that is personally satisfying to patients. Modern technology allows physicians to have such timely information available through test analyses performed in an office laboratory. Studies of physicians' office laboratories in Idaho found the performance, initially, to be unacceptably variable for many hematology, urinalysis, clinical chemistry, and microbiology tests. State regulation, requiring each office laboratory to comply with quality assurance guidelines and to participate in a proficiency testing program, resulted in a marked improvement in the proficiency level of office laboratory testing in Idaho. With the increasing dispersion of clinical laboratory technology, it is essential that standards of practice for the office laboratory be developed that ensure, within reasonable limits, the reliability of test information used in patient care. If widespread acceptance of such standards cannot be developed with a voluntary approach, states should consider regulation of office laboratories within their jurisdiction. Compliance with standards of practice, voluntarily or as a result of regulation, should promote quality performance in the office laboratory and allow the physician to use confidently the timely test information in dealing with diagnostic and management problems in patient care.