Regulation of physicians' office laboratories. The Idaho experience
R. Crawley, R. Belsey, D. Brock and D. M. Baer
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.