How Physicians Diagnose Urinary Tract Infections: The Potential Influence of Laboratory Regulations on Test Availability and Use

Busy clinicians have come to rely on the office laboratory as an important tool in providing timely, efficient, and high-quality patient care. However, concerns have been raised about poor accuracy in physician office laboratories and financial incentives that encourage overuse of tests.^1-7 Recent studies have documented inaccurate office laboratory testing.^8,9 Previously, the Commission on Office Laboratory Accreditation concluded that approximately 5% of office laboratories have serious deficiencies involving quality control, instrument maintenance, specimen management, and proficiency testing.¹⁰ Similar concerns led to the passage of the Clinical Laboratory Improvement Act of 1988 (CLIA-88), which was implemented in the fall of 1994.¹¹ Before CLIA-88, physician office laboratory quality regulations were decided at the state level.¹² Both state and federal regulations require adherence to specific measures (eg, proficiency testing, quality control, and quality assurance) to operate an office laboratory.

The critics of quality regulations assert that the measures might actually decrease the quality of care. They note that the regulations impose a fixed cost on the physician’s practice that must be spent regardless of how busy the laboratory is. The additional costs of compliance could discourage physicians from offering tests that would otherwise be done.^13,14 This reduction in test availability might occur in both high- and low-quality laboratories. Therefore, regulations aimed at improving quality might have the unintended effect of reducing the availability and use of clinically beneficial laboratory tests, thereby decreasing the overall potential benefit of the regulations.

We previously surveyed primary care physicians about their clinical approach to patients with a possible uncomplicated urinary tract infection (UTI).¹⁵ That 1994-1995 survey included primary care physicians in 4 states and contained detailed information on their work settings and clinical behavior concerning cases of UTI. In this paper we use those survey results to examine the potential effects of office laboratory quality regulations and test availability on testing for UTIs. This is possible because one of the states surveyed, Pennsylvania, has had statewide physician office laboratory quality regulations similar to CLIA-88 in place since the mid-1970s.^12,16 All office laboratories in Pennsylvania were required to register with the state, have a written procedure manual, perform quality and proficiency testing, and comply with state regulations, regardless of the level of testing.¹⁶ Office laboratories in the other 3 states were not regulated until the implementation of CLIA-88 in late 1994. Thus, the survey includes 1 regulated state and 3 states that were just beginning to be regulated. This should provide a conservative estimate of the differences between a regulated and a nonregulated situation, since some of the physicians in the previously unregulated states may already have adjusted to CLIA-88 when our survey was done. The adjustment to CLIA-88 did not occur instantaneously; laboratories have continued to move toward a higher percentage of waived and provider-performed microscopy laboratories (from 57.8% of all laboratories in 1995 to 75% in July 2000) since CLIA-88 was implemented.¹⁷ We sought to determine if office laboratory testing capabilities or availability differs by state and if self-reported use of the tests in diagnosing an uncomplicated UTI is related to the availability of the tests.