Variation in proficiency testing performance by testing site.

CONTEXT: Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to promote uniform quality and standards among all testing sites in the United States. The performance indicators specified in the legislation are proficiency testing (PT) performance and periodic inspections. OBJECTIVE: To evaluate variation in PT performance by type of testing facility during the first year of compulsory participation under CLIA. DESIGN: All 1994 PT score data electronically reported to the Health Care Financing Administration as a component of compliance with the CLIA regulations were obtained. Over 1.2 million PT event scores from 17058 unique testing sites were sorted into 2 groups based on the type of testing facility: hospitals and independent laboratories (HI) and all other testing sites (AOT). MAIN OUTCOME MEASURES: Satisfactory and unsatisfactory performance rates for HI and AOT for each analyte and/or test, according to the criteria specified by the CLIA regulations. RESULTS: The aggregate rates of satisfactory event performance for all regulated analytes, tests, and specialties were 97% and 91% for the HI and AOTgroups, respectively. The aggregate odds ratio for unsatisfactory PT event performance for the AOT group compared with the HI group was 2.89, with a range of 2.19 to 7.51 for the individual analytes. CONCLUSION: There was a consistent difference in PT performance during the first full year of compulsory PT under the CLIA regulations based on the type of testing facility performing the analysis. Traditional testing sites achieved higher rates of satisfactory performance than newly regulated, alternative testing sites.

Toward optimal laboratory use. Problems in laboratory testing in primary care.

OBJECTIVE: To examine the frequency and characteristics of problems in laboratory testing in primary care physicians's offices and their impact on health care. DESIGN: Prospective descriptive study in which participating office-based primary care clinicians reported each occurrence of any laboratory incident during a 6-month study. Each identified problem was reported on a structured data collection instrument with an open-ended description of the problem. SETTING: Primary care physicians' offices in North America. PARTICIPANTS: One hundred twenty-four primary care clinicians in 49 practices of the Ambulatory Sentinel Practice Network (ASPN). MAIN RESULTS: A total of 180 problems were reported, yielding a crude rate of 1.1 problems per 1000 patient visits. Problems involving test ordering and specimen handling were the most common (56%), while those attributable to the test analysis itself accounted for 13% of the total. In the judgment of the practice staff, 27% of the reported problems had an impact on patient care. Of the 24 cases for which the specific impact was known and reported, half of the impacts were minor and about half were significant, as judged by whether or not the diagnosis and/or treatment of the patient was measurably affected. CONCLUSIONS: Clinically apparent problems with laboratory testing in primary care were found at a rate of 1.1 problems per 1000 patient visits. Of the laboratory problems that occurred in this study, 27% were judged by the physician to have an effect on patient care.