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Pediatricians' diagnostic approach to pharyngitis and impact of CLIA 1988 on office diagnostic tests
B Schwartz1, S Fries, A M Fitzgibbon
1Childhood and Respiratory Diseases Branch, Centers for Disease Control and Prevention, Atlanta, GA 30333.
Insights
Pediatricians using office throat cultures for pharyngitis diagnosis showed better outcomes. The Clinical Laboratory Improvement Amendments (CLIA) may reduce the use of these essential tests.
Area of Science:
- Pediatric infectious disease diagnostics
- Clinical microbiology laboratory practices
- Healthcare quality improvement
Background:
- Pharyngitis is a common pediatric condition requiring accurate diagnosis.
- Office laboratory tests, including throat swab culture and rapid antigen testing for Group A Streptococcus, are crucial for appropriate management.
- The impact of regulatory changes like the Clinical Laboratory Improvement Amendments (CLIA) of 1988 on these diagnostic practices is not fully understood.
Purpose of the Study:
- To identify factors associated with optimal diagnostic approaches for pediatric pharyngitis.
- To characterize office laboratory methods for throat swab culture and Group A Streptococcus rapid antigen testing.
- To assess the influence of CLIA regulations on the performance and continuation of these office-based tests.
Main Methods:
- A mailed survey was distributed to board-certified primary care pediatricians in seven western states.
- Telephone follow-up was conducted for nonrespondents.
- Practice characteristics and laboratory test usage were compared between physicians with optimal and suboptimal diagnostic approaches, and between those continuing or discontinuing office throat cultures due to CLIA.
Main Results:
- Optimal pharyngitis diagnosis was more common among physicians performing office throat cultures (RR 1.40).
- Factors compromising office throat culture sensitivity include short incubation times, lack of quality control, and inadequate staff training.
- Following CLIA implementation, 24% of pediatricians discontinued or planned to discontinue office throat cultures, and 23% stopped or would stop antigen detection testing.
Conclusions:
- Office-based throat culture for Group A Streptococcus is linked to optimal pediatric pharyngitis diagnosis.
- CLIA regulations may lead to a significant reduction in the use of office throat cultures by physicians.
- A careful assessment is needed to balance potential quality improvements under CLIA with the decreased availability of this diagnostic test.
Objective:
To determine the factors associated with an optimal diagnostic approach to a child with pharyngitis, characterize office laboratory methods for throat swab culture and group A streptococcal rapid antigen testing, and assess the potential impact of the Clinical Laboratory Improvement Amendments (CLIA) of 1988 on the performance of these tests.
Design And Setting:
Mailed survey to all board-certified primary care pediatricians from seven western states with telephone follow-up for nonrespondents.
Outcome Measures:
Differences in practice characteristics and use of office laboratory tests for physicians who usually (> 80%) diagnose pharyngitis using a recommended approach vs those who follow this approach less often (< 50%); characteristics of physicians who indicate that they intend to discontinue office throat culture because of CLIA and those who will continue to perform this test also are compared.
Results:
Responses from 531 pediatricians were analyzed. Forty-four percent diagnosed pharyngitis appropriately for more than 80% of patients, and 17% did so for fewer than 50%. Optimal diagnosis was significantly more common among physicians who cultured throat swabs in their office (relative risk, 1.40; 95% confidence interval, 1.19 to 1.66) and less common among solo practitioners (relative risk, 0.71; 95% confidence interval, 0.56 to 0.88). Factors that may decrease the sensitivity of office throat culture include short duration of incubation (59%), lack of quality control (51%), and limited education of the persons reading results (6%). With implementation of CLIA, 24% of pediatricians reported that they already have discontinued or will discontinue office throat culture, and 23% have discontinued or will discontinue antigen detection testing for group A streptococci. Those most likely to stop office culture include solo practitioners and practitioners who do not currently perform quality control of culture methods.
Conclusions:
Office culture for group A streptococci is strongly associated with an optimal diagnostic approach. Implementation of CLIA regulations may substantially decrease the number of physicians who perform this test. The balance between potential improvements in the quality of office culture with CLIA implementation and the decreased availability of this test needs to be assessed.