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Context: Monitoring customer satisfaction is a valuable component of a laboratory quality improvement program., Objective: To survey the level of physician satisfaction with hospital clinical laboratory services., Design: Participating institutions provided demographic and practice information and survey results of physician satisfaction with defined aspects of clinical laboratory services, rated on a scale of 1 (poor) to 5 (excellent)., Results: One hundred thirty-eight institutions participated in this study and submitted a total of 4329 physician surveys. The overall satisfaction score for all institutions ranged from 2.9 to 5.0. The median overall score for all participants was 4.1 (10th percentile, 3.6; 90th percentile, 4.5). Physicians were most satisfied with the quality/reliability of results and staff courtesy, with median values of excellent or good ratings of 89.9%. Of the 5 service categories that received the lowest percentage values of excellent/good ratings (combined scores of 4 and 5), 4 were related to turnaround time for inpatient stat, outpatient stat, routine, and esoteric tests. Surveys from half of the participating laboratories reported that 96% to 100% of physicians would recommend the laboratory to other physicians. The category most frequently selected as the most important category of laboratory services was quality/reliability of results (31.7%)., Conclusions: There continues to be a high level of physician satisfaction and loyalty with clinical laboratory services. Test turnaround times are persistent categories of dissatisfaction and present opportunities for improvement.

Context: Errors entering orders for send-out laboratory tests into computer systems waste health care resources and can delay patient evaluation and management., Objectives: To determine (1) the accuracy of send-out test order entry under "real world" conditions and (2) whether any of several practices are associated with improved order accuracy., Design: Representatives from 97 clinical laboratories provided information about the processes they use to send tests to reference facilities and their order entry and specimen routing error rates., Results: In aggregate, 98% of send-out tests were correctly ordered and 99.4% of send-out tests were routed to the proper reference laboratory. There was wide variation among laboratories in the rate of send-out test order entry errors. In the bottom fourth of laboratories, more than 5% of send-out tests were ordered incorrectly, while in the top fourth of laboratories fewer than 0.3% of tests were ordered incorrectly. Order entry errors were less frequent when a miscellaneous test code was used than when a specific test code was used (3.9% vs 5.6%; P = .003)., Conclusions: Computer order entry errors for send-out tests occur approximately twice as frequently as order entry errors for other types of tests. Filing more specific test codes in a referring institution's information system is unlikely to reduce order entry errors and may make error rates worse.

Context: Papanicolaou (Pap) tests are often diagnosed as atypical squamous cells of undetermined significance (ASC-US). Human papillomavirus (HPV) DNA testing has been proposed as a quality metric for this diagnosis., Objective: To measure the frequency of HPV positivity in Pap tests diagnosed as ASC-US and to examine laboratory variables that are associated with institutional deviation from the mean percent of HPV positivity., Design: As part of a College of American Pathologist Q-Probes program, 68 participating laboratories retrospectively identified approximately 50 consecutive ASC-US Pap tests that had HPV testing results., Results: The mean percentage of HPV positivity for ASC-US was 43.74% among institutions surveyed, but it had a broad distribution, with an SD of 17.77%. Associations were found for lower difference of the institutional mean from the surveyed interinstitutional mean percentage of positive HPV with (1) higher numbers of Pap tests in the past year that had HPV testing, (2) in-house HPV testing, and (3) teaching hospitals. All 3 factors correlated with a larger volume of Pap tests per institution. An association was found between patient age and the probability of a positive HPV result, indicating a dependence upon prevalence of HPV., Conclusions: Larger volumes of Pap tests may offer an opportunity to gain greater comfort in interpreting Pap tests. While there is significant variability in interinstitutional HPV-positive rates in ASC-US Pap tests, monitoring the HPV-positive rate in ASC-US Pap tests is a valuable broad measure of quality. Performance beyond 2 SDs of the mean should prompt reassessment of diagnostic criteria used in the evaluation of Pap tests and/or investigation of the prevalence of HPV positivity in the population from which the Pap tests are obtained.

Context: Monitoring customer satisfaction is an important and useful quality improvement tool and is required of most clinical laboratories in the United States., Objective: To survey the level of nursing satisfaction with hospital clinical laboratory services., Design: Participating laboratories provided information regarding laboratory demographics and practices. These laboratories then surveyed hospital nursing personnel regarding their level of satisfaction with defined aspects of laboratory service., Setting: College of American Pathologists Q-Probes laboratory quality improvement study in 162 hospital laboratories., Main Outcome Measures: Nursing overall satisfaction score (ranging from 1, not satisfied, to 5, very satisfied) and satisfaction scores for 13 specific aspects of clinical laboratory services., Results: One hundred sixty-two institutions submitted data from a total of 7033 nursing surveys. The overall satisfaction score for all institutions ranged from 2.5 to 4.6. The median overall score for all participants was 3.9 (10th percentile, 3.2; 90th percentile, 4.2). Nursing personnel were most satisfied with the accuracy of test results, phlebotomy courtesy toward patients and nursing staff, and notification of abnormal results. They were least satisfied with stat test turnaround time, laboratory management responsiveness and accessibility, phlebotomy responsiveness to service requests, and routine test turnaround time. The most important aspect of laboratory service reported by nursing personnel was stat test turnaround time., Conclusions: Most nursing personnel are satisfied with the clinical laboratory services that are provided to the patients in their care. Although test result accuracy is very highly regarded, there is room for improvement in several aspects of service, particularly in test turnaround time and laboratory management accessibility and responsiveness.

Context: Misidentified laboratory specimens may cause patient injury, but their frequency in general laboratory practice is unknown., Objectives: To determine (1) the frequency of identification errors detected before and after result verification, (2) the frequency of adverse patient events due to specimen misidentification, and (3) factors associated with lower error rates and better detection of errors., Design: One hundred twenty clinical laboratories provided information about identification errors during 5 weeks., Results: In aggregate, 85% of errors were detected before results were released; one quarter of laboratories identified more than 95% of errors before result verification. The overall rate of patient identification errors involving released results was 55 errors per 1,000,000 billable tests. A total of 345 adverse events were reported. Most of the adverse events caused material inconvenience to the patients but did not result in any permanent harm. On average, adverse events resulted from 1 of every 18 identification errors. Extrapolating the adverse event rate observed in this study to all United States hospital-based laboratories suggests that more than 160,000 adverse events per year result from misidentification of patients' laboratory specimens., Conclusions: Identification errors are common in laboratory medicine, but most are detected before results are released, and only a fraction are associated with adverse patient events. Even when taking into consideration the design of this study, which used imperfect case finding, institutions that did a better job of detecting errors within the laboratory released a smaller proportion of results that involved specimen misidentification.

Context: Field validation of slides used in gynecologic cytology proficiency testing has surfaced as an important issue. Although the precision of diagnoses in peer-reviewed educational programs has been examined, the robustness of the validation criteria for specific types of interpretations used in proficiency testing has not been previously studied., Objective: To evaluate the robustness of validation criteria for slides entering an educational slide program., Design: We reviewed the results of the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology and compared the robustness of validation criteria for different reference diagnoses, using a total of 16,948 circulating slides., Results: Validation criteria could be divided into 2 significantly different groups. The criteria for herpes, Trichomonas, squamous cell carcinoma, and adenocarcinoma were significantly more robust than the diagnoses of unsatisfactory; negative for intraepithelial lesion and malignancy, not otherwise specified; low-grade squamous intraepithelial lesion; and high-grade squamous intraepithelial lesion (P < .001)., Conclusions: The validation criteria used in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology show 2 different levels of robustness or redundancy. These results have implications for the design of fair proficiency tests. Proficiency testing can be designed with the necessary number of reviews needed for slide validation.

Context: Current regulatory proficiency testing scoring results in an automatic failure for identifying high-grade squamous intraepithelial lesion (HSIL) as negative., Objective: The College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology data from January 2004 to April 2005 were analyzed to estimate the percentage of failure based on negative responses for HSIL and validation criteria., Design: More than 15,000 participants received field-validated and educational slide sets for conventional, ThinPrep, and SurePath modules. Educational sets fulfilled the validation criteria of the Center for Medicare and Medicaid Services, which required the consensus diagnosis of biopsy-proven HSIL (not field-validated) after review by 3 pathologists. The College of American Pathologists field validation required at least 20 responses to the HSIL+ series, with 70% matched to HSIL+ (standard error < or = 0.05). Minimum regulatory proficiency testing failure estimates were based on incorrect negative responses for the reference category of HSIL., Results: For both cytotechnologists and pathologists, there was a statistically significant higher failure rate for slides that were not field-validated versus those that were field-validated. In conventional modules, 5.3% of the slides that were not field-validated were called negative, versus 1.2% of the field-validated slides. In all liquid-based preparations, 4.0% of the non-field-validated versus 2.2% field-validated slides were called negative. Pathologists would have failed more often than cytotechnologists for the slides that were not field-validated, whereas there was no statistical difference in failure performance with field-validated slides., Conclusions: Failures were significantly greater with the slides that were not field-validated for both conventional and liquid-based preparations (ThinPrep only) and have implications for both regulatory proficiency testing and expert legal review. Poor performance of pathologists relative to that of cytotechnologists may reflect a lack of prescreening of slides or scope of practice issues.

Context: Blood culture contamination extends hospital stays and increases the cost of care., Objectives: To measure blood culture contamination rates in a large number of institutions over time and to elucidate practice patterns and demographic factors associated with sustained reduction in contamination rates., Design: Longitudinal cohort study of 356 clinical laboratories that provided quarterly data about blood culture results, using a uniform definition of contamination. Mixed linear model analysis of the 1999 through 2003 data set., Results: Blood culture contamination was significantly higher in institutions that used nonlaboratory personnel to collect blood (P = .03) and significantly lower in facilities that used a dedicated phlebotomy team (P < .001). Higher volume of blood collection was significantly associated with lower contamination rates (P < .001). Continued participation in the Q-Tracks monitoring program was associated with significant and progressive reduction in contamination rates. By the fifth year of participation, the median institution had reduced its blood culture contamination rate by 0.67% (P < .001)., Conclusions: Institutions that use decentralized patient-centered personnel rather than dedicated phlebotomy teams to collect blood cultures experience significantly higher contamination rates. Long-term monitoring of contamination is associated with sustained improvement in performance.

Context: Continuous monitoring of key laboratory indicators of quality by hundreds of laboratories in a standardized measurement program affords an opportunity to document the influence of longitudinal tracking on performance improvement by participants focused on that outcome., Objective: To describe the results of the first 2 years of participation in a unique continuous performance assessment program for pathology and laboratory medicine., Design: Participants in any of 6 modules in the 1999 and 2000 College of American Pathologists (CAP) Q-Tracks program collected data according to defined methods and sampling intervals on standardized input forms. Data were submitted quarterly to CAP for statistical analysis. Interinstitutional comparison reports returned in 6 weeks provided each laboratory with its performance profile of key indicators and its percentile ranking compared with all participants in that quarter. This also included longitudinal comparisons of performance during previous cumulative quarters. Control charts graphically displayed data with flags identifying performance points that were out of statistical control., Setting: Hospital-based laboratories in the United States (98%), Canada, and Australia., Participants: Voluntary subscriber laboratories in the CAP Q-Tracks performance measurement program: roughly 70% from hospitals of 300 occupied beds or fewer, 65% from private, nonprofit institutions, slightly more than half located in cities, one third from teaching hospitals, and 20% with pathology residency training programs., Main Outcome Measures: Each module measured several major and additional minor quality indicators and unbenchmarked individualized data for internal use., Results: Participants in 4 of 6 Q-Tracks continuous monitors demonstrated statistically significant performance improvement trends in 1999 and 2000, which were most marked for laboratories that continued participation throughout both years. These monitors were wristband patient identification, laboratory specimen acceptability, blood product wastage, and intraoperative frozen section consultation., Conclusions: Key continuous indicators chosen on the basis of a decade's experience in the CAP Q-Probes quality improvement program are useful measurement and benchmarking tools for laboratories to improve performance. In general, measures in which there is a broad range of demonstrable performance initially are most optimal for subsequent improvement using continuous monitoring. These studies have shown that quality is not static, but rather is a moving benchmark of performance as seen in the redefinition of benchmarks over time by participants in the first 2 years of the CAP Q-Tracks program.