Prevalence of Campylobacter pylori in esophagitis, gastritis, and duodenal disease.

The relationship between the presence of Campylobacter pylori and esophagitis was studied in patients undergoing paired biopsies of distal esophagus and gastric antrum during esophagogastroduodenoscopy. Biopsy specimens were examined for urease activity and for the presence of C pylori by culture and by histologic examination of hematoxylin-eosin- and Warthin-Starry-stained sections. Sixty-two patients were entered into the study. All esophageal biopsy specimens, regardless of histologic findings, were negative for the presence of C pylori by urease test, culture, and histologic examination. Of 35 patients with normal esophageal biopsy specimens, 11 (31%) had antral specimens that were positive for C pylori, while 11 (41%) of the 27 patients with esophagitis had antral specimens that were positive for the organism. Campylobacter pylori was detected in 14 (70%) of 20 patients with chronic gastritis, in 8 (67%) of 12 patients with endoscopically documented duodenal ulcers and erosions, but in only 3 (33%) of 9 patients with endoscopically defined duodenitis. We conclude that histologic esophagitis is not associated with increased prevalence of either gastric or esophageal C pylori. The well-described association of chronic gastritis and duodenal ulcers with C pylori was present in our study population.

Evaluating diagnostic tests with imperfect standards.

New diagnostic tests frequently are evaluated against gold standards that are assumed to classify patients with unerring accuracy according to the presence or absence of disease. In practice, gold standards rarely are perfect predictors of disease and tend to misclassify a small number of patients. When an imperfect standard is used to evaluate a diagnostic test, many commonly used measures of test performance are distorted. It is not widely appreciated that these distortions occur in predictable directions and that they may be of considerable magnitude, even when the gold standard has a high degree of accuracy. The diagnostic powers of clinical tests will be more accurately reported if consideration is given to the types of biases that result from the use of imperfect standards. Several different approaches may be used to minimize these distortions when evaluating new tests.

Sensitivity, specificity, and reproducibility of four measures of laboratory turnaround time.

The authors studied the performance of four measures of laboratory turnaround time: the mean, median, 90th percentile, and proportion of tests reported within a predetermined cut-off interval (proportion of acceptable tests [PAT]). Measures were examined with the use of turnaround time data from 11,070 stat partial thromboplastin times, 16,761 urine cultures, and 28,055 stat electrolyte panels performed by a single laboratory. For laboratories with long turnaround times, the most important quality of a turnaround time measure is high reproducibility, so that improvement in reporting speed can be distinguished from random variation resulting from sampling. The mean was found to be the most reproducible of the four measures, followed by the median. The mean achieved acceptable precision with sample sizes of 100-500 tests. For laboratories with normally rapid turnaround times, the most important quality of a measure is high sensitivity and specificity for detecting whether turnaround time has dropped below standards. The PAT was found to be the best measure of turnaround time in this setting but required sample sizes of at least 500 tests to achieve acceptable accuracy. Laboratory turnaround time may be measured for different reasons. The method of measurement should be chosen with an eye toward its intended application.

Unnecessary microscopy in routine urinalysis.

The consequence of omitting urine sediment microscopy in specimens with normal physicochemical testing was assessed in a retrospective review of laboratory and clinical data in 1,000 patients. The pathologic states of clinical significance most likely to be overlooked were Trichomonas infection and occasional cases of significant bacteriuria. However, the medical benefit of performing urine microscopy in these two groups of patients was not clear. The authors cautiously recommend reserving microscopy for urine specimens that show physicochemical abnormalities.

Corynebacterium xerosis septic arthritis.

A 62-year-old man developed acute septic arthritis due to Corynebacterium xerosis. The patient was treated with ampicillin and rapidly recovered. To the authors' knowledge this is the only reported case of septic arthritis due to C. xerosis. Clinical features of this case and the five previously reported cases of diphtheroid arthritis are discussed.

Pseudomonas alcaligenes endocarditis.

Pseudomonas alcaligenes is a common soil and water inhabitant that has rarely been proven a human pathogen. We describe a fatal case of Pseudomonas alcaligenes endocarditis. The need for accurate identification of unusual organisms isolated in a clinical setting are discussed.

Pharmaceutical cost growth under capitation: a case study.

Rising drug spending has generated concern among purchasers and policymakers. This paper compares drug cost growth in a capitated system with that in managed care systems that generally did not place physicians directly at risk for drug spending. We focus on cost growth because a substantial body of literature indicates that managed care interventions that reduce the level of costs may not influence the rate of cost growth. Drug cost growth under capitation initially was below that of other systems but still above targeted rates. Over time the capitation rates rose, the amount of risk transferred to physicians declined, and spending growth accelerated.

Managing physician use of laboratory tests.

The active management of laboratory test utilization appears to be a practical approach to addressing the financial pressures imposed by managed care and capitated reimbursement, and can complement efforts already underway in most laboratories to reduce the unit cost of testing. Managing laboratory utilization takes time that is often in short supply; however, the literature suggests that the savings from a well-focused effort can easily exceed the costs of a utilization management program. Individuals and institutions that commit themselves to active utilization management need to realize (1) how laboratory utilization is measured, (2) benchmarks within the industry, and (3) the stubborn structural and psychological constraints that are likely to limit progress. Some approaches to reducing utilization, such as education, have poor track records and are best avoided. Other avenues, such as providing financial feedback and making specific changes to the environment in which tests are ordered, have demonstrated moderate success in the past and hold considerably more promise.

Urine culture contamination: a College of American Pathologists Q-Probes study of contaminated urine cultures in 906 institutions.

OBJECTIVE: To examine the frequency and causes of urine culture contamination in outpatients. METHODS: Nine hundred six institutions, ranging in size from less than 50 to more than 600 beds, each examined 250 consecutively ordered urine cultures from outpatients and identified specimens that met the study definition of contamination. Participants also answered questions about the practices used to collect, transport, and process urine specimens. In all, data relating to more than 200,000 urine cultures were analyzed. RESULTS: The median institution reported that 18.1% of urine cultures specimens collected from outpatients were contaminated. The top 10% of institutions (90th percentile) reported that 5.6% or fewer of their cultures were contaminated. In contrast, the bottom 10% of institutions (10th percentile) reported that 36.8% or more of their urine specimens were contaminated. Institutions with lower contamination rates tended to process a lower proportion of specimens from female patients. Pediatric hospitals also reported lower contamination rates in specimens from children than general hospitals. Other factors, including the use of central processing areas, refrigeration, urine screening systems, specimen preservatives, provision of written collection instructions or special collection kits, and thermally insulated specimen transport containers, were not found to be associated with low specimen contamination rates in a multivariate analysis. CONCLUSION: Contamination of outpatient urine cultures is a common occurrence, and facilities differ significantly in their overall frequency of urine culture contamination. Many interventions commonly assumed to reduce contamination were not demonstrably effective in this study.

Outpatient order accuracy. A College of American Pathologists Q-Probes study of requisition order entry accuracy in 660 institutions.

CONTEXT: Laboratory test order entry errors potentially delay diagnosis, consume resources, and cause patient inconvenience. OBJECTIVE: To evaluate the frequency and causes of computer order entry errors in outpatients. DESIGN: Cross-sectional survey and prospective sample of errors. Participants answered questions about their test order entry policies and practices. They then examined a sample of outpatient requisitions and compared information on the requisition with information entered into the laboratory computer system. Order entry errors were divided into 4 types: tests ordered on the requisition, but not in the computer; tests performed but not ordered on the requisition; physician name discrepancies; and test priority errors. PARTICIPANTS: Six hundred sixty laboratories enrolled in the College of American Pathologists Q-Probes program. MAIN OUTCOME MEASURE: Overall order entry error rate. RESULTS: A total of 5514 (4.8%) of 114 934 outpatient requisitions were associated with at least 1 order entry error. The median participant reported 1 or more order errors on 6.0% of requisitions; 10% of institutions reported errors with at least 18% of requisitions. Of the 4 specific error types, physician name discrepancies had the highest error rate, and test priority errors the lowest error rate. Four institutional factors were significantly associated with higher overall error rates: orders verbally communicated to the laboratory; no policy requiring laboratory staff to compare a printout or display of ordered tests with the laboratory requisitions to confirm that orders had been entered correctly; failure to monitor the accuracy of outpatient order entry on a regular basis; and a higher percentage of occupied beds (ie, a busier hospital). CONCLUSIONS: Computer order entry errors are common, involving 5% of outpatient requisitions. Laboratories may be able to decrease error rates by regularly monitoring the accuracy of order entry, substituting written and facsimile orders for verbal orders, and instituting a policy in which orders entered into computer systems are routinely rechecked against orders on requisitions.

Primary intranasal Fusarium infection. Potential for confusion with rhinocerebral zygomycosis.

Fusarium species are saprophytic fungi that may colonize human skin and nails and may rarely cause invasive infections in traumatized tissue and in debilitated and immunocompromised patients. We report herein a case of invasive intranasal Fusarium oxysporum infection in a diabetic patient. This unusual presentation potentially can be confused with early rhinocerebral zygomycosis clinically and histologically. Distinguishing morphologic features and the possible role of diabetes in promoting this infection are discussed.

Ordering accuracy. A College of American Pathologists Q-Probes study of 577 institutions.

Five hundred seventy-seven institutions examined how accurately physicians' test orders on inpatients were transmitted to the laboratory. Written orders could be found on laboratory requisitions or the medical record for 97.5% of 224,431 completed tests (median institution = 99.3%). Participants indicated that entry of extra tests into a hospital computer was the most common reason for completing unordered tests. In a multivariate analysis, factors associated with completing unordered tests were the lack of a policy requiring nursing staff to recheck computer orders against the medical record, average census of 301-450 patients, College of American Pathologists accreditation, and the use of preprinted "checkoff" order forms. Overall, 97.1% of 225,457 test orders were completed by the laboratories (median institution = 98.1%). Factors associated with not completing ordered tests were the lack of a policy requiring staff to check computer orders, teaching hospital status, and urban hospital location. Several interventions commonly thought to improve communication of orders were not found to affect performance. These results indicate that many institutions have a problem accurately transmitting test orders to their clinical laboratories.

Duplicate laboratory orders: a College of American Pathologists Q-Probes study of thyrotropin requests in 502 institutions.

OBJECTIVE: To examine the frequency and cause of duplicate thyrotropin (TSH) testing. METHODS: Five hundred two institutions, ranging in size from fewer than 100 to more than 600 beds, examined consecutively processed TSH assays to identify duplicate orders. Duplicates were defined as two or more TSH tests performed within 7 days. All together, participants submitted data on 221,476 TSH orders. RESULTS: The median institution reported that 1.5% of TSH tests duplicated a TSH order that had been received from the same patient within the previous 7 days. Ten percent of institutions reported that 4.5% or more of their TSH tests were duplicates. Institutions with higher duplicate rates tended to be larger (ie, they had a greater number of occupied beds) and to have duplicate tests that were more likely to be ordered by a physician other than the one who ordered the initial test. Participants reported that for 19% of duplicate orders, physicians were unaware that the first test had been ordered. Physicians also indicated that duplicate assays were ordered to see if a previous result had changed (15%) or to check on the accuracy of a previous result (13%). Participants reported that 11% of duplicate TSH assays that their laboratory performed had apparently never been ordered. CONCLUSIONS: A large number of institutions are performing duplicate TSH tests that, in most cases, appear to be medically unnecessary. Institutions aiming to reduce the frequency of duplicate testing should consider policies that decrease the opportunity for different physicians to order tests on a single patient and should increase the accuracy with which physician orders are transmitted to the laboratory.

The use and abuse of routine stool microbiology: a College of American Pathologists Q-probes study of 601 institutions.

OBJECTIVE: To examine the efficiency with which physicians use routine stool microbiology tests. DESIGN: Questionnaire and structured review of 100 consecutive stool bacteriology and parasitology examinations at each participating institution. SETTING: Six hundred one institutions enrolled in the College of American Pathologists Q-probes Program. RESULTS: Of 59500 bacteriology specimens, 3808 (6.4%) contained a pathogen. The vast majority (99%) of bacterial pathogens were detected in either the first or second specimen submitted. Almost 40% of inpatient specimens were collected after the third day of hospitalization, but only 0.6% of these specimens were positive for enteric pathogens that had not been previously recovered. More than half of the laboratories reported having no limits on the number of bacteriology specimens per patient that could be submitted for testing, and fewer than 8% of laboratories rejected specimens from inpatients after a certain number of days in the hospital. The frequency with which laboratories performed tests for Clostridium difficile varied widely. Of 58500 parasitology specimens, 1463 (2.5%) contained a pathogen; 97.6% of pathogens were detected by the second stool specimen, and 99.8% were detected by the third specimen. Only 0.7% of specimens from inpatients hospitalized more than 4 days contained a new pathogen. CONCLUSIONS: We recommend that no more than two bacteriology specimens and no more that two or three parasitology specimens be processed per patient without consultation. Standard stool examination for a bacterial pathogens has a low yield and should not be performed after 3 days of hospitalization. Likewise, parasitology examinations should not be performed after 4 days of hospitalization.

Teaching pathology residents to evaluate the quality of laboratory testing.

In-house reviews of laboratory quality have become an important component of efforts to preserve the caliber and breadth of laboratory services in the face of contracting budgets. We describe a training rotation in quality assessment that provides pathology residents with the skills necessary to systematically investigate the quality of laboratory testing. The rotation has been of mutual benefit to our residents and our institution, serving as an introduction to a variety of analytic techniques and as a mechanism for documenting and improving the performance and efficiency of our hospital laboratory.

Test-ordering by multiple physicians increases unnecessary laboratory examinations.

In modern teaching hospitals, patients typically receive direct care from a succession of different physicians, each of whom may order diagnostic tests on the same patient. We examined the association of test-ordering by multiple physicians with unnecessary duplication of 20-test chemistry profiles in 198 consecutively admitted patients. In a multivariate regression model, the number of duplicate chemistry profiles ordered for a patient was significantly correlated with the number of physicians ordering profiles after controlling for the overall intensity of profile testing. In a case-control analysis comparing duplicate with nonduplicate profiles, redundant tests were significantly more likely to have been ordered by a new physician who had not ordered a patient's previous profile than by the same physician who had ordered the previous chemistry panel. We conclude that test ordering by multiple physicians, the prevalent pattern in almost all teaching hospitals, predisposes to unnecessary laboratory examinations.

Laboratory computer availability: a College of American Pathologists Q-probes study of computer downtime in 422 institutions.

OBJECTIVE: To determine the frequency, duration, and impact of computer downtime on laboratory operations. METHODS: Four hundred twenty-two laboratories monitored the frequency of computer system downtime and other computer malfunctions over a period of 30 days. Participants classified each instance of unavailability according to its cause, duration, and consequences. In all, data from 11 967 instances were submitted for analysis. RESULTS: During the 30-day study period, the participating institutions experienced a median of eight episodes in which all or a primary computer function was unavailable. The cumulative median duration of downtime during these 30 days was 14.3 hours. The most unfortunate 10% of participants reported having 44 or more episodes in which all or a primary computer function was lost during the 30 days, for a cumulative duration of 77.7 or more hours of system unavailability. Computer installations that served two or more full-service laboratories were significantly more likely to experience unscheduled loss of all or a primary computer function than were sites that served only one laboratory, and unscheduled events were more likely to be of longer duration. Participants reported that 1.3% of downtime events required the use of staff overtime to perform required work. Overtime was more likely with longer-than-average periods of downtime and losses that had not been scheduled. Of all the downtime instances, 0.2% led to the release of inaccurate results, and 0.1% led to an adverse clinical outcome. These events were associated with software failure, unscheduled downtime, a site's overall frequency of downtime, particular software vendors, and not having installed a software patch in the previous 1000 days. CONCLUSIONS: The frequency of laboratory computer downtime varies widely among institutions and is occasionally associated with adverse clinical outcomes or additional staff expense.

Employee competence and performance-based assessment: A college of American pathologists Q-probes study of larboratory personnel in 522 institutions.

OBJECTIVE: To survey employee competence assessment practices in departments of pathology and laboratory medicine and provide suggestions for improvement. DESIGN: A 3-part study consisting of a questionnaire about current competence assessment practices, an evaluation of compliance with stated competence assessment practices using personnel records of 30 employees, and a written appraisal of competence of 5 specimen-processing staff members per institution. SETTING: A total of 522 institutions participating in the College of American Pathologists 1996 Q-Probes program. MAIN OUTCOME MEASURES: Institutional competence assessment practices, compliance of each institution with their own practices, and determination of competence of specimen-processing personnel. RESULTS: Of the participating institutions, 89.8% had a written competence plan and 98.1% reported reviewing employee competence at least yearly. General competence was reviewed by direct observations (87.5%), review of test or quality control results (77.4%), review of instrument preventive maintenance (60.0%), written testing (52.2%), and/or other methods (20.8%). In 8.6% of institutions, employees who failed competence assessment were not allowed to continue their usual work. On review of records of 14 029 employees for adherence to the laboratory's general competence plan, adherence was 89.7% for direct observations, 85.8% for review of quality control and test results, 78.0% for review of instrument records, and 74.0% for written testing. Employee failure rate ranged from 0.9% to 6.4%, depending on the competence evaluated. Adherence to an institution's plan was 90.4% for new employees, 93.1% for computer skills, 95.8% for laboratory safety, and 92.1% for continuing education. When a written competence assessment was given to 2853 specimen-processing staff members, 90.0% responded satisfactorily. CONCLUSIONS: Opportunities for improvement in employee competence assessment are numerous, and we provide several specific suggestions.

Six-year trends in productivity and utilization of 73 clinical laboratories: a College of American Pathologists Laboratory Management Index Program study.

OBJECTIVES: To describe longitudinal trends in the efficiency, labor productivity, and utilization of clinical laboratories in the United States. METHODS: Financial and activity data were prospectively collected from 73 clinical laboratories continuously enrolled in the College of American Pathologists Laboratory Management Index Program from 1994 through 1999. Each laboratory reported quarterly on its costs, labor inputs, and test activity using uniform data definitions. RESULTS: During the 6-year study period, there was a significant increase in laboratory labor productivity (2.1% more tests/full-time equivalent/y; P <.001). Productivity increases were offset by increasing labor expense (1.5%/full-time equivalent/y; P <.001), consumable expense (1.7%/on-site test/y; P =.005), and blood expense, which comprised more than 10% of laboratory expenses by 1999 (4.4% increase/y; P <.001). As a result, overall expense per test showed no significant change in non-inflation-adjusted dollars. Reference laboratory expense per test did not change significantly during the study period; the proportion of tests sent to reference laboratories grew slightly (0.06% increase/y; P <.001). Test volume of the median laboratory grew by 5442 tests per year (2.3% annual increase; P <.001), while the proportion of testing from inpatients declined by 1.7% per year (P <.001). Inpatient test utilization declined on a discharge basis (annual decline of 1.2 tests/inpatient discharge; P <.001) and on a per diem basis (annual decline of 0.08 tests/inpatient day; P =.002). Inpatient laboratory expense declined on a discharge basis (annual decline of $2.40 or 1.3% per discharge; P <.001), but did not change significantly per inpatient day. Most of the reduction in the expense per discharge occurred during 1994-1996. CONCLUSIONS: Between 1994 and 1999, clinical laboratories in the United States experienced significant changes in the cost of operations, utilization, and labor productivity. Laboratory administrators who compare local institutional performance with that of peers are advised to use current or forward-trended peer data. Quarter-to-quarter improvement in many measures of laboratory financial activity may not signal a superior operation, as performance of the whole industry appears to be improving.

Gynecologic cytology turnaround time. A College of American Pathologists Q-Probes Study of 371 laboratories.

OBJECTIVES: To determine the turnaround time for gynecologic cytology in a large sample of laboratories and to identify laboratory and specimen characteristics associated with better and worse performance. DESIGN AND SETTING: Prospective evaluation of gynecologic cytology turnaround times in 371 laboratories. MAIN OUTCOME MEASURE: Gynecologic cytology case turnaround time. RESULTS: Three hundred seventy-one laboratories submitted information regarding laboratory characteristics and processes, and turnaround times of 66 042 gynecologic cytology cases. Half of the participating laboratories had mean turnaround times of 6 calendar days or less and were able to complete 90% of their cases within 8 calendar days. Ten percent of participants had mean turnaround times greater than 13 days and required 19 or more days to report 90% of their cases. Longer turnaround times were associated with the use of reference laboratories for all or part of the evaluation; contacting the physician's office for additional information; using cytotechnology students, residents, or fellows in the evaluation; and providing service on the weekend. CONCLUSION: Practice patterns contribute to the long turnaround times for gynecologic cytology found in some laboratories and may be improved by local site-specific process analysis.