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* Context.--Estrogen receptor and progesterone receptor status is assessed on all newly diagnosed, invasive breast carcinomas and in recurrences to determine patient eligibility for hormonal therapy, but 10% to 20% of estrogen receptor and progesterone receptor test results are discordant when tested in multiple laboratories. Objective.--To define the analytic (technical) validation requirements for estrogen receptor and progesterone receptor immunohistochemistry assays used to select patients for hormonal therapy. Data Sources.--Literature review and expert consensus. Conclusions.--A standardized process for initial test validation is described. We believe adoption of this process will improve the accuracy of hormone-receptor testing, reduce interlaboratory variation, and minimize false-positive and false-negative results. Required ongoing assay assessment procedures are also described. (Arch Pathol Lab Med. 2010;134:930-935), Validation of a clinical laboratory test means confirmation, through a defined process, that the test performs as intended or claimed. Proper validation provides reasonable, but not absolute, assurance that a [...]

* Context.--A variety of document control practices are required of clinical laboratories by US regulation, laboratory accreditors, and standard-setting organizations. Objective.--To determine how faithfully document control is being implemented in practice and whether particular approaches to document control result in better levels of compliance. Design.--Contemporaneous, structured audit of 8814 documents used in 120 laboratories for conformance with 6 generally accepted document control requirements: available, authorized, current, reviewed by management, reviewed by staff, and archived. Results.--Of the 8814 documents, 3113 (35%) fulfilled all 6 document control requirements. The requirement fulfilled most frequently was availability of the document at all shifts and locations (8564 documents; 97%). Only 4407 (50%) of documents fulfilled Clinical Laboratory Improvement Amendment requirements for being properly archived after updating or discontinuation. Policies and procedures were more likely to fulfill document control requirements than forms and work aids. Documents tended to be better controlled in some laboratory sections (eg, transfusion service) than in others (eg, microbiology and client services). We could not identify document control practices significantly associated with higher compliance rates. Conclusions.--Most laboratories are not meeting regulatory and accreditation requirements related to control of documents. It is not clear whether control failures have any impact on the quality of laboratory results or patient outcomes. (Arch Pathol Lab Med. 2009;133:942-949), The term document control refers to a group of information-management practices related to documents. There is no uniformly accepted definition of what constitutes document control in the clinical laboratory industry. [...]

* 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., A high-quality organization meets customers' needs. Clinical laboratory managers often assume they know what customers want (accuracy, precision, speed, economy, etc) and set out to directly measure laboratory performance in [...]

Context.--Hospital accreditors are placing increased emphasis on the timeliness with which critical laboratory results are reported to caregivers. Objective.--To measure the speed of critical result notification at a group of laboratories, identify factors associated with faster reporting, and place findings in the context of the time required to transport and test specimens and to correct critical abnormalities. Design.--Contemporaneous review of 3545 inpatient and emergency department critical result notifications in 121 laboratories enrolled in the College of American Pathologists Q-Probes program. Results.--The median laboratory required a median of 5 minutes for staff to notify someone about a critical result once testing was complete. Laboratories affiliated with smaller institutions (P =.01), rural laboratories (P =.001), and sites that called results before releasing them from the laboratory computer (P =.02) were able to notify caregivers more quickly. There was variation among institutions in the time it took to notify caregivers (interquartile range, 1.5-8 minutes). At the median facility, notification took place 56.5 minutes after the specimen had been collected. Conclusions.--The time required to notify caregivers of critical laboratory result is a small proportion of the time taken to collect and test specimens or the time that has been reported for caregivers to correct abnormalities. Although failure to notify caregivers of critical results may represent an important patient safety vulnerability, the timeliness of laboratory notification is a minor contributor to total test turnaround time at most institutions., Many physicians believe that timely notification of critical laboratory results can pivotally affect patient outcome. (1) Sometimes referred to as critical values or panic values, critical results generally comprise less [...]

* 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., Errors entering laboratory test orders into computer systems waste health care resources and can delay patient evaluation and management. Previous Q-Probes studies conducted by the College of American Pathologists (CAP) [...]

Context.--Eighty-two million surgical pathology and cytology reports were issued in the United States during 2007; a subset of these reports will be misunderstood by readers. Recent attention has focused on standardizing the content of pathology reports, particularly for common malignancies, to facilitate transmission of required information. Comparatively little attention has been focused on the format of reports--the arrangement of headlines, text blocks, and other report elements to optimize communication. Objective.--To provide guidance to report designers and authors about how to format reports to maximize the speed, fidelity, and ease of information transfer. Data Sources.--Review of relevant literature from commercial publishing and aviation and the fields of cognitive psychology and pathology, supplemented with an analysis of 10 000 pathology reports and the author's personal experience as a practicing pathologist. Conclusions.--Four evidence-based and time-tested principles can help pathologists format information to communicate more effectively: (1) use of diagnostic headlines to emphasize key points, (2) maintenance of layout continuity with other reports and over time, (3) optimization of information density for readers, and (4) reduction of extraneous information or "clutter." Practical advice is also provided to help pathologists minimize corruption of formatting as reports are transmitted electronically between medical information systems., In 2007 an estimated 27 million surgical pathology reports and 55 million cytology reports were issued in the United States. (1) The anatomic pathology market in the United States has [...]

* Context.--Standards have been developed for establishing reference intervals, but little is known about how intervals are determined in practice, interlaboratory variation in intervals, or errors that occur while setting [...]

* 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 [is less than] .001). Productivity increases were offset by increasing labor expense (1.5%/ full-time equivalent/y; P [is less than] .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 [is less than] .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 [is less than] .001). Test volume of the median laboratory grew by 5442 tests per year (2.3% annual increase; P [is less than] .001), while the proportion of testing from inpatients declined by 1.7% per year (P [is less than] .001). Inpatient test utilization declined on a discharge basis (annual decline of 1.2 tests/inpatient discharge; P [is less than] .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 [is less than] .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. (Arch Pathol Lab Med. 2001;125:1153-1161), A College of American Pathologists Laboratory Management Index Program Study Financial management of clinical laboratory operations requires accurate and timely information about laboratory test activity, staffing, and expense. Most commonly, [...]

Context.—Eighty-two million surgical pathology and cytology reports were issued in the United States during 2007; a subset of these reports will be misunderstood by readers. Recent attention has focused on standardizing the content of pathology reports, particularly for common malignancies, to facilitate transmission of required information. Comparatively little attention has been focused on the format of reports—the arrangement of headlines, text blocks, and other report elements to optimize communication. Objective.—To provide guidance to report designers and authors about how to format reports to maximize the speed, fidelity, and ease of information transfer. Data Sources.—Review of relevant literature from commercial publishing and aviation and the fields of cognitive psychology and pathology, supplemented with an analysis of 10 000 pathology reports and the author's personal experience as a practicing pathologist. Conclusions.—Four evidence-based and time-tested principles can help pathologists format information to communicate more effectively: (1) use of diagnostic headlines to emphasize key points, (2) maintenance of layout continuity with other reports and over time, (3) optimization of information density for readers, and (4) reduction of extraneous information or "clutter." Practical advice is also provided to help pathologists minimize corruption of formatting as reports are transmitted electronically between medical information systems. [ABSTRACT FROM AUTHOR]

Presents a number of medical abstracts as of July 4, 2001. Outcome in patients with eating disorders; Alcohol abuse, cognitive impairment, and mortality among older people; HIV-infected pregnant women and vertical transmission in Europe since 1986; More.

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.