Physician satisfaction and emergency department laboratory test turnaround time.

OBJECTIVES: To determine the length of time for the components of the emergency department (ED) turnaround time (TAT) study in 1998 and to ascertain physician satisfaction concerning laboratory services to the ED. METHODS: Using forms supplied by the College of American Pathologists Q-Probes program, participants conducted a self-directed study of ED TAT over a 4-week period. Data requested included various times of day associated with the ordering, specimen collection, laboratory receipt, and result-reporting stages of stat ED TATs for potassium and hemoglobin. Additionally, practice-related questions associated with the laboratory were asked. Participating laboratories also provided a physician satisfaction survey for up to 4 physicians who were users of ED services. Results of both the TAT study and the physician satisfaction survey were returned by mail. Participants were drawn from the 952 hospital laboratories enrolled in the 1998 College of American Pathologists Q-Probes study on ED TAT. The main outcome measures included the components of the ED TAT process, factors associated with decreases in ED TAT, and the results of the physician satisfaction survey. RESULTS: Six hundred ninety hospital laboratories (72.4% response rate) returned data on up to 18 230 hemoglobin and 18 259 potassium specimens. Half of these laboratories responded that 90% of potassium tests were ordered and reported in 69 minutes or less, whereas the TAT for 90% of hemoglobin results was 55 minutes or less. Comparison of the components of TAT for both potassium and hemoglobin with similar studies done in 1990 and 1993 showed no change. Factors found to statistically contribute to faster TATs for both tests were laboratory control of specimen handling and rapid transport time. When whole blood specimens were used for potassium determination, TAT improved. Emergency department physicians chose the study-defined lower satisfaction categories of Often, Sometimes, Rarely, and Never for the questions concerning the laboratory being sensitive to stat testing needs (39.1%) and meeting physician needs (47.6%). Many of the physicians surveyed believed that laboratory TAT caused delayed ED treatment more than 50% of the time (42.9%) and increased ED length of stay more than 50% of the time (61.4%) when compared with other specialty users of the ED. CONCLUSIONS: Laboratory ED TATs have remained unchanged for almost a decade. Emergency department physicians are not satisfied with laboratory services. Although it appears that one issue may relate to the other, the interaction between the laboratory and the ED is quite complex and has been evolving for at least 30 years. Improvement in interoperability between the departments is essential for operational efficiency and patient care. Effective communication channels need to be established to achieve these goals.

Characterization of microorganism identification in the United States in 1996.

CONTEXT: The National Inventory of Clinical Laboratory Testing Services (NICLTS) was designed to give an unbiased estimate of all patient testing performed by laboratories registered under the Clinical Laboratory Improvement Amendments in 1996. OBJECTIVE: Survey data were used to develop a profile of laboratory testing primarily intended to identify microorganisms or antibodies to these microorganisms. DESIGN: Estimates of the extent of microorganism identification were derived from the NICLTS database by identifying associated tests and methods. The volumes for tests performed at locations that primarily prepared blood components for distribution were excluded. Organisms of public health importance were identified from the National Notifiable Disease list maintained by the Centers for Disease Control and Prevention. PARTICIPANTS: Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing in 1996. OUTCOME MEASURE: Estimated volumes and associated confidence limits by test, method, specimen type, public health importance, and testing location. RESULTS: Excluding testing of the blood supply, 315 million tests (95% confidence limits, 280-354 million tests) were performed in the United States for microorganism identification. Those tests for which public health consensus requires national reporting represented 38% of this total. Although hospitals performed 46% of all microorganism identification, they only performed 33% of the testing for microorganisms of public health importance. Independent and specialty laboratories performed 38% of all testing but 65% of the testing for microorganisms of public health importance. Direct methods (methods not involving culture) were used in 77% of the tests for microorganisms of public health importance and in 42% of all identification tests. CONCLUSIONS: The distribution of microorganism identification testing found using NICLTS data is consistent with plans to modernize the public health surveillance system in the United States.

Clinical laboratory test menu changes in the Pacific Northwest: an evaluation of the dynamics of change.

To characterize changes in on-site test volumes and test menus and to identify the factors influencing these changes, we gathered information from a network of clinical laboratories in the Pacific Northwest in 1996 and again in 1999. The two studies allow for a snapshot of these changes for specific periods and also an evaluation of the dynamics of change in clinical laboratory practices between 1994 and 1999. Throughout this 5-year span, business-related decisions have had the primary influence in determining where testing is performed. The overwhelming factor in deciding to retain certain tests on-site is whether the patient test volume is adequate to be cost-effective. Decisions to add or delete tests also are closely tied to marketplace competition, costs of testing equipment and supplies, and ability to obtain adequate reimbursement. Laboratory regulations have had a decreasing influence on on-site test menus in the network laboratories and particularly in physician office laboratories (POLs). The use of waived tests has increased dramatically, with POLs accounting for the majority of laboratories that added waived tests.

Monitoring quality requires knowing similarity: the NICLTS experience.

Laboratory tests can appear similar from the test names but may be vastly different in the way a result is achieved. Currently, for example, cervical cancer evaluation is moving from the traditional Papanicolaou smear to new smear preparation technologies and testing for human papillomavirus. Monitoring the quality of these three tests, and of all tests, requires that computers "understand" how these tests are similar and different. The National Inventory of Clinical Laboratory Testing Services (NICLTS) found that the approximately 20,000 most commonly performed tests used combinations of 635 analytes and 1,699 methods. These analytes and methods provide the base data for a semantic model that makes the requisite similarities and differences explicit. The semantic relationships, e.g. the method principle enabling a test and the nature of the substance tested, were evaluated against empirically derived, uni-dimensional relations. The resulting multi-dimensional semantic model expands our ability to monitor the quality of laboratory testing in the face of rapid change. Use of common terminology tools and representations enable the creation, expansion and reuse of this model beyond the needs of NICLTS.

Quality control of test systems waived by the Clinical Laboratory Improvement Amendments of 1988. Perceptions and practices.

CONTEXT: Recent advances in laboratory testing technology have resulted in a rapidly increasing number of test systems targeted for physician office, point-of-care, and home health care settings. With enhanced error detection mechanisms and unitized reagents, these new systems simplify the testing process and the assessment of analytical test performance. Many also meet the criteria set by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to qualify as waived test systems, and laboratories using only waived tests are subject to very limited regulatory oversight. OBJECTIVE: To evaluate use patterns and perceptions about quality control requirements with respect to waived testing. DESIGN AND SETTING: Survey of a network of 431 hospital, independent, and physician office laboratories in the US Pacific Northwest. RESULTS: Responding laboratories (n = 221) were taking advantage of the availability of waived tests and using them to make definitive diagnoses. We found considerable differences between quality control practices and the laboratories' perceptions of quality control requirements. Most respondents were performing traditional quality control on waived tests, influenced by their interpretation of regulations, the intended use of the test, and the testing personnel employed. CONCLUSIONS: Technology optimized for alternate quality control can represent an improvement in ease of use while meeting expectations for accuracy and providing relief from regulatory burdens. However, laboratory personnel exhibit confusion in applying new quality control systems.

National Inventory of Clinical Laboratory Testing Services (NICLTS). Development and test distribution for 1996.

CONTEXT: A statistically valid inventory of the distribution, both geographic and by laboratory type, of clinical and anatomical laboratory testing in the United States is needed to assess the impact of the Clinical Laboratory Improvements Amendments of 1988 and to provide information for other health care and public health policy decisions. OBJECTIVE: To present initial US laboratory testing volume data compiled by the National Inventory of Clinical Laboratory Testing Services. DESIGN: Stratified random sample of laboratories performing testing in 1996 with data on the number of laboratory tests performed, identified by method and analyte. Data were collected by field tabulators (moderate- or high-complexity laboratories) or through a mail/telephone survey (waived or provider-performed microscopy laboratories) for each site. PARTICIPANTS: Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing during 1996. MAIN OUTCOME MEASURE: Laboratory testing distribution for 1996 in the United States by analyte, method, and specimen type. RESULTS: An overall response rate of 79% provided data from 757 moderate- or high-complexity laboratories and 1322 waived or provider-performed microscopy laboratories. The estimated total US testing volume for 1996 was 7.25 +/- 1.09 billion tests. Laboratories performing complex testing, defined as greater than 16 method/analyte/specimen type combinations, comprised 16% of the US laboratories by survey site, but performed 80% (95% confidence limits, 43% to 100%) of the testing volume. Glucose analysis was the most frequently performed test. Automated hematology and chemistry analyzers were the most frequently used methods. CONCLUSIONS: A statistically valid, consistent survey of the distribution of US laboratory testing was obtained. Simple analysis of these data by laboratory type and geographic region can provide insights into where laboratory testing is performed. The study design allows extensions that will facilitate collection of additional data of importance to public health and medical care delivery.

Access to laboratory testing: the impact of managed care in the Pacific Northwest.

Patient access to health-care services has become an important issue owing to the growth of managed care organizations and the number of patients enrolled. To better understand the current issues related to access to laboratory testing, with a particular focus on the impact of managed care, we gathered information from a network of clinical laboratories in the Pacific Northwest. Two questionnaires were sent to the 257 Laboratory Medicine Sentinel Monitoring Network participants in November 1995 and March 1996 to investigate trends in the availability and utilization of laboratory testing services and changes in onsite testing menus. Although laboratories reported that managed care was a factor in their decisions about laboratory practices, testing decisions were more likely made for business reasons, based on medical practice changes and marketplace influences not associated with managed care.

Estimating costs and turnaround times: presenting a user-friendly tool for analyzing costs and performance.

A review of the literature finds wide variation in the costs and turnaround times associated with central laboratories, satellite laboratories, and point-of-care testing. The greatest variation occurs when comparing options for blood gas and electrolyte testing. Some variation can be attributed to costing methods, but substantial variation arises from circumstances under which testing is undertaken in specific sites. These circumstances include the site-specific costs of resources used in testing, volumes of testing conducted, and performance requirements demanded by the users of laboratory information.

Cost analysis for decision support: the case of comparing centralized versus distributed methods for blood gas testing.

Distributed testing, performed in satellite laboratories or at the bedside, is proliferating within healthcare systems. Users prefer it, and it is fast and convenient. A quick look at marginal costs, however, suggests that cost differentials between distributed and centralized testing may be prohibitive. Sound decision making on the part of health system administrators requires a broader understanding of the costs and benefits of testing options. This study illustrates an approach to cost analysis for decision support where opportunity costs (the costs associated with the next best alternative) provide the basis for decision making. Health system administrators need to understand the opportunity costs involved in their decisions to avoid being misled by analyses that omit important cost elements from consideration. We describe approaches to determining the costs of "stat" laboratory testing options. The costs of various blood gas testing options are compared among a central blood gas laboratory, two satellite laboratories, and point-of-care analysis. Opportunity costs were determined by modeling the substitution of one testing process for another. The cost analysis finds that a judicious mix of alternate-site testing methods can generate annual savings of between $250,000 and $330,000, and at the same time reduce test reporting times. In other words, technology that superficially appears more costly can deliver better service with lower costs.

Continuous quality improvement for point-of-care testing using background monitoring of duplicate specimens.

CONTEXT: Despite compliance with quality control standards, concerns remain as to the accuracy and reliability of point-of-care testing. OBJECTIVE: To assess a practical method for quality improvement using the context in which point-of-care testing is done. DESIGN: Quality measures for point-of-care testing, making use of natural duplication of results obtained by other testing methods, were used to monitor testing quality and evaluate quality improvement interventions. SETTING: Five adult intensive care units (total of 88 beds) in a large academic medical center, using point-of-care testing for blood gases, electrolytes, and hematocrit levels. PARTICIPANTS: Nurses performing bedside testing and laboratory personnel assigned the responsibility for supervising their performance. INTERVENTIONS: Quality of testing was monitored continuously, and, where problems were identified, training and support interventions implemented, and their effects evaluated. MAIN OUTCOME MEASURES: Improvement in correlation coefficients and regression parameters of point-of-care hematocrit and potassium testing results compared with contemporaneous results from the core laboratory. RESULTS: The initial survey found point-of-care potassium levels were tightly correlated with core laboratory results (r = 0.958). Baseline correlation coefficients and regression parameters for point-of-care hematocrit levels compared with core laboratory values varied widely from unit to unit. The intensive care units with the highest variances of bedside vs core laboratory testing received targeted interventions. Follow-up yielded evidence of dramatic improvement; 1 unit experienced an increase in correlation from 0.50 to 0.95. CONCLUSIONS: The findings suggest that, when point-of-care testing is highly dependent on operator technique, targeted interventions can resolve problems and provide reliable results at the bedside.

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.

Using outlier events to monitor test turnaround time.

OBJECTIVES: To determine the causes of excessive test turnaround time (TAT) and to identify methods of improvement by studying reasons for those tests reported in excess of 70 minutes from the time the test was ordered (ie, outliers). DESIGN: Self-directed data-gathering of stat outlier TAT events from intensive care units and emergency departments, with descriptive parameters associated with each event and additional descriptive parameters associated with the participant. PARTICIPANTS: Laboratories enrolled in the 1996 College of American Pathologists Q-Probes program. MAIN OUTCOME MEASURES: Components associated with outlier TAT events and outlier TAT rates. RESULTS: Four hundred ninety-six hospital laboratories returned data on 218 551 stat tests, of which 10.6% had TATs in excess of 70 minutes. Ten percent of stat emergency department tests and 14.7% of stat intensive care unit tests were outliers. Major areas in which delays occurred were test ordering, 29.9%; within-laboratory (analytic) phase, 28.2%; collection of the specimen, 27.4%; postanalytic phase, 1.9%; and undetermined, 12.5%. The type of test performed was a significant factor and was independent of location: Chemistry-Multiple Test appeared most frequently ( approximately 40%), followed closely by Hematology-Complete Blood Count (approximately 20%) and Chemistry-Single Test ( approximately 18%). Factors of outlier TAT components for intensive care unit specimens were identified using statistical modeling and included hour of day, type of health care personnel collecting specimen, performing the test in a stat laboratory, and reason for delay. Outlier rates were not associated with any identified factors. The practice parameters of laboratories with outlier rates in the lowest 10th percentile significantly differed from those with rates in the top 10th percentile in test request computerization, report methods, and ordering methods. CONCLUSIONS: We observed that outlier analysis yields new information, such as type of test and reason for delay, concerning test delays when compared with TAT determination alone. Laboratories experiencing stat test TAT problems should use this tool as an adjunct to routine TAT monitoring for identifying unique causes of delay.

Evaluation of vocabularies for electronic laboratory reporting to public health agencies.

Clinical laboratories and clinicians transmit certain laboratory test results to public health agencies as required by state or local law. Most of these surveillance data are currently received by conventional mail or facsimile transmission. The Centers for Disease Control and Prevention (CDC), Council of State and Territorial Epidemiologists, and Association of Public Health Laboratories are preparing to implement surveillance systems that will use existing laboratory information systems to transmit electronic laboratory results to appropriate public health agencies. The authors anticipate that this will improve the reporting efficiency for these laboratories, reduce manual data entry, and greatly increase the timeliness and utility of the data. The vocabulary and messaging standards used should encourage participation in these new electronic reporting systems by minimizing the cost and inconvenience to laboratories while providing for accurate and complete communication of needed data. This article describes public health data requirements and the influence of vocabulary and messaging standards on implementation.

Early morning blood collections: A College of American Pathologists Q-Probes study of 657 institutions.

OBJECTIVE: To determine specimen collection and report times, and delivery, analytic, and total turnaround times (TAT) for routine early morning blood collections. DESIGN: The study was a 2-part College of American Pathologists Q-Probes study. In the first part, participants recorded specimen collection times, receipt in testing laboratory times, and test report times for all routine hemoglobin and potassium samples collected between the hours of 1 AM and 10:30 AM on one intensive care unit and one nonintensive care unit for a 1-week period. In the second part, participants provided information about their specimen collection, delivery, processing, analytic, and reporting practices in a questionnaire. SETTING: An intensive care unit and a nonintensive care unit in 657 institutions. MAIN OUTCOME MEASURES: Median collection time, delivery time, analytic time, total turnaround time, and report time. RESULTS: Median institutional collection times ranged from 3 AM to 9:20 AM, with the institution at the 50th percentile reporting a median collection time of 6 AM. Median institutional report times ranged from 3:45 AM to 12: 20 PM, with the institution at the 50th percentile reporting a median report time of 7:23 AM. Median delivery, analytic, and total turnaround times for the median institution were 25, 42, and 73 minutes, respectively. CONCLUSIONS: Factors shown to correlate with shorter total turnaround times were rural locations, a lower collections to full-time equivalent ratio, intensive care unit specimens, plasma for potassium measurements, the practice of delivering each specimen as it is collected, pneumatic tube delivery system, direct delivery route, and continuous versus batch testing.

Evaluating stat testing options in an academic health center: therapeutic turnaround time and staff satisfaction.

We compared centralized vs distributed methods for delivering "stat" test results for blood gas, glucose, and electrolyte assays. The parameters for comparison were as follows: (a) laboratory turnaround time (TAT), (b) therapeutic TAT, and (c) staff satisfaction. Therapeutic TAT, defined as the time from the initiating order to the receipt of the result and the implementation of any indicated change in treatment, was obtained by direct observation of testing procedures at the bedside and timing each step in the process. Observing therapeutic TAT yields information on the impact of laboratory testing methods in the context of clinical decision making. Therapeutic TAT was 1-2 min shorter for bedside testing compared with a satellite laboratory and 9-14 min shorter in the satellite laboratory compared with centralized testing. Satellite laboratories received the highest staff satisfaction scores, followed by bedside testing, with the central laboratory receiving the lowest scores.

Quality control practices for calcium, cholesterol, digoxin, and hemoglobin: a College of American Pathologists Q-probes study in 505 hospital laboratories.

OBJECTIVE: To assess quality control (QC) practices and their impact on hospital laboratories using the College of American Pathologists (CAP) Q-Probes process. DESIGN: Self-directed data gathering, using a questionnaire to determine QC practices, data input forms for 6 months retrospective quality control use and run failure rates, and input forms for 3 months prospective data concerning QC failure rates and corrective steps taken. Participants submitted data for four analytes: calcium, cholesterol, digoxin, and hemoglobin. PARTICIPANTS: Laboratories enrolled in the 1994 CAP Q-Probes program. MAIN OUTCOME MEASURES: Retrospective and prospective QC failure rates compared with QC protocols and the corrective steps. RESULTS: Five hundred five hospital laboratories returned various components of the study. Median retrospective run rejection rates per 1000 runs: calcium, 4.3; cholesterol, 3.6; digoxin, 4.3; and hemoglobin, 2.4. Corresponding median prospective run rejection rates per 1000 runs: calcium, 5.8; cholesterol, 5.6; digoxin, 6.5; and hemoglobin, 3.6. Participants resolved most out-of-control events in less than 20 minutes, with no patient samples repeated. More than 95% of the time, participants resolved out-of-control events simply by repeating controls. Most participants used a single control rule based on a target mean plus or minus a multiple of the standard deviation. A few laboratories used multirule systems. CONCLUSIONS: Current testing methods yield few out-of-control events, which usually are resolved rapidly, with little impact on laboratory operation. We recommend modification and simplification of laboratory QC practices to decrease false rejection rates and to use modern instrumentation more efficiently.

Clinical laboratory test menu changes in the Pacific Northwest: 1994 to 1996.

Laboratory testing services are presently undergoing dynamic changes in response to a wide range of external factors. Government regulations, reimbursement, and managed care are only a few of the influences affecting the availability of testing services and on-site testing capabilities in hospital, independent, and physician office laboratories. Medical practice changes, marketplace influences, test technologies, and costs also play a role in determining where testing is being performed. To better understand the factors influencing clinical laboratory test volumes and menus and to identify on-site testing deemed essential in physician office laboratories, we gathered information from a network of clinical laboratories in the Pacific Northwest. Questionnaires were sent to 257 Laboratory Medicine Sentinel Monitoring Network participants in March 1996. In the past 2 years, changes in on-site test volumes and test menus have been primarily due to medical practice changes and marketplace influences. When laboratories had a decrease in test volumes or test menu choices, the size of the patient workload and the volumes of test orders have had the greatest impact. Laboratory regulations and managed care contracts have played a role in shifting on-site testing to outside sources; however, these factors did not appear to be primary influences. Only 5% of physician office laboratories identified tests that they believed were essential for optimal patient care but did not perform on-site.

Changes in emergency department turnaround time performance from 1990 to 1993. A comparison of two College of American Pathologists Q-probes studies.

OBJECTIVE: To compare the results of a 1990 College of American Pathologists Q-Probes Emergency Department (ED) turnaround time (TAT) study with a similar study done in 1993 and to identify factors associated with TAT improvement. DESIGN: Participants gathered data over a 4-week period on the various times of day associated with the ordering, specimen-collection, laboratory-receipt, and result-reporting stages of stat tests for potassium and hemoglobin levels, using a mail-in questionnaire that also included practice parameter questions. PARTICIPANTS: Laboratories enrolled in the 1990 College of American Pathologists Q-Probes study on ED TAT and laboratories enrolled in the 1993 program ED TAT study. MAIN OUTCOME MEASURES: Components associated with shorter ED TAT and, for those participating in both the 1990 and 1993 studies, comparison with previous results. RESULTS: Six hundred fifteen hospital laboratories returned data on up to 43,521 hemoglobin and 41,989 potassium specimens. Half of these laboratories collected and reported 90% of their ED potassium results in 53 minutes or less, compared to 61 minutes or less in 1990, and reduced the corresponding median collection-to-reporting TAT for 90% of hemoglobin results from 46 minutes or less to 39 minutes or less. The fastest 10% of laboratories showed interlaboratory median order-to-report TATs of 36 and 50 minutes for potassium and hemoglobin tests, respectively. Comparisons of TATs from 277 laboratories with 1990 and 1993 data were possible. Components found to contribute statistically to improvement of ED TAT between 1990 and 1993 were laboratory control of specimen handling, rapid transport time, and monitoring. Active monitoring was particularly important when the laboratory did not control the specimen-handling process. CONCLUSIONS: Laboratories improved their control of ED TAT from 1990 to 1993 and reduced the number of TAT events exceeding 70 minutes. Internally set TAT goals, however, were not met most of the time.

Clinical laboratory quality control: a costly process now out of control.

We studied laboratory internal quality control (QC) processes using the College of American Pathologists Q-Probes program. Over 500 institutions participated, providing practices based on approximately 710,000 cholesterol, 880,000 calcium, 400,000 digoxin, and 1,180,000 hemoglobin QC results. The costs of QC included participant median control samples rates comprising 9.1, 9.4, 37.0, and 6.8% for the four analytes respectively, repeat patient test rates of 0.36% for hemoglobin to 0.65% for digoxin, and median delays in reporting results when QC exceptions occurred of 15.8 min for calcium to 24.7 min for hemoglobin. Quality control practices were complex and highly variable among participants and frequently differed from internal laboratory protocols and from long-established quality guidelines. We conclude that QC is costly, and laboratorians frequently do not follow established QC practices, in part because they are complex. To improve compliance, we believe QC practices must be simplified.