Practices for Identifying and Rejecting Hemolyzed Specimens Are Highly Variable in Clinical Laboratories.

CONTEXT: Hemolysis is an important clinical laboratory quality attribute that influences result reliability. OBJECTIVE: To determine hemolysis identification and rejection practices occurring in clinical laboratories. DESIGN: We used the College of American Pathologists Survey program to distribute a Q-Probes-type questionnaire about hemolysis practices to Chemistry Survey participants. RESULTS: Of 3495 participants sent the questionnaire, 846 (24%) responded. In 71% of 772 laboratories, the hemolysis rate was less than 3.0%, whereas in 5%, it was 6.0% or greater. A visual scale, an instrument scale, and combination of visual and instrument scales were used to identify hemolysis in 48%, 11%, and 41% of laboratories, respectively. A picture of the hemolysis level was used as an aid to technologists' visual interpretation of hemolysis levels in 40% of laboratories. In 7.0% of laboratories, all hemolyzed specimens were rejected; in 4% of laboratories, no hemolyzed specimens were rejected; and in 88% of laboratories, some specimens were rejected depending on hemolysis levels. Participants used 69 different terms to describe hemolysis scales, with 21 terms used in more than 10 laboratories. Slight and moderate were the terms used most commonly. Of 16 different cutoffs used to reject hemolyzed specimens, moderate was the most common, occurring in 30% of laboratories. For whole blood electrolyte measurements performed in 86 laboratories, 57% did not evaluate the presence of hemolysis, but for those that did, the most common practice in 21 laboratories (24%) was centrifuging and visually determining the presence of hemolysis in all specimens. CONCLUSIONS: Hemolysis practices vary widely. Standard assessment and consistent reporting are the first steps in reducing interlaboratory variability among results.

Clinical Laboratory Quality Practices When Hemolysis Occurs.

CONTEXT: Hemolyzed specimens delay clinical laboratory results, proliferate unnecessary testing, complicate physician decisions, injure patients indirectly, and increase health care costs. OBJECTIVE: To determine quality improvement practices when hemolysis occurs. DESIGN: We used the College of American Pathologists (CAP) Survey Program to distribute a Q-Probes-type questionnaire about hemolysis practices to CAP Chemistry Survey participants. RESULTS: Of 3495 participants sent the questionnaire, 846 (24%) responded. Although 85%, 69%, and 55% of participants had written hemolysis policies for potassium, lactate dehydrogenase, and glucose, respectively, only a few (46%, 40%, and 40%) had standardized hemolysis reports between their primary and secondary chemistry analyzers for these 3 analytes. Most participants (70%) had not attempted to validate the manufacturers' hemolysis data for these 3 analytes; however, essentially all who tried, succeeded. Forty-nine percent of participants had taken corrective action to reduce hemolysis during the past year and used, on average, 2.4 different actions, with collection and distribution of hemolysis data to administrative leadership (57%), troubleshooting outliers (55%), retraining phlebotomist (53%), and establishment of quality improvement teams among the laboratory and at problem locations (37%) being the most common actions. When asked to assess their progress in reducing hemolysis, 70% noted slow to no progress, and 2% gave up on improvement. Upon measuring potassium, lactate dehydrogenase, and glucose, approximately 60% of participants used the same specimen flag for hemolysis as for lipemia and icterus. CONCLUSIONS: Hemolysis decreases the quality and increases the cost of health care. Practices for measuring, reporting, and decreasing hemolysis rates need improvement.

Seven Q-Tracks monitors of laboratory quality drive general performance improvement: experience from the College of American Pathologists Q-Tracks program 1999-2011.

CONTEXT: Many production systems employ standardized statistical monitors that measure defect rates and cycle times, as indices of performance quality. Clinical laboratory testing, a system that produces test results, is amenable to such monitoring. OBJECTIVE: To demonstrate patterns in clinical laboratory testing defect rates and cycle time using 7 College of American Pathologists Q-Tracks program monitors. DESIGN: Subscribers measured monthly rates of outpatient order-entry errors, identification band defects, and specimen rejections; median troponin order-to-report cycle times and rates of STAT test receipt-to-report turnaround time outliers; and critical values reporting event defects, and corrected reports. From these submissions Q-Tracks program staff produced quarterly and annual reports. These charted each subscriber's performance relative to other participating laboratories and aggregate and subgroup performance over time, dividing participants into best and median performers and performers with the most room to improve. Each monitor's patterns of change present percentile distributions of subscribers' performance in relation to monitoring durations and numbers of participating subscribers. Changes over time in defect frequencies and the cycle duration quantify effects on performance of monitor participation. RESULTS: All monitors showed significant decreases in defect rates as the 7 monitors ran variously for 6, 6, 7, 11, 12, 13, and 13 years. The most striking decreases occurred among performers who initially had the most room to improve and among subscribers who participated the longest. All 7 monitors registered significant improvement. Participation effects improved between 0.85% and 5.1% per quarter of participation. CONCLUSIONS: Using statistical quality measures, collecting data monthly, and receiving reports quarterly and yearly, subscribers to a comparative monitoring program documented significant decreases in defect rates and shortening of a cycle time for 6 to 13 years in all 7 ongoing clinical laboratory quality monitors.

Documentation of quality control and operator training at point-of-care testing: a College of American Pathologists Q-Probes study of 106 institutions.

CONTEXT: Operator training, quality control, and proper follow-up for out-of-range quality control (QC) events are crucial steps that must be adequately performed and documented to ensure excellent patient care and regulatory compliance. OBJECTIVE: To examine point-of-care testing (POCT) personnel training and QC documentation/compliance. DESIGN: Participants in a POCT documentation study of the College of American Pathologists Q-Probes program collected data retrospectively for glucose and urine dipstick testing regarding test operators, operator competency assessment, and QC documentation. Documentation was assessed for participant adherence to 4 quality indicators: (1) whether test operator training was up to date, (2) whether the test operator names were noted in the test records, (3) whether QC was performed, and (4) whether out-of-range QC events were followed up. Data were analyzed for associations with institutional demographic and practice variables. RESULTS: The institutional median number of POCT personnel was 648 for blood glucose and 76 for urine dipstick testing, with a median number of 105 948 glucose tests and 9113 urine tests performed. Ninety-four percent (3830 of 4074) of the test operators completed training or competency assessment within the prior 12 months, 96.8% (21 603 of 22 317) of the test records documented the operator, and 95.7% (19 632 of 20 514) of the expected QC events (per institutional regulations) were documented. Approximately 3% (659 of 20 514) of the QC events were outside the designated range (an average of 6 out-of-range QC events were identified per institution [n = 106]). Of the out-of-range QC events, 92.6% (610 of 659) had documentation of appropriate follow-up. Most laboratories (176 of 179; 98.3%) violated specimen requirements by storing POCT urine specimens for less than 24 hours. CONCLUSIONS: There was greater than 90% compliance for POCT documentation and nearly 96% of expected QC events were properly documented.

Rituximab for the treatment of refractory simultaneous anti-glomerular basement membrane (anti-GBM) and membranous nephropathy.

Antibody-mediated anti-glomerular basement membrane (anti-GBM) disease occurs rarely in the presence of another B-cell disorder, membranous nephropathy. The coexistence of these two autoimmune disorders would be anticipated to require differing, specific therapies targeted to each disease process. We describe a case of concomitant membranous nephropathy and anti-GBM disease in which conventional therapy, including steroids, plasmapheresis and cyclophosphamide, failed to attenuate the anti-GBM disease, yet responded to an alternative treatment of rituximab. This B-cell directed, monoclonal, chimeric antibody treatment substantially reduced anti-GBM antibody titers and led to discontinuation of plasmapheresis, while maintaining the remission of membranous nephropathy and anti-GBM disease.

Quality improvement opportunities in gynecologic cytologic-histologic correlations: findings from the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference working group 4.

CONTEXT: Cytopathology experts, interested stakeholders, and representatives from the College of American Pathologists, the Centers for Disease Control and Prevention, the American Society of Cytopathology, the Papanicolaou Society of Cytopathology, the American Society for Clinical Pathology, and the American Society of Cytotechnology convened the Gynecologic Cytopathology Quality Consensus Conference to present preliminary consensus statements developed by working groups, including the Cytologic-Histologic Correlations Working Group 4, using results from surveys and literature review. Conference participants voted on statements, suggested changes where consensus was not achieved, and voted on proposed changes. OBJECTIVES: To document existing practices in gynecologic cytologic-histologic correlation, to develop consensus statements on appropriate practices, to explore standardization, and to suggest improvement in these practices. DATA SOURCES: The material is based on survey results from 546 US laboratories, review of the literature from 1988 to 2011, and the College of American Pathologists Web site for consensus comments and additional survey questions. CONCLUSIONS: Cytologic-histologic correlations can be performed retrospectively, during initial case review, or both. At minimum, all available slides should be reviewed for a high-grade squamous intraepithelial lesion Papanicolaou test with negative biopsies. The preferred monitor for correlations is the positive predictive value of a Papanicolaou test. Laboratories should design cytologic-histologic correlation programs to explore existing or perceived quality deficiencies.

Staffing benchmarks for clinical laboratories: a College of American Pathologists Q-Probes study of laboratory staffing at 98 institutions.

CONTEXT: Publicly available information concerning laboratory staffing benchmarks is scarce. One of the few publications on this topic summarized the findings of a Q-Probes study performed in 2004. This publication reports a similar survey with data collected in 2010. OBJECTIVE: To assess the relationship between staffing levels in specified laboratory sections and test volumes in these sections and quantify management span of control. DESIGN: The study defined 4 laboratory sections: anatomic pathology (including cytology), chemistry/hematology/immunology, microbiology, and transfusion medicine. It divided staff into 3 categories: management, nonmanagement (operational or bench staff), and doctoral (MD, PhD) supervisory staff. People in these categories were tabulated as full-time equivalents and exclusions specified. Tests were counted in uniform formats, specified for each laboratory section, according to Medicare rules for the bundling and unbundling of tests. RESULTS: Ninety-eight participating institutions provided data that showed significant associations between test volumes and staffing for all 4 sections. There was wide variation in productivity based on volume. There was no relationship between testing volume per laboratory section and management span of control. Higher productivity in chemistry/hematology/immunology was associated with a higher fraction of tests coming from nonacute care patients. In both the 2004 and 2010 studies, productivity was inseparably linked to test volume. CONCLUSIONS: Higher test volume was associated with higher productivity ratios in chemistry/hematology/immunology and transfusion medicine sections. The impact of various testing services on productivity is section-specific.

Consequences of long-term oral administration of the mitochondria-targeted antioxidant MitoQ to wild-type mice.

The mitochondria-targeted quinone MitoQ protects mitochondria in animal studies of pathologies in vivo and is being developed as a therapy for humans. However, it is unclear whether the protective action of MitoQ is entirely due to its antioxidant properties, because long-term MitoQ administration may alter whole-body metabolism and gene expression. To address this point, we administered high levels of MitoQ orally to wild-type C57BL/6 mice for up to 28 weeks and investigated the effects on whole-body physiology, metabolism, and gene expression, finding no measurable deleterious effects. In addition, because antioxidants can act as pro-oxidants under certain conditions in vitro, we examined the effects of MitoQ administration on markers of oxidative damage. There were no changes in the expression of mitochondrial or antioxidant genes as assessed by DNA microarray analysis. There were also no increases in oxidative damage to mitochondrial protein, DNA, or cardiolipin, and the activities of mitochondrial enzymes were unchanged. Therefore, MitoQ does not act as a pro-oxidant in vivo. These findings indicate that mitochondria-targeted antioxidants can be safely administered long-term to wild-type mice.

Physician satisfaction with clinical laboratory services: a College of American Pathologists Q-probes study of 138 institutions.

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.

Mitochondria-targeted antioxidants in the treatment of disease.

Mitochondrial oxidative damage is thought to contribute to a wide range of human diseases; therefore, the development of approaches to decrease this damage may have therapeutic potential. Mitochondria-targeted antioxidants that selectively block mitochondrial oxidative damage and prevent some types of cell death have been developed. These compounds contain antioxidant moieties, such as ubiquinone, tocopherol, or nitroxide, that are targeted to mitochondria by covalent attachment to a lipophilic triphenylphosphonium cation. Because of the large mitochondrial membrane potential, the cations are accumulated within the mitochondria inside cells. There, the conjugated antioxidant moiety protects mitochondria from oxidative damage. Here, we outline some of the work done to date on these compounds and how they may be developed as therapies.

The effect of continuous monitoring of cytologic-histologic correlation data on cervical cancer screening performance.

CONTEXT: The use of Papanicolaou (Pap) test cytologic-histologic correlation in quality improvement activities is not well studied. OBJECTIVE: To determine if continuous monitoring of correlation data improves performance. DESIGN: Participants in the College of American Pathologists Q-Tracks program (213 laboratories) self-reported the number of Pap test-histologic biopsy correlation discrepancies every quarter for up to 8 years. A mixed linear model determined if the length of participation in the Q-Tracks program was associated with improved performance. Main outcome measures were predictive value of a positive Pap test, Pap test sensitivity, sampling sensitivity, and proportion of positive histologic diagnoses following a Pap test diagnosis of atypical squamous cells or atypical glandular cells. RESULTS: Institutions evaluated 287,570 paired Pap test-histologic correlation specimens and found 98,424 (34.2%) true-positive Pap test correlations, 19,006 (6.6%) false-positive Pap test correlations, and 6575 (2.3%) false-negative Pap test correlations. The mean predictive value of a positive Pap test, sensitivity, screening and interpretive sensitivity, sampling sensitivity, and proportion of positive histologic diagnoses following a Pap test diagnosis of atypical squamous or glandular cells were 83.6%, 93.7%, 99.2%, 94.2%, 60.3%, and 38.8%, respectively. Longer participation was significantly associated with a higher predictive value of a positive Pap test (P = .01), higher Pap test sensitivity (P = .002), higher Pap test sampling sensitivity (P = .03), and higher proportion of positive histologic diagnoses for a Pap test diagnosis of atypical squamous cells (P < .001). CONCLUSIONS: Long-term monitoring of cytologic-histologic correlation is associated with improvement in cytologic-histologic correlation performance.

The value of monitoring human papillomavirus DNA results for Papanicolaou tests diagnosed as atypical squamous cells of undetermined significance: a College of American Pathologists Q-Probes study of 68 institutions.

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.

Clinical laboratory specimen rejection--association with the site of patient care and patients' characteristics: findings from a single health care organization.

CONTEXT: Programs to track laboratory quality have reported aggregated specimen rejection rates ranging from 0.30% to 0.83%. Because the performance of the laboratory, rather than errors, has been the focus, reasons for specimen rejection or demographic characteristics of individuals at risk for specimens of poor quality may not be fully understood. OBJECTIVE: To calculate the proportions of rejected specimens stratified by point of collections and demographic information of patients. DESIGN: Retrospective cross-sectional study. Data were retrieved from the intrainstitutional electronic databases. RESULTS: The proportions of specimens that were rejected in the emergency department and inpatient services were 2-fold and more than 5-fold higher, respectively, than for the outpatient services. Assessment of data by patients' ethnic heritages yielded no significant differences among African Americans (0.38%), Caucasians (0.38%), or "Others" (0.35%) in the outpatient services (P = .07). In the emergency department, the proportions of rejected specimens for African Americans (2.24%) were almost twice that of Caucasians (1.39%) and 30% higher than for Others (1.70%). A similar finding was observed for the inpatient services. CONCLUSIONS: The effect of ethnicity on the proportions of rejected specimens was significant for samples that were collected in the emergency department and inpatient services, even after adjusting for the total number of specimens. A constellation of factors, that is, disease severity and seriousness, practice of blood sample collection, and lesser proficiency of the nursing staff in phlebotomy may be reasons for this observation. However, the likelihood of differential care, although unlikely, cannot be refuted by the present data.

Hospital nursing satisfaction with clinical laboratory services: a College of American Pathologists Q-Probes study of 162 institutions.

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.

Point-of-care testing error: sources and amplifiers, taxonomy, prevention strategies, and detection monitors.

CONTEXT: In a survey performed 4 years ago, testing venues doing only point-of-care testing (POCT) made up 78% of sites for patient testing licensed under federal regulations. OBJECTIVES: To identify sources of POCT error, to present a classification of such errors, to suggest strategies to prevent errors, and to describe monitors that assess and reduce the frequency of errors. DESIGN: To identify sources of POCT error, large studies of error among US Federal Certificate of Waiver laboratories (CoWs) and practitioner-performed microscopy certificate holders were reviewed. To facilitate investigation and management of POCT error, a taxonomy of such errors (modified from a classification previously published by Gerald Kost) was used to identify 4 steps with error potential in each of the 3 phases (ie, preanalytic, analytic, and postanalytic) of the POCT process. To prevent observed POCT errors, 4 strategies are suggested: direct observation of instrument/method functionality, structured observation of method performance, proficiency testing/use of relevant test scenarios, and autonomation. To assess frequency of errors, a quartet of indices are introduced as detection monitors: order documentation, patient identification, specimen adequacy, and result integrity. RESULTS: Three sources of POCT error were identified: operator incompetence, nonadherence to test procedures, and use of uncontrolled reagents and equipment. Three other characteristics of many point-of-care tests amplify their risk of error: incoherent regulation, rapid availability of results, and the results' immediate therapeutic implications. Two members of the quartet of detection monitors, order documentation and specimen adequacy, are relatively difficult to measure and are controversial, but the other 2, patient identification and result integrity, are easier to assess and are relatively widely accepted. CONCLUSIONS: Point-of-care testing errors are relatively common, their frequency is amplified by incoherent regulation, and their likelihood of affecting patient care is amplified by the rapid availability of POCT results and the results' immediate therapeutic implications. The modified Kost taxonomy offers a reasonable approach to the identification of POCT errors. Direct observation of test functionality, structured observation of test performance, and testing the competence of POCT operators, as well as autonomation of devices, are strategies to prevent such errors. In this context, we suggest monitoring POCT order documentation, patient identification, specimen integrity, and result reporting to detect errors in this sort of testing.

Robotic mitral valve repair: a community hospital experience.

Robotically assisted cardiac surgery has been presented as less invasive than conventional surgery, with shortened hospital stays and faster return to daily activities. We evaluated our experience with the da Vinci robot to determine whether we could in fact demonstrate those findings. All mitral and tricuspid valve repairs were performed by the same surgeon. Cardiopulmonary bypass was performed with femoral cannulation, antegrade cardioplegia, and transthoracic aortic cross-clamping. Multiple valve repair techniques were used, including quadrant resection, cord replacement, Alfieri leaflet coaptation, and ring annuloplasty. Access was by 2 ports and a 5-cm right anterolateral thoracotomy. All annuloplasty rings were secured using surgical clips. From October 2003 through September 2004, 32 patients underwent robotically assisted mitral valve repair. The mean age of our population was 676 years (range, 43-82 years). Four patients also underwent the 1st tricuspid valve repair using the da Vinci robot in the United States. There were 3 conversions for irreparable valves, 1 stroke, and 2 deaths. The average procedure time, cardiopulmonary bypass time, and aortic cross-clamp time were all reduced, when the first 20 patients were compared with the last 12. Length-of-stay also improved. One patient required early mitral valve replacement for recurrent regurgitation. Two patients required late (> 3 month) mitral valve replacement for recurrent regurgitation. We have shown that a dedicated nonacademic institute can develop a robotic cardiac surgery program and perform mitral and tricuspid valve repairs successfully. There is a several-case learning curve, and patient selection is paramount.

Patient safety in point-of-care testing.

In the authors' view, the following four points compose the current state of the question of patient safety in point-of-care testing: The collision of definitions used in this article with actual practice in point-of-care testing is evidence for the likelihood of error in this genre of clinical tests. Uncovering of latent conditions conducive to error is the objective for investigations of this likelihood. A modified Kost classification serves as a basis for determining where latent conditions appear in the point-of-care testing process and as a framework in which to recognize these errors in an error classification process. Errors in point-of-care testing are likely to arise most frequently in the steps of patient identification, specimen collection, and result reporting. In the absence of an adequate evidence base, the authors recommend as measures to build a culture of patient safety in point-of-care testing the components of the standard model of safe laboratory testing. This model inculcates the laboratory ethos of test operator competence, procedure adherence, quality control, and result integrity. These objectives can be achieved by integrating operator training, program supervision, competence assessment, and proficiency demonstration into an institution's or practice's point-of-care testing program. Based on the authors' hypothesis that medical errors in point-of-care testing, which lead to preventable adverse events most often arise in three testing processes--patient identification, specimen collation, and result reporting--they recommend ongoing monitors of these critical steps. If they are wrong, such monitoring will disprove their hypothesis; if they are right, it will measurably reduce medical error in point-of-care testing.

Comparative analytical costs of central laboratory glucose and bedside glucose testing: a College of American Pathologists Q-Probes study.

CONTEXT: One of the major attributes of laboratory testing is cost. Although fully automated central laboratory glucose testing and semiautomated bedside glucose testing (BGT) are performed at most institutions, rigorous determinations of interinstitutional comparative costs have not been performed. OBJECTIVES: To compare interinstitutional analytical costs of central laboratory glucose testing and BGT and to provide suggestions for improvement. DESIGN: Participants completed a demographic form about their institutional glucose monitoring practices. They also collected information about the costs of central laboratory glucose testing, BGT at a high-volume testing site, and BGT at a low-volume testing site, including specified cost variables for labor, reagents, and instruments. PARTICIPANTS: A total of 445 institutions enrolled in the College of American Pathologists Q-Probes program. MAIN OUTCOME MEASURE: Median cost per glucose test at 3 testing sites. RESULTS: The median (10th-90th percentile range) costs per glucose test were 1.18 dollars (5.59 dollars-0.36 dollars), 1.96 dollars (9.51 dollars-0.77 dollars), and 4.66 dollars (27.54 dollars-1.02 dollars) for central laboratory, high-volume BGT sites, and low-volume BGT sites, respectively. The largest percentages of the cost per test were for labor (59.3%, 72.7%, and 85.8%), followed by supplies (27.2%, 27.3%, and 13.4%) and equipment (2.1%, 0.0%, and 0.0%) for the 3 sites, respectively. The median number of patient specimens per month at the high-volume BGT sites was 625 compared to 30 at the low-volume BGT sites. Most participants did not include labor, instrument maintenance, competency assessment, or oversight in their BGT estimated costs until required to do so for the study. CONCLUSIONS: Analytical costs per glucose test were lower for central laboratory glucose testing than for BGT, which, in turn, was highly variable and dependent on volume. Data that would be used for financial justification for BGT were widely aberrant and in need of improvement.

Biochemical markers of myocardial injury test turnaround time: a College of American Pathologists Q-Probes study of 7020 troponin and 4368 creatine kinase-MB determinations in 159 institutions.

CONTEXT: Rapid diagnosis of acute myocardial infarction in patients presenting to emergency departments (EDs) with chest pain may determine the types, and predict the outcomes of, the therapy those patients receive. The amount of time consumed in establishing diagnoses of acute myocardial infarction may depend in part on that consumed in the generation of the blood test results measuring myocardial injury. OBJECTIVE: To determine the normative rates of turnaround time (TAT) for biochemical markers of myocardial injury and to examine hospital and laboratory practices associated with faster TATs. DESIGN: Laboratory personnel in institutions enrolled in the College of American Pathologists Q-Probes Program measured the order-to-report TATs for serum creatine kinase-MB and/or serum troponin (I or T) for patients presenting to their hospital EDs with symptoms of acute myocardial infarction. Laboratory personnel also completed detailed questionnaires characterizing their laboratories' and hospitals' practices related to testing for biochemical markers of myocardial injury. ED physicians completed questionnaires indicating their satisfaction with testing for biochemical markers of myocardial injury in their hospitals. SETTING: A total of 159 hospitals, predominantly located in the United States, participating in the College of American Pathologists Q-Probes Program. RESULTS: Most (82%) laboratory participants indicated that they believed a reasonable order-to-report TATs for biochemical markers of myocardial injury to be 60 minutes or less. Most (75%) of the 1352 ED physicians who completed satisfaction questionnaires believed that the results of tests measuring myocardial injury should be reported back to them in 45 minutes or less, measured from the time that they ordered those tests. Participants submitted TAT data for 7020 troponin and 4368 creatine kinase-MB determinations. On average, they reported 90% of myocardial injury marker results in slightly more than 90 minutes measured from the time that those tests were ordered. Among the fastest performing 25% of participants (75th percentile and above), median order-to-report troponin and creatine kinase-MB TATs were equal to 50 and 48.3 minutes or less, respectively. Shorter troponin TATs were associated with performing cardiac marker studies in EDs or other peripheral laboratories compared to (1) performing tests in central hospital laboratories, and (2) having cardiac marker specimens obtained by laboratory rather than by nonlaboratory personnel. CONCLUSION: The TAT expectations of the ED physicians using the results of laboratory tests measuring myocardial injury exceed those of the laboratory personnel providing the results of those tests. The actual TATs of myocardial injury testing meet the expectations of neither the providers of those tests nor the users of those test results. Improving TAT performance will require that the providers and users of laboratory services work together to develop standards that meet the needs of the medical staff and that are reasonably achievable by laboratory personnel.