Orders on file but no labs drawn: investigation of machine and human errors caused by an interface idiosyncrasy.

In this report, we describe 2 instances in which expert use of an electronic health record (EHR) system interfaced to an external clinical laboratory information system led to unintended consequences wherein 2 patients failed to have laboratory tests drawn in a timely manner. In both events, user actions combined with the lack of an acknowledgment message describing the order cancellation from the external clinical system were the root causes. In 1 case, rapid, near-simultaneous order entry was the culprit; in the second, astute order management by a clinician, unaware of the lack of proper 2-way interface messaging from the external clinical system, led to the confusion. Although testing had shown that the laboratory system would cancel duplicate laboratory orders, it was thought that duplicate alerting in the new order entry system would prevent such events.

Bar Coding and Tracking in Pathology.

Bar coding and specimen tracking are intricately linked to pathology workflow and efficiency. In the pathology laboratory, bar coding facilitates many laboratory practices, including specimen tracking, automation, and quality management. Data obtained from bar coding can be used to identify, locate, standardize, and audit specimens to achieve maximal laboratory efficiency and patient safety. Variables that need to be considered when implementing and maintaining a bar coding and tracking system include assets to be labeled, bar code symbologies, hardware, software, workflow, and laboratory and information technology infrastructure as well as interoperability with the laboratory information system. This article addresses these issues, primarily focusing on surgical pathology.

Reducing communication delays and improving quality of care with a tuberculosis laboratory information system in resource poor environments: a cluster randomized controlled trial.

BACKGROUND: Lost, delayed or incorrect laboratory results are associated with delays in initiating treatment. Delays in treatment for Multi-Drug Resistant Tuberculosis (MDR-TB) can worsen patient outcomes and increase transmission. The objective of this study was to evaluate the impact of a laboratory information system in reducing delays and the time for MDR-TB patients to culture convert (stop transmitting). SETTING: 78 primary Health Centers (HCs) in Lima, Peru. Participants lived within the catchment area of participating HCs and had at least one MDR-TB risk factor. The study design was a cluster randomized controlled trial with baseline data. The intervention was the e-Chasqui web-based laboratory information system. Main outcome measures were: times to communicate a result; to start or change a patient's treatment; and for that patient to culture convert. RESULTS: 1671 patients were enrolled. Intervention HCs took significantly less time to receive drug susceptibility test (DST) (median 11 vs. 17 days, Hazard Ratio 0.67 [0.62-0.72]) and culture (5 vs. 8 days, 0.68 [0.65-0.72]) results. The time to treatment was not significantly different, but patients in intervention HCs took 16 days (20%) less time to culture convert (p = 0.047). CONCLUSIONS: The eChasqui system reduced the time to communicate results between laboratories and HCs and time to culture conversion. It is now used in over 259 HCs covering 4.1 million people. This is the first randomized controlled trial of a laboratory information system in a developing country for any disease and the only study worldwide to show clinical impact of such a system. TRIAL REGISTRATION: ClinicalTrials.gov NCT01201941.

Improving laboratory data entry quality using Six Sigma.

PURPOSE: The Uganda Makerere University provides clinical laboratory support to over 70 clients in Uganda. With increased volume, manual data entry errors have steadily increased, prompting laboratory managers to employ the Six Sigma method to evaluate and reduce their problems. The purpose of this paper is to describe how laboratory data entry quality was improved by using Six Sigma. DESIGN/METHODOLOGY/APPROACH: The Six Sigma Quality Improvement (QI) project team followed a sequence of steps, starting with defining project goals, measuring data entry errors to assess current performance, analyzing data and determining data-entry error root causes. Finally the team implemented changes and control measures to address the root causes and to maintain improvements. Establishing the Six Sigma project required considerable resources and maintaining the gains requires additional personnel time and dedicated resources. FINDINGS: After initiating the Six Sigma project, there was a 60.5 percent reduction in data entry errors from 423 errors a month (i.e. 4.34 Six Sigma) in the first month, down to an average 166 errors/month (i.e. 4.65 Six Sigma) over 12 months. The team estimated the average cost of identifying and fixing a data entry error to be $16.25 per error. Thus, reducing errors by an average of 257 errors per month over one year has saved the laboratory an estimated $50,115 a year. PRACTICAL IMPLICATIONS: The Six Sigma QI project provides a replicable framework for Ugandan laboratory staff and other resource-limited organizations to promote quality environment. Laboratory staff can deliver excellent care at a lower cost, by applying QI principles. ORIGINALITY/VALUE: This innovative QI method of reducing data entry errors in medical laboratories may improve the clinical workflow processes and make cost savings across the health care continuum.

Sistema Gerenciador de Ambiente Laboratorial: relato de experiência de uma ferramenta transformadora para a gestão laboratorial e vigilância em saúde / Laboratory Environment Management System: account of an experience with a transformational tool for laboratory management and health surveillance

Objetivo: apresentar o relato da experiência de implantação do sistema Gerenciador de Ambiente Laboratorial (GAL) como ferramenta de monitoramento e controle de exames laboratoriais, essencial à gestão e ao acompanhamento dos programas de saúde pública brasileira. Métodos: o GAL foi proposto como ferramenta de monitoramento e controle de exames laboratoriais, essencial à gestão e ao acompanhamento dos programas de saúde pública brasileira. O relato foi elaborado a partir de pesquisa documental. Resultados: o GAL tem favorecido a comunicação da informação, fornecendo subsídios para a melhoria na divulgação dos resultados dos ensaios e exames diagnósticos e planos estratégicos na área de saúde. Conclusão: após a implantação do GAL, houve uma melhora substancial na forma de gestão da informação adotada pelos laboratórios de saúde pública.

Objective: to present a report on the experience of implanting the Laboratory Environment Management (GAL) system as a tool for monitoring and controlling laboratory tests. Methods: GAL has been proposed as a tool for monitoring and controlling laboratory tests, vital to the management and monitoring of public health programs in Brazil. The report was compiled from documentary research. Results: GAL has favoured the communication of information, providing input for improving the dissemination of assay and diagnostic test results as well as strategic plans for health. Conclusion: following GAL’s implantation, there has been a substantial improvement in information management by public health laboratories.

Using root cause analysis and form redesign to reduce incorrect ordering of HIV tests.

BACKGROUND: Advances in molecular biology and changes in microbial nomenclature may subject diagnostic microbiology to errors. A patient diagnosed with Pneumocystis jiroveci pneumonia and then with AIDS had received a negative "AIDS test"--"negative for antibodies to HTLV 1 and 2." The test requisition showed that the physician had requested HTLV-I/II testing but not an HIV-1/2 test. A root cause analysis was performed to determine if the erroneous testing represented a systemic problem. A study was conducted to identify and address such testing errors. METHODS: For the 1,952 HTLV-I/II test requests in a 17-month period in the Southern Alberta region, a random representative sample of 555 requests for HTLV-I/II testing were evaluated for appropriateness. Physicians ordering "inappropriate" tests were surveyed to determine root causes, and the HTLV-I/II check box was subsequently removed from the requisition. RESULTS: Some 318 (94%) of the 340 clinically directed HTLV tests were likely or definitely inappropriate--that is, only an HIV-1/2 test was required. At least 81% (127/156) of the 8% (156/1,948) of the HTLV-I/II tests ordered without an HIV-1/2 test concurrently were ordered inappropriately. In the telephone survey, all 69 physicians suspected to have incorrectly ordered HTLV-I/II tests reported erroneously requesting HTLV for HIV. A root cause analysis identified confusing viral nomenclature, diagnostic testing menu, and form design as contributing factors. A requisition recall and redesign has reduced erroneous laboratory testing. CONCLUSIONS: A high proportion of HTLV-I/II tests were ordered erroneously and confused with HIV-1/2. Careful attention to routine test menus and form design, including the exclusion of rare and confusing pathogens, reduces risk of error for practicing physicians.

Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial.

OBJECTIVE: To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. METHODS: Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. RESULTS: For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p<0.001) and culture results (4 vs 8 days, p<0.001) and had a lower proportion of 'late' DSTs taking >60 days to arrive (p<0.001) than the control. For peripheral HCs, the intervention group had similar communication times for DST (median 22 vs 19 days, p=0.30) and culture (10 vs 9 days, p=0.10) results, as well as proportion of 'late' DSTs (p=0.57) compared with the control. CONCLUSIONS: Only point-of-care HCs with direct access to the e-Chasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting.

Red Regional de Laboratorios para la Vigilancia de las Infecciones Fúngicas Invasoras y Susceptibilidad a los Antifúngicos / Regional Laboratory Network for Surveillance of Invasive Fungal Infections and Antifungal Susceptibility in Latin America

This article describes the general objectives of the Regional Laboratory Network for Surveillance of Invasive Fungal Infections and Antifungal Susceptibility in Latin America. Formation of the Network was coordinated by the Essential Medicines, Vaccines, and Health Technologies Unit of the Pan American Health Organization, with the technical and financial support of the National Center for Microbiology of the Carlos III Health Institute (Spain), and the technical support of the Microbiology Department of the Dr. C. Malbrán National Institute on Infectious Diseases (Argentina) and the Microbiology Unit of the Parasitology Service of the Adolfo Lutz Institute (Brazil). The Network's principle objectives are epidemiological surveillance of invasive fungal infections through detection of antifungal resistance and identification of emergent, invasive fungal infections; establishment of norms and common protocols for early diagnosis of mycoses; and strengthening coordination, communications, and transference mechanisms among countries. The Network must be gradually implemented and must include staff training, a systematic process for sharing technology, evaluation of diagnostic techniques, identification of fungal species, and standardized tests for antifungal susceptibility.

High sensitivity for tuberculosis in a national integrated surveillance system in Finland.

Little is known about the sensitivity of surveillance for tuberculosis after integration of formerly dedicated tuberculosis surveillance and control into the general health care system, an integration which took place in Finland in 1987. We compared routine laboratory notifications to the National Infectious Disease Register (NIDR) for Mycobacterium tuberculosis from January 1, 1995, to December 31, 1996, with data collected independently from all laboratories offering M. tuberculosis culture, and with data from patient records. 1059 culture-positive cases were found. The overall sensitivity of the NIDR was 93 % (984/1059). The positive predictive value of a culture-positive case in the NIDR to be a true culture-confirmed case was 99%. For the culture-confirmed cases in the NIDR, one or more physician notification forms had been submitted for 89%. A highly sensitive notification system for culture-positive tuberculosis can be achieved in an integrated national infectious disease surveillance system based on laboratory notification.

Medical errors: impact on clinical laboratories and other critical areas.

The Institute of Medicine (IOM) report (1999) stated that the prevalence of medical errors is high in today's health care system. Some specialties in health care are more risky than others. A varying blunder/error rate of 0.1-9.3% in clinical diagnostic laboratories has been reported in the literature. Many of these errors occur in the preanalytical and postanalytical phases of testing. It has been suggested that the errors occurring in clinical diagnostic laboratories are smaller in number than those occurring elsewhere in a hospital setting. However, given the quantum of laboratory tests used in health care, even this small rate may reflect a large number of errors. The surgical specialties, emergency rooms, and intensive care units have been previously identified as areas of risk for patient safety. Though the nature of work in these specialties and their interdependence on clinical diagnostic laboratories presents abundant opportunities for error-generating behavior, many of these errors may be preventable. Appropriate attention to system factors involved in these errors and designing intelligent system approaches may help control and eliminate many of these errors in health care.

Corrections of clinical chemistry test results in a laboratory information system.

CONTEXT: The recently released reports by the Institute of Medicine, To Err Is Human and Patient Safety, have received national attention because of their focus on the problem of medical errors. Although a small number of studies have reported on errors in general clinical laboratories, there are, to our knowledge, no reported studies that focus on errors in pediatric clinical laboratory testing. OBJECTIVE: To characterize the errors that have caused corrections to have to be made in pediatric clinical chemistry results in the laboratory information system, Misys. To provide initial data on the errors detected in pediatric clinical chemistry laboratories in order to improve patient safety in pediatric health care. DESIGN: All clinical chemistry staff members were informed of the study and were requested to report in writing when a correction was made in the laboratory information system, Misys. Errors were detected either by the clinicians (the results did not fit the patients' clinical conditions) or by the laboratory technologists (the results were double-checked, and the worksheets were carefully examined twice a day). No incident that was discovered before or during the final validation was included. On each Monday of the study, we generated a report from Misys that listed all of the corrections made during the previous week. We then categorized the corrections according to the types and stages of the incidents that led to the corrections. RESULTS: A total of 187 incidents were detected during the 10-month study, representing a 0.26% error detection rate per requisition. The distribution of the detected incidents included 31 (17%) preanalytic incidents, 46 (25%) analytic incidents, and 110 (59%) postanalytic incidents. The errors related to noninterfaced tests accounted for 50% of the total incidents and for 37% of the affected tests and orderable panels, while the noninterfaced tests and panels accounted for 17% of the total test volume in our laboratory. CONCLUSION: This pilot study provided the rate and categories of errors detected in a pediatric clinical chemistry laboratory based on the corrections of results in the laboratory information system. A direct interface of the instruments to the laboratory information system showed that it had favorable effects on reducing laboratory errors.

Surveillance of screening for hepatitis C through the laboratory network RENA-VHC, France, 2000-2001.

Over the period 2000-2001, 189 private or hospital laboratories scattered throughout France participated to the laboratory network RENA-VHC. A total of 759 591 serologies (screening tests and validation of screening tests) were performed, revealing an increase of 10% between 2000 and 2001. The rate of the amount of tests to validate screening found positive over the overall amount of tests performed was 1.2% in 2000 and 1.0% in 2001. This suggests that screening covered more people with little risk of acquiring HCV infection. The per-sons confirmed HCV positive were predominantly men (sex ratio 1.5) of which 31% were 30 to 39 years of age.

[Point care testing in blood gas and electrolyte analysis : examples of implementation and cost analysis]. / Gazométrie et électrolytes sanguins délocalisés: exemples d'organisation et évaluation économique.

An increasing proportion of laboratories manage and organize point of care testing (POCT). The purpose of this article is to describe the implementation made at Lariboisière hospital for three remote blood gas analysers. The most important aspect in this achievement is the comprehensive computerization, making possible real time management of POCT in agreement with the Point of Care unit Management team. In addition, we present a running cost analysis, comparing three Blood gas systems (Rapidlab860, Rapidpoint 400--Bayer Diagnostics and i-Stat Abbott Diagnostics). This study indicates that cost per test hugely varies based on the daily sample demand. In addition to analytical and organizational items, the clinical chemist should consider the testing demand as a key factor in choosing an analyser for POCT.

Linking laboratory and pharmacy: opportunities for reducing errors and improving care.

A myriad of errors and lost improvement opportunities result from failure of clinical laboratory and pharmacy information systems to effectively communicate. Pharmacotherapy could benefit from enhanced laboratory-pharmacy linkage with respect to (1) drug choice (laboratory-based indications and contraindications), (2) drug dosing (renal or hepatic, blood level-guided adjustments), (3) laboratory monitoring (laboratory signals of toxicity, baseline and ongoing monitoring), (4) laboratory result interpretation (drug interfering with test), and (5) broader quality improvement (surveillance for unrecognized toxicity, monitoring clinician response delays). Linkages can be retrospective or real-time. Many organizations could benefit now by linking existing pharmacy and laboratory data. Greater improvement is possible through implementation of electronic order entry with real-time decision support incorporating linked laboratory and pharmacy data. While many guidelines, admonitions, and rules exist regarding drugs and the laboratory, substantial new knowledge and evidence in this area are needed. Focusing on these unmet needs and accompanying logistical challenges is a priority.

Point-of-care testing at the millennium.

Point-of-care testing (POCT) is a major force in the future evolution of hospital care, with prospects for even greater expansion of accessibility, speed, and also, hopefully, accuracy of results. New developments in POCT technology will predictably occur in three areas: connectivity, test menu expansion, and noninvasiveness. Connectivity for POCT devices has evolved from point-of-service workstations to standardized POCT data transmission protocols to remote roaming wireless connectivity with automatic data capture. POCT test menus will continue to expand, with more coagulation testing, chemistries, and infectious screening, but also on-site drug screening, intraoperative hormone levels, and microchip DNA diagnostics. Noninvasive POCT will expand beyond the GlucoWatch glucose monitor and the Bilichek noninvasive bilirubin monitor to noninvasive CBCs and Pap smears.