The Effect of Laboratory Test-Based Clinical Decision Support Tools on Medication Errors and Adverse Drug Events: A Laboratory Medicine Best Practices Systematic Review.

BACKGROUND: Laboratory and medication data in electronic health records create opportunities for clinical decision support (CDS) tools to improve medication dosing, laboratory monitoring, and detection of side effects. This systematic review evaluates the effectiveness of such tools in preventing medication-related harm. METHODS: We followed the Laboratory Medicine Best Practice (LMBP) initiative's A-6 methodology. Searches of 6 bibliographic databases retrieved 8508 abstracts. Fifteen articles examined the effect of CDS tools on (a) appropriate dose or medication (n = 5), (b) laboratory monitoring (n = 4), (c) compliance with guidelines (n = 2), and (d) adverse drug events (n = 5). We conducted meta-analyses by using random-effects modeling. RESULTS: We found moderate and consistent evidence that CDS tools applied at medication ordering or dispensing can increase prescriptions of appropriate medications or dosages [6 results, pooled risk ratio (RR), 1.48; 95% CI, 1.27-1.74]. CDS tools also improve receipt of recommended laboratory monitoring and appropriate treatment in response to abnormal test results (6 results, pooled RR, 1.40; 95% CI, 1.05-1.87). The evidence that CDS tools reduced adverse drug events was inconsistent (5 results, pooled RR, 0.69; 95% CI, 0.46-1.03). CONCLUSIONS: The findings support the practice of healthcare systems with the technological capability incorporating test-based CDS tools into their computerized physician ordering systems to (a) identify and flag prescription orders of inappropriate dose or medications at the time of ordering or dispensing and (b) alert providers to missing laboratory tests for medication monitoring or results that warrant a change in treatment. More research is needed to determine the ability of these tools to prevent adverse drug events.

Interventions to prevent iatrogenic anemia: a Laboratory Medicine Best Practices systematic review.

BACKGROUND: As many as 90% of patients develop anemia by their third day in an intensive care unit (ICU). We evaluated the efficacy of interventions to reduce phlebotomy-related blood loss on the volume of blood lost, hemoglobin levels, transfusions, and incidence of anemia. METHODS: We conducted a systematic review and meta-analysis using the Laboratory Medicine Best Practices (LMBP) systematic review methods for rating study quality and assessing the body of evidence. Searches of PubMed, Embase, Cochrane, Web of Science, PsychINFO, and CINAHL identified 2564 published references. We included studies of the impact of interventions to reduce phlebotomy-related blood loss on blood loss, hemoglobin levels, transfusions, or anemia among hospital inpatients. We excluded studies not published in English and studies that did not have a comparison group, did not report an outcome of interest, or were rated as poor quality. Twenty-one studies met these criteria. We conducted a meta-analysis if > 2 homogenous studies reported sufficient information for analysis. RESULTS: We found moderate, consistent evidence that devices that return blood from flushing venous or arterial lines to the patient reduced blood loss by approximately 25% in both neonatal ICU (NICU) and adult ICU patients [pooled estimate in adults, 24.7 (95% CI = 12.1-37.3)]. Bundled interventions that included blood conservation devices appeared to reduce blood loss by at least 25% (suggestive evidence). The evidence was insufficient to determine if these devices reduced hemoglobin decline or risk of anemia. The evidence suggested that small volume tubes reduced the risk of anemia, but was insufficient to determine if they affected the volume of blood loss or the rate of hemoglobin decline. CONCLUSIONS: Moderate, consistent evidence indicated that devices that return blood from testing or flushing lines to the patient reduce the volume of blood loss by approximately 25% among ICU patients. The results of this systematic review support the use of blood conservation systems with arterial or venous catheters to eliminate blood waste when drawing blood for testing. The evidence was insufficient to conclude the devices impacted hemoglobin levels or transfusion rates. The use of small volume tubes may reduce the risk of anemia.

Identifying Preanalytic and Postanalytic Laboratory Quality Gaps Using a Data Warehouse and Structured Multidisciplinary Process.

CONTEXT.­: The laboratory total testing process includes preanalytic, analytic, and postanalytic phases, but most laboratory quality improvement efforts address the analytic phase. Expanding quality improvement to preanalytic and postanalytic phases via use of medical data warehouses, repositories that include clinical, utilization, and administrative data, can improve patient care by ensuring appropriate test utilization. Cross-department, multidisciplinary collaboration to address gaps and improve patient and system outcomes is beneficial. OBJECTIVE.­: To demonstrate medical data warehouse utility for characterizing laboratory-associated quality gaps amenable to preanalytic or postanalytic interventions. DESIGN.­: A multidisciplinary team identified quality gaps. Medical data warehouse data were queried to characterize gaps. Organizational leaders were interviewed about quality improvement priorities. A decision aid with elements including national guidelines, local and national importance, and measurable outcomes was completed for each gap. RESULTS.­: Gaps identified included (1) test ordering; (2) diagnosis, detection, and documentation, and (3) high-risk medication monitoring. After examination of medical data warehouse data including enrollment, diagnoses, laboratory, pharmacy, and procedures for baseline performance, high-risk medication monitoring was selected, specifically alanine aminotransferase, aspartate aminotransferase, complete blood count, and creatinine testing among patients receiving disease-modifying antirheumatic drugs. The test utilization gap was in monitoring timeliness (eg, >60% of patients had a monitoring gap exceeding the guideline recommended frequency). Other contributors to selecting this gap were organizational enthusiasm, regulatory labeling, and feasibility of a significant laboratory role in addressing the gap. CONCLUSIONS.­: A multidisciplinary process facilitated identification and selection of a laboratory medicine quality gap. Medical data warehouse data were instrumental in characterizing gaps.

Identifying, Analyzing, and Visualizing Diagnostic Paths for Patients with Nonspecific Abdominal Pain.

BACKGROUND: Diagnosis is complex, uncertain, and error-prone. Symptoms such as nonspecific abdominal pain are especially challenging. A diagnostic path consists of diagnostic steps taken from initial presentation until a diagnosis is obtained or the evaluation ends for other reasons. Analysis of diagnostic paths can reveal patterns associated with more timely and accurate diagnosis. Visual analytics can be used to enhance both analysis and comprehension of diagnostic paths. OBJECTIVE: This article applies process-mining methods to extract and visualize diagnostic paths from electronic health records (EHRs). METHODS: Patient features, actions taken (i.e., tests, referrals, etc.), and diagnoses obtained for 501 adult patients (half female, half ≥50 years of age) presenting with abdominal pain were extracted from an EHR database to construct diagnostic paths from a hospital system in suburban Chicago, Illinois, United States. A stable diagnosis was defined as the same diagnosis recorded twice in a 12-month period; a working diagnosis was recorded only once. Three different types of path visualizations were obtained. RESULTS: A stable diagnosis was obtained in 63 (13%) patients after 12 months. In 271 (54%) patients, a working diagnosis was obtained. Mean path duration was 145.3 days (standard deviation, 195.1 days). These 63 patients received 75 stable diagnoses. CONCLUSION: Structured EHR data can be used to construct diagnostic paths to gain insight into diagnostic practices for complaints such as abdominal pain.

Identifying Diagnostic Paths for Undifferentiated Abdominal Pain from Electronic Health Record Data.

The diagnostic process is a complex, uncertain, and highly variable process which is under-studied and lacks evidence from randomized clinical trials. This study used a novel visual analytics method to identify and visualize diagnostic paths for undifferentiated abdominal pain, by leveraging electronic health record (EHR) data of 501 patients in the ambulatory setting of a single institution. A total of 63 patients reached diagnoses in the study sample. We illustrate steps in identifying diagnostic paths of the study patients, both individually and collectively, and visually present the diversity in their diagnostic processes. Patients in whom diagnoses were obtained generally had more clinical encounters and health services utilization, although their diagnostic paths were more variable than those of the undiagnosed group. The capability of identifying diagnostic paths demonstrated from this study allows us to study larger data sets to determine diagnostic paths associated with more timely, accurate, and cost-efficient diagnosis processes.

Interventions to Improve Follow-Up of Laboratory Test Results Pending at Discharge: A Systematic Review.

Failure to follow up test results pending at discharge (TPAD) from hospitals or emergency departments is a major patient safety concern. The purpose of this review is to systematically evaluate the effectiveness of interventions to improve follow-up of laboratory TPAD. We conducted literature searches in PubMed, CINAHL, Cochrane, and EMBASE using search terms for relevant health care settings, transition of patient care, laboratory tests, communication, and pending or missed tests. We solicited unpublished studies from the clinical laboratory community and excluded articles that did not address transitions between settings, did not include an intervention, or were not related to laboratory TPAD. We also excluded letters, editorials, commentaries, abstracts, case reports, and case series. Of the 9,592 abstracts retrieved, eight met the inclusion criteria and reported the successful communication of TPAD. A team member abstracted predetermined data elements from each study, and a senior scientist reviewed the abstraction. Two experienced reviewers independently appraised the quality of each study using published Laboratory Medicine Best Practices (LMBP™) A-6 scoring criteria. We assessed the body of evidence using the A-6 methodology, and the evidence suggested that electronic tools or one-on-one education increased documentation of pending tests in discharge summaries. We also found that automated notifications improved awareness of TPAD. The interventions were supported by suggestive evidence; this type of evidence is below the level of evidence required for LMBP™ recommendations. We encourage additional research into the impact of these interventions on key processes and health outcomes.

Identifying and analyzing diagnostic paths: a new approach for studying diagnostic practices.

Diagnostic error is a serious public health problem to which knowledge gaps and associated cognitive error contribute significantly. Identifying diagnostic approaches to common problems in ambulatory care associated with more timely and accurate diagnosis and lower cost and harm associated with diagnostic evaluation is an important priority for health care systems, clinicians, and of course patients. Unfortunately, guidance on how best to approach diagnosis in patients with common presenting complaints such as abdominal pain, dizziness, and fatigue is lacking. Exploring diagnostic practice variation and patterns of diagnostic evaluation is a potentially valuable approach to identifying best current diagnostic practices. A "diagnostic path" is the sequence of actions taken to evaluate a new complaint from first presentation until a diagnosis is established, or the evaluation ends for other reasons. A "big data" approach to identifying diagnostic paths from electronic health records can be used to identify practice variation and best practices from a large number of patients. Limitations of this approach include incompleteness and inaccuracy of electronic medical record data, the fact that diagnostic paths may not represent clinician thinking, and the fact that diagnostic paths may be used to identify best current practices, rather than optimal practices.

Current evidence and future perspectives on the effective practice of patient-centered laboratory medicine.

BACKGROUND: Systematic evidence of the contribution made by laboratory medicine to patient outcomes and the overall process of healthcare is difficult to find. An understanding of the value of laboratory medicine, how it can be determined, and the various factors that influence it is vital to ensuring that the service is provided and used optimally. CONTENT: This review summarizes existing evidence supporting the impact of laboratory medicine in healthcare and indicates the gaps in our understanding. It also identifies deficiencies in current utilization, suggests potential solutions, and offers a vision of a future in which laboratory medicine is used optimally to support patient care. SUMMARY: To maximize the value of laboratory medicine, work is required in 5 areas: (a) improved utilization of existing and new tests; (b) definition of new roles for laboratory professionals that are focused on optimizing patient outcomes by adding value at all points of the diagnostic brain-to-brain cycle; (c) development of standardized protocols for prospective patient-centered studies of biomarker clinical effectiveness or extraanalytical process effectiveness; (d) benchmarking of existing and new tests in specified situations with commonly accepted measures of effectiveness; (e) agreed definition and validation of effectiveness measures and use of checklists for articles submitted for publication. Progress in these areas is essential if we are to demonstrate and enhance the value of laboratory medicine and prevent valuable information being lost in meaningless data. This requires effective collaboration with clinicians, and a determination to accept patient outcome and patient experience as the primary measure of laboratory effectiveness.

A prospective tool for risk assessment of sendout testing.

OBJECTIVE: Errors associated with laboratory testing can cause significant patient harm. Sendout testing refers to tests sent by a primary lab to a reference lab when testing is unavailable at the primary lab. Sendout testing is particularly high risk for patient harm, due to many factors including increased hand-offs, manual processes, and complexity associated with rare, low-volume tests. No published prospective tools exist for sendout risk assessment. METHODS: A novel prospective tool was developed to assess risk of diagnostic errors involving laboratory sendout testing. This tool was successfully piloted at nine sites. RESULTS: Marked diversity was noted among survey respondents, particularly in the sections on quality metrics and utilization management. Of note, most sites had committees who managed rules for test ordering, but few places reported enforcing these rules. Only one site claimed to routinely measure the frequency clinicians failed to retrieve test results. An evaluation of the tool indicated that it was both useful and easy to use. CONCLUSIONS: This tool could be used by other laboratories to identify the areas of highest risk to patients, which in turn may guide them in focusing their quality improvement efforts and resources.

Primary care physicians' challenges in ordering clinical laboratory tests and interpreting results.

BACKGROUND: The number and complexity of clinical laboratory tests is rapidly expanding, presenting primary care physicians with challenges in accurately, efficiently, and safely ordering and interpreting diagnostic tests. The objective of this study was to identify challenges primary care physicians face related to diagnostic laboratory testing and solutions they believe are helpful and available to them. METHODS: In this study, sponsored by the Centers for Disease Control and Prevention, a random sample of general internal medicine and family medicine physicians from the American Medical Association Masterfile were surveyed in 2011. RESULTS: 1768 physicians (5.6%) responded to the survey. Physicians reported ordering diagnostic laboratory tests for an average of 31.4% of patient encounters per week. They reported uncertainty about ordering tests in 14.7% and uncertainty in interpreting results in 8.3% of these diagnostic encounters. The most common problematic challenges in ordering tests were related to the cost to patients and insurance coverage restrictions. Other challenges included different names for the same test, tests not available except as part of a test panel, and different tests included in panels with the same names. The most common problematic challenges in interpreting and using test results were not receiving the results and confusing report formats. Respondents endorsed a variety of information technology and decision support solutions to improve test selection and results interpretation, but these solutions were not widely available at the time of the survey. Physicians infrequently sought assistance or consultation from laboratory professionals but valued these consultations when they occurred. CONCLUSIONS: Primary care physicians routinely experience uncertainty and challenges in ordering and interpreting diagnostic laboratory tests. With more than 500 million primary care patient visits per year, the level of uncertainty reported in this study potentially affects 23 million patients per year and raises significant concerns about the safe and efficient use of laboratory testing resources. Improvement in information technology and clinical decision support systems and quick access to laboratory consultations may reduce physicians' uncertainty and mitigate these challenges.

Effectiveness of practices to reduce blood sample hemolysis in EDs: a laboratory medicine best practices systematic review and meta-analysis.

OBJECTIVE: To complete a systematic review of emergency department (ED) practices for reducing hemolysis in blood samples sent to the clinical laboratory for testing. RESULTS: A total of 16 studies met the review inclusion criteria (12 published and 4 unpublished). All 11 studies comparing new straight needle venipuncture with IV starts found a reduction in hemolysis rates, [average risk ratio of 0.16 (95% CI=0.11-0.24)]. Four studies on the effect of venipuncture location showed reduced hemolysis rates for the antecubital site [average risk ratio of 0.45 (95% CI=0.35-0.57]. CONCLUSIONS: Use of new straight needle venipuncture instead of IV starts is effective at reducing hemolysis rates in EDs, and is recommended as an evidence-based best practice. The overall strength of evidence rating is high and the effect size is substantial. Unpublished studies made an important contribution to the body of evidence. When IV starts must be used, observed rates of hemolysis may be substantially reduced by placing the IV at the antecubital site.

Effectiveness of automated notification and customer service call centers for timely and accurate reporting of critical values: a laboratory medicine best practices systematic review and meta-analysis.

OBJECTIVE: To conduct a systematic review of the evidence available in support of automated notification methods and call centers and to acknowledge other considerations in making evidence-based recommendations for best practices in improving the timeliness and accuracy of critical value reporting. DESIGN AND METHODS: This review followed the Laboratory Medicine Best Practices (LMBP) review methods (Christenson, et al. 2011). A broad literature search and call for unpublished submissions returned 196 bibliographic records which were screened for eligibility. 41 studies were retrieved. Of these, 4 contained credible evidence for the timeliness and accuracy of automatic notification systems and 5 provided credible evidence for call centers for communicating critical value information in in-patient care settings. RESULTS: Studies reporting improvement from implementing automated notification findings report mean differences and were standardized using the standard difference in means (d=0.42; 95% CI=0.2-0.62) while studies reporting improvement from implementing call centers generally reported criterion referenced findings and were standardized using odds ratios (OR=22.1; 95% CI=17.1-28.6). CONCLUSIONS: The evidence, although suggestive, is not sufficient to make an LMBP recommendation for or against using automated notification systems as a best practice to improve the timeliness of critical value reporting in an in-patient care setting. Call centers, however, are effective in improving the timeliness of critical value reporting in an in-patient care setting, and meet LMBP criteria to be recommended as an "evidence-based best practice."

Laboratory medicine best practices: systematic evidence review and evaluation methods for quality improvement.

OBJECTIVE: To develop methods for systematically reviewing evidence for identifying effective laboratory medicine (LM) practices associated with improved healthcare quality outcomes. RELEVANCE: Although many evidence-evaluation systems have been developed, none are designed to include and rate healthcare quality improvement studies to identify evidence-based practices that improve patient safety and LM quality. METHODS: Validated evidence-based medicine methods established by governmental agencies, the Guide to Community Preventive Services, and others were adapted for the LM field. Key methods modifications included (a) inclusion of quality improvement study designs; (b) mechanisms for inclusion of unpublished evidence, (c) combining of individual ratings of study quality, effect size, and relevance of outcome measures to evaluate consistency of practice evidence; and (d) deriving an overall strength rating to support evidence-based best practice recommendations. The methods follow the process steps of: ask; acquire; appraise; analyze; apply; and assess. Expert panels used the systematic evidence review results on practice effectiveness for improving healthcare quality outcomes consistent with the Institute of Medicine's healthcare quality aims (safe, timely, effective, equitable, efficient, and patient-centered). CONCLUSIONS: Adapting and developing methods from validated systems and applying them to systematically review and evaluate practices in LM by using published and unpublished studies is feasible. With these methods, evidence from quality improvement studies can be systematically synthesized and summarized to identify effective LM practices. Practical and scientifically validated demonstration of a positive impact on outcomes ensures that practitioners, policy makers, and decision makers at all levels have the evidence needed for improving healthcare quality and public health.