- Email: [email protected]
System-Related Factors Contributing to Diagnostic Errors
’
System-Related Factors Contributing to Diagnostic Errors Satid Thammasitboon, MD, MHPE,a Supat Thammasitboon, MD, MSCR,b and Geeta Singhal, MD, MEda
Several studies in primary care, internal medicine, and emergency departments show that rates of errors in test requests and result interpretations are unacceptably high and translate into missed, delayed, or erroneous diagnoses. Ineffective follow-up of diagnostic test results could lead to patient harm if appropriate therapeutic interventions are not delivered in a timely manner. The frequency of system-related factors that contribute directly to diagnostic errors depends on the types and sources of errors involved. Recent studies reveal that the errors and patient harm in the diagnostic testing loop have occurred mainly at the pre- and post-analytic phases, which are directed primarily by clinicians who may have limited expertise in the rapidly expanding field of clinical pathology. These errors may include inappropriate test requests, failure/ delay in receiving results, and erroneous interpretation and application of test results to patient care. Efforts to address system-related factors often focus on technical errors in laboratory testing or failures in delivery of intended treatment. System-improvement strategies related to diagnostic errors
tend to focus on technical aspects of laboratory medicine or delivery of treatment after completion of the diagnostic process. System failures and cognitive errors, more often than not, coexist and together contribute to the incidents of errors in diagnostic process and in laboratory testing. The use of highly structured hand-off procedures and pre-planned follow-up for any diagnostic test could improve efficiency and reliability of the follow-up process. Many feedback pathways should be established so that providers can learn if or when a diagnosis is changed. Patients can participate in the effort to reduce diagnostic errors. Providers should educate their patients about diagnostic probabilities and uncertainties. The patient-safety strategies focusing on the interface between diagnostic system and therapeutic intervention are strategies that involve both processes to facilitate appropriate follow-up and structural changes, such as the use of electronic tracking systems and patient navigation programs.
he term system-related factors refers to organizational vulnerability to diagnostic errors, which vary with contextual features (e.g., policies or organizational characteristics) of the practice settings. The frequency of system-related factors that contribute directly to diagnostic errors depends on the types and sources of the errors involved. In a study by Graber et al., delayed diagnoses had more systemrelated errors (89%), whereas wrong diagnoses had more cognitive errors (92%). Cases extracted from quality assurance and voluntary reports identified system-related factors as the root cause much more frequently (72% and 76%, respectively) than did cases from autopsy discrepancies (10%).1 In one of the
largest physician-reported cases of diagnostic errors, localizing the breakdowns in the diagnostic process revealed that the testing process had the greatest number of reported process failures. Issues surrounding the clinician assessment process and cognitive errors were slightly fewer, however.2,3 Efforts to address system-related factors often focus on either technical errors in laboratory testing or failures in delivery of the intended treatment. Thus, systemimprovement strategies tend to focus on technical aspects of laboratory medicine or delivery of treatment after completion of the diagnostic process. The diagnostic and therapeutic processes are interrelated, as one process impacts the other (Fig). The conceptual diagram illustrates the multiple steps that occur in the relationship of the patient–provider interaction and diagnostic–therapeutic interface, and where the breakdowns (1–7) leading to diagnostic errors can occur. Key to note is that both system failures and cognitive errors, more often than not, contribute to the errors made in the diagnostic process and in the laboratory testing.
T
From the aBaylor College of Medicine, Texas Children's Hospital, Houston, TX; and bTulane University, Pulmonary Diseases, Critical Care and Environmental Medicine, New Orleans, LA. Curr Probl Pediatr Adolesc Health Care 2013;43:242-247 1538-5442/$ - see front matter & 2013 Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.cppeds.2013.07.004
242
Curr Probl Pediatr Adolesc Health Care 2013;43:242-247
Curr Probl Pediatr Adolesc Health Care, October 2013
Fig. The conceptual diagram illustrating the diagnostic and therapeutic loops in the diagnostic process.
Diagnostic Loop Cognitive processing errors (Point 1) in gathering and interpreting clinical information (i.e., clinical history and physical findings) leading to incorrect differential diagnosis and working diagnosis are addressed at length in “Diagnostic decision-making and strategies to improve diagnosis.” In this article, we discuss the diagnostic loop, focusing on the diagnostic testing process, which can be divided into three phases: pre-analytic, analytic and post-analytic (Points 2, 3, and 4, respectively). With the improvements made in clinical pathology in terms of reliability and standardization of analytic techniques, reagents, and instrumentation, along with implementations of information technology, quality control, and assurance methods, the analytic error rate has decreased by more than 10-fold in the last decades.4 Recent studies reveal that the errors and patient harm in the diagnostic testing loop have occurred mainly at the pre- and post-analytic phases, which are directed primarily by providers who may have limited expertise with the ever-growing body of knowledge in clinical pathology.5,6 These errors may include inappropriate test requests, failure/delay in receiving them, and erroneous interpretation and application of test results to patient care. These tasks often are poorly monitored because no consensus exists regarding whether the laboratory or the clinical department is responsible. Several studies in primary care, internal medicine, and emergency departments attest that the rates of errors in test requests and results
Curr Probl PediatrAdolesc Health Care, October 2013
of interpretation, which translate into missed, delayed, or erroneous diagnoses, are unacceptably high.4
Therapeutic Loop Ineffective follow-up of test results could lead to patient harm if appropriate therapeutic interventions are not delivered in a timely manner (Point 6). The problem is amplified when the provider ordering the tests is unknown or the provider responsible for the patient's care is ambiguous (e.g., primary care provider vs. specialist). In addition, patients often do not perceive follow-up as critical; they may assume that the test results are normal (i.e., “no news is good news”). A systematic review that examined failures to follow up test results with ambulatory care patients reported that failed follow-up ranged from 1.0% to 62.0%, depending on the type of test result.7 When a subspecialty consultant is needed to prescribe therapeutic recommendations, the referral process may add another layer to an already vulnerable system, thereby leading to an even greater risk of treatment delay. Another contributing factor is the inherent risk of having ambiguity in roles and responsibilities for both treatment and follow-up when more than one provider is involved in the patient's care.8 For instance, the primary care provider may fail to provide a timely consultation, which in turn may result in the consultant failing to address the issues faced by the referring provider or being confused about his or her role in the
243
case. Contrariwise, the consultant may fail to communicate recommendations to the primary care provider. Patient follow-up also serves as a critical process to monitor responsiveness to the prescribed therapy. Providers should gather additional clinical information during the follow-up visits to ensure that the diagnoses are correct, to tailor the treatments to the individual patients, and occasionally to challenge the working diagnosis (i.e., create a closed-loop feedback system).9
System-related Strategies to Reduce Diagnostic Errors In the section below, we summarize some suggested strategies that can be adopted to address system-related factors to reduce diagnostic errors according to steps in diagnostic process (Table).
Patient–provider Interface Efforts to create a highly reliable diagnostic system have shown positive results in reducing the number of delayed diagnoses and misdiagnoses. The implementation of a designated pediatric trauma response team has been shown to reduce the incidence of delayed diagnoses of injury by nearly 10-fold.10 The routine trauma tertiary survey, a comprehensive re-evaluation of trauma patients within 24 hours of admission, is another example of a highly reliable diagnostic TABLE. System-related strategies to address different steps in diagnostic process
Patient–provider interface Create a highly reliable diagnostic system Restructure human resource to create an efficient health care team Structured process changes Clinical–laboratory interface Implement technology-based interventions to improve test performance Enhance knowledge about laboratory tests and their interpretations Establish collaboration between clinical and laboratory experts Follow-up and tracking Streamline the communication between laboratory, providers, and patients Improve the notification system for reporting critical laboratory values Create a reliable referral system Ensure fail-safe follow-up for therapeutic monitoring Create a non-punitive feedback system to learn from errors Patient education Increase awareness about diagnostic probability and uncertainty Empower the patients to ask questions and engage in the diagnostic process Emphasize the importance of follow-up and monitoring
244
systemic approach aimed at reducing the incidence of diagnostic errors.11,12 The use of specialist consultants or second opinions can support the clinician in an unsure diagnostic or therapeutic encounter. Mandatory second opinions on some key error-prone diagnoses and second readings of key diagnostic tests can be considered.13 The application of second readings in radiology has been shown to be beneficial in detection of cancer, although its impact has been mixed in different settings.14 Human resource-oriented approaches could offer effective interventions. Introducing additional health care providers and substituting certain professionals with others have been studied. This approach may mitigate excessive workloads and staff fatigue. Minimizing disruptions and production pressures also may allow clinicians more time to reflect on their diagnostic decisions.15 Properly trained emergency nurse practitioners using accepted guidelines could provide care for patients with minor injuries that is equal to, or in some ways better than, that provided by junior clinicians.16 An attempt should be made to create a workflow or a schedule that maintains, as much as possible, a continuity of care with individual patients. The continuity of care could enhance communication and allow for implementing a closed-loop feedback to identify diagnostic errors. Structured process changes include the implementation of additional stages in the diagnostic pathway aimed at improving diagnostic performance, avoiding errors, or establishing feedback loops. The strategies may include the addition of triage protocols, feedback steps, and quality-improvement processes. Most interventions involve an implementation of a tool, such as a checklist or a form (e.g., standardizing a complete history, a targeted physical examination, and appropriate tests). These strategies can be organized around high-risk diagnoses (e.g., cancer, infection, and traumatic injury) or around care settings (e.g., routine wellness visit checklist that reminds about screening protocols and sick visit checklist that lists “don't miss” diagnoses).13,17 The implementation of a Clinical Decision Support System can improve the clinician's reasoning directly through provision of data or guidance, as well as decrease the cognitive load in use by the clinician during the reasoning process. The Internet has become a primary resource for information about illnesses and treatments for both medical and nonmedical users (e.g., Google and PubMed). Isabel
Curr Probl Pediatr Adolesc Health Care, October 2013
(http://www.isabelhealthcare.com) is a web-based application that receives the most investigation and has been found to yield high sensitivity in Pediatric settings.18 Medical professionals also may look to FindZebra, which is a specialized search engine that assists in diagnosing difficult patient cases. Medical professionals can use it to look for diagnostic hypotheses. The retrieved information is collected from reputable sources across the Internet that store medical literature on rare diseases. This specialized search engine outperformed Google Search in both default set-up and searches customized to the resources used by FindZebra in one study.19 The integration of computer-assisted feature mapping and/or data visualization tools into the electronic medical record systems could help detect subtle abnormalities that might have been missed otherwise.13
Clinical–laboratory Interface A considerable number of technology-based system interventions have been implemented in laboratory medicine. Although the details of this advancement are beyond the scope of this article, we can assume that technological developments will reduce the number of errors occurring in most of the analytic phases and some areas in pre-post-analytic phases performed by clinical laboratory professionals. The errors commonly occur in the pre- and post-analytic phases outside the laboratory department and under the direction of health care providers with various levels of knowledge related to the laboratory testing. These areas sometimes are called pre-pre-analytic and post-post-analytic phases, respectively. Initiatives for improving the appropriateness of test requests and the interpretations of results could be achieved by two primary approaches. First, efforts to improve specific knowledge about laboratory tests and the correct interpretation of test results should be done by allowing easy and rapid access to knowledge sources at the point of care and/or by introducing narrative interpretation and interpretive comments in laboratory reports.20 The other approach is done through changes in the structured process, which would require a substantial reorganization and collaboration between clinical and laboratory medicine. As molecular diagnostic testing has increased exponentially, it has become more difficult for health care providers to keep pace with the indications for and interpretations of all tests. Given a considerable number of test options to choose from, providers are
Curr Probl PediatrAdolesc Health Care, October 2013
at risk of ordering erroneous or unnecessary tests that may lead to a delay in establishing a diagnosis. Thus, the need for expert consultation with a clinical pathologist before selecting laboratory tests may be critical in enhancing the efficiency of patient care. The involvement of clinical pathologists in the decisionmaking process during the post-post-analytic phase (i.e., interpreting and using laboratory information for patient management) has been widely adopted in transfusion and hemostasis management.21,22 A similar collaborative model should be explored and investigated in other areas of clinical management.
Follow-up and Tracking Tracking results and follow-up systems in health care are crucial to maintaining efficiency of patient care. Simply urging providers to be more vigilant is not the solution for an inefficient and disorganized system with many opportunities for delays and losses to follow up.23 The patient-safety strategies focusing on the interface between diagnostic systems and therapeutic interventions, such as the use of electronic tracking systems and patient navigation programs, involve both processes to facilitate appropriate follow-up and structural changes.24 Explicit communication of test results and documentation of this communication (e.g., acknowledgment of receipt of communication) and clear escalation policies (e.g., contacting the head of the clinic if the primary care provider is not available or the attending physician if the resident does not answer) should be implemented.23 Clear guidelines must be instituted and enforced to ensure that abnormal results are appropriately communicated to a health care provider who can take action.24 The use of highly structured, hand-off procedures, and pre-planned follow-up for any diagnostic tests could improve efficiency and reliability of the follow-up process.24 Despite the use of electronic health records to facilitate communication of test results, follow-up remains a significant safety challenge. In an effort to mitigate delays, some systems have adopted a timedelayed direct notification of test results to patients (e.g., releasing them after 3–7 days to allow physicians to review them).25 Greater engagement of the patient is widely recognized as necessary to promoting better outcomes and lower costs. Having patients assume greater responsibility for their health by giving them direct access to their data from laboratories is
245
increasingly being adopted. What is unknown is what effects this communication would have on follow-up rates if providers explicitly were to share the ownership of the test results and shift responsibility for initiating follow-up to patients. The Result Notification via Alphanumeric Pagers (ReNAP) is an example of many technology-based interventions. ReNAP is an application that enables clinicians to indicate preferences for notification of patient-specific laboratory test results via an alphanumeric pager.26 An effective intervention, however, often requires only strategic improvements in the existing systems. For example, Singh et al.27 reported a dramatic improvement in timely follow-up of positive fecal occult blood tests via a quality improvement process correcting the software misconfiguration in the electronic health record. The Massachusetts Coalition for the Prevention of Medical Error completed a statewide initiative to design interventions to ensure fail-safe follow-up of test results. Solutions to this problem addressed enhancing communication, teamwork, and transfer of information, which are fundamental system factors linked to patient safety. A Consensus Group defined critical test results as values for which reporting delays can result in serious adverse outcomes for patients. The recommendations and the starter set of test results were disseminated in a statewide collaborative, open to all Massachusetts hospitals. Hospitals' team members tested changes and shared successful strategies that improved the reliability of communicating critical test results.23,28 Generally, the diagnostic process is an open-loop system (also called a “nonfeedback-controlled” system).9 The system, operated without the use of feedback to calibrate its output or to determine if the desired goal is achieved, likely will not be accepted in any other industries. Follow-up and feedback on providers' diagnostic performances are important so that they can engage in learning. Including the science of diagnostic error into the culture of patient safety is the most important first step so that the tracking and analysis of errors becomes more acceptable by providers.13 Schiff et al.2 suggested an intervention to reduce diagnostic errors by learning from errors encountered locally. A standardized chart audit tool was used to identify and analyze diagnostic errors systematically from physician reports. Other organizations could identify preventive strategies through a similar process.
246
Many pathways can be established so providers can learn if or when a diagnosis is changed. They may include developing audit protocols to detect diagnostic error, comparing admit diagnoses to discharge diagnoses, auditing diagnoses of patients who return to the emergency department within 48 h after discharge and making note of diagnoses that change from one visit to the next, comparing consulting/referral diagnoses to referring physician diagnoses, tracking radiology and pathology over-reads, and tracking changes to initial laboratory test results.13
Patient-education Strategies Patients can participate in the effort to reduce diagnostic errors. Health care organizations can educate and empower patients to become active partners in the diagnostic process. This approach has gained attention in the patient-safety movement and in public interest.17,29,30 Providers should educate their patients about diagnostic probabilities and uncertainties. This awareness could support and enhance patient initiative in questioning the diagnostic process. Patients can be engaged in the diagnostic process by encouraging and empowering them to give the complete history with an accurate timeline to the providers, to question any step in the diagnostic process, and to report changes in their condition or results of second opinions to their providers. A randomized trial that targeted consumers found that providing patients with education improved discrimination of serious symptoms necessitating clinician diagnosis.31 Patients should not be afraid to ask the following questions: “What else could my illness be?”, or “Is there anything that does not fit?”, or “Could I have more than one problem?” They should feel free to offer their own suggestions for diagnosis, ask about when they can expect all test results, contact the provider if they do not hear about the results, and not presume that “no news is good news.”13,30,32 Patients should be encouraged to advocate for better care by asserting themselves regarding the provider's diagnostic thinking; integrating the diagnosis into the treatment process; and, when the diagnosis is established, asking specific questions to understand treatment options and their risks and benefits.33 In conclusion, the new field of diagnostic error in patient safety is growing, with a large number of strategies and interventions being suggested that involve systems-oriented approaches. Most interventions are likely content- or setting-specific and should
Curr Probl Pediatr Adolesc Health Care, October 2013
be tested and tailored for local implementation. The framework of strategy types may provide a basis for classifying or designing studies. Future research should be multifaceted, be focused on real-world clinical practice, and be designed specifically to measure rates of diagnostic error as primary outcomes.
References 1. Graber ML, Franklin N, Gordon R. Diagnostic error in internal medicine. Arch of Intern Med 2005;165:1493–9. 2. Schiff GD, Hasan O, Kim S, et al. Diagnostic error in medicine: analysis of 583 physician-reported errors. Arch Intern Med 2009;169:1881–7. 3. Norman GR, Eva KW. Diagnostic error and clinical reasoning. Med Educ 2010;44(1):94–100. 4. Plebani M, Laposata M, Lundberg GD. The brain-to-brain loop concept for laboratory testing 40 years after its introduction. Am J Clin Pathol 2011;136(6):829–33. 5. Plebani M. Errors in laboratory medicine and patient safety: the road ahead. Clin Chem Lab Med 2007;45(6):700–7. 6. Plebani M. Exploring the iceberg of errors in laboratory medicine. Clin Chem Acta 2009;404(1):16–23. 7. Callen JL, Westbrook JI, Georgiou A, Li J. Failure to followup test results for ambulatory patients: a systematic review. J Gen Intern Med 2012;27(10):1334–48. 8. Singh H, Weingart SN. Diagnostic errors in ambulatory care: dimensions and preventive strategies. Adv Health Sci Educ Theory Pract 2009;14(suppl 1):57–61. 9. Schiff GD. Minimizing diagnostic error: the importance of follow-up and feedback. Am J Med 2008;121(Suppl 5): S38–S42. 10. Perno JF, Schunk JE, Hansen KW, et al. Significant reduction in delayed diagnosis of injury with implementation of a pediatric trauma service. Pediatr Emerg Care 2005;21(6):367–71. 11. Howard J, Sundararajan R, Thomas SG, et al. Reducing missed injuries at a level II trauma center. J Trauma Nurs 2006;13(3): 89–95. 12. Keijzers GB, Giannakopoulos GF, Del Mar C, et al. The effect of tertiary surveys on missed injuries in trauma: a systematic review. Scand J Trauma Resusc Emerg Med 2012;20:77. / http://www.sjtrem.com/content/pdf/1757-7241-20-77.pdf S. (Accessed 4.2.13). 13. Pennsylvania Patient Safety Authority. Diagnostic error in acute care. Pa Patient Saf Advis 2010;7(3):76–86./http:// patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/ Sep7(3)/Pages/76.aspxS. (Accessed 2.3.13). 14. Graber ML, Kissam S, Payne VL, et al. Cognitive interventions to reduce diagnostic error: a narrative review. Br Med J Qual Saf 2012;21(7):535–57. 15. Kachalia A, Gandhi TK, Puopolo AL, et al. Missed and delayed diagnoses in the emergency department: a study of closed malpractice claims from 4 liability insurers. Ann Emerg Med 2007;49(2):196–205.
Curr Probl PediatrAdolesc Health Care, October 2013
16. Sakr M, Angus J, Perrin J, et al. Care of minor injuries by emergency nurse practitioners or junior doctors: a randomised controlled trial. Lancet 1999;354(9187):1321–6. 17. Schiff GD, Kim S, Abrams R, et al. Diagnosing diagnostic error: lessons from a multi-institutional collaborative project. In: Henriksen K., Battles J.B., Marks E.S., et al.eds. Advances in Patient Safety: From Research to Implementation. Rockville (MD): Agency for Healthcare Research and Quality; [AHRQ pub No. 05-0021-2]. 2005:255-278. 18. Ramnarayan P, Winrow A, Coren M, et al. Diagnostic omission errors in acute paediatric practice: impact of a reminder system on decision-making. BMC Med Inform Decis Mak 2006;6:37. 19. Dragusin R, Petcu P, Lioma C, et al. FindZebra: a search engine for rare diseases. Int J Med Inform 2013;82(6):528–38. 20. Laposata M, Dighe A. “Pre-pre” and “post-post” analytical error: high-incidence patient safety hazards involving the clinical laboratory. Clin Chem Lab Med 2007;45(6):712–9. 21. Marques MB, Anastasi J, Ashwood E, et al. The clinical pathologists as consultants. Am J Clin Pathol 2011;135(1): 11–2. 22. Tormey CA, Smith BR. The transfusion medicine specialist as a coagulation consultant: a new variant of therapeutic pathology. Transfusion 2012. 10.1111/trf.12012. [Epub ahead of print]. 23. Gandhi TK. Fumbled handoffs: one dropped ball after another. Ann Intern Med 2005;142(5):352–8. 24. Singh H, Graber ML, Kissam SM, et al. System-related interventions to reduce diagnostic errors: a narrative review. BMJ Qual Saf 2012;21(2):160–70. 25. Davis Giardina T, Singh H. Should patients get direct access to their laboratory test results? An answer with many questions J Am Med Assoc 2011;306(22):2502–3. 26. Poon EG, Kuperman GJ, Fiskio J, et al. Real-time notification of laboratory data requested by users through alphanumeric pagers. J Am Med Inform Assoc 2002;9(3):217–22. 27. Singh H, Wilson L, Petersen LA, et al. Improving follow-up of abnormal cancer screens using electronic health records: trust but verify test result communication. BMC Med Inform Decis Mak 2009;9:49. 28. Hanna D, Griswold P, Leape LL, et al. Communicating critical test results: safe practice recommendations. Jt Comm J Qual Patient Saf 2005;31(2):68–80. 29. Groopman J. How Doctors Think. New York, NY: Houghton Mifflin Company, 2008. 30. Cohen E. The Empowered Patient: How to Get the Right Diagnosis, Buy the Cheapest Drugs, and Get the Best Medical Care Every Time. New York (NY): Ballantine Books Trade, 2010. 31. McCarthy PL, Sznajderman SD, Lustman-Findling K, et al. Mothers' clinical judgment: a randomized trial of the Acute Illness Observation Scales. J Pediatr 1990;116(2):200–6. 32. Don't be a diagnostic error: 10 common medical mix-ups and how to avoid them. Consum Rep Health 2009;21:1–3. 33. Wen L, Kosowsky J. When Doctors Don't Listen. New York, NY: St. Martin's Press, 2013.
247
System-Related Factors Contributing to Diagnostic Errors Satid Thammasitboon, MD, MHPE,a Supat Thammasitboon, MD, MSCR,b and Geeta Singhal, MD, MEda
Several studies in primary care, internal medicine, and emergency departments show that rates of errors in test requests and result interpretations are unacceptably high and translate into missed, delayed, or erroneous diagnoses. Ineffective follow-up of diagnostic test results could lead to patient harm if appropriate therapeutic interventions are not delivered in a timely manner. The frequency of system-related factors that contribute directly to diagnostic errors depends on the types and sources of errors involved. Recent studies reveal that the errors and patient harm in the diagnostic testing loop have occurred mainly at the pre- and post-analytic phases, which are directed primarily by clinicians who may have limited expertise in the rapidly expanding field of clinical pathology. These errors may include inappropriate test requests, failure/ delay in receiving results, and erroneous interpretation and application of test results to patient care. Efforts to address system-related factors often focus on technical errors in laboratory testing or failures in delivery of intended treatment. System-improvement strategies related to diagnostic errors
tend to focus on technical aspects of laboratory medicine or delivery of treatment after completion of the diagnostic process. System failures and cognitive errors, more often than not, coexist and together contribute to the incidents of errors in diagnostic process and in laboratory testing. The use of highly structured hand-off procedures and pre-planned follow-up for any diagnostic test could improve efficiency and reliability of the follow-up process. Many feedback pathways should be established so that providers can learn if or when a diagnosis is changed. Patients can participate in the effort to reduce diagnostic errors. Providers should educate their patients about diagnostic probabilities and uncertainties. The patient-safety strategies focusing on the interface between diagnostic system and therapeutic intervention are strategies that involve both processes to facilitate appropriate follow-up and structural changes, such as the use of electronic tracking systems and patient navigation programs.
he term system-related factors refers to organizational vulnerability to diagnostic errors, which vary with contextual features (e.g., policies or organizational characteristics) of the practice settings. The frequency of system-related factors that contribute directly to diagnostic errors depends on the types and sources of the errors involved. In a study by Graber et al., delayed diagnoses had more systemrelated errors (89%), whereas wrong diagnoses had more cognitive errors (92%). Cases extracted from quality assurance and voluntary reports identified system-related factors as the root cause much more frequently (72% and 76%, respectively) than did cases from autopsy discrepancies (10%).1 In one of the
largest physician-reported cases of diagnostic errors, localizing the breakdowns in the diagnostic process revealed that the testing process had the greatest number of reported process failures. Issues surrounding the clinician assessment process and cognitive errors were slightly fewer, however.2,3 Efforts to address system-related factors often focus on either technical errors in laboratory testing or failures in delivery of the intended treatment. Thus, systemimprovement strategies tend to focus on technical aspects of laboratory medicine or delivery of treatment after completion of the diagnostic process. The diagnostic and therapeutic processes are interrelated, as one process impacts the other (Fig). The conceptual diagram illustrates the multiple steps that occur in the relationship of the patient–provider interaction and diagnostic–therapeutic interface, and where the breakdowns (1–7) leading to diagnostic errors can occur. Key to note is that both system failures and cognitive errors, more often than not, contribute to the errors made in the diagnostic process and in the laboratory testing.
T
From the aBaylor College of Medicine, Texas Children's Hospital, Houston, TX; and bTulane University, Pulmonary Diseases, Critical Care and Environmental Medicine, New Orleans, LA. Curr Probl Pediatr Adolesc Health Care 2013;43:242-247 1538-5442/$ - see front matter & 2013 Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.cppeds.2013.07.004
242
Curr Probl Pediatr Adolesc Health Care 2013;43:242-247
Curr Probl Pediatr Adolesc Health Care, October 2013
Fig. The conceptual diagram illustrating the diagnostic and therapeutic loops in the diagnostic process.
Diagnostic Loop Cognitive processing errors (Point 1) in gathering and interpreting clinical information (i.e., clinical history and physical findings) leading to incorrect differential diagnosis and working diagnosis are addressed at length in “Diagnostic decision-making and strategies to improve diagnosis.” In this article, we discuss the diagnostic loop, focusing on the diagnostic testing process, which can be divided into three phases: pre-analytic, analytic and post-analytic (Points 2, 3, and 4, respectively). With the improvements made in clinical pathology in terms of reliability and standardization of analytic techniques, reagents, and instrumentation, along with implementations of information technology, quality control, and assurance methods, the analytic error rate has decreased by more than 10-fold in the last decades.4 Recent studies reveal that the errors and patient harm in the diagnostic testing loop have occurred mainly at the pre- and post-analytic phases, which are directed primarily by providers who may have limited expertise with the ever-growing body of knowledge in clinical pathology.5,6 These errors may include inappropriate test requests, failure/delay in receiving them, and erroneous interpretation and application of test results to patient care. These tasks often are poorly monitored because no consensus exists regarding whether the laboratory or the clinical department is responsible. Several studies in primary care, internal medicine, and emergency departments attest that the rates of errors in test requests and results
Curr Probl PediatrAdolesc Health Care, October 2013
of interpretation, which translate into missed, delayed, or erroneous diagnoses, are unacceptably high.4
Therapeutic Loop Ineffective follow-up of test results could lead to patient harm if appropriate therapeutic interventions are not delivered in a timely manner (Point 6). The problem is amplified when the provider ordering the tests is unknown or the provider responsible for the patient's care is ambiguous (e.g., primary care provider vs. specialist). In addition, patients often do not perceive follow-up as critical; they may assume that the test results are normal (i.e., “no news is good news”). A systematic review that examined failures to follow up test results with ambulatory care patients reported that failed follow-up ranged from 1.0% to 62.0%, depending on the type of test result.7 When a subspecialty consultant is needed to prescribe therapeutic recommendations, the referral process may add another layer to an already vulnerable system, thereby leading to an even greater risk of treatment delay. Another contributing factor is the inherent risk of having ambiguity in roles and responsibilities for both treatment and follow-up when more than one provider is involved in the patient's care.8 For instance, the primary care provider may fail to provide a timely consultation, which in turn may result in the consultant failing to address the issues faced by the referring provider or being confused about his or her role in the
243
case. Contrariwise, the consultant may fail to communicate recommendations to the primary care provider. Patient follow-up also serves as a critical process to monitor responsiveness to the prescribed therapy. Providers should gather additional clinical information during the follow-up visits to ensure that the diagnoses are correct, to tailor the treatments to the individual patients, and occasionally to challenge the working diagnosis (i.e., create a closed-loop feedback system).9
System-related Strategies to Reduce Diagnostic Errors In the section below, we summarize some suggested strategies that can be adopted to address system-related factors to reduce diagnostic errors according to steps in diagnostic process (Table).
Patient–provider Interface Efforts to create a highly reliable diagnostic system have shown positive results in reducing the number of delayed diagnoses and misdiagnoses. The implementation of a designated pediatric trauma response team has been shown to reduce the incidence of delayed diagnoses of injury by nearly 10-fold.10 The routine trauma tertiary survey, a comprehensive re-evaluation of trauma patients within 24 hours of admission, is another example of a highly reliable diagnostic TABLE. System-related strategies to address different steps in diagnostic process
Patient–provider interface Create a highly reliable diagnostic system Restructure human resource to create an efficient health care team Structured process changes Clinical–laboratory interface Implement technology-based interventions to improve test performance Enhance knowledge about laboratory tests and their interpretations Establish collaboration between clinical and laboratory experts Follow-up and tracking Streamline the communication between laboratory, providers, and patients Improve the notification system for reporting critical laboratory values Create a reliable referral system Ensure fail-safe follow-up for therapeutic monitoring Create a non-punitive feedback system to learn from errors Patient education Increase awareness about diagnostic probability and uncertainty Empower the patients to ask questions and engage in the diagnostic process Emphasize the importance of follow-up and monitoring
244
systemic approach aimed at reducing the incidence of diagnostic errors.11,12 The use of specialist consultants or second opinions can support the clinician in an unsure diagnostic or therapeutic encounter. Mandatory second opinions on some key error-prone diagnoses and second readings of key diagnostic tests can be considered.13 The application of second readings in radiology has been shown to be beneficial in detection of cancer, although its impact has been mixed in different settings.14 Human resource-oriented approaches could offer effective interventions. Introducing additional health care providers and substituting certain professionals with others have been studied. This approach may mitigate excessive workloads and staff fatigue. Minimizing disruptions and production pressures also may allow clinicians more time to reflect on their diagnostic decisions.15 Properly trained emergency nurse practitioners using accepted guidelines could provide care for patients with minor injuries that is equal to, or in some ways better than, that provided by junior clinicians.16 An attempt should be made to create a workflow or a schedule that maintains, as much as possible, a continuity of care with individual patients. The continuity of care could enhance communication and allow for implementing a closed-loop feedback to identify diagnostic errors. Structured process changes include the implementation of additional stages in the diagnostic pathway aimed at improving diagnostic performance, avoiding errors, or establishing feedback loops. The strategies may include the addition of triage protocols, feedback steps, and quality-improvement processes. Most interventions involve an implementation of a tool, such as a checklist or a form (e.g., standardizing a complete history, a targeted physical examination, and appropriate tests). These strategies can be organized around high-risk diagnoses (e.g., cancer, infection, and traumatic injury) or around care settings (e.g., routine wellness visit checklist that reminds about screening protocols and sick visit checklist that lists “don't miss” diagnoses).13,17 The implementation of a Clinical Decision Support System can improve the clinician's reasoning directly through provision of data or guidance, as well as decrease the cognitive load in use by the clinician during the reasoning process. The Internet has become a primary resource for information about illnesses and treatments for both medical and nonmedical users (e.g., Google and PubMed). Isabel
Curr Probl Pediatr Adolesc Health Care, October 2013
(http://www.isabelhealthcare.com) is a web-based application that receives the most investigation and has been found to yield high sensitivity in Pediatric settings.18 Medical professionals also may look to FindZebra, which is a specialized search engine that assists in diagnosing difficult patient cases. Medical professionals can use it to look for diagnostic hypotheses. The retrieved information is collected from reputable sources across the Internet that store medical literature on rare diseases. This specialized search engine outperformed Google Search in both default set-up and searches customized to the resources used by FindZebra in one study.19 The integration of computer-assisted feature mapping and/or data visualization tools into the electronic medical record systems could help detect subtle abnormalities that might have been missed otherwise.13
Clinical–laboratory Interface A considerable number of technology-based system interventions have been implemented in laboratory medicine. Although the details of this advancement are beyond the scope of this article, we can assume that technological developments will reduce the number of errors occurring in most of the analytic phases and some areas in pre-post-analytic phases performed by clinical laboratory professionals. The errors commonly occur in the pre- and post-analytic phases outside the laboratory department and under the direction of health care providers with various levels of knowledge related to the laboratory testing. These areas sometimes are called pre-pre-analytic and post-post-analytic phases, respectively. Initiatives for improving the appropriateness of test requests and the interpretations of results could be achieved by two primary approaches. First, efforts to improve specific knowledge about laboratory tests and the correct interpretation of test results should be done by allowing easy and rapid access to knowledge sources at the point of care and/or by introducing narrative interpretation and interpretive comments in laboratory reports.20 The other approach is done through changes in the structured process, which would require a substantial reorganization and collaboration between clinical and laboratory medicine. As molecular diagnostic testing has increased exponentially, it has become more difficult for health care providers to keep pace with the indications for and interpretations of all tests. Given a considerable number of test options to choose from, providers are
Curr Probl PediatrAdolesc Health Care, October 2013
at risk of ordering erroneous or unnecessary tests that may lead to a delay in establishing a diagnosis. Thus, the need for expert consultation with a clinical pathologist before selecting laboratory tests may be critical in enhancing the efficiency of patient care. The involvement of clinical pathologists in the decisionmaking process during the post-post-analytic phase (i.e., interpreting and using laboratory information for patient management) has been widely adopted in transfusion and hemostasis management.21,22 A similar collaborative model should be explored and investigated in other areas of clinical management.
Follow-up and Tracking Tracking results and follow-up systems in health care are crucial to maintaining efficiency of patient care. Simply urging providers to be more vigilant is not the solution for an inefficient and disorganized system with many opportunities for delays and losses to follow up.23 The patient-safety strategies focusing on the interface between diagnostic systems and therapeutic interventions, such as the use of electronic tracking systems and patient navigation programs, involve both processes to facilitate appropriate follow-up and structural changes.24 Explicit communication of test results and documentation of this communication (e.g., acknowledgment of receipt of communication) and clear escalation policies (e.g., contacting the head of the clinic if the primary care provider is not available or the attending physician if the resident does not answer) should be implemented.23 Clear guidelines must be instituted and enforced to ensure that abnormal results are appropriately communicated to a health care provider who can take action.24 The use of highly structured, hand-off procedures, and pre-planned follow-up for any diagnostic tests could improve efficiency and reliability of the follow-up process.24 Despite the use of electronic health records to facilitate communication of test results, follow-up remains a significant safety challenge. In an effort to mitigate delays, some systems have adopted a timedelayed direct notification of test results to patients (e.g., releasing them after 3–7 days to allow physicians to review them).25 Greater engagement of the patient is widely recognized as necessary to promoting better outcomes and lower costs. Having patients assume greater responsibility for their health by giving them direct access to their data from laboratories is
245
increasingly being adopted. What is unknown is what effects this communication would have on follow-up rates if providers explicitly were to share the ownership of the test results and shift responsibility for initiating follow-up to patients. The Result Notification via Alphanumeric Pagers (ReNAP) is an example of many technology-based interventions. ReNAP is an application that enables clinicians to indicate preferences for notification of patient-specific laboratory test results via an alphanumeric pager.26 An effective intervention, however, often requires only strategic improvements in the existing systems. For example, Singh et al.27 reported a dramatic improvement in timely follow-up of positive fecal occult blood tests via a quality improvement process correcting the software misconfiguration in the electronic health record. The Massachusetts Coalition for the Prevention of Medical Error completed a statewide initiative to design interventions to ensure fail-safe follow-up of test results. Solutions to this problem addressed enhancing communication, teamwork, and transfer of information, which are fundamental system factors linked to patient safety. A Consensus Group defined critical test results as values for which reporting delays can result in serious adverse outcomes for patients. The recommendations and the starter set of test results were disseminated in a statewide collaborative, open to all Massachusetts hospitals. Hospitals' team members tested changes and shared successful strategies that improved the reliability of communicating critical test results.23,28 Generally, the diagnostic process is an open-loop system (also called a “nonfeedback-controlled” system).9 The system, operated without the use of feedback to calibrate its output or to determine if the desired goal is achieved, likely will not be accepted in any other industries. Follow-up and feedback on providers' diagnostic performances are important so that they can engage in learning. Including the science of diagnostic error into the culture of patient safety is the most important first step so that the tracking and analysis of errors becomes more acceptable by providers.13 Schiff et al.2 suggested an intervention to reduce diagnostic errors by learning from errors encountered locally. A standardized chart audit tool was used to identify and analyze diagnostic errors systematically from physician reports. Other organizations could identify preventive strategies through a similar process.
246
Many pathways can be established so providers can learn if or when a diagnosis is changed. They may include developing audit protocols to detect diagnostic error, comparing admit diagnoses to discharge diagnoses, auditing diagnoses of patients who return to the emergency department within 48 h after discharge and making note of diagnoses that change from one visit to the next, comparing consulting/referral diagnoses to referring physician diagnoses, tracking radiology and pathology over-reads, and tracking changes to initial laboratory test results.13
Patient-education Strategies Patients can participate in the effort to reduce diagnostic errors. Health care organizations can educate and empower patients to become active partners in the diagnostic process. This approach has gained attention in the patient-safety movement and in public interest.17,29,30 Providers should educate their patients about diagnostic probabilities and uncertainties. This awareness could support and enhance patient initiative in questioning the diagnostic process. Patients can be engaged in the diagnostic process by encouraging and empowering them to give the complete history with an accurate timeline to the providers, to question any step in the diagnostic process, and to report changes in their condition or results of second opinions to their providers. A randomized trial that targeted consumers found that providing patients with education improved discrimination of serious symptoms necessitating clinician diagnosis.31 Patients should not be afraid to ask the following questions: “What else could my illness be?”, or “Is there anything that does not fit?”, or “Could I have more than one problem?” They should feel free to offer their own suggestions for diagnosis, ask about when they can expect all test results, contact the provider if they do not hear about the results, and not presume that “no news is good news.”13,30,32 Patients should be encouraged to advocate for better care by asserting themselves regarding the provider's diagnostic thinking; integrating the diagnosis into the treatment process; and, when the diagnosis is established, asking specific questions to understand treatment options and their risks and benefits.33 In conclusion, the new field of diagnostic error in patient safety is growing, with a large number of strategies and interventions being suggested that involve systems-oriented approaches. Most interventions are likely content- or setting-specific and should
Curr Probl Pediatr Adolesc Health Care, October 2013
be tested and tailored for local implementation. The framework of strategy types may provide a basis for classifying or designing studies. Future research should be multifaceted, be focused on real-world clinical practice, and be designed specifically to measure rates of diagnostic error as primary outcomes.
References 1. Graber ML, Franklin N, Gordon R. Diagnostic error in internal medicine. Arch of Intern Med 2005;165:1493–9. 2. Schiff GD, Hasan O, Kim S, et al. Diagnostic error in medicine: analysis of 583 physician-reported errors. Arch Intern Med 2009;169:1881–7. 3. Norman GR, Eva KW. Diagnostic error and clinical reasoning. Med Educ 2010;44(1):94–100. 4. Plebani M, Laposata M, Lundberg GD. The brain-to-brain loop concept for laboratory testing 40 years after its introduction. Am J Clin Pathol 2011;136(6):829–33. 5. Plebani M. Errors in laboratory medicine and patient safety: the road ahead. Clin Chem Lab Med 2007;45(6):700–7. 6. Plebani M. Exploring the iceberg of errors in laboratory medicine. Clin Chem Acta 2009;404(1):16–23. 7. Callen JL, Westbrook JI, Georgiou A, Li J. Failure to followup test results for ambulatory patients: a systematic review. J Gen Intern Med 2012;27(10):1334–48. 8. Singh H, Weingart SN. Diagnostic errors in ambulatory care: dimensions and preventive strategies. Adv Health Sci Educ Theory Pract 2009;14(suppl 1):57–61. 9. Schiff GD. Minimizing diagnostic error: the importance of follow-up and feedback. Am J Med 2008;121(Suppl 5): S38–S42. 10. Perno JF, Schunk JE, Hansen KW, et al. Significant reduction in delayed diagnosis of injury with implementation of a pediatric trauma service. Pediatr Emerg Care 2005;21(6):367–71. 11. Howard J, Sundararajan R, Thomas SG, et al. Reducing missed injuries at a level II trauma center. J Trauma Nurs 2006;13(3): 89–95. 12. Keijzers GB, Giannakopoulos GF, Del Mar C, et al. The effect of tertiary surveys on missed injuries in trauma: a systematic review. Scand J Trauma Resusc Emerg Med 2012;20:77. / http://www.sjtrem.com/content/pdf/1757-7241-20-77.pdf S. (Accessed 4.2.13). 13. Pennsylvania Patient Safety Authority. Diagnostic error in acute care. Pa Patient Saf Advis 2010;7(3):76–86./http:// patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/ Sep7(3)/Pages/76.aspxS. (Accessed 2.3.13). 14. Graber ML, Kissam S, Payne VL, et al. Cognitive interventions to reduce diagnostic error: a narrative review. Br Med J Qual Saf 2012;21(7):535–57. 15. Kachalia A, Gandhi TK, Puopolo AL, et al. Missed and delayed diagnoses in the emergency department: a study of closed malpractice claims from 4 liability insurers. Ann Emerg Med 2007;49(2):196–205.
Curr Probl PediatrAdolesc Health Care, October 2013
16. Sakr M, Angus J, Perrin J, et al. Care of minor injuries by emergency nurse practitioners or junior doctors: a randomised controlled trial. Lancet 1999;354(9187):1321–6. 17. Schiff GD, Kim S, Abrams R, et al. Diagnosing diagnostic error: lessons from a multi-institutional collaborative project. In: Henriksen K., Battles J.B., Marks E.S., et al.eds. Advances in Patient Safety: From Research to Implementation. Rockville (MD): Agency for Healthcare Research and Quality; [AHRQ pub No. 05-0021-2]. 2005:255-278. 18. Ramnarayan P, Winrow A, Coren M, et al. Diagnostic omission errors in acute paediatric practice: impact of a reminder system on decision-making. BMC Med Inform Decis Mak 2006;6:37. 19. Dragusin R, Petcu P, Lioma C, et al. FindZebra: a search engine for rare diseases. Int J Med Inform 2013;82(6):528–38. 20. Laposata M, Dighe A. “Pre-pre” and “post-post” analytical error: high-incidence patient safety hazards involving the clinical laboratory. Clin Chem Lab Med 2007;45(6):712–9. 21. Marques MB, Anastasi J, Ashwood E, et al. The clinical pathologists as consultants. Am J Clin Pathol 2011;135(1): 11–2. 22. Tormey CA, Smith BR. The transfusion medicine specialist as a coagulation consultant: a new variant of therapeutic pathology. Transfusion 2012. 10.1111/trf.12012. [Epub ahead of print]. 23. Gandhi TK. Fumbled handoffs: one dropped ball after another. Ann Intern Med 2005;142(5):352–8. 24. Singh H, Graber ML, Kissam SM, et al. System-related interventions to reduce diagnostic errors: a narrative review. BMJ Qual Saf 2012;21(2):160–70. 25. Davis Giardina T, Singh H. Should patients get direct access to their laboratory test results? An answer with many questions J Am Med Assoc 2011;306(22):2502–3. 26. Poon EG, Kuperman GJ, Fiskio J, et al. Real-time notification of laboratory data requested by users through alphanumeric pagers. J Am Med Inform Assoc 2002;9(3):217–22. 27. Singh H, Wilson L, Petersen LA, et al. Improving follow-up of abnormal cancer screens using electronic health records: trust but verify test result communication. BMC Med Inform Decis Mak 2009;9:49. 28. Hanna D, Griswold P, Leape LL, et al. Communicating critical test results: safe practice recommendations. Jt Comm J Qual Patient Saf 2005;31(2):68–80. 29. Groopman J. How Doctors Think. New York, NY: Houghton Mifflin Company, 2008. 30. Cohen E. The Empowered Patient: How to Get the Right Diagnosis, Buy the Cheapest Drugs, and Get the Best Medical Care Every Time. New York (NY): Ballantine Books Trade, 2010. 31. McCarthy PL, Sznajderman SD, Lustman-Findling K, et al. Mothers' clinical judgment: a randomized trial of the Acute Illness Observation Scales. J Pediatr 1990;116(2):200–6. 32. Don't be a diagnostic error: 10 common medical mix-ups and how to avoid them. Consum Rep Health 2009;21:1–3. 33. Wen L, Kosowsky J. When Doctors Don't Listen. New York, NY: St. Martin's Press, 2013.
247