The fundamental error in this case involved non-standardized detection and report- ing of hemolyzed samples, wrong assumption made by the referring physician that the hyperkalemia was due to a hemolyzed specimen and failure to consider other possibilities and breakdown in information management.
The “Swiss Cheese” Model of Multiple Vulnerabilities
Case 2 demonstrates a cascade of errors caused by a combination of cognitive and system-related factors. It is a medical mishap that fi ts Reason’s Swiss cheese model.
Although the diagnosis was delayed mainly due to system-related errors, cognitive
biases were a contributing factor. The dilemma involving the issue of hemolyzed specimens is a common challenge particularly in pediatric patients. Omission bias led physicians to repeat testing rather than acting upon it despite a reading of a life- threatening level of potassium. A tendency toward inaction (do no harm) is a com- mon approach in medicine because of a belief that the physician is more likely to be blamed for taking action than for inaction when a negative outcome occurs. Some physicians may become desensitized by frequent erroneous results and get into the habit of disputing them rather than considering the risks and benefi ts of watchful waiting. Because a hemolyzed specimen is so common in pediatric practice, some physicians may develop the logical fallacy of assuming or suspecting that every report of hyperkalemia involves a hemolyzed sample. Inadequate knowledge some- times forms the basis of cognitive errors. The physician at the outside hospital did not recognize the strikingly abnormal laboratory data as an ominous sign of con- genital adrenal hyperplasia. The potassium level of 9 mEq/L was reported to the ED after the patient had already been transferred to the PICU.
Errors Associated with Laboratory Testing
Given technological advances in laboratory testing, the risk of errors has decreased signifi cantly within the processes occurring in the laboratory. Still, recent studies from various clinical settings such as primary care, internal medicine, and ED attest that the rates of errors in test request and result interpretation are unacceptably high and cause diagnostic errors [ 9 , 24 ]. An attempt must be made to improve physician knowledge about laboratory tests and the correct interpretation of test results. The sources for point of care knowledge should be readily available. The narrative inter- pretation and interpretive comments in the test reports should be provided [ 25 ]. At the systems level, explicit guidelines to improve coordinated care between labora- tory specialists and physicians must be developed and implemented. In cases of specimen with hemolysis, laboratory personnel should always ask for a new sample.
If the specimen is found to be hemolyzed, it cannot simply be rejected especially in case of critical reading of hyperkalemia, but the laboratory should alert the physi- cian so that any in vivo hemolysis or hyperkalmia can be ruled out.
System-Related Errors
The frequency of system-related factors varies with the types of errors. Based on Graber et al. [ 17 ], delayed diagnosis had more system-related errors (89 %), whereas wrong diagnosis had more cognitive errors (92 %). In one of the largest physician- reported cases of diagnostic errors using DEER taxonomy to localize the break- downs in the diagnostic process, the testing process had the greatest number of reported process failure. Failures in the physician assessment process, cognitive errors, were slightly fewer [ 2 ]. Common system-related factors that contribute to
diagnostic errors include those related to specimen identifi cation, test tracking, reporting of abnormal and critical test results, and transitions in care. The break- down in information management, including ineffi cient processes, poor communi- cation, and coordination of care, are among the most common causes [ 17 , 26 ]. In looking back at the case, poor handoff and communication at transition of care from the referring physician to the hospital contributed to the error. Critical information was lost during inter-facility transfer and was not conveyed in a timely enough man- ner to prevent the patient’s second cardiopulmonary arrest in the PICU.
Remedies for Diagnostic Errors
Strategies to Enhance Diagnostic Decision-Making
Based on existing knowledge in cognitive psychology and medical decision mak- ing, physicians should learn about sources of cognitive errors and familiarize them- selves with different cognitive approaches to making better decisions. Further research is required to investigate if these proposed cognitive strategies can actually optimize diagnostic decision making and decrease errors. Suggested cognitive strat- egies to avoid biases and errors include the following [ 27 ]:
1. Decrease reliance on memory: To improve diagnostic accuracy, physicians should force themselves to use memory aids such as mnemonics, fl ash cards, or computer applications with algorithms and checklists to reduce cognitive load for diagnostic thinking.
2. Enhance metacognitive skills to promote System 2 processes: Metacognition is
“thinking about one’s own thinking.” Physicians should take time to actively refl ect and regulate their own thinking and affective process. Forced generation of a comprehensive list for differential diagnosis and routine use of a “diagnostic pause” (Fig. 15.2 ) to check one’s diagnostic thinking are examples of metacogni- tive strategies [ 28 ].
Fig. 15.2 Diagnostic pause:
a tool to foster metacognition.
Adapted from Quirk [ 28 ]
3. Develop cognitive forcing strategies: Individual physicians should develop generic and specifi c strategies to monitor and override predictable cognitive biases in particular clinical situations (e.g., diagnose anxiety disorder only by careful exclusion, always investigate for multiple drugs in case of suicidal inges- tion, be extra cautious prior to making the conclusion when reliable history is not available, etc.) [ 19 ].
4. Use group decision making: In doubtful situations, collective wisdom likely pro- duces an optimal solution. If a patient care conference is not practical, sharing one’s decision making with another colleague to refl ect on diagnostic thinking is still valuable (i.e., thinking out loud with feedback).
5. Personal accountability: People generally put more effort into decision making when they know that they will be held accountable. Personal accountability using timely constructive feedback will lead to better calibration of future deci- sions [ 23 ].
Addressing issues at the system level can assist physicians with cognitive aspects of diagnostic error. An organization may consider the following system-level strate- gies to reduce cognitive errors:
1. Provide resources for diagnostic decision support system (DDSS): There are commercially available Web-based DDSS applications that provide comprehen- sive list of differential diagnoses and accurate estimates of disease probability.
Isabel ( http://www.isabelhealthcare.com ) is an example of available applications that uses patient’s demographics and clinical features to produce a list of possi- ble diagnoses. These resources could also include point-of-care general medical knowledge references [ 4 , 27 ].
2. Provide resources and encourage use of clinical guidelines and clinical algo- rithms: These resources enhance physician adherence with evidence-based med- ical practice which helps prevent cognitive biases inherent to human judgment and reduce errors.
3. Incorporate forced use of checklists into the diagnostic process: Diagnostic checklists can be used to prevent reliance on memory and overconfi dence for error-prone diagnoses (e.g., chest pain, dizziness). Strategic use of checklists can: (1) guide physicians to optimize their cognitive approach, (2) remind physi- cians to consider a complete list of possible diagnoses for a given clinical prob- lem, and (3) remind physicians of common pitfalls or biases when diagnosing certain diseases (cognitive forcing strategies) [ 29 ].
Strategies to Reduce System-Related Errors
While progress has been made in understanding systems causes of diagnostic errors, studies evaluating the effectiveness of these system-level interventions are lacking.
The important fi rst step should focus on changing the perception of diagnostic errors from “errors in judgment,” “errors in thinking,” or “physician mistakes” to
errors related to cognitive processing, communication, and system design [ 27 ]. This Just Culture oriented patient safety approach would allow scientifi c studies of diag- nostic errors to fi nd effective strategies to minimize them. Figure 15.3 summarizes multifaceted patient safety approach to improve the diagnostic process. System strategies to enhance communication and coordination of care may include the following:
1. Optimize the use of electronic health records to facilitate transfer of patient information across clinical settings. The system needs to ensure that the required follow-up action is completed to close the information loop. The system can generate automatic messages reporting test results to physicians and patients and schedule follow-up in timely and reliable fashion [ 4 , 30 ].
2. Enhance the laboratory-clinical interface by developing coordinated care between laboratory specialists and physicians in all steps of diagnostic testing.
This approach could minimize inappropriate test requests and misleading interpretation of laboratory data [ 31 ].
3. Ensure that specialty expertise is available when needed. An attempt should be made to identify and resolve any potential barriers that compromise effective communication and coordination among all clinical services [ 27 ].
4. Encourage and educate patients to be active participants in every step of the diagnostic process. The patient is a crucial part of the “safety net” for system errors. Patients should offer the complete story, remind physicians to consider
Fig. 15.3 Closed-loop feedback in the diagnostic process
other possibilities, disagree with their physicians, ask for clarifi cation, and request timely follow-up [ 32 ].
5. Develop a system for reliable follow-up. Timely follow-up is crucial for high- risk diagnoses or symptoms for which a diagnosis has not been made (e.g., patients should not think that “no news is good news”) [ 4 ].
6. Establish pathways for reliable, blame-free upstream feedback to physicians in cases of misdiagnosis-related harm. This can be achieved by developing chart audit protocols to look for changed diagnoses (e.g., comparing ED diagnoses to subsequent diagnoses, reviewing all readmissions, morbidity and mortality con- ferences, sentinel event analysis, etc.) [ 4 , 27 ].
Conclusion and Key Lessons
Diagnostic errors are common, costly, and can result in adverse consequences for patients, families, and healthcare professionals. Physicians should educate them- selves about sources of errors, analyze different processes involved in the diagnostic process, and healthcare organizations should implement explicit strategies to mini- mize cognitive- and systems-related factors leading to diagnostic errors.
Key Lessons
1. Diagnostic errors place serious fi nancial burden on the healthcare system and can be devastating for affected patients, families, and physicians.
2. Causes of diagnostic errors are often multifactorial; cognitive processing errors and system design fl aws are contributory factors.
3. Physicians should familiarize themselves with the science of diagnostic decision making and common biases that can affect their decisions.
4. While many available system-level strategies can be implemented to reduce diagnostic errors, further research is required to prove their effectiveness.
References
1. Graber M. Diagnostic errors in medicine: a case of neglect. Jt Comm J Qual Patient Saf.
2005;31(2):106–13.
2. Schiff GD, Hasan O, Kim S, et al. Diagnostic error in medicine: analysis of 583 physician- reported errors. Arch Intern Med. 2009;169(20):1881–7.
3. Wachter RM. Why diagnostic errors don’t get any respect—and what can be done about them.
Health Aff. 2010;29(9):1605–10.
4. Berner ES, Graber ML. Overconfi dence as a cause of diagnostic error in medicine. Am J Med.
2008;121(5 Suppl):S2–23.
5. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients.
Results of the Harvard medical practice study II. N Eng J Med. 1991;324(6):377–84.
6. Bogner MS. Human error in medicine. Hillsdale, NJ: Lawrence Erlbaum Associates; 1994.
7. Croskerry P, Sinclair D. Emergency medicine: a practice prone to error? Can J Emerg Med.
2001;3:271–6.
8. Kachlia A, Ghandi 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.
9. Gandhi TK, Kachalia A, Thomas EJ, et al. Missed and delayed diagnoses in the ambulatory setting: a study of closed malpractice claims. Ann Intern Med. 2006;125:488–96.
10. Lippman H, Davenport J. Sued for misdiagnosis? It could happen to you. J Fam Pract.
2010;59(9):498–508.
11. Hanscom R. CRICO/RMF community targets diagnostic error. CRICO/RMF insight. Available at http://www.rmf.harvard.edu/education-interventions/crico-rmf-insight/ archives/092007/
art1.htm . Accessed 10 Feb 2012.
12. Pidenda LA, Hathwar VS, Grand BJ. Clinical suspicion of fatal pulmonary embolism. Chest.
2001;120:791–5.
13. Wachter RM. Understanding patient safety. New York, NY: McGraw-Hill Medical; 2008.
14. Golodner L. How the public percieves patient safety. Newsletter of the National Patient Safety Foundation 2004;1997:1–6.
15. Isabel Health Care. Misdiagnosis is an overlooked and growing patient safety issue and core mission of Isabel Healthcare. 20 Mar 2006. Available at http://www.isabelhealthcare.com/pdf/
USsurveyrelease-Final.pdf . Accessed 13 Jul 2013.
16. Reason J. Human error: models and management. BMJ. 2000;320:768–70.
17. Graber ML, Franklin N, Gordon R. Diagnostic error in internal medicine. Arch Intern Med.
2005;165:1493–9.
18. Croskerry P. Context is everything or how could I have been that stupid? Healthc Q.
2009;12:e171–6.
19. Croskerry P. Achieving quality in clinical decision making: cognitive strategies and detection of bias. Acad Emerg Med. 2002;9:1184–204.
20. Eva KW. What every teacher needs to know about clinical reasoning. Med Educ.
2005;39:98–106.
21. Balla JI, Heneghan C, Glasziou P, Thompson M, Balla ME. A model for refl ection for good clinical practice. J Eval Clin Pract. 2009;15:964–9.
22. Ark TK, Brooks LR, Eva KW. The best of both worlds: adoption of a combined (analytical and non-analytical) reasoning strategy improves diagnostic accuracy relative to either strategy in isolation. Proceedings of the annual meeting of the Association of American Medical Colleges, 5–10 Nov 2004, Boston.
23. Friedman CP, Gatti GG, Franz TM, et al. Do physicians know when their diagnoses are cor- rect? Implications for decision support and error reduction. J Gen Intern Med. 2005;20(4):
334–9.
24. Wahls TL, Cram PM. The frequency of missed test results and associated treatment delays in a highly computerized health system. BMC Fam Pract. 2007;8:32.
25. Plebani M. Interpretive commenting: a tool for improving the laboratory-clinical interface.
Clin Chim Acta. 2009;404:405–51.
26. Singh H, Graber M. Reducing diagnostic error through medical home–based primary care reform. JAMA. 2010;304(4):463–4.
27. Pennsylvania Patient Safety Authority. Diagnostic error in acute care. Pa Patient Saf Advis.
2010;7(3):76–86. Available at http://patientsafetyauthority.org/ADVISORIES/Advisory Library/2010/Sep7(3)/Pages/76.aspx . Accessed 13 Jul 2013.
28. Quirk ME. Intuition and metacognition in medical education: keys to developing expertise.
New York, NY: Springer; 2006.
29. Ely JW, Graber ML, Croskery P. Checklists to reduce diagnostic errors. Acad Med.
2011;86:307–13.
30. Schiff GD, Bates DW. Can electronic clinical documentation help prevent diagnostic errors?
N Engl J Med. 2010;362:1066–9.
31. 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.
32. Schiff GD, Kim S, Abrams R. Diagnosing diagnostic error: lessons from a multi-institutional collaborative project. In: Henriksen K, Battles JB, Marks ES, et al., editors. Advances in patient safety: from research to implementation. Rockville, MD: Agency for Healthcare Research and Quality; 2005. p. 255–78. AHRQ pub No. 05-0021-2.
Special Considerations
249 A. Agrawal (ed.), Patient Safety: A Case-Based Comprehensive Guide,
DOI 10.1007/978-1-4614-7419-7_16, © Springer Science+Business Media New York 2014
Introduction
Medical errors and patient harm events that occur in pediatric patients differ from those of adults, due to different physical characteristics, developmental issues, and the dependent/legal/vulnerable state of the child [ 1 , 2 ]. Although error and harm due to medications [ 3 – 6 ] are most prevalently cited, diagnostic errors, patient misiden- tifi cation [ 7 ], communication failures, and lack of information system customiza- tion are some of the other frequent problems associated with pediatric safety events [ 8 , 9 ]. It is also important to keep in mind that the defi nition of a pediatric patient is not always limited by age; young adults with chronic and/or unusual diseases are often cared for in the pediatric healthcare setting [ 10 ]. Healthcare safety failures for children are many and include lack of proper equipment (e.g., adult-sized oxygen saturation monitor probes causing erroneous results), over or misuse of technology (e.g., radiation dosing for computed tomography higher than necessary to produce adequate image), lack of awareness of age-specifi c norms (e.g., vital sign changes misinterpreted, resulting in either excessive or conversely no action taken), and fail- ure to anticipate environmental infl uences (e.g., hypothermia due to cold rooms or lack of bundling resulting in physiologic stress) [ 2 , 3 , 7 , 9 ].
Patient Safety in Pediatrics
Erin Stucky Fisher
E. S. Fisher , M.D., M.H.M. (*)
University of California San Diego , San Diego , CA , USA Rady Children’s Hospital San Diego , 3020 Children’s Way, MC 5064 , San Diego , CA 92123 , USA
e-mail: estucky@rchsd.org
“ We are built to make mistakes, coded for error .”
Lewis Thomas
To date, reports on the epidemiology of pediatric safety events have been focused primarily on the hospital setting [ 2 ]. Medication errors are not surprisingly the most commonly cited safety event (5–50 % of errors) and include a combination of calcu- lation, formulation, dispensing, and administration errors [ 2 , 5 ]. There is potentially greater risk of error commitment in the medication process for pediatric patients than for adult patients due to weight-based prescribing needs, dynamic age and dis- ease-state physiologic and developmental changes, and medication delivery issues that are unique to children [ 2 , 5 ]. In addition patient misidentifi cation, delays in care, miscommunication, intravenous access problems, and other incidents have also been reported, some at rates of up to 10 % [ 3 , 7 , 9 ]. Although ambulatory reports are fewer, one multi-center study similarly demonstrated that medication errors occurred most commonly (32 %); however, administrative (documentation) and diagnostic errors were also often reported (22 and 15 %, respectively) [ 6 ]. Importantly, com- munication was deemed a contributing factor in 67 % of all reported events [ 6 ]. In all settings, there are challenges to obtaining accurate and timely error reports and to implementing durable solutions. Despite these unique challenges, the approach toward identifi cation, resolution, and abatement of pediatric harm follows the same tenets of healthcare safety mentioned elsewhere in this book.
A number of case examples could serve to instruct on pediatric error and harm.
As noted, although most information has come from inpatient reports, ambulatory errors are of great importance as well but largely underreported [ 2 ]. Several entities have worked to call attention to pediatric errors and system solutions, including the Institute for Healthcare Improvement (IHI) (High Alert Medications in Pediatrics) [ 11 ], the American Academy of Pediatrics (AAP) (Patient Safety Policy statement) [ 2 ], The Joint Commission (TJC) (various resources) [ 12 ], and the Agency for Healthcare Research and Quality (AHRQ) (Patient Safety Indicators) [ 13 ]. These groups suggest both technology-based solutions such as pediatric-specifi c elec- tronic health record and computerized decision support systems as well as some very basic changes, such as mandatory weight recording in kilograms, that highlight the stark contrast in work yet to be done in pediatric healthcare safety. While the case examples below cannot address all aspects of pediatric error and harm, they call out some of the issues unique to children that deserve attention.
Case Studies
Case 1A: Delayed Diagnosis Leading to Orchiectomy in a 9-Month-Old Infant
Clinical Summary
A.B. is a 9-month-old, previously healthy, term male seen at a community emer- gency department (ED) with parental concern for crying and fussiness for several hours. On arrival vital signs were noted to be stable except for an elevated heart rate thought to be due to crying. Examination was normal except for left-sided
scrotal swelling. Over the next 4ẵ h, the ED physician obtained a scrotal sonogram which was read as nondiagnostic for torsion; the on-call pediatrician was called to admit the patient for pain management and further evaluation. Upon assessment in the ED, the pediatrician called for urgent transfer to the local children’s hospital and immediate urologic consult. The child was met in the children’s ED by the urologist and taken directly to the operating room where left orchiectomy was per- formed due to a necrotic testis.
Case 1B: Missed Diagnosis of Infl ammatory Bowel Disease in an Adolescent
Clinical Summary
L.M. is a 16-year-old boy with infl ammatory bowel disease (IBD) admitted to a large community hospital for upper arm cellulitis thought to be due to an abrasion that occurred when he fell (helmeted) from his bicycle 2 days prior to admission.
The cellulitis improved with treatment. On the day of discharge the patient had a bloody stool and abdominal pain which was recorded by the nurse. A resident assessed the patient when the parent was at work. The patient stated he “was fi ne”
and wanted to go home; he was discharged. One day later, the patient was admitted to the children’s hospital for a severe IBD fl are.
Analysis: Case 1A and Case 1B
These two cases highlight the added vigilance needed when caring for pediatric patients of varied ages. What happened in each case? The fi rst case underscores the need for age and/or disease state- specifi c criteria for pediatric assessments in com- munity settings as is recommended by the Emergency Medical Services for Children and the American Academy of Pediatrics [ 14 ]. Delay in obtaining and interpreting radiological images and delay in transfer to a facility where defi nitive treatment can be rendered are not uncommon at sites where personnel and facilities do not fre- quently care for infants. The second case highlights the need to recognize the impact of unrelated acute medical needs on underlying chronic disease states, to assess and account for clinical changes in the face of patient denial, and to balance adolescent autonomy with family engagement when rendering medical decisions. Adolescents are a special challenge, particularly those with chronic disease who may hesitate to complain, do not want to stay in the hospital, or fail to advocate for themselves when they have issues they would like raised. What can be done to prevent recur- rence of these failures? Protocols should be written for pediatric consultation and testing that acknowledge skill sets available for rendering services to children of different ages and underlying disease states. Patient- and family-centered care (PFCC) principles [ 15 ] and a team approach toward care for adolescents should be