Skip to main content

Thank you for visiting You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

Frequency of diagnostic errors in the neonatal intensive care unit: a retrospective cohort study



To determine the frequency and etiology of diagnostic errors during the first 7 days of admission for inborn neonatal intensive care unit (NICU) patients.

Study design

We conducted a retrospective cohort study of 600 consecutive inborn admissions. A physician used the “Safer Dx NICU Instrument” to review the electronic health record for the first 7 days of admission, and categorized cases as “yes,” “unclear,” or “no” for diagnostic error. A secondary reviewer evaluated all “yes” charts plus a random sample of charts in the other categories. Subsequently, all secondary reviewers reviewed records with discordance between primary and secondary review to arrive at consensus.


We identified 37 diagnostic errors (6.2% of study patients) with “substantial agreement” between reviewers (κ = 0.66). The most common diagnostic process breakdown was missed maternal history (51%).


The frequency of diagnostic error in inborn NICU patients during the first 7 days of admission is 6.2%.

This is a preview of subscription content, access via your institution

Access options

Rent or buy this article

Get just this article for as long as you need it


Prices may be subject to local taxes which are calculated during checkout

Fig. 1: Algorithm for chart review.

Data availability

Data available on request due to privacy/ethical restrictions.


  1. Improving Diagnosis in Health Care. Washington, District of Columbia: The National Academies Press, (2015): 1-18, 31-69.

  2. Berner E. Diagnostic error in medicine: introduction. Adv Health Sci Educ: Theory Pract. 2009;14:1–5.

    Article  Google Scholar 

  3. Graber M, Gordon R, Franklin N. Reducing diagnostic errors in medicine: what’s the goal? Academic Med. 2002;77.10:981–92.

    Article  Google Scholar 

  4. Newman-Toker D, Pronovost P. Diagnostic errors – the next frontier for patient safety. JAMA. 2009;301.10:1060–2.

    Article  Google Scholar 

  5. Thammasitboon S, Thammasitboon S, Singhal G. Diagnosing diagnostic error. Curr Probl Pediatr Adolesc Health Care. 2013;43.9:227–31.

    Article  Google Scholar 

  6. Graber M. The incidence of diagnostic error in medicine. BMJ Qual Saf. 2013;22:21–7.

    Article  Google Scholar 

  7. Singh H, Sittig D. Advancing the science of measurement of diagnostic errors in healthcare: the safer Dx framework. BMJ Qual Saf. 2015;24.2:727–31.

    Google Scholar 

  8. Custer J, Winters B, Goode V, Robinson K, Yang T, Pronovost P, et al. Diagnostic errors in the pediatric and neonatal ICU: a systematic review. Pediatr Crit Care Med. 2015;16.1:29–36.

    Article  Google Scholar 

  9. Bergl P, Taneja A, El-Kareh R, Singh H, Nanchal R. Frequency, risk factors, causes, and consequences of diagnostic errors in critically Ill medical patients: a retrospective cohort study. Crit Care Med. 2019;47.11:e902–e910.

    Article  Google Scholar 

  10. Bergl P, Nanchal R, Singh H. Diagnostic error in the critically III: defining the problem and exploring next steps to advance intensive care unit safety. Ann Am Thorac Soc. 2018;15.8:903–7.

    Article  Google Scholar 

  11. Saber-Tehrani A, Lee HW, Matthews S, Shore A, Makary MA, Ponovost P, et al. 25-year summary of US malpractice claims for diagnostic errors 1986–2010: an analysis from the national practitioner data bank. BMJ Qual Saf. 2013;22.8:672–80.

    Article  Google Scholar 

  12. Shafer G, Suresh G. Diagnostic errors in the neonatal intensive care unit: a case series. Am J Pediatrics Rep. 2018;08.04:e379–e383.

    Google Scholar 

  13. Shafer G, Singh H, Suresh G. Diagnostic errors in the neonatal intensive care unit: state of the science and new directions. Semin Perinatol. 2019;43.8:151175.

    Article  Google Scholar 

  14. Davalos M, Samuels K, Meyer A, Thammasitboon S, Sur M, Roy K, et al. Finding diagnostic errors in children admitted to the PICU. Pediatr Crit Care Med. 2017;18.3:265–71.

    Article  Google Scholar 

  15. Singh H. Editorial: helping health care organizations to define diagnostic errors as missed opportunities in diagnosis. Jt Comm J Qual patient Saf /. 2014;40.3:99–101.

    Google Scholar 

  16. Al-Mutairi A, Meyer A, Thomas E, Etchegaray J, Roy K, Davalos M, et al. Accuracy of the safer Dx Instrument to identify diagnostic errors in primary care. J Gen Intern Med. 2016;31.6:602–8.

    Article  Google Scholar 

  17. Lee H, Bennet M, Schulman J, Gould J. Accounting for variation in length of NICU stay for extremely low birth weight infants. J Perinatol. 2013;33.11:872–6.

    Article  Google Scholar 

  18. Cifra C, Ten Eyck P, Dawson J, Reisinger H, Singh H, Herwaldt L. Factors associated with diagnostic error on admission to a PICU: a pilot study. Pediatr Crit Care Med. 2020;21.5:e311–e315.

    Article  Google Scholar 

  19. Singh H, Giardina T, Meyer A, Forjuoh S, Reis M, Thomas E, et al. Types and origins of diagnostic errors in primary care settings. JAMA Intern Med. 2013;173.6:418–25.

    Article  Google Scholar 

  20. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33.1:159–74.

    Article  Google Scholar 

  21. Gunderson CG, Bilan VP, Holleck JL, Nickerson P, Cherry BM, Chui P, et al. Prevalence of harmful diagnostic errors in hospitalized patients: a systematic review and meta-analysis. BMJ Qual Saf. 2020;29:1008–18.

    Article  Google Scholar 

  22. Raffel KE, Kanto MA, Barish P, Esmailia A, Lim H, Xue F, et al. Prevalence and characterization of diagnostic error among 7 day all-cause hospital medicine readmissions: a retrospective cohort study. BMJ Qual Saf. 2020;29:971–9.

    Article  Google Scholar 

  23. Singh H, Thomas EJ, Wilson L, Kelly PA, Pietz K, Elkeeb D, et al. Errors of diagnosis in pediatric practice: a multisite surgery. Pediatrics. 2010;126:70–9.

    Article  Google Scholar 

  24. Widmann R, Caduff R, Giudici L, Zhong Q, Vogetseder A, Arlettaz R, et al. Value of postmortem studies in deceased neonatal and pediatric intensive care unit patients. Virchows Arch. 2017;470.2:217–23.

    Article  Google Scholar 

  25. Shojania KG, Burton EC, McDonald KM, Goldman L. Changes in rates of autopsy-detected diagnostic errors over time: a systematic review. JAMA. 2003;289.21:2849–56.

    Article  Google Scholar 

  26. Harrison W, Wasserman J, Goodman D. Regional variation in neonatal intensive care admissions and the relationship to bed supply. J Pediatrics. 2018;192:73–79.e4.

    Article  Google Scholar 

  27. Gephart S. The art of effective handoffs: what is the evidence? Adv Neonatal Care. 2012;12.1:37–39.

    Article  Google Scholar 

  28. Lane-Fall M, Collard M, Turnball A, Halpern S, Shea J. ICU attending handoff practices: results from a national surgery of academic intensivists. Crit Care Med. 2016;44.4:690–8.

    Article  Google Scholar 

  29. Derienzo C, Lenfesty R, Horvath M, Goldberg R, Ferranti J. Neonatal intensive care handoffs: a pilot study on core elements and epidemiology of errors. J Perinatol. 2013;34.2:149–52.

    Google Scholar 

  30. Vanderbilt A, Pappada S, Howard S, Harper D, Papadimos TJ. Increasing patient safety with neonates via handoff communication during delivery: a call for interprofessional health care team training across GME and CME. Adv Med Educ Pract. 2017;8:365–7.

    Article  Google Scholar 

  31. Fred H. Hyposkillia: deficiency of clinical skills. Tex Heart Inst J. 2005;32.3:255–7.

    Google Scholar 

  32. Spitzer A. Has quality improvement really improved outcomes for babies in the neonatal intensive care unit? Clin Perinatol. 2017;44.3:469–83.

    Article  Google Scholar 

  33. Wears R, Nemeth C. Replacing hindsight with insight: toward better understanding of diagnostic failures. Ann Emerg Med. 2007;49.2:206–9.

    Article  Google Scholar 

  34. Thomas EJ, Petersen LA. Measuring errors and adverse events in healthcare. J Gen Intern Med. 2003;18:61–7.

    Article  Google Scholar 

  35. Thomas EJ. The future of measuring patient safety: prospective clinical surveillance. BMJ Qual Saf. 2015;24:244–5.

    Article  Google Scholar 

  36. Singh H, Giardina T, Forjouh S, Reis M, Kosmach S, Khan M, et al. Electronic health record-based surveillance of diagnostic errors in primary care. BMJ Qual Saf. 2012;21.2:93–100.

    Article  Google Scholar 

Download references


We would like to thank Dr. Joseph Garcia-Prats, Dr. Mohan Pammi, and Dr. Lakshmi Katakam for their assistance with the secondary review process. The authors would also like to thank Dr. Joseph Hagan for his assistance with the statistical analysis.


This study was funded by the “Evie” Whitlock Fund for neonatal-perinatal medicine fellows at Baylor College of Medicine and Texas Children’s Hospital. Dr. Singh is funded in part by the Houston Veterans Administration (VA) Health Services Research and Development (HSR&D) Center for Innovations in Quality, Effectiveness, and Safety (CIN13–413), the VA HSR&D Service (CRE17–127 and the Presidential Early Career Award for Scientists and Engineers USA 14–274), the VA National Center for Patient Safety, the Agency for Healthcare Research and Quality (R01HS27363), and the Gordon and Betty Moore Foundation. Dr. Thomas is supported by the University of Texas at Houston – Memorial Hermann Center for Healthcare Quality and Safety.

Author information

Authors and Affiliations



GJS conceptualized and designed the study, designed the data collection tool and manual of operations, collected the data, performed the initial record review, carried out the initial analysis, drafted the initial manuscript, and reviewed and revised the manuscript. KSG conceptualized and designed the study, designed the data collection tool and manual of operations, and reviewed and revised the manuscript. HS conceptualized and designed the study, designed the original Safer Dx Instrument, and reviewed and revised the manuscript. EJT and ST conceptualized and designed the study, and reviewed and revised the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Grant J. Shafer.

Ethics declarations

Competing interests

The authors declare no competing interests.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary information

Rights and permissions

Reprints and Permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Shafer, G.J., Singh, H., Thomas, E.J. et al. Frequency of diagnostic errors in the neonatal intensive care unit: a retrospective cohort study. J Perinatol 42, 1312–1318 (2022).

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI:


Quick links