Dr. John James, Author of Shocking 2014 Patient Safety Article on Medical Errors, Calls for National Patient Safety Board

patient safety regulations

To mark the anniversary of the Institute of Medicine’s watershed report “To Err Is Human: Building a Safer Health System,” West Health is running a series of interviews between their Chief Medical and Science officer Dr. Joe Smith and IOM committee members who helped produce the report (which estimates 440,000 lethal errors each year including hospital acquired infections), as well as other national health experts to examine what progress has been made in reducing medical errors in the US. Do you agree that we need a National Patient Safety Board to better regulate healthcare? Leave a comment and let us know!

This week’s Q&A features John T. James, PhD, former chief toxicologist for a federal agency, who has dedicated his life to patient safety after the loss of his teenage son to medical errors in 2002. He is the author of “A Sea of Broken Hearts: Patient Rights in a Dangerous, Profit-Driven Health Care System” and founder of Patient Safety America, a website that provides information for patients on the quality of healthcare in the U.S.

Excerpt from the West Health Article:

Joe Smith: Your recent publication on medical errors in the Journal of Patient Safety has achieved widespread notice, leading to medical errors being identified as the third leading cause of death in the United States, though your background is different than many involved in patient safety efforts. Could you please describe your background and what drove your interest in this important area?

John James: I recently retired from a federal agency where I was the chief toxicologist for 25 years. I am board certified in toxicology and earned a PhD in pathology in 1981 from the University of Maryland while working at a Baltimore hospital and doing research at the National Cancer Institute. In 2002, my 19-year-old son died while running. Three weeks earlier he had been evaluated by cardiologists for five days, primarily as an in-patient after experiencing a non-fatal collapse while running. After obtaining a complete set of his medical records, I realized that multiple, catastrophic medical errors had been made by his doctors. These included failure to follow a widely published guideline for potassium replacement in patients with heart arrhythmias, failure to make an obvious diagnosis of acquired long-QT syndrome and failure to communicate to him that he should not be running. He was also denied informed consent because he was deceived about the outcome of his cardiac MRI, which had not been properly performed. I did not find this information out until long after he died.


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While reading medical literature and looked for root causes, I realized that lethal medical errors are not all that uncommon. In 2000, the late Barbara Starfield, MD, estimated far more lethal medical errors than in the 1999 IOM report. I also discovered that cardiologists board certified before 1990, such as my son’s lead cardiologist, are certified for life with no requirement to demonstrate continuing competency. Furthermore, the Texas Medical Board verifies Continuing Medical Education in only one percent of doctors each year. I also learned that getting doctors, especially cardiologists, to follow evidence-based clinical guidelines is a challenge and that diagnostic errors are common, but often go unrecognized. Doctor-to-doctor and doctor-to-patient communication errors are also common and occurred in my son’s case.

JS: What role do you think government plays in combating medical errors? What agency should have oversight and be charged with reducing medical error deaths?

JJ: Overall government agencies, including Congress, have not been assertive in addressing the problem of medical errors. In some ways, the Affordable Care Act has addressed some patient safety concerns without changing the fundamental culture that permits errors to continue. Government officials can be heavily influenced by money originating from medical industry special interests. Harmed patients or their survivors contribute little to political campaigns or PACs. A new agency controlled by leaders in the patient safety movement is needed. It could be called the National Patient Safety Board, modelled to some extent after the National Transportation Safety Board or Consumer Product Safety Commission. The goal of such an agency would be to discover, track and analyze medical errors, and where appropriate, enforce changes – all in a completely transparent way. The well-known limitations and secret-keeping of state medical boards and hospital accreditation organizations would become history. In addition, the agency would enforce a national bill of rights for patients. Violations of those rights would be as serious as civil rights violations or violations of OSHA standards that put workers in harm’s way.

Other West Health Series Articles on “To Err is Human”:

  • A Look Back, Behind the Scenes of the IOM’s Report on Errors: By William Richardson, PhD, Former Chair, IOM Committee
  • A Mother’s Perspective: Q&A with Sorrel King, Founder, The Josie King Foundation
  • 15 Years Later: Q&A with Molly Coye, MD, MPH, UCLA Health
  • Uniting for Patient Safety: Q&A with Tejal Gandhi, MD, MPH, CPPS, National Patient Safety Foundation

Read the full interview and other Patient Safety Articles on WestHealth.org!


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