Readers familiar with my earlier posts understand that I believe nothing causes physician burnout more than the threat of a lawsuit. The risk for any doctor is 5% per year; hence, a malpractice suit is inevitable for every 20 years in practice. The common denominator is a complication from which no doctor has immunity.
Those who deny ever being sued are either not practicing long enough or the complication has little settlement value. It is not superior communication skills that protect them. When an unhappy patient with a suspicion of fault has a complication, a request for medical records from an attorney is not far behind. Merit aside, if the complication has a settlement value for the attorney, the game is on.
Anything a doctor does afterward is reactive. Anything done when the complication occurs is proactive. It is due diligence to investigate a complication. This does not prevent the lawsuit, but risk management gains control of it.
Risk management has four steps.
Collate. Divide the standard of care and the medical intervention into ten corresponding phases: 1. Presentation phase, 2. Investigation phase, 3, Interpretation phase, 4. Diagnostic phase, 5. Discrimination phase, 6. Informed consent phase, 7. Selection phase, 8. Technical phase, 9. Resolution phase and 10. Discharge phase.
A) Standard of care: Each phase in the standard of care is the benchmark for excellence. Because excellence is never a medical error, any adverse outcome associated with the standard of care can only result from an error of nature.
B) Medical intervention: Each phase in the medical intervention is the actual performance. An adverse outcome can occur from a medical error or from an error of nature. If performance departs from standards of care, the complication is, more likely than not, a medical error.
Compare. Contrast each phase in the standard of care to its counterpart in the medical intervention. The data to make this distinction are:
A) The background risk (µ): It is the population mean for an error of nature. An error-of-nature results from all causes in the universe other than the medical error in question. The background risk is the sine qua non for the standard of care.
B) The observed risk (OR): Actual performance in any phase of the medical intervention produces an outcome having an observed risk. An observed risk greater than the background risk is the sine qua non for a medical error.
C) Risk of harm (ROH): Risk of harm is the relative risk between counterparts and is the proximate cause of a complication. Observed risk is ROH x background risk.
a. If there is no difference, the ROH is 1.0, and the observed risk equals the background risk.
b. If there is a difference, the ROH is greater than 1.0, and the observed risk is greater than the background risk.
c. When repeated for each phase of the medical intervention, there is a sample of 10 observed risks. Some are equal to the background risk; others are greater than the background risk.
D) The burden of proof: The comparison is made with a preponderance of the evidence, which is 50% probability plus a scintilla. Scintilla is generic, but in a scientific investigation, it is 45% (45% plus 50% probability equals 95% confidence, the standard in scientific inquiry).
Conclude. This step is hypothesis testing.
A) The two hypotheses:
a. Null hypothesis (Ho): If there is no statistically significant difference between the sample and the background risk, the medical intervention comports with standards of care.
b. Alternate hypothesis (Ha): If there is a statistically significant difference between the sample and the background risk, the medical intervention departs from standards of care.
B) The test: one sample t-test
a. The sample: The ten observed risks.
b. Level of significance, alpha (α) = 0.05: This corresponds to 95% confidence (50% confidence plus a scintilla of 45%).
c. Population mean, (µ) = background risk
C) The result – p-value:
a. If p ≥ α, retain the null hypothesis
b. If p < α, reject the null hypothesis, which sustains the alternate hypothesis by default.
Certify. The certified report is a sworn, notarized statement prepared by the doctor contemporaneous to the complication. It certifies that the medical intervention either comports with or departs from standards of care. If the null hypothesis is retained, there is 95% confidence that it is true. If the null hypothesis is rejected and the alternate hypothesis is sustained, there is still a 5% chance that the null hypothesis is true, and rejecting it is an error, called a type 1 error.
Once a certified report is prepared and distributed, risk management cannot be undone.
When submitted to the insurance carrier, even before a claim is made, actuaries are placed on notice and have the duty of due diligence.
When seen by defense counsel, the report serves as the framework for answers to the complaint and for opinions in the certificate of merit by the medical expert.
From my experience with the certified report, when the claim is frivolous, the doctor is dismissed with prejudice. If meritorious, the lawsuit is settled out of court.
How the certified report is accepted in the courtroom remains to be seen. When jurors understand that, for the defendant, scintilla is a well-defined 45% and, for the plaintiff, scintilla is just generic, it is common sense that 95% confidence is better than 50% plus a scintilla.
Plaintiff attorneys may move for the presiding judge to disqualify the certified report, arguing that it is too novel and, therefore, is inadmissible. How judges decide is unpredictable, but they know it is relevant, fair, unbiased, not wasteful, not hearsay, or not confidential.
From comments to earlier posts, some readers are outraged when litigation goes too far. Others are outraged when litigation does not go far enough. This post is an objective answer. Risk management offers a tangible solution for both. I hope it is appreciated in this spirit.
Howard Smith is an obstetrics-gynecology physician.