New Federal Study Evaluates the Safety of US Hospitals and the Answer Is…

Harlan Krumholz
5 min readJul 12, 2022

A federal effort to evaluate patient safety in US hospitals published a report in JAMA today, and there is evidence of progress, and also evidence that patients are still not safe enough.

The study identified some solid progress. The rate of adverse events after a heart attack declined from 218 to 139 per 1000, for heart failure from 168 to 116 per 1000, for pneumonia from 195 to 119 per 1000, and for surgical procedures from 204 to 130 per 1000. The progress validates the idea that these events can be prevented. Yet, these rates remain dishearteningly high, even at the end of the period. And there was no improvement for many conditions.

Each adverse event is a major setback or worse for patients. Each one is a tragedy. Patient come to the hospital for care, seeking help to improve their health and ease their suffering. To experience an adverse event as a result of that care, and often due to a lapse in care or a frank error, is tragic.

Our group at the Yale Center for Outcomes Research and Evaluation worked with the Agency for Healthcare Research and Quality (AHRQ) sponsored, in partnership with the Centers for Medicare & Medicaid Services (CMS) to produce the largest ever medical record study of adverse events among patients at US hospitals. Now we are reporting results from 2010–2019, findings that take us right up to the beginning of the pandemic.

The study entailed digging through an enormous number of medical records and identifying, then cataloging, adverse events that hospitalized patients suffered. Using a rigorous methodology, medical experts poured over more than 250,000 medical charts from more than 3000 hospitals in search of information about the adverse events linked to patient safety. The study was not based on conjecture or based on imprecise billing codes. It was built to produce estimates of our national performance and the message seems to be that we are doing good, but not good enough.

Just over 20 years ago, the Institute of Medicine (IOM) released To Err is Human, a report on the patient safety problems in the US health system. Finally, health systems were beginning to recognize the immense harm caused by lapses in patient safety. Many people were suffering irreparable injuries and even dying because of medical mistakes in care. The IOM experts estimated that as many as 98,000 people die each year from medical errors, which outstrips some leading causes of death. There was a controversy about the exact number (more of a debate among academics), but everyone agreed that too many people were being harmed. As a result, there were national calls to action.

Many organizations have sponsored initiatives to improve patient safety in the subsequent two decades. The list is long but worth highlighting because it includes public and private organizations, local and national campaigns, and investments of dollars and time. In addition, these programs often involved people whose families had suffered losses because of these medical errors.

These efforts included (just to give you a sense of the breadth of the efforts) the Institute for Healthcare Improvement 100,000 Lives campaign, the federal Partnership for Patients and HIIN programs, the development of TeamSTEPPS, Medical Team Training, Healthcare Failure Mode and Effect Analysis, Root Cause Analysis 2, the Joint Commission’s development and promotion of National Patient Safety Goals, the National Quality Forum’s identification of Serious Reportable Events, the CDC’s Targeted Assessment for Prevention Strategy, the American College of Surgeons’ National Surgical Quality Improvement Program, and the World Health Organization’s Surgical Safety Checklist program.

A central focus of the patient safety programs is to prevent in-hospital adverse events — harmful events that derive from events during hospitalization and are often linked to lapses in patient safety. A sophisticated health system should be able to prevent these events — and the goal is that healthcare does not harm patients.

But there have been questions about whether anything has really been achieved. And the move has been away from simply urging doctors and nurses to do better toward an approach to strengthen systems and adopt approaches that have been successful elsewhere, such as in aviation. We moved to standard best practices for tasks that were vulnerable to lapses.

To foster accountability and to enable evaluation of progress, the Agency for Healthcare Research and Quality (AHRQ) sponsored, in partnership with the Centers for Medicare & Medicaid Services (CMS), the Medicare Patient Safety Monitoring System (MPSMS). In this program, CMS randomly selected hospitals to audit their medical records for the occurrence of a specified group of adverse events.

Trained experts reviewed the chart, and they even had a double review on a sample to assess the reliability of the approach, with 94–99% agreement on the data elements. Using MPSMS, an assessment of patient safety progress from 2005–2011 found that adverse-event rates markedly improved for patients hospitalized with a heart attack or heart failure but not for those hospitalized for pneumonia or conditions requiring surgery.

Now there is an update, with an expanded range of measures beyond those initially available. The study evaluated the period from 2010–2019 (before the pandemic but after the prior assessment). It assessed 21 in-hospital events in four domains (adverse drug effects, hospital-acquired infections, adverse events after a procedure, and general adverse events, such as hospital-acquired pressure ulcers and inpatient falls. These events included adverse drug effects associated with hypoglycemic agents, heparin, and warfarin, and hospital-acquired infections from central lines and urinary catheters, and adverse events from procedures related to arterial complications after coronary angiography, and general events such as falls.

The list is not complete, and people can quibble about it, but it is a good representative of bad things that can happen to people as a result of lapses in care. To be included the events had to be important, preventable, and ascertainable.

This comprehensive assessment, which involved skilled professionals digging into charts and cataloging adverse events, gives a mixed report card to American healthcare. There are some findings of progress to celebrate — and some that should galvanize action, such as the fact that far too many people still experience preventable adverse events in our hospitals, and we have not done enough to rid our institutions of these risks. And then there is a question about whether the stress of the pandemic has causes any backsliding in progress.

These events are friendly fire; the health system is harming people amid efforts to help them — people who experience preventable harm and whose lives are affected. The investments in safety are paying off, and progress indicates the preventability of these adverse events. The persistence of rates that are far too high shows the challenges to instituting change to make our health care even safer.

We need to re-double efforts and make our health systems sufficiently safe that errors leading to harm are only about our past, not our future.

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Harlan Krumholz

Harlan Krumholz is the Harold H. Hines Jr Professor of Medicine at the Yale School of Medicine.