CEO SUMMARY: This year’s report to Congress on patient harm in hospitals—prepared by the Office of the Inspector General (OIG)—determined that one in four Medicare beneficiaries suffered harm while an inpatient in a hospital. The report garnered little attention outside the healthcare press. Moreover, the OIG’s findings about the incidence of patient harm in hospitals for the study year of 2018 are consistent with its findings over the past 15 years. For clinical labs that want to add value, it would be useful to study these reports to develop solutions to that problem.
ONCE AGAIN, FEDERAL OFFICIALS have issued a report that concludes an unacceptable—and surprisingly high—proportion of Medicare patients are harmed as inpatients in the nation’s hospitals. These findings are consistent with earlier federal studies on patient harm.
The report was issued on May 9, 2022, by the U.S. Department of Health and Human Services (HSS) Office of Inspector General (OIG). It was titled, “Adverse Events in Hospitals: A Quarter of Medicare Patients Experienced Harm in October 2018,” and it concluded that “one in four hospitalized Medicare patients experienced harm during October 2018.”
These findings would certainly alarm the average American, were the national news media to splash headlines about how 25% of Medicare patients are harmed when receiving care as a hospital inpatient. But upon its release, the OIG’s latest findings were mostly reported by various healthcare news sources and publications and not the mainstream press. Few Americans are aware of the OIG’s report and the implications of its findings on themselves and their loved ones should they become Medicare inpatients.
Maybe one reason why this latest OIG report did not get more national attention is that it is consistent with many earlier studies and findings published during the past 20 years. The rate of medical errors and patient harm in both hospital and ambulatory settings is often found to be significant.
As you will read later, there is a collective body of studies of medical errors over the past two decades. These studies determined that medical errors and/or patient harm (as defined by the researchers) happen to patients anywhere from 20% to almost 50% of the time, depending on the focus of the study.
Seen from this historical perspective, the OIG’s May report simply affirms the status quo as it pertains to the rate of negative health events and medical errors that occur to patients within the U.S. healthcare system. The Dark Report is not aware of credible published evidence that refutes the OIG’s findings about the proportion of Medicare patients who experience a medical error or harm when in a hospital.
Opportunity for Clinical Labs?
Along with confirming the status quo, the OIG’s findings validate an opportunity available to the nation’s clinical laboratories and anatomic pathology groups. That opportunity is for clinical lab executives and pathologists to think strategically as to how their lab organizations can contribute to the reduction of medical errors, particularly those that harm patients.
This opportunity is consistent with the Clinical Lab 2.0 model of delivering value and actionable intelligence to physicians that improves patient care and positions the laboratory to be paid for the value of this intelligence. (See TDR, “Clinical Lab 2.0’s Message to Labs: Improve Outcomes, Get Paid More Money!” June 5, 2017.)
Healthcare’s 20-Year Journey
For those pathologists and clinical lab managers interested in the opportunities and benefits that might result from organizing lab testing services that effectively address and reduce medical errors, it is essential for them to understand the U.S. healthcare system’s 20-year journey involving medical errors and patient harm.
For example, the findings of Medicare patient harm in hospitals from this latest OIG study is consistent with its earlier findings over the past 10 years. The May 2022 OIG report is the most recent in a series of reports mandated by the Tax Relief and Health Care Act of 2006.
The 2006 law also requires HHS and OIG to report to Congress the number of “never events” involving Medicare patients. In these reports, OIG describes never events as “a subset of adverse events that should never occur, such as surgery on the wrong patient, among Medicare patients.”
In response to this action, The Dark Report described several of the never events, writing “after implementation of the new rules, Medicare will no longer reimburse hospitals for treatment that resulted from nosocomial infections, surgeries performed to retrieve objects—including sponges or instruments—left in a patient, reactions when transfusion patients get the wrong blood type, bedsores that develop during hospitalization, and injuries from a fall sustained in the hospital.”
In that 2006 law, Congress further directed that Medicare officials stop paying hospitals for never events that affected Medicare beneficiaries. The law also forbids hospitals from billing Medicare beneficiaries directly for care related to medical errors. (See TDR, “Medicare Soon Won’t Pay Hospitals for Errors” Oct. 8, 2007.)
In compliance with the 2006 law, the OIG annually reports to Congress regarding the incidence of never events. Since 2008, OIG has issued 17 reports that focus on adverse events in hospitals and other healthcare settings.
Patient Harm Study in 2010
For example, in its “First National Study of Adverse Events” issued in 2010, the OIG “provided the first nationwide estimate of patient harm.” In the section “In Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries,” the OIG reported the following:
- 27% of hospitalized Medicare patients experienced adverse events and temporary harm events in October 2008.
- 44% of harm events were preventable.
- Care associated with adverse events cost Medicare and patients an estimated $324 million in that single month.
For that same period, OIG estimated that adverse events contributed to approximately 15,000 deaths among hospitalized Medicare patients.
Some of the OIG’s findings are remarkable. In this most recent report, the OIG said, “Subsequent OIG reports [after 2010] on adverse events have focused on incident reporting and incidence rates in different healthcare settings. In a 2012 followup report, OIG found that only 14% of patient harm events were reported to hospitals’ incident reporting systems or other internal surveillance systems. [Italics by TDR.]
Incidence of Harm Events
This statement continued: “In a series of reports regarding the incidence of harm events in post-acute settings, OIG found that 32% of Medicare residents in skilled nursing facilities, 29% of Medicare patients in rehabilitation hospitals, and 46% of Medicare patients in long-term care hospitals experienced harm.”
The OIG, using accepted methodology, is documenting a rate of medical errors and patient harm that seems consistent in the series of reports it has issued since Congress tasked it with reporting on patient harm in the 2006 legislation.
Pathologists and clinical lab managers who started their careers in recent years will find it helpful to understand that the campaign to publicize medical errors and patient harm goes back almost three decades. A key starting point on the story about medical errors in the United States starts in 1999. That’s when the Institute of Medicine (IOM) published “To Err Is Human.”
Up to 96,000 Deaths
In that report, the IOM estimated that 44,000 to 96,000 Americans die in any given year from medical errors that occur in hospitals. This assessment triggered news headlines and caught the full attention of the American public. The study authors gave context to this estimate, noting, “that’s more [people] than die from motor vehicle accidents, breast cancer, or AIDS—three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries.”
Publication of “To Err Is Human” was the trigger that caused a group of business leaders to come together and create an organization specifically to help employers assess the quality of healthcare while also enabling their employees to shop for care. One way to achieve this was to improve transparency in patient outcomes, medical errors, and provider quality.
These efforts led to the formation of the Leapfrog Group, now based in Washington, DC. It launched in 2000, only months after the publication of “To Err Is Human.” Initial membership was 96 corporations and organizations. Included were General Motors, AT&T, General Electric, IBM, and Boeing. Collectively, these members were spending $52 billion annually on healthcare and represented 28 million people.
The next development in this progression toward today’s quality and transparency movement in healthcare came March, 2001. That is when the IOM published a companion document in support of “To Err is Human.” It was “Crossing the Quality Chasm: A New Health System for the 21st Century.”
Emphasis on Quality
In a user’s guide he prepared for acting on “Crossing the Quality Chasm,” Donald M. Berwick, MD, then a member of the IOM, described how that document was a call for providers to pay more attention to:
- Overuse (using medical resources and treatments with insufficient evidence that they improve patient outcomes),
- Underuse (failing to deliver resources or treatments known to be of benefit), and
- Misuse (failing to execute care safely and correctly) of healthcare resources and treatments.
Within months of this second IOM report, Leapfrog acted in support of its mission to improve transparency in healthcare quality and patient outcomes, and reduce medical errors.
In January, 2002, the Leapfrog Group made public its findings on how 241 hospitals in six regions measured up in three performance areas.
“To Err Is Human” and “Crossing the Quality Chasm” also influenced developments at The Joint Commission (then known as The Joint Commission on Accreditation of Healthcare Organizations [JCAHO]).
One day before the Leapfrog Group unveiled its survey of hospital responses to the three performance areas at a Jan. 17, 2002, press conference, The Joint Commission announced it had accepted an invitation from the Leapfrog Group to become a formal partner.
Pathologists and clinical lab managers who started their careers in recent years will find it helpful to understand that the campaign to publicize medical errors and patient harm goes back almost three decades.
The Dark Report considered the timing of The Joint Commission’s (TJC) announcement that it was becoming a member of the Leapfrog Group—just days before the release of the survey of hospital performance measures—not serendipity. At that time, we observed how just weeks earlier, the journal Quality Management in Healthcare had published a peer-reviewed study that investigated if a hospital’s accreditation status statistically correlated to better quality and safety of patient care. (This study was itself influenced by the two earlier publications issued by the IOM.)
In assessing this situation, The Dark Report wrote the following:
The findings of the study revealed that a hospital’s accreditation status did not correlate to better quality and safety of patient care. The study specifically noted that hospitals with higher-than-average rates of deaths and complications often received favorable scores from JCAHO.
One observation by study co-author John R. Griffith, from the University of Michigan School of Public Health, is that the accreditation process relies almost exclusively on surveying the hospital’s organizational structure and process. He noted that little weight is given to objective performance measures, such as the rates of death and unexpected complications, as well as whether the hospital is adaptable and incorporating the latest clinical procedures and new technologies.
That is why JCAHO’s willingness to partner with the Leapfrog Group is a significant event. The timing of JCAHO’s announcement, one day before Leapfrog made its hospital data available to the public, demonstrates that it will become more responsive to the quality concerns of employers. (See TDR, “Provider Performance Ranking Now Hitting Healthcare System,” Jan. 28, 2002.)
Two Consequences
This study in Quality Management in Healthcare had two immediate and long term consequences for quality in healthcare in general, and at The Joint Commission specifically.
First, the study’s conclusions that data on patient quality and patient safety could not be correlated to a hospital’s choice of accreditation organization caught the full attention of executives at TJC. They recognized that this was a situation that needed to be rectified. Joining the Leapfrog Group and supporting the drive for more transparency in quality and patient outcomes was one way to demonstrate that commitment to the public.
The second consequence was more profound. As noted in the quote by John R. Griffith reproduced above, the study team recognized that [as of 2002] the hospital “accreditation process relies almost exclusively on surveying the hospital’s organizational structure and process.”
Researchers were recognizing that hospital accreditation standards at that time were heavily weighted to check compliance with regulations, how staff followed requirements, and how all of these organizational tasks were documented. Essentially, the primary objective of these hospital inspections was to assess compliance with processes. Measuring improvement in patient care, patient outcomes, and reduction in errors received much less emphasis.
Measuring Patient Outcomes
With the benefit of 20 years of hindsight, one can look back to this moment in 2002 and recognize that the second consequence of the Quality Management in Healthcare’s study—in tandem with the two reports published by the IOM—was to launch a drive to expand the role of measuring outcomes and performance in delivering patient care during the accreditation and certification of healthcare providers.
From 2002 forward, U.S. healthcare began a long-term shift in two dimensions. One dimension was to shift the basis of accreditation and certification activities to primarily the assessment of how quality, patient outcomes, and patient safety were measured and improved from one inspection period to the next.
The other dimension was to increase the transparency of this same data to buyers—be they employers selecting the best performing health insurance plans or patients choosing a hospital or doctor.
This review of seminal events in healthcare quality during the decade of the 2000s was followed by equally significant developments in the next decade in how providers improved quality and patient outcomes. A future issue of The Dark Report will advance this retrospective on the quality movement in healthcare.
Contact Robert L. Michel at 512-264-7103 or rmichel@darkreport.com.
It’s been a Multi-Decade Journey to Improve Quality of Patient Care in the U.S. Health System
PUBLICATION IN 1999 OF A MAJOR STUDY OF MEDICAL ERRORS AND PATIENT HARM by a respected healthcare institution caught the attention of Congress and set the nation’s healthcare system on the path: first to increase the transparency of medical errors and healthcare outcomes, and second to trigger greater attention by hospitals and physicians to improving the quality of care they provide. Milestones in the decade following release of that study include the following:
• 1999 “To Err is Human” is issued by the Institute of Medicine (IOM). It estimates that between 44,000 and 98,000 Americans die from medical errors in hospitals in a year. This document generates national headlines.
• 2000 Leapfrog Group formed with the stated goal of improving transparency of healthcare outcomes and the cost of care. Initial membership includes 96 corporations that collectively represented 28 million people who were spending $52 billion annually on healthcare.
• 2001 “Crossing the Quality Chasm” is the follow-up report by the IOM. It was a thorough review of the overall quality of the healthcare system, included an assessment of the healthcare industry’s safety and effectiveness, and made recommendations for a comprehensive strategy for improvement.
• 2002 Peer-reviewed journal Quality Management in Healthcare published a study with this abstract:
This article compares seven non-federal general hospital performance measures derived from Medicare against Joint Commission scores. Joint Commission measures are generally not correlated with outcome measures. The few significant correlations that appear are often counterintuitive. We conclude that a potentially serious disjuncture exists between the outcomes measures and Joint Commission evaluations. (“Structural versus Outcomes Measures in Hospitals: A Comparison of Joint Commission and Medicare Outcomes Scores in Hospitals;” Griffith, John R.; Knutzen, Steven R.; Alexander, Jeffrey A.; QMHC 10(2):29-38, Winter 2002.)
• 2002 Leapfrog issues its first hospital quality rankings.
• 2002 The Joint Commission (then known as The Joint Commission on Accreditation of Healthcare Organizations [JCAHO]) joins Leapfrog Group.
• 2002 The National Committee for Quality Assurance begins to expand the data reported by health plans via the Healthcare Effectiveness Data and Information Set (HEDIS). This includes adding utilization of a larger number of screening tests, along with the tests scores and associated patient outcomes that health plans provided to their beneficiaries.
• 2006 Congress passed the Tax Relief and Health Care Act of 2006.
• 2008 OIG issued the first annual report on quality of care and patient harm experienced by Medicare beneficiaries in hospitals.
• 2009 CMS grants Det Norske Veritas (DNV) deeming authority for hospital accreditation to the Medicare Conditions of Participation (COP). DNV offers ISO 9001 certification and Medicare accreditation for one price.
