Human beings, in all lines of work, make errors. Errors can be prevented by designing systems that make it hard for people to do the wrong thing and easy for people to do the right thing.

Institute of Medicine,* 1999
To Err Is Human: Building a Safer Health System

* The Institute of Medicine (IOM) is now called the National Academy of Medicine. Because their quotations here predate the name change, we have chosen to leave them as is. You will see the traditional [sic] or “thus,” following the old name to indicate it is no longer as it is now.

Twenty years ago, the Institute of Medicine (IOM) released its landmark report To Err is Human: Building a Safer Health System, and with it, raised the consciousness of medical errors within the nation’s healthcare system (IOM, 1999). Since that report was published, the patient safety movement has grown and helped raise awareness not only among healthcare professionals but also among the general public. In many healthcare settings, greater attention is being paid to “the possibility of error and a better understanding of the fact that most medical errors result from faulty systems, not from bad or incompetent people” (IOM, 1999).

A more recent study from the National Patient Safety Foundation (NPSF), however, indicates that the improvements made so far have not been what many hoped for and suggests the need for a new emphasis on a total systems approach to improvement (Gandhi, 2016; NPSF, 2015).

Scope of the Problem

The original IOM report estimated 44,000 to 98,000 deaths each year in the United States, or at least 120 deaths per day, because of human error related to the delivery of healthcare (IOM, 1999). The report spurred debate and further studies, which have placed the actual figure for deaths in a range from 130,000 to 575,000, with those numbers said to be based on definitions of “medical error” that are both too broad and too narrow (Myhre & Sifris, 2017).

A 2016 study by Johns Hopkins University took an entirely different approach by arguing that the compilation of death rate statistics used to arrive at these numbers is flawed. The JHU study formulated a specific definition of medical error as one or more of the following:

• An unintended act (either the result of omission or action)
• An act that does not achieve its intended outcome
• The failure of a planned action (an error of execution)
• The use of a wrong plan to achieve an outcome (an error planning)
• The deviation from a process of care that may or may not cause harm

Researchers then compared national in-patient death statistics with hospital admission rates to arrive at a formula producing a conclusion that almost 10% of all deaths in the United States are a result of “medical care gone awry.” When applied to the data available for 2013 of 35,416,020 admissions, the number of deaths from medical errors would have been 251,141, making medical errors the third leading cause of death behind only heart disease and cancer and well ahead of accidents, chronic lower respiratory disease, and stroke (Myhre & Sifris, 2017).

The most recent data from the CDC suggests that within this scenario medical errors would still be the third leading cause of death in both the United States overall and in Florida (CDC, 2017).

Further debate continues over both definitions and data collection and additional studies are underway. But it is clear that medical errors continue to occur at unacceptable levels, making continued vigilance an imperative for both healthcare workers and the public. A new perspective for achieving “total systems safety” based on the eight recommendations from the NPSF study holds promise:

1. Ensure that leaders establish and sustain a safety culture.
2. Create centralized and coordinated oversight of patient safety.
3. Create a common set of safety metrics that reflect meaningful outcomes.
4. Increase funding for research in patient safety and implementation science.
5. Address safety across the entire care continuum.
6. Support the healthcare workforce.
7. Partner with patients and families for the safest care.
8. Ensure that technology is safe and optimized to improve patient safety. (Gandhi, 2016; NPSF, 2015)

PSOs and The Patient Safety Act of 2005

Congress enacted the Patient Safety and Quality Improvement Act of 2005 (PSQIA) (Public Law 109-41) in response to the IOM report and the concerns it brought to the forefront over preventable medical errors. The privilege and confidentiality protections conferred on providers who work with Federally listed patient safety organizations (PSOs) were intended to promote shared learning to enhance quality and safety nationally (PSOP, n.d.; Howie, 2009).

Patient safety organizations (PSOs) are organizations “that attest to having expertise in identifying the causes of, and interventions to reduce the risk of, threats to the quality and safety of patient care.” The primary activity of a PSO is to conduct activities to improve patient safety and healthcare quality. A PSO’s workforce must have expertise in analyzing patient safety events, such as the identification, analysis, prevention, and reduction or elimination of the risks and hazards associated with the delivery of patient care. There are a total of 82 PSOs in the United States and currently 55 PSOs serve Florida, with 6 domiciled in the Sunshine State (all PSOs can operate nationally regardless of their home state) (PSOP, n.d.-a, n.d.-c).

An additional federal regulation in 2009—the Patient Safety and Quality Improvement Final Rule “establish[ed] a framework by which hospitals, doctors, and other healthcare providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient safety events.” It also delineates the requirements to be met to become a PSO and how applicants will be reviewed and certified (PSOP, n.d., n.d.-b).

The CMS Prospective Payment Rule

In an effort to improve patient safety and curb costs, the Centers for Medicare and Medicaid (CMS) since 2008 no longer reimburses hospitals for care nor allows the hospital to charge the patient for care due to certain medical errors. The initial list comprised “10 hospital-acquired conditions” (later); in 2013, the CMS expanded the list to 14, where it has remained:

• Foreign object retained after surgery
• Air embolism
• Blood incompatibility
• Stages III and IV pressure ulcers
• Falls and trauma
• Manifestations of poor glycemic control
• Catheter-associated urinary tract infection (UTI)
• Vascular catheter-associated infection
• Surgical site infection, mediastinitis, following coronary artery bypass graft (CABG)
• Surgical site infection following bariatric surgery for obesity
• Surgical site infection following certain orthopedic procedures
• Surgical site infection following cardiac implantable electronic device (CIED)
• Deep vein thrombosis (DVT)/pulmonary embolism (PE) following certain orthopedic procedures
• Iatrogenic pneumothorax with venous catheterization (CMS, 2018)

Note: Updates to the details of this list are made each year and can be obtained here: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/icd10_hacs.html.

Provisions like the CMS non-payment for preventable errors appear to be having a positive effect, at least in Florida. A 2013 study using the discharge data from the Florida Agency for Healthcare Administration from 2007 to 2011 suggested “Medicare nonpayment policy is associated with both a decline in the rate of hospital-acquired vascular catheter-associated infections (HA-VCAI) per quarter, and the probability of acquiring HA-VCAI post-policy.” Concurrent infection control practices, however, could have also affected the results (Peasah et al., 2013).

A study of CMS data after 2008 found no positive effects of non-payment incentives but a later, longer study of CMS data did note positive effects, and an early analysis of 2013 Medicare data showed a steadily declining rate of hospital readmissions within 30 days. Many factors can come into play when analyzing date on error reduction including the monetary value of disincentives, initial coding of patient conditions upon admission, specific conditions or errors, and other error prevention programs already in place. Continued monitoring and analysis remain critical (Phillips, 2015; Delbanco, 2014; Lowenfels, 2013; Lee et al, 2012; Tucker, 2012)

CMS maintains an active Hospital-Acquired Conditions Reduction Program (HACRP) and data on specific hospitals is posted to the “Hospital Compare” website (CMS, 2018a). In June 2018, CMS announced a plan to no longer make public information on hospital-acquired infection (HAI), medical errors, and injuries, but backlash from patient safety advocates led to a reversal of that position two months later (PSHQ, 2018). The fact that CMS continues to put medical errors under scrutiny—along with their financial ramifications—is another indication of the serious and pervasive nature of these preventable events.

The Affordable Care Act of 2010 (ACA)

Reducing medical errors and adverse events in healthcare continues to be an important topic in today’s legal landscape. A major theme of the landmark legislation Patient Protection and Affordable Care Act of 2010 (ACA) is improving the quality of the nation’s healthcare. The act has many provisions supporting programs that reduce medical errors and governance on their reporting. For example, ACA “in awarding [demonstration grants for alternatives to medical tort litigation], the Secretary shall give preference to States . . . that make proposals that are likely to enhance patient safety by detecting, analyzing, and helping to reduce medical errors and adverse events” (U.S. House, 2010; KFF, 2013/2018).

In 2012 provisions in ACA required providers to begin moving toward electronic health records in an effort to reduce medical errors. Another ACA program also began in 2012 that offered financial incentives to hospitals that meet certain quality criteria.

A variety of programs mandated by ACA and implemented by Medicare and others were designed to improve the numbers for medical errors. It appears that there has been improvement, although there is disagreement on what exactly the data mean (Bihari, 2018).

Error Reporting: Fear and Finger Pointing

Traditionally, patient safety improvement efforts have been hampered by fear of discovery, resulting in under-reporting of medical errors and an inability to collect sufficient data for analysis of adverse events.

Although prior to publication of the IOM report virtually all healthcare organizations engaged in investigations of events that caused harm to patients, few took a system-based approach to solving problems. The focus was on individuals and mistakes, rather than on the events that combined to cause an incident to occur. “Based on a ‘name and blame’ culture, the emphasis of such investigations was not on prevention, but on punishment” (USDVA, 2015).

The trend in developing programs has moved away from a solely regulatory function toward both regulatory and patient safety improvement goals. Many states have developed electronic methods for data collection and reporting, and there is a push toward standardization to make data comparisons more meaningful.

In an effort to provide a framework as well as a level playing field, the National Quality Forum, a nonprofit organization focused on systemic healthcare quality improvement, in 2002 developed a list of reportable events. First called never events because they were things that should never happen, the term has come to be used to describe adverse events that are:

• Unambiguous (clearly identifiable and measurable)
• Serious (resulting in death or significant disability)
• Usually preventable

Revised a number of times the list now encompasses 29 serious reportable events that can be grouped into the following seven categories:

• Surgical or procedural events
• Product or device events
• Patient protection events
• Care management events
• Environmental events
• Radiologic events
• Criminal events (PSNet, 2019; NQF, 2011)

Since 1995 the Joint Commission has recommended that hospitals report “sentinel events,” which it defines as “an unexpected occurrence involving death or serious physiological or psychological injury, or the risk thereof.” All “never events” are considered sentinel events. The Joint Commission requires that a root cause analysis (RCA) be performed after any sentinel event, and the Leapfrog Group recommends that an organization also disclose the error, apologize to the patient, report the event, and waive all associated costs (PSNet, 2019).

When To Err Is Human was released in 1999, thirteen states were collecting information on medical errors. The National Academy for State Health Policy conducted surveys in 2000, 2007, and 2014 and found the number of states to be 15, 27, and 27 respectively. The 27 includes Florida and the District of Columbia (Hanlon et al., 2015). Texas initiated a reporting system on January 1, 2015.

While this is an improvement since the IOM study’s release, there is still a long way to go. A persistent problem remains with the under-reporting of events despite statutory measures intended to address the problem (Hanlon et al., 2015; Yale, 2008).