Enhancing Quality and Safety Through Transparency

Organizations and clinicians are often fearful to be transparent with patients and families about medical errors that have occurred due to concern of litigation, blame or loss of reputation. A focus on high reliability systems instead of individual blame and transparency of all patient harm and death is key to promoting transparency, which is key to continuously improving safety. Programs like CANDOR (Communication and Optimal Resolution), supported by the Agency for Healthcare Research and Quality (AHRQ), when properly implemented, also drive transparency in addition to improving patient outcomes, reinforcing trust, fostering continuous learning and saving money. Zero harm is not achievable without transparency as the first step. Social and economic disparities and implicit biases also impede transparency and openness when preventable harm occurs. There is data suggesting that care breakdowns, adverse events and errors are more likely to occur in certain patient populations than others. Even more concerning, there is reason to believe that these vulnerable patients are less likely to be treated with openness, empathy, and respect when errors occur in their care. Therefore, we need to hone in on how to address these inequities in being open and honest with all patients and family members. 

Current patient death and injury data are only estimates compiled by researchers. We don’t really know how many people are affected by medical harm each year. This is because we don’t have an accurate method for measurement, the systems used to measure harm are disparate, and we lack a national and global commitment to standardize metrics. There is no requirement that the frequency and severity of all medical errors, or the resulting patient outcomes, are reported to the public or even to public health authorities. Never events are usually reported at the state-level in the United States. Other sources of information around preventable error come from billing and electronic-health records but there is no system to collate all the information together cohesively to give us the true picture of preventable harm and death among patients. Additionally, death certificates mask the problems by not including “preventable medical error” as either a secondary or primary cause of death. They typically state the diagnosis or underlying condition, such as “myocardial infarction (heart attack)” or “sepsis” or “natural causes,” even when treatment or diagnostic failures were a cause. Additionally, the death certificate isn’t always completed by someone who has cared for the patient and therefore can sometimes be incorrect and very difficult to change after it is issued. The current ICD-10 coding doesn’t allow for the coding of communication or diagnostic failures, for example, the coding is currently limited to disease-states. We saw how quickly COVID-19 became urgently measured and reported in late-2019 and early-2020 and surpassed medical errors as the third leading cause of death. However, with a similar epidemic, patient harm, which has been harming and killing patients for decades, we haven’t been able to elicit action from regulators or legislators to help create surveillance mechanisms to generate reliable statistics to establish a baseline.

Care and patient procedures (e.g. hip and knee replacements) are rapidly moving out of the hospital and into ambulatory settings where there is no transparency in place to drive the quality and safety of outcomes, reporting or incentives. Children’s hospitals and very small hospitals (critical access hospitals) don’t have the same reporting requirement as adult acute care facilities so the safety data published can’t be compared apples to apples. Additionally, short-term and long-term nursing homes as well as long-term care services completely lack resident safety data. The public has very little reliable insight into which of these facilities are safe. Even hospitals, which are required to report some safety data, are only required to do so for patients who carry regular Medicare insurance. They are not required to report data for patients on a Medicare Advantage plan, or for those who have any other type of insurance. For this reason, safety grades can be skewed and not paint a complete picture of hospital safety. Patients and families also lack transparency into their own medical records. Through the 21st Century Cures Act, there is support for “Open notes” which provide patients and families the opportunity to review their medical record, confirm the information is correct, identify mistakes, and connect with their provider to discuss changes which can enhance the quality of data in their records, building communication and trust. The gap in the legislation around “open notes” is that there is no requirement for the language in the EHR to be displayed in a way that patients understand. 

The legal system prohibits the ability for sharing learning after harm occurs when NDAs are put in place, when arbitration is forced and includes gag clauses, and when other “gag clauses” are included in legally binding documents. When the information is prohibited from being shared the same types of harm are often repeated, even within the same organization. There is also an additional level of trauma for patients and family members who are prohibited from speaking about the harm their family endured. In some states, Illinois as an example, gag clauses are not allowed. The University of Illinois, for example, provided settlements after patient harm and that case could be used for transforming their health system through that shared learning. From a professional liability standpoint, a medical malpractice insurer learned that gag clauses inhibited their ability for shared learning and improvement when gag clauses were used. The National Academy of Medicine published a 2021 report providing a critique of the U.S. Patient Safety Organization (PSO) program. They found that the PSO system has under-delivered – only three of the 90 federally-recognized PSOs actually shared information back into the national database. The intent of the PSOs is right, and it’s important for them to protect patient safety work product (PSWP), however the PSOs that aren’t feeding back into the national database are depriving the ability for learning nationwide.