Measuring Patient Safety
Following the landmark report To Err is Human: Building a Safer Health System, developed by the Institute of Medicine in 1999, patient safety moved to the forefront of healthcare; the report also inspired a shift toward measuring safety to reduce harm to patients.1 In response to the report, federal agencies such as the Agency for Healthcare Research and Quality (AHRQ) released measures of patient safety. AHRQ’s Patient Safety Indicators (PSIs) focus on measuring if potentially preventable complications occurred during a patient’s procedure or hospital stay and include measures such as accidental punctures/lacerations during a procedure or inpatient fall with a hip fracture. Although there have been gains made in patient safety and a decrease in rates of adverse events in the 20 years since the report’s publication and the introduction of PSIs, such as reducing healthcare-acquired infections, decreasing patient falls, and reducing other healthcare-related complications, gaps still exist. Despite improvements in systems and processes, patient safety event rates increased during COVID, exposing the fact that our healthcare system needs to be more resilient.
As healthcare becomes more complex, measuring safety continues to be paramount to ensure high-quality, effective, and safe care is delivered across the various healthcare settings. National reporting programs, such as the Centers for Medicare & Medicaid Services (CMS) Quality Reporting and Value-Based Programs & Initiatives, aim to use measures like the PSIs to both determine the quality of care given to patients and hold organizations accountable for providing care safely.2 To encourage healthcare organizations to implement best practices and improve patient safety, these programs tie organizational performance on quality and safety measures to public reporting and reimbursements.3 While patient safety measures continue to be a focus for benchmarking safety in healthcare, leaders in the safety community have identified the need to continue to move patient safety measurement forward.4
Advances in Patient Safety Measurement
In the past, retrospective medical chart reviews were considered the gold standard to identify adverse events. Patient charts contain detailed clinical data including information about patient safety events and complications. Prior to the widespread implementation of electronic medical records (EMRs), organizations typically relied on clinicians to abstract data from paper-based charts. Reviewing charts is a resource-intensive and cumbersome process typically completed months after care was provided to a patient. The timeliness of obtaining data is also a critique of administrative or claims-based measures. Claims-based measures use billing data elements that are part of claims data to assess quality performance. These measures may be a low-cost method to track adverse events as the data are already collected and reported for payment purposes, but data are also collected and measured after care is provided. Further, claims data can be highly variable or inaccurate across health systems.5
One of the biggest advances in patient safety measurement in the past decade has been the ability to leverage rich clinical data sources to understand the quality of care provided to patients. While traditional, claims-based measures continue to be important in measuring and identifying harm events, the shift to digital measures has facilitated real-time assessment of the quality of care being provided to patients.6 This shift enables prevention of errors through prospective rather than retrospective reviews. Notifications and trigger tools can also use EMR data to monitor harm and measure adverse events.7
As a part of its plans to build value-based care and promote equity, CMS emphasizes digital quality measurement and is transitioning all quality measures into digital quality measures (dQMs).8 CMS introduced electronic clinical quality measures (eCQM), a subset of dQMs that use EMR data, into its quality reporting programs. This transition has also facilitated the shift from process measures to outcome measures. While many process measures still exist and remain important to ensuring the right care, outcomes measures are important in determining the ultimate impact of care and identifying if patients were harmed.8 One example of this is the Severe Hypoglycemia measure, a measure that was recently added by CMS to its Hospital Inpatient Quality Reporting Program. Severe hypoglycemia events are avoidable adverse drug events. By leveraging laboratory data, hospitals can measure the number of patients who were administered at least one hypoglycemic medication during a hospital stay and subsequently had a severe hypoglycemic event.9
Future Directions for Patient Safety
In addition to these advances, federal agencies such as CMS and AHRQ continue to push the envelope and strategize for better methods of measuring patient safety. As a part of the CMS National Quality Strategy, CMS emphasizes the need to promote safety and highlights its continued focus on the ongoing transition to digital measures and promoting the interoperability of different data sources. Interoperability of data is fundamentally important to healthcare to support learning across health systems and seamless communication across various healthcare settings. Patient safety events can stem from challenges with interoperability between systems or lack of information sharing. Advancements in interoperability and information sharing will facilitate better patient safety measurement, and better patient safety.10,11
Patient safety measures will also continue to evolve and broaden to measure areas that are important to individuals receiving care and services. The National Action Plan to Advance Patient Safety, developed by the National Steering Committee for Patient Safety (NSC) and co-led by AHRQ and the Institute for Healthcare Improvement, emphasizes the need to develop comprehensive patient safety measurement systems that cut across the entire continuum of care. While patient safety has traditionally focused on hospital-based care, measuring ambulatory care safety and safety in pre-hospital settings, including at the point of diagnosis, is an increasing focal point.
Disparity gaps in healthcare have long been recognized;12 recently, mortality rates during the COVID-19 pandemic have further illustrated these gaps. Although the original To Err is Human: Building a Safer Health System report includes equity as an important quality domain, there has not been significant progress addressing these issues. There is increasingly now an important focus on addressing healthcare disparities and inequities in care, including through quality measurement, to close these gaps and ensure that every individual can achieve their maximum health potential.11 Stratification of measurement data by demographic and social determinants of health to better understand health equity is gaining momentum in reporting programs. While studies have shown that there are disparities in healthcare delivery, opportunities exist to measure and understand the severity of these disparities when it comes to patient safety.13
Finally, a key notable advance in patient safety measurement is the inclusion of the patient voice. The NSC recommends including patients, families, and care partners in initiatives that could help improve patient safety efforts and create effective measures. This includes the development of patient-reported safety outcomes measures, having patients and individuals report patient safety events, and ensuring patients are included in robust communication and resolution programs.14
After the onset of the COVID-19 pandemic, patient safety experienced setbacks as the number of adverse events increased with a 40% rise in healthcare-acquired infections and an increase in inpatient falls and pressure ulcers.14 Healthcare leaders recognize the need to do better. There is a renewed commitment to patient safety and advancing patient safety measurement. Prior work focused on patient safety measurement, including the transition to digital measures, will ultimately facilitate this evolution and lead to better and safer care. Ensuring that best practices for safety are deployed throughout healthcare, including patients and individuals in safety, and addressing disparities are all important steps toward eliminating preventable healthcare harm for all individuals.
Michelle Schreiber, MD
Deputy Director of Center for Clinical Standards and Quality (CCSQ)
Director of the Quality Measurement and Value-Based Incentives Group (QMVIG)
Centers for Medicare & Medicaid Services
Cindy Van, MHSA
Crystal City, VA
Sarah E. Mossburg, RN, PhD
Crystal City, VA
1. Institute of Medicine (US) Committee on Quality of Health Care in America, Kohn LT, Corrigan JM, Donaldson MS, eds.To Err is Human: Building a Safer Health System. National Academies Press (US); 2000.
2. Centers for Medicare & Medicaid Services. CMS Quality Reporting and Value-Based Programs & Initiatives. May 2022. Accessed June 28, 2022. https://mmshub.cms.gov/about-quality/quality-at-CMS/quality-programs
4. Statement: Salzburg Global Fellows Design New Global Principles for Measuring Patient Safety. Salzburg Global Seminar. December 9, 2019. https://www.salzburgglobal.org/news/statements/article/salzburg-global-fellows-design-new-global-principles-for-measuring-patient-safety.html
5. Rosen AK. Are We Getting Better at Measuring Patient Safety? November 2010. Accessed June 28, 2022. https://psnet.ahrq.gov/perspective/are-we-getting-better-measuring-patient-safety
7. Institute for Healthcare Improvement. Introduction to Trigger Tools for Identifying Adverse Events. 2022. Accessed June 28, 2022. http://www.ihi.org/resources/Pages/Tools/IntrotoTriggerToolsforIdentifyingAEs.aspx
8. Agency for Healthcare Research and Quality. Measurement of Patient Safety. September 2019. Access June 28, 2022. https://psnet.ahrq.gov/primer/measurement-patient-safety
9. eCQI Resource Center. Hospital Harm – Severe Hypoglycemia. https://ecqi.healthit.gov/sites/default/files/ecqm/measures/CMS816v0.html
10. Schreiber M, Richards AC, Moody-Williams J, Fleisher LA. The CMS National Quality Strategy: A Person-Centered Approach to Improving Quality. June 6, 2022. Accessed June 28, 2022. https://www.cms.gov/blog/cms-national-quality-strategy-person-centered-approach-improving-quality
11. Adams KT, Howe JL, Fong A, et al. An Analysis of Patient Safety Incident Reports Associated with Electronic Health Record Interoperability.Appl Clin Inform. 2017;8(2):593–602. doi:10.4338/ACI-2017-01-RA-0014
12. US Department of Health and Human Services. Report of the Secretary's Task Force on Black & Minority Health. Vol. 1, Executive Summary. August 1985. https://minorityhealth.hhs.gov/assets/pdf/checked/1/ANDERSON.pdf
13. Shimada SL, Montez-Rath ME, Loveland SA, et al. Racial Disparities in Patient Safety Indicator (PSI) Rates in the Veterans Health Administration. In: Henriksen K, Battles JB, Keyes MA, et al., eds. Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 1: Assessment). Agency for Healthcare Research and Quality; 2008. https://www.ncbi.nlm.nih.gov/books/NBK43651
14. Fleisher LA, Schreiber M, Cardo D, Srinivasan A. Health Care Safety During the Pandemic and Beyond—Building a System That Ensures Resilience.N Engl J Med. 2022;386(7):609–611. doi:10.1056/NEJMp2118285