Medical Policy

This document identifies different approaches to the discovery, classification, measurement and reporting of patient safety events from established sources, including The Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), National Quality Forum (NQF), The Joint Commission (TJC), and the American College of Surgeons (ACS) and describes how studies of these methodologies may identify ways to improve patient safety events including hospital-acquired conditions (HACs), healthcare-associated infections (HAIs), surgical complications, including obstetrical and maternal events, and medication errors.

Note: Patient safety events are defined as complications or adverse outcomes that occur during or after medical care. This Medical Policy does not address the medical necessity of any treatments, services or technology that may be used as a result of patient safety events. Patient safety events may be separately addressed under an applicable reimbursement policy or under the terms of Plan benefit contract language. Certain patient safety events may also trigger quality reporting and provider review.

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

This document describes how healthcare organizations track and report patient safety events. A patient safety event is a problem that happens during or after medical care, such as an infection, a fall, or a surgery-related complication. Events are not treatments, services, or technologies, so they are not reviewed for medical necessity. Instead, they are used to measure healthcare quality, support reporting, and help hospitals improve safety. The summary may not contain all of the relevant information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

This document describes clinical studies and expert recommendations and explains patient safety events. It explains how hospitals and national groups define, track, and report patient safety events. These are problems that happen during or after care, such as infections picked up in the hospital, surgery-related problems, falls, pressure injuries, or medication mistakes. The goal of these reporting systems is to find preventable harm, compare results across hospitals, and improve care. Groups such as the Agency for Healthcare Research and Quality, Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, National Quality Forum, The Joint Commission, and the American College of Surgeons all use methods to measure safety. Studies in this document suggest that safety tracking can help hospitals focus on areas that need improvement. Some programs were linked with fewer bloodstream infections or urinary infections. However, results were not consistent for all outcomes, and some measures still have limits because they depend on the quality of the data collected and reported.

What the Studies Show

The studies describe several ways to measure patient safety. For hospital-acquired conditions, some research found that payment penalties or safety programs were linked with better scores or fewer infections in some hospitals. For example, some studies found lower rates of central line bloodstream infections and catheter-related urinary infections after safety efforts were introduced. A program for older adults also lowered delirium, which is sudden confusion, but did not clearly improve other outcomes such as death, readmission, or discharge to a facility. Other studies found little or no clear change in some surgical harm after payment penalties began. These findings suggest that while measuring harm may support improvement efforts, it does not consistently lead to better outcomes on its own.

The document also reviews healthcare-associated infections, surgery-related complications, and medication errors. Studies suggest that hand cleaning, cleaner care environments, and antibiotic stewardship, which means careful antibiotic use, can lower infection risk. For surgery, risk tools may help estimate the chance of heart problems after an operation, but better studies are needed to know which added blood tests improve prediction. For medication errors, the document describes three systems that group mistakes by severity, from events that could have caused harm to errors that caused death. These systems may help hospitals find patterns, respond faster, and compare safety results over time.

Main Types of Patient Safety Events

This document discusses several common types of patient safety events:

• Hospital-acquired conditions. These are health problems that begin during a hospital stay and were not present when the person arrived. Examples include falls, pressure injuries, and some surgery-related problems.
• Healthcare-associated infections. These are infections linked to medical care. Examples include central line-associated bloodstream infection, catheter-associated urinary tract infection, surgical site infection, methicillin-resistant Staphylococcus aureus, also called MRSA, bacteremia, and Clostridioides difficile, also called C. difficile, infection.
• Surgical complications. These include bleeding, wound reopening, pneumonia, blood clots, kidney failure, sepsis, readmission, or death after surgery.
• Maternal and obstetrical complications. These focus on the safety of care during childbirth for both mothers and newborns, for example whether babies experience injuries during delivery, such as nerve damage or fractures, which can sometimes occur if the delivery is difficult and serious tears that can happen during vaginal delivery. These are reported separately depending on whether tools like forceps or a vacuum device are used, since those methods can carry different levels of risk.
• Medication errors. These are preventable mistakes in prescribing, preparing, giving, or monitoring medicine. Some errors do not reach the person. Others reach the person and may cause temporary harm, permanent harm, or death.

Why This Matters

Standard ways to define and report safety events can help hospitals spot preventable harm and improve care. They can also support public reporting and comparison across hospitals. Still, these systems do not measure every problem perfectly. Some events may be missed, and some results depend on how well hospitals collect and report data. Overall, the document supports using standard reporting methods as tools to improve safety, while continuing to refine the measures and study which approaches lead to better health outcomes.

How Hospitals Try to Prevent Harm

Prevention depends on using proven safety steps in a reliable way. For infections, this includes clean hands, clean equipment, careful use of invasive devices, and good cleaning of the care environment. Antibiotic stewardship, which means using antibiotics carefully and only when needed, is also important because overuse can lead to resistant germs that are harder to treat. For surgery, hospitals may use checklists and risk tools before an operation to identify factors that raise the chance of complications. For older adults, programs that support movement, food and fluids, and mental activity may lower some harm, especially delirium.

Overall, standardized reporting enables hospitals to identify preventable harm, compare results fairly, and guide improvement in care.

(Return to Description/Scope)

Summary

This document is supported by nationally recognized definitions and methodologies to ensure consistent, transparent, and reliable evaluation of healthcare quality indicators related to preventable harm. Standardized data collection and analysis are intended to facilitate comparability across settings, support continuous quality improvement efforts, and reduce preventable adverse events to improve patient outcomes. National groups such as the Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), National Quality Forum (NQF), The Joint Commission (TJC), and the American College of Surgeons (ACS) all help define, measure, and monitor patient safety events.

Discussion

In healthcare, “never events,” defined by the National Quality Forum (NQF) as Serious Reportable Events (SREs), are clearly identifiable, preventable events that should not occur in healthcare settings when evidence-based safety practices are followed. These events are typically associated with significant patient harm, including death or permanent injury, and are considered unacceptable occurrences that warrant reporting, investigation, and system-level improvement. Never events are used by national organizations to promote accountability, standardize patient safety measurement, and support quality improvement initiatives aimed at reducing preventable harm.

Several national organizations report and monitor patient safety events including:

• Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicator (PSIs) Measures
• American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP)
• Centers for Disease Control and Prevention (CDC) Healthcare-Associated Infections (HCAIs)
• Centers for Medicare & Medicaid Services (CMS) Hospital-Acquired Condition Reduction Program (HACRP)
• National Quality Forum (NQF):
  • Focus on HARM (Harmonizing Accountability in Reporting and Monitoring)
  • Updating the Serious Reportable Events List
• The Joint Commission (TJC)
• The Leapfrog group

Hospital Acquired Conditions (HACs)

HACs are any condition that an individual develops during a hospital stay that was not present at the time of admission and is considered reasonably preventable through the application of evidence-based guidelines. HACs occur as a result of medical care, treatment, or the hospital environment. Many HACs are linked to lapses in safety practices or quality of care. Both the CMS and the AHRQ use HAC related measures to identify potentially preventable complications of care.

The Leapfrog Group, in collaboration with national patient safety experts, developed a composite patient safety score to provide a standardized, comparative assessment of safety performance across 2652 voluntarily participating U.S. general acute care hospitals. The composite score incorporates publicly reported patient safety measures derived from national data sources. Each measure was weighted using two domains: the scope of patient impact (ranging from rare events affecting few patients to system-wide practices affecting all patients), and the severity of harm (ranging from limited evidence of harm to measures associated with significant mortality reduction). A total of 26 measures were included in the score.

The scope of patient impact dimensions included the number of patients possibly affected:
1 = Rare event (for example, foreign object retained after surgery)
2 = Some patients in hospital affected (for example, ICU physician staffing)
3 = All patients in hospital affected (for example, hand hygiene safe practice)

The severity of harm impact for individual patient dimensions included:
1 = Limited direct evidence of harm or harm reduction (for example, culture measurement safe practice)
2 = Clear documentation of harm or harm reduction; adverse events (for example, foreign object retained after surgery)
3 = Significant mortality reduction (91000 deaths across the US annually or a 10% reduction in hospital-wide mortality)

The values from each dimension were added together and an overall Impact Score given as follows:
1 = Summed value of 2 (low impact)
2 = Summed value of 3 to 4 (medium impact)
3 = Summed value of 5 to 6 (high impact)

Application of this methodology across the 2652 hospitals demonstrated variability in performance, with a mean composite score of 2.97. Safety scores were slightly lower for hospitals that were publicly owned, rural in location, or had a larger percentage of patients with Medicaid as their primary insurance. The results demonstrated that the patient safety composite score provides a standardized method to evaluate patient safety in general acute care hospitals, however, the scores were constrained by available data and publicly reported scores on measures. The authors concluded that the composite score reflects the best available evidence regarding a hospital’s efforts and outcomes in patient safety, however additional analyses are needed to further refine the composite (Austin, 2014).

Waters (2015) published a quasi-experimental study of adult nursing units from 1381 U.S.-based hospitals participating in the National Database of Nursing Quality Indicators (NDNQI). The NDNQI data were combined with the American Hospital Association annual survey data, Medicare Cost Report, and local market data to examine adjusted outcomes. The study measured the association between Medicare's nonpayment policy and four of the outcomes addressed by the CMS HACs Initiative: central line-associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), hospital-acquired pressure ulcers (HAPUs), and injurious inpatient falls. Medicare's nonpayment policy was associated with an 11% reduction in the rate of change in CLABSIs (incidence rate ratio [IRR], 0.89; 95% confidence interval [CI], 0.83-0.95) and a 10% reduction in the rate of change in CAUTIs (IRR, 0.90; 95% CI, 0.85-0.95), but was not associated with a significant change in injurious falls (IRR, 0.99; 95% CI, 0.99-1.00) or HAPUs (odds ratio [OR], 0.98; 95% CI, 0.96-1.01). The HACs Initiative was associated with improvements in CLABSI and CAUTI trends, conditions for which there is strong evidence that better hospital processes yield better outcomes. However, the HACs Initiative was not associated with improvements in HAPU or injurious fall trends, conditions for which there is less evidence that changing hospital processes leads to significantly better outcomes.

Hospital-associated complications in older adults (HAC-OPs), including delirium, hospital-associated disability, incontinence, pressure injuries, and falls, represent common, potentially preventable adverse events associated with acute inpatient care. Evidence-based, age-friendly care principles (for example, early mobilization, adequate nutrition and hydration, and cognitive engagement) have been proposed to mitigate these risks, however, consistent implementation within hospital settings remains challenging. Mudge (2022) published a cluster randomized trial, (Collaboration for Hospitalized Elders Reducing the Impact of Stays in Hospital [CHERISH]) study. Inclusion criteria were inpatients aged 65 years or older, admitted for 3 days or more to study wards, from October 2016 to April 2017, with a 6-month follow-up (n=539). The study evaluated a ward-level quality improvement intervention (“Eat Walk Engage”) designed to enhance delivery of age-friendly care. The primary outcomes measured were the incidence of any HAC-OP and length of stay. Secondary outcomes were incidence of individual HAC-OPs, facility discharge, 6-month mortality, and all-cause readmission. The median length of stay was 6 days for the intervention group and 7 days for the control group (adjusted hazard ratio [HR], 0.96; 95% CI, 0.80-1.15). The incidence of delirium was lower for intervention participants (adjusted odds ratio [aOR], 0.53; 95% CI, 0.31-0.90). However, there were no significant differences in other individual HAC-OPs, facility discharge, mortality, or readmission rates. The study suggests a targeted benefit for delirium complications.

Brewer (2024) conducted a quantitative comparative analysis of 3123 U.S. hospitals to evaluate the association between HACRP penalties and changes in total HAC scores using data from fiscal years 2018-2019. The hospitals receiving repeated penalties demonstrated statistically significant improvements in total HAC scores (p<0.001), with the greatest effect observed among smaller hospitals (less than 100 beds). Disproportionate share hospitals were more likely to incur repeated penalties (p=0.005). However, improvements in HAC scores associated with repeated penalties were observed regardless of disproportionate share status. The findings suggest that HACRP financial penalties may serve as a driver for quality improvement, particularly in smaller hospitals where financial pressures may directly influence operational changes more. In contrast, larger hospitals may have greater capacity to absorb penalties without substantial changes to care processes. Disproportionate share hospitals may face resource constraints that limit their ability to implement effective quality improvement initiatives despite higher penalty exposure. The authors concluded that the results indicate that while penalty-based programs may incentivize improvements in patient safety performance, differential impacts across hospital types highlight the need for tailored incentive structures to ensure equitable and effective quality improvement without exacerbating disparities in resource-limited settings.

Healthcare-Associated Infections (HAIs)

HAIs constitute one of the most frequent and consequential adverse events in modern healthcare, substantially increasing morbidity, mortality, and costs. HAIs are infections acquired during the provision of medical care and not present or incubating at the time of admission, generally emerging 48-72 hours after receipt of care (Asokan, 2026). HAIs may involve bacterial, viral, or fungal pathogens transmitted through invasive procedures, devices, contaminated environments, or healthcare personnel. Approximately 3.2% of U.S. inpatients and 6.5% of European inpatients acquire HAIs, although underdiagnosis is common. Surveillance data from 2020-2025 indicate a trend toward increasing incidence of HAIs and antimicrobial-resistant infections in many healthcare systems coinciding with the COVID-19 pandemic (World Health Organization [WHO], 2026).

The occurrence of HAI is more strongly related to iatrogenic factors due to invasive procedures (for example, surgery, intubation, central venous cannulation, mechanical ventilation, bladder catheterization, and nasal tube insertion) than to patient-dependent factors such as age, comorbidities, and mode of hospitalization (Czerniak, 2024). Healthcare environmental hygiene (HEH), especially in the context of invasive procedures, is important for patient safety; HEH interventions can reduce HAIs and patient colonization by infectious microorganisms. Peters (2022) performed a systematic review of evidence for interventions in the healthcare environment on patient colonization and HAI with multidrug-resistant microorganisms (MDROs) or other epidemiologically relevant pathogens. A total of 26 studies were reviewed and analyzed. HEH interventions were classified as chemical (such as hydrogen peroxide or disinfectant cleanser), mechanical (such as ultraviolet disinfection), human factors (such as training, education, monitoring, and feedback), and bundles combining two or more of these categories. Most studies (23/26, 88%) reported a decrease of MDRO-colonization or HAI for at least one tested organism; over half of studies (58%) demonstrated a significant decrease in colonization or HAI for all of the microorganisms tested. The authors concluded that there was a strong relationship between interventions to improve HEH and a reduction in patient colonization or HAI, and that optimal HEH practices are a key component to improving infection prevention and control.

The single most important HEH practice in reducing HAIs is hand hygiene. This involves strict adherence to the 5 Moments for Hand Hygiene (WHO, 2026). These moments include: 1) before touching a patient, which protects the patient from harmful germs carried on the healthcare worker’s (HCW) hands, 2) before a clean/aseptic procedure, which protects the patient from germs entering their body, including their own, 3) after body fluid exposure risk, which protects the HCW and the healthcare environment from harmful patient germs, 4) after touching a patient, which protects the HCW and the environment from harmful patient germs, and 5) after touching patient surroundings, which protects the HCW and the environment from germs, even if the patient was not touched directly.

A two-pronged approach to reducing HAIs combines: 1) rigorous hand hygiene compliance, with 2) enhanced environmental hygiene and safety bundles. The second prong involves using environmental cleaning to remove pathogens, sterilizing equipment, and implementing active surveillance for antibiotic resistant organisms. Antibiotic stewardship, a supporting strategy for environmental hygiene, is a program aimed at ensuring proper antibiotic use to prevent the spread of drug-resistant organisms. Antibiotics are fundamentally different from other medications in that their efficacy wanes over time, they are a shared resource, and individual use may harm others (Srinivasan, 2017), so it’s important to use them in a thoughtful and responsible way. Antibiotic stewardship efforts should focus on optimizing appropriate use rather than simply reducing use, thereby improving patient outcomes, reducing resistance, and lowering costs.

Surgical Complications

Rude (2018) evaluated national trends in HACs among individuals undergoing major inpatient urologic surgery, with a focus on the impact of the CMS HACRP implemented in 2008. Using data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP), the study analyzed 39,257 surgical cases from 2005 to 2012. Overall, 5.9% of individuals experienced at least one HAC, with urinary tract infections (2.6%) and surgical site infections (2.5%) representing the most common events, followed by venous thromboembolism (0.7%). Patient-related and procedure-related risk factors associated with increased HACs included open surgical approach, diabetes, congestive heart failure, chronic obstructive pulmonary disease, weight loss, and higher American Society of Anesthesiologists (ASA) class. Trend analysis demonstrated a nonsignificant reduction in HAC rates from 7.4% to 5.8% over time. However, implementation of the HACRP was not associated with a statistically significant change in HAC incidence. The findings suggest that while modest improvements in HAC rates may occur over time, policy-driven reimbursement penalties alone may be insufficient to significantly reduce HAC occurrence. The authors concluded that identification and mitigation of patient- and procedure-specific risk factors are critical to the development of effective prevention strategies.

Several tools try to predict an individual’s chance of developing a heart complication after surgery using information collected in the period before surgery. The Revised Cardiac Risk Index (RCRI) estimates the chance of developing heart complications during hospital admission in individuals undergoing surgery other than heart surgery. It uses information on whether the individual has in the past experienced a heart infarction, heart failure and/or a stroke during his/her life, their use of insulin for the treatment of diabetes mellitus, their current renal (kidney) function and whether the individual will undergo high or non-high-risk surgery. The RCRI is commonly used by physicians. Researchers have attempted to improve these predictions by adding extra information to this tool from so-called biomarkers, which are, for example, measurements from blood, imaging techniques or other characteristics, such as age, smoking status or physical condition of the individual. A Cochrane systematic review evaluated the predictive performance of the RCRI when supplemented with additional biomarkers and compared its accuracy to alternative perioperative risk prediction tools in individuals undergoing noncardiac surgery. Across the included studies, 69 candidate predictors were assessed for their incremental value when added to the RCRI, which includes troponin (which measures muscular damage of the heart), brain natriuretic peptide (BNP) and NT-probrain natriuretic peptide (NT-prBNP), which both measure severity of heart failure. The evidence suggests that select cardiac biomarkers, specifically BNP, and NT-proBNP, may improve the RCRI’s ability to predict perioperative cardiac complications. Additionally, BNP and NT-proBNP alone demonstrated potential for superior predictive performance compared to the RCRI in some analyses. Alternative risk stratification tools, including the ACS NSQIP and ACS NSQIP-Myocardial Infarction or Cardiac Arrest (MICA) risk calculators, showed improved prediction of certain postoperative complications relative to the RCRI; however, this advantage was not consistently observed for cardiac-specific outcomes. The authors concluded that interpretation of the findings was limited by significant heterogeneity in study design, variability in methodological quality, and potential bias across the included studies. The overall certainty of evidence was deemed low. While selected biomarkers may enhance perioperative cardiac risk prediction, further high-quality, standardized research is required to establish their clinical utility and generalizability (Vernooij, 2021).

Joseph (2022) conducted a systematic review evaluating the availability and characteristics of postoperative pain management quality measures across inpatient and post-discharge settings using national quality databases (NQF, CMS, AHRQ). The review identified a limited number of relevant measures, with only three specific to postoperative pain management and none endorsed by the NQF. Existing measures were predominantly process-based and focused on opioid prescribing practices, rather than comprehensive, multimodal pain management or patient-centered outcomes. Notably, there was a lack of measures addressing key outcome domains, including functional recovery, patient-reported pain, and post-discharge pain management. Overall, the findings demonstrated a significant gap in standardized and endorsed postoperative pain quality measures. This constrains benchmarking, performance evaluation, and quality improvement efforts. The absence of such measures also limits integration of value-based purchasing and pay-for-performance programs. These results underscore the need for development of robust, standardized metrics to support evidence-based postoperative pain management and enable consistent national benchmarking across healthcare institutions.

Ogunsola (2025) systematically reviewed and analyzed 11 published arthroplasty studies utilizing ACS-NSQIP database to assess smoking as a potential risk factor for poor surgical outcomes in an attempt to reproduce the published arthroplasty studies involving hip or knee arthroplasty and smoking as a potential risk factor for poor surgical outcomes. All analyzed studies included Level III Evidence. Adjusted odds ratios (aORs) and p-values were compared between the original and reanalyzed datasets. Reanalysis of 268 aORs showed that 12.69% of the original studies' aORs changed in interpretation, while 13.43% experienced a change in statistical significance. The average magnitude change of each aOR across all studies was 17.22%, and the sample size in reanalysis varied by up to 47.84%. Among the commonly cited studies, approximately one in eight objective conclusions changed in interpretation or statistical significance. The findings highlight the need for rigorous reporting of study methods, data collection, and statistical analyses when utilizing large-volume databases in orthopedic research.

Medication Errors

A medication error is defined as any preventable event that may cause or lead to inappropriate medication use or potential patient harm while the medication is in the control of the healthcare professional, patient, or consumer (Ciapponi, 2021). Medication errors may occur at any stage of the medication use process including prescribing, transcribing, dispensing, administering, or monitoring; they may or may not result in patient harm (Bobb, 2004).

Medication errors are a significant public health issue in the U.S. and are linked to an estimated 44,000-98,000 deaths annually (Institute of Medicine [US] Committee on Quality of Health Care in America, 2000). Medication errors can occur in both inpatient and outpatient settings. Over 1.5 million people visit emergency departments annually due to these errors, resulting in almost 500,000 hospitalizations (CDC, 2024). Prescribing errors and dosing errors are the most prevalent in the outpatient setting (Naseralallah, 2023). In hospitals or long-term care facilities, a systematic review of 91 direct observation studies of medication error rates found that the error rates during medication administration were common, ranging from 8% to 25% (Keers, 2013). Administration of intravenous drugs had a higher error rate, with an estimated median rate (including timing errors) ranging from 48%-53%. Despite error reduction efforts through implementing new technologies and streamlining processes, medication errors remain a continued patient safety concern.

Three classification systems offer complementary approaches to categorizing medication errors and should be understood as part of a broader toolkit for patient safety reporting and quality improvement. The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index provides the most granular severity stratification across nine categories, with validated inter-rater reliability, and is widely used in U.S. hospital reporting systems and national databases (Bobb, 2004; Forrey, 2007; Goedecke, 2016). The Institute for Safe Medication Practices (ISMP) seven-category scale offers a streamlined alternative that simplifies classification while preserving clinically meaningful distinctions, and is well suited for research, benchmarking, and rapid event triage (Ciapponi, 2021). The European Union (EU) Good Practice Guide framework takes a structurally different approach, classifying errors by whether they were intercepted, reached the patient, or caused harm, and is particularly useful for pharmacovigilance, regulatory reporting, and root cause analysis across the medication lifecycle (Goedecke, 2016).

Organizations should select or adapt the classification system, or combination of systems, that best aligns with their reporting infrastructure, regulatory obligations, and quality improvement goals. Regardless of which framework is adopted, consistent application of a standardized severity classification is essential to enable accurate assessment of medication error data, identification of high-risk failure points, prioritization of corrective actions, and meaningful comparison of safety performance over time.

Hospital Acquired Conditions (HACs)

Agency for Healthcare Research and Quality (AHRQ)

AHRQ is a federal agency within the U.S. Department of Health and Human Services (HHS) responsible for producing evidence to improve the safety, quality, accessibility, and affordability of healthcare. AHRQ developed standardized measures, including the patient safety indicators (PSIs), and provides tools, data resources, and evidence-based guidance to support the identification, measurement, and reduction of preventable adverse events across healthcare settings (AHRQ Quality Indicators, 2014, reaffirmed 2025).

AHRQ Patient Safety Indicators

The AHRQ Focus on HARM (Harmonizing Accountability in Reporting and Monitoring) initiative also aims to reduce preventable harm by updating Serious Reportable Event (SRE) criteria and harmonizing reporting. Key actions include:

• Reviewing and updating the SRE list to reflect today’s full range of care delivery settings and ensure the list continues to be relevant to care delivery today and enables robust meaningful cross-state comparisons, benchmarking, and trending.
• Harmonizing various safety measurement taxonomies to eliminate redundancies and inconsistencies.
• Establishing a consensus-based unified framework and taxonomy of healthcare harms and safety events, with specific data definitions and reporting standards.
• NQF and The Joint Commission worked together to align the SRE and Sentinel Event taxonomies, two of the most widely used frameworks, to streamline the measurement ecosystem, reducing measurement burden and increasing measurement value.
• NQF and The Joint Commission developed new, specific implementation guidance to help different reporting systems, including the 25-plus states currently using the SRE list, to better harmonize SRE definitions, report safety events more consistently, and reduce administrative burden.

Centers for Medicare & Medicaid Services (CMS)

The Centers for Medicare & Medicaid Services (CMS) administers the Hospital-Acquired Condition Reduction Program (HACRP), a Medicare value-based purchasing program that links hospital payment to performance on patient safety measures. Pursuant to Section 5001(c) of the Deficit Reduction Act (DRA) of 2005, CMS implemented the Hospital-Acquired Condition (HAC) payment provision under the Inpatient Prospective Payment System, requiring hospitals to report Present on Admission (POA) indicators for all diagnoses. Each diagnosis code on an inpatient claim must include a POA indicator:

• Y = Yes (present at admission)
• N = No (not present at admission → potentially hospital-acquired)
• U = Unknown
• W = Clinically undetermined
• 1 = Exempt from POA reporting

When a condition within one of the CMS-defined HAC categories is identified as not present on admission (POA = N or U) and would otherwise qualify as a complication or comorbidity (CC) or major complication or comorbidity (MCC), CMS excludes that condition from MS-DRG assignment. As a result, the hospital is paid as though the condition were not present, leading to reduced reimbursement. This payment adjustment applies only to secondary diagnosis codes within 1 of the 14 identified HAC categories. However, if other CC/MCC conditions not subject to the DRA HAC payment provision are present, that is, other CC/MCC conditions which are not within 1 of the 14 identified HAC categories, then payments will not be adjusted.

Additionally, HACRP assesses hospital performance using a composite score derived from AHRQ Patient Safety Indicators (PSI-90) and CDC National Healthcare Safety Network (NHSN) healthcare-associated infection measures. Hospitals in the worst-performing quartile, that is the bottom 25% nationally, receive a 1% reduction in total Medicare inpatient payments for all discharges, representing a hospital-wide payment penalty rather than a claim-specific adjustment. The HAC policy is a payment adjustment, not a direct fine (CMS, 2025).

Furthermore, under Section 2702 of the Patient Protection and Affordable Care Act of 2010, Medicaid programs are required to adopt similar payment prohibitions for provider-preventable conditions, including certain HACs and  “never events,” (currently known as Serious Reportable Events) consistent with Medicare policy, while allowing for program-specific applicability (CMS, 2011).

The HAC Reduction Program encourages hospitals to improve patients’ safety and implement best practices to reduce their rates of infections associated with health care (CMS, 2026).

The Patient Safety and Adverse Events Composite (CMS PSI 90) is a nationally recognized, risk-adjusted composite quality measure developed by AHRQ and adopted by CMS. The measure aggregates multiple PSIs into a single weighted score to evaluate hospital-level performance on potentially preventable adverse events. The CMS PSI 90 is used to support comparative quality assessment and value-based payment programs. Under Section 1886(p) of the Social Security Act, the HAC Reduction Program applies to all subsection (d) hospitals, that is, general acute care hospitals. The score “summarizes patient safety across multiple indicators, monitors performance over time, and facilitates comparative reporting and quality improvement at the hospital level” (CMS, 2019). Lower scores generally indicate superior patient safety performance and fewer adverse events relative to expected rates. CMS uses the Total HAC Score to determine the worst-performing quartile of all subsection (d) hospitals based on data for six quality measures:

• One claim-based composite measure of patient safety:
  • CMS Patient Safety and Adverse Events Composite (CMS PSI 90)
• Five chart-abstracted measures of healthcare-associated infections (HAI), submitted to the Centers for Disease Control and Prevention's National Healthcare Safety Network:
  • Central Line-Associated Bloodstream Infection (CLABSI)
  • Catheter-Associated Urinary Tract Infection (CAUTI)
  • Colon and Abdominal Hysterectomy Surgical Site Infection (SSI)
  • Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia
  • Clostridium difficile Infection (CDI)

CMS reduces the payments of subsection (d) hospitals with a total HAC Score greater than the 75th percentile of all Total HAC Scores, that is, the worst-performing quartile by 1 percent (CMS, 2026).

CMS PSI 90 measure includes the following:

• PSI 03- Pressure Ulcer Rate
• PSI 06- Iatrogenic Pneumothorax Rate
• PSI 08- In Hospital Fall-Associated Fracture Rate
• PSI 09- Postoperative Hemorrhage or Hematoma Rate
• PSI 10- Postoperative Acute Kidney Injury Requiring Dialysis Rate
• PSI 11- Postoperative Respiratory Failure Rate
• PSI 12-Perioperative Pulmonary Embolism or Deep Vein Thrombosis Rate
• PSI 13- Postoperative Sepsis Rate
• PSI 14- Postoperative Wound Dehiscence Rate
• PSI 15- Abdominopelvic Accidental Puncture/Laceration Rate

Some hospitals and hospital units are exempt from the HAC Reduction Program. These include:

• Critical access hospitals
• Rehabilitation hospitals and units
• Long-term care hospitals
• Psychiatric hospitals and units
• Children’s hospitals
• Prospective Payment System-exempt cancer hospitals
• Veterans Affairs hospitals
• Short-term acute care hospitals located in U.S. territories (Guam, Puerto Rico, the U.S. Virgin Islands, the Northern Mariana Islands, and American Samoa)
• Religious non-medical health care institutions
• Rural emergency hospitals

Additionally, Maryland hospitals are also exempt from payment reductions due to an agreement with the CMS and the state of Maryland.

National Quality Forum (NQF)

The NQF is a not-for-profit, nonpartisan membership based organization that seeks to improve healthcare outcomes, safety, and affordability by developing multistakeholder consensus on quality measurement and improvement practices. The NQF supports standardized national measurement and public reporting and is affiliated with the Joint Commission. NQF does not create new HAC measures itself, rather it endorses and maintains consensus-based quality measures, and ensures measures are evidence-based, reliable, and valid. The NQF HAC measures enable CMS value-based purchasing and HACRP.

The 2025 NQF Serious Reportable Events (SRE) establishes a nationally recognized framework for identifying reportable patient safety events and defines a standardized set of 28 serious, largely preventable adverse events intended to support consistent identification, reporting, and quality improvement. Of these, 23 events were updated from the 2011 list and 5 were newly introduced, with accompanying clinical guidance to support their implementation. SREs are organized into four domains: Procedural events, Product or Device Events, Patient Protection Events, and Care Provision Events. The SRE list focuses on preventability, accountability, and the use of standardized reporting to drive patient safety and reduce adverse outcomes. The Serious Reportable Events (SRE) list includes:

• SRE 1. Surgery or other invasive procedure performed at the wrong site, on the wrong patient, or that is the wrong procedure, regardless of the type of procedure or the outcome
• SRE 2. Unintended retention of a medical or surgical item in a patient after surgery or other invasive procedure, regardless of the type of procedure or the outcome
• SRE 3. Patient harm associated with perioperative or periprocedural sedation of an ASA Class I or ASA Class II patient
• SRE 4. Medically assisted reproduction with the wrong donor sperm or egg, regardless of the outcome
• SRE 5. Introduction of an unapproved, unscreened, or inappropriately approved device, implant, or object into an MR Zone IV area, regardless of the outcome
• SRE 6. Patient harm associated with an MRI-related thermal injury (New)
• SRE 7. Delivery of radiotherapy to the wrong patient, wrong body region, unintended procedure, or greater than 25% above the planned radiotherapy dose, regardless of the outcome (New)
• SRE 8. Patient harm associated with the use of contaminated drugs, devices, or biologics
• SRE 9. Patient harm associated with the use or function of a medical device in patient care, in which the device is used or functions other than as intended
• SRE 10. Patient harm occurring when systems designated for oxygen or other gas to be delivered to a patient contain no gas, the wrong gas, or are contaminated by toxic substances
• SRE 11. Fire, flame, or unanticipated smoke, heat, or flashes occurring during direct patient care caused by equipment operated and used by the healthcare, regardless of outcome (New)
• SRE 12. Discharge or release of a patient who does not have decision-making capacity to other than an authorized person or entity, regardless of the outcome
• SRE 13. Patient harm associated with the disappearance or unauthorized departure of a patient who does not have decision-making capacity
• SRE 14. Patient suicide or suicide attempt that occurs after presentation for care or within seven days of discharge or release, regardless of the outcome
• SRE 15. Patient harm associated with the use of chemical restraints, physical restraints, or seclusion
• SRE 16. Sexual abuse or sexual assault within or on the grounds of a healthcare setting, regardless of the outcome
• SRE 17. Patient harm associated with a fall
• SRE 18. Patient harm associated with an unintended burn from any source
• SRE 19. Patient harm associated with a medication error
• SRE 20. Patient harm associated with unsafe processing or administration of blood products
• SRE 21. Patient harm associated with a Stage 3 pressure injury, Stage 4 pressure injury, unstageable pressure injury, or deep tissue pressure injury acquired after admission
• SRE 22. Patient harm associated with the irretrievable loss of a biological specimen that is irreplaceable or is only replaceable by an invasive procedure
• SRE 23. Patient harm resulting from failure to act on clinically significant laboratory, pathology, or radiology test results
• SRE 24. Patient harm associated with an intravascular air embolism
• SRE 25. Maternal patient harm associated with labor or delivery in a low-risk pregnancy
• SRE 26. Neonatal patient harm associated with labor or delivery in a low-risk pregnancy
• SRE 27. Patient harm associated with the care of a neonate (New)
• SRE 28. Patient harm associated with unrecognized clinical deterioration (New)

Medicaid prohibits payment for Other Provider-Preventable Conditions (OPPCs), including wrong-patient, wrong-site, and wrong-procedure surgeries, under 42 CFR § 447.26. These events are considered preventable and align with NQF Serious Reportable Events and are subject to Medicaid payment prohibitions. Medicaid programs must deny payment for services associated with these events, including both the procedure itself and related care required to treat complications. These policies apply across multiple care settings, including inpatient, outpatient, and ambulatory environments.

Medicare does not use the OPPC designation but applies similar payment limitations through the HACRP which removes higher DRG payment when such conditions are not present on admission.

The Joint Commission (TJC)

TJC is an independent, not-for-profit organization in the U.S. that accredits and certifies healthcare organizations and programs. It establishes performance standards and evaluates healthcare entities based on their ability to provide safe, high-quality care. TJCs mission is to continuously improve healthcare for the public. TJC created a Sentinel Events List, which is a list of serious and unexpected events in healthcare settings that results in death, severe harm, or risk of severe harm to a person. TJC defines these events as signals that there may be major problems in how care is delivered.

TJC announced in 2026 a collaborative initiative with The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) to establish a new cardiac care certification program based on patient outcomes. This certification leverages established clinical performance data from nationally recognized registries, including the STS Adult Cardiac Surgery Database (ACSD), the ACC CathPCI Registry^®, and the joint STS/ACC Transcatheter Valve Therapy (TVT) Registry^™ for organizations performing transcatheter aortic valve replacement (TAVR) procedures. These registries collect comprehensive data on patient characteristics, treatments, and outcomes related to cardiothoracic and interventional cardiac procedures. By integrating existing data sources into the certification process, hospitals and other healthcare organizations will be able to link certification directly to real-world clinical performance.

Additionally, TJC will update the Sentinel Events List by adopting the updated NQF SRE List while also including three legacy sentinel events that address workforce safety: Homicide, Sexual Abuse/Assault, and Physical Assault of a staff member. This transition will go into effect in January 2027. Alignment of these previously parallel measurement systems aims to reduce healthcare organization reporting burden.

Healthcare-Associated Infections (HAI)

The U.S. Centers for Disease Control and Prevention (CDC) define HAI as infections that individuals acquire while or soon after receiving healthcare. HAIs are a leading cause of morbidity, mortality, and increased healthcare costs worldwide. Each day, about 1 in 31 hospitalized individuals has at least one HAI, and over a million HAIs occur across the U.S. healthcare system every year.

HAIs occur when microorganisms, some of which may be resistant to antibiotics, enter an individual’s body during care, particularly through invasive procedures. They may spread via airborne transmission, unwashed hands, or contaminated equipment. Prevention measures include environmental cleaning, proper hand hygiene, maintaining sterile procedures, and device management (such as using catheters and ventilators only when necessary and removing them promptly).

Preventing HAIs is a top priority for the CDC. The CDC operates the National Healthcare Safety Network (NHSN) which is the nation’s most widely used healthcare-associated infection (HAI) tracking system. NHSN provides data collection and reporting capabilities needed to identify problem areas, measure progress of prevention efforts, and ultimately eliminate HAIs. NHSN is the gold standard for HAI surveillance. NHSN now serves over approximately 25,000 medical facilities tracking HAIs.

CMS requires reporting of HAIs through NHSN for payment programs, linking the extent of payments to measures of healthcare quality. Under the program, CMS reduces overall Medicare payments for hospitals that rank in the worst-performing quartile of all hospitals on measures of hospital-acquired conditions. A large component of the HAC score used to evaluate hospital performance is five chart-abstracted measures of HAI submitted to the NHSN:

• Central Line-Associated Bloodstream Infection (CLABSI)
• Catheter-Associated Urinary Tract Infection (CAUTI)
• Colon and Abdominal Hysterectomy Surgical Site Infection (SSI)
• Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia
• Clostridium difficile Infection (CDI)

Other examples of HAI include the fungus Candida auris, nontuberculous mycobacteria, scabies, carbapenemase-producing organisms (CPO) that can break down certain antibiotics and make them ineffective, vancomycin-intermediate and vancomycin-resistant Staphylococcus aureus (VISA/VRSA), and ventilator-associated pneumonia.

The NQF develops and endorses consensus-based standards to measure and improve healthcare quality, including for HAIs. NQF works with stakeholders to develop measures that track infections, ensuring they are accurate and actionable for providers. NQF created a guide called the Hospital-Onset Bacteremia and Fungemia Playbook to help hospitals track and prevent a wide range of infections beyond traditional device-related measures. NQF also works with CMS to develop measures used in accountability programs.

Antimicrobial-resistant pathogens are key contributors to the occurrence of HAIs. The implementation of proper hygiene practices and antimicrobial stewardship programs plays a pivotal role in curbing the spread of resistant organisms. Antimicrobial stewardship, which is the responsible use of antimicrobials to avoid contributing to antimicrobial resistance, includes efforts to measure and improve how antibiotics are prescribed by clinicians and used by patients. CDC’s Core Elements of Antibiotic Stewardship offers providers and facilities a set of key principles to guide efforts to improve antibiotic use and, thereby, advance patient safety and improve outcomes. The Core Elements framework complements existing guidelines and standards from key healthcare partner organizations, including the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), American Society of Health System Pharmacists (ASHSP), Society of Infectious Diseases Pharmacists (SIDP), and The Joint Commission (TJC).

The Core Elements of Antibiotic Stewardship framework include five sections:

• Core Elements of Hospital Antibiotic Stewardship Programs
• Core Elements of Outpatient Antibiotic Stewardship
• Core Elements of Antibiotic Stewardship for Nursing Homes
• Core Elements of Human Antibiotic Stewardship Programs in Resource-Limited Settings
• Core Elements of Antibiotic Stewardship for Health Departments

Antibiotic stewardship is part of accreditation, licensing, and regulatory standards for healthcare facilities. Since 2022, CMS has required that hospitals have an antibiotic stewardship program and policies. The CMS antibiotic stewardship program requirement compels hospitals to demonstrate efforts, including best practices, to follow nationally recognized standards for appropriate antibiotic usage. The intent of the requirement was to focus healthcare facilities on surveillance and prevention initiatives to control HAI and combat antimicrobial resistance. Similarly, in 2023 TJC released new and revised requirements for antibiotic stewardship for all TJC-accredited hospitals. The 12 elements of performance (EPs) that address antibiotic stewardship are as follows:

• EP 10: The hospital allocates financial resources for staffing and information technology to support the antibiotic stewardship program.
• EP 11: The governing body appoints a physician and/or pharmacist who is qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship as the leader(s) of the antibiotic stewardship program.
• EP 12: The leader(s) of the antibiotic stewardship program is responsible for the following:
  • Developing and implementing a hospital wide antibiotic stewardship program that is based on nationally recognized guidelines to monitor and improve the use of antibiotics
  • Documenting antibiotic stewardship activities, including any new or sustained improvements
  • Communicating and collaborating with the medical staff, nursing leadership, and pharmacy leadership, as well as with the hospital’s infection prevention and control and quality assessment and performance improvement programs on antibiotic use issues
  • Providing competency-based training and education for staff, including medical staff, on the practical applications of antibiotic stewardship guidelines, policies, and procedures
• EP 13: The hospital has a multidisciplinary committee that oversees the antibiotic stewardship program.
• EP 14: The antibiotic stewardship program demonstrates coordination among all components of the hospital responsible for antibiotic use and resistance, including, but not limited to, the infection prevention and control program, the quality assessment and performance improvement program, the medical staff, nursing services, and pharmacy services.
• EP 15: The antibiotic stewardship program documents the evidence-based use of antibiotics in all departments and services of the hospital.
• EP 16: The antibiotic stewardship program monitors the hospital’s antibiotic use by analyzing data on days of therapy per 1000 days present or 1000 patient days, or by reporting antibiotic use data to the National Healthcare Safety Network’s Antimicrobial Use Option of the Antimicrobial Use and Resistance Module.
• EP 17: The antibiotic stewardship program implements one or both of the following strategies to optimize antibiotic prescribing:
  • Preauthorization for specific antibiotics that includes an internal review and approval process prior to use
  • Prospective review and feedback regarding antibiotic prescribing practices, including the treatment of positive blood cultures, by a member of the antibiotic stewardship program
• EP 18: The antibiotic stewardship program implements at least two evidence-based guidelines to improve antibiotic use for the most common indications.
• EP 19: The antibiotic stewardship program evaluates adherence (including antibiotic selection and duration of therapy, where applicable) to at least one of the evidence-based guidelines the hospital implements.
• EP 20: The antibiotic stewardship program collects, analyzes, and reports data to hospital leadership and prescribers.
• EP 21: The hospital takes action on improvement opportunities identified by the antibiotic stewardship program.

Surgical Complications

The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) defines a standardized set of postoperative complications used to measure surgical quality and outcomes. The complications are risk-adjusted and typically assessed within 30 days of a surgical procedure (ACS, 2023).

ACS NSQIP Postoperative Complications

The ACS also published Strong for Surgery, a preoperative checklist tool that is used to screen individuals for potential risk factors that can lead to surgical complications, and to provide appropriate interventions to ensure better surgical outcomes. The checklists target eight areas known to be highly influential determinants of surgical outcomes:

• Nutrition
• Glycemic control
• Smoking cessation
• Medication use
• Delirium
• Prehabilitation
• Safe and effective pain control
• Patient directives

Additionally, ACS NSQIP published a Surgical Risk Calculator (Version: 4.0.2) for providers. The tool estimates the chance of an unfavorable outcome, such as a complication or death after surgery. The risk is estimated based upon information the patient gives to the healthcare provider about prior health history. The estimates are calculated using data from a large number of patients who had a surgical procedure similar to the one the patient may have.

The CMS PSIs related to surgical complications are derived from the AHRQ PSI measure set and are incorporated into programs such as the HACRP. The following PSIs are most directly associated with perioperative and surgical complications:

CMS/AHRQ Patient Safety Indicators Related to Surgical Complications

Additionally, there are related safety indicators that apply to surgical patients but are not exclusive to surgery:

• PS-08 In-hospital Fall with Hip Fracture
• PSI-03 Pressure Ulcer

The AHRQ Patient Safety Indicators (PSIs) are administrative data-based measures designed to identify potentially preventable adverse events within hospital settings.

In obstetrical care, these indicators provide important insight into both maternal and neonatal safety across the continuum of labor, delivery, and postpartum care. Although they rely on coded data and therefore require careful interpretation, they are widely used for quality surveillance, benchmarking, and targeting improvement efforts.

PSI-04, Death Among Surgical Inpatients with Serious Treatable Complications, is particularly relevant to obstetrics in the context of cesarean delivery and other operative interventions. This measure captures mortality among individuals who develop complications such as sepsis, pulmonary embolism, pneumonia, or shock. Given that most of the obstetric population are young and relatively healthy, deaths associated with these conditions are often considered potentially preventable with timely recognition and intervention. Elevated rates may point to gaps in early warning systems, delays in escalation of care, or deficiencies in standardized response protocols, such as those used for obstetric hemorrhage or sepsis.

PSI-05, Retained Object, applies to obstetric and non-obstetric populations and represents a “never event.” In obstetrics, it is most commonly associated with cesarean deliveries or postpartum surgical procedures. Retained surgical items, such as sponges or instrument fragments, indicate breakdowns in perioperative safety processes, including surgical counts, communication among team members, and adherence to standardized safety protocols. Because these events are considered entirely preventable, even a single occurrence is a significant safety concern and typically prompts root cause analysis and system-level interventions.

PSI-17, Birth Trauma Rate - Injury to Neonate, focuses on injuries sustained by the newborn during the delivery process, excluding those related to congenital anomalies. Examples include brachial plexus injuries, long bone fractures, and intracranial hemorrhage. While some degree of risk is inherent in childbirth, particularly in complicated deliveries, higher-than-expected rates may suggest opportunities for improvement in intrapartum management. This may include better anticipation and management of shoulder dystocia, appropriate use of operative vaginal delivery, and timely decision-making regarding cesarean delivery.

PSI-18 and PSI-19 address obstetric trauma in the individual giving birth, specifically severe perineal lacerations (third- and fourth-degree tears). PSI-18 measures these events in the context of instrument-assisted vaginal deliveries, such as those involving forceps or vacuum. PSI-19 captures the same injuries in spontaneous vaginal deliveries without instrumentation. These indicators are often interpreted together to understand both baseline risk and the additional risk associated with operative vaginal delivery. Elevated rates may reflect factors such as provider technique, patient selection, episiotomy practices, or gaps in training and experience. Because severe perineal trauma can result in long-term morbidity, including anal incontinence and pelvic floor dysfunction, these measures are clinically significant for both immediate and long-term maternal outcomes.

Collectively, these PSIs offer a structured way to monitor key dimensions of obstetric safety, encompassing both maternal and neonatal outcomes. They are most effective when used as screening tools to identify cases for further clinical review rather than as definitive measures of quality. When integrated with clinical data and quality improvement initiatives, they may enhance safety culture, standardize care processes, and reduce preventable harm in obstetric practice (AHRQ Quality Indicators-Patient Safety Indicators Technical Specifications - August 2025).

Medication Errors

There are several standardized severity classification frameworks that support consistent identification, reporting, and analysis of medication errors. Three widely recognized classification systems are summarized below.

I. NCC MERP Index for Categorizing Medication Errors

The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), a collaborative body consisting of the American Society of Health-System Pharmacists (ASHP), the American Pharmacists Association (APhA), the United States Pharmacopeia (USP), the Institute for Safe Medication Practices (ISMP), and other stakeholder organizations, developed the NCC MERP Index as the primary United States standard for classifying medication errors (Bobb, 2004; Goedecke, 2016). The NCC MERP Index assigns each error to one of nine categories (A through I), organized into four tiers of increasing severity:

• No Error
  • Category A: Circumstances or events that have the capacity to cause error.
• Error, No Harm
  • Category B: An error occurred but did not reach the patient (e.g., an order that was impossible to implement without further clarification).
  • Category C: An error occurred that reached the patient but was unlikely to cause harm.
  • Category D: An error occurred that reached the patient and required monitoring or intervention to preclude harm.
• Error, Harm
  • Category E: An error occurred that contributed to or resulted in temporary harm requiring intervention.
  • Category F: An error occurred that contributed to or resulted in temporary harm requiring initial or prolonged hospitalization.
  • Category G: An error occurred that contributed to or resulted in permanent harm.
  • Category H: An error occurred that required intervention necessary to sustain life (near-death event).
• Error, Death
  • Category I: An error occurred that contributed to or resulted in the patient's death.

The NCC MERP Index has demonstrated substantial inter-rater reliability, with a kappa value of 0.61 (95% CI 0.41-0.81), which improves to 0.74 when the nine categories are collapsed to six (Forrey, 2007). It is the classification system used in the MEDMARX national medication error reporting database and has been widely adopted in patient safety research and quality improvement programs across the United States, including the landmark study by Landrigan et al. on temporal trends in rates of patient harm resulting from medical care.

(Forrey, 2007; Landrigan, 2010). In that study, lower-severity harms were defined as NCC MERP category E (temporary harms requiring intervention), while higher-severity harms included categories F through I. For practical purposes, the nine categories may also be collapsed into three broader groups: no harm (A-C), monitoring required (D), and harmful (E-I) (Bobb, 2004).

II. Institute for Safe Medication Practices (ISMP) Severity Classification

The ISMP developed a simplified seven-category numeric scale for classifying the severity of adverse drug events associated with medication errors, as follows (Ciapponi, 2021):

• Category 1: Circumstances or processes that have the potential to cause an adverse drug event.
• Category 2: An event occurred, but the patient was not harmed.
• Category 3: An event occurred that resulted in the need for increased patient assessments but no change in vital signs and no patient harm.
• Category 4: An event occurred that resulted in the need for treatment or intervention, or both, and caused temporary patient harm.
• Category 5: An event occurred that resulted in initial or prolonged hospitalization, affected patient participation in an investigational drug study, and/or caused temporary patient harm.
• Category 6: An event occurred that resulted in permanent patient harm or a near-death event (e.g., anaphylaxis).
• Category 7: An event occurred that resulted in patient death.

This scale is more streamlined than the NCC MERP Index and consolidates some of the finer distinctions, for example, NCC MERP categories G (permanent harm) and H (near-death event) are merged into a single ISMP Category 6. The ISMP classification is often used in pharmacovigilance research and systematic reviews (Ciapponi, 2021).

III. European Union (EU) Good Practice Guide Classification

In 2015, the EU regulatory network published a two-part good practice guide on medication errors to support the pharmaceutical industry and regulators in implementing changes introduced by EU pharmacovigilance legislation (Goedecke, 2016). These changes included a modification of the "adverse reaction" definition to include events associated with medication errors, and the requirement for national competent authorities to collaborate with national patient safety organizations. Instead of a linear severity scale, this framework classifies medication errors based on whether they reached the patient and whether harm resulted (Goedecke, 2016):

• Medication errors resulting in adverse reactions: Errors that reached the patient and caused a clinically manifest adverse reaction.
• Medication errors without harm: Errors that reached the patient but did not result in an adverse reaction.
• Intercepted medication errors: Errors that were caught before reaching the patient.
• Potential errors: Circumstances or conditions with the potential to lead to an error (for example, confusing labeling, look-alike or sound-alike drug names).

This classification is supported by enhanced Medical Dictionary for Regulatory Activities (MedDRA) terminology that allows coding of both the stage of the medication use process where the error occurred and any clinical consequences (Goedecke, 2016). Individual case safety reports involving medication errors are expected to be followed up with root cause analysis, summarized in periodic safety update reports, and addressed in risk management plans. Any risk minimization and prevention strategy for medication errors should consider all stages of a medicinal product's life cycle, particularly the main sources and types of medication errors during product development (Goedecke, 2016).

American Society of Anesthesiologists (ASA) Physical Status Classification System: A standardized way to assess an individual’s preoperative health status and anesthesia risk, including risks related to sedation:
ASA I: Normal, healthy patient
ASA II: Patient with mild systemic disease (e.g., controlled hypertension)
ASA III: Patient with severe systemic disease (e.g., poorly controlled diabetes)
ASA IV: Patient with severe systemic disease that is a constant threat to life
ASA V: Moribund patient not expected to survive without the procedure
ASA VI: Brain-dead patient (organ donor)

Antimicrobial stewardship: The responsible use of antimicrobials to avoid contributing to antimicrobial resistance.

Hospital Acquired Condition (HAC): Any condition that an individual develops during a hospital stay that was not present at the time of admission and is considered reasonably preventable through the application of evidence-based guidelines.

Healthcare-Associated Infection (HAI): An infection that an individual acquires while receiving treatment for another condition in a healthcare setting, which was not present or incubating at the time of admission. The Centers for Disease Control and Prevention (CDC) through the National Healthcare Safety Network (NHSN), provides standardized definitions and criteria for specific HAIs, including:
Central line-associated bloodstream infection (CLABSI)
Catheter-associated urinary tract infection (CAUTI)
Surgical site infection (SSI)
Ventilator-associated events (VAE)
Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia
Clostridioides difficile infection (CDI)

Hospital Acquired Condition Reduction Program (HACRP): A Centers for Medicare & Medicaid Services (CMS) value-based purchasing program designed to improve patient safety by reducing HACs by reducing their Medicare payments.

Medication error: A preventable event that may cause or lead to inappropriate medication use or potential patient harm while the medication is under the control of a healthcare professional, patient, or consumer.

Surgical Complications: Clinically defined risk-adjusted postoperative adverse events occurring within 30 days after surgery, that are used to evaluate the quality of surgical care. They are systematically collected through trained clinical reviewers using strict data definitions and adjusted for patient risk factors to enable fair comparison across institutions (ACS NSQIP).

Serious Reportable Events (SREs): Clearly identifiable, preventable, events that should not occur in healthcare settings when evidence-based safety practices are followed. These events are typically associated with significant patient harm, including death or permanent injury, and are considered unacceptable occurrences that warrant reporting, investigation, and system-level improvement. SREs may also be commonly referred to as “never events” (NQF).

Coding edits are not implemented for this administrative policy. Where a more specific policy or guideline exists, that document will take precedence and may include specific coding edits and/or instructions. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

The following list of ICD-10-CM diagnosis codes are examples of diagnoses and situations that may relate to patient safety concerns (not an all-inclusive list).

Peer Reviewed Publications:

1. Asokan S, Banerjee N, Saleem M, et al. Healthcare associated infections (HAI): insights into epidemiology, microbiology, and diagnostics. Diagn Microbiol Infect Dis. 2026; 115(3):117376.
2. Austin JM, D'Andrea G, Birkmeyer JD, et al. Safety in numbers: the development of Leapfrog's composite patient safety score for U.S. hospitals. J Patient Saf. 2014; 10(1):64-71.
3. Bobb A, Gleason K, Husch M, et al. The epidemiology of prescribing errors: the potential impact of computerized prescriber order entry. JAMA Internal Med. 2004; 164:(7):785-792.
4. Brewer A, Hughes MC, Patel KN. Impact of repeated reimbursement penalties on hospital total quality scores. J Patient Saf. 2024; 20(3):198-201.
5. Czerniak B, Banaś W, Budzyński J. Risk factors for healthcare-associated infections: a single-centre study in a university hospital. Med Res J. 2024; 9(2):198-208.
6. Forrey RA, Pedersen CA, Schneider PJ. Interrater agreement with a standard scheme for classifying medication errors. Am J Health Syst Pharm. 2007; 64(2):175-181.
7. Joseph JM, Gori D, Curtin C, et al. Gaps in standardized postoperative pain management quality measures: a systematic review. Surgery. 2022; 171(2):453-458.
8. Keers RN, Williams SD, Cooke J, Ashcroft DM. Prevalence and nature of medication administration errors in health care settings: a systematic review of direct observational evidence. Ann Pharmacother. 2013; 47:237-256.
9. Landrigan CP, Parry GJ, Bones CB, et al. Temporal Trends in Rates of Patient Harm Resulting from Medical Care. N Engl J Med. 2010; 363(22):2124-2134.
10. Mudge AM, McRae P, Banks M, et al. Effect of a ward-based program on hospital-associated complications and length of stay for older inpatients: the cluster randomized CHERISH trial. JAMA Intern Med. 2022; 182(3):274-282.
11. Naseralallah L, Stewart D, Price M, Paudyal V. Prevalence, contributing factors, and interventions to reduce medication errors in outpatient and ambulatory settings: a systematic review. Int J Clin Pharm. 2023; 45(6):1359-1377.
12. Ogunsola AS, Marinier MC, Hlas AC, et al. Assessing the reproducibility of American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) arthroplasty studies. J Orthop Surg Res. 2025; 20(1):216.
13. Peters A, Schmid MN, Parneix P, et al. Impact of environmental hygiene interventions on healthcare‑associated infections and patient colonization: a systematic review. Antimicrob Resist Infect Control. 2022; 11(1):38.
14. Rude TL, Donin NM, Cohn MR, et al. Analysis of national trends in Hospital Acquired Conditions following major urologic surgery before and after implementation of the Hospital Acquired Condition Reduction Program. Urology. 2018; 119:79-84.
15. Srinivasan A. Antibiotic stewardship: why we must, how we can. Cleve Clin J Med. 2017; 84(9):673-679.
16. Waters TM, Daniels MJ, Bazzoli GJ, et al. Effect of Medicare's nonpayment for hospital-acquired conditions: lessons for future policy. JAMA Intern Med. 2015; 175(3):347-54.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Agency for Healthcare Research and Quality (AHRQ). About AHRQ. July, 2014. Last reviewed September 2025. Available at: https://www.ahrq.gov/cpi/about/index.html. Accessed on April 3, 2026.
2. Agency for Healthcare Research and Quality (AHRQ) AHRQ QI list of indicators. December 2025. Available at: https://qualityindicators.ahrq.gov/Downloads/Modules/V2025/AHRQ_QI_Indicators_List.pdf. Accessed on April 2, 2026.
3. American College of Surgeons (ACS). ACS NSQIP operations manual 2023. Chicago, IL: American College of Surgeons, 2023. Available at: https://www.facs.org/media/ekmnc2ge/nsqip_puf_userguide_2023.pdf. Accessed on May 12, 2026.
4. American College of Surgeons (ACS) optimal resources for surgical quality and safety standards. 2026 Standards. Effective January 2026. Available at: https://www.facs.org/quality-programs/accreditation-and-verification/acs-quality-verification-program/program-standards/. Accessed on April 2, 2026.
5. American College of Surgeons (ACS). ACS NSQIP 2007-2026. Surgical Risk Calculator. Version: 4.0.2. Updated April, 2025. Available at: https://riskcalculator.facs.org/RiskCalculator/PatientInfo.jsp. Accessed on April 6, 2026.
6. American College of Surgeons (ACS). ACS quality programs. Available at: https://www.facs.org/quality-programs/. Accessed on April 2, 2026.
7. American College of Surgeons (ACS). Standards and staging. Strong for surgery. Available at: https://www.facs.org/quality-programs/qi-resources/strong-for-surgery/. Accessed on April 3, 2026.
8. American College of Surgeons (ACS). User guide for the 2024 ACS NSQIP participant use data file (PUF). Chicago, IL: American College of Surgeons; 2024. Available at: https://www.facs.org/media/sx1h1xcx/nsqip-puf-userguide-2024.pdf. Accessed on April 6, 2026.
9. Centers for Disease Control and Prevention. Core elements of antibiotic stewardship. Available at: https://www.cdc.gov/antibiotic-use/hcp/core-elements/index.html. Accessed on April 8, 2026.
10. Centers for Disease Control and Prevention. FastStats: Medication Safety Data. Last reviewed April 17, 2024. Available at: https://www.cdc.gov/medication-safety/data-research/facts-stats/index.html. Accessed on April 27, 2026.
11. Centers for Disease Control and Prevention. Healthcare-associated infections (HAIs). Health department HAI/AR programs. February 11, 2026. Available at https://www.cdc.gov/healthcare-associated-infections/programs/?CDC_AAref_Val=https://www.cdc.gov/hai/HAI-AR-Programs.html. Accessed on April 2, 2026.
12. Centers for Disease Control and Prevention National Healthcare Safety Network (NHSN). Last Reviewed: January 2, 2026. Available at: https://www.cdc.gov/nhsn/index.html. Accessed on April 8, 2026.
13. Centers for Medicare & Medicaid Services (CMS). Hospital-Acquired Conditions (HAC) Payment Provision. February 12, 2026. Available at: https://www.cms.gov/medicare/payment/fee-for-service-providers/hospital-aquired-conditions-hac. Accessed on April 27, 2026. 
14. Centers for Medicare & Medicaid Services (CMS) Hospital-Acquired Condition Reduction Program. March 16, 2026. Available at: https://www.cms.gov/medicare/payment/prospective-payment-systems/acute-inpatient-pps/hospital-acquired-condition-reduction-program-hacrp. Accessed on April 2, 2026.
15. Centers for Medicare & Medicaid Services (CMS) Infection Prevention and Control and Antibiotic Stewardship Program Interpretive Guidance Update. July 6, 2022. Available at: https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/infection-prevention-and-control-and-antibiotic-stewardship-program-interpretive-guidance-update. Accessed on April 8, 2026.
16. Centers for Medicare & Medicaid Services (CMS). Medicaid Program; Payment Adjustment for Provider-Preventable Conditions Including Health Care-Acquired Conditions. 42 CFR § 447.26. April 6, 2026. Available at: https://www.ecfr.gov/current/title-42/section-447.26. Accessed on April 27, 2026.
17. Centers for Medicare & Medicaid Services (CMS). Present on Admission (POA) Indicator Reporting and HAC Payment Policy Fact Sheet. September, 2014. Available at: https://www.cms.gov/files/document/wpoafactsheetpdf. Accessed on April 27, 2026.
18. Centers for Medicare & Medicaid Services (CMS). Provider-Preventable Conditions (PPCs). July 1, 2011. Available at: https://www.medicaid.gov/medicaid/financial-management/provider-preventable-conditions. Accessed on April 27, 2026.
19. Centers for Medicare & Medicaid Services (CMS) Publicly Reported DRA HAC Measures 2025. Available at: https://www.cms.gov/files/document/frequently-asked-questions-publicly-reported-deficit-reduction-act-dra-hospital-acquired-condition.pdf. Accessed on April 27, 2026.
20. Ciapponi A, Fernandez Nievas SE, Seijo M, et al. Reducing medication errors for adults in hospital settings. Cochrane Database of Syst Rev. 2021; (11):CD009985.
21. Goedecke T, Ord K, Newbould V, et al. Medication errors: new EU good practice guide on risk minimisation and error prevention. Drug Saf. 2016; 39(6):491-500.
22. Institute of Medicine (US) Committee on Quality of Health Care in America. To err is human: building a safer health system. Kohn LT, Corrigan JM, Donaldson MS, editors. National Academies Press (US); Washington (DC): 2000.
23. National Quality Forum (NQF) Key initiative. Focus on HARM: Available at: https://www.qualityforum.org/en-us/key-initiatives/focus-on-harm. Accessed on April 2, 2026.
24. National Quality Forum (NQF). Key initiatives updating the serious reportable events list. January, 2026. Available at: https://www.qualityforum.org/en-us/key-initiatives/updating-the-serious-reportable-events-sre-list. Accessed on April 2, 2026.
25. National Quality Forum (NQF). Aligning patient safety event reporting: 2025 updates to sentinel events and serious reportable events. January, 2026. Available at: https://digitalassets.jointcommission.org/api/public/content/b4e8988066e74717ae9801edb2bfb9de?v=e0ff96a2. Accessed on April 6, 2026.
26. National Quality Forum (NQF). Hospital-onset bacteremia and fungemia playbook. 2024. Available at: https://digitalassets.jointcommission.org/api/public/content/5cc1eb128c3240da9cc172d5571267f4?v=ce452aec Accessed on April 8, 2026.
27. The Joint Commission. National Quality Forum. Aligning patient safety event reporting: 2025 Updates to Sentinel Event and Serious Reportable Events. Available at: https://digitalassets.jointcommission.org/api/public/content/b4e8988066e74717ae9801edb2bfb9de?v=e0ff96a2. Accessed on April 2, 2026.
28. The Joint Commission. New and revised requirements for antibiotic stewardship. Effective January 1, 2023. Available at: https://digitalassets.jointcommission.org/api/public/content/b070043c50194fd2a2623d1e83aef60f?v=a419ee1a. Accessed on April 9, 2026.
29. The Society of Thoracic Surgeons (STS) performance measures. Available at: https://www.sts.org/performance-measures. Accessed on April 6, 2026.
30. Vernooij LM, van Klei WA, Moons KG, et al. The comparative and added prognostic value of biomarkers to the Revised Cardiac Risk Index for preoperative prediction of major adverse cardiac events and all‐cause mortality in patients who undergo noncardiac surgery. Cochrane Database of Syst Rev. 2021; (12):CD013139.
31. Veterans’ Health Administration (VHA) national center for patient safety. Available at: https://www.patientsafety.va.gov. Accessed on April 2, 2026.
32. World Health Organization. Key facts and figures - world hand hygiene day. Available at: https://www.who.int/campaigns/world-hand-hygiene-day/key-facts-and-figures. Accessed on April 13, 2026.

1. The Leapfrog Group. Hospital Safety and Quality Ratings.
   • About the Grade. Available at: https://www.hospitalsafetygrade.org. Accessed on April 2, 2026.
   • Errors, Injuries, Accidents, Infections. Available at: https://www.hospitalsafetygrade.org/what-is-patient-safety/errors-injuries-accidents-infections. Accessed on April 2, 2026.

ASA Class
Hospital Acquired Condition (HAC)
Hospital Acquired Infection (HAI)
Hospital Acquired Condition Reduction Program (HACRP)
Present on Admission (POA)
Surgical Complications
Serious Reportable Events (SREs)

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