Measuring Patient Safety: The Medicare Patient Safety Monitoring System (Past, Present, and Future).

ABSTRACT: The explicit declaration in the landmark 1999 Institute of Medicine report "To Err Is Human" that, in the United States, 44,000 to 98,000 patients die each year as a consequence of "medical errors" gave widespread validation to the magnitude of the patient safety problem and catalyzed a number of U.S. federal government programs to measure and improve the safety of the national healthcare system. After more than 10 years, one of those federal programs, the Medicare Patient Safety Monitoring System (MPSMS), has reached a level of maturity and stability that has made it useful for the consistent measurement of the safety of inpatient care. The MPSMS is a chart review-based national patient safety surveillance system that provides rates of 21 specific hospital inpatient adverse event measures, which have been divided into 4 clinical domains (general, hospital-acquired infections, postprocedure adverse events, and adverse drug events) for analysis. The 2014 MPSMS national sample was drawn from 1109 hospitals and includes approximately 20,000 medical records of patients admitted to the hospital (all payors) for at least 1 of the 4 conditions of congestive heart failure, acute myocardial infarction, pneumonia, and major surgical procedures as defined by the Centers for Medicare and Medicaid Services Surgical Care Improvement Project. The MPSMS is now going through a major transformation to capture additional types of adverse events and is being redeveloped as the Quality and Safety Review System (QSRS). As an example of this transformation, QSRS will electronically import electronic data, which are standardized according to the Centers for Medicare and Medicaid Services billing definitions and will be updated and evolve over time to incorporate expanded standardized data available from electronic health records. This article reviews the development of MPSMS, the strengths and limitations of MPSMS, and expected future directions in patient safety measurement, focusing on those issues that are informing the development and implementation of QSRS.

Association Between Hospital Performance on Patient Safety and 30-Day Mortality and Unplanned Readmission for Medicare Fee-for-Service Patients With Acute Myocardial Infarction.

BACKGROUND: Little is known regarding the relationship between hospital performance on adverse event rates and hospital performance on 30-day mortality and unplanned readmission rates for Medicare fee-for-service patients hospitalized for acute myocardial infarction (AMI). METHODS AND RESULTS: Using 2009-2013 medical record-abstracted patient safety data from the Agency for Healthcare Research and Quality's Medicare Patient Safety Monitoring System and hospital mortality and readmission data from the Centers for Medicare & Medicaid Services, we fitted a mixed-effects model, adjusting for hospital characteristics, to evaluate whether hospital performance on patient safety, as measured by the hospital-specific risk-standardized occurrence rate of 21 common adverse event measures for which patients were at risk, is associated with hospital-specific 30-day all-cause risk-standardized mortality and unplanned readmission rates for Medicare patients with AMI. The unit of analysis was at the hospital level. The final sample included 793 acute care hospitals that treated 30 or more Medicare patients hospitalized for AMI and had 40 or more adverse events for which patients were at risk. The occurrence rate of adverse events for which patients were at risk was 3.8%. A 1% point change in the risk-standardized occurrence rate of adverse events was associated with average changes in the same direction of 4.86% points (95% CI, 0.79-8.94) and 3.44% points (95% CI, 0.19-6.68) for the risk-standardized mortality and unplanned readmission rates, respectively. CONCLUSIONS: For Medicare fee-for-service patients discharged with AMI, hospitals with poorer patient safety performance were also more likely to have poorer performance on 30-day all-cause mortality and on unplanned readmissions.

National trends in patient safety for four common conditions, 2005-2011.

BACKGROUND: Changes in adverse-event rates among Medicare patients with common medical conditions and conditions requiring surgery remain largely unknown. METHODS: We used Medicare Patient Safety Monitoring System data abstracted from medical records on 21 adverse events in patients hospitalized in the United States between 2005 and 2011 for acute myocardial infarction, congestive heart failure, pneumonia, or conditions requiring surgery. We estimated trends in the rate of occurrence of adverse events for which patients were at risk, the proportion of patients with one or more adverse events, and the number of adverse events per 1000 hospitalizations. RESULTS: The study included 61,523 patients hospitalized for acute myocardial infarction (19%), congestive heart failure (25%), pneumonia (30%), and conditions requiring surgery (27%). From 2005 through 2011, among patients with acute myocardial infarction, the rate of occurrence of adverse events declined from 5.0% to 3.7% (difference, 1.3 percentage points; 95% confidence interval [CI], 0.7 to 1.9), the proportion of patients with one or more adverse events declined from 26.0% to 19.4% (difference, 6.6 percentage points; 95% CI, 3.3 to 10.2), and the number of adverse events per 1000 hospitalizations declined from 401.9 to 262.2 (difference, 139.7; 95% CI, 90.6 to 189.0). Among patients with congestive heart failure, the rate of occurrence of adverse events declined from 3.7% to 2.7% (difference, 1.0 percentage points; 95% CI, 0.5 to 1.4), the proportion of patients with one or more adverse events declined from 17.5% to 14.2% (difference, 3.3 percentage points; 95% CI, 1.0 to 5.5), and the number of adverse events per 1000 hospitalizations declined from 235.2 to 166.9 (difference, 68.3; 95% CI, 39.9 to 96.7). Patients with pneumonia and those with conditions requiring surgery had no significant declines in adverse-event rates. CONCLUSIONS: From 2005 through 2011, adverse-event rates declined substantially among patients hospitalized for acute myocardial infarction or congestive heart failure but not among those hospitalized for pneumonia or conditions requiring surgery. (Funded by the Agency for Healthcare Research and Quality and others.).

Hospital-acquired pressure ulcers: results from the national Medicare Patient Safety Monitoring System study.

OBJECTIVES: To determine the national and state incidence levels of newly hospital-acquired pressure ulcers (PUs) in Medicare beneficiaries and to describe the clinical and demographic characteristics and outcomes of these individuals. DESIGN: Retrospective secondary analysis of the national Medicare Patient Safety Monitoring System (MPSMS) database. SETTING: Medicare-eligible hospitals across the United States and select territories. PARTICIPANTS: Fifty-one thousand eight hundred forty-two randomly selected hospitalized fee-for-service Medicare beneficiaries discharged from the hospital between January 1, 2006, and December 31, 2007. MEASUREMENTS: Data were abstracted from the MPSMS, which collects information on multiple hospital adverse events. RESULTS: Of the 51,842 individuals in the MPSMS 2006/07 sample, 2,313 (4.5%) developed at least one new PU during their hospitalization. The mortality risk-adjusted odds ratios were 2.81 (95% confidence interval (CI) = 2.44-3.23) for in-hospital mortality, 1.69 (95% CI=1.61-1.77) for mortality within 30 days after discharge, and 1.33 (95% CI = 1.23-1.45) for readmission within 30 days. The hospital risk-adjusted main length of stay was 4.8 days (95% CI = 4.7-5.0 days) for individuals who did not develop PUs and 11.2 days (95% CI = 10.19-11.4) for those with hospital-acquired PUs (P < .001). The Northeast region and Missouri had the highest incidence rates (4.6% and 5.9%, respectively). CONCLUSION: Individuals who developed PUs were more likely to die during the hospital stay, have generally longer hospital lengths of stay, and be readmitted within 30 days after discharge.

Racial disparities in the frequency of patient safety events: results from the National Medicare Patient Safety Monitoring System.

BACKGROUND: Although there is extensive evidence of racial disparities in processes and outcomes of medical care, there has been limited investigation of disparities in patient safety. OBJECTIVE: To determine whether there are racial disparities in the frequency of adverse events studied in the Medicare Patient Safety Monitoring System. DESIGN AND SUBJECTS: Abstraction of 102,623 randomly selected charts from hospital discharges of non-Hispanic white and black Medicare patients between January 1, 2004 and December 31, 2007 to assess frequency of patient safety events in 4 domains: general (pressure ulcers and falls), selected nosocomial infections, selected procedure-related adverse events, and adverse drug events due to anticoagulants and hypoglycemic agents. MEASURES: Racial disparities in risk of patient safety events, and differences in adverse event rates among hospital groups stratified by percentage of black patients. RESULTS: Blacks had higher adjusted risk than whites of suffering one of the measured nosocomial infections (1.34; 95% confidence interval, 1.17-1.55; P < 0.001) and one of the measured adverse drug events (1.29; 95% confidence interval, 1.19-1.40; P < 0.001). After adjustment for patient and hospital factors, patients in hospitals with the highest percentages of black patients were at increased risk of experiencing one of the measured nosocomial infections (1.9% vs. 1.5%; P < 0.001) and adverse drug events (8.7% vs. 7.8%; P < 0.01). CONCLUSIONS: Hospitalized blacks are at higher risk than whites of experiencing certain patient safety events. In addition, hospitals serving high percentages of black patients have higher risk-adjusted rates of selected patient safety events.

Adverse events after total knee arthroplasty: a national Medicare study.

Adverse events from 2033 total knee arthroplasty patients were documented by nonphysician abstractors. The annual rate of adverse events from 2002 to 2004 was 9.2%, 6.4%, and 5.8%, respectively. Congestive heart failure (odds ratio, 2.1; 95% confidence interval, 1.2-3.5; P < .01) and chronic obstructive pulmonary disease (odds ratio, 1.8; 95% confidence interval, 1.2-2.7; P < .01) were associated with a significantly increased risk of experiencing any adverse event during the index hospitalization. The 30-day postprocedure rate of readmission for all causes was 5.5%. Experiencing an adverse event during the index hospitalization increased the length of stay (P < .001). The rate of symptomatic venous thromboembolism 30 days postprocedure was 1.7%. The 30-day postprocedure mortality rate was 0.3%. Experiencing any adverse event was associated with an increased 30-day postprocedure mortality (P < .001). Compared with previous studies of Medicare claims, these data reveal a substantial decrease in the mortality rate, an increased readmission rate, and no substantial change in the rate of venous thromboembolism.

Identification of hospital-acquired catheter-associated urinary tract infections from Medicare claims: sensitivity and positive predictive value.

BACKGROUND AND OBJECTIVE: Hospital-acquired catheter-associated urinary tract infection (CAUTI) is one of the first 6 conditions Medicare is targeting to reduce payment associated with hospital-acquired conditions under Congressional mandate. This study was to determine the positive predictive value (PPV) and sensitivity in identifying patients in Medicare claims who had urinary catheterization and who had hospital-acquired CAUTIs. RESEARCH DESIGN: CAUTIs identified by ICD-9-CM codes in Medicare claims were compared with those revealed by medical record abstraction in random samples of Medicare discharges in 2005 to 2006. Hospital discharge abstracts (2005) from the states of New York and California were used to estimate the potential impact of a present-on-admission (POA) indicator on PPV. RESULTS: ICD-9-CM procedure codes for urinary catheterization appeared in only 1.4% of Medicare claims for patients who had urinary catheters. As a proxy, claims with major surgery had a PPV of 75% and sensitivity of 48%, and claims with any surgical procedure had a PPV of 53% and sensitivity of 79% in identifying urinary catheterization. The PPV and sensitivity for identifying hospital-acquired CAUTIs varied, with the PPV at 30% and sensitivity at 65% in claims with major surgery. About 80% of the secondary diagnosis codes indicating UTIs were flagged as POA, suggesting that the addition of POA indicators in Medicare claims would increase PPV up to 86% and sensitivity up to 79% in identifying hospital-acquired CAUTIs. CONCLUSIONS: The validity in identifying urinary catheter use and CAUTIs from Medicare claims is limited, but will be increased substantially upon addition of a POA indicator.

The safety of warfarin therapy in the nursing home setting.

PURPOSE: We examined the preventability of adverse warfarin-related events and potential adverse warfarin-related events ("near misses") in the nursing home setting. METHODS: We performed a cohort study of all long-term care residents of 25 nursing homes (bed size range, 90-360) in Connecticut during a 12-month observation period. The total number of residents in these facilities ranged from 2946 to 3212 per quarter. There were 490 residents who received warfarin therapy. Possible warfarin-related incidents were detected by quarterly retrospective review of nursing home records by trained nurse abstractors. Each incident was independently classified by 2 physician-reviewers to determine whether it constituted a warfarin-related event, its severity, and its preventability. The primary outcome was an adverse warfarin-related event, defined as an injury associated with the use of warfarin. Potential adverse warfarin-related events were defined as situations in which the international normalized ratio (INR) was noted to be 4.5 or greater, an error in management was noted, but no injury occurred. We also assessed time in specified INR ranges per nursing home resident day on warfarin. RESULTS: Over the 12-month observation period, 720 adverse warfarin-related events and 253 potential adverse warfarin-related events were identified. Of the adverse warfarin-related events, 625 (87%) were characterized as minor, 82 (11%) were deemed serious, and 13 (2%) were life-threatening or fatal. Overall, 29% of the adverse warfarin-related events were judged to be preventable. Serious, life-threatening, or fatal events occurred at a rate of 2.49 per 100 resident-months; 57% of these more severe events were considered preventable. Errors resulting in preventable events occurred most often at the prescribing and monitoring stages of warfarin management. The percentages of time in the less than 2, 2 to 3, and more than 3 INR ranges were 36.5%, 49.6%, and 13.9%, respectively. CONCLUSIONS: The use of warfarin in the nursing home setting presents substantial safety concerns for patients. Adverse events associated with warfarin therapy are common and often preventable in the nursing home setting. Prevention strategies should target the prescribing and monitoring stages of warfarin management.