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“Never Events” and the Quest to Reduce Preventable Harm
The Joint Commission Journal on Quality and Patient Safety Forum
“Never Events” and the Quest to Reduce Preventable Harm J. Matthew Austin, PhD; Peter J. Pronovost, MD, PhD, FCCM
L
apses in patient safety are a major quality problem in health care, causing more than 200,000 deaths, 2.4 billion extra hospital days, and between $17 billion and $29 billion in excess hospital costs in the United States each year.1,2 The exact number of preventable deaths is difficult to estimate because valid and standardized measures for the major causes of preventable death are lacking and because it is difficult to separate inevitable from preventable harm. Yet some types of harm, such as wrong-site surgery, are deemed entirely preventable and viewed as a serious adverse event.3 In its seminal 2000 report, To Err Is Human,4 the Institute of Medicine (IOM) recommended the creation of a nationwide, mandatory, state-based reporting system to understand the frequency of adverse events that could cause death or serious harm.2 The National Quality Forum (NQF) responded to this recommendation with a report of Serious Reportable Events in Healthcare,2,5,6 which identified a standardized list of 27 preventable events to facilitate reporting.1 The objective of the NQF report was to establish consensus definitions among health care stakeholder groups about a list of preventable serious adverse events that should never occur and to guide the reporting of these events.1 The events identified by the NQF were not intended to capture all events that might cause harm. Rather, the list consisted of events that were considered clearly identifiable and measurable, significantly influenced by the policies and procedures of the health care facility, and alarming to health care providers and the public.2,5,6 Given the seriousness and perceived preventability of these events, risk adjustment for hospital and patient characteristics is typically considered unnecessary. Since the NQF’s promulgation of the list of serious reportable events in 2002, many, but not all, of the 50 states and the District of Columbia have required the reporting of these events.2 The NQF has updated the list twice—2006 (28 events) and 2011 (29 events).6 The term never event was introduced in 2001 by Kenneth Kizer, MD, then the NQF’s CEO. He used the term to describe “the most egregious health care errors” (such as transfusing the wrong type of blood into a patient) that should never occur.7 The negative connotation in the term was intended to evoke a strong reaction. Nobel Prize–winning research by Kahneman June 2015
and Tversky on “negative framing” and the “availability heuristic”8 suggests that “humans are more strongly inclined to take action when the actions in question are labeled so as to convey the loss avoided rather than the benefit gained and when the consequences of failing to act are mentally vivid.”9(p. 2390) The Centers for Medicare & Medicaid Services (CMS), The Leapfrog Group (Leapfrog), and the National Health Service (NHS; England), among other organizations, have all used the term never event, although with differing definitions.10 In this article, we explore never event’s evolution, how never event data are used, and the challenges in collecting data. We then provide recommendations for improving the tracking and reporting of these events.
Evolution of a Term
Leapfrog aligns its definition of a “never event” with the NQF’s (2011) list of 29 serious reportable events.11 CMS defines a never event as an “unambiguous; preventable; serious; and either adverse, indicative of a problem in the facility, or important for public credibility and accountability” and identifies 11 such events.12(p. 743) The NHS defines never events as “serious, largely preventable, patient safety incidents that should not occur if the available preventative measures have been implemented by healthcare providers,” and identifies 25 such events.3,13(p.2) The never events defined by each of these three organizations and The Joint Commission are compared in Table 1 (page 280). These types of never events have also been called adverse events, serious reportable events, sentinel events, and patient safety events. The US Department of Health and Human Services, Office of Inspector General, has used adverse event when investigating patient harm in hospitals and nursing homes.14 The NQF uses the term serious reportable event, previously introduced here, when communicating their list of serious, largely preventable events that are of concern to health care providers, patients, and all other stakeholders.6 The Joint Commission uses the terms patient safety event, adverse event, and sentinel event, respectively, to describe from the broadest definition to the narrowest definition, events that could have, or did, result in harm to a patient.15 Its list of sentinel events includes patient Volume 41 Number 6
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The Joint Commission Journal on Quality and Patient Safety Table 1. Comparison of Adverse Events Defined as a Never Event by Different Organizations Event Defined by Organization as a “Never Event” Adverse Event
NQF/LF
CMS
TJC*
UK NHS
Surgical or Invasive Procedure Events Wrong-site surgery
Wrong-patient surgery Wrong surgery performed on patient Wrong implant/prosthesis placed in patient Retention of a foreign object in a patient after surgery
Intraoperative or immediate postoperative death in an American Society of Anesthesiologists Class I patient Product or Device Events Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics Patient death or serious injury associated with the misuse of a device intended for another function
Patient death or serious injury associated with intravascular air embolism
Patient Protection Events Release of a patient/resident of any age, who is unable to make decisions, to other than an authorized person
Patient death or serious disability associated with patient elopement (disappearance) Patient suicide, attempted suicide, or self-harm resulting in serious disability
Patient death or severe injury to a mental health inpatient as a result of a suicide attempt using non-collapsible curtain or shower rails
Escape of a transferred prisoner
Care Management Events Patient death or serious injury associated with a medication error Patient death or serious injury associated with unsafe administration of blood products Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy
Maternal death due to postpartum hemorrhage after elective cesarean section Artificial insemination with the wrong donor sperm or wrong egg Patient death or serious injury associated with a fall while being cared for in a health care setting Any stage III, stage IV, or unstageable pressure ulcers acquired after admission Patient death or serious disability resulting from the irretrievable loss of an irreplaceable biological specimen Patient death or serious injury resulting from failure to communicate lab, pathology, or radiology results Manifestations of poor glycemic control Any catheter-associated urinary tract infection Any vascular catheter-associated infection Surgical site infections following certain procedures A deep vein thrombosis (DVT)/pulmonary embolism (PE) following certain orthopedic procedures An iatrogenic pneumothorax with venous catheterization Death or severe harm arising from inadvertent ABO–mismatched solid organ transplantation
†
(continued on page 281)
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The Joint Commission Journal on Quality and Patient Safety Table 1. Comparison of Adverse Events Defined as a Never Event by Different Organizations (continued) Event Defined by Organization as a “Never Event” Adverse Event
NQF/LF
CMS
Care Management Events (continued) Death or severe harm due to a misplaced naso- or orogastric tube being used where the misplacement of the tube is not detected prior to commencement of feeding, flush, or medication administration Death or severe harm as a result of failure to monitor or respond to oxygen saturation levels in a patient undergoing anesthesia Death or severe harm as a result of administration of the wrong treatment following inpatient misidentification due to a failure to use standard wristband (or identity band) identification processes Severe neonatal hyperbilirubinemia in a neonate
TJC*
UK NHS
Environmental Events Patient or staff death or serious disability associated with an electric shock in the course of patient care
A line designated for oxygen or other gas contains no gas, the wrong gas, or is contaminated.
Patient or staff death or serious injury associated with a burn incurred from any source in the course of patient care
Patient death or serious injury associated with the use of restraints or bedrails
Patient fall from an unrestricted window Death or severe harm as a result of a patient being scalded by water used for washing/bathing Radiologic Events Death or serious injury of a patient or staff associated with introduction of a metallic object into the MRI area Prolonged fluoroscopy with cumulative dose > 1,500 rads to a single field or any delivery of radiotherapy to the wrong body region or > 25% above the planned radiotherapy dose Potential Criminal Events Care ordered or provided by someone impersonating a physician, nurse, pharmacist, or other health care provider Abduction of a patient/resident of any age Sexual abuse/assault on a patient within or on the grounds of a health care setting Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) Rape, assault (leading to death or permanent loss of function), or homicide of a staff member, licensed independent practitioner, visitor, or vendor while on site at the health care organization
NQF, National Quality Forum; LF, Leapfrog Group; CMS, Centers for Medicare & Medicaid Services; TJC, The Joint Commission; UK NHS, United Kingdom National Health Service; ABO, the four major blood types A, B, AB, and O. * In addition to the specific events listed in this table, The Joint Commission defines a sentinel event as “a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in any of the following: death, permanent harm, and severe temporary harm,” or that is one of the 15 additional specific events considered to be sentinel, as listed in the Sentinel Event (SE) Chapter of the Comprehensive Accreditation Manual for Hospitals (see Sources). † The NHS identifies nine individual medication errors as never events. These nine events cover the wrong route of administration, wrong dose, and wrong preparation of specific high-risk medications.
Sources: • NQF: National Quality Forum. List of Serious Reportable Events. Accessed Apr 22, 2015. http://www.qualityforum.org/Topics/SREs/List_of_SREs.aspx. • LF: Leapfrog Group. Leapfrog Group Position Statement on Never Events. Accessed Apr 22, 2015. http://www.leapfroggroup.org/Hospitals/SurveyInfo/never_events. • CMS: Centers for Medicare & Medicaid Services. Hospital-Acquired Conditions. (Updated: Aug 27, 2014.) Accessed Apr 22, 2015. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/Hospital-Acquired_Conditions.html. • TJC: The Joint Commission. Sentinel Events (SE). 2015. Accessed Feb 22, 2015. http://www.jointcommission.org/assets/1/6/CAMH_24_SE_all_CURRENT.pdf. • UK NHS: NHS England, Patient Safety Domain Team. The Never Events List; 2013/14 Update. Dec 12, 2013. Accessed Apr 22, 2015. http://www.england.nhs.uk/wp-content/uploads/2013/12/nev-ev-list-1314-clar.pdf.
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The Joint Commission Journal on Quality and Patient Safety safety events that reach a patient and result in death, permanent harm, or severe temporary harm, in addition to a list of 14 other events of an egregious nature (for example, discharging an infant to the wrong family).16 Over time, use of the term never events has evolved. We now explore the current status of never events and how those events are used in public reporting and pay-for-performance.
Current Use of the Term Many organizations, including, in the United States, Leapfrog, CMS, and the NQF, and elsewhere (NHS), continue to use the term never event. CMS currently uses never events to describe categories of hospital-acquired conditions (HACs), for which Medicare will not pay the marginal costs associated with these conditions.14 Emerging terminology is adding to the longused terms of serious reportable events, sentinel events, and adverse events. For example, the state of Minnesota used adverse health events in its annual public report of adverse events occurring in hospitals,17 and in a New Zealand court case, medical misadventures was used to define “a personal injury caused by medical error or medical mishap.”18
Sources of Never Event Data Never event data are obtained through a variety of methods, including self-reporting from hospitals to either a government agency or a Patient Safety Organization,19 review of claims data submitted by hospitals, and routine screening (by, hopefully, valid and reliable screening methods) of electronic health records for serious adverse events. An advantage of self-reporting is that hospitals can cast a wider net by identifying events through both clinical data and billing data. Some drawbacks of self-reporting are possible underreporting of events to minimize the hospital’s liabilities, and lack of standard definitions for some events, making consistent identification and reporting of events difficult. Advantages of claims data include the ease in obtaining it and the fact that standardized data structure makes it plausible to apply standard algorithms and definitions to identify events. Drawbacks of claims data include the lack of detail needed to identify all events and the limited or unknown validity of the data. An advantage of screening electronic health records is the relative ease of extracting event data. A drawback of this method is that, unless the data are collected using standardized formats, their usefulness could be limited. Health care would benefit from having one “never event” list, bringing standardization to the definition, surveillance, and reporting of these events. Although the NQF’s serious reportable events is a commonly referenced list of never events, it is 282
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not the singular list. The existence of multiple never event lists minimizes the benefits that a singular list could offer. Most of the attention on never events has focused on the hospital setting, but the NQF’s list of serious reportable events does apply to other settings, such as ambulatory practices, ambulatory procedures, long term care, and home care. However, we know very little about the incidence rates of events outside the hospital, and the mechanics for collecting self-reported data and billing data are underdeveloped. Moreover, each care setting likely has additional reportable events that are relevant to those providers and patients. Estimates of the incidence of adverse events in hospitals vary widely, and their measurement is difficult,14 which is perhaps not surprising, given this variation in definitions, data sources, and methods of data collection.
Uses of Never Event Data
Never event data are used in a variety of ways, including for payment, public reporting, and internal quality improvement (QI).
Payment Never event data inform hospital payment. For example, CMS does not pay hospitals a higher reimbursement for certain HACs. As part of Section 5001(c) of the Deficit Reduction Act of 2005, CMS enacted the Hospital-Acquired Conditions Initiative in the Inpatient Prospective Payment Systems final rule for fiscal year 2008. Under this rule, Medicare pays for the treatment of preadmitting diagnoses and denies payment for any marginal costs associated with preventable conditions that occur as a result of care received (or a medical error) during the inpatient stay.20 CMS collaborated with the Centers for Disease Control and Prevention (CDC) to identify HACs that were expensive, high volume, or both12—conditions that, when present as a secondary diagnosis, resulted in assignment to a diagnosis-related group (DRG) with a higher payment; conditions that could be reasonably prevented by using readily available evidence-based guidelines; and conditions that were identifiable on the basis of one or more unique diagnostic codes.14 The following 11 HACs are represented in CMS’s nonpayment program: foreign body retained after surgery, air embolism, blood incompatibility, stage III and IV pressure ulcers, falls and trauma (for example, fractures, burn), manifestations of poor glycemic control, catheter-associated urinary tract infection, vascular catheter-associated infection, surgical site infections following certain procedures (coronary bypass graft surgery, bariatric surgery for Volume 41 Number 6
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The Joint Commission Journal on Quality and Patient Safety obesity, certain orthopedic procedures, and cardiac implantable electronic device), deep vein thrombosis (DVT)/pulmonary embolism (PE) following certain orthopedic procedures, and iatrogenic pneumothorax with venous catheterization.20 Some confusion over the never event definition persists, specifically for the HACs listed as serious reportable events by the NQF but not listed as “non-reimbursable serious hospital-acquired conditions” by CMS.10 The two lists do not fully intersect because the CMS list was created to identify events with a strong financial implication (high cost and/or high volume) and events can be identified through administrative data. Conversely, the NQF list was created to identify a broader set of serious events, regardless of their cost or the ability to identify them solely through administrative data. Reactions to the CMS payment policies have been mixed. Although the resulting reduction in Medicare payments to hospitals is estimated to be less than 0.01% nationally, as the co-occurrence of other comorbidities and complications that are not on the HAC list continue to bump up DRG payments to hospitals, some hospital leaders have voiced objections to its “mean-spiritedness” and to the inclusion of some complications that are not considered wholly preventable by hospitals.9 In addition, hospitals and safety researchers voiced concern about the low, and often unknown, accuracy of measuring complications by using billing data rather than medical record review.21,22 Conversely, not paying to cover the marginal treatment costs of a preventable complication resonates loudly with stakeholder groups that use and pay for the health care system, such as employers, consumer organizations, health insurers, and state Medicaid agencies.9 These perspectives address different concerns. The accuracy of measures should be known and transparently reported, and if the measures meet some accuracy threshold, they should be used in pay-for-performance and public reporting. Health care should be able to accurately measure serious events, and hospitals should not be paid for their preventable complications. Since 2012 Medicaid has stopped paying for about two dozen types of never events that occur in hospitals, such as operations on the wrong body part and certain surgical site infections. Initially, 21 state Medicaid programs had a nonpayment policy for never events, but the reimbursement ban on these types of events has since been extended nationally. Medicaid has a longer list of never events compared to Medicare, as states can extend the nonpayment policy beyond the conditions considered by Medicare.23 Many private health insurers in the United States, including Aetna, Anthem, Cigna, Hospital Corporation of America, June 2015
United Healthcare Systems, Wellpoint, and some Blue Cross and Blue Shield plans, have included the CMS “no-pay” policy for never events in their hospital contracts.1
Public Reporting Despite objections from hospitals, in 2011 CMS began publicly reporting rates of eight hospital-specific never events for which they will no longer reimburse hospitals. Their goal was to help patients with hospital selection and to help hospitals ensure that every patient gets the best care possible.24 In July 2013 CMS discontinued the public reporting of these eight never events on Hospital Compare. Their reasons for this decision were that the events rarely occurred and that two events were already reported in another section of Hospital Compare, three events were included in the AHRQ Patient Safety Indicator composite score, and none of the events were endorsed by the NQF—and the advisory panel of the Measure Applications Partnership (MAP) urged CMS to use only NQF–endorsed measures.25 However, following a storm of protest, including the claim that many of these events, such as retained foreign object, were not rare at all, CMS announced that it would again make the HAC data, incorporated into Leapfrog’s hospital safety ratings, available on its website but would not restore data to the Hospital Compare website.26 Efforts by CMS to report rates of these never events has been the only national reporting of hospital-specific data for any never events in the United States. Although CMS’s Hospital Compare provides hospital-specific data for hospital-acquired infections, such as central line–associated bloodstream infection, that are considered never events, many other never events, such as retained foreign object, are not publicly reported nationally by any other means. Following the IOM’s recommendation in 2000,4 individual states have taken the lead in reporting these data. In 2003 Minnesota was the first state to enact legislation requiring hospitals to report never events to a patient safety registry.1 Other states followed, with the Office of Inspector General noting that as of January 2008, 26 states had reporting systems for hospital adverse events and another state had taken action to develop one.27 Those states that currently have a reporting system for adverse events, and the degree to which those data are publicly reported, are shown in Table 2 (page 284). In contrast to these efforts in the United States, the NHS publicly reports the number of never events happening in each hospital trust in England every three months.28 The NHS has identified 25 never events, and hospitals submit their events through the Strategic Executive Information System (STEIS), a national event reporting system. Volume 41 Number 6
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The Joint Commission Journal on Quality and Patient Safety Table 2. Comparison of the Collection and Public Reporting of Never Events Data by State (Reporting as of February 1, 2015)*
State
Alabama
State Requires Hospitals to Report Adverse Events
State Publicly Reports IndividualHospital Data
State Publicly Reports Aggregated Data†
No
State
State Requires Hospitals to Report Adverse Events
Montana
State Publicly Reports IndividualHospital Data
State Publicly Reports Aggregated Data†
No
No
No
Yes
No
No
No
No
No
Yes Yes
No
Alaska
No
Nebraska
No
Arizona
No
Nevada
Yes
Arkansas
No
New Hampshire
No
California
Yes
Yes
—
New Jersey
Yes
Colorado
Yes
Yes
—
New Mexico
No
Connecticut
Yes
Yes
—
New York
Yes
Delaware
No
North Carolina
No
District of Columbia
Yes
No
Yes
North Dakota
No
Florida
Yes
No
No
Ohio
Yes
Georgia
Yes
No
No
Oklahoma
No
Hawaii
No
Oregon
Yes
Idaho
No
Pennsylvania
Yes
No
Illinois
Yes
Yes
—
Rhode Island
Yes
No
No
Indiana
Yes
Yes
—
South Carolina
Yes
No
No
South Dakota
Yes
No
No
No
No
Tennessee
Yes
No
No
Iowa
No
Kansas
Yes
Kentucky
No
Texas
No
Louisiana
No
Utah
Yes
No
No
Maine
Yes
Vermont
Yes
No
No
Yes
—
No
Yes
Maryland
Yes
No
Yes
Massachusetts
Yes
Yes
—
Michigan
No
Minnesota
Yes
Mississippi
No
Missouri
No
Yes
—
Virginia
No
Washington
Yes
West Virginia
No
Wisconsin
No
Wyoming
No
* State laws and statutes are always evolving, so for the most up-to-date information, review of the state’s website is recommended. † For states publicly reporting hospital-level data, the public reporting of aggregate data was not assessed because the former could be used to determine the latter. Also, because many states’ publicly reported data were outdated, data for 2009 or earlier were excluded. Primary Sources: • National Academy for State Health Policy. National Academy for State Health Policy. State Websites. Accessed Apr 24, 2015. http://www.nashp.org/state-websites. • Consumers Union. State-by-State Adverse Event Reporting Specifics. (Updated: Nov 10, 2003.) Accessed Apr 22, 2015. http://consumersunion.org/wp-content/uploads/2013/04/CHART-adverse-event-mortality.pdf. • Review of individual state websites.
Although Leapfrog does not report rates of never events, it does evaluate how hospitals respond when such an event occurs. In 2007 it began asking hospitals about their process for handling a never event. Leapfrog publicly recognizes hospitals that agree to the following steps when a never event occurs within their facility: apologize to the patient and/or family affected by the event; report the event to either The Joint Commission, a state reporting program for medical errors, or a Patient Safety Organization; perform a root cause analysis of the event; waive all costs directly related to the event; and make a copy of Leap284
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frog’s policy available to patients and payers upon request.11
Internal Quality Improvement Another use of never event data is for internal QI. Although the intended purpose of the NQF’s serious reportable events list was to facilitate public accountability, little will be accomplished if the response is limited to recording them or if the reports are used only to punish health care organizations; accountability and learning must coexist.2 The data should be used to improve the safety and quality of health care delivery. Volume 41 Number 6
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The Joint Commission Journal on Quality and Patient Safety Some studies have found that never events are indicators of unsafe hospital systems, problems with processes for learning and improvement, or an organization’s safety culture.3,29 While progress in reducing never events has been slow,30,31 health care organizations that have reduced the number of events have used strategies such as technology (to track the number of surgical sponges placed in the patient, for example); standardized processes, such as following a checklist for inserting catheters;32 and root cause analyses of previous events.33 Some of the observed improvement could also be attributable to improved coding by hospitals. One example of an external organization helping hospitals facilitate improvement following never events is the health care accreditation organization The Joint Commission, which partners with health care organizations that are dealing with a serious patient safety event to “protect the patient, improve systems, and prevent further harm.”16,34 Reporting systems that link medical errors with patient characteristics and team characteristics to further expand the understanding of at-risk situations are also helpful.35 There are also barriers, including the difficult work of transforming an organization’s culture into one that embraces safety or is comfortable recognizing and learning from mistakes, and the lack of clear organizational leadership for reducing these events.36 Payers, in an effort to incentivize patient safety, are increasingly focusing on never events as metrics of the hospital’s quality of care.29 One concern with this approach is that reported events tend to become the definition of what is safety, whereas nonreported events—such as hospital medication errors, which are estimated to kill 7,000 patients each year4—might actually be more important from a patient safety standpoint. Moreover, most types of never events are rare, and though often egregious, their contribution to the total burden of preventable harm is likely small.
Challenges
The collection and use of never event data is not without challenges. One key challenge is the confusion created by the different definitions of a never event, with, as noted, different definitions used by the NQF, CMS, and private insurers.10 Although the NQF defines a never event as a serious reportable event, CMS defines it as a nonreimbursable serious HAC. For example, a postoperative infection and a thromboembolic event each meets the CMS definition of a never event (a nonreimbursable HAC), but neither one is listed by the NQF as a serious reportable event.10 Another key challenge is determining preventability and the degree to which an event must be fully preventable for it June 2015
to qualify as a never event. Most entities recognize that not all events are fully preventable. Requiring that an event be “largely preventable,” the NQF definition recognizes that some of these events are unavoidable, given the complexity of health care and the severity of the patient’s illness. The CMS list addresses “reasonably preventable events,” that is, “those that are neither uniformly preventable nor inevitable.”1(p. 343) Several of the CMS never events are nosocomial infections, which infection control experts believe are not entirely preventable and would be measured much more accurately with clinical data, using the CDC definitions, than with billing data from Medicare.12 In contrast, there is strong agreement that surgical never events are almost entirely preventable.29 Patients and health care purchasers are frustrated by the move away from using the term never event to softer terminology, such as serious reportable events. These stakeholder groups see never events as health care’s equivalent of transportation’s use of the word crash—events so serious that they deserve a special category of recognition.2 Health care providers, concerned about the preventability of these events, have encouraged a move away from the word never. A challenge with never event data is the lack of transparency and public reporting of these events. States have taken the lead on reporting such data, often without identification of individual hospitals. There is no standardized national reporting system to provide information on the number and type of adverse events, even for the most serious and preventable ones.2 Estimates of the incidence of adverse events in hospitals vary widely, given the absence of a singular “never event” list, which would bring standardization to the definition, surveillance, and reporting of these events. Measurement of these events is difficult and often inexact. To realize the total eradication of never events, we need a better and more accurate mechanism for measuring and reporting them.29 Some people believe that the use of never event data to penalize hospitals is counterproductive and for real progress to occur, in the case of a never event, a root cause analysis should be performed, leading to reporting of areas in need of improvement. The two stances may not be mutually exclusive—hospitals could conduct a root cause analysis but be penalized nonetheless. Health care stakeholders suspect substantial underreporting of adverse events, which they attribute to providers’ lack of time, fear of retribution, and the perception that reporting will not lead to improvement.27 In addition, health care providers are concerned that limiting payment for never events that are not entirely preventable limits access to care—particularly for the sickest patients—and increases hospital costs, thereby reducing hospital revenue.14 Volume 41 Number 6
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The Joint Commission Journal on Quality and Patient Safety Another challenge is concern about the accuracy of never event data derived from administrative data relative to chart review. Because of perceived inaccuracies with data extracted from billing records, hospitals might focus improvement efforts on improving coding rather than caring.37 Given the rarity of most never events, they are typically reported as counts rather than rates, whether it is a rate per number of patient discharges or a rate per number of beds. A drawback of reporting counts is that larger hospitals may appear to have more events than smaller hospitals, which might not reflect the relative safety of the hospital once adjusted for hospital size. Thus, it will be challenging to use counts of never events to compare performance across hospitals of different sizes. A final challenge lies in the timeliness of never event data. There is often an 18-month, or even longer, lag between the event and its public reporting, limiting the value for feedback to clinicians and quality and safety professionals.
Recommendations
Given the number of patients suffering preventable harm and the urgency to improve safety, it is likely that the concept of never events will continue to play a prominent role in reducing harm. We now offer some recommendations for how to enhance the ability of never events to reduce preventable harm in the United States. Underlying these recommendations is our belief that accountability and learning can coexist, that measures should meet a threshold of accuracy, and when that threshold is met, the measures, and their accuracy should be publicly reported. First, policy makers and Patient Safety Organizations should agree on a standard definition of a never event. Although the NQF has taken the lead in creating such a definition, there is no mechanism that requires reporting entities to use it. The following definitional questions need to be addressed if we hope to create a clearer path in the future: Does the event need to be entirely avoidable, or is “largely preventable” good enough? What evidence is needed to determine the preventability of an event? Will or should the degree of preventability change over time? What stakeholders should be involved in determining which events are never events? How do we best assess when and how to expand the list of never events? Second, the health care community should establish standards for the accuracy of never events derived from administrative data, relative to chart review, and publicly report the accuracy of these measures. For many measures, particularly those derived from administrative data, such as HACs, the validity and reliability are unknown or poor.38 For example, in 286
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2014 Johns Hopkins Hospital was criticized by one state agency and congratulated by another for its performance in the same time period on central line–associated bloodstream infection (CLABSI)—congratulated when the CLABSIs used the CDC definitions, and criticized when CLABSIs were measured using billing data. The agreement between the two data sources in positively identifying cases with an infection was 13%.39 The variation in methodological rigor and the lack of standards for existing public reporting of safety data suggest the need for an oversight model to ensure the scientific integrity of these data.40 Third, the number of never events should be transparently reported, much like Minnesota has done for more than a decade. In 2003 Minnesota aligned its definitions with a national definition (the NQF’s), publicly reported hospital-level data, and indicated if the event resulted in death, serious disability, or neither death nor disability.41 This level of transparency and granularity provides a comprehensive picture of the types of events occurring, where they are occurring, and the impact on patients. Without making this type of information transparent, it is almost impossible for other hospitals to understand where there are successes and challenges in their search for best practices. In the first 10 years of public reporting (2003–2013), events with consistent definitions, such as stage III or IV pressure ulcers, saw a reduction in frequency. However, overall rates of reported events remained constant over the 10 years.41 Still, there is no clear evidence to support the idea that hospital performance in Minnesota would be vastly better or worse than what has been achieved elsewhere. Fourth, health care policy makers, insurers, providers, and patients should create mechanisms to share best practices for reducing all types of never events. This could include creating clinical communities in which hospitals collaborate, work through peer norms to learn together, and share best practices.42 Clinical communities, which tap into the intrinsic motivation of clinicians, are powerful tools to support peer learning. With a similar objective in mind, in 2012 CMS created a series of hospital engagement networks (HENS) through its Partnership for Patients program to identify and disseminate effective QI and patient safety initiatives to its member facilities.43 Although the Partnership’s use of unstandardized data collection methods and weak study design makes it difficult to determine whether care improved,44 the learning collaboratives within the HENs likely had a positive impact in reducing harms locally in hospitals. Finally, when all of the above have been accomplished, hospitals should be held accountable through economic incentives and sanctions for eliminating never events.
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The Joint Commission Journal on Quality and Patient Safety Conclusion
The nonsystematic collection of data on valid measures of never events and the lack of longitudinal public reporting at the national level in the United States make it difficult to understand how hospitals are performing over time. Although we group never events in a different class than other preventable but less serious harms, hospital progress in reducing all preventable harms has been slow, suggesting that the barriers to improvement are not unique to never events. From both a policy and research perspective, it is unclear how efforts such as public reporting of never event data and linking that performance to payment have influenced the rates of these events. Additional research on the impact of pay-forperformance and public reporting could help us better understand what strategies are effective in improving performance. Never events are occurring with a troubling frequency. Many of these events, such as wrong-patient surgery, are deemed “fully preventable.” If we hope to see reductions in the frequency of these events, we need to change the decade-long decentralized approach of collect, report, and improve to an approach that entails standardized definitions of events, greater transparency of performance, and collective learnings and accountability to drive performance forward. J This article was commissioned and was subjected to external review. Dr. Austin discloses grant or contract support from The Leapfrog Group and the Agency for Healthcare Research and Quality (AHRQ) for research related to hospital performance measurement). Dr. Pronovost discloses grant or contract support from AHRQ and the Gordon and Betty Moore Foundation (research related to patient safety and quality of care), the National Institutes of Health (acute lung injury research), and the American Medical Association (improve blood pressure control); consulting fees from the Association of Professionals in Infection Control and Epidemiology, Inc.; honoraria from various hospitals, health systems, and the Leigh Bureau to speak on quality and patient safety; book royalties from the Penguin Group; and board membership to the Cantel Medical Group. The authors thank Christine G. Holzmueller, BLA, from the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality, and the Johns Hopkins University Department of Anesthesiology and Critical Care Medicine, for her thoughtful review and editing of this article.
J. Matthew Austin, PhD, is Assistant Professor, Armstrong Institute for Patient Safety and Quality, Johns Hopkins Medicine, Baltimore, and Department of Anesthesiology and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore. Peter J. Pronovost, MD, PhD, FCCM, is Senior Vice President of Patient Safety and Quality, Johns Hopkins Medicine; Director, Armstrong Institute for Patient Safety and Quality; Professor, Department of Anesthesiology and Critical Care Medicine, School of Medicine, Department of Health Policy and Management, Bloomberg School of Public Health, and School of Nursing, Johns Hopkins University; and a member of The Joint Commission Journal on Quality and Patient Safety’s Editorial Advisory Board. Please address correspondence to J. Matthew Austin, [email protected].
June 2015
References
1. Mattie AS, Webster BL. Centers for Medicare and Medicaid Services’ “never events”: an analysis and recommendations to hospitals. Health Care Manag (Frederick) 2008;27(4):338–349. 2. Kizer KW, Stegun MB. Serious reportable adverse events in health care. In Henriksen K, et al., editors: Advances in Patient Safety: From Research to Implementation, vol. 4: Programs, Tools, and Products. Rockville, MD: Agency for Healthcare Research and Quality, 2005, 339–352. Accessed Apr 22, 2015. http://www.ahrq.gov/professionals/quality-patient-safety/patient-safety -resources/resources/advances-in-patient-safety/vol4/Kizer2.pdf. 3. NHS England, Patient Safety Domain Team. Report of the NHS England Surgical Never Events Taskforce. Feb 27, 2014. Accessed Apr 22, 2015. http:// www.england.nhs.uk/wp-content/uploads/2014/02/sur-nev-ev-tf-rep.pdf. 4. Institute of Medicine: To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press, 2000. 5. National Quality Forum (NQF). Serious Reportable Events in Healthcare: A Consensus Report. Washington, DC: NQF, 2002. 6. National Quality Forum. Serious Reportable Events in Healthcare—2011 Update: A Consensus Report. Washington, DC: NQF, 2011. Accessed Apr 22, 2015. https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier =id&ItemID=69573. 7. Agency for Health Care Quality and Research. Patient Safety Primer: Never Events. 2012 (Updated: Dec 2014.) Accessed Apr 22, 2014. http://psnet.ahrq .gov/primer.aspx?primerID=3. 8. McGraw AP, et al. Comparing gains and losses. Psychol Sci. 2010;21(10):1438– 1445. 9. Milstein A. Ending extra payment for “never events”—Stronger incentives for patients’ safety. N Engl J Med. 2009 Jun 4;360(23):2388–2390. 10. Lembitz A, Clarke TJ. Clarifying “never events” and introducing “always events.” Patient Saf Surg. 2009 Dec 31;3:26. 11. The Leapfrog Group. Fact Sheet: Never Events. (Updated: Apr 1, 2014.) Accessed Apr 22, 2015. https://leapfroghospitalsurvey.org/web/wp-content /uploads/neverevents.pdf. 12. Brown J, Doloresco Iii F, Mylotte JM. “Never events”: Not every hospital-acquired infection is preventable. Clin Infect Dis. 2009 Sep 1;49(5):743– 746. 13. NHS England, Patient Safety Domain Team. The Never Events List; 2013/14 Update. Dec 12, 2013. Accessed Apr 22, 2015. http://www.england. nhs.uk/wp-content/uploads/2013/12/nev-ev-list-1314-clar.pdf. 14. Golladay KK, et al. Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries. OEI-06-09-00090. Washington, DC: US Department of Health & Human Services, Office of Inspector General, 2010. Accessed Apr 22, 2015. http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf. 15. The Joint Commission. Patient Safety Systems (PS). 2015. Accessed Apr 22, 2015. http://www.jointcommission.org/assets/1/6/PSC_for_Web.pdf. 16. The Joint Commission. Sentinel Events (SE). 2015. Accessed Apr 22, 2015. http://www.jointcommission.org/assets/1/6/CAMH_24_SE_all _CURRENT.pdf. 17. Minnesota Department of Health. Minnesota’s 29 Reportable Adverse Health Events. (Updated: Sep 26, 2013.) Accessed Apr 22, 2015. http://www .health.state.mn.us/patientsafety/ae/adverse27events.html. 18. MinterEllisonRuddWatts. New Zealand Supreme Court considers a case of medical misadventure, unexpected pregnancy, personal injury and the Accident Compensation Act. Gordon A. Aug 2012. Accessed Apr 22, 2015. http:// www.minterellison.co.nz/New_Zealand_Supreme_Court_considers_a_case _of_medical_misadventure_unexpected_pregnancy_personal_injury_and _the_Accident_Compensation_Act_August_2012/. 19. Agency for Healthcare Research & Quality. Patient Safety Organizations. Accessed Apr 27, 2015. https://www.pso.ahrq.gov/. 20. Centers for Medicare & Medicaid Services. Hospital-Acquired Conditions. (Updated: Aug 27, 2014.) Accessed Apr 22, 2015. http://www.cms. gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/Hospital -Acquired_Conditions.html.
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The Joint Commission Journal on Quality and Patient Safety 21. Pronovost PJ, Goeschel CA, Wachter RM. The wisdom and justice of not paying for “preventable complications.” JAMA. 2008 May 14;299(18):2197– 2199. 22. Haut ER, Pronovost PJ, Schneider EB. Limitations of administrative databases. JAMA, 2012 Jun 27;307(24):2589; author reply 2589–90. 23. Kaiser Health News. Medicaid to Stop Paying for Hospital Mistakes. Galewitz P. Jun 1, 2011. Accessed Apr 22, 2015. http://www.kaiserhealthnews.org /stories/2011/june/01/medicaid-hospital-medical-error-payment-short-take .aspx. 24. MedPage Today. CMS Releases Hospital Error, Injury Data. Walker EP. Apr 8, 2011. Accessed Apr 22, 2015. http://www.medpagetoday.com/Public HealthPolicy/Medicare/25816. 25. Advisory Board Company. CMS to Remove Never Events Data from Hospital Compare. May 3, 2013. Accessed Apr 22, 2015. http://www.advisory .com/daily-briefing/2013/05/03/cms-to-remove-never-events-datafrom -hospital-compare. 26. USA Today, Feds Reverse Course, Will Release Hospital Mistake Data. O’Donnell J. Sep 7, 2014. Accessed Apr 22, 2015. http://www.usatoday .com/story/news/nation/2014/09/07/hhs-change-reporting-hospital-mistakes -foreignobjects/15084175/. 27. Howe CL. A review of the Office of Inspector General’s reports on adverse event identification and reporting. J Healthc Risk Manag. 2011;30(4):48–54. 28. Kmietowicz Z. Individual hospital data on “never events” to be published every quarter. BMJ. 2013 Dec 13;347:f7479. 29. Mehtsun WT, et al. Surgical never events in the United States. Surgery. 2013;153(4):465–472. 30. NHS England, Patient Safety Domain Team. Never Events Reported as occurring between 1 April 2013 and 31 March 2014. Dec 30 2014. Accessed Apr 22, 2015. http://www.england.nhs.uk/wp-content/uploads/2014/12/2013 -14-NE-data-FINAL.pdf. 31. NHS England, Patient Safety Domain Team. Never Events Data Summary for 2012/13. Dec 12, 2013. Accessed Apr 22, 2015. http://www.england.nhs .uk/wp-content/uploads/2013/12/nev-ev-data-sum-1213.pdf.
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32. Rosenthal K. Targeting “never events.” Nurs Manage. 2008;39(12):35–38. 33. Law RL, et al. Avoiding never events: Improving nasogastric intubation practice and standards. Clin Radiol. 2013;68(3):239–244. 34. The Joint Commission. Patient Safety. Accessed Apr 22, 2015. http://www .jointcommission.org/topics/patient_safety.aspx 35. Roumm AR, Sciamanna CN, Nash DB. Health care provider use of private sector internal error-reporting systems. Am J Med Qual. 2005;20(6):304–312. 36. Leape LL, Berwick DM. Five years after To Err Is Human: What have we learned? JAMA. 2005 May 18;293(19):2384–2390. 37. Haut ER, Pronovost PJ. Surveillance bias in outcomes reporting. JAMA. 2011 Jun 15;305(23):2462–2463. 38. Martin J, et al. Measuring adverse events in hospitalized patients: An administrative method for measuring harm. J Patient Saf. Epub 2014 Apr 8. 39. Austin JM, Miller MR, Pronovost PJ. Young and reckless? Greater standardization and transparency of performance is needed for pediatric performance measures. Acad Pediatr 2014;14(5 Suppl):S15–16. 40. Austin JM, Young GJ, Pronovost PJ. Ensuring the integrity and transparency of public reports: How a possible oversight model could benefit healthcare. American Journal of Accountable Care. 2014;2(4):13–14. 41. Minnesota Department of Health, Division of Health Policy. Adverse Health Events: 10 Year Program Evaluation. Jan 2014. Accessed Apr 22, 2015. http://www.mnhospitals.org/Portals/0/Documents/ptsafety/ahe/2014 ahetenyearreview.pdf. 42. Dixon-Woods M, et al. Explaining Michigan: Developing an ex post theory of a quality improvement program. Milbank Q. 2011;89(2):167–205. 43. Centers for Medicare & Medicaid Services. Partnership for Patients. Accessed Apr 20, 2015. http://innovation.cms.gov/initiatives/partnership -for-patients/. 44. Pronovost P, Jha AK. Did hospital engagement networks actually improve care? N Engl J Med. 2014 Aug 21;371(8):691–693.
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“Never Events” and the Quest to Reduce Preventable Harm J. Matthew Austin, PhD; Peter J. Pronovost, MD, PhD, FCCM
L
apses in patient safety are a major quality problem in health care, causing more than 200,000 deaths, 2.4 billion extra hospital days, and between $17 billion and $29 billion in excess hospital costs in the United States each year.1,2 The exact number of preventable deaths is difficult to estimate because valid and standardized measures for the major causes of preventable death are lacking and because it is difficult to separate inevitable from preventable harm. Yet some types of harm, such as wrong-site surgery, are deemed entirely preventable and viewed as a serious adverse event.3 In its seminal 2000 report, To Err Is Human,4 the Institute of Medicine (IOM) recommended the creation of a nationwide, mandatory, state-based reporting system to understand the frequency of adverse events that could cause death or serious harm.2 The National Quality Forum (NQF) responded to this recommendation with a report of Serious Reportable Events in Healthcare,2,5,6 which identified a standardized list of 27 preventable events to facilitate reporting.1 The objective of the NQF report was to establish consensus definitions among health care stakeholder groups about a list of preventable serious adverse events that should never occur and to guide the reporting of these events.1 The events identified by the NQF were not intended to capture all events that might cause harm. Rather, the list consisted of events that were considered clearly identifiable and measurable, significantly influenced by the policies and procedures of the health care facility, and alarming to health care providers and the public.2,5,6 Given the seriousness and perceived preventability of these events, risk adjustment for hospital and patient characteristics is typically considered unnecessary. Since the NQF’s promulgation of the list of serious reportable events in 2002, many, but not all, of the 50 states and the District of Columbia have required the reporting of these events.2 The NQF has updated the list twice—2006 (28 events) and 2011 (29 events).6 The term never event was introduced in 2001 by Kenneth Kizer, MD, then the NQF’s CEO. He used the term to describe “the most egregious health care errors” (such as transfusing the wrong type of blood into a patient) that should never occur.7 The negative connotation in the term was intended to evoke a strong reaction. Nobel Prize–winning research by Kahneman June 2015
and Tversky on “negative framing” and the “availability heuristic”8 suggests that “humans are more strongly inclined to take action when the actions in question are labeled so as to convey the loss avoided rather than the benefit gained and when the consequences of failing to act are mentally vivid.”9(p. 2390) The Centers for Medicare & Medicaid Services (CMS), The Leapfrog Group (Leapfrog), and the National Health Service (NHS; England), among other organizations, have all used the term never event, although with differing definitions.10 In this article, we explore never event’s evolution, how never event data are used, and the challenges in collecting data. We then provide recommendations for improving the tracking and reporting of these events.
Evolution of a Term
Leapfrog aligns its definition of a “never event” with the NQF’s (2011) list of 29 serious reportable events.11 CMS defines a never event as an “unambiguous; preventable; serious; and either adverse, indicative of a problem in the facility, or important for public credibility and accountability” and identifies 11 such events.12(p. 743) The NHS defines never events as “serious, largely preventable, patient safety incidents that should not occur if the available preventative measures have been implemented by healthcare providers,” and identifies 25 such events.3,13(p.2) The never events defined by each of these three organizations and The Joint Commission are compared in Table 1 (page 280). These types of never events have also been called adverse events, serious reportable events, sentinel events, and patient safety events. The US Department of Health and Human Services, Office of Inspector General, has used adverse event when investigating patient harm in hospitals and nursing homes.14 The NQF uses the term serious reportable event, previously introduced here, when communicating their list of serious, largely preventable events that are of concern to health care providers, patients, and all other stakeholders.6 The Joint Commission uses the terms patient safety event, adverse event, and sentinel event, respectively, to describe from the broadest definition to the narrowest definition, events that could have, or did, result in harm to a patient.15 Its list of sentinel events includes patient Volume 41 Number 6
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The Joint Commission Journal on Quality and Patient Safety Table 1. Comparison of Adverse Events Defined as a Never Event by Different Organizations Event Defined by Organization as a “Never Event” Adverse Event
NQF/LF
CMS
TJC*
UK NHS
Surgical or Invasive Procedure Events Wrong-site surgery
Wrong-patient surgery Wrong surgery performed on patient Wrong implant/prosthesis placed in patient Retention of a foreign object in a patient after surgery
Intraoperative or immediate postoperative death in an American Society of Anesthesiologists Class I patient Product or Device Events Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics Patient death or serious injury associated with the misuse of a device intended for another function
Patient death or serious injury associated with intravascular air embolism
Patient Protection Events Release of a patient/resident of any age, who is unable to make decisions, to other than an authorized person
Patient death or serious disability associated with patient elopement (disappearance) Patient suicide, attempted suicide, or self-harm resulting in serious disability
Patient death or severe injury to a mental health inpatient as a result of a suicide attempt using non-collapsible curtain or shower rails
Escape of a transferred prisoner
Care Management Events Patient death or serious injury associated with a medication error Patient death or serious injury associated with unsafe administration of blood products Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy
Maternal death due to postpartum hemorrhage after elective cesarean section Artificial insemination with the wrong donor sperm or wrong egg Patient death or serious injury associated with a fall while being cared for in a health care setting Any stage III, stage IV, or unstageable pressure ulcers acquired after admission Patient death or serious disability resulting from the irretrievable loss of an irreplaceable biological specimen Patient death or serious injury resulting from failure to communicate lab, pathology, or radiology results Manifestations of poor glycemic control Any catheter-associated urinary tract infection Any vascular catheter-associated infection Surgical site infections following certain procedures A deep vein thrombosis (DVT)/pulmonary embolism (PE) following certain orthopedic procedures An iatrogenic pneumothorax with venous catheterization Death or severe harm arising from inadvertent ABO–mismatched solid organ transplantation
†
(continued on page 281)
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The Joint Commission Journal on Quality and Patient Safety Table 1. Comparison of Adverse Events Defined as a Never Event by Different Organizations (continued) Event Defined by Organization as a “Never Event” Adverse Event
NQF/LF
CMS
Care Management Events (continued) Death or severe harm due to a misplaced naso- or orogastric tube being used where the misplacement of the tube is not detected prior to commencement of feeding, flush, or medication administration Death or severe harm as a result of failure to monitor or respond to oxygen saturation levels in a patient undergoing anesthesia Death or severe harm as a result of administration of the wrong treatment following inpatient misidentification due to a failure to use standard wristband (or identity band) identification processes Severe neonatal hyperbilirubinemia in a neonate
TJC*
UK NHS
Environmental Events Patient or staff death or serious disability associated with an electric shock in the course of patient care
A line designated for oxygen or other gas contains no gas, the wrong gas, or is contaminated.
Patient or staff death or serious injury associated with a burn incurred from any source in the course of patient care
Patient death or serious injury associated with the use of restraints or bedrails
Patient fall from an unrestricted window Death or severe harm as a result of a patient being scalded by water used for washing/bathing Radiologic Events Death or serious injury of a patient or staff associated with introduction of a metallic object into the MRI area Prolonged fluoroscopy with cumulative dose > 1,500 rads to a single field or any delivery of radiotherapy to the wrong body region or > 25% above the planned radiotherapy dose Potential Criminal Events Care ordered or provided by someone impersonating a physician, nurse, pharmacist, or other health care provider Abduction of a patient/resident of any age Sexual abuse/assault on a patient within or on the grounds of a health care setting Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) Rape, assault (leading to death or permanent loss of function), or homicide of a staff member, licensed independent practitioner, visitor, or vendor while on site at the health care organization
NQF, National Quality Forum; LF, Leapfrog Group; CMS, Centers for Medicare & Medicaid Services; TJC, The Joint Commission; UK NHS, United Kingdom National Health Service; ABO, the four major blood types A, B, AB, and O. * In addition to the specific events listed in this table, The Joint Commission defines a sentinel event as “a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in any of the following: death, permanent harm, and severe temporary harm,” or that is one of the 15 additional specific events considered to be sentinel, as listed in the Sentinel Event (SE) Chapter of the Comprehensive Accreditation Manual for Hospitals (see Sources). † The NHS identifies nine individual medication errors as never events. These nine events cover the wrong route of administration, wrong dose, and wrong preparation of specific high-risk medications.
Sources: • NQF: National Quality Forum. List of Serious Reportable Events. Accessed Apr 22, 2015. http://www.qualityforum.org/Topics/SREs/List_of_SREs.aspx. • LF: Leapfrog Group. Leapfrog Group Position Statement on Never Events. Accessed Apr 22, 2015. http://www.leapfroggroup.org/Hospitals/SurveyInfo/never_events. • CMS: Centers for Medicare & Medicaid Services. Hospital-Acquired Conditions. (Updated: Aug 27, 2014.) Accessed Apr 22, 2015. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/Hospital-Acquired_Conditions.html. • TJC: The Joint Commission. Sentinel Events (SE). 2015. Accessed Feb 22, 2015. http://www.jointcommission.org/assets/1/6/CAMH_24_SE_all_CURRENT.pdf. • UK NHS: NHS England, Patient Safety Domain Team. The Never Events List; 2013/14 Update. Dec 12, 2013. Accessed Apr 22, 2015. http://www.england.nhs.uk/wp-content/uploads/2013/12/nev-ev-list-1314-clar.pdf.
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The Joint Commission Journal on Quality and Patient Safety safety events that reach a patient and result in death, permanent harm, or severe temporary harm, in addition to a list of 14 other events of an egregious nature (for example, discharging an infant to the wrong family).16 Over time, use of the term never events has evolved. We now explore the current status of never events and how those events are used in public reporting and pay-for-performance.
Current Use of the Term Many organizations, including, in the United States, Leapfrog, CMS, and the NQF, and elsewhere (NHS), continue to use the term never event. CMS currently uses never events to describe categories of hospital-acquired conditions (HACs), for which Medicare will not pay the marginal costs associated with these conditions.14 Emerging terminology is adding to the longused terms of serious reportable events, sentinel events, and adverse events. For example, the state of Minnesota used adverse health events in its annual public report of adverse events occurring in hospitals,17 and in a New Zealand court case, medical misadventures was used to define “a personal injury caused by medical error or medical mishap.”18
Sources of Never Event Data Never event data are obtained through a variety of methods, including self-reporting from hospitals to either a government agency or a Patient Safety Organization,19 review of claims data submitted by hospitals, and routine screening (by, hopefully, valid and reliable screening methods) of electronic health records for serious adverse events. An advantage of self-reporting is that hospitals can cast a wider net by identifying events through both clinical data and billing data. Some drawbacks of self-reporting are possible underreporting of events to minimize the hospital’s liabilities, and lack of standard definitions for some events, making consistent identification and reporting of events difficult. Advantages of claims data include the ease in obtaining it and the fact that standardized data structure makes it plausible to apply standard algorithms and definitions to identify events. Drawbacks of claims data include the lack of detail needed to identify all events and the limited or unknown validity of the data. An advantage of screening electronic health records is the relative ease of extracting event data. A drawback of this method is that, unless the data are collected using standardized formats, their usefulness could be limited. Health care would benefit from having one “never event” list, bringing standardization to the definition, surveillance, and reporting of these events. Although the NQF’s serious reportable events is a commonly referenced list of never events, it is 282
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not the singular list. The existence of multiple never event lists minimizes the benefits that a singular list could offer. Most of the attention on never events has focused on the hospital setting, but the NQF’s list of serious reportable events does apply to other settings, such as ambulatory practices, ambulatory procedures, long term care, and home care. However, we know very little about the incidence rates of events outside the hospital, and the mechanics for collecting self-reported data and billing data are underdeveloped. Moreover, each care setting likely has additional reportable events that are relevant to those providers and patients. Estimates of the incidence of adverse events in hospitals vary widely, and their measurement is difficult,14 which is perhaps not surprising, given this variation in definitions, data sources, and methods of data collection.
Uses of Never Event Data
Never event data are used in a variety of ways, including for payment, public reporting, and internal quality improvement (QI).
Payment Never event data inform hospital payment. For example, CMS does not pay hospitals a higher reimbursement for certain HACs. As part of Section 5001(c) of the Deficit Reduction Act of 2005, CMS enacted the Hospital-Acquired Conditions Initiative in the Inpatient Prospective Payment Systems final rule for fiscal year 2008. Under this rule, Medicare pays for the treatment of preadmitting diagnoses and denies payment for any marginal costs associated with preventable conditions that occur as a result of care received (or a medical error) during the inpatient stay.20 CMS collaborated with the Centers for Disease Control and Prevention (CDC) to identify HACs that were expensive, high volume, or both12—conditions that, when present as a secondary diagnosis, resulted in assignment to a diagnosis-related group (DRG) with a higher payment; conditions that could be reasonably prevented by using readily available evidence-based guidelines; and conditions that were identifiable on the basis of one or more unique diagnostic codes.14 The following 11 HACs are represented in CMS’s nonpayment program: foreign body retained after surgery, air embolism, blood incompatibility, stage III and IV pressure ulcers, falls and trauma (for example, fractures, burn), manifestations of poor glycemic control, catheter-associated urinary tract infection, vascular catheter-associated infection, surgical site infections following certain procedures (coronary bypass graft surgery, bariatric surgery for Volume 41 Number 6
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The Joint Commission Journal on Quality and Patient Safety obesity, certain orthopedic procedures, and cardiac implantable electronic device), deep vein thrombosis (DVT)/pulmonary embolism (PE) following certain orthopedic procedures, and iatrogenic pneumothorax with venous catheterization.20 Some confusion over the never event definition persists, specifically for the HACs listed as serious reportable events by the NQF but not listed as “non-reimbursable serious hospital-acquired conditions” by CMS.10 The two lists do not fully intersect because the CMS list was created to identify events with a strong financial implication (high cost and/or high volume) and events can be identified through administrative data. Conversely, the NQF list was created to identify a broader set of serious events, regardless of their cost or the ability to identify them solely through administrative data. Reactions to the CMS payment policies have been mixed. Although the resulting reduction in Medicare payments to hospitals is estimated to be less than 0.01% nationally, as the co-occurrence of other comorbidities and complications that are not on the HAC list continue to bump up DRG payments to hospitals, some hospital leaders have voiced objections to its “mean-spiritedness” and to the inclusion of some complications that are not considered wholly preventable by hospitals.9 In addition, hospitals and safety researchers voiced concern about the low, and often unknown, accuracy of measuring complications by using billing data rather than medical record review.21,22 Conversely, not paying to cover the marginal treatment costs of a preventable complication resonates loudly with stakeholder groups that use and pay for the health care system, such as employers, consumer organizations, health insurers, and state Medicaid agencies.9 These perspectives address different concerns. The accuracy of measures should be known and transparently reported, and if the measures meet some accuracy threshold, they should be used in pay-for-performance and public reporting. Health care should be able to accurately measure serious events, and hospitals should not be paid for their preventable complications. Since 2012 Medicaid has stopped paying for about two dozen types of never events that occur in hospitals, such as operations on the wrong body part and certain surgical site infections. Initially, 21 state Medicaid programs had a nonpayment policy for never events, but the reimbursement ban on these types of events has since been extended nationally. Medicaid has a longer list of never events compared to Medicare, as states can extend the nonpayment policy beyond the conditions considered by Medicare.23 Many private health insurers in the United States, including Aetna, Anthem, Cigna, Hospital Corporation of America, June 2015
United Healthcare Systems, Wellpoint, and some Blue Cross and Blue Shield plans, have included the CMS “no-pay” policy for never events in their hospital contracts.1
Public Reporting Despite objections from hospitals, in 2011 CMS began publicly reporting rates of eight hospital-specific never events for which they will no longer reimburse hospitals. Their goal was to help patients with hospital selection and to help hospitals ensure that every patient gets the best care possible.24 In July 2013 CMS discontinued the public reporting of these eight never events on Hospital Compare. Their reasons for this decision were that the events rarely occurred and that two events were already reported in another section of Hospital Compare, three events were included in the AHRQ Patient Safety Indicator composite score, and none of the events were endorsed by the NQF—and the advisory panel of the Measure Applications Partnership (MAP) urged CMS to use only NQF–endorsed measures.25 However, following a storm of protest, including the claim that many of these events, such as retained foreign object, were not rare at all, CMS announced that it would again make the HAC data, incorporated into Leapfrog’s hospital safety ratings, available on its website but would not restore data to the Hospital Compare website.26 Efforts by CMS to report rates of these never events has been the only national reporting of hospital-specific data for any never events in the United States. Although CMS’s Hospital Compare provides hospital-specific data for hospital-acquired infections, such as central line–associated bloodstream infection, that are considered never events, many other never events, such as retained foreign object, are not publicly reported nationally by any other means. Following the IOM’s recommendation in 2000,4 individual states have taken the lead in reporting these data. In 2003 Minnesota was the first state to enact legislation requiring hospitals to report never events to a patient safety registry.1 Other states followed, with the Office of Inspector General noting that as of January 2008, 26 states had reporting systems for hospital adverse events and another state had taken action to develop one.27 Those states that currently have a reporting system for adverse events, and the degree to which those data are publicly reported, are shown in Table 2 (page 284). In contrast to these efforts in the United States, the NHS publicly reports the number of never events happening in each hospital trust in England every three months.28 The NHS has identified 25 never events, and hospitals submit their events through the Strategic Executive Information System (STEIS), a national event reporting system. Volume 41 Number 6
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The Joint Commission Journal on Quality and Patient Safety Table 2. Comparison of the Collection and Public Reporting of Never Events Data by State (Reporting as of February 1, 2015)*
State
Alabama
State Requires Hospitals to Report Adverse Events
State Publicly Reports IndividualHospital Data
State Publicly Reports Aggregated Data†
No
State
State Requires Hospitals to Report Adverse Events
Montana
State Publicly Reports IndividualHospital Data
State Publicly Reports Aggregated Data†
No
No
No
Yes
No
No
No
No
No
Yes Yes
No
Alaska
No
Nebraska
No
Arizona
No
Nevada
Yes
Arkansas
No
New Hampshire
No
California
Yes
Yes
—
New Jersey
Yes
Colorado
Yes
Yes
—
New Mexico
No
Connecticut
Yes
Yes
—
New York
Yes
Delaware
No
North Carolina
No
District of Columbia
Yes
No
Yes
North Dakota
No
Florida
Yes
No
No
Ohio
Yes
Georgia
Yes
No
No
Oklahoma
No
Hawaii
No
Oregon
Yes
Idaho
No
Pennsylvania
Yes
No
Illinois
Yes
Yes
—
Rhode Island
Yes
No
No
Indiana
Yes
Yes
—
South Carolina
Yes
No
No
South Dakota
Yes
No
No
No
No
Tennessee
Yes
No
No
Iowa
No
Kansas
Yes
Kentucky
No
Texas
No
Louisiana
No
Utah
Yes
No
No
Maine
Yes
Vermont
Yes
No
No
Yes
—
No
Yes
Maryland
Yes
No
Yes
Massachusetts
Yes
Yes
—
Michigan
No
Minnesota
Yes
Mississippi
No
Missouri
No
Yes
—
Virginia
No
Washington
Yes
West Virginia
No
Wisconsin
No
Wyoming
No
* State laws and statutes are always evolving, so for the most up-to-date information, review of the state’s website is recommended. † For states publicly reporting hospital-level data, the public reporting of aggregate data was not assessed because the former could be used to determine the latter. Also, because many states’ publicly reported data were outdated, data for 2009 or earlier were excluded. Primary Sources: • National Academy for State Health Policy. National Academy for State Health Policy. State Websites. Accessed Apr 24, 2015. http://www.nashp.org/state-websites. • Consumers Union. State-by-State Adverse Event Reporting Specifics. (Updated: Nov 10, 2003.) Accessed Apr 22, 2015. http://consumersunion.org/wp-content/uploads/2013/04/CHART-adverse-event-mortality.pdf. • Review of individual state websites.
Although Leapfrog does not report rates of never events, it does evaluate how hospitals respond when such an event occurs. In 2007 it began asking hospitals about their process for handling a never event. Leapfrog publicly recognizes hospitals that agree to the following steps when a never event occurs within their facility: apologize to the patient and/or family affected by the event; report the event to either The Joint Commission, a state reporting program for medical errors, or a Patient Safety Organization; perform a root cause analysis of the event; waive all costs directly related to the event; and make a copy of Leap284
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frog’s policy available to patients and payers upon request.11
Internal Quality Improvement Another use of never event data is for internal QI. Although the intended purpose of the NQF’s serious reportable events list was to facilitate public accountability, little will be accomplished if the response is limited to recording them or if the reports are used only to punish health care organizations; accountability and learning must coexist.2 The data should be used to improve the safety and quality of health care delivery. Volume 41 Number 6
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The Joint Commission Journal on Quality and Patient Safety Some studies have found that never events are indicators of unsafe hospital systems, problems with processes for learning and improvement, or an organization’s safety culture.3,29 While progress in reducing never events has been slow,30,31 health care organizations that have reduced the number of events have used strategies such as technology (to track the number of surgical sponges placed in the patient, for example); standardized processes, such as following a checklist for inserting catheters;32 and root cause analyses of previous events.33 Some of the observed improvement could also be attributable to improved coding by hospitals. One example of an external organization helping hospitals facilitate improvement following never events is the health care accreditation organization The Joint Commission, which partners with health care organizations that are dealing with a serious patient safety event to “protect the patient, improve systems, and prevent further harm.”16,34 Reporting systems that link medical errors with patient characteristics and team characteristics to further expand the understanding of at-risk situations are also helpful.35 There are also barriers, including the difficult work of transforming an organization’s culture into one that embraces safety or is comfortable recognizing and learning from mistakes, and the lack of clear organizational leadership for reducing these events.36 Payers, in an effort to incentivize patient safety, are increasingly focusing on never events as metrics of the hospital’s quality of care.29 One concern with this approach is that reported events tend to become the definition of what is safety, whereas nonreported events—such as hospital medication errors, which are estimated to kill 7,000 patients each year4—might actually be more important from a patient safety standpoint. Moreover, most types of never events are rare, and though often egregious, their contribution to the total burden of preventable harm is likely small.
Challenges
The collection and use of never event data is not without challenges. One key challenge is the confusion created by the different definitions of a never event, with, as noted, different definitions used by the NQF, CMS, and private insurers.10 Although the NQF defines a never event as a serious reportable event, CMS defines it as a nonreimbursable serious HAC. For example, a postoperative infection and a thromboembolic event each meets the CMS definition of a never event (a nonreimbursable HAC), but neither one is listed by the NQF as a serious reportable event.10 Another key challenge is determining preventability and the degree to which an event must be fully preventable for it June 2015
to qualify as a never event. Most entities recognize that not all events are fully preventable. Requiring that an event be “largely preventable,” the NQF definition recognizes that some of these events are unavoidable, given the complexity of health care and the severity of the patient’s illness. The CMS list addresses “reasonably preventable events,” that is, “those that are neither uniformly preventable nor inevitable.”1(p. 343) Several of the CMS never events are nosocomial infections, which infection control experts believe are not entirely preventable and would be measured much more accurately with clinical data, using the CDC definitions, than with billing data from Medicare.12 In contrast, there is strong agreement that surgical never events are almost entirely preventable.29 Patients and health care purchasers are frustrated by the move away from using the term never event to softer terminology, such as serious reportable events. These stakeholder groups see never events as health care’s equivalent of transportation’s use of the word crash—events so serious that they deserve a special category of recognition.2 Health care providers, concerned about the preventability of these events, have encouraged a move away from the word never. A challenge with never event data is the lack of transparency and public reporting of these events. States have taken the lead on reporting such data, often without identification of individual hospitals. There is no standardized national reporting system to provide information on the number and type of adverse events, even for the most serious and preventable ones.2 Estimates of the incidence of adverse events in hospitals vary widely, given the absence of a singular “never event” list, which would bring standardization to the definition, surveillance, and reporting of these events. Measurement of these events is difficult and often inexact. To realize the total eradication of never events, we need a better and more accurate mechanism for measuring and reporting them.29 Some people believe that the use of never event data to penalize hospitals is counterproductive and for real progress to occur, in the case of a never event, a root cause analysis should be performed, leading to reporting of areas in need of improvement. The two stances may not be mutually exclusive—hospitals could conduct a root cause analysis but be penalized nonetheless. Health care stakeholders suspect substantial underreporting of adverse events, which they attribute to providers’ lack of time, fear of retribution, and the perception that reporting will not lead to improvement.27 In addition, health care providers are concerned that limiting payment for never events that are not entirely preventable limits access to care—particularly for the sickest patients—and increases hospital costs, thereby reducing hospital revenue.14 Volume 41 Number 6
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The Joint Commission Journal on Quality and Patient Safety Another challenge is concern about the accuracy of never event data derived from administrative data relative to chart review. Because of perceived inaccuracies with data extracted from billing records, hospitals might focus improvement efforts on improving coding rather than caring.37 Given the rarity of most never events, they are typically reported as counts rather than rates, whether it is a rate per number of patient discharges or a rate per number of beds. A drawback of reporting counts is that larger hospitals may appear to have more events than smaller hospitals, which might not reflect the relative safety of the hospital once adjusted for hospital size. Thus, it will be challenging to use counts of never events to compare performance across hospitals of different sizes. A final challenge lies in the timeliness of never event data. There is often an 18-month, or even longer, lag between the event and its public reporting, limiting the value for feedback to clinicians and quality and safety professionals.
Recommendations
Given the number of patients suffering preventable harm and the urgency to improve safety, it is likely that the concept of never events will continue to play a prominent role in reducing harm. We now offer some recommendations for how to enhance the ability of never events to reduce preventable harm in the United States. Underlying these recommendations is our belief that accountability and learning can coexist, that measures should meet a threshold of accuracy, and when that threshold is met, the measures, and their accuracy should be publicly reported. First, policy makers and Patient Safety Organizations should agree on a standard definition of a never event. Although the NQF has taken the lead in creating such a definition, there is no mechanism that requires reporting entities to use it. The following definitional questions need to be addressed if we hope to create a clearer path in the future: Does the event need to be entirely avoidable, or is “largely preventable” good enough? What evidence is needed to determine the preventability of an event? Will or should the degree of preventability change over time? What stakeholders should be involved in determining which events are never events? How do we best assess when and how to expand the list of never events? Second, the health care community should establish standards for the accuracy of never events derived from administrative data, relative to chart review, and publicly report the accuracy of these measures. For many measures, particularly those derived from administrative data, such as HACs, the validity and reliability are unknown or poor.38 For example, in 286
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2014 Johns Hopkins Hospital was criticized by one state agency and congratulated by another for its performance in the same time period on central line–associated bloodstream infection (CLABSI)—congratulated when the CLABSIs used the CDC definitions, and criticized when CLABSIs were measured using billing data. The agreement between the two data sources in positively identifying cases with an infection was 13%.39 The variation in methodological rigor and the lack of standards for existing public reporting of safety data suggest the need for an oversight model to ensure the scientific integrity of these data.40 Third, the number of never events should be transparently reported, much like Minnesota has done for more than a decade. In 2003 Minnesota aligned its definitions with a national definition (the NQF’s), publicly reported hospital-level data, and indicated if the event resulted in death, serious disability, or neither death nor disability.41 This level of transparency and granularity provides a comprehensive picture of the types of events occurring, where they are occurring, and the impact on patients. Without making this type of information transparent, it is almost impossible for other hospitals to understand where there are successes and challenges in their search for best practices. In the first 10 years of public reporting (2003–2013), events with consistent definitions, such as stage III or IV pressure ulcers, saw a reduction in frequency. However, overall rates of reported events remained constant over the 10 years.41 Still, there is no clear evidence to support the idea that hospital performance in Minnesota would be vastly better or worse than what has been achieved elsewhere. Fourth, health care policy makers, insurers, providers, and patients should create mechanisms to share best practices for reducing all types of never events. This could include creating clinical communities in which hospitals collaborate, work through peer norms to learn together, and share best practices.42 Clinical communities, which tap into the intrinsic motivation of clinicians, are powerful tools to support peer learning. With a similar objective in mind, in 2012 CMS created a series of hospital engagement networks (HENS) through its Partnership for Patients program to identify and disseminate effective QI and patient safety initiatives to its member facilities.43 Although the Partnership’s use of unstandardized data collection methods and weak study design makes it difficult to determine whether care improved,44 the learning collaboratives within the HENs likely had a positive impact in reducing harms locally in hospitals. Finally, when all of the above have been accomplished, hospitals should be held accountable through economic incentives and sanctions for eliminating never events.
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The Joint Commission Journal on Quality and Patient Safety Conclusion
The nonsystematic collection of data on valid measures of never events and the lack of longitudinal public reporting at the national level in the United States make it difficult to understand how hospitals are performing over time. Although we group never events in a different class than other preventable but less serious harms, hospital progress in reducing all preventable harms has been slow, suggesting that the barriers to improvement are not unique to never events. From both a policy and research perspective, it is unclear how efforts such as public reporting of never event data and linking that performance to payment have influenced the rates of these events. Additional research on the impact of pay-forperformance and public reporting could help us better understand what strategies are effective in improving performance. Never events are occurring with a troubling frequency. Many of these events, such as wrong-patient surgery, are deemed “fully preventable.” If we hope to see reductions in the frequency of these events, we need to change the decade-long decentralized approach of collect, report, and improve to an approach that entails standardized definitions of events, greater transparency of performance, and collective learnings and accountability to drive performance forward. J This article was commissioned and was subjected to external review. Dr. Austin discloses grant or contract support from The Leapfrog Group and the Agency for Healthcare Research and Quality (AHRQ) for research related to hospital performance measurement). Dr. Pronovost discloses grant or contract support from AHRQ and the Gordon and Betty Moore Foundation (research related to patient safety and quality of care), the National Institutes of Health (acute lung injury research), and the American Medical Association (improve blood pressure control); consulting fees from the Association of Professionals in Infection Control and Epidemiology, Inc.; honoraria from various hospitals, health systems, and the Leigh Bureau to speak on quality and patient safety; book royalties from the Penguin Group; and board membership to the Cantel Medical Group. The authors thank Christine G. Holzmueller, BLA, from the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality, and the Johns Hopkins University Department of Anesthesiology and Critical Care Medicine, for her thoughtful review and editing of this article.
J. Matthew Austin, PhD, is Assistant Professor, Armstrong Institute for Patient Safety and Quality, Johns Hopkins Medicine, Baltimore, and Department of Anesthesiology and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore. Peter J. Pronovost, MD, PhD, FCCM, is Senior Vice President of Patient Safety and Quality, Johns Hopkins Medicine; Director, Armstrong Institute for Patient Safety and Quality; Professor, Department of Anesthesiology and Critical Care Medicine, School of Medicine, Department of Health Policy and Management, Bloomberg School of Public Health, and School of Nursing, Johns Hopkins University; and a member of The Joint Commission Journal on Quality and Patient Safety’s Editorial Advisory Board. Please address correspondence to J. Matthew Austin, [email protected].
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The Joint Commission Journal on Quality and Patient Safety 21. Pronovost PJ, Goeschel CA, Wachter RM. The wisdom and justice of not paying for “preventable complications.” JAMA. 2008 May 14;299(18):2197– 2199. 22. Haut ER, Pronovost PJ, Schneider EB. Limitations of administrative databases. JAMA, 2012 Jun 27;307(24):2589; author reply 2589–90. 23. Kaiser Health News. Medicaid to Stop Paying for Hospital Mistakes. Galewitz P. Jun 1, 2011. Accessed Apr 22, 2015. http://www.kaiserhealthnews.org /stories/2011/june/01/medicaid-hospital-medical-error-payment-short-take .aspx. 24. MedPage Today. CMS Releases Hospital Error, Injury Data. Walker EP. Apr 8, 2011. Accessed Apr 22, 2015. http://www.medpagetoday.com/Public HealthPolicy/Medicare/25816. 25. Advisory Board Company. CMS to Remove Never Events Data from Hospital Compare. May 3, 2013. Accessed Apr 22, 2015. http://www.advisory .com/daily-briefing/2013/05/03/cms-to-remove-never-events-datafrom -hospital-compare. 26. USA Today, Feds Reverse Course, Will Release Hospital Mistake Data. O’Donnell J. Sep 7, 2014. Accessed Apr 22, 2015. http://www.usatoday .com/story/news/nation/2014/09/07/hhs-change-reporting-hospital-mistakes -foreignobjects/15084175/. 27. Howe CL. A review of the Office of Inspector General’s reports on adverse event identification and reporting. J Healthc Risk Manag. 2011;30(4):48–54. 28. Kmietowicz Z. Individual hospital data on “never events” to be published every quarter. BMJ. 2013 Dec 13;347:f7479. 29. Mehtsun WT, et al. Surgical never events in the United States. Surgery. 2013;153(4):465–472. 30. NHS England, Patient Safety Domain Team. Never Events Reported as occurring between 1 April 2013 and 31 March 2014. Dec 30 2014. Accessed Apr 22, 2015. http://www.england.nhs.uk/wp-content/uploads/2014/12/2013 -14-NE-data-FINAL.pdf. 31. NHS England, Patient Safety Domain Team. Never Events Data Summary for 2012/13. Dec 12, 2013. Accessed Apr 22, 2015. http://www.england.nhs .uk/wp-content/uploads/2013/12/nev-ev-data-sum-1213.pdf.
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32. Rosenthal K. Targeting “never events.” Nurs Manage. 2008;39(12):35–38. 33. Law RL, et al. Avoiding never events: Improving nasogastric intubation practice and standards. Clin Radiol. 2013;68(3):239–244. 34. The Joint Commission. Patient Safety. Accessed Apr 22, 2015. http://www .jointcommission.org/topics/patient_safety.aspx 35. Roumm AR, Sciamanna CN, Nash DB. Health care provider use of private sector internal error-reporting systems. Am J Med Qual. 2005;20(6):304–312. 36. Leape LL, Berwick DM. Five years after To Err Is Human: What have we learned? JAMA. 2005 May 18;293(19):2384–2390. 37. Haut ER, Pronovost PJ. Surveillance bias in outcomes reporting. JAMA. 2011 Jun 15;305(23):2462–2463. 38. Martin J, et al. Measuring adverse events in hospitalized patients: An administrative method for measuring harm. J Patient Saf. Epub 2014 Apr 8. 39. Austin JM, Miller MR, Pronovost PJ. Young and reckless? Greater standardization and transparency of performance is needed for pediatric performance measures. Acad Pediatr 2014;14(5 Suppl):S15–16. 40. Austin JM, Young GJ, Pronovost PJ. Ensuring the integrity and transparency of public reports: How a possible oversight model could benefit healthcare. American Journal of Accountable Care. 2014;2(4):13–14. 41. Minnesota Department of Health, Division of Health Policy. Adverse Health Events: 10 Year Program Evaluation. Jan 2014. Accessed Apr 22, 2015. http://www.mnhospitals.org/Portals/0/Documents/ptsafety/ahe/2014 ahetenyearreview.pdf. 42. Dixon-Woods M, et al. Explaining Michigan: Developing an ex post theory of a quality improvement program. Milbank Q. 2011;89(2):167–205. 43. Centers for Medicare & Medicaid Services. Partnership for Patients. Accessed Apr 20, 2015. http://innovation.cms.gov/initiatives/partnership -for-patients/. 44. Pronovost P, Jha AK. Did hospital engagement networks actually improve care? N Engl J Med. 2014 Aug 21;371(8):691–693.
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