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The Institute of Medicine (IOM) report To Err is Human: Building a Safer Health System states that patients should not be harmed by the care that is intended to help them, and they should remain free from accidental injury.¹ The 2001 IOM report Crossing the Quality Chasm defined patient safety as one of the essential components of high-quality health care.²

Several types of situations are considered patient safety events (Figure 1). Studies both in the United States and abroad report high rates of harmful patient safety events.^29,30

Figure 1. Patient Safety Terminology

The existence of racial and ethnic disparities in health and health care has been well documented.³¹ IOM's Unequal Treatment was the first major report to highlight that in addition to racial and ethnic disparities in health, there is evidence of racial and ethnic disparities in health care.³² Patient safety efforts are now a central component of efforts to improve the quality of care for all patients. However, the role of language barriers and its impact on adverse events is less well documented.

Nearly 25 million people in the United States (8.6 percent) are defined as limited English proficient (LEP), meaning that they speak English less than "very well." ⁵ Therefore, at least 8.6 percent of the U.S. population is at risk for adverse events because of barriers associated with their language ability.

What We Know About Safety and Limited-English-Proficient Patients

Communication problems are the most frequent root cause of serious adverse events reported to the Joint Commission's Sentinel Event Database.³³ The root causes of patient safety events for LEP patients are related to communication and lack of use of qualified medical interpreters (Figure 2). Research demonstrates that language barriers can have a significant impact on multiple aspects of health care and contribute to disparities in patient safety between English-speaking and LEP hospital patients.^3,26,28

Figure 2: Diagram of Root Causes of Patient Safety Events

For example:

• A study of six hospitals across the United States showed that LEP patients are more likely than English-speaking patients to suffer from physical harm when errors occur.³ (Figure 3 illustrates results from a study by Divi, et al.)
• A study of audiotaped and transcribed pediatric encounters over a 7-month period showed that most medical interpretation errors have potential clinical consequences. Those committed by ad hoc interpreters are significantly more likely to have potential clinical consequences than those committed by hospital interpreters.²⁸
• Pediatric patients with Spanish-speaking LEP families have a much greater risk for serious medical events during hospitalizations than patients whose families are English proficient.²⁶

Figure 3: Types of Physical Harm Experienced From Adverse Events by English-Speaking and LEP Patients

What We Know About Hospitals' Response to LEP Patient Safety

Very limited data are available on how health care organizations nationwide address issues of LEP patient safety and reporting. The Joint Commission's Hospitals, Language, and Culture: A Snapshot of the Nation (HLC) study was designed to gather information about the activities hospitals are undertaking to address cultural and language needs among an increasingly diverse patient population.³⁴ Beginning in February 2005, members of the HLC research team recruited a sample of 60 hospitals from 32 States across the country and conducted surveys and site visits.

The HLC study revealed that although 43 percent of the hospitals identified a direct relationship between patient safety issues and patients' linguistic needs, only one hospital reported stratifying their adverse event data by language. When the link between patient safety, language, and culture was discussed during site visits, only a few hospitals indicated that they were able to quantify this connection. The one hospital that stratified their adverse event data by language found clusters of adverse events in patients with English as a second language. The ability to demonstrate the link between language and safety had sensitized this hospital to the challenges of providing care to LEP patients.

Findings from our research confirm this finding. A town hall meeting we conducted with hospitals from across the country and representatives from hospital associations revealed similar challenges to linking patient safety reporting with language fields. Therefore, none reported actively monitoring patient safety events by language. If anything, errors related to LEP are bundled as being caused by "communication errors," which does not allow analysis based on language, culture, or other LEP-related factors.

Why Hospitals Should Focus on Patient Safety for LEP Populations

Several major trends justify the need for hospital leaders to better identify, prevent, and address medical errors among LEP patients.

A Large and Growing Vulnerable Population

The U.S. population is becoming increasingly diverse, as is the number of LEP individuals. According to a recent report by the Brookings Institute, minority groups are the Nation's fastest growing demographic, accounting for one-third of the U.S. population.³⁵ Recent reports from the U.S. Census Bureau state that the minority population increased from 86.9 million to 111.9 million between 2000 and 2010, indicating a growth of 29 percent.³⁶ Since 2000, the Asian population has increased by 43.3 percent, making it the fastest growing major racial group.³⁶

In 2008, metropolitan areas contained 68 percent of the Nation's multiracial population, and roughly one in six of these residents was foreign born. Minority groups, including immigrants, also rapidly contributed to high growth rates in smaller metropolitan areas and nonmetropolitan areas.^35,37,38 For example, between 1990 and 2008, the immigrant population grew fastest in nonmetropolitan areas (183 percent), followed by smaller metropolitan areas (122 percent).³⁵

Between 2000 and 2010, the Hispanic-origin population increased by 43 percent, which accounts for more than half of the 27.3 million increase in total population of the United States in that decade.³⁶ Projections suggest that the Hispanic-origin population will contribute 45 percent of the growth from 2010 to 2030 and 60 percent from 2030 to 2050.³⁹ Most important, studies of language maintenance and language shifts suggest that Hispanics, more than any other ethnic group, tend to remain loyal to their native language.

Even third-generation bilingualism is higher among Hispanics than among other ethnic groups; Mexicans tend to be the most committed Spanish speakers.⁴⁰

Both the growth and wider dispersal of minority and LEP populations signify the broadening relevance of policies aimed at more diverse communities, including immigrants. With the passage of health care reform and an additional 32 million uninsured Americans having access to health insurance, it is anticipated that hospitals will care for a more diverse patient population than ever before. Further, these numbers likely underestimate the number of patients seen by hospitals as many undocumented immigrants with language barriers also present to hospitals for care. As we look toward the future, this issue will take on greater importance and hospitals must be prepared to provide safe, high-quality care to patients from diverse social, cultural, and linguistic backgrounds.

Patient Safety, Quality, and Cost Drivers

The Institute of Medicine report Crossing the Quality Chasm states that quality means that patients are not harmed by the care that is intended to help them, and they remain free from accidental injury, misdiagnosis, and inappropriate treatment. Communication between patients and health care providers, and the barriers many LEP patients face in this regard, has an important impact on quality, cost, and patient safety and may lead to misdiagnosis and inappropriate treatment.¹⁹ For example:

• Both published research^3,26,28 and our research suggest that LEP patients who may not be able to communicate effectively with their health care providers may be at greater risk for medical errors.
• LEP patients are at greater risk of line infections, surgical infections, falls, and pressure ulcers due to longer hospital stays than English-speaking patients with the same clinical condition.⁶

Medical errors are not the only result of communication difficulties in the inpatient setting that are problematic and costly:

• Longer length of hospital stays for LEP patients when professional interpreters were not used at admissions and/or discharge.⁶⁸
• LEP patient have greater difficulty understanding discharge instructions, including how to manage their condition, take their medications, recognize symptoms that should prompt a return to care, and know when to follow up.^11,12
• Racial and ethnic minorities are more likely to be readmitted for certain chronic conditions than their non-Hispanic white counterparts.^{9, 10} This difference may relate to the greater likelihood for a patient with limited English proficiency, low literacy, or other communication barriers to misunderstand discharge and medication instructions.^11,12 When financial disincentives exist for readmissions, greater attention should be placed on ensuring effective communication, including appropriate medication reconciliation, at discharge.

These situations have significant cost implications for hospitals, given the potential for unnecessary and prolonged hospital stays, as well as the occurrence of nonreimbursable "never events." These all can be prevented by ensuring that patients can communicate clearly with their health care providers.^41-43

This issue will take on greater financial importance because as part of the Patient Protection and Affordable Care Act, the Centers for Medicare & Medicaid Services will limit reimbursement to hospitals that have excessive readmissions.^41,44 It also has direct implications for length of stay, complications, and readmissions related to surgical care.

As our health care systems move toward improving quality and controlling costs, particular focus needs to be placed on how to prevent medical errors for all patients in general and for vulnerable patients in particular.

Risk Management

Identifying areas that expose the hospital or its health care providers to liability is critical in managing risk. Multiple liability exposures arise when providing care to LEP populations.^13-15 These include situations related to⁴⁵:

• Patient comprehension of their medical condition, treatment plan, discharge instructions, complications, and followup.
• Inaccurate and incomplete medical history.
• Ineffective or improper use of medications or serious medication errors.
• Improper preparation for tests and procedures.
• Poor or inadequate informed consent.
• Use of interpreters who are not properly trained, cannot operate effectively in a health care environment, or are not proficient in the patient's and clinicians' languages.

A recent study analyzed medical malpractice claims of a malpractice carrier that insures in four States to identify when language barriers may have resulted in harm to the patient.¹⁴ In 35 claims (2.5 percent of the carrier's total claims reviewed), the carrier paid $2,289,000 in damages or settlements and $2,793,800 in legal fees. These claims highlight several points related to the failure to provide appropriate language services:

• The cases resulted in many patients suffering death or irreparable harm.
• In the claims analyzed, 2.5 percent of malpractice suits were related to language/interpretation problems at a cost of approximately $5 million to the malpractice carrier.
• In 32 of 35 cases, the health care providers did not use competent interpreters. In 12 cases, family members or friends were used as interpreters, including minor children in two cases.
• Twelve of the claims involved the failure to translate important documents such as informed consent forms and discharge instructions.
• Nearly all the cases demonstrated poor documentation of a patient's limited English proficiency or the need for an interpreter (as well as documentation of other basic information).

The root causes of many of these claims constitute patient safety issues that expose hospitals to liability risks. For example, a patient's ability to read, understand, and act on health information has a direct impact on the physician-patient interaction and patient safety. As it relates to prescriptions, patients' ability to know if they have received the correct medication, or their ability to follow instructions regarding their medication (including dose, frequency and time), both constitute safety and risk management scenarios.

Written communications, in the form of appointment slips (appropriate time, date, location), referral slips (reason for referral, name and location of provider, instructions regarding preparation), intake and discharge instructions, and most commonly, informed consent, are all open to liability. As we look toward the future, developing provisions to address issues related to LEP will become a critical requirement of any risk management and patient safety strategy. If hospitals address LEP safety issues, many of these cases can be avoided.

Accreditation

In August 2008, the Joint Commission, recognizing that the accreditation and regulatory environment provides a strong impetus for health care systems to respond to the needs of diverse patient populations, strategically charted a path for hospitals. The initiative advances the issues of effective communication, cultural competence, and patient- and family-centered care in hospitals. The project focused on developing accreditation standards for the hospital program and resulted in the monograph Advancing Effective Communication, Cultural Competence, and Patient- and Family-Centered Care: A Roadmap for Hospitals.

The Joint Commission monograph helps hospitals address unique patient needs, meet the new Patient- Centered Communication standards, and comply with existing Joint Commission requirements.⁴⁶ Several standards have direct relevance to patient safety. They include the following requirements:

• Hospitals orient staff on sensitivity to cultural diversity based on their job duties and responsibilities.
• Hospitals identify, and document in the medical record, the patient's oral and written language and communication needs.
• Hospitals communicate with patients in a manner that meets these needs, including through the provision of language interpreting and translating services.

(Figure 4 contains the Joint Commission position on qualifications for medical interpreters.)

Common Causes of Adverse Events for LEP and Culturally Diverse Patients

In addition to gathering the empirical data presented above, we conducted qualitative interviews and reviewed incident reports submitted by interpreters as part of an Interpreter Pilot. (Appendix D discusses methods.) We identified three common causes of errors (or potential errors) for LEP and culturally diverse patients: (1) use of family members, friends, or nonqualified staff as interpreters; (2) provider use of basic language skills to "get by"; and (3) cultural beliefs and traditions that affect care delivery.

Participants identified nonqualified interpreters as a primary root cause, as described above, and pointed more specifically to three situations affecting the safety of LEP patients. Qualified medical interpreters should receive basic training on medical interpretation and meet the standards of practice of the International Medical Interpreters Association or the National Council on Interpreting in Health Care (Figure 5). Use of the term "interpreter" in this guide refers to a qualified medical interpreter, unless otherwise specified.

Use of Family Members, Friends, or Nonqualified Staff as Interpreters

• This is the most commonly reported cause of errors by frontline staff and leaders.
• It can lead to significant miscommunications between the patient and providers/care team.
• Time and time-related stressors (impatience by patient or provider, overbooked schedules, and prolonged waiting time for interpreters) contribute to the use of nonqualified interpreters.
• Family members and friends typically may not understand the subtle nuances of language and culture that may influence the interaction and may not question the use of medical terminology that they and the patient do not understand. Further, issues of confidentiality may prevent patients from disclosing critical health information.
• Research confirms that hospital staff often serve as interpreters for LEP patients, despite evidence that hospital staff who serve as interpreters on an ad hoc basis are more likely to make clinically significant mistakes than qualified medical interpreters.^{17, 18}

Provider Use of Basic Language Skills To "Get By"

• This is the second most commonly reported behavior by frontline staff and leaders.
• Clinicians with basic or intermediate foreign language skills often attempt to "make do" or "get by" without the use of a qualified interpreter.^{17, 19} In some cases, providers mistakenly used seemingly similar languages, such as Spanish for Portuguese or French for Haitian Creole.
• A major factor contributing to errors are providers' assumptions that patients understand the information exchanged based on nonverbal clues, such as nodding or smiling.
• Using a provider's language skills instead of an interpreter may also contribute to the risk of patient safety events, even if the provider is proficient, by adding to the provider's cognitive load. In addition, nonbilingual team members cannot identify potential patient safety concerns.
• It is critical that bilingual staff are language certified and receive training in interpretation if they are used when medical interpreters are not present or are unavailable for the medical encounter. Language and interpretation skills should be tested and validated on a regular basis.

Cultural Beliefs and Traditions Affecting Patient Care

• LEP patients may also have cultural beliefs and traditions that can influence the medical encounter and subsequent health outcomes in subtle and often invisible ways. These include minimizing reports of pain, respecting authority, and adhering to specific gender roles, as well as class biases.
• If providers or the medical team do not have the general knowledge of cultural traditions or beliefs of their patients, these cultural nuances are easily overlooked.

Real-life case examples, taken from a participating hospital's patient safety reports, provide insight into commonly reported LEP safety issues (Figure 6, below).

High-Risk Scenarios

Our research has identified several clinical situations, which we call high-risk scenarios, where adverse events and medical errors are most likely to occur among LEP and culturally diverse patients.

Medication Reconciliation

Medication reconciliation is essential to ensure patient safety. It requires both patients and providers to communicate accurately about the patient's medications, including mode of administration, allergies, and potential side effects. This is complicated for all patients and may be even more difficult for LEP patients due to language barriers.

Patient Discharge

Understanding discharge instructions, such as information on how to manage the condition, what should trigger a return visit, when to return for routine followup, and how to take prescribed medications, is important and challenging for all patients. LEP patients have been shown to have limited understanding about discharge instructions. Speaking Together: National Language Services Network, a project funded by the Robert Wood Johnson Foundation, found the need for greater use of interpreters at key moments of information exchange, such as at assessment and discharge, not just during the acute phase of treatment.⁴⁷

Informed Consent

Ensuring patient safety requires that patients be informed and participate in their own medical decisionmaking as fully as they want and can. LEP patients should not be excluded from learning about uncertainty, risks, and treatment choices that might affect their health and well-being. Obtaining informed consent for diagnostic and therapeutic procedures, including for emergent or elective surgery, can be a complicated and difficult process. But it remains a hallmark of patient safety and a critical medical and legal responsibility. Due to language and cultural barriers, achieving truly informed consent for LEP patients may require extra effort.

Emergency Department Care

Care in the emergency room is commonly provided in a hectic and hurried fashion, especially given the high volume and breadth of issues managed in that environment. Frequently, important decisions need to be made quickly, and accurate information about previous conditions, surgeries, medications, and allergies are paramount to high-quality patient care and the prevention of medical errors.

Surgical Care

Several key provisions are essential to a successful, uncomplicated surgical procedure. For example, prior to surgery, patients need to understand when to begin fasting and which medications to continue, discontinue, or alter. Surgeons must know whether the patient has had any prior complications with surgery. Anesthesiologists need to ensure that the patient can tolerate anesthesia and intubation and does not have any allergies that might pose a risk. Just before surgery, the surgical team needs to ensure that they are performing the correct procedure on the correct side on the correct patient. After surgery, patients must have a clear understanding of how to care for themselves in the hospital (e.g., whether to get up without assistance or call for help). Miscommunication at any of these stages can have serious, if not fatal, consequences.

Figure 6 shows examples from actual patient safety reports that illustrate the delays and errors that can occur without appropriate language assistance.